1. Introduction: Intellectual Property Rights and its impact on access to medicines Anand Grover United Nations Special Rapporteur on Health East Africa Consultation, 10-12 September 2010

2. RIGHT TO HEALTH AND ACCESS TO MEDICINES Access to medicines is an integral part of the right to health. Nearly two billion people lack access to essential medicines. [“WHO Medicines Strategy: Countries at the Core, 2004-2007”, (2004).] In the case of HIV, it is presently estimated that around 15 million people living with HIV (PLHIV) need ARV treatment (based on revised WHO Guidelines). However, as of end-2009, only 5.2 million PLHIV are receiving treatment. A recently published study showed how millions would be pushed into poverty on account of prices of medicines, especially branded medicines.

3. WHAT IS A PATENT? Monopoly given to inventors for a specific period. Why: To reward inventions and to induce R&D investment A bargain between private and public interest ProsCons Encourages innovation Creates a monopoly  raises costs, hinders competition Encourages public disclosure of useful inventions Too many patents discourage innovation

4. WHAT IS A PATENT? Types of patents: product and process. Negative right to prevent others from: – manufacturing, using or selling patented product or product obtained using patented process Territoriality: Limited to jurisdiction of granting country Granted or refused according to laws of a particular country No international or cross-border patent

5. PATENTS = HIGH COSTS OF MEDICINES Patents  monopolies  monopolistic prices  high costs for medicines Examples of prices of patented medicines: –Anti-retrovirals (mid-1990s to 2000): USD 15,000 per patient per year –Imatinib mesylate (Gleevec) – Anti-cancer medicine to treat chronic myeloid leukemia: Novartis’ price = 2400 USD per patient per month Generic version price = 160 to 200 USD per patient per month –Tenofovir + Lamivudine + Efavirenz (Atripla): Gilead’s price = 1800USD per patient per month Generic version = 15 USD per patient per month

6. COMPETITION REDUCES PRICES Eg: Indian Patent law and Impact –1911 : Patents and Designs Act, 1911 Product and process patent protection Term of patent: 16 years –Patents Act, 1970 (For pharmaceuticals and agrochemicals): No product patent protection, only process patent Process patent for best process known to inventor Maximum term of patent: 7 years Consequence: –No monopoly on pharmaceutical products –Indian pharmaceutical companies used alternate, non-infringing processes to manufacture drugs –> 1 manufacturer of drug  competition  lower prices –Prices of medicines in India are the lowest in the world. –Indian companies supply generic drugs to other countries

7. EFFECT OF COMPETITION ON PRICES Graph 1: Fall in the prices of first line combination of stavudine(d4T)+ lamivudine (3TC), Nevirapine (NVP). Lowest world price per patient per year Source: Untangling Web of Price Reductions, 11 Edn, 2008, Médecins Sans Frontières

8. NEW DRUG APPROVALS [1989-2000] 1,035 new drugs approved by US FDA (1989-2000) Only 15% of new drugs approved in 1989–2000 were highly innovative priority NMEs. India estimates 12,000 pharmaceutical applications have been filed mostly relating to incremental improvement over existing old drugs. “ Changing Patterns of Pharmaceutical Innovation”, National Institute for Health Care, Management Research and Educational Foundation, May 2002

9. EXTENDING PATENT TERMS: NEW USE 1964 Zidovudine discovered and patented. Thereafter Explored as anti-cancer treatment and shelved 1984-85 Discovered to work against HIV 1985 Patent granted on new use

10. EXTENDING PATENT TERMS: COMBINATIONS 1964 + 20 Zidovudine patented. 1985 + 20 Zidovudine (new use) patented 1989 + 20 Lamivudine patented 1992 + 20 Combination of Zidovudine + Lamivudine patented

11. EXTENDING PATENT TERMS: NEW FORMS 1993 + 20 Imatinib and all pharmaceutical salts patented. 1995-96 Mesylate salt of imatinib published 1997 + 20 Application for different crystal forms of mesylate salt of imatinib

