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In a previous blog I said that I had requested access to documents on the dealings between DG Enterprise and pharmaceutical industry associations while the EMA was developing (and watering down) its transparency policy. I was given a few “mostly harmless” documents but the rest were refused on the grounds that they contained material that… » read more

Posted by Jim Murray

Citing Regulation (EC) 1049/2001, I asked last month for access to the following documents: ‘All communications in any form, and notes or records in any form of communications between DG Enterprise and any pharmaceutical Industry association concerning the policy, draft policy or decision making process of the European Medicines Agency on the issue of access… » read more

Posted by Jim Murray

At the Ombudsman’s recent conference two points were made that seem to contradict things I’ve said here. It is nice to have a blog to answer back. I said that the Commission had the final say on EMA’s transparency policy (Article 80 of Regulation (EC) No 726/2004 ). I was immediately contradicted by a member… » read more

Posted by Jim Murray

Joint letters with like-minded organisations are never easy to write, even among friends. Each organisation wants to add its own nuance.Different organisations may have different rules for sign-off on final drafts, and amendments can ping-pong from one to the other. I’ve been there. Sometimes, however, an issue is so important and clear that a joint… » read more

Posted by Jim Murray

Some years ago, DG Sanco, the health directorate for public health, took over the lead role for medicines and medical devices from DG Enterprise the industry DG, which was responsible for promoting industry, including the pharmaceutical industry. The change was a good one, enabling a clearer focus within the Commission on medicines as an essential… » read more

Posted by Jim Murray

As I mentioned previously the Ombudsman had, on her own initiative, looked into the apparent change of policy on transparency in the European Medicines Agency. She has now published on her website copies of correspondence between the Commission and the EMA on the subject. For those of us who can sometimes get excited about such… » read more

Posted by Jim Murray

In my previous blog, I covered the apparent change of policy on transparency in the EMA and told how I requested access to various documents in the agency. You can see their letter of refusal again here. So, I appealed the refusal at some length (see here ). The response (attached) came within the time… » read more

Posted by Jim Murray

Intermune have withdrawn one part of their legal challenge to EMA’s disclosure of documents concerning the medicine Esbriet. This needs careful explaining. The cases started when Intermune took legal action to stop disclosure by the EMA of documents relating to the medicine. They also applied for and received an interim order prohibiting disclosure until the… » read more

Posted by Jim Murray

The latest version of the EMA transparency policy gives significant weight to copyright law and intellectual property rights (IPR). In responding to the Ombudsman’s concerns about changes in its transparency policy, the agency cited a “clear message” from the Commission of the requirement to respect intellectual property rights That requirement, whatever it is, is also… » read more

Posted by Jim Murray