A landmark\u2019 agreement between the EU Council and the European Parliament has formalised the Critical Medicines Act (CMA), designed to strengthen medicines supply chains and prevent shortages across the continent. This has been celebrated as a \u2018significant milestone\u2019 for Europe, but where does it leave the UK?<\/p>\n
\u2018The Critical Medicines Act (CMA) is Europe\u2019s essential safety-belt: preventing shortages, reducing dependence on single suppliers and strengthening production closer to home,\u2019 says European health commissioner Oliv\u00e9r V\u00e1rhelyi<\/p>\n
It includes measures to encourage EU-based manufacturing of medicines and active ingredients, aiming to make it easier for member states to work together to procure medicines in the face of ongoing shortages across Europe.<\/p>\n
For the EU, this is a strategic response to months of disrupted medicines supply, driven in part by geopolitical turbulence in the Middle East. Pharmacy leaders have said that tensions around the Strait of Hormuz \u2013 an important shipping route between Iran, and United Arab Emirates (UAE) and Oman \u2013 threatens the supply of raw materials used in many common drugs such as aspirin, paracetamol and antibiotics.<\/p>\n
But for a post-Brexit UK \u2013 where pharmacists are already grappling with persistent and ongoing shortages \u2013 it could have dire consequences.<\/p>\n
What is the EU Critical Medicines Act?<\/p>\n
The European Commission first proposed the CMA in March 2025. Just over a year later, on 12 May 2026, the European Parliament and the EU Council reached a provisional agreement on the new Act.<\/p>\n
The provisional document is still subject to final endorsement by the EU Council and the European Parliament in the coming months, but it is likely to be published in the Official Journal \u2013 where all legally-binding EU legislation must appear \u2013 towards the end of 2026.<\/p>\n
The deal was heralded by the European Medicines Agency (EMA) as a \u2018significant milestone towards strengthening Europe\u2019s capacity to improve the availability, supply and production of critical medicines\u2019.<\/p>\n
Key elements of the provisional deal include:<\/p>\n
Related Article: New MHRA and FDA liaison programme announced<\/a><\/p>\n The creation of an EU list of critical medicines, developed with the European Medicines Agency; These provisions benefit pharmaceutical companies that manufacture and supply medicines within the EU.<\/p>\n This sparks concern over medicine supply to the UK, which has already been disrupted by the geopolitical tension in the Middle East, mentioned previously, and comparatively low medicine prices.<\/p>\n The UK is currently facing some of the \u2018most severe\u2019 shortages on record<\/a> for commonly dispensed medicines such as painkillers, blood pressure medication, epilepsy medication, and pancreatic enzyme replacement drugs. In February, a House of Lords committee report declared medicine shortages a \u2018national security issue\u2019<\/a> given the risk they pose to health and urged the government to be more proactive in protecting the UK from fragile supply chains.<\/p>\n The report noted that four out of five (80%) prescribed medicines used by the NHS are generic and therefore can be made by any manufacturer. Yet it said only a quarter of these drugs are made in the UK, with the rest produced largely in Europe and Asia. It also warned that many active ingredients required for NHS medicines are controlled by China, India or other single sources leaving UK medicine supply vulnerable to changes in geopolitics, trade or national disasters.<\/p>\n Baroness Morris of Yardley, who chaired the committee during the inquiry, urged the government to consider compiling a critical medicines list like the CMA \u2013 a proposal which the government decided<\/a> not to adopt.<\/p>\n Meanwhile, pharmacists are spending a significant amount of time sourcing scarce medication, with 98% of pharmacies saying they encountered patients last year who had visited several pharmacies<\/a> in a day to find a medication.<\/p>\n Why is this a threat to UK pharmacists?<\/p>\n UK leaders and healthcare professionals have been nervously watching medicine shortages worsen as the CMA take shape across the Channel.<\/p>\n Mark Dayan, Brexit programme lead at the Nuffield Trust, says that the EU CMA poses several risks to the UK and its pharmacy sector.<\/p>\n Firstly, the CMA incentivises pharmaceutical companies to produce critical medicines in EU countries through \u2018strategic projects\u2019 which are also meant to prioritise medicine supply to EU member states, rather than the UK, in the event of a shortage, he says.<\/p>\n Secondly, the Act also strengthens the EU\u2019s \u2018Voluntary Solidarity Mechanism\u2019 which allows EU members to track one another\u2019s medicines supply and potentially transfer stock between them \u2013 giving them an advantage when there\u2019s a supply crisis.<\/p>\n Mr Dayan says: \u2018It’s been a torrid few years for UK pharmacists in terms of shortages. Unfortunately, the CMA along with the ongoing situation at the Strait of Hormuz is a new risk to medicine supply \u2013 there’s no doubt about that.