12. EVERGREENING OF PHARMA PATENTS Evergreening: Extending monopolies by obtaining patents on –New forms (salts, polymprhs, etc) –Combinations –Formulations –New use Due to this, a single drug has multiple patents  patent thickets This prevents introduction of generic versions of the drug even after the expiry of the original patent. Extending life cycle of patent  longer monopolies  high prices  no access to medicines

13. TRIPS: A COMPROMISE 1980s onwards: –Developed countries, at the behest of industry, sought uniform international standards of intellectual property protection –Intellectual property subsequently included in GATT negotiations –Developing and least developing countries subjected to pressure by developed countries to yield to inclusion of intellectual property Supposed advantages for developing countries –Increased investment –Transfer of technology to developing countries Developing countries managed to obtain flexibilities in implementation

14. TRIPS REGIME Minimum standards of intellectual property protection with effect from 1 January 1995. What is patentable?: Invention which –is new, –involves an inventive step and –is capable of industrial application. [Article 27] Protection to both products and processes [Article 27] Period of protection: Minimum 20 years [Article 33] Varying deadlines for developing and least developed countries on condition of provisions for Exclusive Marketing Rights and mailbox facility [Article 70] Prospective operation: Inventions on or post 1 January 1995 Dispute settlement mechanism [Article 64] Non-compliance can lead to imposition of sanctions.

15. TRIPS AND DOHA DECLARATION TRIPS is not a stand-alone agreement and has to be seen within the broad framework of international law. Does not override existing international obligations under ICESCR and ICCPR, which include –Right to life, right to food, right to health –Right to enjoy the progress of science and technology TRIPS contain flexibilities, which can be used by member states. Conflict between intellectual property rights and public health resolved by the Doha Declaration. Doha Declaration on TRIPS Agreement and Public Health, 2001: –Reaffirms the right of WTO Members to use the flexibilities under TRIPS –TRIPS to be interpreted as per objectives (Article 7) and principles (Article 8) –TRIPS does not and should not prevent countries from taking measures to protect public health.

16. TRIPS FLEXIBILITIES Members free to determine appropriate method of implementing TRIPS [Article 1.1] Protection and enforcement of IPRs should contribute to promotion of technological innovation and to the transfer and dissemination of technology … and in a manner conducive to social and economic welfare. [Article 7] Members may adopt measures to protect public health. [Article 8]

17. TRIPS FLEXIBILITIES Countries free to determine patentability criteria –Criteria of “new”, “inventive step” and “capable of industrial application” not defined. [Article 27] –Countries can exclude certain categories of inventions from patentability In order to prevent evergreening of patents by pharmaceutical companies, countries can set higher patentability criteria. –For eg: In 2005, India amended its patent law to disallow patents for new forms of known substances (such as salts, polymoprhs, combinations) unless the new form exhibits a significant increase in “efficacy”. –“Efficacy” means therapeutic efficacy, not decrease in pill burden, improved storage conditions, increased stability, etc

18. TRIPS FLEXIBILITIES TRIPS lays down minimum standards. Allows several flexibilities: Criteria of patentability: Novelty, inventiveness, industrial application Transition period International exhaustion principle for parallel imports Allow compulsory licenses Limited exception to patent rights Allows for opposition and revocation procedures Flexibilities allow countries to take into account public health concerns and take steps to ensure access to medicines for all. However, there have been concerted attempts to whittle away the flexibilities and prevent countries from using TRIPS flexibilities.

19. TRIPS: WHAT ARE THE BENEFITS? Expected benefits: –Increased investment –Increased technology transfer [Article 7, TRIPS] –Member countries to adopt measures to prevent practices that affect technology transfer [Article 8, TRIPS] Is there any evidence of increased investment?? Is there any evidence of technology transfer? Is there a need to review TRIPS?