It is important to understand the implications of the EU-India FTA on the access to affordable medicines for millions of people of the developing countries. India is aptly called the ‘pharmacy of the developing world’ because it produces quality affordable generic versions of medicines used in the treatment of HIV and other diseases. More than 80% of the affordable HIV medicines used to treat 6.6 million people across Asia, Africa and Latin America come from producers in India. But certain harmful provisions in the Free Trade Agreement (FTA) currently under negotiation between the EU and India could greatly restrict the ability of manufacturers in India to continue producing these affordable generics that millions of people rely on to stay alive. The EU is pushing India to accept the following that go beyond the international trade rules requirements and can jeopardize the existence of millions of people - Intellectual property (IP) enforcement measures will dictate the way disputes around patents and trademark infringements will be managed by Indian courts. The effects of these provisions can range from legitimate medicines being blocked from leaving India on their way to people in developing countries, to third parties (like MSF) being embroiled in court cases simply for buying or distributing generic medicines. If India signs up to these clauses, the Indian judiciary will no longer be able to balance intellectual property rights with people’s right to health.
Investment rules would allow multinational drug companies to sue the Indian government, in case it decides to override a drug patent and allow generic manufacturers to produce more affordable versions, in order to increase access to the medicines for its people. The same could apply if the government tried to regulate drug prices. The company could claim the government action negatively impacts their ‘investment’ in the country, and could sue the government for large sums in damages in secret dispute settlement panels, outside of the court system.
Data exclusivity (DE) or Exclusive rights over pharmaceutical test data, that the EU continues to push, is a backdoor way for multinational pharmaceutical companies to get a monopoly status and charge high prices, even when their drug does not deserve to be patented under India’s strict patent law, or when the patent has expired. It would protect originators from price-busting generic competition and keep prices unaffordable. DE would apply to all drugs and would delay the entry of generic medicines into the market, by preventing India’s drug controller from registering a more affordable generic medicine as long as exclusivity over the clinical trial data lasts (usually five to ten years). Generic producers would have to submit their own safety and efficacy data to register the generic versions. This would require them to repeat clinical trials—something that takes years and involves costs that the generic companies usually cannot afford. But more importantly, repeating clinical trials is unethical, as it requires withholding medicines already known to be safe and effective from some patients (the control group), solely for registering the generic version. It is heartening that India has stated clearly that it will not accept DE, and the EU have claimed they are not pushing for it anymore, but they have not made this official and continue to pressurise India to change its laws.
Protesters plan to carry a giant medicine pill through the streets of Delhi, as they urge the Indian government to stand strong against EU demands to include harmful intellectual property (IP) provisions in the FTA that will hinder access to quality, affordable generic medicines produced in India. With their livelihood at stake, farmers will also join the rally as the EU is demanding that India reduce import duties to zero not only on wine but also on cereals, dairy products and poultry. The flood of imported food products into the Indian market will impact millions of local farmers. Public interest groups are also extremely concerned that the EU’s demands for opening up the financial (particularly banking) sector in India could have a severe impact on the ability of the Indian government to implement capital control measures and regulate risky financial activities.
Let us all join hands in solidarity in this campaign to protect our right to food and affordable health for all. Let Europe keep hands off our generic medicines.
Shobha Shukla - CNS
(The author is the Managing Editor of Citizen News Service (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. She also co-authored a book (translated in three languages) "Voices from the field on childhood pneumonia" and a report on Hepatitis C and HIV treatment access issues in 2011. Email: shobha@citizen-news.org, website: http://www.citizen-news.org)
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