artikel / 16 maj 2019

Collaborative model for introduction of medtech

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In mid-March 2019, the Swedish Association of Local Authorities and Regions (SALAR, known as SKL in Swedish) decided to recommend that the regions establish a collaborative model for the orderly introduction of medtech. A similar model already exists for pharmaceuticals, which has served as a model for the recommendation.

The collaborative model for orderly introduction of pharmaceuticals involves the regions working together on pricing, introduction and follow-up of pharmaceuticals. SALAR has now chosen to recommend that the regions establish a similar collaborative model for medtech.

SALAR describes difficulties in today’s system, for example, medtech products are being introduced unsystematically, which ultimately risks leading to unequal care and unnecessary costs for society. The purpose of the introduction is thus to achieve good and equal care throughout the country, as well as a cost-effective use of new products and methods. The model is also expected to provide an opportunity to phase out older, less well-functioning products. In addition, it is expected that worked up knowledge to a greater extent will be shared between the regions.

It has been suggested that a working function will be created, with responsibility for coordination, communication and follow-up. Further, a procurement project with a focus on strategic collaboration on medtech products has been suggested.

The recommendation from SALAR includes the establishment of a MedTech Council. The council will be a sister function to the pharmaceutical model’s counterpart, the New Therapies Council (NT Council, Sw. Rådet för Nya Terapier). The MedTech Council will be tasked with advising the regions on medtech products. In this context, it is worth mentioning that in its final report, Clearer responsibility and rules for pharmaceuticals (SOU 2018: 89; Sw. Tydligare ansvar och regler för läkemedel), the Investigation on Pharmaceuticals (Sw. Läkemedelsutredningen) proposes that the NT Council’s task in the pharmaceutical field should be taken over by a new authority called the Medical Products Council (Sw. Läkemedelsrådet). An important reason for establishing a new authority is that the advice and recommendations from the current NT Council have a significant impact. Thus the remitting body should be subject to for example the regulations of the Administrative Procedure Act on case handling, service obligation, party transparency and decision motivation.

We believe that the reasons presented by the Investigation on Pharmaceuticals for setting up an authority that provides recommendations regarding pharmaceuticals also apply to the medtech field. Thus if the Medical Products Council is established, there is reason to also review the proposed MedTech Council.

According to the recommendation, the collaborative model for the orderly introduction of medtech will be established in 2019 and be in operation in 2020. By 15 May 2019, the regions must report to SALAR how they intend to process the recommendation.

We are following this matter with interest.



Life Sciences

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