Brussels – The Commission today (March 11) proposed a regulation to improve the availability of essential medicines in the EU. The proposal aims to protect human health by encouraging supply chain diversification and promoting pharmaceutical production in the EU. The EU executive says this will support the Union’s pharmaceutical sector, which contributes significantly to our economy.
The law also aims to improve access to other medicines of common interest that may not be available in some markets. This initiative contributes to the European Health Union’s goal of ensuring that EU patients have access to the medicines they need, when they need them. President Ursula von der Leyen announced the Essential Medicines Act in her policy guidance to reduce addiction and improve resilience, particularly for drugs and active ingredients for which there are only a few manufacturers or supplier countries. It complements legislative proposals already submitted to address drug shortages in the EU, particularly pharmaceutical reform.
In recent years, member states have faced severe drug shortages and global challenges such as the COVID-19 pandemic and geopolitical tensions, which have exposed significant vulnerabilities in the Union’s pharmaceutical supply chain. Shortages can put patients’ lives at risk and represent a significant burden on our health systems. These shortages, the Commission explains, can be caused by production problems, supply chain vulnerabilities, or global competition for resources.
The Essential Medicines Act aims to provide an industrial toolkit to address these issues, making the EU a market where the production of essential medicines will be more attractive. The law will facilitate investment for companies that increase production of essential medicines in the EU, while incentivising actions that make supply chains more resilient. It will also offer member states the opportunity to join together to increase their purchasing power.
Key elements of the Essential Drugs Law include the Strategic projects that will create, increase or modernise production capacity for essential drugs or their ingredients. These industrial projects will benefit from easier access to funding and accelerated administrative, regulatory, and scientific support. A State Aid Guide has been published to assist member states in financially supporting such strategic projects. Member states can use public procurement to diversify and boost the resilience of supply chains. For essential medicines, purchasers will need to include a broader set of requirements in their procurement procedures, such as diversified sources of input materials and monitoring of supply chains. In cases of high dependence on a single country or a limited number of countries, they will also have to use procurement requirements that favour production of essential medicines in the EU. This will also be possible for other medicines of common interest where justified.
The Commission will support collaborative procurement between different member states at their request, to address disparities in availability and access to essential medicines and other medicines of common interest across the EU. International partnerships with like-minded countries and regions will be explored to expand the supply chain and reduce dependence on a single or limited number of suppliers.
Addressing shortages and ensuring access to medicines has been a priority for the EU for many years. The Pharmaceutical Strategy for Europe 2020 set out a series of regulatory measures and additional support for industry to promote research and innovation in medicines while addressing shortages and lack of access for patients. It also led to the launch of a structured dialogue on the industrial dimension of security of supply with all stakeholders.
In 2022, the European Medicines Agency (EMA) received a stronger mandate to manage shortages. Since then, together with groups of national authorities, it has played a key role in monitoring and responding to shortages of critical medicines. In 2023, the Commission proposed an ambitious overhaul of EU pharmaceutical legislation to improve access and strengthen drug supply chains. This reform is currently being negotiated by the European Parliament and the Council. Other initiatives being undertaken include the publication of a Union list of essential medicines, to help identify and monitor essential medicines, and a Commission communication to address drug shortages in the EU. The Essential Medicines Act complements these measures with industrial policy tools to address vulnerabilities in the supply chain of essential medicines and reduce EU dependencies in this strategic sector.
English version by the Translation Service of Withub
