1. Pink Sheet
  2. >>Legislation

Off-Patent Industry Proposes Extensions To EU Market Protection Rather Than Data Exclusivity

 
• By Chloe Kent

Medicines for Europe proposed several alterations to the European Commission’s planned changes to exclusivity incentives at its recent Regulatory and Pharmacovigilance Conference in Brussels, most notably suggesting that the proposed extensions to data exclusivity should instead apply to market exclusivity.

Sergio Napolitano speaking at Medicines for Europe's 22nd Regulatory Affairs and Pharmacovigilance Conference
Napolitano explained Medicines for Europe's proposals at its 22nd Regulatory Affairs and Pharmacovigilance Conference • Source: Medicines for Europe

The off-patent industry association, Medicines for Europe, has put forward an alternative approach to the European Commission’s proposed new incentives scheme, in a move to facilitate earlier access to generic and biosimilar medicines.

Key Takeaways

  • Instead of multiple conditions which can extend an originator’s data exclusivity period, off-patent industry trade group Medicines for Europe has recommended that the European Commission use these conditions to grant extended periods of market exclusivity.

  • This would still allow originators to benefit from various market incentives, while providing clarity to generics companies about market authorization application timeframes.

  • The association has also spoken out against the use of transferable exclusivity extension vouchers for priority antimicrobials

In its planned overhaul of the EU pharmaceutical legislation, the commission is proposing to cut the regulatory data protection (RDP) period by two years, with companies being

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
Start Free Trial

Already a subscriber?

More from Legislation

Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 
• By Eliza Slawther

The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.

More from Pink Sheet

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.