PUBLIC CONSULTATION WITH U.N. SPECIAL RAPPORTEUR Impact of 301 on Access to Medicines October 28, 2010 Dr.Amit Sengupta All India Peoples Science Network

2010 Special 301 Report: Complaints against India “counterfeiting, including the counterfeiting of medicines, remains widespread and India’s enforcement regime remains ineffective at addressing this problem” “One concern … is a provision in India’s Patent Law that prohibits patents on certain chemical forms absent a showing of increased efficacy” “The United States also encourages India to provide protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products”

The Bogey of ‘Counterfeit’ Again! Deliberate attempt to confuse issues. Counterfeiting is a trade mark violation and under Indian law it is clearly an offence. Counterfeiting is different from quality issues (drugs of sub- standard quality) and from sale of spurious products (that do not contain the ingredients claimed in the label) Counterfeiting does not pertain to generic drug manufacture, as this is clearly permitted under Indian Law and as per provisions of International treaties (viz. TRIPS) However, there are continuous attempts to confuse the above, and by inference label Indian generics of good quality as Counterfeits This has been a major cause of disagreement in the last World Health Assembly, where India, Brazil and others have refused to accept a confusing definition of ‘counterfeit’ that conflates issues related to: a) trade mark violation; b) quality control; and c) generic drug production

Section 3(d) of Indian Act Section 3(d) explicitly designed to prevent ‘evergreening’ –bars fresh patents on: a) small alterations to existing drugs unless significant change in efficacy can be shown; b) combinations of existing drugs; c) new use; d) new dosage forms It discourages frivolous claims and thus actually encourages real innovative activity It addresses the crisis in pharma R&D with too little activity in developing novel products – e.g. Prescrire’s examination of 359 drugs introduced between showed only 3% were a “real advance” while 72% were a “marginal” or no advance

Examples of Use of 3(d) in India Patent application for Imatinib (used to treat chronic myeloid leukemia) by Novartis rejected as claim was for new form of an old chemical patented before led to generic production at 5% of the cost of Novartis’ product Patent application for Nevirapine hemihydrate (first line anti-HIV drug) in syrup form by Boehringer rejected as it is a new form of an existing chemical Patent application for Lamivudine/ Zidovudine combination (first line anti-HIV drug) by GSK withdrawn (after patent opposition by patient groups) as it is a combination of two existing drugs patented around 1995

Data Exclusivity Government appointed committee had opined that India is not required to provide data exclusivity as per obligations under TRIPS (as opposed to ‘data protection’) Clear evidence that Data Exclusivity introduces another layer of obstacle to generic drug production by:  Delaying introduction of generics after patent expiry or grant of a Compulsory License  Creating a patent like monopoly even when a drug is not granted a patent (can bypass section 3(d) of IPA)  Forces unethical duplication of clinical trials Caution against its adoption of data exclusivity has been issued by the WHO and CIPH Recently released study of medicine prices in Guatemala has shown price differences in the same therapeutic class ranging up to % because of data exclusivity

Implication of ‘concerns’ in 301 Report ALL the ‘concerns’ expressed are designed to undermine production of generic drugs in India Has to be seen in the context of:  While India is the 4 th largest producer of medicines (about 9% by global volume), huge unmet needs exist in the domestic market with 65% lacking access to all essential drugs – a WB study (2001) suggests that 2.2% of the population are pushed below the poverty line each year as a result of out of pocket medical costs  India exports generics to 200 countries, including resource poor countries of the South  A 2010 study estimates that 80% of ARVs in the developing world were procured from Indian generic companies

Huge Price Differentials without Generic Manufacture A course of Pegylated interferon (to treat hepatitis C), patented in India now, costs between $11,000 and $15,000 Raltegravir (a new ARV drug) also patented in India, costs $2,500 per patient per year Contrast this with the generic price of the 3 antiretrovirals, used as first line treatment in India, at $60 per patient per year

A Proactive US Embassy! “My key role is to promote high standard Intellectual Property protection and enforcement in India…We have worked with Indian government on various programmes to promote the knowledge of Intellectual Property and to educate Indian officials like police officers, customs officers, etc. on various intellectual property related issues.” Interview with Dominic Keating, Secretary, Intellectual Property, By KPO Consultants, 2009 IPR toolkits of the US embassy in India Implies data exclusivity is required in TRIPS In explanation of what is not patentable under Indian law, does not include the provisions of Section 3(d)

US regulatory bodies ‘fronting’ for US Companies! USPTO and Pfizer Mr. Dominic Keating, IPR attaché representing USPTO, conducted two meetings jointly with Pfizer. Meetings featured attacks on Section 3(d) and on data exclusivity. US Federal Judge in Pharma funded event George Washington University’s India Project hosts “IP Summits” in India. funded by PHRMA, Microsoft, Qualcomm and others. Participants include Judge Randall R. Rader, for U.S. Court of Appeals for the Federal Circuit USFDA’s “safe medicine” initiative Meeting attended by the USFDA and the USPTO with a strong thrust on ‘counterfeits’

In Preparation for President Obama’s visit “The US is "lobbying" for an intellectual property rights (IPR) regime in India that protects American patents, a senior official of the Obama Administration said on Tuesday.” Economic Times (Oct. 26, 2010)

At the heart of……… At the heart of this discussion today lies a question: What provides legitimacy to a process that secures the commercial interests of a few corporations over decisions in sovereign countries that determine whether people shall live or die?