Under the European Union’s proposed regulations, companies will have data protection for at least seven-and-a-half years preventing competitors from accessing their product data.
Pictured: Flags outside EU headquarters in Belgium/iStock, Alexandros Michailidis
The European Union’s Environment, Public Health and Food Safety Committee on Tuesday expressed its support for proposed legislation designed to attract pharmaceutical investment, foster innovation and make medicines more affordable.
The legislative reform would give pharma companies regulatory data protection for at least seven-and-a-half years, during which time competitors will have no access to their product data.
The new regulation also provides for 12 more months of data protection if a particular pharmaceutical product addresses an “unmet medical need,” according to the committee’s announcement. Companies are also eligible for additional data protection extensions depending on specific criteria, such as if the majority of their product development takes place in the EU and in collaboration with EU entities.
The parliament members want to cap the combined data protection at eight-and-a-half years.
Under the new legislation, companies will also have two years of market protection after their products win marketing authorization. During this time, generics, biosimilars and hybrid products cannot be sold.
Companies can also extend their market protection by 12 months if they secure approval for another therapeutic indication “which provides significant clinical benefits” compared with existing therapies, according to the announcement. Meanwhile, drugs designed to target rare disease can earn up to 11 years of market exclusivity, particularly those that address a high unmet medical need.
Despite these protections, Europe’s biopharma industry does not seem to be on board with the proposal, arguing that the new legislation would have the opposite effect and make the EU less attractive to pharmaceutical companies.
Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations, in a statement to Endpoints News said that “the industry remains concerned that the net impact of the proposals will make Europe less competitive and less attractive as a region for researching and developing medicines and vaccines.”
“It is hard to comprehend how reducing incentives for companies to discover, develop and deliver new treatments in Europe is in the best interests of patients in the region,” Moll said.
In addition to the data and market protections, the EU’s proposed legislation also seeks to incentivize companies to develop novel antimicrobial agents through market entry rewards and milestone payment schemes, such as early-stage financial rewards upon reaching certain R&D targets. The members of parliament also want to improve antimicrobial stewardship through stricter requirements for prescription and dispensation.
The new regulations will also require companies to file an environmental risk assessment when they seek market authorization, while boosting the EU’s preparedness for health threats and emergencies.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
