EU: When even the date is secret

BRUSSELS – 12 / 9 / 2009 - The European Medicines Agency has been criticised for not being open enough. Now it has sent its future transparency policy into a public hearing. Comments possible until September 25th 2009.

Censorship. The French medical journal Préscrire used the toughest possible word after having analysed the outcome of 81 wob-requests to the European Medicines Agency EMEA. Amongst other documents Préscrire received one, where even the date in a scientific evaluation document was kept secret.

Now the EMEA has sent to public hearing its plans for future transparency. So if you want safety information about your medicine in the future, act now! The deadline is September 25^th 2009.

Medicine information professionals like Préscrire address serious criticism against the openness practice of the European agency. Préscrire systematically has tested the transparency of EMEA according to existing European access to documents regulations, and the outcome was rather devastating:

“The European agency censors certain important parts of documents including informations of scientific interest, among them information about pharmacovigilance (safety of medicines). The interest of the patients is not taken well enough into account,” was the conclusion of Préscrire as late as July 2009.

Also EMEA in its hearing paper suggests, that it intends to establish a register of documents. A register that has been obligatory according to the European access to documents regulation since December of 2001.

It is more than laudable, that the EMEA now addresses the problems, particularly as there is an increasing number of requests from the public (page 2 line 52 of the EMEA hearing document), and as the EMEA has to walk a delicate balance between patients interests and the pharmaceutical industry’s interest.

European patients make 31% of the world market for the industry. And alone in Europe the pharmaceutical industry with a production worth € 187.153.000.000 provides more than half a million jobs throughout the continent, the 2008 estimate according to the European pharmaceutical industry association was 635.000 jobs. See the industry figures here.

Seen from an openness point, the current draft does raise some concerns. The EU has – fortunately – an access to documents regime with a regulation and developing case-law. The EMEA being an agency is fully covered by this regulation and case-law and may not go its own ways. On the contrary it should comply fully with the regulation as it has been obliged to for years.

These are the immediate problems in the EMEA hearing document traced by Wobbing in Europe:

The policy concerns documents produced by EMEA (page 2, line 72). Given the delicate character of the balancing described above – a balancing, that the EMEA is obliged to do when considering access to documents, it would have been helpful, if the entire scope of European access to documents regulation had been sent into this public hearing. The regulations article 2.3 includes all documents held by an institution:

This Regulation shall apply to all documents held by an institution, that is to say, documents drawn up or received by it and in its possession, in all areas of activity of the European Union.

The EMEA intends to “strive for harmonisation of key elements on transparency across the EU.” (page 2 line 81).This is principally problematic, as the levels of openness among the countries ranges from access to the obligatory safety-reports by the industry in for example Denmark and the Netherlands to zero access to information in some other EU countries, as they do not have access to information legislations.

On page 7 of its document EMEA addresses the balance between transparency and commercially confidential information – a highly relevant question concerning the regulations exception 4.2.

A harmonisation is not the task of the EMEA, its task is to fulfill the EU regulation, which the European institutions transparency is governed by. On commercially confidential information the regulation says:

The institutions shall refuse access to a document where disclosure would undermine the protection of  commercial interests of a natural or legal person, includingintellectual property (…)  unless there is an overriding public interest in disclosure.

Read the EMEA background documents on the public hearing. 

Read the Préscrire evaluation based upon 81 wob-requests between 2005 and 2008.

Read the Préscrire comment and se the example document.

Read the blog post on Euobserver.