February 21. 2024. 8:14

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The gifts that keep on giving


After a record-breaking legislative process in terms of speed, EU lawmakers managed to avoid the risk of medical device shortages pushing back the implementation of the new EU framework, but this is not the last time we’ll be hearing of the new medical devices rules.

A legislative act published last week (15 March) in the EU official journal extended the deadlines for implementing the two key regulations for medical devices (MDR) and in vitro diagnostics (IVDR) – which respectively entered into application in May 2021 and May 2022.

Such an amendment had become necessary once developers of medical devices experienced troubles in implementing these new frameworks – mostly because all medical devices currently authorised in the EU needed to be registered again according to the new conformity rules.

However, there was a lack of designated organisations to assess the conformity of these devices (ranging from simple contact lenses and syringes to sophisticated pacemakers and hip replacements) under the new rules.

That meant that medical device certificates required under the new rules have not been issued yet for the overwhelming majority of the more than 500,000 devices registered under the previous regime.

The bad news was that the transition period before the application of the new rules was supposed to end in May 2024. The European Commission then acknowledged that the capacity of notified bodies remains insufficient to carry out all these conformity assessments by that deadline.

In early January, the Commission presented the targeted legislative amendment to the relevant regulations introducing new deadlines: December 2027 for most of the medical devices, and December 2028 for the higher-risk devices, such as pacemakers and hip implants.

The amendment was approved in record time by the EU lawmakers, with the Council sealing the text on 7 March, following a positive vote by the MEPs in February’s plenary – if you want more of this, be sure to listen to EURACTIV’s special podcast on the new EU medical devices rule.

All’s well that ends well? Not so fast.

Although recognising this extension is a new milestone, the EU’s health chief Stella Kyriakides cautioned that the work on the implementation of the directive has just begun.

“We have a long road ahead of us before this transition is completed,” she told the EU-27 health ministers in Brussels last week.

Kyriakides confirmed the ambition of the EU executive in offering more support to SMEs in order to shape a regulatory environment that really fosters innovation. In this sense, the EU’s newly revamped budget line for health spending, called EU4Health, will be used to support this effort, she added.

“But by 2027, we will undertake a broader evaluation of this framework. And we will be able to decide together if changes are needed,” she warned.

It is indeed normal to conceive a mid-term review for big regulatory frameworks such as the ones on medical devices, or the one on pharmaceuticals that is expected to be unveiled next week.

But it is also a useful reminder to those – like us and most of our readers – who monitor EU policies, to keep the focus broader than just on the mere legislative process, as there’s an entire world that comes after the publication in the EU official journal, made of complex secondary legislation and difficult national application of the rules.

When it comes to policymaking, we often refer to an ideal world of what a certain framework should be. But then there’s the implementation on the ground, where something can always go wrong.

After all, certain pieces fo legislation – and the medical devices framework is one of those – are like those gifts that keep on giving.


The EU rules for sperm in SoHo

This week, EURACTIV’s health team explores the outstanding revision of the EU framework on substances of human origins (SoHo) together with Annemette Arndal-Lauritzen, CEO of the European Sperm Bank, with a focus on the revision of the EU rules for …

No comment on Justyna Wydrzynska’s sentence. The European Commission and European Parliament President said they will not comment on the Polish court’s landmark decision to convict a woman for helping to provide another woman with abortion pills, while cross-party EU lawmakers denounced the verdict.

SANT is set. On Wednesday (15 March), the names of 30 parliamentarians who will be sitting on the new subcommittee on public health (SANT) were announced.

The biggest group in the committee is Christian democrats (EPP), with seven members, followed by S&D – six members, Renew – four members, Greens, conservatives (ECR) and ID group having three representatives each, and the Left with two members as well as two non-attached members.

On Monday (20 March) EPP announced that Croatian MEP Tomislav Sokol will lead the EPP Group’s work in the subcommittee.

In a press release, Sokol said: “The EPP Group aims to strengthen EU healthcare policies, address issues such as medicine and medical device shortages, improve access to healthcare, improve disease treatment and prevention, and promote cross-border cooperation in healthcare.”

The constitutive meeting of the new sub-committee will take place on Thursday (23 March). The subcommittee will deal with programmes and specific actions in the field of public health, pharmaceutical and cosmetic products, health aspects of bioterrorism, the European Medicines Agency, and the European Centre for Disease Prevention and Control. The ENVI committee remains responsible for examining and voting on legislative proposals.

The decision to set up a subcommittee on public health, under the umbrella of the Committee on the Environment, Public Health and Food Safety (ENVI), was approved in February.

Kyriakides announces plans to set up expert group on long COVID. On 14 March, during the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), Health Commissioner Stella Kyriakides presented to the ministers a plan to set up a network of centres of expertise on the management and treatment of long COVID. Additionally, the commission is putting €110 million of financial support into research to understand the causes of long COVID and find treatments. Seventeen million people within the EU have been affected by long COVID In the last two years and the number is set to grow. “It has an impact, of course, on the quality of life of those it affects but also on societies and economies,” Kyriakides told reporters on 14 March.

What was EPSCO all about? Long COVID was not the only topic on agenda. Global health strategy, European medicine agency (EMA)’s fees, and more health topics were discussed at EPSCO in Brussels on 14 March.

