MedTech Europe has endorsed a new plan to strengthen the EU’s response to future pandemics and public health emergencies, with a few caveats.
European Commission President Ursula von der Leyen outlined the plan to create a European Health Union in her state of the union speech on Nov. 11. The plan is a response to lessons learned from the first stage of the COVID-19 pandemic, which showed that the EU must improve preparedness and response to manage serious cross-border health threats more effectively at both EU and member state level, von der Leyden said.
The proposals would give the EU and member states stronger tools to take quick, decisive and coordinated action, including new crisis mandates for the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA), as well as a revamped cross‑border health threat legal framework, according to the European Commission.
While welcoming better preparedness for another health crisis, MedTech Europe cautioned that the proposed plan could duplicate existing regulations or cause “legal uncertainty for all stakeholders affected.”
Specifically, the medtech trade group asked for clarification and further consideration of the role, composition and practical operation of a proposed new EMA medical device executive steering group in light of the role of the Medical Devices Coordination Group, which is implementing the new IVD Regulation (IVDR) and Medical Device Regulation (MDR).
The EMA must not be allowed to jeopardize “the urgently needed deployment” of the EU MDR, due to take effect May 26, 2021; and EU IVDR, scheduled to go into effect May 26, 2022, MedTech Europe said in a statement. The group praised the proposal to not duplicate crisis purchasing efforts on a national level, but asked for greater transparency and coordination with crisis purchasing initiatives that fall outside EU joint procurement agreements (JPAs).
Under the new regulation, the European Union would be able to:
- Adopt common measures at an EU level to face future cross-border health threats.
- Declare an EU-level public health emergency.
- Strengthen preparedness planning, reporting and auditing at an EU level.
- Put in place an integrated EU monitoring system for infectious disease and other health threats.
The proposed regulation would allow the EMA to:
- Permanently monitor events that could lead to medication shortages during future crises.
- Monitor and report on the risk of medication and medical device shortages during a crisis.
- Activate a dedicated crisis-management structure.
- Play a key role in the development and faster approval of medicines to treat or prevent a disease that could cause a public health crisis.
- Fast-track scientific advice on clinical trial protocols and carry out rolling reviews of evidence from clinical trials and other studies.
- Host medical device expert panels on a permanent basis.
The proposal would not enable the EMA to regulate medical devices, according to the commission.
“In addition to what is already proposed in the EU Health Union package, MedTech Europe also urges EU decision-makers to stay focused and take action in establishing the necessary infrastructure to make the new regulatory frameworks for medical devices and in vitro diagnostics a success,” the trade group said. “Having a functioning legislative framework is a prerequisite to ensure the continued patient access to existing and new medical technologies, especially during a health crisis.
“Key elements of the new infrastructure are still awaited and are urgently needed to allow for the required recertification of products ahead of the implementation deadlines,” the group added. “The situation with the IVD Regulation, in particular, remains extremely alarming. For instance, there are still only four notified bodies designated to the IVDR to assess – for the very first time – some ~45.000 IVDs needing certification in the 18 months remaining until the 26 May 2022 deadline.”
MedTech Europe has been pressing for a extension of the IVDR deadline, to no avail.
