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Polpharma Group Calls for Urgent Action to Protect early equitable access to medicines for European patients
Polpharma Group Calls for Urgent Action to Protect early equitable access to medicines for European patients

Yahoo

time14-05-2025

  • Health
  • Yahoo

Polpharma Group Calls for Urgent Action to Protect early equitable access to medicines for European patients

Polpharma Group Joins the Call to Action to Finalize Pharmaceutical Reform and Secure Early and Sustainable Healthcare for European Patients WARSAW, Poland, May 14, 2025 (GLOBE NEWSWIRE) -- Polpharma Group, a leading pharmaceutical company, urges the European Union to take decisive action to conclude the pharmaceutical reform and strengthen Europe's capacity to produce essential medicines. We advocate for early access to generics to optimize health payer budgets and enable treatments for more patients. In the face of unprecedented geopolitical uncertainty, it is crucial to place public health at the center of all political decisions. Commitment to Health Security Public health is a fundamental right. As EU Health Ministries approach the final stages of negotiations on the future of Europe's pharmaceutical rules, Polpharma Group emphasizes the need to ensure that every European has access to the medicines they need. This is about avoiding shortages, bringing production back to Europe, and making our health systems more resilient and fair. Key Recommendations 1. Reduced Periods of Exclusivities = increases healthy Competition On-patent pharmaceutical companies are pushing for extended exclusivities in Europe as part of the late-stage revision of the EU pharma legislation. This move, spurred by the threat of tariffs, aims to stifle competition from the off-patent medicines industry. The EU already has the longest exclusivity period in the world, and extending it further would only hinder competition and delay access to affordable medicines. 2. Timely Access = Savings to Healthcare Systems The needs of patients are growing faster than health systems can manage. Extending exclusivities would exacerbate this issue, as health systems in Europe are already struggling with exponential medical care costs. Innovation is happening globally, and what drives access to medicines - it is competition among equivalent medicines after patent expiry, not extended exclusivities. Early entry of off-patent medicines has been proven to save costs for health payers, with significant price reductions observed upon entry from minus 25 up to 75% upon first and multiple entrants. 3. Investment in EU Manufacturing = Security of Supply Off-patent medicines bring access, competition, and effective savings. It is crucial to ensure these medicines are manufactured in Europe at proximity of patients. The COVID-19 pandemic highlighted the fragility of supply chains, and shorter exclusivities would allow faster sourcing of generics, thus improving medicines security. Recently proposed by EU Commission Critical Medicines Act (CMA) is designed to address this issue. As Polpharma Group large European based manufacturer we strongly advocate to make this act equipped with strong 'toolbox' to invest in the European pharmaceutical sector. Polish Presidency's Aspiration to Close Pharmaceutical Directive position in the Council The Polish Presidency has been highly ambitious in working towards the alignment of member states position on Pharmaceutical Directive. It is in view of securing early access to medicines for more patients thus increasing the medicines security for Europe. As Polpharma Group we strongly support this ambition. Time is of the essence. Polish Presidency has set ambitious goals for the safety of European citizens, encompassing not only military, food, and hybrid attack protection but also medicines security. During the Polish Presidency, Critical Medicines Act (CMA) has been presented by Health Commissioner Varhelyi and as significant actions have been taken in the European Parliament to advance legislative process under the SANT Committee leadership. It is critically important to secure dedicated funds for investments under the CMA in the Multiannual Financing Framework for 2027-2032. Financial Impact of Extended Exclusivities Extending exclusivities could cost health systems up to €20 billion extra per year. In contrast, generic medicines, which account for 70% of those dispensed in Europe, have saved health systems over €100 billion. Biosimilar medicines have generated €56 billion in savings since 2006. The EU's system of data exclusivity of 11 years means generics wait up to 11 years to enter the market, compared to just 5 years in the U.S., providing faster access to savings for health payers. Struggling Health Systems Off-patent medicines are a crucial lever to support these systems. Early entry of generics has been proven to save costs, with significant price reductions observed upon generic entry. The current IP framework in Europe is delivering on innovation, and there is no evidence that extending exclusivities would drive further innovation. Polpharma Group Call to Action Polpharma Group calls on the EU to resist attempts to derail the review of pharmaceutical legislation and back competition for the benefit of patients. Ensure timely entry of generics to strengthen competition, improve access to medicines, and alleviate the impact on health budgets. A reduction of data exclusivity periods from 8 to 6 years could save up to EUR 10 Bn per year. A unified Bolar clause to ensure Day 1 entry is essential and would increase access to medicines in Eastern European countries. Support the CMA to strengthen supply chain resilience and facilitate investment into Europe. Advocate for a US-EU deal to ensure the free movement of pharmaceuticals, benefiting patients. Polpharma Group calls on the EU to resist attempts to derail the review of pharmaceutical legislation and back competition for the benefit of patients. The current review of the Pharmaceutical Directive can rebalance exclusivities, increase competition, and ensure timely access to medicines. It's time for Europe to take responsibility, finalize the pharmaceutical reform, empower the Critical Medicines Act, and protect patients. Quote from Markus Sieger, CEO of Polpharma Group: "In these challenging times, it is imperative that we place public health benefit at the forefront of our political decisions. The Pharmaceutical Directive revision and the Critical Medicines Act are crucial steps towards ensuring that every European has access to the medicines they need and when they need. At Polpharma Group, we are committed to supporting these legal initiative and we are advocating to enhance competition, drive all incremental innovation, and secure the supply of essential medicines for all. The active role of the Polish Presidency in promoting the security and early access to medicines highlights our dedication to the safety and well-being of European citizens." About Polpharma Group Polpharma Group is a leading off-patent pharmaceutical company dedicated to improving health and quality of life. With a strong commitment to innovation and sustainability, Polpharma Group continues to drive advancements in the portfolio of essential medicines we offer to patients in Europe and globally. Source: Polpharma Group CONTACT: Beata Zduńczyk-Golędzinowska Corporate Communications Head M: +48 693 307 630 Grazyna Stachowska Corporate PR Content Expert M: +48 885 610 273

