Latest news with #Várhelyi
Euronews
25-03-2025
- Health
- Euronews
Health ministers urge the European Commission to boost anti-tobacco action
ADVERTISEMENT Health ministers have urged the European Commission to step up its fight against tobacco and questioned the blocking of several pieces of tobacco legislation in a letter to Commissioner Várhelyi seen by Euronews. In the letter, dated 21 March, health ministers from Belgium, Estonia, Finland, France, Ireland, Latvia, Lithuania, Luxembourg, Malta, Slovenia, and Spain, at the initiative of the Netherlands, voice their concerns over the increasing use of new nicotine products among youth, cross-border distance sales, and the responsibility of social media platforms. 'We encourage you to take swift and decisive action to protect the health of our youth and to create a smoke-free generation by 2040,' the letter urges. They also question the delay in some of the key anti-tobacco initiatives presented by the Commission, such as the Tobacco Products Directive and Tobacco Taxation Directive, which under the European Beating Cancer Plan were initially planned for 2022 and 2024, respectively. 'We are concerned with the fact that there is no foreseen date in the near future for the revisions in the updated roadmap,' reads the letter. 'We urge you to publish these legislative proposals in 2025 and ensure they are aligned.' For that, they call to prioritise and allocate the resources needed for the revision of European tobacco control legislation and the inclusion of all new and future tobacco and nicotine products. Health ministers consider these delays especially harmful 'considering the rapidly evolving market of tobacco and nicotine products.' Protecting children Regarding the use of novel nicotine products, ministers call for the development of future-proof EU legislation to reduce the attractiveness of e-cigarettes and other emerging nicotine products. According to the letter, this should include restrictions on flavours, nicotine levels, and packaging. This is especially targeted at protecting children, alongside their call to prevent access to these products online. The letter states that the online sale and cross-border trade of tobacco and nicotine products undermine national efforts to restrict access to these products and asks the Commission to adopt proposals to effectively tackle challenges and problems related to cross-border distance sales within member states.
Euronews
15-03-2025
- Business
- Euronews
5 takeaways on the Critical Medicines Act
The European Commission unveiled this week one of its most significant health proposals, the Critical Medicines Act, which aims to enhance the security of supply and availability of essential medicines across the EU. While ambitious in some areas, such as a proposed "Buy European" mechanism and new class of 'common interest' medicines, in other respects it was unspectacular, particularly in coordinating contingency stock. Funding, as so often on health matters, remains a key concern. Euronews highlights the main open questions that still need to be addressed. One of the most talked-about aspects of the proposal is the 'Buy European' principle, which prioritises security of supply over cost in public procurement. Under this new proposed rule, EU contracting authorities will apply procurement requirements favouring suppliers that manufacture a significant portion of critical medicines within the EU. 'This fits perfectly within the limits of what we have already in the EU. This is, after all, an overriding reason of public health because we have a problem with the security of supply,' said EU health Commissioner Olivér Várhelyi. This new approach could expose the EU to international trade discontent. After all, it is not far from Beijing's 'Buy China' policy on medical devices recently openly challenged by the EU as it restricts foreign suppliers, including those from the EU, from government contracts. Earlier this year, the EU executive released a report providing evidence of China's unfair restrictions, arguing that market openness should be reciprocal. If implemented, "Buy European" could put the EU in a similar position—risking retaliation from trade partners and reduced market access abroad. To reduce dependence on non-EU countries, the proposal promotes increased European production of critical medicines as well as the new category of medicines of common interest. But do these drugs need to be manufactured on European soil? According to the new proposal, not really. The Commission plans to strengthen bilateral cooperation and establish new strategic partnerships to ensure diverse sources of supply. 'I very much rely on the candidate countries and countries in our closest neighbourhood who should be in pole position to help us to bring back production in the EU or closer to the EU," said Várhelyi. EU officials have also mentioned potential collaboration with other broader European third countries like the UK and Switzerland, given their strong trade links and proximity. A major shortcoming of the proposal is its limited funding. The indicative budget of €83 million for 2026-2027, primarily from the EU4Health program, is relatively modest. This funding will likely only cover the coordination efforts of the European Medicines Agency (EMA) and the European Commission, rather than supporting large-scale production shifts. While strategic projects could receive additional funding from EU programs like Horizon Europe and the Digital Europe Programme, it's uncertain whether these resources will be enough. Ahead of the proposal's presentation, 11 EU health ministers called for expanding the scope of EU defence funding to include critical