The Covid-19 pandemic exposed a vulnerability that still affects everyday healthcare: recurring shortages of essential medicines. From antibiotics to blood pressure treatments, supply disruptions continue to pose problems for patients and pharmacists across Europe. To address this, the EU wants to become less dependent on third countries such as China and India by strengthening pharmaceutical production within Europe.
This goal is central to the Critical Medicines Act, which was adopted by a large majority on 20 January in the European Parliament and is expected to enter into force later this year. The legislation is designed to secure the supply of medicines that are essential for the functioning of healthcare systems and whose absence could cause serious harm to patients.
Critical medicines are defined as treatments that are indispensable for public health and where shortages can have severe consequences. According to Tilly Metz, MEP of The Greens and rapporteur on the legislation, this includes everyday medicines of general interest as well as high-cost and innovative treatments, such as cancer therapies, medicines for rare diseases and, importantly, antibiotics. She stressed that all of these categories are vital to safeguarding public health across the EU.
In the long term, EU lawmakers see the relocation of pharmaceutical production to Europe as the most sustainable solution. Metz explained that the Critical Medicines Act provides targeted support to encourage this shift, including financial incentives and measures to help manufacturers comply more easily with EU regulations. She also pointed out that the legislation introduces a “fast procedure” to allow medicines to reach the market more quickly.
While rebuilding production capacity will take time, the legislation also includes measures that could have a more immediate effect. Metz highlighted the possibility for EU member states to carry out joint procurement of key medicines. By purchasing together, countries could improve availability and obtain better prices, making medicines more accessible across Europe.
This approach is particularly important for smaller countries such as Luxembourg, which are more exposed during supply disruptions, according to Metz. She also underlined that the European Parliament has voted in favour of stronger cooperation on medicine stockpiling. Metz explained that, in practice, this could mean that countries with large reserves, for example Germany, would be expected to support countries facing shortages, such as supplying paediatric paracetamol to Luxembourg if needed.
For pharmacists, medicine shortages are already part of daily work. Certain antibiotics, antidepressants, hormone treatments, and cardiovascular medicines regularly become unavailable. European figures show that pharmacists spend an average of 11 hours per week searching for alternatives for patients when medicines are unavailable.
Claude Hostert-Pfeiffer, manager at the Union of Luxembourg Pharmacists, explained that when shortages occur, pharmacists first try to obtain the same active substance under a different brand name or as a generic alternative. If that is not possible, they attempt to order the medicine from neighbouring countries, provided it is available there, she said. She stressed that when these options fail, pharmacists work closely with doctors to switch patients to alternative treatments.
Regarding the Critical Medicines Act, Hostert-Pfeiffer welcomed the EU initiative but cautioned that relocating production back to Europe will take many years. She noted that much of today’s pharmaceutical manufacturing, including key active ingredients, has been outsourced to Asia, particularly to China and India, and that reversing this trend could take a decade or more.
In the shorter term, she sees hope in improved coordination of medicine stocks across Europe, allowing medicines to be redistributed more quickly from countries with surplus supplies to those facing shortages.
The pharmaceutical industry has broadly welcomed the Critical Medicines Act, but some concerns remain. Romain Labé, Secretary General of Innovative Medicines for Luxembourg, argued that the current definition of critical medicines may be too wide. He believes the focus should remain on medicines with a clear impact on public health and particularly fragile supply chains.
At the same time, Labé stressed that the EU must ensure that the European market remains attractive for pharmaceutical companies. In his view, maintaining an efficient and innovative industry is essential to guaranteeing that medicines are consistently available to patients.
