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Access 2 Medicines - how come we can not treat anymore Dr. Peter Tinnemann, MPH Institute for Social Medicine, Epidemiology, and Health Economics
Charité – Universitätsmedizin Berlin http://epidemiologie.charite.de
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Learning Objectives • Concept of essential medicines & access • Factors influencing access to essential medicines • Explain what Intellectual Property Rights and its framework is – and how they influence access – Allow for discussion on changes in EU countries affected by the ongoing financial crisis
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Globalisation, Interests & the Political Landscape • Pharmaceutical (globalised) Industry – – – – – –
Global Space & Globalisation as (the only) model of development Free movement Regulation of Quality, Safety, Efficacy Trade Agreements Intellectual Property Regulation – Intervention in an imperfect market in the public interest
• All interests are affected… – – – – –
Civil Society Patients (as consumers?) Healthcare Professionals Pharmaceutical Industry Government UNIVERSITÄTSMEDIZIN BERLIN
As a patient, health professional or medical doctor: What kind of medicines do you want? What do you expect from your medicines? 3 min brainstorm, cards & mind-map
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Basic global health problem +/- 350 medicines – deal with 90% of the world’s diseases – yet, are denied to billions of people in LMICs & increasingly in HIC
TOO EXPENSIVE or
NOT AVAILABLE UNIVERSITÄTSMEDIZIN BERLIN
???
Framework
Access to essential drugs – fundamental right to health – nedicines are NOT simply another commodity
WHO framework for access to essential medicines, http://www.who.int/medicines/areas/access/en/ UNIVERSITÄTSMEDIZIN BERLIN
Access Unaffordability, def – share of out of pocket payment is significant and rising (especially in southern, central & eastern EU member states)
Unavailabilty, def – Medicines not available due to stock outs, lack of supply, lack of cash flow
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Factors affecting medicine prices • transparent price information • competition & negotiation • price controls • reduced duties & taxes on essential drugs • distribution efficiency • marketing, distribution & dispensing expenses • intellectual property protection status
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Essential Medicines & Health Products (EMP) • first edition 1977 • revised every two years • contains 423 medicines – including children's medicines – patent status NOT considered in selection – has contained 5%-10% patent protected medicines
http://www.who.int/medicines/en/; http://apps.who.int/iris/bitstream/10665/112729/1/WHO_TRS_985_eng.pdf?ua=1 9 UNIVERSITÄTSMEDIZIN BERLIN
WHO perspective
• Intellectual property (IP) / patent protection – has been an effective incentive for research & development (R&D) for new drugs, BUT, should – be managed in an impartial way – protect the interests of the patent-holder – safeguarding public health principles
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Definitions
Essential Medicines, def Essential medicines are those that satisfy the priority health care needs of the population ‌ selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness
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Definitions Rational Use of Medicines “Patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community." (WHO, 1985)
Irrational Use of Medicines Patients receive the wrong medications inappropriate to their clinical needs, in doses that do not meet their own individual requirements, for an inadequate period of time, and at an often unaffordable cost to them and their community. UNIVERSITĂ„TSMEDIZIN BERLIN
Conflicting interests Public (health)
Pharmaceutical Industry
Rational use of medicines
Maximize sales & returns to shareholders
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R&D Modelling
• innovation rewarded with/ IP (patent) – market monopoly (removes market forces)
• cost of medicines linked to R&D cost • encourages promotion • market failure: no R&D for diseases disproportionately affect the poor
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Pharmaceutical Industry R&D • High ‘costs’ & ‘risks’ in resarch & development – Development costs: DiMasi $800million – Development risks: approx. 1 in 10,000 compounds
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Access & Research Gap
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Research Gap
10/90 gap < 10% Research > 90% global disease burden
Ad Hoc Committee on Health Research, Investing in Health Research and Development (1996) "Report of the Ad Hoc Committee" WHO UNIVERSITÄTSMEDIZIN BERLIN
Key Problem: Intellectual Property
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Harvard Law School (10-02-205)
The South African AIDS Controversy A Case Study in Patent Law and Policy W.W. Fischer III, C.P Rigamonti
(movie: http://fireintheblood.com/ )
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What is a patent? • Legal document granted by a nation • Provids owner with certain legal rights • Limited in time Owner may exclude others from – making – using – selling – offering to sell – importing the invention UNIVERSITÄTSMEDIZIN BERLIN
Criteria for patentability subject matter patentable? industrial application? new?
inventive step?
