Will Europe's Regulatory Watchdog Come Of Age In 2014?

Feb 01, 2014

TheEuropeanMedicines Agency (EMA) is 20 years old this year — and it confronts many of the problems familiar to anyone at that age. After the vigorous growth and boundless optimism of its early adolescence, the agency now must make up its mind about what it wants to be. This is not just a matter of defining its personality. It also means taking on greater responsibility obtaining the resources it will need, and asserting its mission isuccessfully in the face of the often harsh realities of the outside world.

The agency's own sharpened awareness of the complex conditions beyond Canary Wharf is its programme for 2014, which identifies half a dozen new priorities. As EMA's executive director, Guido Rasi, publicly observed at the end of last year, "The environment in which we are operating is ever-changing, continuously presenting us with new challenges."

Clinical trials dust up

Perhaps the biggest challenge is the agency's intention to publish clinical trial data from marketing authorization applications. This has provoked criticism from industry that the EMA is going too far, while health cacpaigners contend it is not going far enough. Resolution may take longer than anticipated. Late last year the agency deferred its decision on precisely how it would disclose rtrial data as recently as December. As recently as December. Rasi was speaking of how "we will continue to discuss our approach to achieve this goal with our stakeholders so that we finalise a policy that is carried by a broad consensus." The cautious wording recognizes how contentious the debate has become — intensified by legal action that AbbVie and InterMune are taking against the agency's current, and much more limited, data-release policy, and by conflicting demands from the European Parliament that no clinical trial data should be regarded automatically as confidential.

Accelerating authorization

The other really tough issue the agency must confront is the longstanding disconnect between marketing authorization and drug reimbursement. For industry, the resulting delays in market access are seen as a disincentive for innovation, while the expanding demands of national health technology assessment agencies hold a threat of inefficient duplication. For patient groups, the concerns focus on inequalities of treatment and lack of access. And now even regulatory agencies are recognising the intrinsic risk of wasted effort and overlap that will please no one.

2014 will see EMA addressing "the evolving nature of our interaction with health technology assessment bodies." He sees the agency as moving towards running the processes of regulatory licensing and HTA assessments in parallel, "with the aim of accelerating and facilitating access to authorized medicines for patients".

His officials point out that the agency has been conducteding a growing number of parallel scientific advice procedures since 2010, and the aim is to build on that experience. The agency is planning for imminent release of draft guidance on how applicants can seek simultaneous feedback from regulators and HTA bodies on their product development plans. This work will also tie into the ongoing policy reflection exercise on the design of clinical trials that would allow for the development of more targeted medicines.

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