On the 27 of February the 21 Swedish regions and the Swedish Association of Local Authorities and Regions (SALAR) launched a unified message for the ongoing revision of the EU general pharmaceuticals legislation: Europe needs a pharmaceutical legislation that truly safeguards public health and ensures the sustainability of national health care systems in Europe.

EU pharma legislation – a high priority for Region Västerbotten

– The pharmaceutical legislation has contributed to increased availability of new medicines, but it has been a legislation with a clear industry perspective and a suboptimal focus on market authorisation. What we now need is a shift in legislative focus, with emphasis on factors that facilitate access to relevant treatment options for our patients, says Anna-Lena Danielsson, Regional Council and Chair for the Health and Medical Care Board in Region Västerbotten.

As the revision process for the legislative package intensifies, health care providers are awaiting the European Commission’s final draft expected to be published at the end of March 2023. 

– The European pharmaceutical legislation is of great significance to national health care systems in many ways, not only through the authorisation of medicines for the European market. It indirectly impacts on our availability to effective, safe, affordable, and cost-effective treatment options for our patients and for us as payers. This legislative process is therefore a high priority for us, says Anna-Lena Danielsson.

The advocacy work of Region Västerbotten – a university health care region of north Sweden – is politically mandated and part of the region’s patient access agenda in the pharmaceutical field. It aims at enabling the translation of research, development and innovation into new health care practice and treatments that benefit patients in sustainable ways for Swedish health care.

Swedish regions unify for a pharmaceutical legislation that safeguards public health

The 21 regions responsible for health care in Sweden, together with SALAR, now call for a sustainable pharmaceutical legislation.

The key messages are further elaborated in the policy brief with recommendations for legislative action which were presented by SALAR in November 2022.

What needs to be reflected in the revised legislation?

The SALAR policy brief emphasize five key recommendations that can help enhance the patient access perspective in the legislative package:

1. Greater consideration to national health care systems, beyond suboptimal focus on development and authorisation of new medicines.

2. Increased focus on premiering truly unmet medical needs, and authorisation of medicines with proven added clinical benefit in comparison with other available treatment options.

3. Increased focus on relevant and robust clinical evidence prior to market authorisation.

4. Strengthened availability of both older and established treatment options as well as new medicines and safeguarding the use of treatment options beyond industry developed and EMA authorised medicinal products.

5. Greater possibility of interchangeability of medicines and availability of generic medicinal products and biosimilars.

Read the full policy brief here.

Watch the video produced by Region Västerbotten, signed by all 21 regions here.