The proposal for a regulation on Health Technology Assessment (HTA) has been high on the agenda of the European Parliament during the last months. The Committee on the Environment, Public Health and Food Safety (ENVI) passed by great majority (only 3 votes against) a text that unfortunately waters down the points the patient community including EFA has been asking to be covered in the legislation.
The issues with the most divergences among the groups concern the introduction of medical devices beyond the high-risk devices initially proposed by the Commission, to the scope and the mandatory versus voluntary nature of the uptake of joint health technology assessments. Although the rapporteur from ENVI Ms Soledad Cabezón Ruiz (S&D, Spain) was of the view that these should be included, ENVI’s final text ultimately aligned with the Commission’s proposal — although it gave the medical devices sector more time to comply, thereby not reducing the inequalities on the access to health technology for patients in the European Union.
Many MEPs also included amendments on the patient participation in the many committees that will be created at national level to assess technology for health, but unfortunately for the inclusion of the patients’ perspective and the empowerment of patients, the full participation of patients across the HTA process has not been retained in the ENVI vote.
The other two European Parliament committees giving an opinion on this legislation have been the Industry, Research and Energy (ITRE) and Internal Market and Consumer Protection (IMCO). The final vote for this first European Parliament reading of the proposal will take place in Plenary starting the 1st October. After that, EFA will inform you via this newsletter about the outcome of the vote for this important legislation piece for patients in the EU. The next step will be the revision at the Council of the European Union, where several Member States have publicly shown their disagreement with some of the key aspects asked by the patient community.
More about EFA’s work on HTA.