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Why patents? • Commercial advantage in a free market – owner can charge a premium, but may still be subject to competition – ensure inventors receive an return on their investment by providing a monopoly – provide an incentive to innovate – distribute knowledge: inventor must disclose the details of his invention – innovations boost economic performance
Hence, patents lead to better economic performance!!?? UNIVERSITÄTSMEDIZIN BERLIN
A different point of view… 1. Pressure of competition drives innovation 2. Public benefits from : – wider access to knowledge – lower prices from competition
3. Patents slow technological progress by – impeding the dissemination & use of knowledge – slowing follow-on research & innovations – diverted R&D funding to getting around patents of others
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Generic Competition
• Generic, def – therapeutical equivalent copy of originator – Market entry after patent expiration – Most effective way to lower prices (~25% after 2 years)
• BUT – rise in expenditure on new (patented) medicines outpace the savings by generic use…..
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Patents: Monopoly Protected
20 yrs (effectively 7̶ 12 yrs)
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Patents: Monopoly Protected
20 yrs (effectively 7̶ 12 yrs)
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How A2M became trade-related • Since early 20th century
– harmonize & internationalize IP protection – BUT do not enforcement mechanisms
• In 1980s
– push stronger international protection & enforcement of IP
• Business community
– IP protection = trade-related & belongs to WTO (General Agreement on Tariffs and Trade, GATT) Agreement
on the Trade Related Aspects of Intellectual Property Rights (TRIPS)
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Globalisation of Intellectual Property 1980
Global Global
1964: Declaration of Helsinki. World Medical Association Ethical principles Guiding clinical research.
1990
2000
2010
1994: WTO Uruguay Round.
2001: WTO Doha Declaration.
2003: WTO Para 6 decision
Growth in TRIPs+.
TRIPS ratification, key provisions: • patent length (≥20 yrs) • process & product patents • Transitional periods agreed (2000 and 2005) • Burden of proof reversal
Interpretive statement: • Health vs. pharma interests • Transitional periods revised (2016) • Reaffirmed flexibilities
Countries allowed to export in case of a PH problem.
IP negotiated bilaterally i.e.‘ outside of TRIPS & the WTO’
2001: WHO prequalification.
TRIPS flexibilities: “public health crises” can represent “a national emergency or other circumstances of extreme urgency”, & “emergency” may be either a short-term problem, or a long-lasting situation. Compulsory Licences: government can license for the production without the consent of the patent-holder Parallel Importation: importation without the consent of the patent-holder UNIVERSITÄTSMEDIZIN BERLIN
WTO – Structure of Agreements Umbrella
Basic Principles
AGREEMENT ESTABLISHING WTO
Goods
Services
Intellectual Property
GATT
GATS
TRIPs
Dispute Settlement
Transparency
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DISPUTE SETTLEMENT TRADE POLICY REVIEWS
Trade related aspects of international property rights „A small group of powerful corporate interests lobbied their governments to include intellectual property (IP) norms within the agenda for the negotiations surrounding the General Agreement on Tariffs and Trade…“ aus Cynthia Ho. „Access to Medicine in the Gobal Economy: International Agreements on patents and related rights.“ 2011 Oxford University Press
„…[TRIPS] had been long sought by the United States and other advanced industrial countries in order to force other countries to recognize their patents and copyrights. (…) As they signed TRIPs, the trade ministers were so pleased they had finally reached an agreement that they didn‘t notice they were signing a death warrant for thousands of people in the poorest countries of the world.“ aus Joseph Stiglitz „Making Globalization Work“. 2006 Penguin Books
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Patents on Medicines!?