  • Global health strategy. Ministers recognised that the EU global health strategy, described by Kyriakides as “the external dimension of the European Union health union” is an important element of the EU’s response to current and future global health challenges such as COVID-19, antimicrobial resistance and the health and humanitarian crisis caused by the war in Ukraine. “Health challenges, such as pandemics, do not recognise borders. […] Stronger health systems around the globe benefit us all, quick action against health threats – wherever they occur – is vital in an interdependent world,” said the Swedish minister of health care, Acko Ankarberg Johansson, during a press briefing on 14 March.
  • EMA fees. Ministers welcomed the Commission’s draft law, presented last December, which aims to ensure that the fees better reflect the costs of the work done by EMA and to put EMA’s budget on a more sustainable footing. “There was agreement among the ministers on a targeted approach to adjusting fees and remuneration, as well as on flexibility and future-proofing including a larger rule for member states in this,” Johansson said.
  • Medicines shortages. A number of countries – the Czech delegation, supported by the Austrian, Cyprus, Greek, Hungarian, Italian, Lithuanian, Maltese, Netherlands, Portuguese, and Slovenian delegations – highlighted the shortages of medicines in the EU market. Johansson said that this issue is on the agenda for the informal meeting of health ministers in Sweden in May. One of the actions to address the shortages was to extend EMA’s mandate. For a year now EMA is monitoring how public health emergencies affect the supply of critical medicines. The next step: pharmaceutical legislation that will be presented next week. “One of its aims is to address exactly the long-term issue that involves access to medicines and security of supply and hopefully this will help to mitigate shortages in the future,” Kyriakides told reporters on 14 March.
  • COVID-19 vaccine procurement. The informal discussion focused on the future of COVID-19 vaccine procurement, especially for purchases at the EU level “to better align supply and demand of vaccines with member states’ needs,” according to Kyriakides.

Football and dementia. The most popular sport in the world – football – increases the risk of neurodegenerative disease compared with the general population, a study has warned.

Peter Ueda, assistant professor at Karolinska Institutet, Sweden, said this study confirms that elite footballers run a greater risk of developing a neurogenerative disease later in life. “As there are growing calls from within the sport for greater measures to protect brain health, our study adds to the limited evidence base and can be used to guide decisions on how to manage these risks,” Ueda said

Unlike outfield players, goalkeepers did not have an increased risk of dementia – supporting the hypothesis that mild head impacts sustained when heading the ball could explain the increased risk in outfield players.

“Goalkeepers rarely head the ball, unlike outfield players, but are exposed to similar environments and lifestyles during their football careers and perhaps also after retirement,” Ueda said.

He continued: “It has been hypothesised that repetitive mild head trauma sustained through heading the ball is the reason football players are at increased risk, and it could be that the difference in neurodegenerative disease risk between these two types of players supports this theory.”

Athens awarded for pubic health achievements. Athens was one of the five cities recognised for public health achievements at the Partnership for Healthy Cities Summit convened in London by Bloomberg Philanthropies, World Health Organization, Vital Strategies, and London Mayor Sadiq Khan on 15 March. The city, like the other four, will receive €139 000, thanks for the work on increasing access to the opioid overdose reversal agent, naloxone, at community-based organisations and among healthcare professionals. The city also started researching causes of death among people who inject drugs to understand the impact of the overdose crisis better. The other four winners are Montevideo, Uruguay for food policy; Mexico City, Mexico for road safety; Vancouver, Canada for surveillance; and Bengaluru, India for tobacco control.

BRATISLAVA

Slovak school cafeterias banned from selling soft drinks, fried food. School cafeterias will no longer be allowed to sell energy and sugary drinks or fried foods, while sweets, crisps, and similar products can make up at most half of the range offered, according to a new decree. By Michal Hudec | EURACTIV.sk

BRUSSELS

Belgium, Netherlands among Western Europe’s main cocaine hubs. Belgium and the Netherlands have become Western Europe’s main import centres for cocaine, a report by the UN Office on Drugs and Crime (UNODC) presented in Vienna on Thursday reads. By Anne-Sophie Gayet | EURACTIV.com

HELSINKI

Drug policy key issue for voters in Finnish elections. Drug-related issues and drug policy will be a determining factor for 57% of the voters in Finland’s upcoming April elections, a new survey by the A-Clinic Foundation has found. By Pekka Vanttinen | EURACTIV.com

WARSAW

Poland sentences activist for assisting woman to get abortion. A Polish court has sentenced pro-abortion activist Justyna Wydrzynska to eight months of community service for illegally helping another woman get an abortion, but the European Commission and Parliament have remained tight-lipped. By Aleksandra Krzysztoszek | EURACTIV.pl

ZAGREB

Croats are ‘the fattest nation’ in EU, health officials warn. Croats are the most overweight nation in the European Union, and the annual cost of treating related health conditions amounts to almost 3% of the GDP, an official of the national institute of public health (HZJZ) said on 15th March. By Zoran Radosavljevic | EURACTIV.com

21-23 March – European Health Tech Summit

22-23 March – European Parliament’s environment and health committee meeting

22-24 March – UN 2023 Water Conference

23 March – Prioritizing the most needed paediatric formulations: a focus on COVID-19 and antibiotics

24 March – World Tuberculosis Day

27-28 March – International Medical Devices Regulators Forum