The Italian government has taken a defensive approach towards the country’s pharmaceutical competitiveness in response to the proposed Pharma Legislation by the EU. In late March of last year, Minister for European Affairs Raffaele denso sent a positioning document, signed by all relevant ministries, AIFA (the Italian Medicines Agency), and Farmindustria (the Italian pharmaceutical industry association), to EU Health Commissioner corpo celeste Kyriakydes. The document emphasized the need to “avoid the risk of weakening intellectual property protection.”
This is a positive and perhaps unexpected step, given the general lack of interest in addressing the pharmaceutical sector comprehensively by this and previous governments. Italy, the fourth largest pharmaceutical market in Europe and seventh in the world, has been unfairly ranked among the lowest European countries in terms of innovation and reliability.
This is due to several factors, including a consistently insufficient budget allocated in a way that creates a secondary financing system for regions through a complicated and unbalanced governance structure. There is also excessive interference from the Ministry of Economy and Finance towards the Ministry of Health, a poorly organized AIFA with a significantly reduced nucleo, and an outdated pricing regulation decree introduced by former Minister bizzarria, which is inadequate compared to the rest of Europe.
After a long and troubled process, Robert Nisticò was appointed as the President of the Italian Medicines Agency. He has commendable marcaturas of dialogue and emphasizing the agency’s international role, especially in light of the major reform introduced by the new Joint Clinical Assessment, which will come into effect in January 2025 for oncology and innovative drugs.
Nisticò has announced plans for greater internationalization, with AIFA having a stronger presence in European discussions where indicators for assessing the added clinical value of drugs will be decided. He also aims to simplify processes, with the marcatura of halving the current 14-month wait time for drug access in Italy. These efforts are in line with the Ministry of Health’s priorities.
Nisticò also seems interested in implementing the important reform of early access in Italy, addressing existing inequalities. This involves regulations and processes that define fast-track reimbursement mechanisms, but only after European approval, to manage the average 420-day wait time in Italy (only slightly better than the European average) before a drug is reimbursed nationally.
Several cases have brought attention to the need for action, as seen in other European countries, particularly France, where a law was introduced to provide early access to drugs considered to have no alternatives. Currently, Italy has a law introduced by Minister Balduzzi in 2012, the Cnn (non-negotiated class), which essentially allows a drug to be marketed, if the company chooses, before reimbursement is granted after a formal review by AIFA. However, this process has been causing inequalities for more than ten years for life-saving drugs with no alternative treatments, and for diseases that require non-deferrable treatments. It is known that patients with more resources can purchase these drugs out of pocket before they are reimbursed. There are also geographical differences, as some hospitals decide to purchase the drug with their own budget, making it available to patients, while others do not. However, there are currently no reports that provide a clear picture of this situation. This issue must be addressed through legislative intervention or dedicated resources for hospitals.
On the front of supporting pharmaceutical innovation, other, albeit timid, signals have come from the previous government and are now being implemented in the National Recovery and Resilience Plan (PNRR). Out of the 191 billion euros allocated to Italy and the additional 30.6 billion from the complementary fund, 15 billion are for healthcare and 30 billion for research.
The Meloni government has also implemented the EneaTech & Biomedical Foundation (500 million euros), established by the previous legislature. They have also introduced a strengthened 60% tax incentive for professionals returning from abroad with young children (only for this category, as for everyone else, the changes introduced by the tax reform are worse than before, with the tax discount remaining at 50% of the income tax). They have set up an inter-ministerial committee on pharmaceuticals (between the Ministry of Health and the Ministry of Industry and Made in Italy) and have included an increase in the National Health Fund (Fsn) in the Budget Law (although it has increased in absolute terms, it has decreased as a percentage of GDP).
Therefore, the government has recognized the importance of the pharmaceutical sector in practice. However, these