Open Medicine EU

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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

It’s Not All Bad News

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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

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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

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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

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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

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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

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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

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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

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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

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I wrote a number of blogs on the apparent change of policy on transparency by the European Medicines Agency when it published a new draft policy for targeted consultation last May – see here, here, and here for example. The Management Board of the agency were due to decide on this changes in June but… » read more