Health Pro Brief

Wed 16 October 2024 | View online

Estimated reading time: 4-5 minutes

Hello ,

The debate on medical devices is heating up. There is concern from some quarters that the push to table a revised proposal in a short time frame could work against having a more considered review of current legislation.

Today’s news

• Biomedical Alliance warns of ‘short-term political expediency’ in medical devices review
• EPP pushes for urgent action on medical device rules
• Lancet Commission plan would halve premature deaths by 2050
• Global Health Connect: Health Diplomacy at the G7/G20
• It’s a wrap: Building trust for a healthier world
• MSF finds gaps in tuberculosis diagnosis and treatment remain large
• Does the EU have a patient-centred approach?
• €10 million increase in prevention budget is not enough, say Flemish patient groups
• What’s on

🟡 Medical devices

Biomedical Alliance warns of ‘short-term political expediency’ in medical devices review

The Biomedical Alliance in Europe, is worried that the recent urgent statement on revision of the Medical Devices Regulation by the Commission and push for a new proposal from some MEPs might put “short term political expediency” ahead of a careful review of the medical devices and in vitro diagnostics regulations (IVDR).

The Alliance complains that the the system is “remarkably complex”, but worry that plans made in haste to change medical device regulations risk further neglecting the needs of patients.

While recognising that “immediate short-term measures are necessary to address pressing issues,” including the limited availability of orphan and paediatric devices, they say that these should be separate from a structured and in-depth evaluation process of the MDR and the IVDR.

Clinical evidence requirements: The single greatest cause of current dysfunction, according to the Alliance, is a lack of clarity concerning clinical evidence requirements, “In simple terms, it is not clear whether a technology requires a clinical study, or how that study should be designed.”

The US system where the Food and Drug Administration (FDA) can provide clear advice on clinical evidence requirements in a consistent way, stands in contrast to the EU where they describe the advice structures as, “partial and uncoordinated, leading to a persistent ambiguity in the system.”

The Alliance are concerned that a proposal from Peter Liese MEP (Germany, EPP) would include changes to some reassessment of clinical and safety reports that lack “a clear rationale and impact assessment to understand the public health consequences.” They are also worried that Liese’s proposal seeks to remove requirements for reassessing some products and postmarket safety reports.

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EPP pushes for urgent action on medical device rules

The EPP Group continues to pile on the pressure for an urgent review of the Medical Devices regulation.

Peter Liese MEP, the EPP Group's Spokesman on Environment and Health in the European Parliament, is organising a briefing on the need for a revision of the law during next week’s plenary session. Fellow EPP MEP, Tomislav Sokol (Croatia), the group’s spokesperson on health will speak, as will Erik Vollebregt, specialist in EU medical device law and data protection.

Who he? Vollebregt, who has been a key expert source for Liese has blogged on his views of where amendments are most needed. He believes that the current decentralised governance arrangements don’t work, that the notification bodies are poorly controlled, meaning that procedural mistakes are not easily corrected.

Vollebregt questions whether the five year recertification cycle is needed and points to the “general regulatory lasagne” of horizontal legislation including the batteries regulation and AI rules that create a very complex environment.

For innovative manufacturers in particular, Vollebregt says more and more are abandoning the EU as the first jurisdiction to launch because the system is “too slow, too costly and too unpredictable”.

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🟡 World Health Summit, Berlin

Lancet Commission plan would halve premature deaths by 2050

The 2024 World Health Summit concluded with a bold new target from The Lancet Commission on Global Health: a plan to halve premature deaths by 2050.

“Our first message is that by 2050, countries can reduce the probability of premature death, which is the probability of dying before the age of 70, ”said Professor Dr Angela Chang from University of Southern Denmark and one of the commissioners working on the report, launched at the WHS.

Dubbed the '50 by 50' goal, the Commission assesses that it can halve premature deaths before the age 70, focusing on enhanced health interventions for 15 key diseases and greater investment in global healthcare systems.

Strengthening Primary Healthcare Systems: A major emphasis of the report is on the need to strengthen primary healthcare systems and first-level hospitals.

Countries like Bangladesh and Ethiopia that are leading the way in reducing premature death rates have focused on their primary healthcare systems and targeted interventions.

The Lancet Commission calls for centralised procurement and streamlined supply chains to ensure vital medicines and treatments are affordable and available when needed.

Dr Seth Berkley, former CEO of Gavi Vaccine Alliance. "We can't rely on the pharmaceutical sector to make the products we need."

Helen Clark, former Prime Minister of New Zealand and chair of the board at the Partnership for Maternal, Newborn and Child Health (PMNCH), said, “the report is so important in prioritising, in saying that if you do these things, you can expect to get these results.”

“Donors tend to be very results-oriented these days, the thought that when you back these horses, you’d get results. That has an appeal.” Read more here.

