Peter O'Donnell
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Any regular commentary on the environment for the pharmaceutical industry in Europe is bound to have a predominantly negative
tone, so it is a welcome change to be able to record a positive development in the regulatory context—and one that should
make life a little easier for everyone involved in developing new medicines.
Starting July 1st, the European Medicines Agency is changing the way it provides scientific advice on the research and development
of new medicines, including assistance on protocols. Sponsors can expect final advice after as little as 40 days, and certainly
within 70 days—compared to the previous 100-day procedure. The experts will be involved earlier and more systematically. The
agency's Scientific Advice Working Party is being expanded from 22 to 26 members.
And with the same attention to broadening the relevance and legitimacy of the advice, internal assessors will be backed up
by more external experts. For example, the agency is introducing a formal peer review of advice before it is issued, to maximize
clarity and to ensure consistency. It is also ensuring closer collaboration with academia, learned societies, and patient
organizations.
At first sight this might not seem so momentous. But it represents another important step in bridging the gap that regulators
in Europe have been trying to straddle for nearly half a century. A theoretical balance
From the very first steps in European-level drug regulation, which led in 1965 to the first EU directive on pharmaceuticals,
a theoretical balance has been sought between making drugs safe and making drugs available. But for decades, as EU drug legislation
evolved, the emphasis was very much more on the safety aspects, while getting useful new treatments onto the market was relatively
neglected. As Pierre Joly, the larger-than-life boss of Roussel Uclaf and long-time president of the French drug industry
association, famously remarked back in the 1980s: "If the pharmaceutical industry was building a car, they'd start by designing
the engine. But the regulatory authorities would start by designing the brakes."
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In recent years, this trend has been gradually modified, as the once-unchallenged supremacy of the European pharmaceutical
sector came under increasing attack from global competitors and as its share of innovation started to decline. Even the most
conservative regulators started to notice that not only were the brakes they had designed very effective, but that the motor
was misfiring and in need of maintenance.
Intermittently, but increasingly, the authorities in Europe admitted that a one-dimensional view of the role of regulator
was not enough. The needs of patients would not be best served if new drugs were systematically kept off the market. The art
of the exercise came to be seen not just as excluding new drugs with inadequate merits, but in providing a context conducive
to the emergence of demonstrably effective medicines. The underlying philosophical drift was from confrontation to collaboration—or,
in that overworked phrase, synergy.
One of the consequences was the explicit stress in the last major revision in 2004 of the EU's pharma rules on improving the
competitiveness of European-based research and development of medicines. And although much remains to be done in that direction—particularly
on the economics of drug provision in Europe—there has been a perceptible shift in the approach of the Medicines Agency.
Faster development
The agency, which by its nature is at the sharp end of so many critical decisions on the development of individual drugs,
has made a priority out of providing scientific advice to sponsors, whether pharmaceutical industry or other researchers.
It aims to help sponsors to develop new medicines faster and more effectively, "which, ultimately, helps to speed up access
of patients to innovative new medicines," it openly states in the announcement of its modified "Framework for Scientific Advice
& Protocol Assistance."
