The EU Pharmaceutical Package: Will It Strike a Balance Between Stimulating Research and Facilitating Equal Access?

Abstract

Through the revision of EU pharmaceutical legislation, the Commission has tried to solve the problem of unequal access to medicines within the EU, while also making Europe more competitive in the global pharmaceutical market. Even though there are some positive aspects in the Commission proposal, such as cutting the deadlines for conducting the marketing authorisation procedure, there are also issues which can be seen as problematic and representing a step backwards in terms of promoting innovation within Europe. The Parliament is taking a more realistic and balanced approach between the need to stimulate research and innovation on one hand, and to facilitate equal access to medicines on the other. In relation to the issue of antimicrobials, the Parliament is combining a number of push and pull incentives, thereby motivating the industry to create new antimicrobials, but also ensuring these antimicrobials are finally developed and made accessible for European patients. All this means that the final text aiming at striking a balance between stimulating innovation and enabling equal access should follow, as far as possible, the balanced approach of Parliament. The revision of the pharmaceutical legislation is not a silver bullet to resolve all the problems relating to equal access. The revision of the Transparency Directive, which would at least accelerate national pricing and reimbursement decisions and set a strong enforcement mechanism, would definitely improve patients’ equality and make new medicines more accessible for them. Finally, the revision of the cross-border healthcare legislation, which would simplify the legal framework and make it more understandable for patients, would provide all European citizens with the same, or at least a similar, opportunity to avail themselves of best-quality treatments and medicines anywhere in the EU.

Keywords: cross-border healthcare, equal access to medicines, innovation, pharmaceutical legislation, regulatory data protection, research, transferable exclusivity voucher.

This work is licensed under the Creative Commons Attribution − Non-Commercial − No Derivatives 4.0 International License.

Suggested citation: T Sokol, ‘The EU Pharmaceutical Package: Will It Strike a Balance Between Stimulating Research and Facilitating Equal Access?’ (2025) 21 CYELP (‘Online First’).