The EU’s first major reform of pharmaceutical legislation in more than two decades is expected to improve access to medicines in Malta, with new rules obliging manufacturers to supply smaller and island Member States on request and introducing a multilingual digital patient information system that will allow Maltese authorities to source medicines from across the EU single market. The measures seek to address long-standing delays and shortages affecting patients, particularly for innovative and rare treatments.
A key development of the revised framework will allow manufacturers of generic and biosimilar medicines to carry out studies and trials required for regulatory approval before exclusivity expires, helping ensure quicker market entry once protection ends.
A central feature of the reform for Malta is the introduction of enforceable supply obligations. Pharmaceutical companies will be required to supply any Member State that formally requests market entry, including smaller and island markets. Failure to comply could result in the loss of valuable years of market protection, a provision designed to prevent companies from prioritising only larger, more profitable markets.
“We pushed for change in EU rules, and we managed to secure improvements for the benefit of consumers and patients all across the EU, especially in Member States which face difficulties when it comes to medicinal availability, including Malta,” said Maltese MEP Peter Agius.
Agius also highlighted the introduction of a digital multilingual electronic code for patient information, a measure expected to expand Malta’s sourcing options well beyond English-speaking markets. “The market supplying Malta will suddenly expand from Ireland and the UK to all the 26 other Member States of the EU,” he said, noting that this would support public procurement, improve availability and indirectly help address pricing pressures.
European data underlines the scale of the problem. According to the latest WAIT Report by the European Federation of Pharmaceutical Industries and Associations, Malta consistently ranks at the bottom in terms of medicinal availability, particularly for rare diseases and innovative treatments. The most recent report indicates that some medicines take up to five years longer to become available in Malta compared to mainland Europe. The gap is especially stark in oncology, where Malta records just 2 per cent availability compared with 96 per cent in Germany.
The reform also introduces new measures to strengthen security of supply and address antimicrobial resistance, described by EU lawmakers as a growing “silent pandemic”, through targeted incentives and reinforced stewardship obligations.
The new rules are expected to enter into force in phases starting in 2028. Agius stressed that national authorities must now ensure the reforms deliver tangible results for patients. “These are two giant leaps forward for Maltese patients thanks to our direct intervention in Brussels,” he said, adding that he would continue pushing for a smooth transition, including the extension of Brexit-related derogations until the new system becomes fully operational.
