Italy Presses EU on Gene Therapy Accounting

Subsecretary Marcello Gemmato told lawmakers that gene therapies generate both direct and indirect savings, but that “European accounting systems” do not allow those outlays to be treated as investments. He added that accounting must still reflect the full cost in the year of purchase, effectively limiting how much room finance ministries have to smooth the fiscal impact.

That tension is already shaping access policy. Italy’s medicines agency, Aifa, has been using conditional access agreements and outcomes-based payments for advanced therapies, a model that lets the state spread risk with manufacturers and pay only if treatments work as intended. Gemmato said the issue will be discussed further in the budget law, suggesting the government is looking for a fiscal workaround rather than a wholesale rewrite of EU accounting standards.

For investors, the policy debate reinforces a key valuation question in rare disease, oncology and cell therapy: how quickly can expensive, potentially curative therapies win reimbursement without triggering a backlash over budget impact? Companies with strong evidence on durability and outcomes, such as Vertex and Regeneron, stand to benefit if payers accept value-based models. Bristol Myers Squibb and other rivals with broader exposure to high-cost specialty drugs could also gain if Italy’s approach becomes a template for wider European access.

The near-term bull case is that Italy expands early access and supports reimbursement mechanisms that favor breakthrough therapies. The bear case is that fiscal rules keep forcing payers to treat these medicines as current-year costs, preserving pressure for rationing, delayed launches and tougher price negotiations. That makes the budget law and any follow-up guidance from Aifa the key catalysts for the sector in Europe.