15-03-2025
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.
