Spain pushes EU debate on early access incentives for innovative medicines

Javier Padilla, Secretary of State for Health; Juan Yermo, Director General of Farmaindustria (the Spanish pharmaceutical industry association); and Fina Lladós, president of the employers' association (patronal).

Spain is advancing a proposal for a new EU-level “early pull” incentive aimed at helping innovative medicines reach patients sooner after European marketing authorisation. The idea, championed by Spanish Secretary of State for Health Javier Padilla, would create an early access or early procurement mechanism to cover the period between EU authorisation and the completion of national pricing and reimbursement procedures. 

The proposal is being presented in the context of the European Biotech Act and the wider debate on how Europe can improve competitiveness, attract investment, and accelerate access to innovation. Much of the current discussion has focused on “late pull” incentives, particularly the possible extension of supplementary protection certificates by one or two years. Spain’s argument is that incentives should not only operate at the end of a product’s commercial life, but also much earlier—at the moment when companies are making decisions about launch, investment, and market entry. 

Padilla has argued that earlier access may in some cases be more valuable than additional protection many years later. This is especially relevant in a fast-moving innovation environment, where new therapies may be overtaken by competing products well before the end of formal patent protection. In his words, a start-up may prefer an incentive in two years rather than one in fifteen. The proposal would therefore seek to create market access earlier, benefiting companies, patients, and health systems at the same time. 

Importantly, Spain no longer appears to be positioning early procurement as a direct alternative to extended protection. Instead, Padilla is arguing that both discussions should proceed in parallel and could be complementary. Spain does not reject supplementary protection certificates outright, but warns against making them the only European response to declining competitiveness. From this perspective, access is not simply something that happens after innovation; it is part of the innovation ecosystem itself. 

The proposal is now expected to move into a more concrete EU phase. Padilla has said Spain will bring the idea to the EU Council and circulate a document on the initiative in the coming weeks. He has also discussed the proposal with other Member States and indicated that some have already responded positively. 

The pharmaceutical industry, however, remains cautious. Industry representatives argue that joint procurement is not automatically an incentive and could, depending on its design, put downward pressure on prices, anchor future national negotiations, and increase uncertainty for companies and investors. They also raise practical questions: whether participation would be voluntary for companies and Member States, who would fund early procurement, how it would interact with national pricing and reimbursement systems, and whether multilateral negotiations might take so long that the mechanism would no longer be “early.” 

There are also legal and operational concerns. A common EU price could benefit some countries but disadvantage others, potentially reducing incentives to participate. Limited supply early in a product’s life cycle could raise difficult questions about allocation across Member States. Industry also warns that sharing pricing and volume strategies could create competition law sensitivities, while the current EU public procurement framework may not be well suited to such a centralised approach for innovative medicines. 

As an alternative, industry has suggested access from day one after EU authorisation at list price, with later adjustments once each country completes its pricing and reimbursement decision. It also continues to push for faster regulatory processes, arguing that Europe should move closer to US timelines. 

The debate captures a broader tension at the heart of Europe’s life sciences agenda: how to improve patient access while also sending credible signals to companies that Europe is a serious place to launch, invest, and innovate. Spain’s proposal adds an important new dimension to the Biotech Act discussion by shifting attention from protection at the end of the commercial life cycle to access and market creation much earlier.