PHARMACEUTICAL REFORM FROM EHU: ‘SINGLE MARKET FOR MEDICINES’

The European Health Union has taken a key step for more accessible, affordable, and innovative medicines.

On April 26,2023, the Commission introduced proposal for the revisions on the EU’s pharmaceutical legislation which aims to replace the existing pharmaceutical legislation with a patient-centred regulation. This proposal is seen as the largest reform in over 20 years in which the needs of citizens across EU are considered.

The motivation behind the scenes is the fact that EU citizens do not have equal access to the medicines authorized in EU in terms of time and prices. By also including proposals in relation to medicines for children and rare diseases, a better access for innovative health treatments is targeted.

It is noted that the patients are waiting for months to meet the burdens of administrative procedures and take necessary treatment and medicines. Additionally, the high prices for the innovative health treatments have been one of the major obstacles for EU health systems. The revisions by the proposal aim to reduce these burdens and create single market for medicines in Europe by ensuring timely and equal access to safe and effective medicines.

The proposal also included an essential approach to fighting against antimicrobial resistance (AMR) while proposing amendments to meet the objective of the European Green Deal especially in medicine production.

The proposal focuses on the simplification on the market authorization procedures through digitalization and opens a room for generic and biosimilar medicines to be able to enter to the market at an earlier stage.

For the next step, this proposal will be discussed in the European Parliament and the Council.

Sources:

• European Commission. (26 April 2023). “European Health Union: commssion proposes pharmaceutical reform for more accessible, affordable, and innovative medicines”. Retrieved on July 05, 2023, from https://ec.europa.eu/commission/presscorner/detail/en/IP_23_1843

• European Commission. “Reform of the EU pharmaceutical legislation Affordable, accessible, and innovative medicines”. Retrieved on July 05, 2023, from https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/promoting-our-european-way-life/european-health-union/reform-eu-pharmaceutical-legislation_en

• European Commission. “A pharmaceutical strategy for Europe”. Retrieved on July 05, 2023, from https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe_en