Medicines for Europe calls on Heads of State and Governments to build on the lessons learned from the COVID-19 pandemic, with a thoughtful Industrial Policy that should strengthen European manufacturing and critical medicines supply chain resilience, while ensuring equitable access for patients.

The European structured dialogue initiative is a first positive step in this direction and, if combined with smart policy reforms, results will be delivered: sustainable market reforms to incentivise resilience, a flexible and digitalised regulatory framework focused on quality and efficiency and smart investments through  the recovery and resilience facility to maintain and expand the EU manufacturing ecosystem for medicine.

• Lowest-price purchasing policies are incompatible with Europe’s essential medicines manufacturing resilience and security of supply. Reforms are needed to make markets sustainable, including the introduction of Most Economic Advantageous Tender (MEAT) criteria, such as environmental, supply reliability, manufacturing resilience and/or product specific characteristics criteria, in procurement to reduce industrial consolidation pressure and create a level playing field. Pricing and reimbursement policies should also recognise the importance of manufacturing security for affordable generic medicines rather than focusing only on obtaining the lowest price possible.

• A digital transformation of the regulatory system would maintain high EU scientific standards while dramatically reducing administrative burdens and vastly improve the EU crisis response to shortages. It would stimulate an evidence based two-way communication and bottom up cooperation between Member States, EU Institutions, regulators, industry and actors of the supply chain to coordinate an effective crisis response and to address potential supply bottlenecks. As demonstrated by COVID19, regulatory flexibilities are needed to prevent medicines shortages, to enable, for example, faster cross border movement where medicines are needed.

• The Recovery and Resilience Facility, centrepiece of the Next Generation EU recovery instrument, is an opportunity to strengthen manufacturing resilience: Member State National Plans should include dedicated investments in medicines manufacturing. Investments in manufacturing technology (greening, digital, process technology, automation) are needed to enable EU manufacturers to upgrade their technology to compete and to meet societal expectations for security, value added innovation and the environment.

Commenting ahead of the EUCO meeting, Medicines for Europe President Christoph Stoller (Teva) said “COVID-19 has highlighted the strategic importance of a strong and open medicine value chain in Europe. Despite pronounced EU important dependencies and demand surges in critical areas such as ICU medicines, we have demonstrated the resilience of the pharmaceutical supply chain during this unprecedented time, as well as the power of two-way collaborative work with policy-makers to secure access to critical medicines. With smart policy reforms, Europe can address the current drivers responsible for the growing vulnerabilities of its essential pharmaceutical production and supply. I call on EU leaders to support a vibrant medicines manufacturing sector in Europe. it is now  time to act to increase Europe’s resilience, diversity and sovereignty while capitalising on fair and open trade”.