The Swedish Government is appointing a new medical products inquiry

The Swedish Government has decided to appoint a new inquiry tasked with analysing and proposing how the Swedish state’s responsibility for medical products and vaccines should be expanded, strengthened and organised. The appointed committee is to submit an interim report by 1 June 2027 at the latest and a final report by 31 December 2027 at the latest.

Challenges in the current system

In the directive to the inquiry it is noted that the current system is fragmented and unequal, with disparities in access to treatment between different parts of Sweden. The Swedish medical products system has evolved gradually through various reforms over a long period. The result is a complex structure in which responsibility, funding and decision-making processes are divided between the Swedish state and the Regions in Sweden. Decisions on new medical products and vaccines are made through parallel systems, and several key processes currently lack national coordination. At the same time, medical developments have progressed rapidly, without the system for managing medical products and vaccines keeping pace. This has led to unequal access to treatments and long waiting times before new medical products reach patients.

Therefore, a more coordinated approach to medical products and vaccines in Sweden is needed.

The inquiry’s mandate

The overall aim of the inquiry is to create a transparent, efficient and sustainable medical products system in Sweden capable of capitalising on medical advances and meeting the increased demands placed on healthcare. The system must also ensure that patients throughout Sweden have access to cost-effective and medically justified treatments and vaccinations at the right time.

The inquiry will therefore take a holistic approach to the area and analyse how an expanded and uniform state responsibility can be structured. This encompasses the entire chain – from funding and governance to concrete processes for how medical products and vaccines are assessed, procured, introduced, subsidised and monitored. A central part of the remit is to propose a new funding model within the framework of the state budget process, with appropriate governance and division of responsibilities, as well as regulation that enables consistent assessments of medical products and vaccines.

The inquiry is to, among other things, analyse and propose how the Swedish state’s responsibility for medical products and vaccines should be expanded, strengthened and organised, including which authority or authorities, or which actors, should be responsible for governance and monitoring, and how information sharing and other solutions should be organised to ensure an effective system.

Furthermore, the inquiry shall develop uniform and coordinated national processes for the management of medical products. This involves, among other things, reviewing how a centralised state management of confidential prices can be designed, with the aim of enabling the effective management of price negotiations and agreements between the state and pharmaceutical companies. The inquiry shall also analyse and propose clear incentives to ensure that all relevant stakeholders take responsibility for the cost development and effectiveness of medical products and vaccines.

The inquiry shall also propose models for risk-sharing and financing that ensure risks and costs are distributed in an appropriate manner, whilst the system encourages medical innovation. Another key issue to be addressed by the inquiry is how medical prescribing freedom can be safeguarded, whilst protecting the system against the misuse of state-controlled medical products subsidies. At the same time, it is emphasised that the inquiry’s remit does not include making proposals to change or restrict patients’ medical products subsidies.

A further issue is to analyse whether the authority to decide on pharmacies’ trade margins should remain with the Dental and Pharmaceutical Benefits Agency, TLV, or be transferred to the Swedish Government. Finally, an implementation plan is to be drawn up setting out how expanded state responsibility can be introduced in practice, together with a timetable. The inquiry is to submit an interim report by 1 June 2027 at the latest and a final report by 31 December 2027 at the latest.

The fact that responsibility for medical products is divided between the state and the Regions in Sweden, creating unequal access and a lack of predictability, has been highlighted by various actors for some time. However, the area is complex and the task is very extensive, and must be carried out within a relatively short timeframe. Setterwalls will follow the progress of the inquiry and will revert on the matter.