EU Seized in Vienna: EU Claims to Drop Some TRIPS-Plus Measures
July 22, 2010
At the International AIDS Conference in Vienna Wednesday, AIDS activists clashed with EU DG Trade, and appeared to pry out some new public admissions. AIDS activists undertook two actions to "seize" the EU's booth and podium. In response to tough questioning by activists, the DG Trade representative appeared to divulge some new information: EU has dropped its demands for patent extensions in the India FTA and may have made data exclusivity subject to compulsory licensing.
Activists "seized" the EU display booth in the afternoon. They marched to every pharmaceutical firm sponsor booth and staged die ins and shouted "shame." They criticized lack of research and development on HCV and TB co-infection and with women and then seized the EU booth in a dramatic expression against in transit seizures of legitimate medicines. For a video collage form the action, see:
At a session sponsored by the EU on its role in promoting access to medicines, activists disrupted the introduction of Patrick Ravillard, Office of DG Trade, with signs, shouts and a song criticizing EU trade policies on seizures and enforcement. Pauline Londeix of ACT Up Paris took the podium and gave a powerful speech denouncing EU drug seizures and its positions in the ACTA negotiations. See the video of the action, and also the transcript of the activists' speech.
PRESENTION: Patrick Ravillard, Office of DG Trade
After the disruption, the EU representative from DG trade took the podium and gave a talk on the EU perspective on IP and access to medicines.
Ravillard's presentation did not mention ACTA or seizures - even after the EU booth was "seized" and his introduction was interrupted with a march carrying signs against EU seizures.
His presentation discussed the EU embrace of the Doha declaration and its inclusion in bilateral FTAs. He claimed that the EU does not promote measures that inhibit the ability to use TRIPS flexibilities "in full."
The most important new revelation, if he is to be taken at his word, is on data exclusivity.
In response to a criticism that he should not claim compulsory licensing as a protected flexibility in FTAs when the EU it is promoting data exclusivity, he said:
"We have embraced the Doha declaration. It is our position that if there is a conflict between compulsory licenses and data exclusivity, compulsory licenses should prevail."
This is serious new news because there is an EU Commission opinion in the public domain that, in response to a question from Poland about bird flu vaccine licensing, claimed that Members can license patents but not data, even in an emergency. Note that EU data exclusivity is 10 years.
The US has responded to pressure by including specific language in FTAs that state that data is subject a CL. The EU has not yet included that concession in any FTA.
There is a rumor circulating that the EU and India have reached a major breakthrough in its negotiations and may announce an FTA soon. It appears possible that, at least in the India FTA, the EU has agreed to a CL concession in its data exclusivity demands.
The devil, of course, will lie in the details. India grants many fewer patents and so there will be a high percentage of new drugs there that receive monoply rights only through data exclusivity. Will the CL exception in the FTA only apply where a patent has been issued, or will it allow CL of data as such, even when there is no patent to license? Acceptance of any data exclusivity in the India FTA is likely to be a game changer. It makes the default rule for new nono-patented drugs that they will have a monopoly in the Indian market. That will make it harder to turn to india for immediate roll out of copies of non-innovative new drugs (because the potential domestic market to help economies of scale wil be lacking). And will be much harder for other countries to resist data exclusivity in FTA demands if the country with the largest domestic industry interest in the issue ultimately caves.
DROPPING PATENT EXTENSIONS IN INDIA
In response to criticism of patent extensions and data exclusivity in the India FTA, he explained:
"We do not intend to continue the discussion on patent extensions in the India free trade agreement."
This is because, he said, during the negotiation it became clear that there are not excessive regulatory delays in India.
In response, Loon form India said that he had seen the most recent version of the agreement, after the last time the EU announced this position, and it still has patent extensions as EU proposals.
On criticism of his claim that the EU does not promote TRIPS plus measures in spite of his admissions that they seek data exclusivity and patent extensions, he explained:
"Yes, we ask for TRIPS plus measures because it is in the interests of the trading partners. When it comes to public health, on our own initiative we raised the reference to the doha declaration. On the balance, it depends on the trading partner. For an LDC we do not ask for data exclusivity or patent extensions. But with Korea we do. Korea has a higher GDP than some EU members. With India and other middle income countries we have to discuss those issues. We will take into account the specific situation of the country. We know that India is the main producer of medicines for the world."