medicines. However, Várhelyi dismissed this idea, emphasising reliance on state aid instead. To facilitate this, the Commission has loosened restrictions on state aid definitions in some new guidelines, encouraging member states to invest their national budgets in this initiative. The proposal includes enhanced mechanisms for joint procurement, with the Commission taking on a stronger role. Traditionally, joint procurement allows the Commission and at least nine Member States to negotiate as a single purchasing bloc, leveraging collective demand for better terms. The new proposal formalises and expands this mechanism, enabling the Commission to act as a central buyer when requested by at least nine member states. Additionally, a Commission-facilitated cross-border procurement model is introduced, where the EU executive provides logistical and administrative support to member states managing their own procurement. This formalisation builds on past Commission-led procurement efforts, such as the purchasing of vaccines for mpox and influenza. One key recommendation from the Critical Medicine Alliance—a stakeholder body analysing supply chain vulnerabilities—was the establishment of a harmonised EU framework for contingency stockpiling. However, this aspect was entirely omitted from the proposal. A European-wide stockpiling approach would ensure that member states do not compete against each other for supplies and could rely on EU solidarity during shortages. Without coordination, stockpiling efforts risk being fragmented, leading to inefficiencies and potential inequities. 'It cannot happen again that larger states stockpile medicines without sharing them with smaller countries in need,' stressed Croatian MEP Tomislav Sokol from centre-right European People's Party. With the proposal now moving to the legislative process, MEPs are expected to introduce amendments pushing for coordinated stockpiling measures Vegetarian and vegan diets are associated with both health benefits and risks, which is why it's important for people thinking of eating plant-based foods to pay attention to balancing their meals, a group of experts has said in two new reports. Experts from France's Agency for Food, Environmental and Occupational Health & Safety (Anses) said there's moderate evidence that suggests vegetarian diets are linked to a lower risk of developing type 2 diabetes compared with non-vegetarian diets. There's also some weaker evidence that vegetarian diets could lead to a reduced risk of heart disease, ovulation disorders, certain cancers, eye problems, and gastrointestinal issues. Some more tenuous evidence suggests, however, that plant-based diets could lead to a higher risk of bone fractures or congenital urethral malformations – though some experts posit there is not enough information on the possible link. The two new reports – which include a wide-ranging scientific literature review and dietary recommendations – are the result of five years of work for Anses experts who said that vegetarian diets are becoming more popular in France. 'We know that it's a diet that is increasingly popular [so] Anses first carried out a systematic review of published studies to identify the link between vegetarian diets and health and established dietary benchmarks to enable vegetarians to optimise their nutritional intake,' Perrine Nadaud, deputy head of the French agency's nutritional risk assessment unit, told Euronews Health. The scientific literature review included 131 studies on vegetarian diets' impact on health, while the dietary recommendations were created with an optimisation tool that considers nutrition, possible food contamination, and eating habits. For associations based on weaker evidence, Nadaud said the experts were still able to come to a determination, but that 'new studies published in the future could make us adjust this conclusion a bit'. The review also found that vegetarians had 'less favourable' levels of iron, iodine, vitamins B12 and D, and calcium-phosphate balance compared to non-vegetarians, with vegans also having a 'less favourable nutritional status for vitamin B2'. Not getting enough of some of these vitamins, for instance, could put someone at a higher risk of bone fractures. The UK's National Health Service (NHS) says that with 'good planning and an understanding of what makes up a healthy, balanced vegan diet, you can get all the nutrients your body needs'. But they warn that without proper planning, vegans could miss out on 'essential nutrients'. An IFOP survey in 2021 found that the vegetarian population in France remained 'marginal' at around 2.2 per cent, but at least 8 per cent of people were attempting to limit how much meat they consumed. It noted that meat is part of the country's culinary culture. Some of the main reasons those surveyed had for limiting their meat consumption include concern for animals and the impact of eating meat on the environment. A study published in the journal Nature in 2023 found that eating less meat reduced a person's environmental impact on greenhouse gas emissions, land use, water use, and biodiversity. As part of its dietary recommendations, the French agency says that vegetarians and vegans should consume fruits, vegetables, legumes such as lentils, starchy carbohydrates or bread, nuts and seeds, brewer's yeast, dairy products, or a fortified vegan equivalent every day. They noted that vegetarians can have a hard time meeting nutritional needs for certain Omega-3 fatty acids and vitamin D, and for vegans, it can be difficult to meet these needs for vitamin B12 and zinc in men. 'This is why we are developing these dietary guidelines: to help vegetarians improve their diets,' said Nadaud.
