On May 15th we were amongst the 8 patient, consumer and public health associations invited by the EU Commissioner on Health and Food Safety Vytenis Andriukaitis to present our views on the proposed regulation on Health Technology Assessment. Our Director Susanna Palkonen brought the views of allergy, asthma and COPD patients on this new policy proposal, which can step up patient involvement and working together in the assessments, like we do for evaluation already!
The European Commission has decided this year to adopt a regulation to monitor the EU cooperation on Health Technology Assessment (HTA). HTA refers to the systematic evaluation of properties, effects, and/or impacts of health technology, taking into account the social, economic, organizational and ethical issues and national specificities. It supports policy-makers in healthcare by assessing the added value of health technologies compared to other health technologies and/or current standard of care.
Thanks to a future EU regulation on HTA, joint assessments would be carried out in Europe and would allow Member States to use common, high quality HTA tools, methodologies and procedures across the EU, working together in four main areas: joint clinical assessments, joint scientific consultations, identification of emerging health technologies and voluntary cooperation in other areas. Consequently, standardized methods on HTA could improve the level of transparency in HTA methodology and decisions based on joint evidence could be taken on the same medicines and medical products across Europe. The proposal also provides for patient involvement but is not specific about it. However, Member States will continue to carry out their non-clinical assessments (assessing economic evaluation, organisational, social, legal and ethical aspects) as well as taking their own decisions on pricing and reimbursement of health technologies.
EFA congratulated the Commissioner for the ambitious but pragmatic proposal. We welcome the proposal on HTA cooperation in Europe because it implies that patient involvement in HTA cooperation at EU level not only it is recognized, but also could enable patients to provide their structured perspective on HTA processes and decisions. In our position we however insist that the regulation should ensure appropriate involvement on patients at early stages, especially in joint scientific consultations and joint clinical assessment, to give input in an easy and accessible way and following the good experience at the EMA. For this reason, EFA supports the idea of optimizing patient involvement through the development of guidelines and promoting training for patients.
Some member states see the proposal as a threat to their ownership in assessments and quality, but in fact at the EMA as well, it is the member states themselves who are doing the evaluation together and the outcome has been success story, not to mention for patient involvement! EU at its best serving people.
The legislation process is in its early stages. For now the European Parliament and the Council are examining the proposal and will take a decision in the upcoming months. Meanwhile EFA will monitor the status of the legislation proposal and will develop amendments to support a patient centred regulation.
Find out more here about the proposal!
Read our HTA Position Paper.
Read the full European Commission Proposal here.