Patients should precede Patents

The 10th International Congress on AIDS in Asia and the Pacific (10th ICAAP), recently held in Busan, Korea concluded with a message, ‘Narrow national economic interests should not outweigh a global commitment to save lives of People Living With HIV (PLHIV), and development of quality inexpensive generic medicines is the key to life-saving /life-extending therapies for people who need it.’

The credit goes to Indian generic drug manufacturing companies for the economical pricing of life-saving first line AIDS treatments, which have been lowered from a whopping $10,000 per person per year in 2000 to $60 presently. However, aggressive trade politics are being pursued by Europe and other developed countries, which will most likely reverse the process. While the European Union (EU) is busy negotiating with India, Thailand, Indonesia, and Philippines, the US is in discussions regarding Trans Pacific Partnership Agreements with Australia, Malaysia, New Zealand, Singapore, and Vietnam.

These Free Trade Agreements (FTA) restrict the access to life saving medicines to millions of people in the developing world by preventing countries from manufacturing or importing ARV generic medicines, and demanding higher level of Intellectual Property protection expanding monopolies of multinational pharmaceutical companies. The damage is further worsened 10-fold due to the recent alarming buy offs of Indian firms manufacturing generic medicines by multinational companies, which is likely to shoot up drug prices in the Indian market in the near future.

Independent Legal Researcher on HIV, health, and human rights, Kajal Bhardwaj, spoke at a session organized at the 10th ICAAP, by Medicins Sans Frontieres (MSF) and said, “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.”

She 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.”

DE has had a devastating impact in countries like,

• Jordan – the introduction of cheaper generic versions for 79% of medicines has been delayed due to DE, despite the absence of patent on them, and the purchase of medications takes away 25% of the budget from the Ministry of Health.
• Colombia – By 2030, the country would necessitate an additional US$1.5billion for annual medications. If this cannot be achieved, then Columbians will have to slash their drug consumption by 44% by 2030.
• Guatemala – has noted price differences of up to 845000% in the same therapeutic class of medicines.

Under the FTA negotiations with the United States, the Korean National Health Insurance Corporation will have to spend US $529 million for a 3-year extension of drug patents, and US $757 million for a 4-year extension, according to a Korean study.

APN + (Asia Pacific Network of People Living with HIV/AIDS) advisor, John Rock, voiced his concern at the Community Forum saying, “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.”

Participants of the Inter Faith pre-conference said that unjust trade agreements definitely influence Universal access to prevention, treatment, care, and support. Considering the fact that ARVs efficiently prevent HIV transmission, life saving medication and diagnostic procedures should not be governed by pharmaceutical companies. The survival requirements for people infected and affected by life threatening diseases should be addressed by intellectual property rights regimes.

UNAIDS Executive Director’s Senior advisor, Dr JVR Prasada Rao, urged that developed countries should not bind developing countries to rigid TRIPS provisions that 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 reporter 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.”

The spirit of the Doha Declaration should always be remembered: “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)

Leave a Reply