EU rapid drug approval plan worries some national agencies

Wed Mar 29, 2017 7:40am EDT
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By Ludwig Burger

FRANKFURT (Reuters) - A push by the European Medicines Agency to speed up the approval of new drugs that show promise is running into resistance from some of the national agencies that will ultimately decide whether the medicines are worth buying.

Pharmaceutical companies, patient advocacy groups and lawmakers around the world are pushing regulators to cut through what they see as red tape and adopt more streamlined approval processes for new drugs.

Europe has been looking at new approaches to drug testing for several years and the issue came to the fore again in January after U.S. President Donald Trump vowed to accelerate approvals to get new drugs to patients faster.

However, critics of new approaches, such as lowering the requirements for lengthy clinical trials, worry that selling drugs with relatively little testing data, even if the go-ahead comes with strict limits, will expose patients to greater risks.

The independent authority in Germany (IQWiG) that evaluates new drugs and plays a key role in what price health services pay for them has been one of the most vocal opponents of such new approaches within Europe.

Given Germany is Europe's biggest drugs market and the fourth in the world, its misgivings risk hurting a broader drive to bring new treatments to patients faster, not least because drug companies may conclude that dealing with price-setting authorities country-by-country ends up being too costly.

"Accelerated approval on the basis of reduced data should be limited to special situations. But there is reasonable concern that it is intended to become the norm," said Stefan Lange, the deputy director of Germany's Institute for Quality and Efficiency in Health Care (IQWiG).

The agency has in the past rejected pivotal studies that had convinced the EMA to approve a drug, saying they were not statistically valid. This has resulted in some drugs not getting launched in Germany, or being withdrawn soon after their launch.   Continued...

Pharmaceutical tablets and capsules are arranged in the shape of a Euro currency sign on a table in this picture illustration, August 20, 2014.   REUTERS/Srdjan Zivulovic/Illustration/File Photo