“Lobbying never sleeps” is Marc-Pierre Möll’s stock phrase. It sums up how he views his role as chief executive of German medtech industry association Bundesverband Medizintechnologie (BVMed).
Möll passed six years in the post on 1 April, and the job has arguably never had more urgent political, economic and innovation dimensions in the quarter century since the precursor industry body moved to Berlin in 2001, and “BVMed” started to gain currency in German healthcare political circles.
Predicting change and preparing for contingency needs are part of a chief executive’s remit. Möll had to call on that skillset in March when the US began introducing export tariffs, starting with steel and aluminium. This frustrating distraction – for world trade – added workload to an already long list of BVMed themes, like hospital reform, the EU Medical Device Regulation and pressing the government for a dedicated medtech strategy.
For many, the application of US tariffs appeared out of the blue. Möll was not wrongfooted. “They did not come as a big surprise to us at BVMed,” he told Medtech Insight. “Trump had talked about tariffs for months, and we were prepared,” he said. Already in February the association had briefed the federal chancellery and MPs on what it all could mean.
“Tariffs are very dangerous for patient care, because we will probably see problems with supply chain, components and prices,” Möll said. There could be shifts in the market whereby some European companies might withdraw from the US, he suggested. BVMed would also argue against any EU counter-tariffs as they could have negative effects on medtech supply chains.
“The uncertain situation means we must negotiate with the US administration to get rid of the tariffs.” BVMed has had regular tariff talks with US industry association AdvaMed. In February, together with MedTech Europe, the groups set up a three-way transatlantic coalition to present a consolidated medtech industry position to the US government and the European Commission.
BVMed’s lobbying on tariffs has included outreach to the Global Medical Technology Association (GMTA) and Germany’s outgoing chancellor Olaf Scholz and chancellor designate Friedrich Merz. Finance and economics ministers and other senior political figures able to convey BVMed’s position to the Council of the EU and European Commissioner Ursula von der Leyen were also briefed.
Medtech: A Designated ‘Growth Industry’
Getting agreement on tariffs is an unenviable job, but BVMed has gained forward motion via its “zero for zero” medtech tariffs negotiations, and has started to get a good deal for both sides, Möll said.
On 9 April, the industry received another boost on learning that medtech was expressly identified as a leading German growth industry in the draft coalition agreement reached between the center-right Union parties and Social Democrats (SPD).
“This is a first, and a big success,” Möll said. Until now, medtech has been rather unfamiliar to those in high-level political circles. “Although people have always talked about ‘big pharma,’ that mindset has not reached medtech – but ‘mighty medtech’ is now seen as a leading industry in Germany.” BVMed engaged in talks with Merz and his team to achieve this public accreditation.
Proof of the economic power of Germany’s medtech industry was illustrated by BVMed based on WifOR Institute data published in autumn 2024 – which for the first time definitively showed the relative size of the German medtech industry. The data showed that medtech is bigger than pharma in most economic comparisons.
A German MedTech Strategy
Germany already has a pharma strategy, and BVMed is now calling on the new government to develop a MedTech Strategy.
The hope is that the coalition government will view medtech not just in a healthcare context, but also from the angles of economic growth, sustainability and innovation. “Ideally, it should be a complete strategy embracing industrial, healthcare, research and quality considerations – as has been done for pharma, but not yet for medtech,” Möll stressed.
The next pivotal stage would be to develop initial plans with incoming ministers for health, economy and research. All three ministers are from the CDU-CSU Union, which potentially makes agreement between them – and the chancellor’s office – more predictable. They would all have a role in developing the MedTech Strategy.
One of the candidates for the new health minister is Tino Sorge (CDU): “We will engage well with him,” said Möll, who worked with Sorge when he was CDU health spokesman in the shadow government.
“We need an industrial deal for Germany, in which medtech as a high-tech industry will play a fundamental part over the next four years,” Möll said. “After the industrial deal, they will probably look at the individual industry branches, including medtech.”
The government last tapped the dedicated expertise of the medtech industry in 2024, when it organized a medtech industry-only round table to discuss possible changes to the MDR. The findings informed the Germany-France white paper discussed at the December 2024 EPSCO council of ministers’ meeting. There, new health commissioner Olivér Várhelyi promised to act on industry’s calls for MDR changes in 2025.
