Penn Bioethics Journal and Society The Penn Bioethics Journal (PBJ) is the nation’s premier peer-reviewed undergraduate bioethics journal based at the University of Pennsylvania. The Society is comprised of a group of undergraduate students dedicated to the research and discussion of medicine, biotechnology, philosophy, health care, and ethics culminating in the publication of the Penn Bioethics Journal.
CURF WRITING PRIZE In collaboration with PBJ, the Center for Undergraduate Research and Fellowships (CURF) supports a writing prize. Nominations were given by the PBJ editorial board, and the winner was selected by an outside editorial committee from the Penn Bioethics Center.
www.dolphin.upenn.edu/bioethic www.bioethicsjournal.com
Email penn.bioethics.society@gmail.com to get more information about bioethics at Penn.
Michael Weintraub EDITOR IN CHIEF
Vishesh Agrawal PUBLISHER
Daniel Albornoz Armin Gollogly Palak Kundu Ingrid Lindquist Timothy Pian Tuua Ruutiainen MANAGING EDITORS
Contents
1 Letter from the Editor Michael Weintraub 2 Bioethics in Brief Leila Glass, Tuua Ruutiainen 4 Octuplets Case Study Armin Gollogly 7 Induced Pluripotent Cells Vineet Patil
articles 9
Vineet Patil
ASSOCIATE EDITORS
Lemuel Sibulo COVER DESIGN
Jonathan Moreno, Ph.D. Connie Ulrich, Ph.D., RN FACULTY ADVISORS
Markley Foreman
Evaluates the impact of the ‘Trade Related Aspects of Intellectual Property’ Agreement in India, and its influence on global equity in health access.
BUSINESS MANAGER
Vishesh Agrawal Shirley Ahn Anand Bhagwat Diana Chang Markley Foreman Rob Fuino Leila Glass Rebecca Han Tucker Johns Lulu Liu Megan Kauffman Katie McCarthy Sascha Murillo Ali Nill Eva Noble Vineet Patil Bo Peng Nayan Ramirez Sasha Riser-Kositsky Lauren Talman Lee Vandivier Kavita Vinekar Kristine Wong Emily Xue
The TRIPS Agreement and Developing Countries
Opt-out Organ Donation System 14 The Emily Frydendall
Comparison of organ donation models in various countries and an argument supporting the “opt-out” model for the US.
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The Ethical Repercussions of Patenting Human Genes Stephanie Hylmar
Intellectual and biological property disputes presented by human gene patenting.
Chinese Primary Care System 24 The Thomas Hou
National-local cooperation and citizen action are important agents of reform as China tries to modernize its primary-care system.
Ethics of Condition and Circumstance 29 The Ari Schriber Explores Islamic stances towards abortion by examining both ancient and modern texts.
in Healthcare 34 Computers Julia Yinxin Zhu Review of the state and implications of current and future technology of electronic health care records.
Questions or Comments? Please direct all inquiries to the Editor in Chief at editors@bioethicsjournal.com
a More Ethical Medical Environment 39 Towards Jeremy Schifberg While there is a clear consensus on the value of Hospital Ethics Committees, this article aims to outline the optimal roles and functions of HECs.
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Pe n n B i o e t h i c s J o u r n a l
Penn Bioethics Journal
PBJ
Letter from the Editor
Michael Weintraub Editor in Chief
-Michael Weintraub
Editor in Chief University of Pennsylvania CW’11
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I present you with the eighth publication (Volume V, Issue ii) of the Penn Bioethics Journal. The New Year began with a bioethical bang and international media frenzy when Nadya Suleman gave birth to octuplets via in vitro fertilization. Armin Gollogly, a senior at Penn and a PBJ managing editor, discusses this issue in his editorial, “Octuplets Case Study: Should we regulate reproduction?” Other current bioethical issues such as opt-out organ donation, roles of hospital ethics committees, and disputes of human gene patenting are discussed in papers presented in this issue. I also present you with an editorial written by Vineet Patil on the controversy over embryonic stem cells and how utilizing induced pluripotent cells presents solutions to the ethical controversy. Also included in this issue of PBJ are news briefs of current bioethical issues written by our editors. In continuation of our Award for Excellence in Undergraduate Bioethics, we selected an exceptional paper from this issue, “The TRIPS Agreement and Developing Countries: India’s Experience with Patent Law and Public Health.” We sincerely congratulate Markley Foreman for her work and encourage those reading our journal to submit for this award. Thanks to Vishesh Agrawal for designing the layout and to Lemuel Sibulo for designing the cover. Thanks to all the editors for devoting countless hours toward this issue. Enjoy your next bite of PBJ.
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Dear PBJ readers,
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Bioethics in Brief
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The Catholic Church’s Instructions on Bioethics In December, the Vatican issued “Dignitas Personae,” an authoritative document outlining the Catholic Church’s views on a broad range of bioethical issues. The 32-page text, which was written by the Congregation for the Doctrine of the Faith, the Vatican’s doctrinal office, and approved by Pope Benedict XVI, reiterated the Church’s opposition to in vitro fertilization, human cloning, genetic testing on embryos prior to implantation, and embryonic stem cell research. The Vatican maintains that these practices violate the sanctity of life and the principle that children should be conceived only through intercourse by a married couple. Furthermore, the morning-after pill, the intrauterine device, and the RU-486 pill were prohibited
on the grounds that they could lead to abortions. The document did not, however, forbid the development of alternative techniques for creating embryonic-like stem cells for medical treatment, so long as such cells could be developed without destroying embryos. Although experts are not surprised by any of the bans that were outlined, the instructions may serve to inform policy makers who were unaware of the Church’s stance on these technologies. -Tuua Ruutiainen
http://www.nytimes.com/2008/12/13/world/europe/13vatican. html?scp=4&sq=catholic%20bioethics&st=cse
Bioethics In Brief
Students at Harvard Medical School question conflicts of interest Four years ago, Matt Zerden, a student at Harvard Medical School, became skeptical of his pharmacology professor’s attempts to tout the benefits and minimize the side effects of cholesterol medications. After searching online, Zerden discovered that his professor was a paid consultant for five manufacturers of cholesterol drugs. At present, 200 Harvard Medical Students have joined the movement to draw attention to and limit such conflicts of interests that are potentially affecting the quality of research and teaching being performed in Harvard’s laboratories and classrooms. Already Harvard students have prompt-
ed the institution to require professors and lecturers to disclose their industry connections. Some argue that connections with the profit driven pharmaceutical industry conflict with the aims of academic research and should be banned altogether. Nonetheless, industrial funds continue to be an important source of funding for research and continuing education for physicians. -Tuua Ruutiainen
http://www.nytimes.com/2009/03/03/ business/03medschool. html?pagewanted=1&sq=harvard%20conflict%20of%20interest&st=cse&scp=1
on Zimbabwe, limiting exports, financial transactions, and the use of the international bank as a negative response to President Mugabe’s policies and leadership of the country. Treatment and patient care is being provided currently by UNICEF, non-governmental organizations, Doctors without Borders and other community service groups from around the world. The role of the United States in the international issue is under debate.
flickr/Nieuwslicht
-Leila Glass http://www.who.int/csr/don/2009_03_23/en/index.html http://www.unicef.org/infobycountry/zimbabwe_31248.html http://www.cnn.com/2008/WORLD/africa/12/12/zimbabwe.mugabe/ index.html
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A cholera epidemic has spread throughout Zimbabwe killing almost 100,000 people in the past five years. On March 17th, the World Health Organization reported that there had been 91,164 cases and 4,037 reported deaths since the beginning of the outbreak in August 2008. Cholera is a completely treatable and curable disease that is spread by contaminated water systems. The lack of access to clean water has also contributed to other public health issues. Cholera can be treated without the care of a trained medical professional through rehydration and use of a cheap antibiotic, Tetracycline. The current president of Zimbabwe, Robert Mugabe, has publicly denied the epidemic stating, “there is no cholera in this country.” The information minister of Zimbabwe, Ndlovu, claimed that “Cholera is a calculated, racist attack on Zimbabwe by the unrepentant former colonial power, which has enlisted support from its American and Western allies so that they can invade the country.” These false accusations have led to decreased public awareness and education. Following the smallpox precedent, the United States has offered care in the past to third world countries to help eliminate curable disorders and ameliorate other public health concerns. In this situation, the United States and other Western powers have decided to place sanctions
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Cholera in Zimbabwe: What is the role of the United States?
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Octuplets Case Study: Should we regulate reproduction?
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Armin Gollogly
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On January 26, 2009, Nadya Suleman gave birth to octuplets at a hospital in the Los Angeles suburb of Bellflower. The babies were born nine weeks prematurely and required 46 doctors, nurses, and assistants for the caesarian delivery.1 Many early newspaper reports marveled at the event, given its rarity and the remarkable fact that all eight infants survived. Yet as details of Ms. Suleman’s history began to emerge, especially the fact that she already had six children, the public’s reaction turned distinctly negative.2 The 33 year old Ms. Suleman is unemployed and currently receiving federal welfare benefits, including $490 a month in food stamps. A graduate student at Cal State Fullerton, she has student debts amounting to $50,000 and admitted to struggling financially before the birth of her octuplets.3 Financial considerations have dominated much of what has been written in the news, but equally important are the bioethical issues, which will affect the likelihood of such an event happening again. In the long term, after bioethicists, the public, and policymakers have had their say, we may hope that new laws and regulations are put in place to prevent such high-multiple births in the future. There are a variety of arguments both for and against the creation of additional legislation governing in vitro fertilization (IVF) and other assisted reproductive technologies. Those who support new laws are concerned about the health of the mother and babies, about neonatal complications and the enormous costs they entail, and whether parents can put at risk the future well-being of their children. Others would rather keep the status quo, citing anxieties about state interference and the desire to preserve individual autonomy. IVF is used in a plethora of unique and highly personal circumstances, which many believe are more conducive to careful decision making between doctors and patients than blanket, government-imposed rules.4 The risks of high-multiple births include high blood
pressure/pre-eclampsia, gestational diabetes, and a higher likelihood of postpartum hemorrhage for the mother as well as a range of developmental problems for the children.5 Dr. R. Dale McClure, president of the American Society for Reproductive Medicine (ASRM), writes that “a pregnancy with eight human babies is a medical failure,” adding “they bring with them high risk of prematurity, birth defects and long-term disabilities.”6 Women of different ages and histories have varying chances of getting pregnant, and these probabilities are difficult to determine beforehand, so how should the high failure rate and immense costs of IVF treatment be balanced against the possibility of too many births? From a policy perspective, the issue is whether there should be a legally-prescribed limit to the number of embryos implanted per IVF cycle. According to Dr. McClure, “A government mandate dictating the same treatment for all women in all circumstances would be bad medicine and an unprecedented intrusion into the patient-physician relationship.”7 Thus, it would be professional organizations like the ASRM and practitioners themselves who would self-regulate, negating the need for the government to become involved. McClure attempts to argue that reproductive medicine is a transparent and highly-regulated field; for example, the Centers for Disease Control and Prevention (CDC) collect data from fertility clinics.8 However, there are no penalties for clinics that do not disclose their results and, unlike in some European countries, there is no legal limit to the number of embryos that can be implanted per IVF cycle.9 Instead, professional organizations like the ASRM advocate certain (unenforceable) benchmarks. These guidelines suggest that no more than one embryo be implanted in a woman under the age of 35 with a favorable prognosis (these numbers rise based on age and other factors, with an upper limit of five for women over 40). Nadya
medicine: “Historically, we have been very hesitant to regulate anything close to procreation from parents making judgments about how many children they will have and when. However…there are serious questions about whether it works in an era of scientifically enhanced procreation.”18 The fundamental argument against legislating a limit on the number of embryos transferred and other aspects of IVF treatments is the feeling that such decisions are better handled by individuals than by the government. In most cases, this is surely true, but Mr. Hanson brings up a crucial point: new technology changes the paradigm completely, and therefore old assumptions may no longer be valid. While some may fret that allowing government regulation infringes the rights of parents, as the law stands now we do not recognize an unlimited right of parents to risk the safety and well-being of their children. If this is the case, they should also not have an unlimited right to knowingly undermine their children’s future safety and well-being – and high-multiple pregnancy puts this in grave danger, given the vastly increased probability of cerebral palsy and other complications. A second major objection to new legislation is based on the claim, forwarded by McClure and others, that professional bodies are sufficiently able to self-regulate. Clearly, they were not able to do so in Ms. Suleman’s case, and given Dr. Kamrava’s questionable practices, including insurance fraud, the investigative and enforcement capability of the government is needed to ensure compliance. At least 50,000 babies are born each year in the United States from IVF, generating about $1 billion in revenue for reproductive clinics. The cost per treatment, whether successful or not, is about $12,000, and it is almost never covered by health plans.19 This creates a huge financial incentive for prospective mothers to ask their doctors to implant more embryos. “The point is, there was greater pressure for U.S. clinics to deliver, no pun intended, on the first try” said Dr. David Hill, a Beverly Hills embryologist.20 Given these contrary incentives, on one hand the high cost of IVF and on the other the risk of high-multiple pregnancy, the law should provide a standard that will prevent patients and doctors from making rash decisions. Reproductive medicine is a highly competitive and lucrative industry, and doctors may feel multiple pressures to acquiesce to implanting more embryos than their best judgment would suggest.21 Therefore, legislation must be enacted, and the guidelines promoted by the ASRM, the most widely-recognized professional body in the field, are a good model for these new statutes.
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Suleman, due to her age and prior IVF success, belongs in the former category.10 However, in an interview with NBC she said that no less than six embryos had been implanted, two of which had split into twins. The doctor who performed the procedure was Michael Kamrava, who runs West Coast IVF Clinic in Beverly Hills.11 Dr. Kamrava has since been scrutinized by the ASRM, the California Medical Board, and journalists over whether he violated accepted standards of care by implanting so many embryos. Dr. Kamrava’s average embryo transfer rate is 3.5, whereas the national average is 2.3 (higher than all but 10 of the nation’s 426 fertility clinics). At the same time, the pregnancy rate at his clinic is extremely low, just five pregnancies and two births from a total of 61 procedures conducted in 200612 (the national average for the same year is 30%, which would translate to about 20 pregnancies).13 Dr. Mark Surrey, a fertility specialist from Beverly Hills, said “These are the worst numbers I’ve ever seen. This is absurdly low.” Ms. Suleman gave birth to twins after treatment at West Coast IVF in 2006, accounting for one of the two births Kamrava reported that year.14 Furthermore, several newspapers revealed that Dr. Kamrava implanted six embryos in all six of Ms. Suleman’s pregnancies.15 Dr. Philip McNamee, a specialist from Honolulu, explains the situation succinctly: “Kamrava may have believed he had little to worry about when he transferred six embryos to Suleman last year since his success rates were so low.”16 Suleman’s story is less sensational than its media portrayal. Dr. Kamrava is clearly a mediocre fertility doctor who tried to mask his low success rate by implanting more embryos than almost anyone else in the country. Further stories cast doubt upon his professional behavior. In 1999, a former office administrator, Shirin Afshar, mounted a case against him for financial irregularities and insurance fraud, but the suit was settled before it went to trial. On a separate occasion, Dr. Shantal Rajah won more than $300,000 in back pay and damages. She moved from Britain to work for him in 1996 but quit after three weeks because of disagreements about the way the clinic was run. Dr. Rajah told the London Times “I saw details emerge and I thought of him – frankly I am shocked he’s still in business.”17 One obstacle to legally regulating the practice of fertility doctors like Kamrava is the popular perception that such legislation would infringe patients’ right to privacy and autonomy. Kirk O. Hanson, director of the Markkula Center for Applied Ethics at Santa Clara University, explains America’s relatively laissez faire approach to reproductive
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Octuplets Case Study
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Octuplets Case Study References
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1. Ricks, D. (2009, February 4). Debate grows over octuplets’ birth. Newsday. 2. Yoshino, K., Garrison, J., Ho, C. (2009, February 7). Public fury overtakes awe after the birth of octuplets; As the economy sours, many express concern over a variety of costs. The Los Angeles Times. 3. Yoshino, K., Garrison, J. (2009, February 11). Octuplets’ care could end up costing taxpayers millions; Their Medi-Cal tab is rising and their mom is eligible for substantial public assistance. The Los Angeles Times. 4. McClure, R.D. (2009, March 8). Births of octuplets raises questions. The Washington Times. 5. Goff, K.G. (2009, March 4). Giving IVF a bad name; Fertility doctors on defense after ‘Octo-Mom’. The Washington Times. 6. McClure, R.D. (2009, March 8). Births of octuplets raises questions. The Washington Times. 7. Ibid. 8. Ibid. 9. Saul, S., Williams, M. (2009, February 12). Birth of octuplets puts focus on fertility industry and risks. The New York Times. 10. Goff, K.G. (2009, March 4). Giving IVF a bad name; Fertility doctors on defense after ‘Octo-Mom’. The Washington Times. 11. Saul, S., Williams, M. (2009, February 12). Birth of octuplets puts focus on fertility industry and risks. The New York Times.
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12. Ibid. 13. Motivation of octuplet mom’s fertility doctor questioned. (2009, February 22). Newsday. 14. Zarembo, A., Garrison, J., Yoshino, K. (2009, February 10). Octuplet doctor’s record dubious; His pregnancy rate is low – and Suleman’s 14 children account for much of it. The state is paying a cost. The Los Angeles Times. 15. Lister, S. (2009, February 13). Ex-worker tells of ‘secretive’ octuplets doctor. The London Times. 16. Zarembo, A., Garrison, J., Yoshino, K. (2009, February 10). Octuplet doctor’s record dubious; His pregnancy rate is low – and Suleman’s 14 children account for much of it. The state is paying a cost. The Los Angeles Times. 17. Lister, S. (2009, February 13). Ex-worker tells of ‘secretive’ octuplets doctor. The London Times. 18. Yoshino, K., Garrison, J., Zarembo, A. (2009, February 13). Octuplets doctor has quads case; He transferred at least 7 embryos to a woman now pregnant with 4. The Los Angeles Times. 19. Saul, S., Williams, M. (2009, February 12). Birth of octuplets puts focus on fertility industry and risks. The New York Times. 20. Ibid. 21. Ibid.
Induced Pluripotent Cells (iPS) first executed by Shinya Yanamaka at Kyoto University ( Japan) in 2006; the method of reprogramming is simple, efficient, and has been recreated by a number of laboratories across the globe.4 iPS cells have the potential to greatly benefit biomedical researchers and clinicians while avoiding the bioethical issues faced by ES cells. Namely, iPS cell utilization avoids destruction of the pre-implantation embryo. In contrast, iPS cell appropriation simply requires the isolation of any adult somatic cell, followed by cellular reprogramming.3 The final product of both methods are a set of pluripotent stem cells, which can then be as used as starting material for differentiated cells, tissues or organs.5 The idea of induced pluripotency is incredibly exciting in the world of biomedical research. Pluripotent cells have the potential to improve clinical therapies and augment basic science research. For example, the pluripotency of iPS cells enables these cells to serve as an important tool in better understanding the process of cellular differentiation and proliferation. Also, iPS cell lines show significant potential in serving as models for human diseases, such as cancer. Finally, perhaps the most exciting application of iPS cells is the possible use in patient-based therapies as ES cell substitutes.4 For example, iPS cells could be isolated from a patient with a problematic liver and subsequently used to (1) ascertain the effectiveness of certain drugs, (2) create new, healthy liver cells to replace the damaged ones, (3) study the pathology of the disease. Also, iPS cells have certain clinical advantages compared to ES cells; for example, the problem of autoimmunity or “cell rejection” would be avoided since iPS cells are derived from the patient’s own tissue.6 Despite these potential benefits, it is important to question just how similar the two cell types are. Investigators have shown that mouse-iPS cells are the functional equivalents of mouse-ES cells. The two cell types exhibit similar gene expression and differentiation capacities.7 However, in humans, the answer is a bit more complex, partly because the characterization of human ES cells is still ongoing.8 Studies suggest that although the two cell types have very similar gene expression profiles, there are some notable differences. The functional consequences of these differences are currently unknown. Therefore, further studies on ES cells must be conducted to fully ascertain the differences between the two cell types before clinical use is permitted.9 Furthermore, certain technical challenges must be overcome before clinical utilization would be permitted.