Euronews
11-03-2025
- Health
- Euronews
Romanian constitutional court unanimously rejects Calin Georgescu's candidacy, sparking protests
The European Commission has proposed new rules aimed at strengthening the security of supply and availability of critical medicines, prioritising EU-based suppliers in public procurement. ADVERTISEMENT The EU executive included a new 'Buy Europe' mechanism with its long-awaited proposal for a Critical Medicines Act, unveiled on Tuesday, a key piece of health legislation for this term. The proposal came just in time to meet Health Commissioner Olivér Várhelyi's self-imposed deadline of 100 days in office. This accelerated timeline for the proposal has sparked controversy due to the lack of a comprehensive impact assessment and limited stakeholder feedback, but the Commission said the proposal was urgently needed in view of ongoing medicine shortages. The Act aims to secure stable and reliable supply chains within the EU, ensuring a high level of public health protection and security. 'The Critical Medicines Act ensures that EU patients have access to the medicines they need, when and where they need them at an affordable price. In the current geopolitical context this has become an even bigger priority,' said Várhelyi. The proposal establishes the security of supply and availability of critical medicines as a strategic EU objective. Achieving this requires a coordinated approach at both national and European levels, the Commission acknowledged. The Act primarily targets critical medicines included in the EU's list of critical medicinal products drafted by the European Medicines Agency (EMA) in 2023, focusing on drugs used to treat serious conditions or those with limited alternatives. What's the issue about The proposal seeks to tackle severe medicine shortages in the EU, particularly for essential drugs such as antibiotics, insulin, and painkillers. Many of these medicines have become difficult to obtain due to reliance on a limited number of manufacturers or countries. The Commission acknowledges the EU's heavy dependence on foreign suppliers for active pharmaceutical ingredients (APIs) and the risks posed by export disruptions. The COVID-19 pandemic exposed these vulnerabilities, underscoring the need for a more resilient supply chain. While pharmaceutical companies are responsible for ensuring sufficient medicine supply, individual EU member states oversee distribution within their territories. Most shortages are currently managed at the national level. 'Buy European' is the solution The new proposal aims to boost investment in manufacturing essential medicines and key ingredients within the EU, reducing external dependencies. A key measure is a sort of 'Buy European' principle, which introduces public procurement award criteria that prioritise the security of supply over price alone. In practice, when a vulnerability in supply chains and dependence on a single third country is identified, EU contracting authorities will, where justified, apply procurement requirements favouring suppliers that manufacture a significant portion of these critical medicines within the EU. These measures will be implemented in compliance with the Union's international commitments. 'This is about increasing EU production capacity and diversifying supply chains to make them more resilient, while also leveraging demand,' an EU official explained. "The Act will have a positive impact on EU's competitiveness by fostering a more stable and predictable market environment," said Commissioner Olivér Várhelyi in Strasbourg. European Union - Valentine Zeler A joint procurement scheme? The proposal also introduces a novelty, a category of medicines under close review: medicines of common interest. These include medicines with little availability and accessibility in at least three EU member states, such as are used for treatments for rare diseases. For these medicines, the Commission proposes coordinated procurement mechanisms with member states to prevent inequalities and supply gaps. ADVERTISEMENT This could be seen as an attempt to put into practice a much-awaited joint procurement of medicines at the EU level, with the involvement of the European Commission supporting member states in the use of different collaborative procurement tools for critical medicines and other medicines of common interest. Additionally, the proposal introduces the concept of strategic projects, aimed at bolstering the EU's capacity to manufacture and develop critical medicines. These projects, located within the EU, will benefit from incentives such as fast-tracked permitting, streamlined environmental assessments, administrative and scientific support and potential EU funding. Lack of ambition (and money) Commenting on the proposal, Luxembourgish Green MEP Tilly Metz called for bolder initiatives to reshore medicine production in Europe. 'Joint procurement and just accelerating the processes is not enough,' she told Euronews. ADVERTISEMENT Meanwhile, Romanian liberal MEP Vlad Voiculescu welcomed the proposal as a positive step toward greater access to affordable medicines. 'It's a beginning. We hope to see it backed by funding, budgets, and national legislation as soon as possible,' Voiculescu told Euronews. Concerns remain over financing. Others fear that the proposal's indicative budget of €83 million for 2026-2027, primarily through the EU4Health program, will be insufficient. Ahead of the proposal's presentation, 11 EU health ministers advocated expanding the scope of the upcoming EU defence funding scheme to include critical medicines. Belgian Health Minister Frank Vandenbroucke, one of the signatories, urged the Commission to integrate the Act into Europe's security and defence framework. ADVERTISEMENT 'Medicine security is just as important as defence or energy security. Our collective safety depends on it,' he pointed out.
