EU proposes legislation to bolster medicines supply chain

The European Commission has proposed new legislation to safeguard the supply of critical medicines in the EU by boosting manufacturing within the bloc and reducing dependency on suppliers from other parts of the world.

The Critical Medicines Act (CMA) has been put forward at a time when the Commission has become increasingly concerned about shortages, which have been rising since 2013 and peaked during the COVID-19 pandemic, as well as variable access to drugs between EU member states leading to accusations that some are stockpiling to the detriment of access in others.

Shortages pose "a substantial risk to public health and patient safety and undermine the functioning of healthcare systems," it said, while also pointing to the increased reliance on overseas manufacturers for generic medicines and pharmaceutical ingredients at a time when geopolitical tensions are on the rise.

The toolkit of measures in the act includes collaborative procurement decisions and investment for companies that increase manufacturing of critical medicines in the EU, which could include state aid, as well as the creation of strategic projects that could qualify for easier access to EU funding and fast-tracked administrative, regulatory, and scientific support.

Olivér Várhelyi, EU Commissioner for Health and Animal Welfare, said the act "is a key initiative to improve access and availability to medicines for everyone in the EU, and to strengthen our health security." He added that it will have a positive effect on the EU's competitiveness by creating a more stable and predictable operating environment.

There's no indication yet about the medicines that will come under the scope of the CMA, which has alarmed industry groups that have voiced concerns that problems may arise if it is too broad and disrupts existing national pricing and reimbursement pathways.

They have also pointed to the lack of a comprehensive impact assessment and limited opportunities to consult on the proposal, and urged lawmakers to make use of existing data systems like the European Medicines Verification System (EMVS) – which records and authenticates dispensed medicines – to avoid the duplication of reporting requirements.

The European Federation of Pharmaceutical Industries and Associations (AFPA) said it supported the principles of the CMA and efforts to introduce criteria beyond price for the public procurement of critical medicines.

"However, while these options may be appropriate under very specific circumstances where they accelerate patient access to critical medicines, a systematic application could create more harm than offering a more permanent solution to access related issues," it pointed out.

EFPIA is also calling for the act to go further and provide "an effective response to fragmented national contingency stock requirements that disrupt the functionality of the single market."

The European Patients' Forum (EPF) also welcomed the move, but said the CMA leaves serious gaps that must be addressed to ensure its effectiveness, questioning - for example - how the initiatives will be financed in the longer term, given that the current plan is to divert money from the EU4Health and Horizon Europe programmes in fiscal 2026-27.

"From our standpoint, there is insufficient focus on structured cooperation and involvement of civil society, particularly patient organisations, in the decision-making processes at the national and European level," according to the EPF.