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On March 9, 2009, President Obama lifted the ban on government-funded research involving human embryonic stem (ES) cell lines. Obama’s order declares that the National Institutes of Health (NIH) are now able to fund “responsible and scientifically worthy” research associated with human ES cell lines. The President stated that the order will allow scientists to actively and responsibly seek cures and treatments, “not just by opening up this new frontier of research today, but by supporting promising research of all kinds, including groundbreaking work to convert ordinary human cells into ones that resemble embryonic stem cells.” Obama was referring to induced pluripotent stem (iPS) cells. The similarities between iPS and ES cells (which are also pluripotent) and iPS cells’ simple methods of appropriation give them great potential to solve many therapeutic problems while avoiding bioethical issues faced by ES cell research.1 The controversy surrounding ES cell research arises from the methods of stem cell appropriation. Isolation of the ES cells requires extraction from the inner cell mass of the pre-implantation embryo at the blastocyst stage of fetal development—resulting in fetal death.2 Induced Pluripotent Stem Cells are a product of cellular reprogramming. Essentially, a scientist first aims to isolate normal somatic cells—for example, skin cells. Then, the scientist attempts to reprogram these cells into their developmental precursors to induce pluripotency, which is defined as the ability to differentiate into virtually any cell found in the human body. The process is carried out by the introduction of a specific set of transcription factors into the isolated somatic cells. These transcription factors subsequently regulate DNA transcription and translation and, as a result, the cell’s activity and function.3 The process was
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Vineet Patil
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Induced Pluripotent Cells
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Although the method of appropriation has successfully been applied to human somatic stem cells, the efficiency level remains low—it takes several weeks to back-differentiate a somatic cell into an iPS cell, and several more weeks to appropriate an adequate number of iPS cells for clinical use. Depending on the severity of the disease, this time constraint could present a problem during clinical application. Also, the genetic manipulations required to isolate iPS cells are another significant issue.6 For example, isolation of iPS cells requires a genetic selection marker inserted into the host cell’s genome via a viral vector. When DNA is randomly inserted in a host cell’s genome, there is the possibility of incidental expression of proto-oncogenes, which are known to cause cancer.9 Furthermore, genetically modified cells face significant regulations before they can be clinically utilized. Essentially, researchers need to more fully understand the consequences of their genetic manipulations in order to allow for iPS utilization in a clinical setting.4 Although iPS-technology avoids many controversial bioethical issues, this research is not completely devoid of ethical concerns. While it is true that iPS use does not require the destruction of the embryo during the blastocyst stage of development, future clinical use does require further contemporary studies which characterize ES cells. So, significant clinical use of iPS cells indirectly requires appropriation of embryonic cells. Overall, the advantages of iPS cells are that they are patient-derived and they avoid the use of ES cells and associated bioethical issues. The disadvantages are that
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the isolation of patient-derived iPS cells could take several months and the genetic manipulations required to isolate iPS cells may lead to the expression of cancer-causing genes. iPS cells have the potential to revolutionize the world of medicine, transforming basic science research and expanding clinical therapeutic techniques. However, in order for these cells to fulfill their potential as a clinical therapeutic tool, many challenges must be overcome. Improving the efficiency of the reprogramming process and better understanding genetic manipulations within iPS cells are required. Finally, investigators must attempt to fully characterize human ES cells in order to thoroughly understand the differences between iPS cells and ES cells. If these challenges are overcome, iPS may open new pathways of treatment for a number of problematic diseases.
References 1. Gorelick, D. (2009, March 9). Obama Lifts Ban on GovernmentFunded Stem Cell Research. America.gov: Telling America’s Story 2. Thomson, J. A. et al. ES cell lines derived from human blastocysts. Science 282, 1145–1147 (1998) 3. Takahashi, K. & Yamanaka, S. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell 126, 663–676 (2006). 4. Nishikawa, S.-I., Goldstein, R. A., & Nierras, C. R. (2008). The promise of human induced pluripotent stem cells for research and therapy. Nature Reviews: Molecular Cell Biology , 725-729. 5. Lerou, P. H. & Daley, G. Q. Therapeutic potential of ES cells. Blood
Rev. 19, 321–331 (2005). 6. Yamanaka, S. Strategies and new developments in the generation of patient-specific pluripotent stem cells. Cell Stem Cell 1, 39–49 (2007). 7. Okita, K., Ichisaka, T. & Yamanaka, S. Generation of germline-competent induced pluripotent stem cells. Nature 448, 313–317 (2007). 8. The International Stem Cell Initiative. Characterization of human ES cell lines by the International Stem Cell Initiative. Nature Biotech. 25, 803–816 (2007). 9. Lowry, W. E. et al. Generation of human induced pluripotent stem cells from dermal fibroblasts. Proc. Natl Acad. Sci. USA 105, 2883–2888 (2008).
CURF Prize Winning Article
The TRIPS Agreement and Developing Countries: India’s Experience with Patent Law and Public Health
The Debate: TRIPS and Access to Essential Medicines
A 2005 World Health Organization (WHO) article on access to medicines highlighted intellectual property and TRIPS as having an important impact on global public health. The WHO used a human rights perspective on the agreement, stating that its implementation in member countries must take into account major public health principles such as effective response to health emergencies, supply of affordable medicines, effective competition of suppliers, and equal opportunity for countries in need. The WHO acknowledged the importance of patents as financial incentives to medical innovation but noted that prices for patented products are often higher than pharmaceutical production costs and lead to profits higher than research, development, and production costs combined. Such profits are unnecessary in view of the fact that developing countries constitute only a fraction of the world market for pharmaceuticals and many consumers in developing
countries pay out of pocket for such drugs. Since most pharmaceutical companies are motivated by profit, the WHO suggests it is ineffective to rely on the private sector to develop medicines essential to Less Developed Countries (LDCs) and to price them affordably. (World Health Organization, 2005) The contradictory claims made by the WHO are illustrative of the greater scholarly debate over TRIPS and access to essential medicines in developing countries. A major point of contention is not whether the TRIPS flexibilities will increase access to medicines, but whether these flexibilities sufficiently accommodate the enormous health needs around the world. TRIPS public health flexibilities cannot be evaluated in a vacuum. They must be evaluated within the context of the global burden and distribution of disease around the world, as well as the political and economic constraints under which countries have operated in recent decades. Much scholarly debate assesses whether TRIPS allows sufficient flexibility to help alleviate the excess burden of disease around the world.
‡ 4530 Linnean Ave. NW, Washington, DC 20008. markleyn@sas.upenn.edu
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In 2005, the Indian government issued the Patents (Amendment) Act 2005 which catapulted the country into a new global system of trade and legal governance. This legislation deviated from India’s historically lenient system of intellectual property by strengthening the country’s minimum standards for patent protection in compliance with a new global agreement: Trade Related Aspects of Intellectual Property (TRIPS). With its large generic pharmaceutical industry and significant burden of infectious and chronic disease, India is a particularly unique case where patent law has had and will continue to have far-reaching consequences. Indeed, patent protection or lack thereof is literally a matter of life or death for developing countries like India where large populations depend on affordable access to essential or life-saving medications. TRIPS is administered by the World Trade Organization (WTO) and sets minimum standards for intellectual property rights (IPR) in member countries. The Agreement includes five major public health “flexibilities” which aim to alleviate the possible negative effects of strict patent law on access to affordable medicines in developing countries The five most important flexibilities include: transition periods for TRIPS compliance, compulsory licenses, parallel imports, experimental use of patented products or processes, and the Bolar exception (or use of a patented product or process for regulatory approval). While India’s incorporation of these flexibilities into domestic legislation has been complete, there is question as to whether the TRIPS flexibilities are capable of fully addressing the health needs of the Indian population. By incorporating all of the major flexibilities that accommodate public health, India took every measure possible, within the constraints, to afford its people secure access to their health needs. Philosopher Thomas Pogge suggests two major alternatives to the TRIPS model for research incentives: the differential- pricing strategy and the public-goods strategy. These alternatives, however, are inconsistent with the currently accepted rules and norms of global trade. Continued legislative success for TRIPS and global equity in access to essential medicines will depend on the interpretation and application of TRIPS-related legislation by Indian courts and enforcement bodies.
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Markley Foreman‡
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Philosopher Thomas Pogge argues that while TRIPS corrects the market failure of undersupply of medical innovation, it violates standards of human rights and distributive justice by limiting access to medicines for large population sectors. Pogge’s analysis is based on John Rawls’ theory of justice which maintains that, among possible arrangements for the distribution of goods, the arrangement should be chosen which maximizes benefits to the worst off. Pogge pre-supposes that human beings have a collective duty to one another and that if harm is avoidable, it should be avoided. In “Human Rights and Global Health: A Research Program,” Pogge offers two ways to minimize avoidable mortality and morbidity throughout the world: eradicating severe poverty and increasing global access to medical treatments. Pogge acknowledges that these are interconnected mechanisms but focuses his attention on increasing global access to medical treatments and asks whether TRIPS, which enshrines the classic solution to the market failure of undersupply of medical innovation, sufficiently addresses global need. Pogge argues that the monopoly feature of TRIPS is irrational because it impedes sales to customers willing to pay more than the marginal price of a drug but less than the monopoly price. Such potential sales, Pogge argues, would be mutually beneficial to drug companies and suffering patients. (Pogge, 2005) Many would agree that the distribution of global benefits, including health and health care, depends on international trade agreements such as TRIPS. (Sen, 2000) How we distribute these global benefits, then, is the major point of contention between differing scholars. If these benefits are defined in terms of human rights, then we use a very specific moral and ethical framework to decide who is entitled to receive these benefits. However, if such benefits are defined as economic rewards, or as utility, an entirely different system will dictate who receives them. Taking a stance on the TRIPS and access to medicines debate requires scholars to assume a certain conception of who is responsible, what they are responsible for and to whom they are responsible. (Marckman & Synofzik, 2007)
Thomas Pogge and Indian TRIPS Legislation
Pogge views TRIPS through the lens of human rights and aims to match-up the incentives for medical innovation with the goal of alleviating the global burden of disease. Global agreements relating to medicines, he argues, require a level of moral reflection beyond that required for other Intellectual Property (IP)-protected goods such as music and software because health and health care are basic human rights. Such human rights form, “the core values of our moral and political discourse, central to how justice is conceived in the modern world,” and should thus form the basis of our social rules and laws. (Pogge, 2005) Pogge’s conclusion that TRIPS is unjust is based on his belief that it produces avoidable mortality and morbidity and violates human rights. The moral framework used by Pogge to analyze TRIPS can be applied to India’s passage of the Patents (Amend-
ment) Act 2005. Pogge suggests that lawmakers have a duty to create social rules, or laws, that fulfill human rights. He states, “To be just, such rules must not violate human rights, that is, they must afford human beings secure access to the objects of their human rights insofar as this is reasonably possible.” (Pogge, 2005) According to this framework, Indian lawmakers have a duty to create laws that reasonably fulfill the human rights of their citizens. The extent to which this was, “reasonably possible,” for Indian lawmakers depends on the constraints under which they operated. While theoretically, India could have refused to participate in the WTO, they could not have done so reasonably. For better or worse, WTO membership is essential to a country’s active participation in international trade today. WTO membership provides industries with the capacity and access to capital required for economic development and trade in the modern era. As of 2008, nearly every sovereign nation in the world is now a WTO member and faces strict regulation on trade with the limited number of non-WTO members. (Choi, 2005) India had little genuine choice in its decision to sign onto the WTO, and TRIPS, if it wanted to continue to develop its economy and engage in foreign trade vital to many of its indigenous industries. We cannot evaluate the justice of India’s Patents (Amendment) Act 2005 without taking into account the constraints of the TRIPS agreement. Within the constraints of TRIPS, India adopted the provisions of the agreement in a way that is just. By incorporating all of the major flexibilities that accommodate public health, India took every measure possible, within the constraints, to afford its people secure access to the objects of their human rights. Pogge further clarifies that the creators of social rules are violating human rights only when they, “could and should have known that there are feasible and practicable reforms of these rules through which a substantial portion of existing deprivations could be avoided” (Pogge, 2005). Beyond the basic use of transition periods, compulsory licensing, parallel imports, experimental use and the Bolar exception, there was little else that India could have feasibly and practicably done within the constraints of TRIPS to avoid further deprivation of human rights. While India’s situation has been just, countries that do not incorporate every reform possible to secure access to human rights may be unjustly adopting the TRIPS agreement. Most scholars who support India’s use of the public health flexibilities argue that they create sufficient room to secure access to the human rights of the population. Indian TRIPS negotiator Jayashree Watal argues that TRIPS’ public health flexibilities, if implemented effectively, will help attenuate the negative effects of TRIPS on affordable access to medicines. Watal argues that only a limited number of essential medicines are patented and that there are few diseases with only one treatment option. As a result, any essential medicines that remain on patent are likely to have off-patent substitutes. Many companies only file patents for drugs in a few strategic countries, leaving the same drugs off-patent in others. She also
Suggested Alternatives to the TRIPS Model
Suggested alternatives to TRIPS must be both feasible and realistic, with tangible appeal to governments, pharmaceutical companies and the public. (Pogge, 2005) Pogge suggests two alternative models to the TRIPS regime for incentivizing research: the differential-pricing strategy and the public-good strategy. Differential pricing refers to the sale of products at different prices to different populations based on their ability to pay. In a 2007 Brandeis Law Journal article, Brittany Whobrey proposed a similar tiered pricing scheme that would obligate patent holders
to sell medicines at lower prices in LDCs using a sliding scale formula based on a country’s GDP (Whobrey, 2007). Pogge argues that this strategy may work for certain types of intellectual property but is nearly impossible in the case of pharmaceuticals and is, “morally highly problematic in the case of essential medicines” (Pogge, 2005). He claims that the strategy can only be workable if the different categories of buyers can be prevented from knowing about, or trading with, the other categories. Whobrey proposes banning parallel imports as a solution to the potential trade arbitrage that may occur as a result of differential pricing. (Whobrey, 2007) While in theory this strategy makes sense, it grants the creator of the pricing scheme far too much power in calculating prices for different countries. GDP is only one measure of a country’s economic status and does not take into account other measures, such as availability of insurance or employment rates, which affect people’s ability to pay for medicines. Banning parallel imports is not a feasible solution because counterfeit trade, or the illegal trade of patented products, will become more lucrative as variable prices are institutionalized under a differential-pricing model. Indeed, counterfeit trade was the motivation for including IPR in 1980s trade negotiations and was the impetus for increased international standards for the protection of intellectual property. Pogge’s second proposed solution, the public-good strategy, aims to reward innovation based on the amount of good it does for the society at large. This strategy would reward medical innovations with public funds in proportion to their impact on the global disease burden and thus re-align research incentives to match up with diseases that cause the greatest amount of harm. His proposed reform is limited to essential medicines only, or in other words, medicines for diseases that destroy human lives. By doing so, research incentives for non-essential medicines would remain in place under the current TRIPS regime and not disturb the ability of pharmaceutical companies to profit from these ventures. Pogge argues that taxpayers in developed countries ought to pay slightly higher taxes to support this program because it will result in lower drug prices overall and will show goodwill towards developing nations. He also argues that the reform would create quality medical research jobs around the world, increase overall world health and minimize health threats from future invasive diseases. (Pogge 2005) Pogge’s suggestions operate under an idealistic worldview where humans feel compelled to help others and make investment decisions based on morals. He argues that, “we ought to support such a reform, even if it involves significant opportunity costs for us, because it is necessary for rendering minimally just (in the explicated sense of ‘realizing human rights insofar as this is reasonably possible’) the rules of the world economy considered as one scheme.” (Pogge, 2005) Pogge is right that this scheme would significantly alleviate the burden of disease in the long-run and necessarily provide for the greater fulfillment of human rights. But this scheme is inconsistent with the
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argues that India’s statutory provisions on non-voluntary compulsory licenses may even encourage the voluntary grant of licenses and stimulate further competition (Watal, 2000). Radhika Bhattacharya similarly argues that India’s Patent (Amendment) Act 2005 and its provisions for compulsory licenses represent a balance between the goals of stimulating growth and preserving the right to health (Bhattacharya, 2008). Bhattacharya states that the Indian Controller of Patents has a great deal of leeway in interpreting the patents rules and states, “How the Controller grants compulsory licenses and how the relevant rules and regulations limit the Controller’s decision-making process will determine the extent to which generics companies will continue to supply essential medicines to LDCs [Less Developed Countries].” Shondeep Banerji calls on India to use the new international patent regime to its advantage and to increase its research and development initiatives (Banerji, 2000). As long as the Indian government responsibly administrates the Patents Acts and Amendments and interprets the statutes and rules in a way that favors public health, TRIPS may not create new barriers to affordable medicines. Other scholars measure the possible long-term economic benefits of TRIPS against their short and long-term costs to health and access to medicines. The independent humanitarian medical relief organization Médecins Sans Frontières (MSF) published a paper in 2005 pleading with Indian lawmakers to incorporate the full flexibilities of the TRIPS agreement. MSF refers to drug prices as a major barrier to access to medicines and states its fear that drug prices will increase under a strict interpretation of the TRIPS patent obligations. MSF argues that a strict TRIPS implementation in India will not only increase prices for Indian patients, but will cut the lifeline of affordable generic-version medicines to other LDCs. With an estimated 70% of the 25,000 AIDS patients treated by MSF in 27 countries taking Indian generics, MSF refers to India as the number one source of affordable medicines. MSF urged India to use compulsory licensing, a strict efficacy standard and a system of pre-grant patent opposition as mechanisms to combat the possible drug price increases under TRIPS. (Médecins Sans Frontières, 2005) However, since India’s passage of the Patents (Amendment) Act 2005, MSF has argued that drug prices may still increase despite India’s incorporation of these flexibilities.
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current rules of global trade which are motivated by utility and not by morality for morality’s sake. TRIPS is part of a broader WTO system (the General Agreement on Tariffs and Trade) that lays down rules for global trade and facilitates trade and investment using economic incentives. India, like many other nations participating in global trade, is a capitalist democracy and thus has industries that are rationally motivated by utility and profit-maximization. Under the capitalist framework, financial exchanges should be voluntary, without any type of compulsion (Friedman, 2001). The public goods strategy goes against this system because it justifies reward to the private sector with the use of public funds based on feelings of obligation. If the public goods strategy could motivate voluntary giving by the public towards private venture in order to provide the greatest amount of good to the greatest number of people, it might be internationally feasible under a capitalist framework. Patents themselves represent a balance between capitalist and socialist notions of innovation and knowledge ownership: you may profit from your inventions for a limited amount of time if you publicly disclose your ideas for future use by the public. Completely private knowledge ownership is overly capitalistic and limits long-run innovation by failing to disclose information that might be useful in further invention. On the other hand, completely public knowledge ownership is overly socialist and lacks the lure of profit to incentivize future innovation. Patents are the classic and essential solution to this riddle of innovation. The question is not whether to use patents, but how to use patents effectively to stimulate innovation in the long-run while simultaneously allowing the fulfillment of human needs in the short-run. India has two major responsibilities in its implementation of TRIPS and continuing interpretation of its patents acts and rules. The first is a responsibility to the people of its country and their health outcomes. While there are large regional variations in health outcomes within India, the central government and judiciary play an important role in interpreting legislation that governs much pharmaceutical and medical activity. This responsibility refers to the supply of medicines at affordable prices as well as the prioritization of innovation and development that meets the specific needs of the Indian people. India’s second major responsibility is to continue its role as a major supplier of medicines around the globe. Countries in Sub-Saharan Africa, Latin America and elsewhere in the world rely on Indian manufacturers to supply vital medicines at low-costs on the world market. Indian pharmaceutical production and exports have historically played an important role in meeting this global demand for medicines and India’s ability to maintain its role as supplier will be increasingly important in a globalized world. Médecins Sans Frontières keenly stated in 2005 that, “it is crucial that India continue to develop policies that promote access to medicines, not
just out of responsibility to its own people, but as a lifeline to patients in other developing countries” (Médecins Sans Frontières, 2005).
