Archive for the 'Health' Category :

Intermune Withdraws (partly)

Posted by jim on 09/06/14

Intermune have withdrawn one part of their legal challenge to EMA’s disclosure of documents concerning the medicine Esbriet.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 action to stop disclosure by the EMA of documents relating to the medicine. They also applied for and received an interim order prohibiting disclosure until the [...]

Letter to EMA from Glenis Willmott MEP

Posted by jim on 06/06/14

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.

Maladministration in the European Medicines Agency?

Posted by jim on 05/06/14

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 transparency policy, the agency cited a “clear message” from the Commission of the requirement to respect intellectual property rights That requirement, whatever it is, is also [...]

Transparency – Is the Commission Pulling the Strings in the EMA?

Posted by jim on 29/05/14

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 [...]

Transparency – Why the Change in EMA Policy?

Posted by jim on 23/05/14

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 [...]

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 [...]

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