EU Biotech Act Reaches Turning Point as Parliament Rewrites Report and Commission Splits Proposal

The process of drafting the future Biotech Act has entered a crucial phase in both the European Parliament and the European Commission.

In addition to the intense political activity within the Committee on Public Health (SANT), where an alternative compromise to the initial report by rapporteur Margarita de la Pisa (Patriots–Vox) will be voted on December 2nd, the European Commission has now confirmed its decision to divide the legislative initiative into two parts. The first proposal, focused on the healthcare sector, will be officially presented on December 16th.

These movements, which occur almost simultaneously, mark a turning point in the processing of one of the most relevant regulatory initiatives of the European legislative cycle for the biotechnology sector.

Blocking the original report

The initiative report (INI) prepared by Margarita de la Pisa for the SANT committee has been virtually discarded. Although the text had progressed in technical meetings with the shadow rapporteurs , the political dynamics within the committee and the objective of blocking the report have been decisive in recent weeks in triggering events.

According to several parliamentary sources, the European People’s Party ( EPP ), the Socialists and Democrats ( S&D ), Renew Europe, and the Greens have reached an agreement to promote an alternative compromise that will replace the rapporteur’s draft. This pact, forged after several weeks of discreet negotiations, creates a new majority that prevents the original text from being adopted and ensures a vote on an alternative agreed upon by the main groups.

The vote for the new Biotech Act will take place at the SANT committee meeting on December 2nd, a date reached after several postponements. The rapporteur had denounced in various public statements that these delays were political maneuvers aimed at preventing the approval of her report; however, internal dynamics show that the majority groups were working on a common text that has now garnered sufficient support to be voted on with confidence.

The alternative compromise to be voted on at the next SANT meeting is neither a minor document nor a simple package of amendments. Sources consulted indicate that it is a comprehensive document that reorganizes the content, modifies the approach, and adjusts the political language , retaining some of the technical work developed in recent months but integrating it into a vision aligned with the parliamentary majority.

The outcome of this alternative compromise is politically significant. In practice, the approved text of teh Biotech Act will become the European Parliament’s benchmark political position in the face of the Commission’s imminent proposal. These reports do not determine the wording of the future law, but they do shape the political climate and can influence the negotiating mandate during the legislative process.

The Commission divides the Biotech Act into two phases

In parallel with parliamentary activity, the European Commission has taken the strategic decision to divide the Biotech Act into two separate proposals. This approach responds to the heterogeneity of the package, which combines health, industrial, regulatory, and bioproduction areas with varying levels of legislative maturity and urgency.

As Diariofarma has confirmed, the Commission will present the first package, focused exclusively on the healthcare sector, on December 16th. This first part will include the most advanced and urgent elements of the dossier, especially those related to healthcare innovation , medical biotechnology, clinical trials, and regulations concerning patients and medical devices.

The second part, of a more industrial nature and focused on biomanufacturing, production and value chains, will arrive throughout 2026, within the medium-term legislative calendar.

The Biotech Act: a high-impact file

The Biotech Act has been presented by the von der Leyen Commission as one of the flagship initiatives to boost the European Union ‘s biotechnology competitiveness . According to EU officials, the goal is to “move from innovation to industrial scaling,” reduce regulatory barriers, accelerate the arrival of new developments to market, and strengthen strategic autonomy in biotechnology-based sectors.

The sector has been demanding clarity and speed for months. European and national associations, including Asebio in Spain, have been participating in the prior consultation processes since the beginning of the year and have requested a stable, harmonized, and growth-oriented regulatory framework.

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(Featured image by Frederic Köberl via Unsplash)

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First published in diariofarma. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

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