Peter O’ Donnell

The European Union's extensive links with the US FDA and Health Canada have reached a further level of maturity, writes Peter O' Donnell.

The entry into force of the new EU clinical trials regulation last June is really little more than a virtual event. The new rules will apply only once the EU Clinical Trials Portal and Database now under development are fully operational.

So at last it’s happened. Adaptive licensing has leapt from the pages of learned journals into the real world of European regulation.

This week (February 28), Europe will celebrate Rare Disease Day. This is an interesting example – one might almost say a rare example – of a successful attempt by a European interest group to capture public attention.

As the United Kingdom debate about whether to stay in the European Union becomes more bitter and intense, an insight into how EU membership impacts on medicines and pharmaceuticals has appeared from a British politician who was until recently the UK Government Adviser on Life Sciences, George Freeman.

Although a broad compromise was reached in late December on the future shape of the European Union’s clinical trials rules, there are still many details to be resolved – including on that perennial issue of data transparency.

The annual worldwide antibiotic awareness event - celebrated in Europe on November 15 - generated some alarming statistics, some reassuring statements from official sources, and some expressions of urgency from drug developers

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

Europe moved one step closer to a passport for physicians in earlier this month. The European Parliament gave its backing to creating a virtual professional qualifications card that will allow doctors, pharmacists, and other professionals to practice in another EU country.

Europe’s closest thing to an Oscar’s ceremony for bioscience will take place in early October. The EuropaBio award for the most innovative European Union biotechnology firm is limited to firms with fewer than 250 staff or turnover or balance sheet of less than about $50 million.

Momentum is gathering in Brussels for real battles over carving up the 1 trillion dollars that the European Union has now agreed to spend between the end of this year and the end of the decade.

With the shadow cast by Mediator across Europe now receding to a focus on the French law courts, the European Union (EU) said in late November that its pharmacovigilance arrangements offer “one of the most advanced and comprehensive systems in the world”.