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MALTATODAY 5 APRIL 2025

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9 maltatoday | SUNDAY • 5 APRIL 2026 OPINION 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 re- minded that health is not an ab- stract principle—it is a lived re- ality. It is the difference between hope and despair, between ac- cess and inequality, between in- novation and stagnation. After more than two decades without major reform, the Eu- ropean Union has now taken a decisive step. Following intense negotiations across more than 400 legislative articles, the EPP Group has led the way in achiev- ing what many once considered out of reach—the most ambi- tious overhaul of EU pharma- ceutical legislation in a genera- tion. This is not merely an EPP legislative success; it is a com- mitment fulfilled. Our target has been clear from the beginning: to build a regu- latory framework that puts pa- tients first, while ensuring that Europe remains a global leader in innovation and our national healthcare systems are econom- ically sustainable. These goals are not contradictory; they are inseparable. Recent data shows why action was needed. According to Eu- rostat, health inequalities per- sist across member states, with millions of Europeans still re- porting unmet medical needs due to cost, distance, or waiting times. Public expenditure on healthcare continues to rise, re- flecting both demographic age- ing and increasing demand for innovative treatments. At the same time, shortages of medi- cines have been reported in an increasing number of countries, underscoring the fragility of sup- ply chains. These figures are not just statis- tics, 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 can- cer or someone living with a rare disease, this reform strengthens incentives to develop treatments where none exist today. By pro- viding 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 sav- ing 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 pro- tection expires, will help reduce costs and widen access. This is a balanced approach, protecting intellectual property while pre- venting unnecessary delays in competition. According to the EPP Group, strategic autonomy in health is no longer optional; it is essen- tial. In this view, we reinforced the competitiveness of the Eu- ropean pharmaceutical sector. Less bureaucracy, clearer rules, and a strong push for 'Made in (or with) Europe' medicines will help anchor production and in- novation on our continent. Moreover, antimicrobial resist- ance, one of the most pressing health threats of our time, often described as a 'silent pandemic', demands urgent action. With harmonised prescription re- quirements, clear warning labels, and the possibility of stricter measures, we are taking decisive steps to preserve the effective- ness of antibiotics for future gen- erations. Crucially, we worked to en- sure that the reform legislation also recognised a fundamental principle; healthcare begins at the local level. Pharmacists, of- ten the first point of contact for patients, are empowered to play a greater role, including prepar- ing essential medicines when no alternatives are available. At the same time, the introduction of digital package leaflets modern- ises 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 nego- tiations, and the new framework will help ensure wider availabili- ty of medicines at more afforda- ble prices by opening access to markets beyond language-relat- ed barriers as electronic labelling becomes standard across the EU. We also secured a smooth tran- sition for importers by extend- ing 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 Eu- rope? It means delivering real change, fair and forward-look- ing, so that every citizen, in every member state, can access the medical care they deserve. Not slogans, but solutions; not promises, but progress. Dolors Montserrat & Peter Agius Montserrat is EPP Group vice- president and health committee member. Agius is an EPP MEP and health committee member Europe's health revolution begins now The reform also ensures 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 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

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