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Tue 22 October 2024 | View online Estimated reading time: 4-5 minutes |
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Hello , The ombudsman has dished out some harsh criticism for delays in regulating chemicals that present a danger to human health, IQVIA research finds Europe is falling behind in running clinical trials and WHO launches survey of mental health of the healthcare work force. Today’s news
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Commission accused of persistent failure to implement chemical rules, posing threat to human health |
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The European Ombudsman, Emily O’Reilly, has accused the European Commission of persistently failing to meet deadlines under the ‘REACH’ rules designed to limit exposure to dangerous chemicals, presenting a threat to human health.
In her conclusions, O’Reilly found that systemic delays by the European Commission amounted to maladministration.
“It takes the Commission on average 14.5 months to prepare draft decisions, although the deadline for doing so is three months. In certain cases, it takes several years,” she said.
ClientEarth and the European Environmental Bureau said in a statement, “The delays have allowed firms to continue using thousands of hazardous chemicals in ways that officials determined were likely to impact fertility, cause cancer and present other serious impacts on human health and the environment.”
Insufficient meeting rooms: The NGOs were heavily critical of some of the reasons offered by the Commission for the delays, including "insufficient meeting rooms," saying that this was a weak excuse for delaying potentially life-saving measures.
Replying to these accusations, the Commission Spokesperson Johanna Bernsel said, “We are willing to examine how our internal procedures can be improved so that decision-making becomes more efficient.”
Bernsel added that REACH was a very ambitious piece of legislation and that Commission President von der Leyen has stated that she will be looking into ways to simplify the REACH legislation. Read more here. Back to the top |
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Europe loses out in growth of clinical trials |
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Today (22 October) EFPIA and Vaccines Europe have published a report by IQVIA assessing the clinical trial ecosystem in Europe.
The report shows that overall the European Economic Area (EEA) is falling behind in its share of commercial clinical trials. While still a strong player in commercial multi-country trials, Europe has been outperformed by both the US and China. |
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“European clinical trials are hampered by a slow and fragmented research ecosystem, and current initiatives are insufficient to stop and reverse a decade of decline,” said Director General, EFPIA Nathalie Moll. “For Europe to be competitive it needs to function as a unified region, not as individual Member States and be supported by policies to attract global research investment.”
China has a particularly notable lead in cell and gene therapies, where the report claims Europe has had a particularly poor performance.
The loss of share to the US is thought to be driven by more rapid regulatory approval timelines and greater ease in patient recruitment, especially of more niche populations. One of the key recommendations in the Draghi report was the streamlining of the set-up and management of multi-country trials in the EU, “to advance the EU as an attractive place for conducting clinical R&D.”
Not all doom and gloom: The situation is not even across the EU; Spain, Portugal and Greece showed a relatively strong performance. While Denmark and Belgium have maintained the highest level of starts on a per capita basis. Spain, in particular, has become the leading country for clinical trial starts in Europe, overtaking Germany.
Spain’s success is attributed to four main factors: It’s timely implementation of the Clinical Trials Regulation (CTR), its universal healthcare system, effective collaboration between commercial and non-commercial trials and large research centres, with Barcelona as the main hub for trials. Back to the top |
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WHO/Europe survey on mental health of healthcare workforce |
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WHO/Europe is launching a survey on the mental health and well-being of healthcare professionals across the 27 European Union countries, as well as Iceland and Norway. The survey aims to gather data to better understand the challenges doctors and nurses face in their working environments.
The health workforce was placed under incredible strain during the pandemic, add to this the existing and growing difficulty in recruitment has meant that doctors and nurses in most countries remain overstretched and often suffer from burnout.
To address these concerns, WHO/Europe, with funding from the European Commission, will collect responses from doctors and nurses to understand the key factors affecting mental health and well-being.
The aim is to develop a strong evidence base to guide effective strategies for improving working conditions. Back to the top |
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Hungarian Presidency struggles to resolve impasse on incentives |
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The Working Party on Pharmaceuticals and Medical Devices meeting yesterday, failed to make progress on the issue of incentives.
"We feel that no fundamental progress has been made. Member states are still holding their positions. They did not comment much on individual incentives, but rather confirmed that their positions on incentives from the June EPSCO Council remain unchanged," a source told Euractiv.
The Hungarian Presidency of the EU Council has been working hard to break the impasse. The meeting was an opportunity for states to examine the proposal put forward by Czechia.
