Today’s publication of the EU pharmaceutical legislation is an important milestone as the EU, Member States and industry strive to improve access to medicines and vaccines, and reinvigorate science and innovation in Europe.

Nathalie Moll, Director General, EFPIA, said: “From its inception, EFPIA, its member companies and associations have supported the aims of the EU Pharmaceutical Strategy. Delivering faster, more equitable access to medicines, avoiding and mitigating shortages as well as ensuring that Europe can be a world leader in medical innovation are goals we share. Unfortunately, today's proposal manages to undermine research and development in Europe while failing to address access to medicines for patients”

Hubertus von Baumbach, President, EFPIA, said: “We welcome moves to future-proof Europe’s regulatory framework and stimulate research in to new treatments to tackle AMR.  However, although the revised legislation was meant to improve Europe’s competitiveness, the ‘net’ impact of policies set out across these proposals, in their current form, puts European competitiveness at risk: overall, it weakens the attractiveness for investment in innovation and hampers European science, research and development. In order to truly realise a patient-focused EU life science ambition, it is vital that a comprehensive competitiveness check is conducted on the impact of the revised pharmaceutical legislation.”

Nathalie Moll continued: “The approach set out in the pharmaceutical legislation, penalising innovation if a medicine is not available in all Member States within two years is fundamentally flawed and represents an impossible target for companies. The vast majority of delays in access to new medicines are known to occur after a company has filed for pricing and reimbursementt and is awaiting a decision, so that the new treatment can be made available to patients. Fixing the tenfold variation in access to new medicines across the EU, requires all partners to urgently get round the table and address the real issues rather than unworkable EU-level legislation that is destined to fail.

Over the coming months, we are committed to working with Members of the European Parliament, Council and other stakeholders to ensure the revised pharmaceutical legislation and patent package meets the needs of patients, our healthcare systems, Member States and Europe’s life science sector.

If changes are not made “the legacy” of this Commission will be for Europe to be simply consumers of other regions' medical innovation, and European patients waiting longer than ever for the latest advances in care.”

ENDS.