New regulation of the pharmaceutical market: exclusive interview with Sandra Gallina from the European Commission's Health and Food Safety Directorate-General (SANTE)

A few days ago, a proposal for EU pharmaceutical legislation was approved which aims, from the Commission's point of view, to ensure a "future-proof" regulatory system for medicine. SDA Bocconi had the honor and privilege of hosting Sandra Gallina, Director General of the European Commission's Directorate General for Health and Food Safety (SANTE), to give an exclusive talk to the Campus audience on this highly current topic. Professor Monica Otto, Director of the Pharmaceutical Observatory of the Centre for Research on Health and Social Assistance (CERGAS) at SDA Bocconi, moderated the speech.

Dr. Gallina, what are the expected implications of this reform for stakeholders who contribute to the healthcare ecosystem?

Healthcare is undoubtedly a very complex issue because it encompasses multiple aspects, including economic, political, and financial aspects, and above all because it is so closely connected to citizens. Healthcare does not only mean curing diseases, but also preventing them, and this is the real challenge for the future. Today, Europe is the leader in the pharmaceutical sector with a market of €1.3 trillion, but to maintain this leadership we need to prioritize the patient, maintain a high level of research and innovation, and facilitate access to pharmaceutical products as much as possible. The pharmaceutical sector is very different from any other type of market because it involves several players: states, institutions, and the pharmaceutical industry. And the process that leads from the birth of a medicine to its placement on the market is also long and complex, because a series of negotiations have to be undertaken with regard to price and availability. For all these reasons, the implications that we expect for all stakeholders are that they need to be able to build a platform for debate that is shared by all EU member states and aimed at creating a single market for pharmaceuticals and ensuring fair access to safe and quality medicine.

What impact could this reform have on the sustainability of healthcare systems?

It will definitely have a big impact in terms of environmental sustainability but also economic sustainability. The main goal must be to have innovative products where we really need them. Just think of the issue of antibiotics. It’s important that we reduce their use but at the same time we must also promote innovation. Our reform is aimed at offering incentives to the pharmaceutical industry that will push it to invest in innovation, which can offer stable contracts and an environment that is conducive to research and development. While the choice of priorities remains in the hands of the member states, which decide how to distribute their health budgets between prevention, healthcare and drug-based measures, the reform aims to offer a European system that allows the states themselves to achieve the greatest possible impact from the resources spent on medicine, balancing different responses to different needs and requirements for each state through scientific, technical and political considerations.

Professor Amelia Compagni, Director of CERGAS, pointed out at the close of the conference that SDA Bocconi, as a study and research center, also feels a strong responsibility in this context to actively contribute to this space of collective conversation, offering its support in measuring and evaluating the impact of this reform, from a research perspective that is increasingly European.

SDA Bocconi School of Management