Conclusion
Within the confines of the TRIPS agreement, India has adopted the provisions of the agreement in a way that is just. The incorporation of the five major public health flexibilities by Indian legislation allows ample opportunities for the country to engage with its duties to its own citizens and to the rest of the world. Yet legislation is not enough to fully solve these problems. The continuing interpretation of these laws by the central government and judiciary will be essential to India’s success in attenuating public health dilemmas, both domestic and abroad. As stated by Radhika Bhattacharya, “…the government’s application of the 2005 Patents Act is critical to [health] outcomes in India as well as other LDCs. India’s interpretation of this legislation, through the statute, case law and regulations, determines the degree to which the law diminishes access to medicines” (Bhattacharya, 2008). India can still feasibly and justly promote access to essential medicines under their Patents (Amendment) Act 2005 if it continues to interpret the flexibilities in light of domestic and international health needs. The role of governments in the free markets of both developed and developing countries may undergo significant recalibration due to the current financial and economic turmoil. In Barack Obama’s inaugural address, he keenly stated that the market is a force for good and observed, “[The market’s] power to generate wealth and expand freedom is unmatched, but this crisis has reminded us that without a watchful eye, the market can spin out of control…” (Associated Press, 2009). The watchful eye of the Indian government will be essential to India’s continuing ability to address its public health needs through patent legislation. However, it must be noted that affordable access to medicines is a complex issue where social, economic and political processes all play important roles in shaping the way in which people encounter and address health. The fair and informed application of TRIPS in India, as well as public and private strategies to address poverty will help minimize future barriers to affordable access to medicines. Markley Foreman is a senior at the University of Pennsylvania studying Health and Societies concentrating in Health Policy and Law and minoring in History. This paper is a selection from her honors thesis that covers the topic more in depth. Prof. Jonathan Moreno is the faculty sponsor for this submission. He is a Professor of Medical Ethics at the University of Pennsylvania Center for Bioethics. 3401 Market Street, Suite 320, Philadelphia, PA 19104 morenojd@mail.med.upenn.edu
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Associated Press. “‘Time has come to reaffirm our enduring spirit:’ Text of Obama’s speech for his inauguration as 44th President.” MSNBC, posted January 20, 2009. http://www.msnbc.msn.com/id/28751183/ page/2/ (accessed January 22, 2009). Banerji, Shondeep. “The Indian Intellectual Property Rights Regime and the TRIPs Agreement.” in Intellectual Property Rights in Emerging Markets, edited by Clarisa Long, 47-95. Washington D.C.: AEI Press, 2000. Bhattacharya, Radhika. “Are Developing Countries Going Too Far on TRIPs? A Closer Look at the New Laws in India.” American Journal of Law and Medicine 34 (2008): 395-421. Choi, Won-Mog. “Legal Problems of Making Regional Trade Agreements with Non-WTO Member States.” Journal of International Economic Law 8 (2005): 825-860. Friedman, Milton. “Capitalism and Freedom.” in Democracy: A Reader, edited by Ricardo Blaug and John Schwarzmantel, 367-372 . New York: Columbia University Press, 2001. Marckmann, Georg and Matthis Synofzik. “Access to Essential Medicines: Global Justice beyond Equality.” in Globalisation and Business Ethics, edited by Karl Homann, Peter Koslowski, and Christoph Luetge, 173-185. (Ashgate Publishing, 2007). Médecins Sans Frontières. “Will the lifeline of affordable medicines for poor countries be cut? Consequences of medicines patenting in India.” Médecins Sans Frontières Campaign for Access to Essential Medicines. Geneva: February, 2005. http://www.who.int/hiv/amds/ MSFopinion.pdf (accessed December 10, 2008). Pogge, Thomas. “Human Rights and Global Health: A Research Program.” In Global Institutions and Responsibilities: Achieving Global Justice, edited by Christian Barry and Thomas Pogge, 190-217. Oxford: Blackwell Publishing, 2005. Sen, Amartya. “Why Human Security?” Text of presentation at the International Symposium on Human Security. Tokyo, July 28, 2000. http://www.humansecurity-chs.org/activities/outreach/Sen2000.pdf (accessed December 15, 2008). Watal, Jayashree. “Access to Essential Medicines in Developing Countries: Does the WTO TRIPS Agreement Hinder It?” Harvard University, Center for International Development. Science, Technology and Innovation Discussion Paper No. 8, 2000. http://www.hks.harvard.edu/ cid/archive/biotech/papers/discussion8.pdf (accessed November 23, 2008). Whobrey, Brittany. “International Patent Law and Public Health: Analyzing TRIPs’ Effect on Access to Pharmaceuticals in Developing Countries.” Brandeis Law Journal 45 (2007). World Health Organization. “Access to Medicines- Intellectual Property Protection: Impact on Public Health.” WHO Drug Information 19 (2005): 236-241.
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Article
The Opt-out Organ Donation System: Why it is superior to the opt-in system and why the US should adopt it Emily Frydendall‡
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Currently, the US is facing an enormous organ shortage and many citizens are dying because they have not received necessary organ transplants. One possible solution to this problem is for the US to switch from opt-in organ donation, in which organ donors must actively commit themselves to the donor pool, to an opt-out organ donation system in which everyone is presumed to be part of the donor pool unless they have specifically opted out. However, many individuals object to switching to the opt-out system due to varying considerations of autonomy, nonmaleficence, and justice. This paper analyzes the merits of these arguments and concludes that the US could substantially and ethically reduce the organ shortage by adopting an opt-out system.
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The United States is facing an organ shortage because so few people donate their organs. In October 2008, the waiting list for organ transplants exceeded 100,000 people for the first time in US history. In 2007, approximately 7,000 people on the waiting list died because they did not receive an organ (United Network for Organ Sharing, 2008). Clearly, there is a great need for organs in the US but not enough donors to meet that demand. In comparison, many countries around the globe such as Spain and Austria are not experiencing organ shortages and do not even have waiting lists for organ transplantation (BBC News, 2007). What then is the difference between the US and these other countries that can explain this discrepancy in the number of organ donors? There are two distinct systems of organ donation practiced throughout the world: the opt-out model and the opt-in model. The opt-in model, also known as the explicit consent model, holds that every member of society can make the active decision to become an organ donor when they reach a certain minimum age. If an individual decides to become an organ donor, it is his or her personal responsibility to register as a donor; in the US this is usually done at the Department of Motor Vehicles. This system is practiced in countries such as the US, Canada, England, and Germany, among others (BBC News, 2007). Conversely, in the opt-out model, also known as the dissent or presumed consent model, everyone is considered an organ donor unless they actively remove themselves from the donor pool. The opt-out system can be further subdivided into “soft” and “hard” systems. In soft systems, families can still intervene after the death of a person and can contest the use of the person as an organ donor. In hard systems, the individual is considered an organ donor regardless, and posthumous interventions by families are not considered. Most countries that practice opt-out organ donation
employ the soft model, including Spain, France, Belgium, Sweden, Italy, Norway, and Singapore. Few countries, such as Austria, employ the hard model (BBC News, 2007). In short, there are two distinct models of organ donation which vary greatly in their legislative approach. The US’s current opt-in system is often considered to be ineffective as reflected by the enormous waiting lists and low donor participation, thus making the opt-out system more desirable. However, there are some important objections to adopting the alternative opt-out organ donation system based on the principles of bioethics. First, critics argue that opt-out systems infringe patient autonomy, especially if the appropriate information is not made available so people can make an informed decision about their donation status, or if they do not have the means to execute their decision. Second, if everyone is treated as a potential donor, care may be compromised by doctors whose main concern is to harvest organs. Third, critics of the opt-out system suggest there is no guarantee the organ shortage would be alleviated. Although these criticisms bring up important concerns, they are problematic because the opt-out system effectively upholds all of the principles of bioethics, can legitimately reduce the organ shortage as reflected by data from countries already using the opt-out donor system, and will be cost-beneficial.
Consideration of Autonomy
One criticism of the opt-out system reflects a broad concern about whether or not the autonomy of the patient is upheld. For example, many individuals are wary of governmental control over an individual’s body. However, it must be known that although everyone is initially assumed to be an organ donor, all individuals can make a completely autonomous decision to opt-out. So, when there are serious conflicts of interest like personal or religious
‡ 5937 Greenridge Circle, Fort Collins, CO 80525. Emily.Frydendall@colorado.edu
The Opt-out Organ Donation System
Consideration of Nonmaleficence:
Other critics of opt-out organ donation maintain that the system risks harming patients at the hands of overzealous doctors. Nonmaleficence is a concern because patient care could theoretically be compromised by altering care, therein expediting death to harvest organs. This is an
unreasonable claim because it assumes that most doctors have questionable ethical standards. In reality, doctors follow stringent ethical guidelines as stated in the American Medical Association’s Principles of Medical Ethics, which are based in part on the Hippocratic Oath (2008). For example, the first of these guidelines explicitly states that “a physician shall be dedicated to providing competent medical care, with compassion and respect for human dignity and rights” (American Medical Association, 2008). Another guideline states that “a physician shall, while caring for a patient, regard responsibility to the patient as paramount” (American Medical Association, 2008). Based on these guidelines, compromising patient care to take organs is wrong, and no ethical physician would perform such an act. The majority of physicians hold themselves to these strict ethical standards, and moreover hospital boards and patient advocacy groups exist to ensure that no violations occur. Additionally, organ snatching is unlikely because laws, such as the Dead Donor Rule, are in place to protect patients. The Dead Donor Rule encompasses ethical and legal standards of organ procurement. According to Ascension Health, it
Organ snatching is an alarmist fear. If a physician violated this rule, he would be subject to legal prosecution. Recently, a case occurred in the US in which a physician was charged with hurrying the death of a patient in order to harvest organs. In 2008, Dr. Hootan C. Roozrokh was charged with felony counts of dependent adult abuse, mingling a harmful substance, and unlawful prescription of a controlled substance for allegedly expediting the death of a 25 year old disabled man (McKinley, 2008). However, the case of Dr. Roozrokh represents “what transplant experts believe is the first case in the country” (McKinley, 2008). Transplants have been occurring since the 1950s, and such abuse is rare due to hospital oversight, patient advocacy groups, and oversight from the deceased’s family. Moreover, the Roozrokh case shows that when a physician acts unethically, he will be tried in a court of law. Opt-out systems have more organ donors and therefore much smaller organ shortages than opt-in programs. If organ snatching were a real problem, then the opt-in programs, not the opt-out programs, would probably encounter more violations because the need for organs is far greater. For example, the Roozrokh case took place in the US. In sum, the opt-out system is not more hampered by issues of nonmaleficence than any opt-in system, and measures to protect organ donors already exist.
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Refers to two widely accepted ethical norms that govern practices of organ procurement for transplantation: (1) vital organs should only be taken from dead patients, and (2) living patients should not be killed for or by organ procurement. These norms are subsumed under the Ethical and Religious Directives, n. 30. It is generally assumed that a violation of these ethical norms would constitute euthanasia, violate state laws, and therefore have legal consequences (2007).
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views, as in the case of Jehovah’s witnesses, these individuals can freely remove themselves from the donor pool and are never forced into organ donation. Patient autonomy is further protected in countries that practice a soft opt-out model because the family is consulted upon death and gets a final say in the organ donation process. If family members have objections on behalf of the deceased, doctors will not procure the deceased’s organs (BBC News, 2007). Participation by the family in the final decision allows for one last safeguard for the patient’s autonomy to be upheld and protected. Another criticism against the opt-out organ donation system is that infringement of patient autonomy could occur if appropriate information is not given to the people so they can make an informed decision. Critics contend that citizens may have difficulty accessing donation policy information and could not make a fully informed decision. While thought provoking, this criticism is unwarranted because information regarding organ donation is readily available to the general public, ranging from basic tenets of the organ donation policy to the specifics of which organs will be removed after death. For example, Sweden has websites and national advertisement campaigns, made available by the ministry of health, to inform the public about the details of the nation’s opt-out policies (Coppen, Friele, Gevers, Blok, & Van der Zee, 2008). The last concern for patient autonomy in the opt-out model relates to situations where individuals do not have sufficient access to the available information or the means to carry out their decisions. For example, an opt-out system may unfairly target marginalized groups such as the illiterate, learning disabled, or non-English speakers because these individuals have not received appropriate information about the donation system (British Association of Critical Care Nurses, 2007). Another problem is that these marginalized groups may not have the means to opt out of the system. For example, a non-English speaker may have difficulty opting-out because he cannot understand the paperwork. While this criticism holds more weight, it is critical to realize that the information surrounding organ donation is still available through governmental agencies and health care providers such as physicians or public health workers who can explain the policy orally. Health care providers can also help these individuals opt-out by assisting with paperwork and registration protocols if they choose not to be an organ donor. Although the opt-out system requires the need to invest in translators, public health workers, and advertisement strategies, there are still ways to deliver the information to all people and ensure their wishes are carried out.
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Concerns about the Opt-Out System and Donation Rates
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Perhaps the most crucial criticism is by those who do not want the opt-out system because it has not been definitively proven to increase organ donation rates. While it is true that there is no guarantee that an optout program will reduce the organ donation shortage, its projected outcomes can be examined by looking at data obtained from other countries with opt-in systems. Typically, it is difficult to compare the efficacy of opt-in and opt-out systems between Figure 1. Amount of cadaveric donors per country. Opt-out (presumed consent) countries are depicted in countries because of differgrayand opt-in (informed consent) countries in white. The 5 countries with the highest donation rates were ences in data availability and Spain, Austria, Latvia, Portugal, and Belgium. Of the 10 countries with the highest donation rates, 8 have data collection standards. De- opt-out models. The US had the 6th highest donation rate, the highest for an opt-in system. (Abadie & spite the difficulty of collecting Gay, 2006) accurate information, a study from around 30% in the early 1990’s to approximately 15% in 2006 conducted by Harvard researcher Alberto Abatoday (BBC News, 2008). die and University of Chicago researcher Sebastien Gay The reason that the US has comparable organ donawas successful in comparing organ donation rates, type of tion rates to opt-out countries may be the US’s large scale donation system, and country. The researchers examined 22 campaigns to increase organ donation in the past decade. countries over a 10 year period from 1992-2002. Abadie In past years, governmental spending to increase donors and Gay found many determinants, such as level of wealth, has been about $10 million per year. In 2004, the Organ religious beliefs, social norms, education, and medical Donation and Recovery Improvement Act was signed into infrastructure, that explain some of the variation in donor law, allocating a further $25 million per year to increase rates between countries (2006). However, after controlling organ donation rates by funding research, educational for these factors, Abadie and Gay found that opt-out or services, and advertisement campaigns (Missouri Dept of presumed consent legislation sizably increased organ dona- Health and Senior Services, 2004). While the US has a tion rates (2006). relatively high donation rate, the shortage of organs must Figure 1 depicts Abadie and Gay’s comparison of donabe addressed. In the US, enormous waiting lists exist tion policy and organ donation rate. Compared to an largely as a result of the the growing prevalence of chronic opt-out country such as Spain, the US had significantly diseases, such as end stage renal failure, which require orfewer organ donors. However, compared to other opt-out gan transplantation for treatment (University of Maryland countries such as Belgium and Portugal, countries with the Medical Center, 2006). So, although the US has a high fourth and fifth highest donation rates, respectively, the donation rate among opt-in systems, it is still in dire need US has similar donation rates. Spain’s high rate of organ of organ donors. donation can be partially attributed to the presence of an Another study by Columbia researchers Eric Johnson opt-out organ donation system; however, the organ donaand Daniel Goldstein found results similar to Abadie and tion rates are still much higher compared to other opt-out Gay’s study, as shown in Figure 2 (2003). systems. Another factor that could be driving up Spain’s In both data sets, organ donation was higher in countries organ donation rates is the wide presence of transplant that adopted an opt-out system of organ donation. These coordinators. Transplant coordinators are physicians spestudies provide additional evidence that an opt-out organ cifically trained to “identify potential organ donors and to donation system corresponds to higher donation rates. speak to bereaved families in the midst of grieving” (BBC Increased donor rates would shorten waiting lists and save News, 2008). Spain practices a soft version of the optlives. There is no absolute guarantee that organ donation out system in which families have a final say in donation. rates will increase, but comparative data strongly indicates After hospitals began implementing these coordinators in that opt-out systems have higher organ donation rates. hospitals, refusal rates by families decreased dramatically,
The Opt-out Organ Donation System ing the cost of the transplant” (NATCO: the organization of transplant professionals, 2007). By adopting an opt-out system, the number of kidney transplants will increase and fewer individuals will require dialysis. Getting patients off dialysis, in turn, would decrease the cost of health care for both individuals and governmental programs such as Medicaid and Medicare.
Figure 2. Estimated donation rate as a function of default policy: either opt-in or opt-out. The blue, dashed line represents the data set of Johnson and Goldstein. The red, solid line represents a separate data set by Gimbel et al. which includes a broader set of European countries. The data depicted is the mean donation rate per million +/- the standard error of the means. Both data sets show that opt-out donation rates are higher than opt-in donation rates. ( Johnson & Goldstein, 2003)
Cost Benefits of Increasing Organ Donation
Another point to consider is how a new opt-out system would impact the cost of US health care. Consider some specifics regarding kidney donation: according to the University of Maryland Medical Center, the one-time cost of a kidney transplant in 1999 was about $90,000 and has since come down (2006). In comparison, the cost of dialysis in 1999 was about $45,000 per year, with many individuals requiring multiple years of this treatment (University of Maryland Medical Center, 2006). As a result, “the cost of a kidney transplant has dropped so significantly that researchers say it is cheaper to have a transplant than to stay on dialysis for more than two and a half years, even among the sickest patients” (University of Maryland Medical Center, 2006). A reason behind passing the Organ Donation and Recovery Improvement Act was the potential cost benefits: “Medicare would avoid direct dialysis costs exceeding $55,000 per patient per year for each patient transplanted. With an average wait of 4 years for a transplant, Medicare would save a minimum of $220,000 per transplanted patient over 4 years, not includ-
Emily Frydendall is a Senior at the University of Colorado at Boulder majoring in Integrative Physiology. Prof. Donald Wilkerson is the faculty sponsor for this submission. He is a Senior Instructor in the Program for Writing and Rhetoric at the University of Colorado. Address: 1B60 Environmental Design, 317 UCB, Boulder, CO 80309 Email: Donald.wilkerson@colorado.edu
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Despite current criticisms of the opt-out organ donation system, it is superior to the opt-in system because it upholds the principles of bioethics and, as current data suggest, could alleviate the organ shortage. To address the alarming current organ shortage, the US should overhaul its opt-in program and replace it with a soft opt-out donor system. Undoubtedly, this restructuring program will require government funds and time to rewrite legislation. To streamline the process the US could follow Sweden and Italy’s examples of effective transitions, since both countries changed from opt-in consent programs to soft opt-out systems in 1996 and 1999, respectively. These changes were accomplished by rewriting and passing new presumed consent legislation, and by launching national information campaigns (Coppen, Friele, Gevers, Blok, & Van der Zee, 2008). In short, other countries have successfully changed their systems and increased donation rates. Along with changing to the opt-out system, the US should also focus on training transplant coordinators to further increase organ donation rates. In the US, thousands of people die each year while on the waiting list for an organ, and this number could be greatly diminished without compromising ethical standards by changing to an opt-out system.
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Conclusion: Why the US Should Overhaul its Opt-In System
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The Opt-out Organ Donation System
References
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Abadie, A., & Gay, S. (2006). The impact of presumed consent legislation on cadaveric organ donation: a cross country study. Journal of Health Economics , 599-620. American Medical Association. (2008, September 23). Principles of Medical Ethics. Retrieved December 7, 2008, from AMA: http:// www.ama-assn.org/ama/pub/category/2512.html Ascension Health. (2007). Dead Donor Rule. Retrieved November 16, 2008, from Ascension Health: http://www.ascensionhealth.org/ethics/ public/issues/dead.asp BBC News. (2007, July 17). Everyone ‘should donate organs’. Retrieved November 3, 2008, from BBC News: http://news.bbc.co.uk/1/hi/ health/6902519.stm BBC News. (2008, January 13). How the Spanish donor system works. Retrieved March 31, 2009 from BBC News: http://news.bbc.co.uk/1/ hi/health/7183798.stm British Association of Critical Care Nurses. (2007). Presumed Consent or Opt Out System for Organ Donation in Adults. Retrieved December 7, 2008, from BACCN: http://www.baccn.org.uk/news/presumedconsent.asp Coppen, R., Friele, R. D., Gevers, S. K., Blok, G. A., & Van der Zee, J. (2008). The impact of donor policies in Europe: a steady increase, but not everywhere. BMC Health Services Research, 1-22. Johnson, E. J., & Goldstein, D. (2003). Do defaults save lives? Science ,
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1338-1339. Missouri Dept of Health and Senior Services. (2004). Organ Donation and Recovery Improvement Act - Signed into Law. Retrieved December 11, 2008, from Missouri Dept of Health and Senior Services: http://www.dhss.mo.gov/OrganDonor/04ODAct.pdf NATCO: the organization of transplant professionals. (2007). Round table talking points about organ donation law. Retrieved December 11, 2008, from NATCO: www.natco1.org/public_policy/documents/ RoundtableTalkingPointsOrganDonationLaw.pdf McKinley, Jesse. (2008, February 26).Transplant Surgeon Charged in Patient’s Death. New York Times. Retrieved March 31, 2009 from http://www.nytimes.com/2008/02/26/us/26cnd-transplant. html?hp=&pagewanted=all The Gallup Organization. (2005). 2005 National Survey of Organ and Tissue Donation Attitudes and Behaviors. Retrieved December 7, 2008, from Organdonor.gov: http://www.organdonor.gov/survey2005/ organ_behavior.htm United Network for Organ Sharing. (2008). Retrieved November 3, 2008, from UNOS : http://www.unos.org University of Maryland Medical Center. (2006, September 8). The “break even” cost of kidney transplants is shrinking. Retrieved December 7, 2008, from UMM: http://www.umm.edu/news/releases/kidcost.htm
Article
The Ethical Repercussions of Patenting Human Genes Stephanie Hylmar‡
Patenting human genes is a legal practice in North America and throughout much of the world (CBAC, 2002). Various gene sequences, human cell lines and stem cells of human origin, which are relevant to human health and disease, have been successfully patented by individuals and corporations ( Jensen and Murray, 2005). The ethical and moral implications of human gene patenting have been, and continue to be, hotly debated in the international scientific community. Recently, the ethical and moral questions surrounding human disease gene patenting have resurfaced in legal debates as new genetic technologies push the limits of our medical understanding. Proponents, as well as critics, of gene patenting have recently been forced to ask, is “it ethical”? Human gene patenting, especially the patenting of human disease genes, is unethical for three critical reasons: tissue ownership is not clearly defined, genes are products of nature not inventions of mankind and gene patenting does not uphold the seven moral principles of the Canadian Biotechnology Advisory Committee (CBAC).
