EU

A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.

European pharma leaders want to see a deal so that no tariffs are imposed on medicines – but they also want the European Union to urgently rethink its sector policies that they believe will lead to massive investment loss.

The UK’s “New Approach” to regulation has created a lot of noise, but what’s the end product? asks Taylor Wessing partner Alison Dennis, who says the UK medtech regulator should look afresh at the EU’s ready-made solution.

The EMA has accepted for review Henlius’ Perjeta biosimilar, which is to be commercialized by the Chinese company’s global partner Organon in the EU.

A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.

The European Medicines Agency is this week set to issue an opinion on whether pan-EU marketing should be granted to Lilly’s Alzheimer’s disease drug donanemab.

The estimated costs to the pharmaceutical and cosmetics industry of introducing a fourth level of urban wastewater treatment are unclear, with the European Commission’s estimate of €1.2bn in dispute.

Assimilated EU medtech law used in Great Britain will not be sunsetted on 26 May 2025, as originally provided for. That was the first decision published by the MHRA in the wake of its recent consultation on shaping the regulatory system.

Some changes to the contentious social security financing bill have been made, but industry and the government remain at odds over a €1.2bn drugs overspend.

Improving reimbursement and integrating digital process across health care should be two priorities for the incoming German coalition, says Martin Walger, chief executive of the IVD industry association, the VDGH, in part two of his interview with In Vivo.