Conflicting amendments to Europe’s pharma legislation
Deciphering the first of many expected changes to EU’s proposed pharma law
The first draft of parliamentary amendments to the EU’s pharma legislation may alleviate some industry concerns about data exclusivity in Europe, but they raise other worries, such as the future of orphan drugs and an overall tilt toward a more punitive framework. They also showcase contradictory views among rapporteurs of the legislation’s purpose, as well as proposals that are in direct conflict with each other.
The amendments were published on Oct. 3 and pertain to two separate legislative documents: the EU pharma directive, which is the basic law governing the approval and regulation of medicines, and the EU pharma regulation, which sets out additional rules for medicines authorized under the centralized procedure and the rules governing the function of EMA...