Ownership of Human Tissue
It is commonly believed that humans own their own bodies, however in the biotechnology age of the twentyfirst century this is a widespread misconception (Dickenson, 2008). Thousands of human DNA patents that assert ownership rights over human gene sequences of health and disease have been granted across the public and private sectors (Nuffield Council on Bioethics, 2002). According to Jensen and Murray’s (2005) findings, approximately 20% of the human genome has been patented as intellec‡ 14 Knoll Dr., Toronto, ON, M9A 498. shylmar@uwo.ca
tual property, granting the patent holder exclusive rights over the specified gene sequence. With exclusive rights to a gene or gene sequence implicated in human health and disease, the patent holder has the right to decide who can study and test for the gene (Radick, 2002). Although grants for biomedical research are largely funded by public means, private corporations hold 63% of these genomic patents, 78% of which are in the United States ( Jensen and Murray, 2005). The reason that such patents were passed without question until recently comes down to the simple concept of property. An important point to consider in reference to property and gene patenting of human tissue is the relationship we have to our bodies and any bodily tissue that is removed (Charo, 2006). The meaning of property in the biomedical field is very unclear, especially when dealing with ownership of human tissue and ownership of our genes (Charo, 2006). By nurturing and living in our bodies, how is it that we are not given ownership of the tissue, blood and DNA that come from us? The most recognized scandal associated with human gene patenting is the case of John Moore, which set the precedent for several tissue ownership cases to follow (Dickenson, 2008). In 1976, John Moore sought treatment for hairy-cell leukemia at the University of California Medical Center. Attended to by Dr. David Golde, John Moore underwent a necessary splenectomy, after which Dr. Golde realized that Moore’s tissue had economic value. Thus, when Moore’s medical treatment was complete, Dr. Golde continued to call Moore back for further tissue samples, using them for personal gain (Dickenson, 2008). In 1981, Moore discovered a 15-million-dollar cell line from his excised tissue had been patented to Dr. David Golde (United States Patent Office, 1981). Moore sued Dr.
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Introduction
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The issue of human gene patenting is a vehemently debated topic which questions the possession of biotechnological knowledge. A broad scope of bioethical concerns must be carefully considered when discussing the patenting of human genetic material, especially that which deals with human health and disease. At the center of these concerns is the question surrounding the ownership of human tissue; do we own our own bodies or does someone else? Also, human gene patenting is heavily impacted by the classification of human genes as inventions of human ingenuity or discoveries which are products of nature and are shared heritage of mankind. In debating these concerns human dignity must be observed while maintaining the possibility of furthering biotechnological innovation. The Canadian Biotechnology Advisory Committee has put forth a set of guiding principles which could effectively serve as an international standard to establish whether patenting of human genes should continue as a legitimate practice or be banned once and for all.
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Golde on the grounds of illicit interference with someone’s rightful property (Supreme Court of California, 1990). The courts ruled in Dr. Golde’s favor, stating that there was no evidence to support the argument that tissue removed from an individual’s body is a form of that person’s property (Supreme Court of California, 1990). An argument held by proponents of gene patenting is that once tissue has been removed from the body, it is no longer considered ours (Dickenson, 2008). The Moore case has set an international precedent and “follows the common law principle that we cannot be said to own any tissue taken from our bodies” (Dickenson, 2008, p.23). Those in favor of gene patenting state that patients have the right to give or withhold consent for an operation. However, once our tissue is separated from the body it is assumed to have been abandoned by the owner becoming res nullius, meaning that it is no one’s property and comparable to waste (Dickenson, 2008). Bearing in mind the definition of res nullius, the argument that we cannot own our own bodies is gravely mistaken and the 1990 ruling of the Moore case has made a serious contradiction to this point. If human tissue excised from the body is no one’s property, how is it possible that John Moore’s tissue belonged to Dr. Golde by rights of his patent (Dickenson, 2008)? Further, how can excised tissue be classified as waste if it is considered a commodity possessing biovalue, which can be patented for 15 million dollars (Dickenson, 2008)? Biovalue, as discussed by Mitchell and Waldby (2006), is the possibility to transform tissue, blood or DNA into resources. Without a clear definition of tissue ownership and guidelines for possession of biovaluable genetic material, patenting human genes contributes to dangerous commodification of the human body (Dickenson, 2008). Commodification of the human body is hazardous because it is happening without rules, regulations or the ethical framework of policy (Nuffield Council on Bioethics, 2002). Without strict rules to govern the commodification of the human body, legal and ethical issues arise forcing the courts to make uninformed decisions about gene patenting based on incomplete information. Since the Moore case is somewhat dated, one would assume that the issues of commodification surrounding human gene patenting have by now been resolved. However, debate over patented human gene sequences, especially those which disclose markers of human disease, are still raging ( Jensen and Murray, 2005). One of the most recent contemporary issues surrounding human gene patenting is the patent on human breast and ovarian cancer genes; BRCA 1 and BRCA 2 are held by Myriad Genetics, a private United States based biopharmaceutical company (Matthijs, 2006). Myriad Genetics “requires anyone wishing genetic testing to send their sample to them” to be analyzed at a cost of US $2500, while a comparable test in Canada would cost Can$1150 and be covered by the
patient’s Provincial insurance (Caulfield et al., 2002, p.256). It is because of the price discrepancy and economic loss that Myriad is attempting to stop Canadian laboratories from performing breast and ovarian cancer screening tests (Eggertson, 2002). Myriad’s claims to the BRCA genes is motivated purely by economic reasons, which inarguably commodify the human body and exclude a large group of women from seeking preventative testing (Matthijs, 2006). Eggertson (2002, p.494) argues that “since Myriad is building on years of publicly funded research,” it should not have the right to collect royalties for gene tests which are vitally important for medical diagnosis of a very rampant and life-threatening disease. This begs the question of why the Canadian and American biotechnology communities have accepted Myriad’s monopoly over such important human disease genes. The issue at stake with control of the patent on the BRCA genes is that people have a right to access that which is found in their own bodies (Eggertson, 2002). Withholding preventative diagnosis of breast and ovarian cancers for economic reasons is absurd and exemplifies the constant and current issue—the commodification of the human body, up for sale to the highest bidder. Matthijs (2006) refers to this case of human gene ownership as the most unprecedented and uncontrolled case of gene patenting run amuck in the field of genetic disease testing. Using the human body as a commodity, the biotechnology industry is allowed to exploit the fiduciary relationship between doctor and patient. This causes physicians to face a variety of ethical and legal dilemmas instead of attaching accountability to the patent holder (Caulfield et al., 2002). In addition, if interests not pertinent to a patient’s health, such as biovalue or royalties for preventative testing affect a physician’s judgment, the patient has the right to know (Dickenson, 2008). Proponents of patent law argue that patents aid in forming the market forces of our economies (Poste, 1995). However, the economic interest in a patient’s tissue, such as in the Moore case, or the patenting of medically important genetic information, such as the Myriad BRCA gene patents, severely diminishes the dignity of human beings (Dickenson, 2008). The dignity of human beings relates to intrinsic value, or something being valuable for its own sake (Resnik, 2001). In normative ethics, human beings have dignity and worth for their own sake. Humans have intrinsic value amounting to a certain way in which they should be treated, befitting of their dignity and not for mere profit (Resnik, 2001). Thus, having intrinsic value, human beings cannot be captured in terms of the market (Resnik, 2001). However, patenting human genes places humans on the market by quantifying their DNA monetarily through gene patents. It is impossible to treat something as having a price and priceless at the same time. Thus, patenting of human genes related to health and disease should not be allowed on the grounds of adding to market forces (Resnik, 2001, Mat-
Human Gene Classification – Invention vs. Discovery
For a patent to be granted on an invention of intellectual property it must satisfy three conditions: novelty, non-obviousness and usefulness (Nuffield Council on Bioethics, 2002). Proponents of gene patenting argue that patents on genes uphold these three conditions, meaning that genes should be considered inventions (Goldstein & Golod, 2002). It is true that a gene sequence that does not uphold these three conditions will not be granted a patent. However, the conditions of novelty, non-obviousness and utility are not judged by the most rigorous standards, which should be used when deciding the fates of human gene patents (Goldstein & Golod, 2002). Consequently, human genes and associated proteins should always fail on all three conditions because their patenting is inherently wrong (Radick, 2002). Obtaining and upholding a patent on the grounds of novelty and non-obviousness is an easy task since the patenting process lacks the insight required to analyze patents in the biotechnology field (Goldstein & Golod, 2002). A gene submitted for patenting will be approved on the grounds of novelty and non-obviousness even if the gene has been isolated and its details are in the public domain (Goldstein & Golod, 2002). This seems counter productive, but due to the possible degeneracy of the DNA code novelty and non-obviousness are satisfied by a gene sequence that has already been identified and patented (Goldstein & Golod, 2002). Because patenting of human DNA sequences is easily accomplished by the standards of novelty and non-obviousness, some genes have up to 20 patents asserting rights to it ( Jensen & Murray, 2005). As a pertinent example, the BRCA genes have multiple patents asserting rights to their ownership; however only Myriad has been aggressive in asserting ownership even as litigation over rightful ownership ensues (Matthijs, 2006). This strongly suggests that on the
basis of novelty and non-obviousness, human genes should not be patentable. On the basis of utility, obtaining a patent describing a human gene or gene sequence is slightly more challenging. Nevertheless, discrepancies in granting gene patents on the basis of utility occur due to a lack of clear understanding of what is being patented. On the basis of utility, the patent application must be credible, specific and substantial (Goldstein & Golod, 2002). However, patent offices have difficulty separating patents that claim useful and innovative gene sequences from those that merely disclose a sequence of human DNA ( Jensen & Murray, 2005). Several thousand DNA sequences have been found to be useful and have been granted patents, but these patents have been based purely on informatics. In applying for a patent on a gene sequence, no real chemical analysis must go into the patent application (Goldstein & Golod, 2002). The genetic sequence up for patent approval can be patented based on previous knowledge amassed by other sources, without real utility established by the patent applicant. Therefore, utility is not a basis on which human gene patents should be granted. Proponents of gene patenting advocate that genes are inventions and thus intellectual property patents should be granted on them (Ossorio, 2002). However, opponents of human gene patenting state that patents imply that living things are designed by human beings (Sagoff, 2002). Advocating the view of living things as inventions belonging to humans categorizes genes as artifacts rather than products of nature (Sagoff, 2002). Genes should not be considered inventions of human ingenuity and thus are not artifacts because they are found in nature and are the shared heritage of humankind. This idea of heritage supports the idea that human DNA is a form of commons, to be owned by all or by none (Ossorio, 2002). The concept of a common heritage would be the most egalitarian route, since genes are shared by all of mankind. Human disease genes should be considered as little more than discoveries (Matthijs, 2006). The Nuffield Council on Bioethics (2002) has recommended that the BRCA genes are essentially discoveries and according to patent law, discoveries cannot be patented (Matthijs, 2006). Credit for genetic discoveries can be given to individuals, but the benefit of the information should be shared by all. Many authors and researchers in the field of genetics share the opinion that genes are unpatentable products of nature that should not belong to individuals (Andrews, 2002). To classify genes as creations, rather than natural products, makes it impossible to draw a line between that which is natural and that which is synthetic (Resnik, 2001). Placing genes in the category of manmade artifact makes it impossible to metaphysically distinguish the natural elements in the human body from the artificial elements (Resnik, 2001). Therefore, it cannot be argued that genes are inventions created by biotechnology firms. Patents should not be granted on them since biotechnology merely discovers and manipulates naturally occurring genes by
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thijs, 2006). Protecting human embodiment means ownership of human tissue must be established to prevent treating the human body as anybody’s property, which can be bought and sold (Henk, et al., 1998). Treating the human body as mere property would compromise our embodied existence (Henk, et al., 1998). Thus, “to assert a person is the owner of their body and its parts is to acknowledge their right to control what happens to them” (Henk, et al., 1998, p. 6). Advocates of full ownership of the human body argue that people’s body parts are their personal property (Henk, et al., 1998). In support of owning our own body is the fact that in the United States the human body is already treated as property. This property approach where each individual owns themselves is the only way to assure that people can protect their interests (Henk, et al., 1998). Protecting the interests of every individual’s body and body parts is crucial to limiting genetic patenting as the biotechnology industry pushes the limits of dignity, embodiment and genetics.
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Patenting Human Genes
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conventional means (Sagoff, 2002). Establishing that genes are naturally occurring substances, which are discoveries as opposed to inventions, means they should not be eligible for patenting. Still, advocates of gene patenting argue that patenting genes increases the dissemination of knowledge by removing incentives to hoard information and instead spurs technological innovation (Ossorio, 2002). When a patent is granted on a human gene or gene sequence, the “inventor” has the right to decide who will and who will not study the genes identified in the patent (Radick, 2002). In other words, patents are a means by which “inventors” can hoard the rights and access to information. Thus, the decision to study certain human genes important to developing our knowledge of human health and disease is not in the hands of the scientist but rather his pocket book. This “limited monopoly created by gene patenting” has actually been known to decrease further research on patented genes (Radick, 2002, p.64). Individuals or corporations that hold the patent rights to a valuable gene sequence—such as the BRCA gene sequences— can charge scientists who wish to study the sequence exorbitant amounts of money. Future research and innovation on specific parts of the human genome which are patented will decrease, if not stop all together, and scientists will instead research genes that are more affordable to study instead of those which need to be studied (Radick, 2002). Some of the most heavily patented genes are those associated with human disease ( Jensen & Murray, 2005). Each of these genes may have up to 20 patents pending, and the chaos of litigation concerning the rightful owner stifles research on it (Radick, 2002, Jensen & Murray, 2005). When the ownership of a gene and the rights to study it are not clear, the rate of innovation on that gene is choked. Whether individuals, academic institutions or private corporations are asserting rights to a gene, the battle is always messy and promotes commercialization and risk taking, sacrificing genetic innovation (Goldstein & Golod, 2002). Therefore, human genetic information should not be subject to patents, which impede rather than stimulate research in the field of human genetics and disease.
The Seven Ethical Principles of the CBAC
The Biotechnology Advisory Committee (CBAC) is part of the Government of Canada’s Biotechnology Strategy, which promotes the scientifically sound development, application and export of biotechnology (Government of Canada BioPortal, 2009). The Canadian Biotechnology Advisory Committee gives council to the Canadian Biotechnology Strategy, providing comprehensive advice on current policy issues associated with the ethical, legal, social, regulatory, economic, scientific, environmental and health aspects of biotechnology (Government of Canada BioPortal, 2009). Advisory committees similar to the CBAC exist around the world, offering ethical advice on biotechnology issues such as human gene patenting. Committees such as the
Nuffield Council on Bioethics in the United Kingdom, the President’s Council on Bioethics in the United States of America and the Bioethics Conseil de l’Europe for the joint countries of the European Union, purport to guide their respective countries in sound decision making when biotechnology issues arise. The CBAC has outlined a set of principles by which it aims to guide Canadian decision making for patenting of higher life forms. These principles are: Autonomy, Accountability, Justice, Beneficence, Diversity, Knowledge and Caution. Using these guiding principles, the CBAC has recommended that “in particular to respect the non patentability of the human body” (CBAC, 2002, p. 7). The strongest case for the non patentability of human genes is the principle of autonomy, which promotes informed choice among patients and the public in regards to human gene patenting (CBAC, 2002). Proponents of gene patenting assert that the autonomy of researchers is upheld because patenting deters others from replicating their work or stealing credit (Ossorio, 2002). However, it is the autonomy of the public that is at stake since autonomy is premised on the notion that one’s body is one’s property (Charo, 2002). Losing our own property to patents that, uninvited, claim rights to tissue can be considered theft or trespass (Charo, 2002). Further, “researchers need the trust of those whom they study,” and by patenting human genes, the trust of the public is lost (Andrews, 2002, p.807). On the basis of the principle of autonomy, the CBAC (2002) has recommended that human gene patenting not be allowed. The second guiding principle of the CBAC is accountability: the commitment to promote conditions which allow individuals to pursue their values and interests while upholding transparency and responsibility (CBAC, 2002). Supporters of human gene patenting argue that patent law attaches accountability of ethical conduct to the patent holder (Poste, 1995). However, patenting of human DNA actually causes physicians to face a variety of ethical and legal dilemmas instead of the patent holder (Caulfield et al., 2002). To allow the public to pursue their values a prima facie irrational exists in granting monopoly rights over something that all could use (Ossorio, 2002). On the basis of the principle of accountability, the CBAC (2002) has recommended that human gene patenting not be allowed. The next principles are justice and beneficence. Justice is the commitment to ensure fair distribution of burdens and benefits, while beneficence is the commitment to pursue benefits for the greater good of society (CBAC, 2002). Advocates of gene patenting argue that justice and beneficence are upheld because innovations in human disease research are furthered through gene patenting, which benefits society (Poste, 1995). Conversely, as discussed by Dickenson (2008), it is unjust for biotechnology companies to take out patents that impede other researchers’ progress when they cannot pay the license fees. This creates a disincentive for researchers and hampers further research that could benefit international society. On the basis of the
Patenting Human Genes that assert right over human DNA sequences the exceptions rather than the norm”. On the basis of the principle of caution, human gene patents are not supported by the CBAC (2002).
Conclusion
“I compare this information to the discovery of celestial galaxies. I would patent the moon.” (Radick, 2002, p.63). These are the words of French geneticist Axel Kahn upon learning of the first attempts to patent human genes. As Kahn suggested, patenting of human genetic material seems absurd and outrageous. Genetic information should be tied to the concept of ownership of human tissue and the inheritance of mankind. Each individual is a unique specimen with unique DNA, but we all still posses a majority of genetic similarities that bind us and classify us as the human race. Each individual’s DNA should rightly belong to him or her and yet become part of a shared bank of knowledge and innovation that is guided by the seven principles of biotechnology. Stephanie Hylmar is a Senior attending the University of Western Ontario in the Honors Bachelor of Health Science program.
References Andrews, L. B. (2002). Genes and Patent Policy: Rethinking Intellectual Property Rights. Nature Review: Genetics, 3, 803-808. Canadian Biotechnology Advisory Committee. ( June, 2002). Patenting Higher Life Forms. Ottawa, Ontario: Canadian Biotechnology Advisory Committee. Caulfield, T. A., Gold, R., Ray, P. N. (2002). Gene Patents and the Standard of Care. Canadian Medical Association Journal, 167 (3), 259-257. Charo, A. R., (2006). Body of Research – Ownership and use of Human Tissue. The New England Journal of Medicine, 355 (15), 1517-1520. Dickenson, D. (2008). Body Shopping. Oxford, England: OneWorld Publications. Eggertson, Laura (2002). Ontario Defies US firm’s genetic patent, continues cancer screening. Canadian Medical Association Journal, 166 (4), 494. Goldstein, J. A., Golod, E. (2002). Human Gene Patents. Journal of Academic Medicine, 77 (12), 1315-1328. Government of Canada BioPortal. (2009). BioPortal: Canadian Biotechnology Advisory Committee. Retrieved Tuesday March 31st 2009 from: http://bioportal.gc.ca/english/BioPortalHome.asp Henk, T. H. A. M. J., Spicke, A. F., Welie, J. V. M. (1998). Ownership of the Human Body; Philosophical Considerations on the Use of the Human Body and its Parts in Healthcare. Dordrecht, The Netherlands: Kluwer Academic Publishers. Jensen, K., Murray, F. (2005). Intellectual Property Landscape of the Human Genome. Science Mag Policy Forum, 310, 239-240. Matthijs, Gert. (2006). The European opposition against the BRCA gene
patents. Springer, Familial Cancer, 5: 95-102. Mitchell, R., Waldby, C. (2006). Tissue Economies: Blood, Organs and Cell Lines in Late Capitalism. Durham: Duke University Press. Nuffield Council on Bioethics. (2002). The Ethics of Patenting DNA a discussion paper. London, England: Nuffield Council on Bioethics. Ossorio, P. (2002). Legal and Ethical Issues in Biotechnology Patenting. In A Companion to Genethics (p. 408-419). John Wiley & Sons, Ltd: Blackwell Publishers. Poste, G. (1995). The Case for Genomic Patenting. Nature, 378, 534-536. Radick, G. (2002). Discovering and Patenting Human Genes. In Body, Lore and Laws (p. 63-78). Hart Publishing, Oxford. Resnik, D. B. (2001). DNA Patents and Human Dignity. Journal of Law, Medicine & Ethics, 29, 152-165. Sagoff, M. (2002). Are Genes Inventions? In A Companion to Genethics (p. 420-437). John Wiley & Sons, Ltd: Blackwell Publishers. Supreme Court of California. ( July 9, 1990). John Moore, Plaintiff and Appellant v. The Regents of the University of California et al., Defendants and Respondents. California. Retrieved Thursday December 4, 2008, from http://www.kentlaw.edu/perritt/courses/property /moore-v-regents-excerpts2.htm United States Patent Office. (March 20, 1984). United Sates Patent, Golde et al. Retrieved Thursday December 4, 2008, from http://patft. uspto.gov/netacgi/nph-Parser?Sect 2=PTO1&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsear ch-bool.html&r =1&f=G&l=50&d=PALL&RefSrch=yes&Query=PN%2F4438032
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Dr. Kenneth Kirkwood is the faculty sponsor for this submission. He is the Assistant Professor of Applied Health Ethics at the University of Western Ontario Faculty of Health Science. Address: Room 221, Labatt HSB, London, ON N6A 588 Email: kkirkwo2@uwo.ca
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principles of beneficence and justice, the CBAC (2002) has recommended that gene patenting not be allowed. The next set of principles of the CBAC is respect for diversity: respect for various ways and forms of life, and knowledge: the value of scientific and traditional information (CBAC, 2002). Proponents of human gene patenting argue that these principles are upheld because patents increase the dissemination of knowledge (Ossorio, 2002). However, when someone else owns you, your respect and autonomy are diminished, playing into the self-denying prophecy. The self-denying prophecy provides researchers with the ability and incentive to patent human tissue while staying immune from patient lawsuits because patients are not granted ownership over excised tissues (Dickenson, 2008). This “actually makes the researchers less likely to share samples and slows biomedical research” (Dickenson, 2008, p.32). Based on the principles of respect for diversity and knowledge, the CBAC (2002) does not support gene patenting. Lastly, the CBAC has recommended not allowing patenting of human genes based on caution: the precautionary approach taken when information is lacking (CBAC, 2002). Proponents of human gene patenting insinuate that caution is being taken because to obtain a patent the invention must be novel, non-obvious and useful (Poste, 1995). However, these criteria are not scrupulous enough to ensure that patenting of human genetic material is safe (Goldstein & Golod, 2002). The Nuffield Council of Bioethics (2002, p.13) aims to make “the granting of patents
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Article
The Chinese Primary Care System: Its evolution, challenges and legal aspects of reform
Thomas Hou‡
There has been much interest in China and abroad in the Chinese health care system and legal systems. To date, however, there has not been adequate study tying legal reform and health care reform in China. This paper seeks to bridge those disciplines by studying the most crucial aspect of the Chinese health care system: the primary care system. The author examines recent efforts at reform in primary care, and explores some major legal and policy issues relating to both national and local governments’ efforts at reform, as well as citizens’ efforts using the expanded power of the legal system. For this study, the author looks at other academic and government studies on China’s health care system and legal system. He also attended and reviewed presentations and interviewed professors with direct knowledge of the situation in China. The research shows that the Chinese primary care system, and in fact its entire health care system, is undergoing tremendous change and faces similar problems as the United States. National-local government differences in responsibilities hamper efforts at reform while changes in administrative law have empowered citizens to a degree, although they still depend on the government to take action. Overall, China will need to find a culturally acceptable and practically workable balance between national and local power, and between governmental and citizen responsibility, to achieve health care reform.
