The Patient Is More Important Than The Patent



By Shobha Shukla, CNS
September 6, 2011
The author is the Editor of Citizen News Service (CNS) and reported on-site from 10th ICAAP, Busan, South Korea for CNS. She is a J2J Fellow of National Press Foundation (NPF) USA. She has worked earlier with State Planning Institute, UP and taught physics at India's prestigious Loreto Convent. Email: shobha@citizen-news.org, website: http://www.citizen-news.org

(CNS): 'Production of quality affordable generic medicines is key in access to life saving /life-extending treatments for people who need it, and narrow national economic interests should not take precedence over a global commitment to save lives of People Living With HIV (PLHIV)...'. This message was brought out clearly at the recently concluded 10th International Congress on AIDS in Asia and the Pacific (10th ICAAP), held in Busan, Korea.

The discounted price for life saving first line AIDS treatment has been brought down from the 2000 whopping price of $10,000 per person per year to the current $60, thanks to the Indian generic drug manufacturing companies. But Europe and other developed countries are pursuing aggressive trade policies that are likely to reverse the process. The European Union (EU) is negotiating with India, Thailand, Indonesia, Philippines, and the US is involved in talks on Trans Pacific Partnership Agreements with Australia, Malaysia, New Zealand, Singapore, and Vietnam. These Free Trade Agreements (FTA) demand higher level of Intellectual Property protection expanding monopolies of multinational pharmaceutical companies and threaten the ability of countries to manufacture or import ARV generic medicines, thus restricting access to life saving medicines to millions of people in the developing world. To add insult to injury, the recent alarming spate of buy offs by multinational companies of Indian firms manufacturing generic medicines, is likely to push up drug prices manifold in the Indian market in the near future.

At a session organized at the 10th ICAAP, by Medicins Sans Frontieres (MSF), Kajal Bhardwaj, Independent Legal Researcher on HIV, health and human rights from India informed that "India is a key drug supplier to the world with 92% of patients on ARVs in low- and middle-income countries using generic drugs coming mostly from India. Also 67 % of medicines exports from India go to developing countries, and 75-80% of all medicines distributed by the International Dispensary Association are manufactured in India. However, in its FTA with India, EU is asking for strong Intellectual Property Protection which could stop the flow of affordable and life-saving medicines for millions of patients in developing countries."

Kajal further added: "As of now, every member country of the World Trade Organization has to implement the agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), which requires countries to grant 20 year patents on medicines, but it is up to countries to decide whether they will have strict standards or not in granting patents, thus prohibiting evergreening—a practice of pharmaceutical companies of making small changes to old medicines to extend patent life. But developed countries are now demanding inclusion of ever-greening of patents and TRIPS+ (data exclusivity) provisions in which one may have to give patent for longer than 20 years (patent term extension) . Contrary to TRIPS requirement of only data protection, data exclusivity (DE) mandates that the generic cannot rely on the originator’s clinical trial results for 5-11 years and would have to repeat the clinical trials if it wants to be approved in the DE period, or wait for 5-11 years before it can be registered and reach patients."

The impact of DE has been devastating in countries like (i) Jordan where data exclusivity has delayed the introduction of cheaper generic versions of 79% of medicines even though there is no patent on them, and over 25% of the Ministry of Health’s budget is now spent on buying medicines; (ii) Colombia which would require an extra US$1.5billion to be spent on medicines every year by 2030. If this is not spent, Colombians will have to reduce their medicine consumption by 44% by 2030; (iii) Guatemala where there have been price differences of up to 845000% in the same therapeutic class of medicines.

According to a Korean study, the extension of patent term is likely to cost the Korean National Health Insurance Corporation US $529m for extending drug patents for 3 years and US $757m if it has to agree to a 4 yr extension as proposed under the FTA negotiations with the United States.

John Rock, adviser with APN + (Asia Pacific Network of People Living with HIV/AIDS) voiced his concern at the Community Forum-- "the community is concerned about the free trade agreement (FTA) currently under negotiation between India and European Union, which threatens the production of generic medicines which will among others affect HIV patients. The EU-India draft FTA, as it stands, places trade interests over human rights, there is an immediate need for global action to ensure affordable access to treatment."

The Inter Faith pre-conference participants also agreed that ‘Universal access to prevention, treatment, care and support are also being influenced by unjust trade agreements. Life saving medication and diagnostic procedures should not be at the mercy of pharmaceutical companies particularly in the knowledge that ARVs are effective in preventing HIV transmission. Intellectual property rights regimes need to address the survival needs of people who are affected and infected by life threatening diseases.

Dr JVR Prasada Rao, senior adviser to UNAIDS Executive Director exhorted the developed countries not to bind developing economies to inflexible TRIPS provisions which are counterproductive to Universal access for PLHIV.

He agreed that "FTA TRIPS agreements and their actual operation at country level have become serious impediments to affordable HIV/AIDS treatment. Added to this is the new slogan of anti-counterfeiting, which confuses generic drugs with counterfeit medicines of spurious quality. On one side we say that millions of PLHIV need to be provided with affordable treatment, while on the other side we throttle supply of good quality but cheap generic drugs."

The UN special rapportuer on health has also agreed that "As FTAs can directly affect access to medicines, there is a need for countries to assess multilateral and bilateral trade agreements for potential health violations and all stages of negotiations should remain open and transparent. International negotiations on issues related to intellectual property rights and health should be coherent in their approaches to the promotion of public health."

Let us not forget the spirit of the Doha Declaration which states that “We affirm that the (TRIPS) 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.” (CNS)

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Posted on: September 06, 2011 12:39 PM IST