Medicines: Italy a record-breaker, but quick and courageous choices are needed on governance and innovation

Pharmaceuticals and vaccines are in first place in Italy in terms of surplus with foreign countries, with over 21 billion in assets in 2024, while new records for production (56 billion) and exports (54 billion) confirm the leading role of the Italian pharmaceutical industry in the EU, together with Germany and France. Marcello Cattani, President of Farmindustria, is already looking further ahead: 'The Made in Italy pharmaceutical industry with the numbers it has, the excellence it can count on - from human resources, to the partnership with the public, which relies on a SSN that is unique globally - has the ambition of being the most competitive in the world'. During the Assembly in Rome, Cattani reiterated that 'we can really make it, if we intervene through some reforms of the regulatory framework to enhance investments in research and production, with a new governance that increases resources for pharmaceuticals and immediately reduces the unsustainable payback, to then overcome them from 2027, with an adjustment of health spending to the real health needs of citizens'. For Farmindustria, what is also needed is 'quicker and more homogeneous access to medicines throughout the territory, with an increase in investments in prevention as proposed by the Minister of Health, and with measures that allow the use of clinical data for research needs, while respecting privacy'. All this, for Cattani, needs 'courageous and fast political choices'.

On the other hand, the world scenario is changing rapidly. In 20 years, war scenarios have increased from 30 to 60. The demographic trend in the West is that of an ageing society, with an increasing demand for healthcare. There are difficulties in supply chains, and the costs for their sustainability are growing (+30% compared to 2021). "China," Cattani recalled, "now contributes 20% to world GDP, 20 years ago it made up 5%, while the EU is at 18%, 20 years ago it was 25%. In this scenario, with increasing technological development, 'a clear and rapid change of course is needed. The rules of 20 years ago cannot be adapted to a radically different and ever-changing world'. And then there is the unknown factor of tariffs: 'Our goal is to reach zero to zero or an exclusion of pharmaceuticals from tariffs, precisely because of the value that drugs and vaccines represent in terms of the possibility of treatment. If we were to eventually close at 10 per cent, it would be a defeat with an impact of about EUR 2.5 billion'.

The Ministry of Foreign Affairs is working to find an agreement that does not penalise Europe. "A tariffs war is not in anyone's interest," said the head of the Farnesina, Antonio Tajani, "For pharmaceuticals there must be a global guarantee, this strategic sector must not be penalised compared to others. The minister expects a tug-of-war "but we will engage in negotiations to encourage the emergence of a large market in the West with zero tariffs where it is possible to develop innovation, training, and wellbeing for citizens". In this direction 'we are working with Commissioner Maros Sefcovic to find an agreed solution with the United States'.

A commitment, that of supporting the pharmaceutical industry, "fundamental to guaranteeing safe, effective, innovative treatments for all citizens" was also assured by the premier, Giorgia Meloni. "We are determined to carry on the work of reforming and simplifying the regulatory procedures for accessibility of drugs and enhancing investments in research and development," she said in a video message, "which we have started in recent years and are yielding results. For Meloni, the government 'will continue to stand by this essential sector for Italy, because supporting the pharmaceutical industry means investing in the future, in health, in quality employment, in Italy's and Europe's ability to lead innovation'.

The government's next moves were anticipated by the Minister of Health, Orazio Schillaci: the opening of a table to redesign the governance of the pharmaceutical sector and an acceleration of talks with the Ministry of the Economy to overcome the age-old issue of the payback. "We must recognise with great honesty," he said, "that the governance of the Italian pharmaceutical sector needs an overhaul: we are aware that there are critical issues that have been waiting for answers for several years," starting with the payback established twenty years ago "and which today deserves to be reviewed. "With this government," Schillaci added, "there has already been a change of step towards the pharmaceutical sector, with which we have engaged in a constructive, fair and never ideological dialogue, because we recognise its social and strategic value for the health wellbeing and socio-economic development of the Italian population". The minister recalled 'the reform of Aifa with the 46% reduction in the timing of pricing and reimbursability procedures'.