HKMUN 2014 World Health Organization Topic 1: Drug Patents and Generics
NOTE This document serves as an introductory report on the topic of Drug Patents and Generics for HKMUN 2014. While this document outlines the framework and the scope for this topic, further reading and extra research in regards to current affairs and your country’s domestic/foreign policies are highly recommended.
Introduction Drug Patents and Generics have been extensively debated in regards to the intellectual property rights, but they can also impact global public health, especially providing wider access to essential medicines. A generic drug is a legally approved pharmaceutical product without a brand name but is as effective as the original brand-named product. Since it is marketed under a non-proprietary name, it is significantly cheaper than pharmaceutical drugs sold under patents. It is intended to give more people, especially the economically deprived families, to have access to medicines. A pharmaceutical patent is a grant made by a government that grants the manufacturer of a drug the sole right to produce, utilize and sell that drug for a certain period of time. The international community has been recognizing “the right to health� in various national constitutions and legally binding human rights treaties in the past 30 years. This includes the right of every individual to access the highest attainable standards of health; every human being should have access to essential medicines and health services to treat priority health conditions as defined by the World Health Organization. However, the WHO reported in 2012 that only 51.8% of public and 68.5% of private health facilities in developing countries are able to provide patients with essential medicines. Since pharmaceutical drugs in those countries cost multiple of international reference prices, many low-income families are prohibited from obtaining medicines and treatments that they need. Having multiple family members suffering diseases further aggravate the general health of a household, and many families could not even afford the lowest-priced generic drugs. Generic drugs become important as significant proportion of the people in world’s low- and middle-income countries are suffering from preventable and treatable illnesses, such as tuberculosis and cholera. Furthermore, they are able to reduce morbidity and mortality among people living with HIV/AIDS by producing antiretroviral therapy as generic substitution. Unfortunately, the Millennium Declaration of 2001 to achieve universal access to antiretroviral therapy for all who need it by 2010 was missed. As pharmaceutical companies continue to raise prices of medicines in developing countries or generic drugs are not sufficiently sold into market with affordable prices, many international targets for global public health may default as a result of slippery slope. In this conference, it is the duty and responsibility of delegates to examine the current situation of drug patents and generics in relation to access to medicine on an international scale. Additionally, by analyzing the flexibilities of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), delegates should come up with practical solutions that would satisfy the current public health objectives of the WHO. Delegates should use this study guide along with their personal research to find and construct the stance to be taken in the conference. Source: http://www.who.int/medicines/mdg/mdg8report2012_en.pdf
Key term
Definition
Explanation/Significance
Generic drugs
“A generic drug is a pharmaceutical product, usually intended to be interchangeable with an innovator product, that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights.” (WHO – Glossary of globalization, trade and health terms)
1. Marketed under a non-proprietary or approved name (not a brand name)
2. A brand name is a name given to a drug by the manufacturer – the use of the name is reserved exclusively for its owner
3. Usually as effective as but less expensive than brand-named drugs
4. Their low prices allow the poor to have access to medicine
5. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement does not forbid governments from allowing generic substitution (Doha Declaration)
6. Argued that competition between drug companies
and generic producers has been more effective than negotiations with drug companies in reducing the cost of drugs, especially ones used to treat HIV/AIDS
7. Not to be confused with counterfeit medicine. It is a type of medicine that is illegally mislabeled in regards to identity and/or source, such as having the incorrect ingredients, lacking active ingredients or with incorrect quantities of active ingredients or forged packaging. Counterfeiting can occur to both branded and generic drugs Pharmaceutical Patents
“A patent is a title, grated by the public authorities, conferring a temporary monopoly for the exploitation of an invention on the person who reveals it, furnishes a sufficiently clear and full description of it and claims this monopoly.” (WHO – Glossary of globalization, trade and health terms)
A pharmaceutical patent is a grant made by a government that grants the manufacturer of a drug the sole right to produce, utilize and sell that drug for a certain period of time.
