The EU Commission proposes updates to EU pharmaceutical legislation

The EU Commission proposes reform to the current EU pharmceutical legislation in regard to the protection of data and the use of generics and biosimilars for drug companies in the EU. 

“Today’s vote is a step towards delivering the tools to tackle present and future healthcare challenges, particularly for our market attractiveness and access to medicine across EU countries,” said Pernille Weiss, rapporteur for the file alongside Tiemo Wölken.

The proposed legislation has sparked some controversy as it marks the most significant reform in pharmaceutical legislation in more than 20 years, leading to much back and forth over whether to prioritise patient access compared to innovation in medicine development. 

The Commission was advocating for reducing the baseline regulatory data protection from 8 years to 6 years. The current data protection window means that companies cannot access or use clinical trial data from other companies that has been submitted to the European Medicines Agency for marketing approval in this time, with two additional years of market protection for the product where generics or biosimilars cannot be marketed. 

The initial proposal also included scope for extensions to the data protection, for example for another 2 years of protection if a company launches a drug in all EU member states. However, industry leaders advised against this citing that companies can exert no control over the timing of pricing and reimbursement decisions in each country, which regularly leads to delays. 

As a compromise, the MEPs instead suggested that the countries themselves should be responsible for requesting pricing and reimbursement applications from the prospective companies. Then, they were further able to negotiate a time period of 7.5 years for regulatory protection for access to clinical trial data, and the additional 2 years for market protection. 

There are some exceptions to the rule of course, where some medicines are specifically designed to address an area of unmet need, along wither certain other criteria including conducting comparative clinical trials, a large proportion of the R&D taking lace in the EU and in association with EU research entities. The extension here could be granted up to 8.5 years of protection. 

Another exception where a 12-month extension can be gained is if the drug gains authorisation for another therapeutic indication, with significant benefits when compared to already market-available therapies. 

When it comes to treating rare diseases, orphan drugs, which meet the requirements of an area of high unmet medical need, can receive up to 11 years of data protection. 

Source:

Science Business. European Parliament approves pharma reform compromise. [Date accessed 12/04/2024] https://sciencebusiness.net/news/data/european-parliament-approves-pharma-reform-compromise