Euronews
11-03-2025
- Health
- Euronews
Commission to push 'buy European' in new critical medicines act
The European Commission has proposed new rules aimed at strengthening the security of supply and availability of critical medicines, prioritising EU-based suppliers in public procurement. ADVERTISEMENT The EU executive included a new 'Buy Europe' mechanism with its long-awaited proposal for a Critical Medicines Act, unveiled on Tuesday, a key piece of health legislation for this term. The proposal came just in time to meet Health Commissioner Olivér Várhelyi's self-imposed deadline of 100 days in office. This accelerated timeline for the proposal has sparked controversy due to the lack of a comprehensive impact assessment and limited stakeholder feedback, but the Commission said the proposal was urgently needed in view of ongoing medicine shortages. The Act aims to secure stable and reliable supply chains within the EU, ensuring a high level of public health protection and security. 'The Critical Medicines Act ensures that EU patients have access to the medicines they need, when and where they need them at an affordable price. In the current geopolitical context this has become an even bigger priority,' said Várhelyi. The proposal establishes the security of supply and availability of critical medicines as a strategic EU objective. Achieving this requires a coordinated approach at both national and European levels, the Commission acknowledged. The Act primarily targets critical medicines included in the EU's list of critical medicinal products drafted by the European Medicines Agency (EMA) in 2023, focusing on drugs used to treat serious conditions or those with limited alternatives. What's the issue about The proposal seeks to tackle severe medicine shortages in the EU, particularly for essential drugs such as antibiotics, insulin, and painkillers. Many of these medicines have become difficult to obtain due to reliance on a limited number of manufacturers or countries. The Commission acknowledges the EU's heavy dependence on foreign suppliers for active pharmaceutical ingredients (APIs) and the risks posed by export disruptions. The COVID-19 pandemic exposed these vulnerabilities, underscoring the need for a more resilient supply chain. While pharmaceutical companies are responsible for ensuring sufficient medicine supply, individual EU member states oversee distribution within their territories. Most shortages are currently managed at the national level. 'Buy European' is the solution The new proposal aims to boost investment in manufacturing essential medicines and key ingredients within the EU, reducing external dependencies. A key measure is a sort of 'Buy European' principle, which introduces public procurement award criteria that prioritise the security of supply over price alone. In practice, when a vulnerability in supply chains and dependence on a single third country is identified, EU contracting authorities will, where justified, apply procurement requirements favouring suppliers that manufacture a significant portion of these critical medicines within the EU. These measures will be implemented in compliance with the Union's international commitments. 'This is about increasing EU production capacity and diversifying supply chains to make them more resilient, while also leveraging demand,' an EU official explained. "The Act will have a positive impact on EU's competitiveness by fostering a more stable and predictable market environment," said Commissioner Olivér Várhelyi in Strasbourg. European Union - Valentine Zeler A joint procurement scheme? The proposal also introduces a novelty, a category of medicines under close review: medicines of common interest. These include medicines with little availability and accessibility in at least three EU member states, such as are used for treatments for rare diseases. For these medicines, the Commission proposes coordinated procurement mechanisms with member states to prevent inequalities and supply gaps. ADVERTISEMENT This could be seen as an attempt to put into practice a much-awaited joint procurement of medicines at the EU level, with the involvement of the European Commission supporting member states in the use of different collaborative procurement tools for critical medicines and other medicines of common interest. Additionally, the proposal introduces the concept of strategic projects, aimed at bolstering the EU's capacity to manufacture and develop critical medicines. These projects, located within the EU, will benefit from incentives such as fast-tracked permitting, streamlined environmental assessments, administrative and scientific support and potential EU funding. Lack of ambition (and money) Commenting on the proposal, Luxembourgish Green MEP Tilly Metz called for bolder initiatives to reshore medicine production in Europe. 'Joint procurement and just accelerating the processes is not enough,' she told Euronews. ADVERTISEMENT Meanwhile, Romanian liberal MEP Vlad Voiculescu welcomed the proposal as a positive step toward greater access to affordable medicines. 'It's a beginning. We hope to see it backed by funding, budgets, and national legislation as soon as possible,' Voiculescu told Euronews. Concerns remain over financing. Others fear that the proposal's indicative budget of €83 million for 2026-2027, primarily through the EU4Health program, will be insufficient. Ahead of the proposal's presentation, 11 EU health ministers advocated expanding the scope of the upcoming EU defence funding scheme to include critical medicines. Belgian Health Minister Frank Vandenbroucke, one of the signatories, urged the Commission to integrate the Act into Europe's security and defence framework. ADVERTISEMENT 'Medicine security is just as important as defence or energy security. Our collective safety depends on it,' he pointed out.
