Twelve Months or Faster Access: What Europe Asks in Return for Public Money in Biotech

Public capital in biotech makes sense. The science is slow, failure is expected, and private investors often step back at exactly the point where the risk is highest. That much is settled. The harder question is what Europe asks for in return, and the European Biotech Act is currently the place where that question is being answered by default rather than by design.

The Commission published its proposal on 16 December 2025. Most of the public argument since then has concentrated on a single article. Article 27 would grant holders of Supplementary Protection Certificates an additional twelve months of protection for certain frontier biotechnology medicines, raising the maximum extension from five years to six. It is a narrow provision with an outsized share of the debate, and the reason is straightforward: it is the one place where the Act hands out something with a clear market value attached.

What matters for anyone planning around this file is not whether the extension survives. It is what each of the competing proposals asks the recipient to do in exchange, because those conditions are what a company actually has to build against.

What Article 27 asks, and what it does not

The extension is not automatic. Four conditions apply cumulatively. The medicinal product has to contain a new active substance distinctly different from that of an already authorised product in the EU. It has to show a distinctly different mechanism of action, with safety and efficacy at least equivalent to any authorised product for the same disease. The clinical trials supporting the marketing authorisation have to have been conducted in more than two Member States. And at least one manufacturing step, excluding packaging, quality testing and certification, has to be performed inside the Union.

Read that list again and notice what is in it. Three of the four conditions are about scientific distinctiveness and where the work was done. The fourth is about industrial footprint. None of them is about what the medicine will cost, when patients will get it, or on what terms a health system will be able to buy it. The Act asks where you manufacture. It does not ask what you charge.

There is a defensible logic behind that design. The stated purpose of the Biotech Act is competitiveness, and the instruments are aimed at keeping development and manufacturing in Europe rather than at regulating prices, which remains largely a national competence. The conditions are calibrated to that purpose. Still, the effect is that the most valuable single incentive in the package is granted against commitments that a payer would not recognise as concessions.

The mechanics also deserve more attention than they have received. Under Article 27(2) the European Medicines Agency assesses compliance with the extension requirements and issues a statement, which then accompanies the SPC application filed with national patent offices. That places a regulatory agency at the gate of an intellectual property right, and as Clifford Chance noted in its February analysis, the routes available to biosimilar competitors to challenge such an extension are not clearly established in the current text. Terms like “distinctly different” and “same disease” have a long history of ending up in litigation. An incentive whose boundaries get drawn in court years later is a weaker planning instrument than its headline suggests.

The Spanish counter-offer

In July, speaking at a biopharmaceutical forum, Spanish Secretary of State for Health Javier Padilla set out an alternative that Spain intends to put to other Member States from September. His argument is about timing. The SPC extension arrives at the end of a product’s protected life, when it is already competing against newer therapies, so an extra year of exclusivity buys less than it appears to and does relatively little to move a manufacturing or investment decision taken fifteen years earlier.

The alternative Spain proposes is an early procurement mechanism operating in the window between EMA approval and national pricing and reimbursement decisions. The Commission would establish a framework for purchasing innovative medicines during that pre-pricing phase, giving companies preferential access to the whole European market from the moment of authorisation rather than a reward at the far end of exclusivity. Padilla argued this would speed up patient access while leaving biosimilar competition undisturbed once protection expires.

It is worth registering the objections alongside the proposal. Vital Signs, reporting the remarks, observed that Padilla did not address the fact that the SPC extension is itself conditional on EU production, which is precisely the manufacturing lever he says the measure fails to pull. Farmaindustria’s Director General Juan Yermo welcomed the debate but warned that Europe cannot afford a reform that takes three or four years to materialise. A mechanism that has to be designed, funded and agreed across twenty-seven health systems is not obviously faster than an article that already exists in a draft regulation.

Two Spanish tracks, one substitution

The counter-offer did not appear from nowhere, and this is the part of the story that has gone largely unremarked.

In June the co-rapporteurs Vytenis Andriukaitis (S&D, SANT) and Wouter Beke (EPP, ITRE) tabled their joint draft report, dated 16 June. It proposes no amendment to Article 27, leaving the most contested element of the proposal exactly as the Commission wrote it, and only asks for the impact of the SPC extensions to be covered in a later review. The first committee debate showed broad agreement that Europe has ground to recover against the United States and China, and open disagreement about incentives, with Tiemo Wölken warning that longer exclusivity would delay biosimilar competition and push up costs for health systems.

