National Association of People Living with HIV in Nepal | 13 Oct 2010

Press release

Join the protest in front of EU and Indian mission at 13th Oct 2010, 1 pm

Don’t sign on to intellectual property provisions in the India-EU FTA

Re: Open letter to HE Manmohan Singh, Prime Minister of India

We are writing on behalf of patient groups, people living with HIV (PLHIV) networks, HIV & public health organizations, medical organizations, public interest groups and individuals, to express our concerns before the next round of negotiations on the EU-India bilateral free trade and investment agreement (FTA), which is 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 and concludes that about four million people started treatment between 2003 and 2008, largely due to India’s ability to produce low cost quality medicines. The report documents that Indian generic producers supplied the majority of ARVs in developing countries. Indian-produced generic antiretroviral (AIDS drugs) comprised 87 per cent of ARV purchase volumes and accounted for 91 per cent of pediatric ARV volumes in 2008. The report raises the concern that trade agreements being currently discussed may further reduce India’s vital role as provider of life-saving treatments1.

We are therefore concerned 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 has 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 Union (EU) – will further restrict this access. If India signs up to the IP clauses demanded by the EU, which go significantly beyond TRIPS standards (TRIPS Plus), it will further reduce the country’s ability to provide affordable 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. The EU is also using the FTA negotiations with India to pursue ‘TRIPS Plus’ IP provisions and enforcement rules that will hinder the production and flow of life-saving generic medicines.

Issues of Concern in EU-India FTA that could affect access to medicines:- Patent term extension known as “Supplementary Protection Certificates” in the negotiations, is a straightforward way to extend a pharmaceutical company’s monopoly by extending the patent life on a medicine beyond 20 years. If India accepts this clause, the years added to the patent in India are extra years in which the company can 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 drug regulatory authority (Drug Controller General of India). If India accepts this clause, India’s drug regulator 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 may not pass the scrutiny of ethical committees, making it difficult 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.

A study on the impact of data exclusivity in Jordan found that of 103 medicines registered and launched since 2001 that currently have no patent protection in Jordan, at least 79 per cent have no competition from a generic equivalent as a consequence of data exclusivity.2 Data exclusivity in Jordan was introduced as a result of the US-Jordan FTA.

Intellectual property enforcement provisions include a number of different measures (criminal sanctions for IPR infringement, evidence, injunctions etc.) that 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. In addition, the impact of border enforcement measures is clear from the seizure of generic medicines by the EU that were on their way from India to Africa and Latin America.

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 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 so called “expropriation”. Even labeling requirements in the interests of public health can be questioned under such provisions as a recent investment dispute3 filed by Phillip Morris, the tobacco company against Uruguay demonstrates. Philip Morris has alleged that Uruguay’s requirement to increase the size of pictorial warnings of the effects of tobacco on cigarette packets violate their trademark rights. A clear example of how companies can use a bilateral investment treaty to challenge government decisions related to public health on grounds of IP infringement.

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 call upon India to NOT TRADE AWAY OUR LIVES and right to health in the name of another trade agreement. We urge India to refuse the IP provisions outlined above. We request India to ensure that generic competition remains possible in India. So many lives depend on it worldwide.

Rajiv Kafle
President
National Association of People Living with HIV in Nepal
Ph: 4373910, 9803862107

Signed by:

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Parsa Sakriya Samuhav
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