MDR Changes Underway
The new German government is likely to champion deregulation, which has long been a BVMed priority. “The MDR is the biggest issue to tackle, and we now see a major opportunity in Europe to change the MDR substantially. These efforts were driven by the past two German governments and I’m sure the new minister from the CDU will push the issue as well.”
There is undoubtedly a lot of work to do to improve the MDR, but the mood of BVMed picked up markedly on 20 March when industry heard Várhelyi proclaim at the first ever European Parliament committee on public health (the Sant Committee) that certain MDR changes not requiring parliamentary legislation will be complete by summer 2025.
“Even more important,” Möll added, “Várhelyi said he would address ‘substantial changes’ to the MDR – maybe even issuing a draft amending law to the MDR – before the end of this year.”
BVMed had sent a detailed 80-page document suggesting concrete changes to the commission, and it has since engaged in constructive talks with the German government, the European Commission, DG Sante and German MEPs.
At the Sant Committee, the commissioner spoke among other things of: delivering both on pediatric product needs and device electronic instructions for use in the second quarter of 2025; expanding the list of well-established technologies and helping with reclassifications to ensure products are available on the market; and driving down notified body costs.
Möll said: “We are delighted to hear that Mr Várhelyi wants to solve this problem in two stages.” The outcomes will be cost- and time-efficiencies, and possibly the end of five-year recertifications and more.
Whither Krankenhausreform?
The hospitals and DRGs reform law vies with MDR as the most important long-term issue facing medtechs in Germany. The Krankenhausreform was championed by former health minister Karl Lauterbach as an affordable but necessary way to continue delivering sustainable, high-quality care. It passed in parliament in late 2024
Möll said: “This is a massive theme for industry in Germany and for companies looking to enter the German market.” Two thirds of BVMed members’ revenues are made in the inpatient setting, according to Olaf Winkler, the association’s head of industrial health applications.
Under the provisions of the reform, the 2,000 hospitals in Germany could be reduced by 400 by 2030, Winkler said, due to a combination of the government’s drive to focus more on centers of excellence than general hospitals, and the fact that fewer staff will be available.
The reform also introduces a way of paying for care that is not based solely on the number patients treated. The new system enables the post-reform hospitals to access twin funding from a reserve budget and from diagnosis related groups (DRGs). The system it is replacing was prone to perverse incentives.
Hospitals will be categorized according to the level of specialist care they can deliver, and no longer according to the number of beds. Minimum quality requirements will be set for different aspects of care, defined by 60 service groups. Only those hospitals that have the requisite medtech and specialist medical staff will be able to provide services defined by the individual service groups.
Hybrid DRGs – the new method of paying for outpatient care – are being introduced to encourage a reduction in inpatient cases. However, outpatient care reimbursement is some 40-50% lower than inpatient DRG rates – although devices are still included in the payment, leaving medtechs to ponder having to their product prices.
Pre-election, the Union parties said they would not subject the Krankenhausreform – which is being implemented over several years – to wholesale change. BVMed has hired a new staffer whose sole task will be to engage with the 16 federal states on the issue of hospital reform.
Lengthy List Of Lobby Issues
A range of other high-level themes are also there to keep Möll, Winkler and colleagues on their toes at any give time.
No one must forget sustainability and supply chain compliance. Möll said: “The EU Green Deal is here to stay, and now it’s important that we have a new focus on the Clean Industrial Deal – in particular a focus on reducing unnecessary burdens on industry, like documentation of regulations.”
He said: “We need time to look closely at what is needed and see what is not important.”
The Clean Industrial Deal, launched in February, outlines how decarbonization efforts can drive industrial growth by, for instance, lowering energy prices and creating jobs in the new niche. It is part of the EU’s drive to become climate neutral by 2050.
Elsewhere, monitoring the ongoing – if slower-than-hoped – progress towards implementation of the electronic patient record (ePA); tracking sickness fund obstacles placed in front of the ground-breaking apps on prescription (DiGA) program; generally keeping up the pressure to expedite digitization and data usage across the heath system are some of the remaining themes for industry to meet head on.
Lobbying might never sleep, but maybe BVMed doesn’t get much time for that either.
