The European med tech business has referred to as for affected person entry to progressive applied sciences to be preserved underneath a brand new legislative proposal.
Last week, the European Council agreed to start out negotiations with the European Parliament regarding joint work on the EU Health Technology Assessment (HTA) Regulation.
The Council referred to as for the institution of a coordination group comprising nationwide well being authorities, which might work on joint medical assessments and joint scientific consultations on well being applied sciences.
However, commerce affiliation MedTech Europe mentioned 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 mentioned the EU HTA Regulation might intrude with regulatory assessments performed underneath the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), which have been utilized since May 2020.
This might result in “delays in patient access to innovation and increased confusion in the market authorisation process in Europe,” MedTech Europe mentioned.
It added that CE marking ought to stay the one course of for market approval demonstrating security and efficiency for the med tech sector. Any joint medical evaluation performed on medical applied sciences ought to have clear and ample choice standards, it mentioned.
WHY IT MATTERS
The European Council says the proposed laws ought to profit sufferers, member states and well being know-how builders by enhancing sufferers’ entry to well being applied sciences. It added that joint work carried out at EU stage would supply useful scientific info to nationwide well being authorities.
THE LARGER CONTEXT
The Commission adopted a proposal for an EU HTA Regulation in January 2018 and the European Parliament agreed on its place in February 2019.
Following the settlement of member states’ ambassadors, negotiations with the European Parliament can now begin.
The well being know-how evaluation is an evidence-based course of that permits competent authorities to find out the relative effectiveness of recent or present applied sciences, enabling nationwide well being authorities to take selections on their pricing or reimbursement.
Health know-how contains medicinal merchandise, medical gadgets or medical and surgical procedures, in addition to measures for illness prevention, analysis or remedy utilized in healthcare.
ON THE RECORD
Marta Temido, Portuguese minister of well being mentioned: “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 assertion mentioned: “As decision-makers embark on this vital stage of the legislative course of, will probably be essential to make sure that well timed entry to innovation is safeguarded and improved for sufferers and well being methods throughout 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.”