Open Medicine EU

Archives for BioTech

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

It’s Not All Bad News

In telling the Parliament on Wednesday that the units on medicines and pharmaceutical products will stay with DG Sanco Mr Juncker added “..I agree with you that medicines are not goods like any other”. I couldn’t have put it better myself. This is good news and thanks to those who worked to achieve it, especially… » 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

Mr Juncker has replied by letter to the concerns of the health sector on the transfer of medicines from DG Sanco to DG Enterprise/Internal Market. The letter says that one of the main priorities of the new commission is to create “A Deeper and Fairer Internal Market with a Strengthened Industrial Base” and to that… » 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

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