Most-Favoured-Nation status: new rules to counter US pressure

It’s all very well to talk about innovation. Let’s try to give this term some substance, to explore its various aspects. “Innovation in healthcare only creates value if it translates into real access: prevention, diagnosis and treatment that reach people at the right time. In this sense, accessible innovation means simultaneous benefits for citizens’ health and for the country’s competitiveness: a reduction in the burden of disease, a better quality of life, greater productivity and a boost to growth”. These are the words of Antonino Biroccio, Chairman and Chief Executive Officer of GSK Italia.  The issue takes on strategic importance in a rapidly changing global context. The pharmaceutical sector represents one of the most solid industrial assets for positioning Italia and Europe in international competition, particularly in light of the US–China technological and industrial duopoly. It is a sector capable of attracting investment, creating skilled jobs and enhancing advanced supply chains, from research to production.

“The figures confirm the sector’s central importance,” continues Biroccio. “In Europe, the life sciences sectors are a major economic driver: according to the European Commission, in 2022 they generated approximately 1.5 trillion euros in added value, equivalent to 9.4 per cent of the EU’s GDP, and supported around 29 million jobs. (Data from the European Council⁠) In terms of innovation, the European pharmaceutical industry invested around 55 billion euros in Research & Development in 2024. Investment is concentrated primarily in the United Kingdom (€10.2 billion), Germany (€9.9 billion) and Switzerland (around €9.2 billion); Italia contributed around €2 billion, ranking sixth in terms of pharmaceutical investment in R&D. (creasanita.it⁠). Italia, too, is a major industrial hub: the sector comprises 411 companies and has a production value of around 56 billion euros. The health sector also has a significant multiplier effect on the economy. According to the FNOMCeO-Censis report, every euro of public expenditure invested in the National Health Service generates approximately 1.84 euros in production value, taking into account direct, indirect and induced effects. These figures show that health, innovation, research and industry are not separate spheres, but closely interconnected components of the economic system’s capacity for growth and competitiveness.”

But this future also requires investment in the healthcare system’s capacity to embrace innovation. “A targeted drug,” says Prof. Rossana Berardi, Professor of Oncology at the Polytechnic University of the Marche and President-elect of AIOM, “requires timely access to the test that identifies eligible patients. A complex treatment requires trained professionals, organisation and continuity of care. We need to strengthen cancer networks, molecular diagnostics and clinical research, whilst reducing regional disparities.Sustainability must be built into the entire care pathway: by assessing clinical benefit, avoiding inappropriate procedures, promoting generics and biosimilars, integrating supportive care at an early stage, and allocating resources to innovations that deliver value. We need adequate funding and planning that takes into account not only expenditure but also the benefits for people.”

In this scenario, however, there is one uninvited guest: the US Most Favoured Nation (MFN) policies, which aim to bring US drug prices into line with the lower prices charged in economically comparable countries. And this poses a risk. Biroccio says: “I’m not here to judge whether it’s right or wrong. The US market alone accounts for the lion’s share of revenue and funds global research and development. If it were to strictly adopt the MFN principle – and I see no reason why it shouldn’t – multinational pharmaceutical companies would have no choice but to make radical decisions. To prevent a low price granted in Europe from automatically depressing margins in the United States, companies would be forced to raise prices in European markets. Or, and this would be a dramatic consequence, to delay – if not actually curtail – the launch of new, innovative and life-saving treatments in Europe.

What is needed? Certainly a reform of pharmaceutical policies. Those who make decisions and set the rules must be able to move beyond the logic of siloed spending caps and consider pricing models that reward genuine innovation whilst ensuring the system’s sustainability. But it is also an industrial and economic issue, in terms of GDP and employment. Ignoring American pressure means putting this industrial heritage at risk, encouraging capital flight and the shift of clinical trials to more attractive destinations.” “The MFN approach,” says Berardi, “is a choice that makes decisions on pricing and access to medicines even more interdependent. Among the risks to be averted are upward pressure on European prices and possible delays in the launch of new medicines in less profitable markets. These are scenarios that need to be monitored, and this is why a cohesive and shared vision is needed, both in Italia and across Europe. Institutions, the scientific community, patient organisations and businesses must all work together, each fulfilling their respective responsibilities, to strike a balance that supports research and guarantees timely, equitable and sustainable access. Europe’s capacity to promote innovation must go hand in hand with the protection of universal healthcare systems. Innovation realises its full value when it reaches the cancer patient who needs it. Making this possible, regardless of place of residence or financial circumstances, is the shared responsibility we have for the coming years.”