1. Also referred to as chemical patent or drug patent. Not to be confused with patent medicine
2. Obtaining a pharmaceutical patent has similar
legal procedures compared to obtaining a grant in other fields – an invention must consist of novelty and could not be reproduced by a person with an average technical knowledge; must be accepted as “patentable” under law
3. Ongoing debate over what is classified as
“patentable” – are scientific theories, discoveries of natural substances and new methods or medical treatment (ex. medical advice on-line) patentable?
4. A manufacturer (patent owner) may give
permission to other parties to use or sell the invention in the form of a license
5. A patent is a mechanism for providing a profit incentive for investment in research and development
6. Patented drugs must go through rigorous testing
and approval before they can be put on the market
7. The patent holder of a drug can charge a high price
on the invention because there is no competition for the original product (market monopoly) -> people in the developing world cannot afford them
8. If parties other than the patent holder wishes to market the patented product, they must obtain a voluntary license under Trade-Related Aspects of Intellectual Property Rights (TRIPS)
9. A judicial or administrative authority of a country can waive the need for a voluntary license in the events of a national emergency, extreme urgency, or public non-commercial use
10. Doha Declaration of 2001 agreed that countries could break patents in the interests of public health Therapeutic substitution
A form of drug substitution. Occurs when a pharmacist substitutes a chemically different drug for the drug that the physician actually prescribed. The drug substituted by the pharmacist belongs to the same pharmacologic class and/or to the same therapeutic class.
The difference in chemical structures between the prescribed medicine and the substituted drug can cause potentially adverse outcomes for the patient.
(World Medical Association) Parallel imports
Goods that are imported into a country without the authorization of the intellectual property right holder for that country, but all the goods have been legally placed on sale in another country. (WHO – Glossary of globalization, trade and health terms)
Compulsory licensing
Governments may issue a license to allow the use of an invention, including a patented drug, without the consent of the patent holder on grounds of public interest (WHO – Glossary of globalization, trade and health terms)
Essential medicines
Essential medicines are drugs/services that satisfy the priority health care needs of the population. (WHO)
1. Used as a method to provide safeguards against a patent holder who charges excessively high prices in a particular market.
2. Recognized as TRIPS public health safeguards as it enhances the affordability and availability of medicines
1. Used as a method to provide safeguards against a
patent holder who charges excessively high prices in a particular market.
2. Recognized as TRIPS public health safeguards as it enhances the affordability and availability of medicines
1. Essential medicines are selected with due regard to public health relevance, evidence on efficacy and safety and comparative cost-effectiveness
2. They are intended to be available within the
context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford
3. The Model List of Essential Medicines prepared by the WHO Expert Committee is a guide for the development of national and institutional essential medicine lists, and not designed as a global standard. However, the Model List has led to a global acceptance in the past three decades on grounds of a global acceptance of the concept of essential medicines as a powerful means to promote health equity. Most countries have national lists and some have provincial or state lists as well. National lists have been used for the training and supervision of health workers. The most recent version of the Model List was published in April 2013 (18th edition).
4. WHO recognizes essential medicines as one of the
most cost-effective elements in modern health care
(WHO)
Explanation of the Problem •
What can generic drugs be used for?
•
Implications of pharmaceutical patents
Access to Medicines in relation to Human Rights The provision of access to medicines depends on four main factors:
1. Rational selection and use of medicines 2. Affordable prices (mostly affected by globalization) 3. Sustainable financing 4. Reliable health and supply systems Developing countries are heavily reliant on the availability of affordable medicines, as expenditure on medicines consists of a large proportion of health costs. However, current trade in medicines mostly takes place between developed countries, with developing countries accounting for only 17% of imports and 6% of exports. WHO estimates that one-third of the developing world is unable to attain essential medicines on a regular basis. Since the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement grants extensive patent rights to pharmaceutical companies, some argued that the agreement will prevent developing countries from manufacturing or purchasing generic drugs that are significantly cheaper than brand name drugs. The United Nations Development Program (UNDP) has questioned the TRIPS agreement against human rights law (“the right to health”) due to its impact on access to essential drugs in low-income countries. The right to health first emerged as a social right in the WHO Constitution of 1946 and in the universal Declaration of Human Rights of 1948. It is
then recognized in other legal instruments, including the International Covenant on Economics, Social and Cultural Rights (Article 12.1 and 12.2) of 1966, which is legally binding. The World Health Organization Constitution (1946): “Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition (...)”