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Introduction
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China is undergoing tremendous changes that permeate the entire society and its institutions. Its health care system is no exception. Currently, China faces similar problems as the United States in matters of controlling costs, increasing access and providing quality health care. As China adjusts to the 21st century and the increasingly market-oriented economy, its health care system must respond and reform in order to maintain social order and provide for the health of 1.3 billion people. Likewise, China’s legal system has undergone reform after the introduction of the market socialist economy in the early 1980s. As the Chinese government and people tackle health care problems, the law and the legal system will play an increasingly important role. One aspect of the health care system in the process of reform is the primary care system. According to Barbara Starfield (1998), primary care “provides entry into the [health care] system for all new needs and problems, provides person-focused care over time and … coordinates or integrates care provided elsewhere or by others” (Starfield, 1998, p. 8-9). Primary care usually consists of physicians and health care facilities that interact personally with patients and provide for the prevention and treatment of the most common diseases and illnesses. Unlike other forms of care, such as hospital or specialized care, primary care acts as the base of any health care system, for
it emphasizes health in a holistic respect. Its importance in promoting health, especially that of the rural and the poor, cannot be underestimated (Starfield et al., 2005, p. 466-8). China, with 56.1% of its population rural as of 2006 and 41% living below the poverty level, still heavily relies on its primary care system (National Bureau of Statistics, 2008, section 4-4) (Huang, interview 2008). With its primary care problems significant and complicated, China must reform its system according to its unique characteristics and challenges. This paper will examine the Chinese primary care system and some relevant legal and policy issues relating to primary care reform (and health care reform in general).1 An overview of the primary care system with its historical development and recent reforms will be presented. Afterwards, the paper will examine legal and policy issues facing reformers from the government – both national and local – and of the citizens. This paper will demonstrate that the evolution of the Chinese primary care system follows that of the economy, and the national government has directed its reform and will continue to do so. Furthermore, localnational tensions and the concept of the “rule of law” will affect national efforts at reform while changes in administrative law will likewise affect citizens’ efforts at reform, especially at the local level.
‡ 3650 Chestnut St. Box 357 Philadelphia, PA 19104. houp@sas.upenn.edu
According to the Constitution of the People’s Republic of China, health is a right for all citizens for whom “the right to material assistance from the state and society” in the event of illness or disability is guaranteed (Constitution of the PRC, article 45). Guided by this principle and the pressing need to provide health services for the large population of rural poor, the government established a national primary health care system in 1949 ( ). A multi-level network was constructed where each level (such as village, town and county) combined administrative leadership with technical guidance and supervision.2 The national government enacted legislation for provincial governments and local administrators while maintaining the final say in all matters (WHO, 1983, p. 36). On principle and in practice, the national government decided most of the health care policy, leaving local level administrators to enact necessary regulations to suit local needs. To finance the program, a system of Cooperative Medical Schemes (CMS) was introduced in the 1950s and well-promulgated by the 1970s (Peabody et al., 1999, p. 225). Under this arrangement, farmers, local governments and the national government contributed funds to cover primary care services. Barefoot doctors, groups of semi-trained village and local physicians, provided most of the primary care services (Cui, 2008). With the emphasis on prevention and self-sufficiency, the barefoot doctor-based system proved effective in improving overall health outcomes and earned praise from the international community. The primary care system began to weaken in wake of modernization efforts in the 1980s. The national government withdrew its support for the rural cooperative medical programs and reduced overall health care investment, as it reasoned that the new market mechanisms would solve any problems (Brant et al., 2006, p. 4 & 7). Without government support, the CMS collapsed and the primary care system framework was essentially dismantled. Barefoot doctors, who by then lacked stable sources of funding, disbanded to look for other sources of income (Cui, 2008). The aftereffects included rising preventable hospitalizations – a direct result of inadequate primary care – a rise in overall health care costs and prices, and a lack of insurance, especially among the rural poor. In fact, around 2000, the once-viable rural CMS system barely existed and up to one-third of the rural population could not afford the costs of care and avoided seeing doctors at all (Brant et al., 2006, p. 5). In other cases, especially in urban areas, health care services, especially high-tech hospital facilities, were over-utilized and contributed to rising health care costs in the 1980s and 1990s (Peabody et al., 1999, p. 277). The national government was culpable, for it had neglected investment in basic and preventive services while supporting new and expensive inpatient technologies (Lee, 2004, p. 334-5). Such a pattern characterized the government
and its reform program. Its fiscal policies were strongly decentralized and large institutional and geographic variations in planning were evident (Liu and Rao, 2006, p. 76 & 80). State-run institutions and those close to the coast were disproportionately favored. This contributed to ever more pronounced disparities in health care, between rural and urban, coastal and inland and rich and poor. Concerns about equity, cost control and community-focused care were not considered important and thus ignored by the national government (Meng, 2007, p. 15). In the late 1990s and early 2000s, the national government began to address the problems in the health care system, with an emphasis on primary care reform. For the access problem, affordability was correctly targeted as the main issue for most Chinese (Brant et al., 2006, p. 2). The government re-established a rural Cooperative Medical Scheme in 2003 which sought to replicate the old system and cover all of China’s rural population. This new program differed from the previous one in that it aimed to protect rural people from catastrophic losses and participation was voluntary, whereas the old system was mostly mandatory and focused on preventive care (Yip and Hsiao, 2008, p. 464). Even though government subsidies for the new co-op system were small compared to other expenditures, the CMS still proved a significant relief for uninsured farmers, and many rural counties joined (Liu and Rao, 2006, p. 72). As of 2007, the system had expanded to cover around 80% of the rural population (Zhang, 2007, slide 5). In urban areas, where the primary care system remained largely intact, the government attempted to reorganize the system into community health centers for primary care and district hospitals for inpatient care (Meng, 2007, p. 3). Similar to a barefoot doctor, a family physician ( ) became the model provider of primary care in urban areas and, increasingly, in semi-rural areas as well (Wang et al., 2007, p. 639). Such reforms underscored the government’s focus on promoting quality health care in urban as well as rural areas. In all, the national government has become more aware of the need for equity and efficiency, not just growth (Reddy, 2007, p. 65). It has begun to bridge the seemingly enormous gaps between rural and urban, coastal and interior. In 2006, prompted by the success and pace of reforms, the national government announced its intention to provide universal health coverage for both rural and urban residents by 2020, with a focus on providing quality primary care (Meng, 2007, p. 16) (Yip and Hsiao, 2008, p. 464 & 467). While the major problems in the health care system – rising national expenditure, unaffordable prices for consumers, lack of coordination, inefficiencies, and disparities – will persist in the near future, China’s commitment to reform and its emphasis on primary care suggest that the government and its citizens are giving attention to the health care challenges ahead.
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Overview of Primary Care in China
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Issues Relating to Government Efforts at Reform – National-Local Differences
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In China, the national government assumes all sovereign power and determines policy for the whole country. National legislation and regulations are passed downwards for local governments to follow and implement (Rothstein et al., 2003, p. 63-5). Since the reform era of 1980s and the advent of the health care market, the national government has become mostly a regulator of the market (Fang, 2008, p. 952). It recognizes the need for regulation of an uncertain market and for local governments to help. Nonetheless, despite the involvement of local governments in setting some regulations, they lack independent sovereign power and mostly carry out national policies using their own resources, personnel and innovative ideas (Li, 2006, p. 172). Usually, solutions from the local level are undermined by the lack of administrative and managerial capacity in major matters, especially in finances3 (Brant et al., 2006, p. 10). Officials in local governments often do not get much support from the national government to compensate for these limitations. In fact, many local governments do not consider granting and administering rural insurance programs a worthwhile venture. Despite their reservations, local governments are required to help administer the new rural CMS system. Generally, strong national government support for rural and local insurance schemes is necessary as local communities differ in needs, lack much backing from non-governmental organizations and lack institutional authority (Liu, 2004, p. 162 & 164). Without national government backing and funds, the rural CMS system and many other health care initiatives would likely fail. Such differences in authority and capability between the national government and local governments often give rise to significant tensions that may derail efforts at health care reform. Local protectionism is prevalent in China as local regulatory institutions often have incentives to partner with local party officials and health providers, to the chagrin of the national government (Fang, 2008, p. 954).4 While the Communist Party has widespread control down to the bottom level of administration, reform efforts are often in vain due to local protectionism and corrupt regulatory agencies. Often, the national government needs to resort to financial incentives rather than formal sanctions to ensure compliance. Consequently, there are large variations in the extent of local governments administering national policies; for example, hospital studies show that exemptions and subsidies for the poor exist in principle (from national laws), but rarely in practice (local administration) (Reddy, 2007, p. 65). Currently, the central government and local governments still debate the proper role in not only providing health care but also levying taxes and promoting agricultural policies (Liu, 2005, p. 162). There is still uncertainty over ultimate decision-making in issues relating to local health needs and policies. Many local governments are in a transition between de facto (actual or real) and de jure (empowered by law) autonomy, both of which entail complex relationships with the national government
(Zheng, 2007, p. xv). After all, China has a “long history of dispersed power over its enormous territory, with considerable provincial and county integrity, and local-government autonomy” (Walker and Buck, 2007, p. 62). Given the enormousness of the country and the tradition of local autonomy, debates over national and local control will likely persist in the future. The introduction of the concept of the “rule of law” has had a significant effect on the Chinese government’s relationships to the local governments and its approach to regulation and reform. China does not have a strong legal tradition and only after reforms in the 1980s did law and legal institutions assume any substantial importance (Rothstein et al., 2003, p. 61). Its system is based on French civil law and has since the 1980s borrowed much from international concepts of law. Even so, one of the main criticisms of Chinese law is its character of “instrumentalism”, i.e. the law is used to promote market-based economic development and maintain the rule of the Communist Party, rather than to establish a society in which the government, institutions and people subscribe to the supremacy of the law, i.e. “rule of law” (DeLisle, p. 7-8). According to DeLisle and many experts, a rule of law legal system consists of key elements such as judicial review, an independent judiciary, legal accountability of public officials and mechanisms to keep officials under the auspices of the law. A marked shift has occurred in recent years, as evidenced by Hu Jintao championing the rule of law as one of the pillars of his model of a “harmonious society” (Hu, speech 2005). On a more practical level, the rule of law idea, especially the last two elements noted above, helps to legitimize administrative structures used to ensure that other actors and regulatory institutions comply with existing laws (Fang, 2008, p. 961). Such mechanisms have been employed to indicate that the national government does intend to regulate within the limits of the law. Nonetheless, potential problems with the approach include limited infrastructures for the judicial and administrative systems, the possible exclusion of non-governmental actors with no statutory power from the government accountability process and the use of the law to legitimize powers such as fee-collecting that do not protect rights or promote equality (Fang, 2008, p. 961). In many cases, auditing structures for health care regulatory institutions fall victim to the corruption they are intended to prevent. Despite the increased use of the rule of law in official dialogue and practice, China is far from a society governed by the rule of law and still often follows earlier, more instrumentalist notions of law, such as the use of the law to promote Communist Party policy and to prevent social disorder against the party (Liu, 2004, p. 162). While the current state of affairs may be beneficial for keeping the government in charge of reform, it prevents complete and transparent reforms that normally require a true rule of law society.
Issues Relating to Citizen Efforts at Reform – Administrative Law
resort to petitioning the legislature to claim land rights and resolve disputes with each other and national or local governments (Pils, 2005, p. 33-34). Although such methods may not succeed and may lead to social unrest, they often garner public media attention and result in changes in administrative procedure and local reforms. The Administrative Litigation Law has increased the use of courts and litigation to resolve disputes with physicians and government agencies. There has been a traditional distrust between doctors and patients stemming from the low status of the doctor in traditional Chinese society and its lack of professional status. With the increased prominence and effectiveness of the legal system, more people are using the legal system to sue physicians, especially after the standardization of the malpractice law in 2002 (Harris and Wu, 2007, p. 456).6 Nonetheless, China has a legal system that many feel is not fair or transparent (ibid., p. 460). The process is still new and relatively time-consuming and expensive, which discourages many citizens. Citizens are still limited in the extent to which they may use the legal system: a citizen can challenge a state action – such as a state agency or local health department’s refusal to reimburse for care – but not administrative regulations – an abstract and more general rule set by a state agency, such as a stipulation that it will not reimburse (Rothstein et al., 2003, p. 462). In rural China, most villagers are distrustful of using administrative litigation against the state and have found themselves at a distinct disadvantage when they do litigate. Even so, they persist in their efforts and often achieve some success when they employ collective mass action or other informal means (O’Brien, 2004, p. 76-77). Such cases of collective mass litigation are becoming increasingly prominent in rural and urban China. While the objectives and results are often local and limited, such as rooting out a corrupt official or revoking an unfair land seizure, some larger suits have brought about substantial reforms including those in local health policy and health equity.
Conclusion
In conclusion, China faces some major legal challenges in its attempts at reform, notably in the health care system. Its primary care system will continue to undergo a long evolution with plans for universal health coverage on the horizon. The national government will continue to be the main agent for reform, but it needs to navigate its relationships with local governments and uphold and promulgate the rule of law. China’s citizens will play an increasingly important role in holding the government accountable and pushing for reforms on the local level. China will find a way to reform its health care system with its legal system providing a crucial aspect. Further research and study are needed to assess China’s future primary care and health care reforms. The government’s implementation of its promise for universal health care will be interesting to note. While “health care” and “primary care” are similar systems and used interchangeably in this paper, primary care is a distinct element within
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Increasingly, Chinese citizens of various backgrounds have made efforts to push for health care reform. In a departure from the Mao years, when the state was supreme and the party emphasized that people look to the state, the family is now emphasized as the first line of support for health matters (Liu, 2004, p. 162). Individuals have begun to look to themselves and their families in assessing matters of health. A more concrete change was the empowerment of the courts to hear complaints against administrative decisions starting in the early 1980s and the enactment of a comprehensive Administrative Litigation Law (ALL) in 1990 (Potter, 1994, p. 273). This new law empowered citizens and allowed for judicial review of administrative agencies in order to increase their accountability. With greater knowledge of health care, citizens have since then continually pressured the government to act in health care reform and many surveys show that health care, including equity, is close to the top of most people’s concerns (Meng, 2005, p. 16) (Warren, email 2007). Many citizens have become involved in affecting health care policy and issues, especially locally. Despite these improvements, the participation of civil society in many public decision-making processes is still low (Huang, interview 2008). The government discourages large civic organizations and monitors those that are allowed to form. The absence of independent and powerful civic organizations will continue to limit the ability of citizens to push for reform despite the availability administrative litigation or informal processes.5 Many informal processes of petitioning have long existed for citizens, such as organizations formed by rural farmers to give themselves some political voice. Such efforts are somewhat effective but, because many farmers depend on the government for individual subsidies and leases, they are more beholden to the government than to other farmers (Liu and Rao, 2006, p. 77). Likewise, professional groups and organizations such as physicians’ associations or independent auditors, which can help address problems and enforce standards in facilities such as hospitals, are also limited by their lack of autonomy and status (Fang, 2008, p. 961). One successful effort that has spread across China is village elections legitimized by the Organic Law of 1998. Villagers use elections to elect some of their own nonparty leaders and to dislodge corrupt officials and push for reforms (O’Brien and Li, 2000, p. 481-2). These elections hold promise for long-term democratic change starting at the local level. Finally, the People’s Congress, the supreme legislature, has a supervisory role and often hears direct grievances from the people (Fang, 2008, p. 958). In the petitioning process, ordinary citizens can send petition letters or grievances to higher administrative bodies, including the People’s Congress, to correct mistakes or to protest the unjust actions of lower bodies (China Labour Bulletin, 2003, p. 3). The legislature in turn can request reports and inspections to address grievances. In many cases, petitioning the legislature is effective as an informal, collective action taken by a group of citizens. Many rural people, either unaware of the formal legal system or dissatisfied with its results,
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Chinese Primary Care System the health care system as a whole and can be viewed as a separate entity. This paper focuses on two major legal and policy aspects of reform – national and local tensions from the governmental side and administrative law from the citizens’ side – but other legal and policy issues deserve attention too. It will also be worth observing how the notions of rule of law and litigation versus petitioning play out in China’s political and legal culture. A study of China and its health care system is and ought to be of interest not only to policymakers, academics and the citizens of China, but also to their counterparts across the world.