The Environment, Climate and Food Safety Committee has delivered its opinion, dated 2 October in the Parliament’s procedure file. ENVI is not a lead committee on this file, so its opinion carries political weight rather than procedural force, and it does not amend Article 27. Its rapporteur, Nicolás González Casares (S&D, Spain), aimed his objection at the parallel extension for veterinary medicines against zoonotic diseases, arguing that it lacks a proper econometric impact assessment and that additional exclusivity is poorly suited to the problem. Where an extension is retained, he writes, it should not transfer value from public health systems to industry without a clear counterpart. As alternatives the opinion points to push incentives such as research grants, public-private partnerships and support for clinical development, and to pull incentives including advance purchase commitments, market guarantees and strategic procurement.

Set the two Spanish interventions side by side and they describe the same move. A Spanish rapporteur in Parliament argues for procurement-type instruments over additional exclusivity. A Spanish government proposes an early procurement mechanism to Member States. Neither is arguing that Europe should spend less on biotech. Both are arguing that Europe should buy something specific with the money.

That is the distinction worth holding onto. An extension of exclusivity is a transfer whose value is realised through price, and it asks nothing about access. A purchase commitment is a transfer whose value is realised through volume, and access is the thing being bought. The two instruments can be aimed at the same objective and still produce entirely different obligations for the company receiving them.

The first committee vote, 7 September 2026

The Legal Affairs Committee adopted its opinion on 7 September, by 19 votes to 5 with 1 abstention; according to Agence Europe, the compromise amendments were carried 18 to 3 with 4 abstentions. The twelve-month extension survives, and on easier terms. The first two conditions are merged into an alternative: a product now qualifies with a new active substance or with a different mechanism of action, and the word “distinctly” disappears from both. The list of steps that do not count as EU manufacturing is also widened to exclude import, repackaging and labelling. Agence Europe reports that rapporteur Tiemo Wölken had first proposed deleting the extension and in the end presented the compromise.

The counterpart he obtained sits on the other side of the market. The opinion widens the SPC manufacturing waiver, so that biosimilar producers can manufacture and store for an unlimited period before protection expires, against six months today, and sell from the first day after it does. Wölken’s argument was that stockpiling a product is not placing it on the market.

The exchange was therefore settled, and it was settled between originators and biosimilar producers, over the timing of competition. What a health system pays and when a patient gets the medicine stayed outside it. SANT and ITRE, the lead committees, have yet to vote; Parliament’s indicative date for the plenary is 14 December.

Planning while the incentive is unresolved

For a European biotech, a university spin-off or an investor with a position in one, the practical difficulty is that the conditions have longer lead times than the negotiation.

The manufacturing condition in Article 27 is the clearest example. Establishing a qualifying manufacturing step in the Union is a decision measured in years and capital, and it has to be taken well before anyone knows whether the article survives the trilogue in its current form. The same is true, in reverse, of the procurement route: a company that would benefit from early European purchase needs its regulatory and supply planning aligned with authorisation rather than with national reimbursement, and that is also not a switch to flip late.

There are three things worth doing now, none of which depend on knowing the outcome.

The first is to work out which of the two logics your pipeline is actually built for. A product whose commercial case rests on the tail of exclusivity and one whose case rests on rapid European volume are not helped by the same instrument, and most portfolios contain both.

The second is to treat the manufacturing footprint decision on its own merits. If a European manufacturing step only makes sense because of a twelve-month extension that may be deleted, it probably does not make sense.

The third is to read the conditions as a statement of intent rather than as a checklist. Whichever instrument survives, the direction is consistent across all of them: Europe is moving from unconditional support toward support that comes attached to something. Today that something is where you manufacture. The debate now under way is about whether it should also be when patients get the product and on what terms.

Public money in biotech is not the problem. Writing the cheque without filling in the conditions is.

Updated on 7 October 2026: dates and committee positions corrected against the adopted JURI and ENVI opinions.

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Sources

• European Commission, Proposal for a Regulation establishing a framework of measures for strengthening the Union’s biotechnology and biomanufacturing sectors (European Biotech Act), 16 December 2025
• Clifford Chance, European Biotech Act eyes extension of Supplementary Protection Certificates (SPCs) for novel biotech products, 19 February 2026
• Vital Signs, Inside EU Health: Spain to propose alternative to SPC; clinical trials transparency; AI, 15 July 2026
• EU Reporter, MEPs supportive of draft Biotech report, but divisions over incentives remain, 5 July 2026
• Agence Europe, European Parliament Committee on Legal Affairs backs biosimilar stockpiling before expiry of pharmaceutical protection, 9 September 2026
• European Parliament, Committee on Legal Affairs, Opinion on the European Biotech Act, PE789.902, adopted 7 September 2026
• European Parliament, Committee on the Environment, Climate and Food Safety, Opinion on the European Biotech Act, PE788.881, adopted 1 October 2026
• European Parliament, Joint draft report SANT/ITRE, PE789.987, 16 June 2026
• European Parliament, Legislative Observatory, procedure 2025/0406(COD)