Looking Back - and Forward

Applied Clinical Trials

When 2012 started, the clinical trials community in Europe was anxious about the impending appearance of the European Union's long-mooted update of its clinical trials rules. It was also concerned at the broader prospects for pharmaceutical research in Europe, under the twin challenges of advancing science and diminishing resources.

One year on, not many of those concerns have been assuaged.

Draft legislation on clinical trials did appear in the middle of the year, and was initially greeted with enthusiasm by many who conduct clinical trials, both in industry and academia. It seemed to promise that some of the administrative shackles might be removed so that trials - and particularly multi-country trials - would become easier to conduct. But that was before the proposals came under scrutiny from those whose job it is to evaluate and authorize clinical trials. It did not take long for serious objections to start emerging. Some national authorities felt the proposed approach would railroad them into assenting to decisions taken in other countries, with little possibility of running their own checks. And many ethics committees took offence at the omission of any explicit reference to them in the new rules, and to the tight new deadlines envisaged by the proposals. By December, when national health ministers met in the EU Council, they had to frankly accept that progress had been very slow and very minimal, and plenty of objections stood in the way of progress.

On the prospects for research, too, the year has brought promises but little fulfilment. The EU's major research funding program remains undecided, because agreement on the overall EU budget for the next seven years (of which the research program budget is a component) has eluded countless meetings of member states. Some progress was registered with the joint EU-pharmaceutical industry Innovative Medicines Initiative, raising hopes that it could benefit from bigger funding and wider scope - but these hopes have again been deferred to 2013, until the EU budget is settled.

And all the while, economic austerity and ballooning healthcare costs led to new moves to contain healthcare spending, often driven by intensified discussion of health technology assessment. The consequence was further downward pressure on pharmaceutical pricing - of greater indirect significance for most clinical research than any amount of state-funding.  Draft legislation on drug pricing and reimbursement that appeared during the year, and early hopes that his might lead to more research-sensitive pricing practices by national authorities were quickly dashed when member states almost unanimously trashed the proposals, and registered strong objections to any interference with their right to do as they please on drug pricing.

With more questions than answers still perplexing Europe about how to realize the potential of personalised medicine, there was disappointment that a promised policy document on "-omics" failed to emerge from the EU, and that two years of brainstorming sessions on issues such as managed entry schemes or the evaluation of biosimilars delivered, in the end, almost nothing of note.

In consequence, as 2013 starts, the clinical trials community in Europe is now anxious about the evolution of the European Union's update of its clinical trials rules, and remains concerned at the broader prospects for pharmaceutical research in Europe, under the twin challenges of advancing science and diminishing resources.

Plus ça change, plus c'est la même chose!