Legislative reforms aligned with current off-patent market conditions are the precondition for a coherent policy to improve the secure supply of essential medicines. The EU structured dialogue on medicines manufacturing is a critical first step to align stakeholders on workable reforms.

As the biggest supplier of prescription medicines, our industry is committed to improving security of supply in Europe.

for security of supply, legislative reform should cover:

1. Up-to-date European regulation based on interconnected digital tools to improve the predictability of supply and demand on the EU market.
2. Alignment of Member States on security of supply based on EU solidarity – notably on what are critical products, to reward companies for investments in supply chain resilience, notably by introducing smart multi criteria tenders, and to prevent distortive national stockpiling requirements.
3. Restore European leadership in manufacturing by adapting state aid rules to enable the generic medicines and API industry to participate in national Recovery and Resilience plans for green and digital technology investments.

Speaking at the EU Structured Dialogue, Medicines for Europe President, Christoph Stoller (TEVA) outlined ““Pharmaceutical and industrial policy, must be an enabler for robust supply chains and support our industry efforts to mitigate and address the root causes of supply chain vulnerabilities, while ultimately supporting more investments in European manufacturing. The urgency is to agree and implement smart regulatory and economic policies!  In the off patent sector, the race to the lowest price has reached its limit. And rather than punishing companies via penalties or by implementing distortive national requirements such as stockpiling, we should think win win”.

Medicines for Europe Vice President Rebecca Guntern (Sandoz) said: “We need to jointly design a coherent policy to ensure security of supply for essential medicines, which is better aligned with the prevailing market conditions for off-patent medicines. Medicine manufacturing costs cannot be compressed indefinitely. We need policies that enable a meaningful digital framework, promote flexible regulatory systems and phase out unhelpful and short-sighted cost-containment measures”.

Medicines for Europe

Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.