Revised European Union pharmaceuticals legislation is expected to significantly improve the availability of medicines in Malta, following the approval of amendments aimed at addressing long-standing challenges faced by small and island member states.
MEPs on Monday confirmed the outcome of negotiations between the European Parliament, the European Commission and the European Council on the updated pharmaceuticals package. Among the agreed changes were amendments proposed by Maltese MEP Peter Agius, intended to improve access to medicines and, indirectly, reduce prices in smaller markets such as Malta.
According to Agius, the reforms will allow Maltese authorities and importers to source medicines from across the EU rather than being largely limited to English-speaking markets. Central to this change is the introduction of a multilingual digital electronic code for patient information, which removes language barriers that have traditionally restricted procurement options.
“The market supplying Malta will suddenly expand from Ireland and the UK to all the 26 other Member States of the EU,” Agius said, describing the changes as a major step forward for patients in Malta and other countries facing supply difficulties.
Another key element of the revised legislation is the introduction of obligations on pharmaceutical companies to supply smaller markets. Under the negotiated text, companies that fail to comply with requests from member states such as Malta to provide new medicines could face the loss of patent protection.
Malta has consistently ranked among the lowest in Europe for the availability of medicines, particularly innovative treatments and drugs for rare diseases. Data from the European Federation of Pharmaceutical Industries and Associations (EFPIA) WAIT reports show that some medicines become available in Malta up to five years later than in mainland Europe. The situation is especially acute in oncology, with Malta recording availability rates of around two per cent compared with figures as high as 96 per cent in countries such as Germany.
The new rules, which are expected to be introduced in phases starting in 2028, are intended to help overcome barriers linked to Malta’s small market size by giving authorities stronger leverage when engaging with pharmaceutical companies.
Agius said the changes represented “two giant leaps forward” for Maltese patients but stressed that their success would depend on effective implementation at national level. He also warned of the need to avoid disruptions in medicine supply during the transition period, calling for the extension of existing Brexit-related derogations until the new measures come into force.
The European People’s Party said the reforms mark an important milestone in addressing inequalities in access to medicines across the EU, particularly for patients in smaller and geographically isolated member states.