The impact of the Milleproroghe Decree on biotech research in Italy

Commentary by Giorgio Racagni, Scientific Director ITTBIOMED | EDRA

The Milleproroghe Decree is an annual legislative measure that extends deadlines and modifies existing regulations across various sectors. It aims to provide stability and continuity to critical initiatives, including scientific research and innovation. Recently approved definitively by the Italian Senate, the 2025 edition of the decree introduces provisions that indirectly impact the biotech sector by extending funding, tax incentives, and regulatory adjustments.

A Strategic Perspective on the Milleproroghe Decree

The recent Milleproroghe Decree presents an important yet nuanced impact on the Italian biotech research landscape. While the decree does not explicitly target the sector, its provisions indirectly shape the operational framework for research institutions, biotech firms, and public-private collaborations.

Strengthening Research and Development

1. Extending Research Funding Programs

Biotech research in Italy heavily relies on structured funding mechanisms. The decree’s extension of existing programs provides a lifeline for ongoing and future projects, ensuring continuity in scientific advancements.

2. R&D Tax Incentives: A Welcome Continuation

The extension of tax benefits for research and development is crucial for maintaining Italy’s competitive edge in the global biotech market. These incentives facilitate innovation, enabling companies to invest in pioneering therapies and medical technologies.

3. Public-Private Partnerships: A Key Driver for Growth

Institutions like ENEA play a fundamental role in bridging academia and industry. The decree’s provisions enhance the stability of these collaborations, fostering an ecosystem where innovation can thrive.

Addressing Regulatory and Operational Challenges

4. Regulatory Adjustments for Biomedical Advancements

In an industry where compliance dictates market readiness, the decree’s regulatory extensions provide biotech firms with the necessary time to adapt to evolving medical regulations, thereby safeguarding their ability to innovate without disruption.

5. Human Capital Investment and Talent Retention

The biotech sector is knowledge-intensive, and talent retention remains a priority. Provisions aimed at stabilizing research personnel employment are pivotal in preventing a brain drain and sustaining scientific excellence.

Opportunities and Persistent Challenges

While the Milleproroghe Decree provides essential support, the sector still faces hurdles:

  1. Delays in funding disbursement: Bureaucratic inefficiencies can hinder timely project execution.
  2. Regulatory misalignment: Italy must strengthen its harmonization with European biotech standards.
  3. Long-term sustainability: Short-term extensions, while beneficial, need to be supplemented by robust, structural investments.

Final Thoughts

The Milleproroghe Decree represents a crucial step in safeguarding and promoting biotech research in Italy. However, as a sector deeply rooted in long-term innovation cycles, we must push for more structured and sustainable funding strategies. The success of Italian biotech will depend not only on continued governmental support but also on the ability of stakeholders to advocate for a coherent, future-proof strategy for research and development.