European Parliament chooses middle ground in pharma legislation

The European Parliament’s final report on the EU pharma legislation appears to be an exercise in compromise, as the text is less punitive than the initial draft, but with some proposals around equitable access across the EU that may make life more challenging for industry.

Last October, draft amendments to the legislative package took very different approaches. The EU pharma directive, which is the basic law governing the approval and regulation of medicines, offered an incentive-laden approach to improving broad access to medicines across Europe. In contrast, the draft pharma regulation, which sets out additional rules for medicines authorized under the centralized procedure and the rules governing the function of EMA, was filled with penalties to force industry compliance...