The right to the highest attainable standard of health = "Right to Health"
Universal Declaration of Human Rights (1948): Art.25.1 “Everyone has the right to a standard of living adequate for the health of himself and of his family, including food, clothing, housing and medical care and necessary social services”
The International Covenant on Economics, Social and Cultural Rights further declared that the right to health care includes the right to emergency care and health facilities, goods and services. This covers the provision of essential drugs as defined by the World Health Organization. Source: http://www.who.int/trade/glossary/story002/en/ http://www.who.int/medicines/areas/human_rights/en/
Essential Medicines (please refer to the table above for detailed explanations) Essential medicines are pharmaceutical drugs that satisfy the priority health care needs of a population. The World Health Organization selects them with regards to disease prevalence, safety, efficacy, and comparative costeffectiveness, and they are listed to the WHO Model List of Essential Medicines. Including over 350 medicines to treat priority conditions, the Model List is updated biannually using a transparent evidence-based process backed up by clinical treatment guidelines. With the advice of this list, countries are expected to develop their own national essential medicines list based on priority health care needs of their populations. The list is not binding the implementation of the concept of essential medicines is intended to be flexible and adaptable to many situations, and countries are expected to take responsibility for identifying which drugs are important in their contexts. Many international organizations, including UNICEF, UNHCR and UNFPA, and nongovernmental organizations have adopted the Model List to supply medicine. The list is available to the general public via the WHO Essential Medicines Library, an online service that provides access to information concerning medicine. The selection of essential medicines has a considerable impact on the quality of health care and the cost of medical treatment. The WHO argued that identifying a limited number of essential drugs would lead to better supply, more effective use, and lower costs. In relation to pharmaceutical patents, some argued that patenting restricts access to essential drugs in developing countries that endangers and hinders betterment in public health. While generic drugs can resolve the problem of cost, some new drugs cannot be legally produced as generic drugs. Generic drugs can only be produced in cases where: a) the patent has expired; b) the generic company certifies the brand company’s patents are invalid; c) for drugs which have never held patents, or d) in countries where patents are not enforced by law. Source: http://www.who.int/topics/essential_medicines/en/ http://www.who.int/mediacentre/factsheets/fs325/en/index.html http://www.who.int/medicines/services/essmedicines_def/en/index.html
http://www.news-medical.net/health/Drug-Patents-and-Generics.aspx
Past International Actions Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Doha Declaration The TRIPS Agreement was created in January 1995 to introduce minimum standards for protecting and enforcing intellectual property rights at the international level. Article 27.1 of the treaty requires members of the World Trade Organization (WTO) to make patents “available for any inventions, whether products or processes, in all fields of technology”, including patents for pharmaceutical products and processes. Countries are required to abide by the minimum term of protection under the TRIPS Agreement, 20 years from the date of filing application for the patent. However, the Doha Declaration of 2001 states that the TRIPS Agreement “does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.” Nevertheless, pharmaceutical patents do play an important incentive for the development of new medicines and their protection; Article 7 of the TRIPS Agreement states that “the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge in a manner conductive to social and economic welfare, and to a balance of rights and obligations.” While the TRIPS Agreement instituted various obligations and protection in regards to intellectual property rights, WTO Members retained the following flexibilities:
Moreover, some key terms were not clearly defined in the TRIPS Agreement:
•
“invention”
•
“new/novel”
•
“involve an inventive step/non-obvious”
Member states are also expected to apply the three criteria of patentability – novelty, inventive step and industrial applicability, which are not firmly defined in the agreement, within their national laws. Source: http://www.who.int/phi/phi_trips_policybrief_en.pdf
Proposed Solutions Delegates are expected to mention flaws in past international policies and actions when outlining solutions. In regards to the second factor of the provision of access to medicines, affordable prices, here are some strategies recommended by the WHO to increase affordability of medicines:
•
To develop pricing policies and reduce taxes/tariffs
•
To promote competition for multi-source products
•
Use generic medicines
•
Encourage equity pricing and competition for single-source products. Equity pricing policies ensure that the price of a drug is fair, equitable and affordable from the point of view of the public. Arguments in favor of equity pricing claim that the poor should pay less for essential medicines.
