New Rules for Clinical Trials
I have been looking at the proposed regulation for the revision of the Clinical Trials Directive. To help my own understanding I prepared a “simplified” summary of most of the provisions of the...
View ArticleGood Book Bad Pharma
At a recent lunch in the European Parliament I met a hero of mine, Dr Ben Goldacre, author of Bad Pharma, a great book on science and medicine in the pharmaceutical industry. It is a worthy follow-up...
View ArticleClinical Trials in the European Parliament
Well, it’s been a long time since my last post but I have not been neglecting the subject of science and medicine. I have been following the progress of the European Commission’s proposed regulation to...
View ArticleDirective relative aux essais cliniques: le dilemme politique du Parlement
EurActiv a publié aujourd’hui une version française de mon article au sujet de la proposition de règlement de la Commission révisant la directive relative aux essais cliniques qui sera discuté cette...
View ArticleClinical Trials – Join the Discussion on Transparency
Euractiv has a piece on the clinical trials proposal that has attracted a number of comments – including one from me. It would be great if more people joined in – on any side of the question. Here is...
View ArticlePharma vs the European Medicines Agency- the case of AbbVie(Abbott)
Two American pharmaceutical companies, AbbVie and Intermune, have taken legal action to prevent or restrict the European Medicines Agency from disclosing certain clinical trial data after a medicine is...
View ArticlePharma vs The European Medicines Agency – the case of InterMune
Like AbbVie, described in my last post, a second American company, InterMune, has taken legal action to prevent or restrict the European Medicines Agency from disclosing certain clinical trial data...
View ArticleA bigger Voice on the EMA case
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.
View ArticleClinical Trials – Compromise in the European Parliament?
The proposal for the revision of the Clinical Trials Directive will be discussed tomorrow (29th May) in the Envi Committee of the European Parliament. On transparency and disclosure of trial results I...
View ArticleVote on Clinical Trials in the ENVI Committee
The Report on Clinical Trials agreed yesterday in the ENVI Committee would bring more transparency than before, but less than was originally proposed by the Rapporteur, Glenis Wilmott. She had proposed...
View ArticleHARD 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...
View ArticleSubmission to the European Medicines Agency
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...
View ArticleBlogging at the BMJ
The British Medical Journal have invited me to be a guest blogger. My first effort has just been published, and you can see it here But, don’t worry! I will continue with this blog.
View ArticleCould 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...
View ArticleNew battles in the struggle for transparency
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 –...
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...
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 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 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 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...
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