Press Release: EU HTA Proposal – Council on the verge of a compromise?

EUCOPE welcomes the important collaborative effort made today 16 March by the Council of the EU to reach a compromise on the EU on a Proposal for a Regulation on health technology assessment (HTA) and amending Directive 2011/24/EU. The Portuguese Presidency underscored the difficulty of the ongoing negotiation and the need for additional political discussion during today’s informal meeting of health ministers. Nevertheless, we are pleased to hear that Portugal still aims to receive a mandate to start trilogue negotiations with the Commission and Parliament in the next weeks.

However, we note that the direction of the current compromise is substantially changing important parts of the proposed Regulation. We understand that the current proposal follows the idea of “non-duplication” principle, meaning that the evidence submitted in joint clinical assessment at the EU level shall not be requested again at Member States level. Yet our reading is that this does not explicitly preclude Member States to ask for additional data.

If the Council proposal does not allow for any binding effect on Member States, this will inevitably result in duplication of work, posing continued regulatory burdens on companies and, in particular for small to mid-size companies, that lack the resources to face both the uncertainty and the additional workload that such a process might bring.

Since the beginning of the legislative procedure, EUCOPE raised the need for adjustments to provide for a sufficient level of flexibility in specific cases, such as for Orphan Medicinal Products (OMPs) and Advanced Therapy Medicinal Products (ATMPs). A “one-size-fits all” methodology not accounting for specificities of therapies developed for small patient populations would inadvertently cause considerable delays in assessments and ultimately hinder patients’ access to those medicines across the EU. We, therefore, reiterate the need for a flexible framework that can manage evidential uncertainty in specific cases where appropriate.

We look forward to engaging in a fruitful discussion with the European institutions and contributing to the achievement of the potential of the EU HTA proposal: contribute to more transparency and convergence in value assessment of health technologies across Europe, to the ultimate benefit of patients.

Read our full statement here.