The European Commission recently proposed revisions to the EU pharmaceutical legislation.  While the legislation is meant to “enhance innovation and ensure timely and equitable access to medicines,” these changes are poised to do the opposite, jeopardizing access to innovative biopharmaceutical products that promote health and wellbeing across the continent.

One central concern about the legislation is its impact on regulatory data protection (RDP). RDP is an intellectual property (IP) right that ensures a period of protection for innovator’s clinical trial and other test data. According to Philip Stevens, founder and executive director of Geneva Network, “regulatory data protection is critical for biopharma innovators because it ensures that competitors cannot gain regulatory approval and enter the market on the back of an innovator’s test data before the innovator has had a fair opportunity to recoup the costs of compiling it.”

As it stands, the proposed legislation would reduce the RDP term in Europe by two years and provide illusory “opportunities” for the innovator to restore lost years if the innovator is able to launch and supply that product in all EU member states within 24 months of approval. Meeting that condition is entirely outside the control of innovators because EU member states must individually price and reimburse biopharmaceutical products.  

Additionally, the proposed legislation reveals other concerning issues. For example:

• The proposal would impose subjective criteria for determining whether a medicine meets an unmet need and whether the product then qualifies to restore six months of the two years of lost data protection.
• The current proposal would reduce critical incentives for most medicines combating orphan (e.g., rare) and pediatric diseases. For example, the EU currently provides 10 years of exclusivity for each orphan indication, but the proposed legislation would only provide one exclusivity period across the same active substance. Nearly 300 new pediatric medicines were approved between 2007, when incentives began, and 2019.

Without this crucial IP protection, a lack of adequate R&D infrastructure will ultimately lead to a loss of necessary investment that spurs innovations.

European legislators have an opportunity to improve current systems to promote innovations that benefit the health of patients. But current revisions its pharmaceutical legislation would erode the EU’s innovation ecosystem and disincentivize the development and delivery of novel medicines and treatments. To address this, legislators must enhance IP, including regulatory data protection, policies that are fundamental to the R&D of novel products that promote overall health.