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EPP’s Liese calls for urgent revision of EU’s Medical Devices Regulation

2 months ago 12

Ahead of next week’s European Parliament plenary session in Strasbourg, German Conservative MEP Peter Liese (CDU, EPP) outlined his centre-right group’s priorities for the new term, including the urgent revision of the EU’s Medical Devices Regulation.

“The prompt revision of the Medical Devices Regulation (MDR) and the adoption of a Critical Medicine Act to fight and overcome the shortage of critical medicines are top priorities for the next parliamentary term,” Liese told a press briefing on Friday morning (12 July). 

Medical devices

Although Liese told journalists that the current regulation was “well-intended”, saying it was prompted by the PIP (Poly Implant Prothèse) scandal, in which industrial-grade silicone was used to make silicone gel breast implants.

MEPs have learnt from industry that the regulation has created an overwhelming bureaucratic burden and proved prohibitively expensive for some medical device manufacturers.

However, he stressed that reform is possible without compromising safety and voiced optimism that the regulation could be tackled immediately as the draft proposal to amend the MDR already has the support of other political groups.

Medicine shortages

Liese, a doctor by training, also spoke about medicine shortages, saying “it is catastrophic that a rich region like the European Union is suffering from shortages in medicines”.

He said that  while the production of generic medicines on EU territory increases production costs, this should be weighed against the cost of not having access to medicines.

To overcome such problems, Liese suggested that supply chain sustainability should be taken into account in the procurement process, permitting should be made easier and state aid made more flexible to support EU-based production facilities.

Cardiovascular and mental health action plans

Liese also called for building on the success of ‘Europe’s Beating Cancer’ action plan and applying the tools for success to cardiovascular disease and mental health – an approach that has won the support of various political groups despite some reluctance on the part of the Commission.

Pharma package

Liese was “95% sure” that the EU’s Pharmaceuticals Package, agreed in first reading before the June elections, would not be reopened by the new Parliament but rather delayed in Council.

According to Liese, the new MEPs would not question the package, especially as the rapporteur and shadow rapporteur on the package, Tiemo Wölken (S&D, DE) and Tomislav Sokol (EPP, Croatia), have both returned to the European Parliament.

As for the likely replacement of Pernille Weiss (EPP, DK),  Liese said it might be someone like Dolors Montserrat (EPP, Spain) who was a former Spanish health minister, or Andras Kulja (EPP, Hungary), a surgeon from the new anti-Orban TISZA party, it is very likely that they will toe the line, he said.

Pandemic and pandemonium  

Speaking about possible future pandemics, Liese said he regretted cuts to the health budget, which he said would reduce the funds available to the Health Emergency Preparedness and Response Authority (HERA).

Asked if next week’s General Court ruling on access to the advance purchase agreements for COVID-19 vaccines negotiated by the European Commission could damage Ursula von der Leyen’s bid for a second term in office, Liese said he was not a lawyer but stressed the need to remember the context of the discussions at the time.

“Europe didn’t have a US-style BARDA (Biomedical Advanced Research and Development Authority). Unlike Israel, we didn’t have a fully digitised healthcare system; we didn’t have EHDS (European Health Data Space) in place.”

“At the start of the pandemic, Europe was behind the US, Israel, and the UK. Everyone was shouting that von der Leyen should do more and that she should reach out to pharma companies to ensure Europe’s access to vaccines. That was her responsibility and that was what she did, we needed to act.”

Ways and means

On the idea of splitting the European Parliament’s ENVI committee into separate health and environment committees, Liese, who could not yet confirm whether he would be the EPP’s coordinator on the ENVI committee, said he was in favour, but pointed out that other parties were more sceptical.

“The committee had 25% of the co-decision procedures, which was a lot for everyone, including the parliament’s staff”.

Six names are in the mix for the role of chairmanship of the committee, who will come from the S&D group and is likely to be Italian.

Liese said the previous chair, French MEP Pascal Canfin (Renew), neglected health, and the new chair should strike the right balance.

[Edited by Daniel Eck/Zoran Radosavljevic]

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