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Access to Essential Medicines and Intellectual Property Rights
in Developing Countries
Rachel M. CohenAccess to Essential Medicines Campaign
Doctors Without Borders/Médecins Sans Frontières (MSF)
5th Meeting of the Transatlantic Consumer Dialogue
Workshop on Intellectual Property Rights: October 31, 2002
The Access to Medicines Crisis
Communicable diseases = leading causes of death in developing countries, accounting for over 25% of all deaths globally 14 million die each year, 97% in
developing countries- HIV/AIDS: 3 million per year- Tuberculosis: 2 million per year- Malaria: 1-2 million per year
1/3 of world lacks access to essential quality drugs, diagnostics, vaccines
The Example of HIV/AIDS…
HIV/AIDS: The Price Barrier
HIV/AIDS- 40 million people infected with HIV worldwide- Antiretroviral (ARV) therapy proven to dramatically extend and improve lives of people living with HIV/AIDS in wealthy countries, reducing AIDS-related deaths by over 70%.- Average cost of antiretroviral “cocktail” in the US = $10,000-$15,000 per patient per year- Over 95% of PWAs in developing countries lack access to ARVs, largely because of the price of drugs
8,000 people with HIV/AIDS will die today
High Prices Linked to Patent Protection
Effects of Generic CompetitionSample AIDS Triple Combination: Lowest World Prices
(stavudine (d4T) + lamivudine (3TC) + nevirapine)
0
2000
4000
6000
8000
10000
12000
May
June Ju
lyAug
Sept
OctNov Dec Ja
nFeb M
ar
Apr 2
001
BrandGeneric
Best offers for first-line regimens proposed in the
WHO guidelinesOctober 2002
Yearly cost in US$
Best offer generic
companies
Best offer proprietary companies Differential
ZDV/3TC/NVP 316 1,059 3.35ZDV/3TC/NVP as FDC 419 N.A. ...ZDV/3TC/EFZ 642 1,121 1.75ZDV/3TC/ABC 1,576 1,607 1.02ZDV/3TC/ABC as FDC 1,648 1,624 0.99ZDV/3TC/NFV 1,737 3,325 1.91ZDV/3TC/IND/r 1,129 1,304 1.16
TRIPS Agreement: What Is It?
World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (1994 Uruguay Round)Most comprehensive international agreement on intellectual property rights such as patents, copyrights, and trademarksSets forth minimum standards for intellectual property protection that must be met by all WTO Members (by 2005 at the latest)
TRIPS Agreement: What Is It?
Research-based pharmaceutical companies key architects of TRIPSMedicines treated like any other commodity (Barbie dolls, computer software, CDs, etc.)Commercial interests protected over public health
Patent Rights vs. Patient Rights
Correcting the ImbalanceImpact of TRIPS is not fully visible todayIn years to come, new medicines invented since the signing of the TRIPS Agreement in 1994 will be potentially patentable in all WTO Member States depending on the will of the patent owner only Challenge to correct imbalanceWTO Members can provide for a number of “public health” safeguards in national legislation to protect public health, e.g. in cases of patent abuses or emergencies
What Was Accomplished in Doha?
The fundamental argument was settled:
“We agree 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. In this connection, we reaffirm the right of WTO Members to use, to the
full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.”
- Ministerial Declaration on the TRIPS Agreement and Public HealthNovember 2001
Unresolved Issues
Paragraph 6: “production for export” => How countries with insufficient or no manufacturing capacity in the pharmaceutical sector will be able to make effective use of compulsory licensing under the TRIPS Agreement Paragraph 7: How to encourage and promote technology transfer to LDCs
The CIPR Report: IPRs & Health September 2002
Patents are tools of public policy and must operate to serve the greater public good. Developing countries should narrow to an absolute minimum the type and scope of pharmaceutical patents, and LDCs should consider delaying the granting of pharmaceutical patents for as long as possible. Need quick, easy-to-use measures to ensure generic competition to bring drug prices down in developing countries (e.g. compulsory licensing as rule rather than exception to ensure that patent system does not hamper the development of a competitive pharmaceutical market).Solution to production for export problem must be quick and easy to implement, give long term security and be economically viable (Article 30 approach). Patent system is failing to stimulate innovation to meet many medical needs, particularly the needs in developing countries. Further recognition of the need for greater action and support to help developing countries put health first.
What More Is Needed for Existing Medicines?
Equity pricing for equitable access…
Prices of essential medicines in developing countries
Generic competition
Monopolies
Local production
Differential pricing
TRIPS safeguards
High volume
Low volume, low demand
What About Future Medicines?
The Crisis in R&D for Neglected Diseases
An Empty Pipeline for Neglected Diseases
1975-1999: 1,393 new chemical entities marketed
Tropical diseases: 13
Tuberculosis: 3
Trouiller, et al., Lancet
Will Strengthening IP Protection in Developing Countries Stimulate R&D for Diseases of the Poor?
A Fatal Imbalance
Market Failure
• Drug development is almost exclusively confined to the R&D-based pharmaceutical industry, operating in a global market economy• Market forces skew the direction of drug R&D towards those diseases and patients (consumers) that assure the highest financial returns • Market potential does not mirror health needs
Market Failure = Public Policy Failure
Societal choice: drug development can be confined to the private sector Medicines are considered commodities
that need to generate profit in return for private investment
- public policy initiatives only stimulate R&D for diseases that affect wealthy markets
- drug R&D capacity in developing countries is not adequately cultivated
What Kinds of Solutions Are Needed?
• Market “push/pull mechanisms” mechanisms?Push: e.g. tax credits, R&D grants, support for clinical trialsPull: e.g. purchase funds, temporary monopolies, patent
extensions
• Public Private Partnerships (PPPs)? e.g. IAVI, GATB, MMV
• WHO/UNDP/World Bank Special Program on Tropical Disease Research (TDR)?
Very broad mandate, chronically under-funded, political constraints
• A Drugs for Neglected Diseases Initiative (DNDi): Partnership for Public Response?
Needs-based, field-driven, with clear public sector responsibility
What Kinds of Solutions Are Needed?
Increased public sector funding for R&D for neglected diseases (including support for not-for-profit R&D)“Essential research obligation” (mandatory reinvestment of percentage of profits toward R&D for neglected diseases either directly or through public R&D programs)Global treaty on R&D for neglected diseases
Overcoming the Gap: Toward a New R&D
ParadigmEnsuring access to medicines is a public sector responsibility (when the market fails, governments have a duty to step in)Must develop an R&D agenda that is needs-driven, not profit-drivenMust acknowledge differences between neglected and most neglected diseases, and develop strategies accordingly