Euronews
31-01-2025
- Health
- Euronews
Commission cuts feedback amid races to push Critical Medicines Act
Health Commissioner Olivér Várhelyi's determination to deliver the Critical Medicines Act within a 100-day timeframe has left no space for an impact assessment raising concerns among stakeholders concerned that speed will trump consultation and evidence gathering in the process. The Critical Medicines Act is designed to address severe shortages of essential medicines in the EU, including antibiotics, insulin, and painkillers, particularly those that are difficult to source or depend on limited manufacturers or suppliers. Várhelyi committed to deliver the proposed legislation within the rapid timeline during his initial appearance as Health Commissioner, despite no deadline being set by Commission President Ursula von der Leyen. But stakeholders have raised doubts about the feasibility of an expedited process on such a complex issue, and whether due process such as an impact assessment and proper consultation will be by-passed. The latest Commission agenda tentatively schedules the Act for release on 11 March - exactly 100 days after the new Commission took office - barely meeting the self-imposed deadline. Call for high-speed evidence The Commission published its call for evidence - typically a key step in gathering feedback before a legislative initiative is presented - meaning that the executive intends to proceed without an impact assessment. Such assessments are intended to ensure evidence-based policymaking and were introduced in 2022 under the EU's Better Regulation principles. 'As there is pressing urgency to address the policy problem identified, the act will be adopted without an impact assessment,' the Commission stated in its paperwork, adding that a staff working paper will be published within three months of the proposal's adoption to provide evidence and analysis of its expected impacts. To justify this, the Commission points to the final recommendations of the Critical Medicines Alliance, a consultation body of 250 stakeholders established in April 2024 to analyze supply chain vulnerabilities. These recommendations are expected on 12 February 2025, and will supposedly inform the development of the Critical Medicines Act. Meanwhile the call for evidence will only be open for four weeks, closing at the end of February - roughly 10 days before the expected publication of the act. Among the stakeholders invited to provide feedback are EU member states, civil society and patient organizations, business and trade associations, public health sector procurers, academia, international organizations, and the general public. The interservice process—where all relevant directorates within the Commission review and give formal opinions—usually takes at least 10 working days, a former senior Commission official told Euronews. The source added that this could be shortened to just four days if pushed through for political reasons by von der Leyen's cabinet. Additional time is also required for the so-called 'legal scrubbing' and translations into all official EU languages, making it clear that the text will likely be finalised only a few days after the Critical Medicines Alliance's conclusions - and well before the consultation period ends. 'That means that, in a cynical move, the call for evidence will be a pure formality, and stakeholders won't be heard at all,' the former Commission official told Euronews. 'We deeply rely on comprehensive engagement of our members and advisors and the formulation of detailed, consensus-based positions to effectively influence policy,' Alessandro Gallina, Senior Policy Manager at European Public Health Alliance (EPHA) told Euronews. He added that quick turnarounds can strain capacity to mobilise resources, gather expert opinions, and forge a unified stance, resulting in less effective advocacy and potentially leading to policies that do not fully address the nuances of public health needs. Similarly, the European Patients Forum (EPF), together with EPHA members of the Critical Medicines Alliance, told Euronews that they do not consider the timeframe sufficient for meaningful stakeholder participation or for the European Commission to develop a legislative act "grounded in robust evidence and a comprehensive impact assessment." While recognising the importance of addressing medicines shortages, the patients' organisation added that any legislative initiative must be carefully designed to ensure it effectively tackles the issue and provides tangible benefits to patients.
