Spain pushes EU to use its purchasing power on innovative medicines

Spanish State Secretary for Health Javier Padilla met with European Commissioner for Health Olivér Várhelyi in Brussels on Wednesday (9 September) to discuss the importance of timely access to innovative medicines and how the Biotech Act and the Critical Medicines Act could advance this objective.

While the Critical Medicines Act has been agreed and is tabled for adoption in Parliament in November, the Council is still discussing the Biotech Act in detail. The discussions have some way to go, but the Irish Presidency is committed to advancing the file under its watch.

Minutes from the meeting with Várhelyi have not emerged; it is fair to assume that the discussion concerned the proposed changes to the Biotech Act that Spain has been working on. Spain’s Diariofarma health journal gained exclusive access to the ministry’s thinking, which aims to use Europe’s collective demand as a lever to attract launches of high-value biotechnological medicinal products and production to the EU.

European Co-ordinated Market Access Toolbox

The Spanish proposal recognises that each medicine will be different and that states will retain their jealously guarded role in pricing and reimbursement. The extent of co-operation could range from a simple assessment of aggregate demand for a medicine across the EU to collaborative, and possibly even joint procurement; but each state could opt out of participation.

The ‘European Biotechnology Market Access Coordination Group’ would be managed by a secretariat within the European Commission, which would convene one representative from each member state responsible for pricing and reimbursement or access, with EMA and the member state Coordination Group on HTA (HTACG) also present as observers. According to Diariofarma, the group would identify medicines suitable for joint action, decide on the appropriate instrument and approve a common negotiating mandate.

Interestingly, the selection goes beyond meeting unmet need or securing the benefits of collective bargaining and could extend to attracting R&D and manufacturing to the EU - an approach that may reflect lessons learnt from Trump’s negotiations with pharma.

The proposal also safeguards national competences through strict confidentiality rules. An amendment to Article 66 would protect negotiating positions, demand and volume estimates, and commercially sensitive terms, while preventing the reuse of information without consent unless required by law.

These safeguards are unlikely to eliminate opposition from the pharmaceutical industry. Despite assurances on confidentiality, national competences and the voluntary nature of co-operation, pharmaceutical companies and their trade bodies have previously resisted mechanisms that strengthen co-ordination among public purchasers and increase their collective negotiating leverage.

Spain is urging Europe to make use of its collective demand and deploy it strategically. Will other countries be willing to follow? Could the bullying tactics from across the Atlantic over “most-favored-nation” pricing and Section 301 procedures finally galvanise EU states into taking a firmer stand? It remains to be seen, but this might be an idea whose time has come.