Thomas Hou is a Senior in Health and Societies major, concentrating in Health Law and Policy, at the College of Arts and Sciences at the University of Pennsylvania. Prof. Arnold J. Rosoff is the faculty sponsor for this submission. He is a Professor of Legal Studies & Health Care Systems at the the Wharton School in the University of Pennsylvania. Address: 3730 Walnut Street, Suite 600, Philadelphia, PA 191046340 Email: rosoffa@wharton.upenn.edu
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References
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Brant, S. et al. (April 2006). Access to Care in Rural China: A Policy Discussion. From http://www.umich.edu/~ipolicy/china/1)%20Access%20to%20Health%20Care%20in%20Rural%20China,%20A%20 Policy%20Discussion.pdf China Labour Bulletin Research Report. “Public Interest Litigation in China”. From http://www.clb.org.hk/en/files/File/research_reports/ Overview_of_PIL_2.pdf (2004). Constitution of the P.R.C. Article 45. Beijing: China Legal Publishing House. Cui, W. (December 2008). China’s Village Doctors Take Strides. WHO Bulletin, 86(12). DeLisle, J. Traps, Gaps and Law: Prospects and Challenges for China’s Reforms. Foundation for Law, Justice and Society. Fang, J. (2008). Chinese health care regulatory institutions in an era of transition. Social Science and Medicine, 66, 952-962. Harris, D & Wu, C. (Fall 2005). Medical Malpractice in the People’s Republic of China: the 2002 Regulation on the Handling of Medical Accidents. Journal of Law, Medicine and Ethics, 456-477. Hu, J. (2005). Speech given at National People’s Congress. Huang, Y. (6 November 2008). Health Security in China. Personal interview. Lee, L. (2004). Current State of Public Health in China. Annual Review Public Health, 25, 327-339. Li, L. (2006). Differential Actors: Central-Local Politics in China’s Rural Tax Reforms. Modern Asian Studies, 40(1), 151-174. Liu, Y. (2004). Development of the Rural Health Insurance System in China. Health Policy and Planning, 19(3), 159-165. Liu, Y. & Rao, K. (February 2006). Providing Health Insurance in Rural China. Journal of Health Politics, Policy and Law, 31(1), 71-92. Meng, Q. ( Jan 2007). Developing and Promoting Equity-promoting Health Policies in China. Health-Systems Knowledge Network study. From http://www.who.int/entity/social_determinants/resources/ csdh_media/equity_health_china_2007_en.pdf National Bureau of Statistics of China. (2008). 2007 China Statistical Yearbook. Beijing: China Statistics Press. O’Brien, K. & Li, L. (2000). Accommodating Democracy in a One-Party
State: Village Elections in China. China Quarterly, 465-488. O’Brien, K. & Li, L. (2004). Suing the Local State: Administrative Litigation in Rural China. The China Journal, 51, 75-93. Peabody, J. et al. (1999). Policy and Health: Implications for Development in Asia. Cambridge: Cambridge Univ. Press. Pils, E. (Fall 2005). Land Disputes, Rights Assertion, and Social Unrest in China: A Case from Sichuan. Columbia Journal of Asian Law, 235. Potter, P. (1994). Domestic Law Reforms in Post-Mao China. M.E. Sharpe. Reddy, S. (May-June 2007). Death in China. New Left Review, 75. Rothstein, M. et al. (2003). Quarantine and Isolation: Lessons from SARS. Report for CDC. From http://archive.naccho.org/documents/ Quarantine-Isolation-Lessons-Learned-from-SARS.pdf Starfield, B. (1998). Primary Care: Balancing Health Needs, Services, and Technology. Oxford: Oxford Univ. Press. Starfield, B. & Shi, L. & Macinko, J. (2005). Contribution of Primary Care to Health Systems and Health. Milbank Quarterly, 83(3), 457502. Walker, R. & Buck, D. ( July-August 2007). The Chinese Road. New Left Review, 46. Wang, J. et al. (2007). Primary Care Reform in the Peoples’ Republic of China: Implications for Training Family Physicians. Family Medicine, 39(9), 639-643. Warren, D. (14 November 2007). China’s Health? Personal Email. World Health Organization. (1993). Primary Health Care: the Chinese Experience. Geneva. Yip, W. & Hsiao, W. (2008). The Chinese Health System at Crossroads. Health Affairs, 27(2), 460-468. Zhang, H. ( July 2007). Health Workforce Development on the Primary Health Care in Rural China [Powerpoint slides]. Retrieved from http://portal.saude.gov.br/portal/arquivos/pdf/zhang%20hong%20 -%20Health%20Worforce%20Developmente%20on%20the%20Primary%20Health%20Care%20in%20Rural%20China.pdf Zheng, Y. (2007). De Facto Federalism in China. New York: World Scientific.
Additional Notes 1. Primary care reform and health care reform, and even later, reforms in general, are used liberally throughout this paper, especially in the later sections. While the three domains not interchangeable, for the purposes of this paper, the first two are very similar and the latter often involves or includes the first two. 2. China is divided administratively into provinces, then counties, towns and villages. Such divisions are based on population and geography. These divisions also correspond to the health care system, both in the past and the present. 3. Additionally, many local governments face budget shortfalls and lack solutions for those. Regional budget planning from the central government is often slow and ineffective.
4. Such incentives are often financial, such as an arrangement in which local government inspectors overlook a hospital’s faults in quality and standards in exchange for monetary arrangements or promotion of the local government among the (hospital) community. 5. In this section, general legal issues relating to administrative law will be discussed. There is sparse literature on the effect of administrative law on citizens’ reforms at health care specifically. Nonetheless, administrative law does apply to citizens’ efforts at all kinds of reforms, which include and are applicable to health care. 6. This change may result in the invidious effect of ruining fragile provider-patient relationships more as more citizens resort to litigation to address individual grievances against physicians.
Article
The Ethics of Condition and Circumstance: The Search for Moral Standards of Abortion in Islam. Ari Schriber‡
decree the religious stance on a particular issue. Given the complexity and ambiguity surrounding the issue of abortion, both classical and especially modern Muslim jurists have been unable to formulate a universally tenable basis for the legality of abortion. In what follows, I will explain from my research why this is the case. I will show the impracticability of matching scientific and religious points in time to identify the fetal acquisition of the uniquely human spirit (rūh). I will further examine the conditions cited as grounds for permitting abortion and how their circumstantial nature cannot demarcate clear ethical limits. Finally, I will contrast the problematic traditional and current approaches of abortion’s criminology and moral status with the unique ideas/ propositions of one classical and one modern writer—Abū Hāmid al-Ghazālī and Abdulaziz Sachedina, respectively—to emphasize the aspects of the approach heretofore inimical to the development of solid ethics. This analysis, I believe, will explain why Muslim thought has yet to put forth a distinct formula for the allowances and prohibitions of abortion in the Muslim faith. God’s celebrated creation of Adam ostensibly marked the beginning of humankind as we know it. In the discourse concerning the divine properties of reproduction (i.e. for humans after Adam), this story serves as a source of ethical premise for how God Himself shaped human attributes. The Qur’ān explains in Sura (chapter) fifteen, “And when
‡ 1702 Gordon Ave., Charlotfesville, VA. schriber@virginia.edu
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At its core, Islam requires a faithful submission to God’s will. As laid out through God’s communication to the Prophet Muhammad in the Qur’ān and the subsequent examples set by the Prophet in the reported Traditions (Hadīth), each human’s time on earth must be marked by deference to the conditions of creation. These conditions give rise to a distinct set of convictions regarding the sanctity of human life, which define spiritual transience in the earthly world. God’s bestowment of the spirit that makes humans unique can never be violated by unjustifiably taking a life, including one’s own. The prescription of Muslim life as decreed through Islamic religious law (Sharī’a), then, must work to address all earthly issues that may arise and compromise this value. Given that procreation serves as the means by which humans come into existence, the regulations that surround it emphasize its circumstantial peculiarities. As holy as the process of creation may be, humans have the conscious ability to prevent and terminate pregnancies during and after engaging in sexual intercourse. In Islam, temporary contraception is generally considered acceptable by analogical reasoning from a report of the Prophet condoning coitus interruptus (Bahishti, 1974, p. 408). The practice of aborting after conception, however, engenders an entirely different realm of ethical discourse. Unlike Catholicism and some Protestant Christian denominations, Islam does not have a centralized authority to
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Rapid development of biotechnology challenges long-held tenets of religious knowledge. Especially in topics dealing directly with the ethics of human life, the availability of technology allows for the proliferation of scientifically based claims for which only speculation formerly sufficed. Islam places great emphasis on the divine nature of creation as manifested through human existence. As a faith that has given way to significant juridical interpretation, Islam provides many laws and doctrines to help guide humans through life in deference to God. However, when faced with an ethical issue such as abortion—one for which there is no explicit command in the scripture—modern Muslims have yet to put forth a universally applicable stance that theology can definitively substantiate in light of recent scientific advancements. As such, in the following paper, I attempt to examine why one of the largest faiths in the world has encountered such difficulty in reconciling its conception of life’s creation with knowledge about fetal development only recently acquired (relative to the religion’s over 1400 years of existence). I discuss the complexities in the way Muslims historically handled abortion that have raised ethical concern now that scientists understand human embryonic development . Thus, when I consider the traditions (not necessarily the theology) and their inherent conflicts with quantifiable science, I try to find a way that Muslims can reconcile the circumstances giving rise to abortion with the reverence for human life paramount in Islam.
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I shall fashion [Adam] and breathe of my spirit into him, then fall ye down and worship him” (1974, p. 410). Hence, God’s breath of life gave Adam the first uniquely human qualities to be breathed into every human thereafter. This bequest of “spirit” from God is crucial in the context of defining the beginning of personhood—a threshold after which abortion would be analogous to infanticide. In essence, between the time of conception and the time of birth, God “ensouls” the fetus to give it this distinct human individuality. Therefore, while differing on circumstances before this point (to be discussed later), virtually all classical Muslim scholars denounce terminating the life of an ensouled fetus. However, delineating a point at which biological matter becomes a divinely infused being is intrinsically difficult. Without a clear Qur’ānic assessment of the temporal bounds of personhood, humans are left attempting to peg their reason with God’s will. In doing such, the individual schools of Islamic jurisprudence (madhhāb) have attempted to pinpoint the number of days after conception that a fetus may be considered an inviolable entity. Based on the writings of classical scholars Imām Bukhārī and Imām Muslim, traditional Sunni jurists generally agreed on the 120 day mark as the crucial threshold of fetal development (Sachedina, 2009, p. 90). While most schools agree that, at the latest, this is the point at which a fetus moves into personhood, there remains a disparity of opinion about the inviolability of the fetus before this point. The most liberal of the schools on this matter, the Hanafīs, find abortion to be permissible any time before the first 120 days (Katz, 2003b). By contrast, many in the Māliki school forbid abortion anytime after implantation in the mother’s womb. Some in the Shāf ’ī school, one with a spectrum of opinions within itself, have attempted to match the process of attaining the divine spirit with the formation of human physical features (takhalluq). According to a report of the Prophet from Ibn Mas’ud, God sends an angel to ensoul the fetus after “the drop of semen has spent forty-two days [in the womb]” (2003b, p. 30). Consequently, this faction of Shāf ’īs prohibits abortion after the forty-second day. As these variations show, no obvious method of finding the moment of ensoulment has emerged with great legal prominence. For this reason, and especially due to their lack of knowledge about embryology, Sachedina states that the classical jurists deferred to the physical features of the fetus after its ejection from the womb to assess the abortion’s criminality (2009, p. 185). Even as modern biotechnology allows the exact stages of biological development to be compared with the days prescribed in the cited reports of the Prophet, the metaphysics human ensoulment clearly cannot be assessed by scientific advancement. Thus, the large amount of ensuing conjecture precludes a clear-cut timeframe of human spiritual development to which Muslims can confidently adhere. While this lack of a rigid time standard certainly negates simplicity, Muslim jurists find themselves with an ability to judge each individual case rather than enforcing a blan-
ket standard. Near the end of her analysis of abortion in classical Sunni jurisprudence (fiqh), Marion Katz remarks that Islamic legal discussions reveal, “[the jurists’] underlying commitment to casuistry—that is, the examination of specific cases rather than the generation of abstract rules” (2003a, p. 46). She goes on to explain how being a casuist in this sense removes the negative connotation from the word in juxtaposition to supposedly universally applicable laws. Finding the circumstances under which Muslims can consider abortion permissible requires a balance of the values that such an act would invariably affect. Dealing with the termination of a potential life, especially of a spiritinfused fetus, forcibly brings into question the reasons for which it can be allowed. Even though jurists have focused on the severity of aborting a fetus after ensoulment, they have not simply condoned any termination beforehand. If any party involved (parent, doctor, jurist) seeks to abort the pregnancy, his motive for doing so must be examined. As previously explained, “in Islam, abortion… is decided on a case by case basis” (Bowen, 2003a, p. 52). Thus, despite the relatively strict or lax attitudes of the jurisprudential school to which one abides, the decision-maker cannot capriciously make a decision to abort. With this outlook, jurists are suited to contemplate the merit of the numerous circumstances in which an abortion is requested. Medical conditions arise in pregnancy that can jeopardize the life of not only the mother, but also the fetus. In many such situations, the termination of the pregnancy could subsequently save the mother’s life. Yet, the fetus may have attained the divine human spirit and perhaps could be saved itself at the expense of the mother’s life. Such a dilemma necessitates deciding how to balance the lives of two humans at very different stages. Substantiated by the classical rulings allowing womb dissection only to save the life of a child, abortion is deemed permissible, “only if it is certain that the mother’s life is in danger and that abortion is the sole recourse for saving the mother as dictated by the requirement to choose the lesser of two harms” (Sachedina, 2009, p. 195). Implicitly, this ruling seems to give primacy to the mother’s right to live over that of the fetus. Indeed, Hanafī scholars cite a report of the Prophet, where in the case of an abortion, he prescribes a ghurra (monetary compensation) to be paid by the one aborting rather than the more severe diya (blood money) prescribed for murder otherwise. Similarly, the other three schools gradually increase the ghurra depending on the stage of development. These rulings imply that the fetus has lesser legal status than the mother. Whether or not these legal rules (i.e. as opposed to ethical rules) justify abortion I shall discuss later. Nevertheless, this case paradigmatically shows the invocation a fundamental tenet of Islamic, jurisprudence—choosing the least harmful option—to deduce a difficult moral and legal question. Although most Muslim jurists have generally ruled in favor of the mother’s legal preeminence in this circumstance, they have done so without considering the ethical rights of the fetus. The latter concern emerges as a fundamental aspect of modern rulings.
where abortion was legalized). Realistically, however, the idea that developed regions would act as strong social communities that “provide for you and them” seems rather implausible (2003b, p. 70). This sort of reasoning proves to be a manifestation of one of Dr. Aroua’s central points: “Man’s judgment on abortion is always in an uncomfortable position between moral rigor and personal convenience” (1993, p. 55.). This acutely points out one of the main conflicts in abortion as well as most other modern issues of morality in traditional Muslim societies. Aroua believes that in such cases, contemporary Muslim scholars must use independent reasoning (ijtihād) to consider each presented situation. Similar to the circumstance of birth defects, the abortion of a child prospectively born into poverty begs a deeper understanding of how to pragmatically uphold religious principles in modernity. My explanations of these two main phenomena—the critical role of ensoulment and the circumstantial justification of abortion—show the infeasibility of a single broad opinion on the legality of abortion. However, to comprehensively understand the question at hand (i.e. why Muslims do not have set standards for abortion), I must also look at the methodology and motives behind the stipulations that do exist. One of the first major patterns in the foundations of classical rulings is the focus on discerning the amount of diya or ghurra to pay. An account of the Prophet’s son-in-law, ‘Alī (who Shī’a consider the first Imām), describes how he prescribed the positive correlation of blood money with the stage of development. One owes twenty dinars when aborting in the “sperm” stage, one-hundred dinars when “the bones are covered with flesh”, and 1000 dinars after ensoulment (Bahishti, 1974, p. 411). Correspondingly, the Caliph ‘Umar reportedly imposed a penalty of kaffāra (a Qur’ānic penalty requiring the emancipation of a slave or a two-month fast) on a woman who purportedly caused the miscarriage of another woman’s child (2003b, p. 28). In doing so, ‘Umar penalized the woman who caused it, and more importantly, served justice for the mother. Both of these cases show that the limits and restrictions on abortion were delineated to ensure the appropriate payment from the perpetrator to the victim. The jurists formulating these opinions did not give any significant consideration to the actual entity of the fetus and its potential personhood. The correspondence of the standards of abortion’s legality with the apportionment of monetary penalty raises serious ontological questions about the fetus in utero. This correspondence leaves the fetus, in what Katz terms, an “anomalous status” (2003b, p. 28). This anomaly, paradoxical in nature, involves giving certain legal protections to the fetus yet still not treating it as a “full-fledged” human. Whereas a fetus can typically not be aborted after receiving its human spirit from God, the one exception comes if it puts the mother’s life in danger as previously explained. Furthermore, due to the use of criminological standards, the notion of fetal inviolability before ensoulment does not evoke serious consideration. The payment of the ghurra,
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Another very pertinent issue in the contemporary Muslim world surrounds a fetus with known birth defects. Modern doctors can perform tests on the fetus to check for genetic malfunctions that could lead to chronic debilitation in that fetus’ future with relative ease. Given the potential burden that a birth defect can put on the parents, such a condition leads to questions about the legitimacy of abortion based on such information. Quite aware of the fragile implications of such an issue, Sachedina notes that, “any consideration regarding the fetus’s health raises serious questions as to what constitutes a sufficient defect to warrant abortion” (2009, p. 202). He argues that if Muslim jurists imply that any fetus with a birth defect may be aborted (they have already permitted aborting embryos with Down’s syndrome), then the justifiable limits of what may be considered a terminable abnormality become dangerously blurred. In Dr. Ahmed Aroua’s discussion of abortion in a more socially-oriented context, he lists, “detection of near-certain genetic risk… [that would make the child] incompatible with a normal life” (1993, p. 67) as acceptable grounds to “interrupt the pregnancy.” In diametrical opposition, former head of Al-Azhar University Jad al-Haqq hypothesized that just as modern science helps to find these defects early, it has progressively helped to treat/counteract them as well (Bowen, 2003a, p. 65). As such, unless it is endangering the mother’s health, the fetus ought to be afforded its rights to emerge as a human being (namely after the 120 day period). Clearly then, at least some semblances of independent fetal rights begin to emerge. Nonetheless, Sachedina’s skepticism of broad rulings on genetically defective fetuses shows how such rulings lead to the dreaded “slippery slope” phenomenon whereby extrapolated ethical standards know no bounds. In such discourses about circumstantial abortion, there is a highly relevant and oft-quoted (it starts Sachedina’s chapter) verse of the Qur’ān, 17:31: “Slay not your children for fear of poverty; we will provide for you and them. Surely, the slaying of them is a grievous sin” (Sachedina, 2009, p. 179). In effect, this verse condemns any notion that a child should not exist due to the destitute conditions into which he or she would be born. Taking into account the importance of mutual aid for those in the religious community (umma), community members must give the child sustenance such that, “God’s provision for his creations” (Bowen, 2003a, p. 70) becomes the primary focus in early life. Comparably, Sachedina contends that a number of rulings have fallaciously allowed for abortion to take place as a method of population control (2009, p. 180). However, the maintenance of the principles reported of the Prophet disallows economic and population considerations to be used as grounds for abortion (the Prophet himself was an orphan). Bowen (2003b) describes how modern practicality has overshadowed the aforementioned divine principles: Because of the prevalence of broken families and increasing economic liberalization in Muslim countries, preventing the birth of an impoverished child may seem sufficient justification for abortion (e.g. in Tunisia
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imposed after induced abortion and assumedly before ensoulment, implies a placement of monetary value on the fetus—to get out of a pregnancy, a woman must simply pay a fee. Moreover, given the fetus’ total dependence on its mother, the rulings of many Muslim jurists designate the fetus as a part of the mother’s body. While none of this negates Islam’s consistantly high valuation of a human life, Sachedina observes that, “most of the verses quoted against abortion actually deal with life’s sanctity,” as opposed to defining the bounds of such (2009, p. 187). Therefore, to better clarify classical rulings in modern times, the basis for ruling on the fetal status must transcend traditional legal technicality. Using Qur’ānic and Traditional [should tradition be capitalized?] (i.e. the reported stories of the Prophet) standards, Sachedina works to disprove the status quo from both philosophical and technical religious precepts. Regarding the devaluation of a fetus based on its insignificance on the Day of Judgment, he shows how such a viewpoint lacks a broader consideration for traditional views of the fetus. From a textual standpoint, Tradition asserts that, “the fetus will intercede on behalf of its parents on the Day of Judgment” (2009, p. 192), thus giving the fetus a degree of significance. To this end, Sachedina notes that the Tradition does not specify a developmental stage at which the fetus becomes qualified to do so. Since the Tradition unequivocally affords “the spiritual status of the fetus, then how can one say that it has not attained personhood and that its life is not inviolable?” (2009, p. 192). Similarly, a legal tradition regarding the case of a pregnant woman condemned to death does not differentiate between fetuses regarding its ensoulment status. Despite the stage of pregnancy at the time of condemnation, the execution must be postponed until the birth of the child, unless it conflicts with the welfare of an existing infant (2009, p. 193). While these cases do not prove concretely that a fetus has rights prior to ensoulment, they do show that jurists have often provided these rights when no monetary penalty is at stake. If a set of ethical standards can be established that gives the fetus its own rights to weigh before aborting, then perhaps Islamic law can elucidate the aforementioned blurry circumstantial justifications to abort. Because the standards for abortion were either attributable to the parents’ conditions or the interpretation-based standards of religious law, Katz’s perspective involves a look at the fetus as, “the node of complex relationships” (2003b, p. 38) that develop in accordance with the fetus. This, she explains, could allow the, “legal status of the fetus [to be] defined in its ability to enter relationships [and] defined by rights and obligations, with others” (2003b p. 38) She cites the writings of a 16th century Hanafī jurist Qadi Zadeh who differentiated legal rights from the legal responsibilities of a fetus towards society. A fetus has no legal responsibilities given its dependent status, yet because of its potential to attain full personhood (nafs) and thereby acquire legal responsibility in society, it must have recognized legal rights. This interpersonal and social outlook, which includes the fetus
in the discourse of rights, may be one of the necessary components of forcing the discourse of abortion to include distinct fetal rights within society. In the search for ethical underpinnings for fetal rights, to solidify standards for abortion, the similarities of the theories of two writers—writing 900 years apart—provides intrigue meriting further examination. As a classical Muslim thinker (d. 1111 c.e.), Abū Hāmid al-Ghazālī, provided substantive writings on the subject of abortion (2003b, p. 41). Although he staunchly opposed abortion, he framed it in a way that reflected his very unique perspective and spiritual disposition. Relatively late in his life, al-Ghazālī determined Sufism (Islamic mysticism) to be the most personally fulfilling avenue of practicing Islam. The nature of practicing Sufism largely involves meditation and spiritual introspection as a channel for becoming closer with God. Engaging Islam in this manner, al-Ghazālī found an intriguing interplay between the use of Sufism’s tenet of “moral self-improvement” and the rigid juridical aspects within Islamic legal principles (usūl al-fiqh). (2003b, p. 40). In his view, the latter must be used to regulate earthly “external” affairs whereas the former makes accessible “conditions of the heart” (2003b p. 40). Al-Ghazālī subsequently maintains that ideally, external and internal affairs must be treated as separate but complementary. As it pertains to abortion, allowing this relationship to exist would give way to the pre-eminence of “moral perfection” in matters of ethical legality. Thus, by not measuring every action by the stringencies of legal principle, Muslims have an opportunity to find a suitable morally based answer to the issue at hand. As a modern scholar of Islam educated and teaching in both the Middle East and North America, Sachedina attempts to underscore the practical and moral dilemmas of abortion in the Muslim world—a field that has been offered relatively little ethical reflection from recent Muslim scholars. One of Sachedina’s main arguments, transcending deontological concern for the fetus, involves the potential usage of embryos for ends such as stem cell research that disregard their inviolability (2009, p. 205). He fears that if Islamic medical professionals endorsing embryonic research disregard the “dimensions of embryonic sanctity,” ethics will lose its ability to appropriately check scientific advancement. In this light, he writes, “I am proposing… an educated partnership between medical profession and religious sciences in the Muslim world to solve the pressing problems in modern biotechnology with global dimensions” (2009, p. 205). This contemporary approach echoes the same basic premise about which al-Ghazālī wrote in the eleventh century. The main tenets of these two theories emphasize a type of dichotomization in which scientific knowledge and moral ethics are distinguished, yet capable of being interrelated. Formerly, the methodology of dealing with abortion involved a form of either grafting objective data onto subjective moral concerns or a disproportionate preference for either science or religion. The resulting jurisprudence has struggled to synthesize the clear de-
Ethics of Condition and Circumstance human spirit at the near-forefront, Islam must embrace religious and scientific epistemology, rather than forcibly attempt to mix them. Al-Ghazālī metaphorically refers to the mixture of the sperm and egg as the acceptance of a “contract” (2003b, p. 41), which, like any contract, cannot whimsically be voided. While many contracts account for specific conditions, the essential feature of the contract is to confirm a mutual agreement, not circumstantial exceptions. Analogously, since procreation is the purpose of procreating (obvious only in semantics), adjudications of abortion cannot deliberately circumvent this point by keeping criminology as the status quo basis for fetal rights. Whether or not, as Sachedina suggests, embryonic rights have been, “totally ignored” (2009, p. 205) by those Muslims endorsing stem cell research, uncertainties of the fetus’s ethical worth disallow any criteria to ensure some degree of inviolability. For this reason, the attribution of original fetal rights can bring about a redirection of the foundations for ruling on abortion. In this way, the ethical ambiguities become answerable to the primacy of universal morals, not universal law. Ari Schriber is a Sophomore at the University of Virginia majoring in Religious Studies.
