Government supports reform of EU pharmaceutical legislation
On 26 April 2023, the European Commission put forward a proposal for a major reform of the pharmaceutical legislation, with the aim of ensuring the quality, safety and efficacy of medicinal products used in the EU. As a rule, the Finnish Government supports the Commission’s proposal and, on 12 October, it submitted a Union communication to Parliament concerning its position on the proposal.
The purpose of the Commission’s proposal is to clarify and harmonise the legislation, improve the availability of medicines and the EU’s competitiveness and combat antimicrobial resistance, for example. The proposal includes four sets of measures with the following objectives:
- Promote the development of medicines.
- Ensure the accessibility and affordability of medicines.
- Reduce the adverse environmental effects of medicines.
- Streamline the administrative processes related to the different phases of the life cycle of medicines.
In its Communication, the Government supports the Commission’s proposal and its objectives. The Communication states that an innovation- and investment-friendly operating environment must be ensured for businesses in the European internal market. Preparedness for disruptions in the availability of medicinal products is considered good, but the proposed measures are deemed to have a limited effect on availability problems.
Government has reservations about proposed incentives
The Government has reservations about the Commission’s proposal to amend the incentives for the pharmaceutical industry, because incentives should be predictable in the long run. It is particularly important to avoid uncontrollably high costs for national healthcare systems.
Targeting the pharmaceutical development incentives at medicines that are needed by small groups of patients must not lead to a situation where insufficient incentives are provided to develop medicines for more common diseases.
The Government points out that the division of responsibilities between the European Medicines Agency and the national medicines agencies should be defined clearly. In addition, the opportunities of the Member States to exert influence must be ensured when it comes to applying the legislation, and the financial and other effects of the proposed measures must be clarified during deliberations.
Mari Laurén-Häussler, tel. +358 295 163 762, firstname.lastname(at)gov.fi