Access to Documents – Another Thrilling Episode
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...
View ArticleIt’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”....
View ArticlePersonal and Private? Correspondence between DG Enterprise and the...
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...
View ArticleClearing the Air on Transparency Decisions, and on Industry Demands to the...
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...
View ArticleMore Bad News – Mr Juncker replies to Concerns on Medicines
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...
View ArticleThe Pharmaceutical Industry against Patients, Doctors and Pharmacists.
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...
View ArticleA Bad Start for the New Commission
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...
View ArticleOmbudsman Publishes Commission/EMA Correspondence on Transparency
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...
View ArticleLifting the veil in the European Medicines Agency Part 2
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...
View ArticleLifting the Veil in the European Medicines Agency
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...
View ArticleIntermune Withdraws (partly)
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...
View ArticleLetter to EMA from Glenis Willmott MEP
Good news. Glenis Willmott MEP has written an open letter to the European Medicines Agency to express her concern about changes to its transparency policy.
View ArticleMaladministration in the European Medicines Agency?
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...
View ArticleTransparency – Is the Commission Pulling the Strings in the EMA?
The European Medicines Agency has published its letter of reply to the Ombudsman’s concerns about changes in transparency – see my previous blog. The letter makes the point that the new transparency...
View ArticleTransparency – Why the Change in EMA Policy?
There has been an apparent volte-face by the European Medicines Agency on its earlier promise of a pro-active transparency policy that was about “establishing trust and confidence and enabling...
View ArticleUh Oh – Did I Speak Too Soon?
Abbvie’s withdrawal of the case against the EMA was not entirely unilateral – it followed an agreement by the agency to accept a redacted version of the document they were going to publish in January...
View ArticleTwo days – two pieces of good news
Yesterday (2nd April) the Plenary Session of the European Parliament approved the final text of the Regulation revising the Clinical Trials Directive. The announcement from the Parliament can be seen...
View ArticleComments on the Proposal for a Directive on Trade Secrets
These are my notes for a speech I made today in the European Parliament on the proposal for a directive on trade secrets. 1 I will not say anything here about the proposal itself in terms of its...
View ArticleMedicines, Industry and Trade
For years, BEUC and many other organisations pressed for the transfer of responsibility for medicines from DG Enterprise to DG Sanco. It seemed wrong that one DG should combine responsibility for...
View ArticleSome MEPs Work Very Hard
I sometimes feel sorry for MEPs, and not just at Christmas. I’m thinking of those who do a good job as rapporteur on important dossiers, such as the revision of the Clinical Trials Directive. They put...
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