1960
1967
1977
1978
1992
Product patents on medicines are a very recent Where did the pharmaceutical industry thrive before the 1960s? In Germany, Switzerland and Italy! Italy was 5th producer of drugs in the 1970s, its pharmaceutical industry has now practically disappeared ď&#x192;§ introduction of stronger patent protection. UNIVERSITĂ&#x201E;TSMEDIZIN BERLIN
NEW Discurs
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Voluntary Licensing Mechanisms An TNC licenses a patent, for purposes of local production, to a third party company in a lesser developed country. Success: Entirely dependent on the terms of the licenses
• Group/Global Licensing systems i.e. Medicines Patent Pool • Company NEVL* agreements: i.e. Boehringer Ingelheim *Non-exclusive voluntary licensing (NEVL) UNIVERSITÄTSMEDIZIN BERLIN
PUBLICLY financed research
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www.med4all.org Prof. Dr. Christine Godt (Universität Oldenburg) Dr. Peter Tinnemann (Charité – Universitätsmedizin Berlin) Dr. Christian Wagner-Ahlfs (BUKO Pharmakampagne)
Funded by
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Product Development Partnerships (PDPs) Krankheit
Malaria
Leishmaniose Afrikanische Schlafkrankheit Chagas-Krankheit Japanische Encephalitis Cholera Meningitis
TB
Produkt Coartem D Artesunate Injection Euratesim Pyramax ASAQ ASMQ Paromomycin
Art des Produkts Medikament Medikament Medikament Medikament Medikament Medikament Medikament
PDP MMV MMV MMV MMV DNDi DNDi OneWorld Health
KalazarDetect SSG/PM-Kombination NECT Pädiatrische Variante von Benznidazol JE Vaccine India Oraler Cholera-Totimpfstoff MenAfriVac
Diagnostikum Medikament Medikament Medikament
IDRI DNDi DNDi DNDi
Impfstoff Impfstoff Impfstoff
PATH IVI MVP/PATH
Flüssigkultur Resistenztest (DST)
Diagnostikum
FIND
Rapid MTB ID LPA Line-Probe-Assay Minicolumns (mAETC) GeneXpert
Diagnostikum Diagnostikum Diagnostikum Diagnostikum
FIND FIND FIND FIND
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Timeline of the Access Movement
Global Global
1980
1977: WHO Fist Essential Medicine List (EML) 186 drugs
1990
1984: USA Hatch-Waxman Act (patent term restoration act)
2000
2001: WTO Doha 1994: WTO Uruguay Round. Declaration. TRIPS ratification. 2001: WHO prequalification.
1995: South Africa became WTO member 1997: South Africa New Medicines Act
2010
2003: WTO Para 6 Growth in decision. Countries TRIPs+. allowed to export IP negotiated in case of a PH bilaterally i.e.‘ problem. outside of TRIPS & the WTO’ GFATM (purchasing since 2002):
1999: MSF uses funds from Nobel Prize to Fund new campaign
PEPFAR (purchasing since 2005):
2010 2001: UAEM to coordinate efforts to improve the research, licensing and patenting decisions of universities
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Essential Medicines: supporting countries to prioritise WHO Definition Medicines that satisfy the priority health care needs of the population
Criteria • disease prevalence • evidence on efficacy and safety • evidence of comparative costeffectiveness
Essential Medicines Lists • • • • •
available at all times in adequate amounts appropriate dosage forms assured quality affordable price
Source: http://www.who.int/medicines/services/essmedicines_def/en/index.html UNIVERSITÄTSMEDIZIN BERLIN
Conflicting interests Public (health)
Pharmaceutical Industry
Rational use of medicines
Maximize sales & returns to shareholders
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Promoting health or pushing medicines?
Chico Weekly Record, Chico, California, 11 Dec 1897 UNIVERSITĂ&#x201E;TSMEDIZIN BERLIN
The Promotion Imperative Accountability to Share Holders Incentivised R&D Modelling Poor Innovation
= to make money = markets not needs = not much therapeutic advantage
Disease Mongering
= ‘new’ non-diseases
Me-Too Medicines
= more of the same – No therapeutic innovation – Placebo Trials: required to demonstrate efficacy against placebo (only)
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Types of promotion • • • • • • •
Sales representatives Free Samples Journal advertising Direct-to-consumer advertising (DTCA) Funding of physician ‘ key opinion leaders’ (KOL) Gifts – large and small Sponsoring – continuing medical education (CME), symposia and conferences – patient groups, professional societies, guideline development
• Market seeding ‘research’ • Public relations, advertorials, ghostwriting
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WHO Ethical Criteria for Medicinal Drug Promotion (1988) ‘…claims concerning medicinal drugs should … not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug use or to give rise to undue risks.’ “Promotional material should not be designed so as to disguise its real nature.”
“Scientific and educational activities should not be deliberately used for promotional purposes.’ WHO Ethical Criteria for Medicinal Drug Promotion, 1988
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