EFPIA supports the European Commission’s ambition to strengthen Europe’s medicines supply chain through the Critical Medicines Act.  

Ensuring timely access to critical medicines is a shared priority. To achieve this, policy solutions must be targeted, evidence-based, and aligned with international commitments to avoid unintended consequences for supply sustainability and patient access. 

EFPIA welcomes the efforts to introduce criteria beyond price for the public procurement of critical medicines. We note the inclusion of strengthened collaborative procurement options to improve availability of medicines in certain circumstances.   

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. Therefore, clarity is required to identify those circumstances where collaborative procurement options would improve access beyond existing national pricing and reimbursement pathways. EFPIA and its members remain committed to reducing disparities in access to medicines across Europe, by placing their products on the market as soon as possible 

EFPIA believes that the Act needs to go further and provide an effective response to fragmented national contingency stock requirements that disrupt the functionality of the single market.  

With respect to obligations for market actors to provide information, we urge authorities to make use of existing data systems to avoid the duplication of reporting requirements. The information already stored in the European Medicines Verification System provides timely intelligence on the number of packs for all prescription products being supplied in the various Member States. Leveraging this data would reduce the burden on manufacturers and streamline the vulnerability assessment exercise. 

The life sciences sector is an important strategic asset, delivering innovative medicines and interventions that are fundamental to the long-term health and security of citizens. Given its important role, EFPIA and Vaccines Europe believe broader EU defense spending plans - including financial mechanisms within the new defense package - should support the Critical Medicines Act to strengthen the supply of critical medicines in Europe, as well as other measures that play an important role in increasing health security and resilience, including life-course immunisation and secondary prevention strategies.  

EFPIA strongly supports the strengthening of strategic partnerships to diversify sources of critical medicines. 

EFPIA calls on authorities responsible for existing and future EU legislations on food, chemicals, and the environment to conduct systematic impact assessments evaluating the extent these legislations affect the security of supply of critical medicines in the EU.  

The innovative pharmaceutical industry remains committed to working alongside European institutions, national authorities, and healthcare partners to shape policies that ensure patients across Europe have reliable access to life-saving medicines. 

Nathalie Moll, Director General, EFPIA, said:  

“As an industry we back the European Commission’s ambition to strengthen Europe’s medicines supply chain through the Critical Medicines Act. As the EU is the largest exporter of finished medicines globally, patients across the world depend on Europe for the supply of medicines. Given this and a challenging geopolitical backdrop, it is important to collaborate internationally to support and increase global supply chain resilience.”