•
Encourage differential pricing (a.k.a tiered pricing), which sells the same drug to different buyers at different prices. It aims to increase the affordability of medicines but also generating revenues for the pharmaceutical industry at the same time. The strategy has significantly reduced the cost of many HIV/AIDS therapies by up to 90% in low-income countries, while they continue to be sold at market price in developed countries. Critics of differential pricing argued that the strategy will cause product diversion, with cheaper drugs leaking back into wealthy countries.
•
Encourage the use of therapeutic substitution
•
Promote competition under the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), such as parallel importation and compulsory licensing
The Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property Evaluate the elements of the strategy outlined in May 2008 resolution WHA61.21:
1. Prioritizing research and development needs 2. Promoting research and development 3. Building and improving innovative capacity
4. Transfer of technology 5. Application and management of intellectual property to contribute to innovation and promote public health
6. Improving delivery and access 7. Promoting sustainable financing mechanisms 8. Establishing and monitoring reporting systems Source: http://www.who.int/phi/implementation/phi_globstat_action/en/index.html http://apps.who.int/gb/ebwha/pdf_files/wha61-rec1/a61_rec1-part2-en.pdf
Case Studies
India’s Criteria for “Patentability”
The Indian Patents Act introduced the following criteria (Section 3d of Patents Amendment Act of 2005): “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.”
In 2007, a patent organization filed an opposition against the Indian Patent Office for its refusal to grant a pharmaceutical company for the cancer drug imatinib mesylate. Using the section above, the Indian Patent Office justified its refusal that the beta-crystalline form of imatinib mesylate is merely a new form of a known substance without the enhancement in its effectiveness, thus rejected to issue a patent for the pharmaceutical manufacturer. The company filed two lawsuits against the patent office: 1) Imatinib mesylate fulfills the criteria of patentability as it enhances the efficacy of a known substance; 2) Section 3d does not comply with the TRIPS Agreement and it is directly against the Indian Constitution. The court rejected both cases in 2009 and 2007 respectively. The patent applicant appealed the first lawsuit, and the decision on whether a new form of a known substance can be patented is pending – this will have a significant impact on many drugs, as more drugs will be eligible for patents if every new form of a known substance must be recognized.
Relevant Partners In developing a national medical policy of essential drugs, generic drugs or pharmaceutical patents, the usual partners include the Ministry of Health, government departments, missions, academia, pharmaceutical industry and professionals. In order to promote wider cooperation, resolution should also outline the possible roles of:
•
Rural communities & local governments
•
Nongovernmental organizations (NGOs)
•
Patient and consumer groups – possibly through advocates and awareness campaigns
•
Representatives of vulnerable groups (ex. low-income, ethnic minorities)
Questions Resolution Must Answer Considering that the promotion of “the right to health” is a principle purpose of the WHO, delegates must address the following in regards to pharmaceutical patents:
•
How can countries use the flexibilities of the WTO agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to increase access to essential drugs?
•
On what standards and strategies should countries regulate pricing for pharmaceutical drugs so that more people can have access to essential medicines? (“freedom from discrimination”)
•
How can ethical competitions among pharmaceutical companies be encouraged with the aim to increase access to medicines and to improve the quality of pharmaceutical products?
•
How can the WHO ensure commitment from governments to regularly update therapeutic selections (including the essential medicines list) to reflect new medical options and changing needs?
•
How can generic drugs be used to ensure sufficient access to essential medicines in developing countries?
•
Should government ever intervene the use of generic drugs? In what occasions?
•
Does right to health include quality of life?
