OBJECTIVES: In 2025 Joint Scientific Consultation (JSC) will be in place and specific new treatments are subject to Joint Clinical Assessment (JCA) for the first time in Europe. The regulation may either enhance market access due to timely assessment or impose additional efforts as still national submissions are still required and final appraisal and decision making falls under the national/regional authorities as before. The implementation and it’s impact is being assessed from an access perspective.

METHODS: Based on available draft/final processes and guidance documents, proposed methodologies have been reviewed. Pros and cons are being discussed in view of current standard requirements and decision making in Europe as well as consequences for manufacturers.

RESULTS: JSC will allow product developers of specific new treatments to receive recommendations from European Medicines Agency (EMA) and HTA bodies before start of pivotal trials. This is a promising approach as developers can get into a dialogue early on. However, the prioritization criteria and time constraints seem to impose a substantial barrier to such consultations and raise concerns that not all interested and willing to get into a dialogue will be considered.

Guidance documents for JCA follow evidence-based medicine (EBM) and reflect the follow up of the EUnetHTA pilots. The PICO is meant to cover a broad scope and comparators of the countries represented. The comprehensive evidence compilation may save resources for following national/regional submissions. Additional efforts remain for economic evidence which is not part of the HTA regulation as well as for country specific aspects.

CONCLUSIONS: JSC and JCA are a huge step towards more unified market access in Europe. However, operational limitations and country-based appraisals may cause delays, lead to diverse conclusions and could throw obstacles on the road while the pavement is still soft. Review of the implementation and refinements will be key in the future.