Latest Changes To EU Regulatory Data Protection Mean New ‘Uncertainties & Risks’

Law firm Sidley Austin says the net overall effect of the pharmaceutical package on innovation and investment is “uncertain at best.”

A businessman in formal wear signing a contract. Padlock Hologram icons over the working desk.
Regulatory data protection is a hot topic in the EU • Source: Shutterstock

The amendments to the proposed reform of the pharmaceutical legislation approved by a European Parliament committee this week have received a mixed reception from industry bodies and life science lawyers.

According to law firm Sidley Austin, the text approved by the environment and public health (ENVI) committee on 19 March offered some improvements over the original text of the European...

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.