What You Need To Know About Liability Protection For COVID-19 Products

Companies developing medical countermeasures for COVID-19 need to become familiar with divergences in the liability protection offered by different countries with regard to possible safety issues that may arise when products are fast-tracked for public health reasons. By doing so they can adopt a systematic process for prospectively evaluating and managing international risks, say Dan Kracov, Lincoln Tsang and Alexander Roussanov.

Liability
Liability should be a key concern for developers of COVID-19 products • Source: Shutterstock

The COVID-19 pandemic has brought unprecedented challenges. The rapid cross-border spread of the virus has prompted the international regulatory community to work closely together. For this reason, a consistent international approach has rightly been adopted towards collecting robust and reliable evidence to establish the safety and efficacy of medical countermeasures for COVID-19.

About The Authors

Dan Kracov, Lincoln Tsang and Alexander Roussanov are partners in, respectively, the Washington, DC, London and Brussels offices of law firm Arnold & Porter.

While the intention of the regulators is to hold such products to the usual high standards and ensure they have a favorable benefit-risk profile, the urgent need for cures and...

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 Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By 

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

More from Geography

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By 

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.