India could soon agree to the pact to get more of the countries other products onto EU shelves. However, low coast vaccines could disappear from the under-developed world. A majority of drugs distributed in poor countries come from the generic firms in India.
From the Guardian, health writer Sarah Boseley gives us background on the posible agreement.
Back a few years, the argument over access to medicines was all about patents - the 20 years' copyright protection given to a pharmaceutical company so that it could recoup the millions of dollars it had invested in research and development. A World Trade Organisation agreement on intellectual property required all nations to respect patents - but campaigners won an exemption to allow generics firms to make cheap copies for poor countries.
Big Pharma was down, but not out. The big, research-based drug companies consider the generics companies a major threat to their profits. There is every sign that they are behind the clauses in the EU trade agreement that could end the flow of cheap copycat drugs in the developing world. The trade agreement asks for "data exclusivity" on drugs, for a period which may be five or may be ten years.
This stops generic companies in their tracks. At the moment, they can make a copy of a drug and all they have to do is demonstrate that it is bio-equivalent to the original - they don't have to do new trials. Their drug can be licensed on the basis of trials carried out by the original company. Data exclusivity would stop this happening. Unless the generics company carried out its own trials, it would not be permitted to market a copycat drug.
Does a delay of five or ten years matter? Oxfam and Médecins Sans Frontières consider it a matter of life and death. The obvious example is HIV/Aids. The virus mutates easily and fast. In rich countries, resistance has set in to one drug after another. Poor countries at the moment have generic copies of basic drugs, but as resistance spreads, new drugs will be needed. Patients will not be able to wait ten years for the data exclusivity on those new drugs to expire.