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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 policy is an initiative of the agency itself and is quite distinct from the access to documents regime under Directive 1049/2001, and also… » read more

Posted by Jim Murray

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 independent re-analysis of the evidence used by the EMA scientific committees to determine the benefits and risks of medicines “ See here for a critique of… » read more

Posted by Jim Murray

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 here. Since this text was negotiated with the Commission and Council (the national governments) it will soon be agreed formally in Council. Today (3rd April)… » read more

Posted by Jim Murray

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 medicines with responsibility for promoting the European pharmaceutical industry. It was not, in my view, a question of impropriety but rather that it would… » read more

Posted by Jim Murray

Some 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 this on their website and in their press releases but in most cases their constituents have no idea what… » read more

Posted by Jim Murray

Could it happen here?

There have been many serious cases of mis-selling and off-label promotion of medicines in the US. Could the same thing be happening here, or do pharmaceutical companies behave better on this side of the Atlantic? For my BMJ blog I compiled a table of cases taken by the US Department of Justice since 2004 involving… » read more

Posted by Jim Murray

I made a personal submission to the EMA Consultation on the Publication and Access to Clinical-Trial Data, which you will find here. As I said in the submission, public consultations are more effective when it is possible … to comment on submissions from others. My submission was partly in the form of a comment on… » read more

Posted by Jim Murray

HARD TALK ON SOFT LAW

“Are you aware you are working in a health care industry with patients and human beings?” It Is not often you hear a regulator putting this question to a speaker from the pharmaceutical industry but this happened (twice) at a meeting I attended a couple of weeks ago. The speaker was Neal Parker, a lawyer… » read more

Posted by Jim Murray

Glenis Wilmott, MEP, leader of the UK Labour Group in the European Parliament has posted a blog here on the GlaxoSmithKline fraud case. I will look at this case myself more closely in a future blog (I’m on holidays in Ireland at present). It has implications for the regulation and reporting of clinical trials, as… » read more

Posted by Jim Murray

I covered previously the written question from Nessa Childers MEP arising from the extensive bribery of surgeons in Greece some years ago – see my earlier post here. The Commission has now given an answer, and it is bizarre. While the bribery was going on, certain orthopedic devices were twice as expensive in Greece compared… » read more

Posted by Jim Murray