France urges meningitis vaccination amid 'high' number of cases
France urges meningitis vaccination amid 'high' number of cases

Euronews

time15-03-2025

  • Health
  • Euronews

France urges meningitis vaccination amid 'high' number of cases

France is facing a "particularly high" number of meningococcal infections this year, with the country's public health agency urging infants, adolescents, and young adults to get vaccinated to prevent the serious and sometimes deadly illness. Meningococcal infections are caused by bacteria and can lead to meningitis – an infection of the membranes around the brain and spinal cord – and to sepsis. There were 95 cases of the disease in January and 89 cases in February, Public Health France said, adding that this was "well above" what had been observed in previous years. The agency noted there were two clusters of meningococcal group B bacteria, which is the most common, among students at a university in Lyon and among a family and students in Rennes. Vaccination campaigns have been recommended and carried out, particularly among young people, the public health agency said. Last year, there were 615 cases of meningococcal infections in France, the largest amount since 2010. The infections may be linked to the severe flu season, as influenza can increase the risk of getting meningitis, the agency added. Vaccination of infants against meningitis B and against serogroups A, C, W, and Y has been mandatory since the beginning of the year in France. The vaccine for the ACWY serogroups is also recommended for adolescents between the ages of 11 and 14, with a booster up to the age of 24, Public Health France said. Meningitis can cause symptoms such as fever, headache, and a stiff neck, while meningococcal sepsis may lead to a fever, rash, and septic shock, according to the European Centre for Disease Prevention and Control (ECDC). The ECDC said the disease has a rapid progression and a case fatality rate of between 8 to 15 per cent. Outbreaks are rare but often occur on university campuses or among groups of people. Vaccines are the primary way of preventing infection and antibiotics can be used for treatment, the ECDC added. 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

5 takeaways on the Critical Medicines Act
5 takeaways on the Critical Medicines Act

Euronews

time15-03-2025

  • 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.

Which critical medicines are in short supply in the European Union?
Which critical medicines are in short supply in the European Union?

Euronews

time12-03-2025

  • Health
  • Euronews

Which critical medicines are in short supply in the European Union?

