The European med tech industry has called for patient access to innovative technologies to be preserved under a new legislative proposal.
Last week, the European Council agreed to start negotiations with the European Parliament concerning joint work on the EU Health Technology Assessment (HTA) Regulation.
The Council called for the establishment of a coordination group comprising national health authorities, which would work on joint clinical assessments and joint scientific consultations on health technologies.
However, trade association MedTech Europe said it was “unclear how the Council proposal, as it stands now, would contribute to better or earlier patient access to medical technology innovation.”
In a statement on its website, MedTech Europe said the EU HTA Regulation could interfere with regulatory assessments conducted under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), which have been applied since May 2020.
This could lead to “delays in patient access to innovation and increased confusion in the market authorisation process in Europe,” MedTech Europe said.
It added that CE marking should remain the only process for market approval demonstrating safety and performance for the med tech sector. Any joint clinical assessment conducted on medical technologies should have transparent and adequate selection criteria, it said.
WHY IT MATTERS
The European Council says the proposed legislation should benefit patients, member states and health technology developers by improving patients' access to health technologies. It added that joint work carried out at EU level would provide valuable scientific information to national health authorities.
THE LARGER CONTEXT
The Commission adopted a proposal for an EU HTA Regulation in January 2018 and the European Parliament agreed on its position in February 2019.
Following the agreement of member states' ambassadors, negotiations with the European Parliament can now start.
The health technology assessment is an evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing technologies, enabling national health authorities to take decisions on their pricing or reimbursement.
Health technology includes medicinal products, medical devices or medical and surgical procedures, as well as measures for disease prevention, diagnosis or treatment used in healthcare.
ON THE RECORD
Marta Temido, Portuguese minister of health said: “The regulation on health technology assessment, once adopted, will be a major step forward in the field of health. It will constitute a robust framework for cooperation for the benefit of member states, industry and, above all, patients.”
A Med Tech Europe statement said: “As decision-makers embark on this critical stage of the legislative process, it will be crucial to ensure that timely access to innovation is safeguarded and improved for patients and health systems across Europe.
“To achieve this, any joint clinical assessment conducted on medical technologies must have a clear purpose, and their results must also enable appropriate real-life funding or reimbursement decisions taken within member states.”