EU Committee OKs More Pharma-Friendly Compulsory Licensing Plan

The rapporteur for the draft EU legislation says it will help to balance the public health interests of European citizens with the need for the pharma industry to keep innovating.

Patent files and documents in cabinet in office. 3D rendered illustration.
Patented drugs could be subject to EU-level compulsory licensing • Source: Shutterstock

The European Parliament’s legal affairs committee (JURI) has approved a draft EU regulation that would allow the European Commission to issue compulsory licenses to improve access to crisis-relevant medicines in times of health emergencies.

In its draft report, the JURI – which is the lead committee for the regulation – has inserted some amendments...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

EU Medical Countermeasures Strategy Promises More AMR Pull Incentives

 

A new EU strategy to ensure access to essential medicines will boost the development of critical medical counter measures, including vaccines and therapies, according to one pharmaceutical industry group.

Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

More from Geography

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

Global Pharma Guidance Tracker - June 2025

 

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.