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EC Says ‘Bolar Exemption’ Should Cover Pricing, Reimbursement & HTA Processes

 
• By Ian Schofield

Pricing and reimbursement processes as well as health technology assessments should be explicitly included in the procedures that can be conducted for generic and biosimilar products without infringing patent rights, according to the European Commission’s legislative revision proposals.

generic drugs bottle
The EU wants to facilitate the market entry of generics and biosimilars • Source: Shutterstock

Among the many novelties in the European Commission’s legislative revision package is a plan to broaden the scope of the EU “Bolar exemption,” which facilitates the early market entry of generic and biosimilar medicines once IP protections have expired for the reference products.

Under Bolar, generics and biosimilars firms can conduct certain studies and trials necessary for marketing authorization of their versions of the originator product and fulfil the “consequential practical requirements,” without

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More from Europe

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

More from Geography

Brazil To Upgrade Pricing Framework To Keep Up With Market Developments

 
• By Francesca Bruce

Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.