The European Cancer Patient Coalition (ECPC) would like to express its concerns on the compromise pursued by the EU Member States during the Employment, Social Policy, Health and Consumer Affairs Council configuration (EPSCO) meeting held virtually on Wednesday, 2nd December 2020 regarding the European Commission Proposal for a European Regulation on Health Technology Assessment (HTA).

ECPC is the largest European cancer patient association representing more than 450 cancer patient organisations in Europe and beyond. Therefore ECPC would like to voice its fear that the current compromise diverts from the initial scope of the HTA Regulation proposed by the European Commission, that is to harmonise transparent health technology assessment criteria and to increase timely access of patients to safe innovative medicine while ensuring equality for all cancer patients in this matter. As well as the discussed Pharmaceutical Strategy for Europe states that the HTA Regulation is aimed to break the silos, support collaboration among Member States in making timely and evidence-based investment decisions with added clinical value for patients. It promotes cooperation in meeting clinical evidence requirements and designing clinical trials to ensure that patient’s access to new medicines is both well-timed and evidence informed.

Regardless, the current compromise proposal of the Council of EU Member States Health Ministers is rather misleading and burdensome. Instead of enabling a process towards high-quality joint clinical reports that could be directly used by national authorities, it seems to aim at activities that might rather encumber the process than harmonising it and that could further lead to disagreement between decision-makers and therefore delay patient access to innovative medicines.

The fragmented and inconsistent requirements pursued by the Council compromise can potentially create discontinuity within the global clinical assessment regulatory landscape. “We are worried that what was discussed at the Council meeting does not consider a patient-centric approach. Our priority is to ensure that there are no delays for cancer patients to access innovative medicines; on the contrary, this time to access should be reduced. To reduce inequalities to innovative cancer treatment access across Europe is at the heart of ECPC, but this compromise will not allow to adequately address this” said Ken Matris, ECPC President.

Avoiding to propose a legally binding EU joint assessment may lead to:

  • duplication of work and data,
  • discrepancy between assessment outcomes at national level
  • and confusion and misinterpretation on the actual clinical impact and added value of innovative medicines.

The coronavirus crisis taught us that the European Union needs to build sustainable health systems that include a coherent legislative framework for joint clinical assessments and that are able to cope with the technological breakthrough for the benefit of patients. Therefore, ECPC questions the added value of the current Council compromise and is concerned that this could create pointless obstacles for cancer patients, negatively impact their treatment outcomes and hamper the viability of the EU healthcare systems at once.