MedTech Europe has welcomed plans proposed this month for a European Health Union but warned of the risk of duplication and legal uncertainty.
The European Commission proposed the union to learn lessons from the COVID-19 pandemic and improve the region’s ability to respond to cross-border health crises, including by taking steps to prevent shortages of medical devices and enable assessment of high-risk products.
MedTech Europe voiced support for greater cooperation between European countries in a statement in which it yet again sounded the alarm over the number of notified bodies ready to certify products under the In Vitro Diagnostic Regulation.
The early weeks of the coronavirus outbreak exposed a lack of unity in the European Union. When Italy, the first EU country to suffer a major COVID-19 outbreak, made an urgent request for help from its fellow member states in February its call went unanswered. Italy was suffering shortages of face masks, ventilators and other devices. France was accused of blocking masks bound for Italy. In the absence of EU support, Italy turned to China for the devices it needed to manage the pandemic.
Ursula von der Leyen, the president of the Commission, wants the EU to ensure it is better prepared to mount a collective response to the next public health crisis. That focus led the Commission to put out several documents earlier this month covering the lessons of the coronavirus pandemic and the changes it wants the EU to make in light of the learnings.
One of the documents covers a proposal for reinforcing the role of the European Medicines Agency in crisis preparations and management. The Commission wants to empower EMA to stop shortages, support timely development of new products and "ensure smooth functioning of expert panels for the assessment of some high-risk medical devices."
MedTech Europe said the Commission proposal could improve early alertness to threats and harmonize response measures. Those improvements are in line with the trade group's desire for a ban on unilateral restrictions on the cross-border trade of devices and improved coordination of procurement mechanisms in the EU.
However, industry has some reservations about the Commission proposals. The trade group is concerned moving responsibility for administering the IVDR and MDR expert panels to EMA could slow deployment of the panels. Similarly, the group called for efforts to ensure the proposed EMA Executive Steering Group for Medical Devices and existing Medical Devices Coordination Group work in harmony. The Commission sees benefits to the changes that gave MedTech Europe pause.
"By providing a permanent structure within the Agency for the functioning of expert panels, the proposal will create the ability to quickly provide scientific advice and technical support on demand in case of crisis and to support the assessment of certain high-risk medical devices," the Commission wrote.
The Commission proposal is the first step in a long process. Next, the Council and the Parliament will work to adopt a legislative proposal based on the ideas put forward by the Commission. On occasion, the Council and the Parliament are unable to reach an agreement, necessitating the formation of a conciliation committee. Once an agreed text is in place, the legislative text is adopted, although even then there may be a transition period before the changes take effect.
Depending on how long that process takes, MedTech Europe may have more pressing concerns than the EU Health Union. MedTech Europe used its response to the Commission to reiterate its worries about IVDR preparations, reminding officials that around 45,000 IVDs need certifying before the regulation takes effect in May 2022. There are currently only four notified bodies to handle the work.