Some EU states fear that the European Commission's proposal could weaken incentives for innovation, while others see the conditional extensions of regulatory data protection periods as a way to accelerate access to more innovative and affordable medicines. Back to the top |
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France’s left-wing LFI call on the state to block the sale of Doliprane by Sanofi |
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France - On Monday (21 October) members of the French National Assembly from La France Insoumise (LFI, The Left) strongly criticised Sanofi's decision to sell its subsidiary Opella, which produces Doliprane, to the American investment fund CD&R.
“We must block the sale (...) We refuse to allow strategic sectors to come under the American flag (...) We must open the way for a public pharmaceuticals cluster,” LFI’s national coordinator Manuel Bompard said in an interview on TF1.
Minister of Economy and Finance, Antoine Armand announced in a tweet posted on Sunday (20 October) that the state will acquire a stake through the national investment bank (BPI - Banque Publique d’Investissement).
“Either he is naive, or he is taking people for fools, because it is not with a 1% stake (initial reports suggested 1%, editor's note) in the capital that the State will have any say in the strategic decisions that will be taken by the group,” Bompard criticised. Back to the top |
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French MPs table an amendment to extend medical cannabis trials |
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France - Two MPs from Ensemble pour la République, Emmanuel Macron's presidential party group, and the NGO “Santé France Cannabis” have tabled an amendment in the 2025 health budget bill (PLFSS) to extend the medical cannabis experiment.
For the past three years, 2,000 people in France have been taking part in a medical cannabis experiment, but extending the experiment did not feature in the 2025 health budget presented by the government a fortnight ago.
The amendment tabled aims to extend the experiment by 6 months “until a medicine is authorised and available [...] and by 31 December 2025 at the latest.”
The amendment will be put to a vote at the first reading of the 2025 health budget, which begins on Monday 28 October at the National Assembly. Back to the top |
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Denmark’s regions defend incident reporting system government was set to scrap |
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Denmark - Denmark’s regions have stepped in to support the country’s respected patient safety incident reporting system, which the government was set to scrap next year. A new deal is being negotiated with health stakeholders.
The Danish coalition government proposed ending the system in which health professionals report unintentional incidents to a government database without facing any sanctions.
The Danish Ministry of the Interior and Health recently announced that an agreement was reached between the government and Denmark’s regions, where the regions will run the system until 1 May 2025. In the meantime, a new legal framework is to be negotiated between the parties.
“It is crucial for patient safety that the staff can continue to feel confident about reporting without a penalty,” said Anders Kühnau, chairman of the Association of Danish Regions. “Other countries envy us that we have created a culture of safety where you can openly talk about and learn from adverse events. This develops and improves the quality and safety of our healthcare system.”
Denmark was the first country in the world to introduce the system in 2004. Today, many European countries have similar systems, and the WHO recommends such approaches to prevent patient harm.
“The agreement runs until 1 May 2025, and we will, of course, have a very strong focus on ensuring that the scheme continues after that date,” Director of the Danish Society for Patient Safety, Inge Kristensen, told Euractiv. Read more here. Back to the top |
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Poland to crack down on alcohol packaging and promotion |
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Poland - In early October, ‘alcohol tubes’ hit the shelves of Polish shops, drawing attention to their packaging, which closely mimics that of children's products like fruit purées and juices. The packaging sparked public outrage, with fears that such packaging could lead to accidental consumption by minors.
In response the Polish Ministry of Health has proposed a bill which proposes changes to alcohol sales regulations, focused on packaging.
"A draft amendment to the Act on Sobriety Education and Alcoholism Prevention has been included in the legislative and programme work plan of the Council of Ministers," the Ministry of Health told Euractiv.
In addition, the government wants to have more control over alcohol promotion.
"We want to expand the definition of promotion. This includes banning beer promotions, removing exemptions for designated alcohol stalls, enforcing a complete ban on alcohol promotion at such stalls, and increasing penalties for illegal advertising and promotion," said Deputy Health Minister Wojciech Konieczny during a parliamentary committee session. Read more here. Back to the top |
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| WHO launches survey on mental health of healthcare professionals |
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| Strasbourg plenary week: Vote on budget for 2025, Resolution on MDR |
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| Urban wastewater treatment (recast) on the agenda |
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| Working Party on Pharmaceuticals and Medical Devices |
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Today’s brief was brought to you by Euractiv’s Health team |
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Today’s briefing was prepared by the Health team: Catherine Feore, Clara Bauer-Babef, Emma Pirnay, Thomas Mangin, and Lydia Williams. Additional reporting from Monica Kleja and Paulina Mozolewska. Share your feedback or information with us at digital@euractiv.com. |
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