Europe’s health revolution begins now

What does it truly mean to put patients at the heart of Europe? On 7 April, as the world marks World Health Day, we are reminded that health is not an abstract principle—it is a lived reality. It is the difference between hope and despair, between access and inequality, between innovation and stagnation.

After more than two decades without major reform, the European Union has now taken a decisive step. Following intense negotiations across more than 400 legislative articles, the EPP Group has led the way in achieving what many once considered out of reach—the most ambitious overhaul of EU pharmaceutical legislation in a generation. This is not merely an EPP legislative success; it is a commitment fulfilled.

Our target has been clear from the beginning: to build a regulatory framework that puts patients first, while ensuring that Europe remains a global leader in innovation and our national healthcare systems are economically sustainable. These goals are not contradictory; they are inseparable.

Recent data shows why action was needed. According to Eurostat, health inequalities persist across member states, with millions of Europeans still reporting unmet medical needs due to cost, distance, or waiting times. Public expenditure on healthcare continues to rise, reflecting both demographic ageing and increasing demand for innovative treatments. At the same time, shortages of medicines have been reported in an increasing number of countries, underscoring the fragility of supply chains.

These figures are not just statistics, they are a call to action. One of the reform’s central pillars is improving access to medicines for all Europeans. No patient should be left behind because of geography or market dynamics. Whether it is a child battling cancer or someone living with a rare disease, this reform strengthens incentives to develop treatments where none exist today. By providing up to 11 years of data and market protection, extended further for critical innovations like new antimicrobials, we are sending a strong signal—Europe rewards those who invest in saving lives.

At the same time, we ensured that innovation does not come at the expense of affordability. The immediate entry of generics and biosimilars, the moment protection expires, will help reduce costs and widen access. This is a balanced approach, protecting intellectual property while preventing unnecessary delays in competition.

According to the EPP Group, strategic autonomy in health is no longer optional; it is essential. In this view, we reinforced the competitiveness of the European pharmaceutical sector. Less bureaucracy, clearer rules, and a strong push for 'Made in (or with) Europe' medicines will help anchor production and innovation on our continent.

Moreover, antimicrobial resistance, one of the most pressing health threats of our time, often described as a ‘silent pandemic’, demands urgent action. With harmonised prescription requirements, clear warning labels, and the possibility of stricter measures, we are taking decisive steps to preserve the effectiveness of antibiotics for future generations.

Crucially, we worked to ensure that the reform legislation also recognised a fundamental principle; healthcare begins at the local level. Pharmacists, often the first point of contact for patients, are empowered to play a greater role, including preparing essential medicines when no alternatives are available. At the same time, the introduction of digital package leaflets modernises access to information, while ensuring that no one is excluded from it.

For smaller member states such as Malta, these improvements carry particular importance. Maltese patients were at the heart of our efforts during negotiations, and the new framework will help ensure wider availability of medicines at more affordable prices by opening access to markets beyond language-related barriers as electronic labelling becomes standard across the EU. We also secured a smooth transition for importers by extending the derogation that allows Maltese operators to continue importing medicines from the United Kingdom on favourable terms until the new rules enter into force.

So, what does it truly mean to put patients at the heart of Europe? It means delivering real change, fair and forward-looking, so that every citizen, in every member state, can access the medical care they deserve. Not slogans, but solutions; not promises, but progress.