The drug shortages are the result of manufacturing problems, increased demand, and other issues. ADVERTISEMENT The European Union is in short supply of 16 medicines that are considered 'critical' for people's health. A drug can be put on the EU's shortages list because of production issues, a surge in demand, or a drugmaker deciding to pull it off the market – anything that limits the bloc's supply on either a temporary or permanent basis. There are ongoing shortages of 34 medicines, according to the European Medicines Agency (EMA). Sixteen of those are on the EU's list of essential drugs that the European Commission aims to bolster through its new Critical Medicines Act. Here are the critical medicines in short supply in the EU, according to the latest available information from the EMA and member states. Cyanide poisoning antidote Cyanokit is the only EU-approved medicine to treat cyanide poisoning. It contains the active ingredient hydroxocobalamin or vitamin B12a, which is on the EU's critical medicines list. In December 2024, health authorities said Cyanokit manufacturing was being suspended after the drugmaker discovered that some batches may have been contaminated. However, because the risk of contamination is low and there is no alternative antidote, they are still in circulation, according to the EMA. The shortage is expected to be resolved by May 2025. Amoxicillin Amoxicillin is an antibiotic for bacterial infections. Shortages began in October 2022 after an uptick in respiratory illnesses led to higher demand for antibiotics. Related Big pharma urges Commission to slow down on new critical medicines rules Manufacturers also lacked enough staff to make the medicine, the EMA said. These issues have since eased in most countries, but some intermittent supply problems persist across Europe. Some inhalers People with asthma, chronic obstructive pulmonary disease (COPD), and other breathing issues take salbutamol, typically using an inhaler or a nebuliser. Manufacturers are struggling to meet the growing demand for inhalers, leading to intermittent shortages of salbutamol across most of the EU. Alternatives are available, but the scarcity is expected to last until at least mid-2025. A few types of insulin Patients with type 1 or 2 diabetes take insulin to control their blood sugar. Manufacturing problems for certain types of insulin – Insuman Rapid, Basal and Comb 25 – in early 2023, caused delays across the supply chain. The drugmaker also decided to stop producing these types of insulin, prompting the EMA to urge doctors to transition their patients to other brands. Seven cancer drugs The EU does not have enough of seven drugs used to treat various types of cancers, including hycamtin, methotrexate, fludarabine, fluorouracil, cisplatin, fasturtec, and paclitaxel. The shortages are mainly due to manufacturing problems, though unexpected demand for methotrexate injections – which can also help treat inflammatory conditions like rheumatoid arthritis, psoriasis, and Crohn's disease – has exacerbated their scarcity in some European countries. Shortages are beginning to be resolved for several of these medications, and in the meantime, alternative options are available for some of them. ADVERTISEMENT Vaccine for mosquito-borne virus Ixiaro is a vaccine for Japanese encephalitis, which is related to the dengue, yellow fever, and West Nile viruses and causes brain inflammation. Increased demand and manufacturing problems caused a shortage of the vaccine, though supply levels have since improved. The EMA expected the shortage, which has affected Ireland, Italy, Poland, Portugal, and Spain, to be resolved by late January, but Irish authorities now say it should be back in stock there by the end of April 2025. Blood disease medicine Peginterferon alfa-2a, sold as Pegasys, is used to treat chronic hepatitis B and C as well as other blood diseases. Unexpectedly high demand for the medicine has led to shortages that the EMA said should be resolved later in 2025. ADVERTISEMENT Schizophrenia treatment Zypadhera, also known as olanzapine, helps treat schizophrenia. Patients who have taken the drug by mouth can then start taking it via injection – but the needles are in short supply due to manufacturing issues, leading to intermittent shortages of Zypadhera in some European countries. Limited quantities are now available in places like Belgium. Heart attack prevention drug Integrilin can help prevent heart attacks for adults with severe chest pain and those who have already had a certain type of heart attack. Supply issues with the active ingredient, eptifibatide, prompted drugmaker GlaxoSmithKline to stop manufacturing the medicine and pull it off the EU market. However, alternatives are available. ADVERTISEMENT Eye problems medicine Verteporfin, sold as Visudyne, is a treatment for people with certain eye problems, for example a type of age-related macular degeneration. Manufacturing has been limited since May 2020, leaving the medicine in short supply, though other treatments are available. Limited quantities are now available in places like Austria, with a restock there expected by the end of 2025.

Romanian constitutional court unanimously rejects Calin Georgescu's candidacy, sparking protests
Romanian constitutional court unanimously rejects Calin Georgescu's candidacy, sparking protests

Euronews

time11-03-2025

  • 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.

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