References Aroua, Dr. A. (1993). Islam et Contraception. Algiers: Office des Publications Universitaires. (Self-translated). Bahishti, M. M. (1974). Rules of Abortion and Sterilization in Islamic Law. In I. Nazer, H. Karmi, & M. Zayid (Eds.) Islam & Family Planning (pp. 407-425). Beirut: IPPF. Bowen, D.L. (2003a). Contemporary Muslim Ethics of Abortion. In J. Brockopp (Ed.), Islamic Ethics of Life (pp. 51-76). Columbia: USC Press.
Katz, M. H. (2003b). The Problem of Abortion in Classical Sunni Fiqh. In J. Brockopp (Ed.), Islamic Ethics of Life (pp. 25-47). Columbia: USC Press. Sachedina, A. (2009). Terminating Early Life. In Islamic Biomedical Ethics (pp. 179-206). New York: Oxford UP.
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Prof. Abdulaziz Sachedina, the faculty sponsor for this submission, is the Frances Meyers Ball Chair Professor of Religious Studies. Address: P.O. Box 400126, Charlottesville, VA, 22904 Email: aas@virginia.edu
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scriptions and directives of the Qur’ān about personhood, with the empiricism provided by modern technology. The current prescriptive measures of abortion, therefore, do not meaningfully engage the recent scientific stipulations into the religious ethical standards of Islam. The intransience of the distinct human spirit first breathed into Adam persists as the locus of ethical premise on terminating life. As I have shown, the departure from this as the integral point of reference leads to dependence on standards developed in the name of legality or circumstantial problem-solving. Even with relative clarity on the legal implications of aborting a fetus, the dearth of ethical influence creates standards incongruous with the modern knowledge of embryonic development. In effect, attempts to rationalize the bases of abortion from the Prophet’s era with the influx of facts about embryology lead to the forcible imposition of scientific knowledge onto revelatory knowledge. Unable to use this as a comprehensive source of adjudication and without a centralized authority, Islam cannot put forth an immutable set of ethical principles simply by referencing the fetus’ progression in utero. Even if individual legal schools and their jurists attempt to judge on a case-by-case basis, the exclusive use of standards with criminological foundations leaves formidable uncertainties concerning the morality of aborting a fetus at any stage. While I have described cases in which abortion may be deemed necessary, new and unique circumstances invariably create caveats for which broad rulings (e.g. regarding mental/physical deformities) do not suffice. In order to create a utile point of ethical reference with the divine
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Article
Computers in Healthcare: Benefits and Risks of Electronic Health Records Julia Yinxin Zhu‡
Transforming paper-based health records to electronic health records (EHRs) has been an evolution in the field of healthcare in the past 15 years. The implementation of the EHRs has had a profound impact at many levels in Canadian and many other nations’ healthcare systems. This paper explores and analyzes both the positive and negative effects that EHRs would bring. The definition, scope, motivation and risks of implementing EHR systems have been carefully examined. Some concerns over privacy, confidentiality, security, as well as technology dependencies and reliability are also explored and discussed in this paper. Enhancing overall healthcare service and research outcomes has enhanced the progress of EHR. However, on the way to successful EHR implementation, a number of outstanding issues need to be resolved, including integration with old systems and interoperability among different healthcare institutions. To overcome the hurdles faced at the national, organizational and technical level, concerted actions by all healthcare stakeholders, policy makers, governments and other parties are needed.
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Introduction
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The development of computer science has profoundly changed human society. With the ubiquitous usage of computers, databases, internet and other related technologies, modern people are enjoying a more convenient, more efficient and healthier life than people had in any other historical time. In the field of healthcare, there has been an evolution from paper-based records to electronic health records (EHRs) throughout the world in the past 15 years. Integrated EHRs have the potential for enhanced sharing of information and communications among healthcare providers, therefore reducing healthcare costs and medical errors, as well as improving the overall healthcare quality, safety and research outcomes. In recent times, the focus in healthcare has changed from whether EHRs should be introduced to how to implement EHRs. However, since EHRs include sensitive information, this raises concerns over privacy, confidentiality and security of such information. Some also argue that integrating EHRs will make the healthcare industry overly dependent on the usage of computers and internet, which actually raises the bioethical concerns not only in loss of privacy, but also in technology dependence and risks. To analyze and evaluate the impact of EHR in healthcare system, this paper first explains the definition of EHR and investigates the terminology challenges around this concept. Furthermore, it explores and analyzes both the positive and negative effects that EHRs would bring. On the one hand, there are both challenges and risks involved
when introducing EHRs. On the other hand, the social, material and ethical rewards from a well-implemented EHR system are tremendous. At the end, the paper comes to the conclusion that concerted action by all healthcare stakeholders is necessary to ensure the benefits of EHRs exceed the risks.
Definitions of EHR/EHRs
An electronic health record (EHR) is a secure and private lifetime record of an individual’s health and care history, available electronically to authorized healthcare providers (“A Look at the Future,” 2008). By creating and providing a longitudinal view of clinical information, it “supports other care-related activities directly or indirectly, including evidence-based decision support, quality management and outcomes reporting” (“Electronic health records,” 2008). The goal of seeking and implementing an EHR solution is to provide accurate patient health information electronically to authorized healthcare organizations and individual professionals anywhere and anytime in support of care. In Canada, the key organization that promotes the development and adoption of EHR systems is the Canada Health Infoway Incorporated (Infoway), a federally funded, independent, non-profit organization with members coming from 14 federal, provincial and territorial Deputy Ministers of Health. The definition and interpretation of the EHRs and EHR systems in this paper derive from the explanation of Infoway. There are several terminology variations of EHR, includ-
‡ 206-555 Jervis St., Vancouver, BC V6E4N1. juliazyx@uvic.ca
Motivations and Benefits
There are many motivations related to the integration of EHRs in current healthcare industries, including the needs to reduce overall healthcare cost, to avoid medical mistakes and medication errors, to optimize billing processes, to improve overall patient care quality and outcomes, as well as to facilitate health research. These motivations, coming from both individual healthcare and clinical research perspectives, also reflect the numerous advantages that EHRs will provide over the traditional paper-based patient records. Physical records usually require significant amounts of space and cost to store them. Using EHR, large amounts of storage space are no longer required. Electronic record storage will also reduce the expenses of using paper, film, and other expensive physical media usage. In addition, EHR will enhance the sharing of health records among multiple locations. Paper records need to be stored in different locations and collecting and transporting them is both time-consuming and expensive. EHR systems will significantly save the costs in copying, faxing and transporting health records. Another problem of paper-based medical records is that because different healthcare organizations cannot share health records in time, the patients usually need to take repeated or redundant tests. In 2004, an estimate was made that 1 in 7 hospitalizations occurred when medical records were not available. Additionally, 1 in 5 lab tests were repeated because results were not available at the point of care. EHR solution can solve these problems effectively by supporting inter-organizational health record sharing. According to Evans et al., EHRs are estimated to improve efficiency by 6% per year, and the monthly cost of an EHR is offset by the cost of only a few unnecessary tests or admissions (Evans, Nichol, & Perlin, 2006). Another benefit EHR would bring is the reduction of medical errors. Handwritten paper medical records can be associated with poor legibility, which can contribute to medical errors. According to a ScienceDaily news article in June 2007, “illegible handwriting and transcription errors are responsible for as much as 61% of medication errors in hospitals.” Furthermore, a review of studies shows that hospitals that switched to computerized physician order entry systems in the US saw a 66% drop in prescription errors (“Computerized Doctors’ Orders,” 2007). In addition,
the adoption of EHR will help with the standardization of forms, terminology and abbreviations, and data input. The introduction of EHR will also help to optimize the medical scheduling and billing processes in a way that paper-based medical records cannot. An EHR system will electronically check insurance status upon patient check-in to find out whether the patient has coverage and what his or her co-pay amount will be. All of the information captured during a patient visit can be automatically transferred to the electronic claim. A scheduling plan can be made immediately after the patient data is captured and billing reports can be customized for the healthcare providers to show charges, cash receipts and billable services. It will also speed up the client bills and statements generation. Besides reducing costs and errors as well as expediating billing processes, EHR will also reduce the risks of health records loss that paper-based medical records usually have. Paper-based medical records are notoriously vulnerable to damage or disappearance. This is especially true under extreme situations. Hurricane Katrina’s destruction of Gulf Coast physician office practices has been cited as an example of the need for electronic medical information storage (Mandl, Szolovits, & Kohane, 2001). According to a federal government report in the U.S., “[T]the adoption of interoperable EHR systems will support first responders and health providers and dramatically improve the quality and efficacy of care to displaced patients across a population.” There is no doubt that the EHR system holds great promise for improving the efficiency and quality of patient care. In contrast to paper-based records, electronic records have clear advantages in organization, structure, and ease of retrieval. With a paper-based record system, doctors usually have to go through page by page trying to find out what has been done with the patient. With access to comprehensive information, which is possible with an EHR, doctors can read the patient data from electronic devices such as PDA and cell phone before they make rounds or talk with patients in person. An EHR system can also track patients when they are transferred among healthcare organizations. This is especially important for the patients who have serious allergies, specific needs for medication, or difficulties in communication. With a centrally stored database, EHR will also significantly enhance the research uses of care records, which have been referred to as the “secondary use” of patient care data. Health research, particularly in the areas of epidemiology, health policy, population and public health, critically depends on the secondary uses of existing health data, including hospital, physician and laboratory records. These records are usually in paper format and located in certain healthcare organizations, consequently it is difficult for public health researchers to access them. This situation impedes the efforts of health research to depict patterns of diseases, to improve prevention and treatment, as well as to develop health policies. As EHRs are typically stored in central databases and thus can be remotely accessed by
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ing Electronic Medical Record (EMR), Electronic Patient Record (EPR) and Computerized Patient Record (CPR). These terms are used interchangeably in many academic or non-academic works. However, a closer look will reveal that among all these terms, EHR holds the broadest semantic implication, which refers to a longitudinal view of clinical information. EMR is created and held typically by a general practitioner; EPR and CPR refer to the records about the periodic care provided mainly by one institution and typically relate to the healthcare provided to a patient by a hospital (Dick & Steen, 1997).
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any authorized user, they will overcome the drawbacks of paper-based records and facilitate new possibilities, benefits and convenience in the secondary use of health records, leading to great improvements in both individual healthcare and population or public healthcare. In sum, EHRs will not only reduce the costs of transporting and copying paper-based medical records as well as the costs of repetition of tests for patients, but also enhance the legibility of medical records. With EHRs, healthcare providers can speedily check a patient’s record, helping to minimize medical errors and improve patient care quality; scientists would have access to a wealth of data about diseases; public health officials would spot disease outbreaks quickly and track their spread (Foreman, 2006).
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Challenges and Risks
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Although EHRs would bring numerous benefits for healthcare service and improvement for healthcare system, the introduction of EHR solutions also comes with challenges and risks, such as the difficulties in adding older records, the complexity in introducing standards, the policy making to ensure privacy, confidentiality and security, as well as concerns for technology dependencies and reliability. Modern technologies have made the implementation of EHRs possible in most technical perspectives. However, how to migrate vast paper-based health records into an EHR system remains a challenge. Currently, most organizations that are implementing EHR systems scan important documents and then store the images in an unstructured format. According to Lærum, Karlsen and Faxvaag (2003), the rigid structure, slow processing, and limited functionality of the scanned document images have a negative impact on clinical work. Another method to convert written records into electronic format is to scan the documents then perform optical character recognition. However, about 4-10% of typed documents cannot be accurately recognized, not to mention most handwritten medical notes ( Jung, Liu, & Kim, 2008). For this reason, scanning documents is not only expensive and time-consuming, but also increases the risks of data loss and distortion. Challenges to introducing EHR systems also come from the demand of standards. As stated in earlier sections in this paper, one of the motivations of introducing EHR solution is to increase communication and collaboration among healthcare providers. The ability to exchange records among different EHR systems would facilitate the co-ordination of healthcare delivery in non-affiliated healthcare facilities. This is also called “interoperability”(“IEEE Standard Computer Dictionary,” 1991). For this purpose, nationwide standards, in both technological and semantic spheres, are needed. However, currently no single country or jurisdiction in the world has succeeded in developing a nation-wide/territory-wide standards system to facilitate an absolute barrier-free EHR solution. Besides the technology and policy challenges, privacy,
confidentiality and security are important considerations in the successful implementation of EHR systems. In our society, in terms of personal sensitivity, health-related information is considered to be second only to financial information. Issues of confidentiality and abuse of data cause many healthcare providers to oppose the integration of medical databases despite the potential benefits (Win & Fulcher, 2007). Undoubtedly, the implementation of EHRs needs to ensure privacy and confidentiality, though it is unclear if it can achieve this goal. According to a report from the U.S. Department of Health and Human Services, roughly 150 people including nursing staff, X-ray technicians and billing clerks, have access to at least part of a patient’s records during a hospitalization. The implementation of EHRs, however, is expected to enlarge the number. This brings the question: do we really want to make it easier for more and more people to see sensitive medical data? In a report entitled “Building Privacy by Design in Health Data Systems,” Alan Westin (2005) mentioned several key facts affecting the EHR implementation in the U.S., including: “an explosion in 2004-05 of incidents involving leakage and compromise of personal medical records from health providers, against a national backdrop of rapidly rising identity theft and fraud.” This has created a public concern regarding whether the benefits of further computerization and networking in healthcare are likely to outweigh the potential risks to privacy. More concerns about the privacy issues come from both the vulnerability of electronic records and the distrust of governments. As mentioned in Baase’s book (2008), many governments in the world have secretly been collecting the phone call records of tens of millions of people. And credit card information is vulnerable to hacking and accidental release. Some human rights experts claim that “the surveillance society has crept upon us, without our even realizing.” In these circumstances, many worry that EHRs may place highly sensitive information at risk to disclosure and breach, especially in the case of centrally stored EHRs. Some recent revelations of “secure” data breaches at centralized data repositories, in banking and other financial institutions, in the retail industry and from government databases, therefore have further raised the concern about storing EHRs in a central location (Gonzales, 2006). EHRs that are exchanged over the internet are subject to the same security concerns as any other type of data transaction over the internet. A case study by the eHealth Vulnerability Reporting Program (eHVRP), a collaborative of healthcare industry practitioners and technology providers shows that most healthcare information systems can be penetrated and control of data compromised. Unlike banking systems, most current health information systems have no elaborate security mechanisms monitoring them (Tucci, 2007). An EHR risk may also result from the concept of a unique identifier (UI) for each patient, which is essential for building a nationwide EHR system. To link between an
Computers in Healthcare EHRs face. A system failure that happened in January 2008 in Ontario brought public attention to the unreliability of electronic health information system. This accident affected 330 sites – roughly 5% of the medical clinics, hospitals and other health-care providers connected to the province-wide network. Hundreds of doctors across Ontario have been unable to access patients’ EHRs because of a failure in the province’s digital health network (Hamilton, 2008). Although in many other industries, a three-day loss of network and database connection would not be extreme, in healthcare it could create a life-or-death situation. From accidents like this, many healthcare professionals questioned whether the modern healthcare systems overly depend on computers and related technologies. Extensive system testing for reliability and contingency plan-making have received more emphasis in the field of health informatics. The implementation of the EHRs has had a profound impact at many levels in our nation’s healthcare system, involving both benefits and challenges. Enhancing overall healthcare service and research outcomes has enhanced the progress of EHR. However, on the way to successful EHR implementation, a number of outstanding issues need to be resolved, including integration with old systems and interoperability among different healthcare institutions. The issues related to privacy, confidentiality and security, as well as the concerns in technology dependencies and reliability are still the key topics in the successful implementation of EHR systems (Rynning, 2007). The hurdles that will be faced at the national, organizational and technical level will, however, not be insurmountable if are properly. A concerted action by all healthcare stakeholders, policy makers, governments and other parties is needed in order to streamline the process. The benefits for both patient care and health research are expected to be well worth the effort, and good planning will certainly pay off. Julia Yinxin Zhu is a Senior at the University of Victoria majoring in Health Information Science. Prof. Melanie Tory is the faculty sponsor for this submission. She is an Assistant Professor of Computer Science at the University of Victoria. Address: ECS Room 504, P.O. Box 3055, STNCSC, Victoria, BC V8W3P6 Canada Email: mtory@uvic.ca
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individual and his/her stored records, EHR systems must be capable of overcoming the current confusion in paperbased health record identifiers, where one patient may be known as 123ABC in one place and XYZ456 in another. For this reason, a single ‘cyber-identity’ approach has been advocated and has been implemented as an identity card in some jurisdictions. However, this is opposed strongly by some civil liberties groups, because they believe that it is only a short step from having a national unique identifier to carrying out cross-sector data (Neame, 2000). With modern technologies, such as computer matching, the UI may provide a key to harvest-and-match personal health information, especially if there are no proper legal protections. To deal with the above issues, many policy efforts have been taken to establish a nationwide/territory-wide framework of privacy and confidentiality rules in many nations and regions. Although cases are dealt with differently in different countries, it is common that the disclosure of sensitive information, such as health records, to governing authorities needs to be discussed with the patient and the patient’s permission sought beforehand. Several countries have enacted legislation to enhance information privacy of personal health information. The American HIPAA (Health Insurance Portability and Accountability Act) and Canadian PIPEDA (Personal Information Protection and Document Act) are two typical examples. HIPAA was passed in the U.S. in 1996 to establish rules for access, authentications, storage and auditing, and transmittal of electronic medical records (“Health Insurance Portability,” 2008). This standard made restrictions for electronic records more stringent than those for paper records. In Canada, PIPEDA was given Royal Assent in 2000 to establish rules on the use, disclosure and collection of personal information, including both non-digital and electronic form. In 2002, PIPEDA extended to the health sector in Stage 2 of the law’s implementation (“Personal Information Protection,” 2003). PIPEDA also promotes the development of standards for both the privacy and security of all health information used electronically. A successful partnership for administrative health data standards can promote the development of clinical data standards and their application in computer-based patient record systems. Although EHR shares many similar problems with paper-based records, such as the long-term maintenance for patients’ records and safeguard access, there are some unique problems that the developers and designers of
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Baase, S. (2008). A gift of fire: Social, legal, and ethical issues for computing and the internet (3rd ed.): Prentice-Hall. Computerized doctors’ orders reduce medication errors. (2007). Health Behavior News Service, Newswise. Retrieved Mar 31, 2008, from http://www.newswise.com/articles/view/530698/ Dick, R., & Steen, E. (1997). The computer-based patient record: An essential technology for healthcare. Washington, USA: National Academy Press. Electronic health records/overview. (2008, 02/28/2008). Retrieved Mar. 31, 2008, from http://www.cms.hhs.gov/EHealthRecords/ Evans, D., Nichol, W., & Perlin, J. (2006). Effect of the implementation of an enterprise-wide electronic health record on productivity in the veterans health administration. Health Economics, Policy and Law(1), 163-169. Foreman, J. (2006, June 26, 2006). At risk of exposure. Los Angeles Times. Gonzales. (2006). Fbi seeks stolen personal data on 26 million vets. Retrieved Mar. 31, 2008, from http://www.cnn.com/2006/US/05/22/ vets.data/index.html Hamilton, T. (2008, January 24, 2008). Glitch blocks mds from getting patient data. Toronto Star, The (Ontario, Canada), p. A03. Health insurance portability and accountability act. (2008). Retrieved Mar 31, 2008, from http://en.wikipedia.org/wiki/Health_Insurance_ Portability_and_Accountability_Act IEEE standard computer dictionary: A compilation of IEEE standard computer glossaries. (1991). Institute of Electrical and Electronics Engineers.
