Peter O'Donnell, ACT's Brussels Correspondent
Articles by Peter O'Donnell, ACT's Brussels Correspondent

With the European Union's new rules on clinical trials?including data access?approaching their final legislative stage, and the European Medicines Agency planning to announce its new rules on data disclosure within weeks, the European drug industry is still running to catch up with transparency issues.

Adaptive licensing has leapt from the pages of learned journals into the real world of European regulation.

The just-published responses to a UK government evaluation of the merits and demerits of EU membership highlight some of the issues.

Next week Europe will celebrate Rare Disease Day.

An insight into how EU membership impacts on medicines and pharmaceuticals has appeared from a British politician

The drug industry and drug regulatory authorities have been among the most conspicuous targets of this intense monitoring

To believe the European Parliament, the battle to create new clinical trials rules for the European Union is over.

April might be - as T S Eliot suggested - the cruellest month, but for pharmaceuticals in Europe, this October is certainly a contender to win an award as the busiest month.

Europe moved one step closer to a passport for physicians in early October.

Europe's closest thing to an Oscar's ceremony for bioscience will take place in early October.

With all the discussion in Europe of how to move towards personalized medicine and more flexible authorization procedures, it is the rare disease community that is, in many ways, offering guidance on the route ahead.

A triangle ? an inverted black triangle ? will be seen on the pack leaflets and summary of product characteristics (SPC) of certain medicines in Europe from next week.

New legislation for transparency - currently underway for clinical trial data, national drug pricing rules, and personal privacy - is clearly not enough to satisfy the transparency hawks in Europe.

In the febrile atmosphere of Europe's debates on transparency, could there have been a worse moment for the recent allegations in the UK daily newspaper, The Guardian, that the drug industry is secretly pressuring patient associations to advocate restrictions on the release of clinical trial data?

The European Union's bid to update its clinical trials rules, "is particularly important for better competitiveness at global level, by encouraging research and innovation, maintaining a strong pharmaceutical industry and more clinical trials in Europe, and seeking better access to drugs for EU citizens."




Debate rages on, European Parliament set to decide on new clinical trial rules in late October.










