ITALY Trends and Developments Contributed by: Luca Liistro, Chiomenti
ing players, enabling them to scale operations and compete more effectively in global markets. Nevertheless, Italian biotech companies continue to face challenges related to access to access to capi- tal, especially from equity capital market, regulatory complexity, and the time required to achieve market authorisation and reimbursement. The proposed Bio- tech Act may offer opportunities to improve the legal scenario and allow those initiatives to thrive. Tax incentives and fiscal considerations Italy’s 2026 Budget Law introduces fiscal measures that may benefit life science companies making new investments. The law provides for an enhanced depre- ciation regime as well as the use of tax-suspended subject to a 10% substitute tax, potentially freeing up capital for reinvestment. The use of R&D credits is still subject to significant scrutiny by the agencies, and therefore specific tax due diligence for acquisition of companies historically active in the R&D space is recommended. The same applies in general for proper structuring of extraordi- nary transactions, where the contribution of tax advi- sors is certainly appropriate. Compliance, governance and corporate liability The compliance landscape for life science com- panies operating in Italy continues to evolve, with new requirements affecting whistleblowing, corpo- rate criminal liability, and data protection. The Ital- ian National Anti-Corruption Authority published final guidelines on internal whistleblowing reporting chan- nels in December 2025, providing operational guid- ance for entities subject to the Italian whistleblowing decree. These guidelines set out procedures, roles, and responsibilities for handling reports and provide instructions for aligning compliance programmes adopted pursuant to Legislative Decree 231 on cor- porate criminal liability. In general, the sensitivity of Italian authorities to com- pliance standards and procedures reaches a higher level whenever the health sector is relevant. That is even more true in the discussions regarding health- care industry and all activities that are funded with public money, therefore including reimbursements
and payback procedures. The Ministry of Justice also published a report on the reform of corporate crimi- nal liability, giving statutory recognition to essential elements of compliance programmes including risk mapping, preventive protocols ensuring segregation of activities, and adequate information flows. Italian companies are, in general, increasing the level of pre- ventive compliance, and extraordinary transactions in the Italian healthcare sector are seeing the introduc- tion of covenants and obligations, both pre-closing and post-closing, aimed at isolating and managing compliance risks between the parties to the transac- tion. Looking ahead: strategic considerations for legal practitioners As 2026 unfolds, legal professionals advising the life sciences sector in Italy will need to balance multi- ple competing priorities. Legislation regarding ordi- nary processes such as supply chain, market access dynamics and R&D require a proper management and the contribution of external advisors is essential to raise the level of compliance and preserve the attrac- tiveness and market positioning. On the corporate side, the favourable M&A environ- ment and government incentives for investment pre- sent opportunities for strategic transactions, though navigating foreign investment screening, competition review, and corruption risk assessment will require sophisticated legal guidance. Proper tax structur- ing preserves value in extraordinary transactions and ensure correct management of risks. Finally, the heightened emphasis on supply chain resilience and potential compulsory licensing mechanisms introduc- es considerations that clients must address in their long-term strategic planning. Italy’s life sciences sector stands at the intersection of scientific innovation and regulatory transformation. For legal practitioners willing to develop deep exper- tise in this specialised field, the opportunities to add value for clients is substantial. The year ahead prom- ises to be one of both challenge and opportunity, and those who navigate it successfully will help shape the future of healthcare innovation in one of Europe’s most important markets.
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