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Global Health Connect: Health Diplomacy at the G7/G20

As the G20 summit in Brazil approaches (18-19 November) the WHS discussed the importance of keeping health at the forefront of discussions and diplomacy.  

Brazil’s Secretary of Health Surveillance and Environment Dr Ethel Leonor Noia Maciel called for greater cooperation between the Global North and South on health supply chains.

Antoine Saint-Denis from France’s Ministry of Health reflected on the balance between local and global responsibilities, “When you’re a health minister, your duty is to your population, but you also realise you are part of a global community. The problems of the world, or your counterparts, are also yours."

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It’s a wrap: Building trust for a healthier world

As the World Health Summit draws to a close, Euractiv's Jeremias Lin had the chance to speak to Professor Dr Beate Kampmann, Director of the Charité Center for Global Health in Germany.

Kampmann said the WHS showed the demand for in-person dialogue, despite modern concerns like the carbon footprint of travel.

“What happens in the corridors can be just as crucial” for fostering relationships and driving collaboration, says Kampmann. This year's theme, "Building Trust for a Healthier World" struck a chord, especially on the need for better collaboration between European countries and low- and middle-income countries.

Kampmann noted that while the event ran smoothly, the perennial challenge remains: turning dialogue into actionable results.

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🟡 Tuberculosis

MSF finds gaps in tuberculosis diagnosis and treatment remain large

The Medicines Sans Frontier (MSF) have released a report (15 October) stating that governments and donors are failing to aid children with tuberculosis (TB).

The World Health Organisation (WHO) estimates that 1.25 million children and young adolescents (0-14 years) fall ill with tuberculosis (TB) each year, but that only half of these children are diagnosed and reported to national TB programmes (NTPs). The report also indicated that out of the 14 policy indicators measured, only one country’s policies fully aligned with WHO’s 2022 tuberculosis guidelines.

“We urge countries, donors and technical agencies to put an end to this deadly status quo and step up their efforts to ensure timely diagnosis and treatment of TB in children,” said Stijn Deborggraeve, the diagnostics advisor at MSF’s access campaign. “We can no longer afford inaction—every delay means that more children die unnecessarily.”

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🟡 Patient-centred policy

Does the EU have a patient-centred approach?

At its first event of the new 2024-2029 political mandate, the European Patients Forum (EPF) will be assessing progress in putting patient involvement on the policy agenda. The organisation has championed the need to involve patients in every aspect of decision making.

In a speech at EPF’s high-level meeting  today (16 October), Health Commissioner Stella Kyriakides will underline the importance of patient involvement, saying that without the lived experience of millions of Europeans the EU’s actions would be much less effective.

Kyriakides will say that the patient is at the centre of the European Health Union. From timely access to medicines to very real - and sometimes mandatory - involvement in how policies are developed.

Patients are increasingly not just the beneficiary, but involved in determining treatment and identifying  and defining their own needs. EPF wants to keep the pressure up and today’s meeting will be a good chance to remind politicians of their demands for change.

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🟡 In the capitals

Supported by Efpia

€10 million increase in prevention budget is not enough, say Flemish patient groups

Belgium - The new Flemish government commitment to increase its prevention healthcare budget by only €10 million has prompted patient groups to call for more investment.

After months of negotiations following the regional election on 9 June, Flanders, Belgium, has a new regional government and a new Minister of Wellbeing.

Prevention seems to have drawn the short straw: “In our country, only 2.7% of the healthcare budget is allocated to prevention - half the European average and far below WHO recommendations,” David Vansteenbrugge of the Belgian cancer organisation Stand up to Cancer (Kom Op Tegen Kanker) told Euractiv.

“The strong emphasis on mental wellbeing, the focus on children and young people, the link with addictions (vaping, alcohol, gaming), and the attention to preventing obesity and eating disorders are all positive steps,” said Linda De Boeck, director of the Flemish Institute for Healthy Living (Vlaams Instituut Gezond Leven vzw). “But we worry whether an additional €10 million will be enough to make a real difference.”

Belgium spends €24 billion annually on chronic disease care, according to VOKA Health Community. This includes €8 billion allocated to sick workers’ benefits and €11.5 billion lost in economic productivity.

“Investing in prevention could significantly reduce these costs,” said Vansteenbrugge. Read more here.

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🟡 Agenda

What’s on

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Today’s brief was brought to you by Euractiv’s Health team

Today’s briefing was prepared by the Health team: Catherine Feore, Clara Bauer-Babef, Emma Pirnay, Thomas Mangin, and Lydia Williams. Additional reporting from Jeremias Lin who is attending the World Health Summit in Berlin and Nicole Verbeeck. Share your feedback or information with us at digital@euractiv.com.

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