Archive for the 'Health' Category :

Uh Oh – Did I Speak Too Soon?

Posted by jim on 03/04/14

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 2013 and which was the subject of the legal challenge by Abbvie. Here is what the EMA said today: 03/04/2014 [...]

Two days – two pieces of good news

Posted by jim on 03/04/14

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) [...]

Comments on the Proposal for a Directive on Trade Secrets

Posted by jim on 19/03/14

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 principal objective but will talk about some possible indirect effects. – in relation to journalists, whistleblowers and [...]

Medicines, Industry and Trade

Posted by jim on 10/03/14

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 [...]

Some MEPs Work Very Hard

Posted by jim on 21/01/14

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 [...]

New battles in the struggle for transparency

Posted by jim on 16/12/13

According to rumour, we are making progress on transparency in the revision of the Clinical Trials Directive but the industry (and the Commission, apparently) are fighting back on two other fronts – the proposed free trade and investment agreement with the US (TTIP), and a recent proposal from the Commission for a directive on trade [...]

Could it happen here?

Posted by jim on 09/12/13

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 [...]

Submission to the European Medicines Agency

Posted by jim on 08/10/13

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 [...]

HARD TALK ON SOFT LAW

Posted by jim on 17/09/13

“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 [...]

A bigger Voice on the EMA case

Posted by jim on 10/05/13

The European Voice has just published my opinion piece on the legal actions taken against the European Medicines Agency. It’s behind a paywall but you can read it here.

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