Consultation To Help Determine Whether EU SPC Framework Fit For Purpose

The European Commission has launched a consultation on proposals to “recalibrate” supplementary protection certificates and patent research exemptions.

RulesRegulationsBooks_1200x675
Consultation could lead to change in SPC system

The European Commission has launched a consultation that could pave the way for new measures that would update the supplementary protection certificate (SPC) system, including a unitary SPC and an SPC manufacturing waiver for export purposes. It says the findings will help it determine whether the EU SPC framework is still fit for purpose.

Through its consultation the commission wants to better understand stakeholder experience and knowledge of SPCs with a view to introducing proposals set out in the EC’s 2015 Single Market Strategy....

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

More from Geography

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By 

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.