UK-EU Deal Allows For ‘Significant Divergence’ In Data Protection & SPCs

But No Sign Yet Of Intent To Differ

The agreement on trade and cooperation between the UK and the EU requires both sides to offer regulatory data exclusivity and supplementary protection certificates, but it does not specify any minimum periods of protection.

Compliance Rules Law Regulation Policy Business Technology concept.
The UK-EU deal allows divergence from current standards • Source: Shutterstock

The Trade and Cooperation Agreement (TCA) between the UK and the EU allows “potentially significant divergence from current standards” in areas such as regulatory data protection (RDP) and supplementary protection certificates (SPCs), says lawyer Mike Snodin of Park Grove IP.

There is no reason to believe either side is planning to use this flexibility to limit or expand such rights,...

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

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.

Lawyers Weigh In On ‘Sunshine’ Clause In EU Pharma Reform Package

 

The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.

Ireland Could Follow France And Italy With Mandated Pharma Payment Disclosure

 

Ireland’s current voluntary system for disclosing pharmaceutical company payments to health care professionals and organizations is flawed and does not adequately deal with conflicts of interests, according to an Irish law maker.

EU Pharma Overhaul May Reshape Aspects Of Drug Promotion And HCP Partnerships

 

Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”

More from Geography

COVID-19 mRNA Vaccine Labels Now Quantify Myocarditis Risk, But ACIP Wants Other Changes

 
• By 

New members of the CDC’s Advisory Committee on Immunization Practices suggested concerns beyond myocarditis, questioning whether test-negative observational studies are giving an incorrect picture of effectiveness.

Medicare’s Combo Products Negotiation Plan Conflicts With US FDA Standards, Firms Argue

 
• By 

The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.

EU Pharma Overhaul May Reshape Aspects Of Drug Promotion And HCP Partnerships

 

Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”