<\/p>\n \u2018It puts the UK at the back of the queue because manufacturers are induced to relocate to the EU, and favour EU purchasers. This may mean if there’s a shortage hitting the UK and the EU, it’s a lot harder for the UK to deal with it,\u2019 he adds.<\/p>\n Professor of technology and innovation management (healthcare) at Imperial Business School, Professor James Barlow, echoes these fears, saying: \u2018The current UK approach seems to be largely operational and reactive \u2013 focusing on shortage management and supply chain monitoring. Compared with the EU, the UK still has no formal critical medicines act, no critical medicines list, and no system for comprehensive national stockpiling.<\/p>\n \u2018The main strategic risk for the UK is not immediate exclusion from medicines supply \u2013 unless EU stockpiling is poorly coordinated and scarce supplies are diverted into EU reserves at times of crisis \u2013 but that the UK gradually becomes disadvantaged by drug companies prioritising the EU market due to stronger procurement coordination, investment incentives and contracts designed to ensure supply resilience.<\/p>\n Related Article: Incomplete prescription information putting patients at risk<\/a><\/p>\n \u2018In short, the UK risks being left behind unless it develops its own critical medicines framework while also maintaining close alignment and cooperation with EU resilience initiatives.\u2019<\/p>\n Chair of the all-party parliamentary group (APPG) on pharmacy, Sadik Al-Hassan worries that, while the EU is prioritising resilience over price when purchasing medicines, the UK is \u2018addicted to low cost drugs\u2019<\/a> which is damaging our supply chains and causing our manufacturing power to dwindle.<\/p>\n He says: \u2018The support in this Act is designed to provide self-sufficiency to the EU but without legislation like it in the UK there is a risk that it could damage some of our already fragile supply chains. We should seize the opportunity now to balance the scales for UK pharma investment and resilience.\u2019<\/p>\n What needs to happen next? <\/p>\n The Association of the British Pharmaceutical Industry (ABPI) said in a recent report<\/a> on supply issues that \u2018we cannot be complacent\u2019 as global pressures grow, or the risk to patients will increase.<\/p>\n Mr Dayan believes that stronger cooperation between the EU and the UK government is the way forward, arguing that closer collaboration would benefit both sides by helping to diversify supply chains and reduce reliance on long supply routes in Asia.<\/p>\n He says that the UK\u2019s smaller size makes it less able to offer state aid incentives \u2013 like the CMA\u2019s \u2018strategic projects\u2019 \u2013 so independently establishing equivalent legislation may be difficult.<\/p>\n He says: \u2018We could take the approach of trying to encourage production of certain medicines, or certain active pharmaceutical ingredients, inside the UK. The issue is, you would really want to be doing that in cooperation with the EU, so you’re not all just clashing, trying to attract manufacturers of the same medicines in a potentially unproductive way.<\/p>\n \u2018It would make a lot more sense for the UK to do something in collaboration with the EU. But that’s obviously not going to be easy as we’re not in the EU, and there is some bad blood around.\u2019<\/p>\n The CMA does provide some opportunities to collaborate with third party countries and Mr Dayan feels that the UK needs to make this a diplomatic priority, presented in a way that demonstrates it is willing to contribute rather than simply \u2018looking for favours\u2019.<\/p>\n Related Article: \u2018Most severe\u2019 medicine shortages ever pose serious patient safety risk, health leaders warn<\/a><\/p>\n The EU remains the UK\u2019s largest trading partner and in 2024, the UK imported around \u00a316.6 billion and exported around \u00a39.7 billion pharmaceutical products from the EU.<\/p>\n In spring 2024, the Department of Health and Social Care (DHSC) became a member of the EU Critical Medicines Alliance, which works to identify areas where the supply of critical medicines in the EU can be strengthened.<\/p>\n Despite this \u2018positive initial step\u2019 in cooperation, the UK cannot take part in key decision-making, and it must go further, the Nuffield Trust has said.<\/p>\n
\n\u2018Strategic projects\u2019 \u2013 initiatives designed to build manufacturing capacity within the EU and avoid overreliance on cheaper Asian markets, supported by fast-tracked permits and state funding;
\nA lower threshold for collaborative procurement, making it easier for groups of EU countries to pool their buying power and secure medicines \u2013 the number of member states needed to submit a joint request to the Commission will be reduced from nine to five under the new Act;
\nAn obligation for resilience criteria to take precedence over price when purchasing critical medicines; and
\nMore coordinated national stockpiling so that the EU can respond faster to shortages.<\/p>\n