Response from the European Commission

Campaigners have received responses from the European Commission (EC) in response to our action on the Free Trade Agreement negotiations between India and the European Union. If you received a response and are able to follow this up with a further letter, here are some pointers to help with your reply…


The EC states that:

“…the commission has already proposed an explicit reference to the Doha Declaration on the TRIPS Agreement and Public Health so as to ensure that the flexibilities granted by the TRIPS Agreement, especially as regards patents on medicines, can be fully used by India”“…the commission has proposed a provision stating that ‘nothing in this Agreement shall be construed as to impair the capacity of the Parties to promote access to medicines”

In fact these provisions have only been proposed and as of yet have not been accepted. It is vital that India have the ability to use the TRIPS flexibilities and that the Agreement does not block access to life-saving generic medicines for developing countries around the world.

•    With regards to the seizure of live-saving generic medicines on transit from India to developing countries in Europe, the EC states that:

“You will have noticed that following these incidents, the Commission took measures to prevent their reoccurrence.”

However they have not gone on to explain what preventative measures the Commission took to prevent their reoccurrence.  Ask the EC to explain what steps they have taken to ensure this does not happen again.

They also write:

“ Furthermore, the Commission is currently engaged in consultations with India and Brazil to find a long term solution in the context of the ongoing review of the relevant customs regulation that would clarify the applicable EU legislation and thereby ensure the smooth flow of generic medicines which are not destined for the EU market, but are merely transiting through it”

The Commission is currently engaged in consultations with India and Brazil regarding customs regulation. However no agreement has yet been reached and there is therefore still a significant risk that life-saving generic medicines could be held in European ports.
Generic medicines on transit from India to Africa have also been seized in the past, for example AIDS drugs intended for Nigeria were held up in the Netherlands.  Ask the EC if they are also clarifying customs regulation with African countries as well as Brazil to ensure life-saving generic medicines are not held up in Europe on transit to Africa.

•    With regards to the definition of counterfeit medicines, the EC states:

“With respect to counterfeit, let me assure you that the Commission does not make any confusion between generics and counterfeit medicines. In this respect, a definition of ‘counterfeit medicines’ is currently being discussed at the international level in the context of the WHO and there is no intention to include a specific definition in the EU-India FTA.”

In May 2010, the World Health Assembly prioritised negotiations about the definition of the term counterfeit in relation to medicines. The negotiations failed and no agreement was reached.  It is crucial that a precise definition that clearly states the difference between a counterfeit and generic medicine will be agreed upon in the very near future.

The statement that ‘there is no intention to include a specific definition in the EU-India FTA’ is of concern. Without a precise definition there is an even greater chance that perfectly safe life-saving generic medicines could be deemed to be counterfeit or conversely real counterfeit medicines could be defined as safe generic medicines. This decision could cost lives.  It is imperative a definition of counterfeit that clearly differentiates between counterfeits and generic medicines is used within this FTA. Ask the EC to clarify their position on this issue.

If you do write again and get a further reply, let us know. You can forward correspondence or get any further information from us by emailing: campaign@healthpovertyaction.org.


Last modified: 03/07/2011