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Jung, C., Liu, Q., & Kim, J. (2008). A new approach for text segmentation using a stroke filter. Signal Processing, 2008(88), 1907-1916. Lærum, H., Karlsen, T. H., & Faxvaag, A. (2003). Effects of scanning and eliminating paper-based medical records on hospital physicians’ clinical work practice. Journal of American Medical Informatics Association, 10(6), 588–595. A look at the future. (2008). Infoway: Electronic Health Record Retrieved Mar. 31, 2008, from http://www.infoway-inforoute.ca/en/ ValuetoCanadians/EHR.aspx Mandl, K. D., Szolovits, P., & Kohane, I. S. (2001). Public standards and patients’ control: How to keep electronic medical records accessible but private. BMJ, 2001(322), 283-287. Neame, R. (2000). Communications and ehr: Authenticating who’s who is vital. International Journal of Medical Informatics(60), 185-190. Personal information protection and electronic documents act - implementation schedule. (2003). In Office of the Privacy Commissioner of Canada (Ed.). Rynning, E. (2007). Public trust and privacy in shared electronic health records. European Journal of Health Law, 14(2), 105-112. Tucci, L. (2007). Electronic medical records at risk of being hacked, report warns, CIO News. Westin, A. F., & Gelder, V. v. (2005). Building privacy by design in health data systems: Center for Social and Legal Research, American Medical Informatics Association. Win, K. T., & Fulcher, J. A. (2007). Consent mechanisms for electronic health record systems: A simple yet unresolved issue. J Med Syst, 2007(31), 91-96.
Article
Towards a More Ethical Medical Environment: An Analysis of the Role and Function of Hospital Ethics Committees
Jeremy Schifberg‡
Dr. Walter Davis of the Center for Biomedical Ethics at the University of Virginia nicely summarizes what the American Society of Bioethics and Humanities, the American Medical Association, the American Nurses Association and many other medical organizations have already made clear: A majority of those in the medical field endorse hospital ethics committees (HECs). For the purposes of this paper, HECs can broadly be defined as consulting bodies composed of an interdisciplinary group of members who aim to resolve the ethical dilemmas that arise in the course of hospital practices. And although there is near unanimity regarding the value of HECs in some form, there is no such consensus on how these committees should be structured or on what functions and roles they should fulfill. Indeed, despite the increased prevalence of HECs over time, there is still no clear understanding of the most effective means for implementing ethical proceedings within hospital settings. Instead, these programs are still implemented in an ad hoc fashion with no clear consistency in methods (Caulfield, 2007). Still, as initially proposed by the President’s Commission for the Study of Ethical Problems in Medicine and Biomedi-
cal and Behavioral Research, there are three functions that consistently arise in discussions concerning HECs: education, policy development, and case consultation (Van Allen, 1989). With these purported functions in mind, this paper aims to answer two distinct but related questions. First, what should be the chief purpose of HECs: to attempt to determine the moral or ethical resolution to cases, to establish a procedural framework or guidelines to make reasonable policy decisions, or both? And second, what should be the chief role of HECs: an advisory role or an activist, decision-making role? Here it is argued that HECs should have as their primary function the goals of educating and of helping to resolve cases in a moral or ethical manner while serving an advisory role only. The notion of an HEC arguably has its roots in a 1976 dispute involving the life support of a young woman who was left in a vegetative state following an auto accident. The court that saw the case recognized that it would be very difficult, given the limited medical expertise of most judges, for the courts to be consistently involved with patient care decisions, and thus suggested the new concept of a facility ethics committee that would elucidate proper action and aid a facility in managing the risk of the liability associated with failing to provide necessary care (Caulfield, 2007). In 1983, the concept of an interdisciplinary HEC was strongly encouraged by the President’s Commission for the Study of Ethical Problems in Biomedical and Behavioral Research. In 1992, the Joint Commission on the Accreditation of Healthcare Organizations ( JCAHO)
‡ 1420 Chicago Ave. Apt. 5B, Evanston, IL 60201. j-schifberg@northwestern.edu
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Clinical ethics consultation has always sounded like a good idea, at least in theory, to most of us in the healthcare field. Coping with the rapid advance of complex medical technologies, the exploding population of aging and chronically ill patients, and the uneasy tension between the traditional “art” of medicine and the realities of business-oriented healthcare organizations can often require of us additional information, specialized reasoning skills, and interdisciplinary collaboration – all demands that challenge our formal professional training…(Davis, 2006)
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Despite their short history, hospital ethics committees (HECs) have quickly become common in hospitals across the country. While there is a clear consensus on the value of these bodies, no such clarity exists regarding their ideal structure, function and role. Moreover, although HECs are present in hospitals nationwide, recent studies have indicated that they are utilized at surprisingly low rates. A lack of discussion and agreement about how HECs should function may underlie this phenomenon, thus this article aims to outline the optimal roles and functions of HECs. By means of an analysis of the three most common functions brought up in discussions of HECs – education, policy development and case consultation – this paper seeks to answer two distinct but related questions: First, should the chief purpose of HECs be to attempt to determine the moral or ethical resolution to cases, to establish a procedural framework or guidelines to make reasonable policy decisions, or both? And second, should the chief role of HECs be an advisory role or an activist, decision-making role? It is concluded that HECs should have as their primary function the goals of educating and of helping to resolve cases in a moral or ethical manner while serving a solely advisory role.
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began requiring a formal “mechanism” to assure that ethical issues in patient care were addressed. One study found that by 2000, over 95 percent of all community hospitals in the U.S. offered ethics consultation (Caulfield, 2007), and the most recent data, taken from a study published in 2007 in the The American Journal of Bioethics, found that 100 percent of hospitals with more than 400 beds offer ethics consultation services (Fox, 2007). Thus, in their contemporary context, HECs of some form are fixtures in American hospitals, and the value of interdisciplinary committees (often including medical professionals, religious representatives and ethicists) designed to help resolve ethical issues in hospitals is widely acknowledged. A typical HEC might, for example, work with a physician, patient and patient’s family to help resolve an issue over end-of-life treatment. However, the same 2007 study mentioned above also revealed that, at the median, the ethics consultation services analyzed in the study handled only 3 cases in the year prior to the survey, indicating that while there is general acceptance of the value of HECs, much work still needs to be done to increase their effectiveness. Thus, a discussion of their optimal role and function is timely and important. One of the primary functions of HECs should be to educate hospital staff and the community at large regarding pertinent ethical issues. The current need for widespread medical ethics education of physicians as well as the general public is particularly dire. Two reasons for this are immediately evident. First, modern society is generally ill-prepared for ethical discussions. Professor David Blake puts it succinctly:
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Over the last ten years a growing body of philosophical research and reflections has addressed the problematic state of ethical discourse in this society….the common impression one gets from these critiques is that Americans no longer have a single, common, comprehensive, and coherent way of addressing ethical issues or dilemmas (Blake, 1992).
There is no singular, agreed-upon method for addressing ethical dilemmas, and few involved with hospitals, professionally or indirectly, have extensive backgrounds in ethics. Second, the incredible rate at which technology is currently advancing makes bioethics a particularly challenging ethical realm. Entirely novel cases resulting from new treatments and medical technologies mean even those well-read in ethics may find these particular discussions difficult or unfamiliar, and there may be no precedent to rely on for a particular case. HECs, however, are uniquely well-situated to aid in these discussions and help with the education of physicians and the public alike. Although the precise, optimal composition of HECs is a contentious issue and beyond the scope of this paper, it is widely acknowledged that HECs are ideally interdisciplinary bodies, often consisting of physician representatives, ethicists, religious representatives, laypeople or some combination thereof. And as these bodies typically include people who specialize in medical ethics, they are in prime position to help alleviate the problem described above and to further ethics education and awareness. Moreover, broader discussion and education
regarding bioethical issues will help bring both hospital staff and the wider community onto the same discursive ground, aiding in creating a common ethical language from which specific discussions of cases can be enacted more effectively. In this way, the dual roles of educative body and case reviewing body can be mutually reinforcing. Thus, there is a clear need for increased bioethical education, and HECs can effectively serve that function. With education justified as a vital function of HECs, the function of case consultation will now be discussed. Alongside education, the other primary goal of HECs should be to help resolve contentious cases in an ethical manner. Clinicians typically are not trained ethicists, and may not, given the busy and rigorous nature of their profession, be ideally situated to tackle ethical dilemmas. Indeed, empirical results have indicated that ethical dilemmas that arise during clinical practice are frequently left unresolved precisely because of a lack of suitable skills applicable to the situation (Bernardi, 2007). Also, given the logistical difficulties and amount of time associated with bringing a case to court, the legal route may be problematic as well. Indeed, as described earlier, it was largely these concerns that led to the notion of HECs in the first place. Thus, case consultation is perhaps the primary and most important function of HECs. Moreover, committees that take on this function likely help preserve the psychological wellbeing of physicians. Ethics committees can relieve some of the burden from those who, without consultation, would have to make these difficult decisions on their own. This can help prevent second-guessing and guilt on the part of clinicians. This is not to say that the responsibility of physicians should be abdicated, but rather that this is an important issue, as second-guessing and guilt could certainly influence the quality of future patient care. HECs that serve a case consulting role also help families cope with difficult medical decisions and have symbolic importance. They are well-situated to lend support and advice to families in difficult circumstances and can help prevent the perception that a lone authority figure (i.e. the presiding physician) is simply pushing his or her own agenda. This latter point is important as it relates to the wider community as well. Controversial hospital ethics cases are often big news, and having an HEC involved in the case consultation can help lend legitimacy to a decision and create a better perception of the hospital and the larger medical community in the eyes of the public. This is true, because the introduction of a plurality of views and voices prevents the perception that an all-powerful physician can use his or her expertise to take advantage of a court and further his or her own ethical agenda. In this way HECs can be an important symbolic force. Even if they have little actual substantive influence on the involved parties or the decision made, their involvement in a case consulting function lends legitimacy to a decision. This is empirically proven. A study published in 2003 divided 551 patients with whom value-related treatment conflicts (typically issues regarding end-of-life/life-sustaining treatment) arose
(T)he ethics committee will generally do its job best if it does not concern itself with the hospital’s interests…it may be the one decision-making body that remains fully insulated from the need to act as a team player in a competition which rewards narrow institutional gains, rather than success in meeting community needs (Wikler, 1989).
This problem could even go so far as to affect the make-
up of the committee itself, as the hiring or appointing of ethics committee members by hospitals may very well be carried out to serve management interests (Leavitt, 2000). One can easily imagine, for example, a committee being pressured to advocate liberal do-not-resuscitate policies in order to conserve resources. While these problems may exist to a degree with any function an HEC carries out, they are certainly worsened in a situations regarding broad hospital policy but mitigated in the context of individual case consultations. Clearly, making policy development a primary function hinders the ability of HECs to consult in the best interests of patients and the community by increasing the degree of institutional pressure. On the other hand, establishing education and case consultation as the primary functions of HECs fosters a more ethically aware hospital environment and thus may even serve the additional and indirect function of increasing the likelihood of ethically sound policymaking. Hence, HECs should deemphasize their role in policy development and should hold education and case review as their primary functions. While HECs can certainly aid in the development of hospital policies by facilitating dialogue and providing ethical consultation, policy development should not be a primary function of HECs and should be largely carried out by administrators. This answers the first overarching question outlined at the outset of this paper. The chief purpose of HECs should be to serve as an ethical body concerned with resolving cases, not a body primarily concerned with establishing procedural guidelines. With that established, a discussion of the proper role of HECs – advisory or decision-making – is necessary. Taking only an advisory role is required to preserve physician autonomy and for HECs to remain viable and well-utilized. The relationship between the physician who is treating a patient and the HEC is important, because the clinician must call in the HEC if it is to become involved with a case. If HECs were to take on a decision-making role, they would strain this relationship by restricting physician autonomy and significantly reducing physician authority. This would likely result in doctors being less likely to call on HECs in the first place, creating a worst-case scenario where, even when faced with ethical dilemmas, physicians neglect to utilize the HEC for fear of losing control over their patients. Indeed, an American Society of Bioethics and Humanities (ASBH) position paper published in 2000 calls an approach that emphasizes consultants as primary moral decision-makers “authoritarian”. According to the ASBH, the organization that represents clinical bioethicists, ethics consultants should gather facts, clarify relevant ethical issues and help identify resolutions (Aulisio, 2000) Thus, HECs should properly fill an advisory role, not one of decision-maker. The Judicial Council of the American Medical Association takes this position as well, writing explicitly that HECs should be “voluntary, educational, and advisory in purpose so as not to interfere with the primary
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during the course of treatment and divided them into two groups: an intervention group to which ethics consultation (often in the form of an HEC) was proactively given and a control group to which usual care without proactive ethical intervention was given. The study found that although the two groups showed no difference in mortality and small reductions in hospital days, ICU days and life-sustaining treatments, the vast majority (87%) of physicians, nurses and patients/surrogates felt that the ethics consultations were helpful in addressing conflicts (Schneiderman, 2003). Thus, while HECs serving case consulting functions can certainly influence the decisions made by involved parties to some degree, there is also clear evidence that their presence in consultation can reassure those involved that a given outcome was satisfactory, even if the ethics consult likely caused little or no change in the substantive choices made. The value of HECs serving educational and case reviewing functions is clear, and the mutually reinforcing nature of those functions has also been established. Moreover, creating a common ethical language and furthering involvement with ethical resolutions of concrete cases can only serve to promote a more ethically aware hospital environment. This surely has the effect of aiding in a more ethical approach to policy development, the third purported function of HECs. The distinction between the functions of case consultation and policy development is subtle but important. While case consultation involves the ethical review of specific instances, policy development is focused on creating general hospital policies regarding, for example, advanced directives, identification of surrogates and orders not to attempt resuscitation. Thus, the former can be thought of as dealing with applying ethics to resolve particular cases, while the latter is more general and procedurally based. With education and case review already justified as important functions of HECs, policy development will now be addressed. Policy development embroils HECs in legal and administrative issues that take away from their other functions and thus should be subordinate to the primary functions of education and case consultation. Issues of policy development are necessarily intertwined with the administrative interests of the hospital and are thus often tainted by motives such as profit maximization and resource conservation. Therefore, having policy development as a primary function of HECs is problematic, as the same administrators concerned with these interests often pay the salaries of those on the committee, thus creating the potential for undue influence of members of the HEC. This could shift the focus away from the needs of the community, as Daniel Wikler notes:
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Hospital Ethics Committees responsibility and relationship between physicians and their patients” (“Guidelines for ethics committees in health care institutions. Judicial Council.,” 1985). It is imperative that the role of HECs be strictly advisory; else there is clear incentive for physicians to avoid involving them in the first place. An advisory role is also preferable in order to avoid dangerous issues of legal immunity and a poor distribution of responsibility. Placing HECs in an advisory role forces physicians to remain accountable and responsible for patient care. Embracing a decision-making role, on the other hand, abdicates clinicians of responsibility and may force legal immunity to be granted to HECs in order for them to be willing to make decisions. In order for ethics committees to function effectively without the constant fear of liability, those who comprise the committees and follow proper procedures may need immunity. Thus, HEC members may require legal protection if they are to be decision-makers (Fleetwood, 1994). This is problematic because it represents a significant shift in power and authority to HECs:
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Immunity-conferring statutes…would give ethics committees vastly increased authority…if ethics committees are to change from arenas for discussion to decision-making bodies, we need to examine our expectations and to ask if committee members are sufficiently qualified and if committee processes are rigorous enough to merit such an authoritative role (Fleetwood, 1994).
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While HECs have a great deal of value in an advisory role, their lack of consistent, rigorous procedures or due process makes granting them immunity and vesting so much authority in them an issue. A decision-making role for HECs would take power out of the hands of doctors, meaning they would not need to be accountable for their patients. This would leave no one legally accountable for patient care. Also, giving HECs decision-making power would shift responsibility for the patient away from the physician who is most familiar with the medical intricacies of the case towards a body that may be more prepared to consult or discuss than to make a decision on a grave medical matter. This represents an erosion of the physicianpatient relationship. Ultimately, HECs are much better suited for an advisory role, helping doctors resolve difficult
cases and promoting education in the hospital environment. The above analysis answers the second overarching question outlined at the outset of this paper. The chief role of HECs should be advisory, not decision-making. With both of the questions that drove this investigation answered, a clearer picture of the optimal arrangement for HECs emerges. These committees should consider education and case consultation as their primary functions, as these goals are mutually reinforcing and serve to create a more ethically aware and educated hospital and communal environment. This, in turn, can only aid in establishing more ethical hospital policies. Moreover, these committees should serve an advisory role only, not a decision-making role. By giving physicians more of an incentive to call on the help of HECs, committees that serve an advisory role should help to change the current reality of ethics committees advising only a very small number of cases. With advances in medical technology posing new ethical dilemmas at a rapid pace, the need for hospitals prepared to deal with these issues is perhaps more dire now than ever before. HECs represent a valuable model for aiding in the handling of difficult ethical problems, but if they are to be successful, their role and primary functions must be clearly defined. This paper aimed to address the optimal role and functions of HECs. A well-operated and successful HEC has the potential to aid in finding satisfactory resolutions to difficult cases as well as to promote a more ethical medical environment. These are developments from which all parties – clinicians, patients and the public alike – stand to benefit.
Jeremy Schifberg is a Junior in the Integrated Science Program at Northwestern University. He is pursuing a triple major in Integrated Science, Biological Sciences and Mathematics, as well as a certificate in Managerial Analytics from the Kellogg school of Management. Prof. Mark Sheldon, the faculty sponsor for this submission, is the Assistant Dean, and the Distinguished Senior Lecturer in Philosophy and Medical Humanities and Bioethics Program in the Feinberg School of Medicine. Email: sheldon@northwestern.edu
References Aulisio, M. P., Arnold, R.M., & Youngner, S.J. (2000). Health Care Ethics Consultation: Nature, Goals, and Competencies. Annals of Internal Medicine, 133(1), 59-69. Bernardi, A., Jirillo, A., Pegoraro, R., & Bonavina, M. G. (2007). Allocation of public sources in oncology: which role can ethics play? Annals of Oncology, 18, 1129-1131. Blake, D. C. (1992). The Hospital Ethics Committee Health Care’s Moral Conscience or White Elephant? The Hastings Center Report, 22(1), 6-11. Caulfield, S. E. (2007). Health Care Facility Ethics Committees New Issues in the Age of Transparency. ABA human rights, 34(4). Retrieved from http://www.abanet.org/irr/hr/fall07/caulfifall07.html Davis, W. (2006). Failure to Thrive or Refusal to Adapt? Missing Links in the Evolution from Ethics Committee to Ethics Program. HEC Forum, 18(4), 291-297. Fleetwood, J., & Unger, S. S. (1994). Institutional Ethics Committees and the Shield of Immunity. Annals of Internal Medicine, 120(4), 320-325.
Fox, E., Myers, S., & Pearlman, R.A. (2007). Ethics Consultation in United States Hospitals: A National Survey. The American Journal of Bioethics, 7(2), 13-25. Guidelines for ethics committees in health care institutions. Judicial Council. (1985). Journal of the American Medical Association, 253(18), 2698-2699. Leavitt, F. (2000). Hospital ethics committees may discourage staff from making own decisions. British Medical Journal, 321(7273), 1414. Schneiderman, L. J., Gilmer, T., Teetzel, H.D., Dugan, D.O., Blustein, J., Cranford, R., Briggs, K.B., Komatsu, G.I., Goodman-Crews, P., Cohn, F., & Young, E.W.D. (2003). Effect of Ethics Consultations on Nonbeneficial Life-Sustaining Treatments in the Intensive Care Setting. Journal of the American Medical Association, 290(9), 1166-1172. Van Allen, E., Moldow, D. G., & Cranford, R. (1989). Evaluating Ethics Committees. The Hastings Center Report, 19(5), 23-24. Wikler, D. (1989). Institutional Agendas and Ethics Committees. The Hastings Center Report, 19(5), 21-23.