•
What roles can generic drugs play in countries where the “right to health” is not granted in their constitutions?
•
How can the WHO ensure that the Model List of Essential Medicines apply outside of the scope of national governments (refugee camps, ships, etc.)?
•
How can the international community encourage member states to regard human rights as the framework for creating national policies in regards to generic drugs and pharmaceutical patents?
•
Are there criteria for what can be classified as “patentable”?
•
How can countries promote generic competition?
•
What can potentially replace intellectual property rights to become the incentive for the development of new pharmaceutical products? Otherwise, how can balance be established between the interests of the pharmaceutical companies and those of the consumers?
•
How much do the TRIPS flexibilities (on patenting) can contribute to reducing prices of drugs?
Suggestions for Further Reading More on criteria for selection and lists of essential medicines: http://www.who.int/medicines/services/essmedicines_def/en/index.html WHO Model Lists of Essential Medicines (only for reference): http://www.who.int/medicines/publications/essentialmedicines/en/index.html WHO May 2008 resolution WHA61.21 and WHA62.16: http://apps.who.int/gb/ebwha/pdf_files/wha61-rec1/a61_rec1-part2-en.pdf Medicines and human rights: http://www.who.int/medicines/areas/human_rights/articles_docs/en/index.html Pharmaceutical patents after the Doha Declaration: http://www2.law.ed.ac.uk/ahrc/script-ed/docs/doha.pdf More publications on intellectual property related to public health: http://www.who.int/phi/documents/en/index.html UN Millennium Project report on essential medicines: http://www.unmillenniumproject.org/documents/TF5-medicines-Chapter1.pdf The World Trade Organization and pharmaceuticals: http://www.wto.org/english/tratop_e/trips_e/tripsfactsheet_pharma_2006_e.pdf
Bibliography Health Action International. (2004, March). Increasing access to essential drugs [PDF Document]. Retrieved from http://www.haiweb.org/pdf/FocusAreas_Access_E1.pdf. News Medical. (n.d.). Drug patents and generics [Website]. Retrieved from http://www.news-medical.net/health/Drug-Patents-and-Generics.aspx. World Health Organization. (2010, June). Medicines: essential medicines [Website]. Retrieved from http://www.who.int/mediacentre/factsheets/fs325/en/index.html. World Health Organization. (2012). The global partnership for development: making rhetoric a reality [PDF Document]. Retrieved from http://www.who.int/medicines/mdg/mdg8report2012_en.pdf. World Health Organization. (n.d.). Access of medicines [Website]. Retrieved from http://www.who.int/trade/glossary/story002/en/. World Health Organization. (n.d.). Access to essential medicines as part of the right to health [Website]. Retrieved
from http://www.who.int/medicines/areas/human_rights/en/. World Health Organization. (n.d.). Essential medicines [Website]. Retrieved from http://www.who.int/topics/essential_medicines/en/. World Health Organization. (n.d.). Essential medicines [Website]. Retrieved from http://www.who.int/medicines/services/essmedicines_def/en/index.html. World Health Organization. (2010, June). Medicines: essential medicines [Website]. Retrieved from http://www.who.int/mediacentre/factsheets/fs325/en/index.html. World Health Organization. (n.d.). Patents [Website]. Retrieved from http://www.who.int/trade/glossary/story071/en/index.html. World Health Organization. (n.d.). The global strategy and plan of action on public health, innovation and intellectual property [Website]. Retrieved from http://www.who.int/phi/implementation/phi_globstat_action/en/index.html. World Health Organization. (n.d.). Trade, foreign policy, diplomacy and health – Generic drugs [Website]. Retrieved from http://www.who.int/trade/glossary/story034/en/. World Health Organization. (2010). Using TRIPS flexibilities to improve access to HIV treatment [PDF Document]. Retrieved from http://www.who.int/phi/phi_trips_policybrief_en.pdf. World Medical Association. (n.d.). World Medical Association resolution on therapeutic substitution [Website]. Retrieved from http://www.wma.net/en/30publications/10policies/20archives/s17/.