Indian activists challenge proposed EU tradeagreements: Global access to Indian generic ARVs threatened

Delhi Network of Positive People

In the coming weeks India and European Commission are negotiating on the provisions of a free trade agreement between India and the EU. Chief negotiators met on 23 September, but key negotiations on Intellectual Property (IP) will be held in New Delhi in the first week of October.

The European Commission is putting pressure on India to adopt new IP provisions that are even more restricted than TRIPS, plus provisions such as data exclusivity, patent term extensions and IP-enforcement provisions (injunctions, third party liability, criminal remedies, damages, border measures).

These provisions, if accepted by India, will further undermine generic production and supply of essential medicines to developing countries.We request organisations and individuals across the world to join Delhi Network of Positive People in a sign on letter to issue an appeal to the Indian government to agree to any IP provisions in the FTA negotiations.


If you want to join the sign on letter, send your name, organisation and country to: Vikas Ahuja, DNP+:

Letter to Indian Prime Minister Dr. Manmohan Singh

Hon’ble Prime Minister of India The Prime Minister’s Office South Block, Raisina Hill New Delhi, India-110 011 Telephone: 91-11-23012312. Fax: 91-11-23019545 / 91-11-23016857

New Delhi, October 1, 2010

Re: India’s central role in medicines supply is under threat Don’t sign on to intellectual property provisions in the India-EU FTA

Dear Prime Minister,

We are writing on behalf of patient groups, of people living with HIV (PLHIV) networks, HIV & public health organisations, medical organisations, public interest NGOs and concerned individuals to express our concerns before the next round of negotiations between India and the European Union (EU) in the name of a bilateral free trade and investment agreement (FTA) to be signed before the end of 2010.

India plays a key role in producing, registering and supplying essential medicines, not only for Indian patients, but to all developing countries. A study published recently in the International AIDS Society journal “A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries” highlights the central role that India’s generic production plays in AIDS treatment. It concludes that Indian generic manufacturers have supplied more than 80% of donor-funded AIDS medicines to developing countries in the last seven years.

We are alarmed that the Indian government may accept intellectual property (IP) provisions that will undermine the production, registration and worldwide availability of essential generic medicines.   This is not the first time. India through a series of legal amendments in the last decade has already enforced the requirements for intellectual property protection under international law.

The TRIPS agreement, which bound India to introduce a product patent regime in 2005, has already begun to curtail the country’s ability to produce low-cost generic versions of newer HIV, hepatitis and cancer medicines.  Because India signed the TRIPS Agreement, some new essential medicines have already been patented in India and cannot be domestically produced, leaving patients in India and across the developing world without access to affordable versions of these medicines.

Trade agreements being currently discussed–particularly the one with the European Commission–will further restrict this access. If India signs up to the IP clauses therein which go significantly beyond TRIPS standards, it will further reduce the country’s vital role as provider of essential medicines.   As you know, the EU is trying hard in every forum to increase IP standards that will benefit European pharmaceutical companies but will have a grave impact on generic production and supply of medicines and ultimately access to medicines for patients in the developing world.

Issues of Concern in EU-India Free Trade Agreement that could affect access to medicines

The EC is using these bilateral trade and investment agreement negotiations with India to pursue IP provisions that goes significantly beyond the TRIPS standards (“TRIPS-plus”).

Patent term extension known as Supplementary Protection Certificates in the negotiations would extend a pharmaceutical company’s monopoly by increasing the
life patent on a medicine beyond 20 years. These extra years enable the patent holder to maintain a monopoly position and continue to charge artificially high prices for the drug, free from generic competition.

Exclusive rights over pharmaceutical test data (so called “data exclusivity”) figures prominently in the negotiations. The current text of the IP chapter on pharmaceutical test data as proposed by the EU to India essentially requires that India amend its drug regulatory legislation in a manner that will not permit the placing of a generic pharmaceutical product on the market if the originator has submitted any clinical trial data relating to the medicine to the Indian DRA (Drug Controller General of India).

If India accepts this clause, the Drug Controller General of India (DCGI) will be legally prohibited from registering a generic medicine as long as the exclusivity lasts over the trial data (usually several years). Generic producers will have to submit their own safety and efficacy data to register the generic. This will oblige generic companies to repeat clinical and pre-clinical trials.

The repetition of trials raises grave ethical issues, as it would require withholding safe and effective medicines from some patients (the control group), solely for the purpose of proving something that is already known. This will not pass the scrutiny of ethical committees, making it impossible for generic companies to repeat the clinical trials. In addition, repetition of clinical trials will take time and involve costs that the generic producers usually cannot afford.

Intellectual property enforcement provisions include a number of different measures (border measures, criminal sanctions for IPR infringement etc.) and attempt to govern the way the disputes around patents and civil trademark infringements will be managed by Indian courts.  If India signs up to these clauses, the Indian judiciary will have its hands tied and will no longer be able to balance IP rights with the right to health of patients.

The investment chapter extends the definition of investment to include intellectual property. If accepted by India, multinational drug companies would then have the standing to sue the Indian government potentially in a bid to block sovereign actions like compulsory licensing, price control and regulation. It is critical to remove IP from the definition of investment so that both the use of compulsory licensing, price regulation, as well as refusal to provide exclusive rights over test data (data exclusivity) cannot be linked to either the definition of investment or factored in the consequences of expropriation. Accepting the IP provisions will benefit European pharmaceutical companies – but they will have a grave impact on generic production of medicines and
ultimately access to medicines for patients in the developing world.

The Indian government will be trading away our lives by agreeing to the EU’s demands on intellectual property and enforcement in FTA negotiations.

We request India to not TRADE AWAY OUR LIVES and right to health in the name of another trade agreement to be signed before the end of 2010.

As the Prime Minister of India, we urge you to refuse the IP provisions outlined above.

We request you to ensure that generic competition remains possible in India. So many lives depend on it worldwide.

Signed by:

Delhi Network of Positive People (DNP+), India

LOCOST (Low Cost Standard Therapeutics), India

Medico Friends Circle (MFC), India

Drug Action Forum – Karnataka, India

India All India Drug Action Network (AIDAN), India

Nikhil Gurung, AAVASH SAMUHA, Nepal

Bijay Pandey, Youth Vision, Nepal

Syaiful Brasila, PKNK (South Kalimantan of PUD), Indonesia

Paul Cawthorne, MSF Access Campaign, Thailand

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