Earlier yesterday, several student organisations including the European section of International Students Access to Medicines Organisation as well as the Universities Allied for Essential Medicines, amongst others, sent a letter to the EU Trade Commissioner Karel de Gucht asking for a reconsideration of the EU-India free trade agreement that is currently being drafted. (We have previously written on this agreement here). Incidentally, we are also currently in the week of international action against EU-India FTA – (Oct 4th – Oct 9th) just before Oct 10th when the next informal round of negotiations are scheduled, which in turn are before the India-EU summit later this month.
There are several controversial provisions currently being negotiated on in this Free Trade Agreement, and these student organisations have tried leveraging some pressure against these very provisions. These provisions would have severe detrimental effects on India as well as the many developing countries which depend on India for their generic medicines. They point to a study in the Journal of International AIDS Society which shows that about 4 million people could start treatment between 2003-2008 primarily due to India’s low priced generic medicines. The provisions in the FTA would affect the ability of India to make and/or provide these medicines at the same costs, if at all, and this is the effect to which the words in the letter are nested.
The three provisions they pinpoint specifically are: (italicised text reflects my own additions)
a) Patent term extensions through Supplementary Protection Certificates. This would delay generic entry in to the market by extending the exclusion period over their patents.
While there may be a valid criticism that pharma companies need this to extend their actual exclusion period to 20 years, (due to the market approval delays – the ‘promised’ period of 20 years is often a few years shorter) is there any data or proof showing that they actually need this whole 20 years in the first place? The Pharma industry has consistently been one of the top grossing industries even with these market approval delays, perhaps even hinting that 20 years minus market approval time may even be too much protection time.
b) Data exclusivity provisions requiring generic companies to conduct, or rather, re-conduct clinical trials. Clinical trials often represent a tremendous cost and are one of the major factors which deter more players entering the pharmaceutical market. Forcing generic companies to re-conduct clinical trials on drugs which are the equivalent of the patented drug is redundant and unnecessarily shoots up costs and/or removes players from the generic market as well. dfd
c) Border and enforcement mechanisms allowing confiscation of in-transit medicines. More details on their efforts on this are available here at
Berkeley Declaration on Intellectual Property Enforcement and Access to Medicines. Jul 15 2010. Available from: http://www.law.berkeley.edu/files/Berkeley_Declaration.pdf
This would essentially import a provision such as EU regulation 1383 into the FTA, the problems of which we’ve discussed thoroughly on this blog in earlier entries. See here.
In addition to pointing out the problems with these provisions, the letter also points out that the EU is entering into FTAs with other middle and low income countries such as Brazil, Thailand and South Africa, and says that it is imperative that no such provisions exist in those FTAs either.
We certainly applaud this effort by these student groups and hope that they have some effect on the right people!
