Revised pharmaceutical rules to include amendments for Malta proposed by MEP Peter Agius

Agius welcomes pharmaceuticals package as important step forward for Maltese patients

• medicine sourcing being expanded beyond English-speaking markets;

• supplies being obliged to serve small states like Malta.

Strasbourg: MEPs on Monday confirmed the outcome of negotiations of the revised EU pharmaceuticals legislation with the European Commission and the European Council confirming amendments submitted by MEP Peter Agius aimed to improve availability, and, indirectly, prices of medicines in islands and smaller markets like Malta.

"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 for those in Member States which face difficulties when it comes to medicinal availability, including Malta.

"The new provisions include a digital multilingual electronic code for patient information making it possible for government procurement and importers to buy from all across Europe instead of being restricted to the 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," said the Maltese MEP.

As member of the European Parliament Health Committee, MEP Agius in September submitted amendments to the proposed pharmaceuticals legislation foreseen to improve the availability and, indirectly, the price of medicines in Malta. Pharmaceutical producers will also have an obligation to supply smaller markets like Malta. 

According to European statistics, Malta is persistently at the bottom of the European chart when it comes to medicinal aviability, especially for rare diseases and innovative drugs. This is clearly visible in the yearly WAIT reports by the European Pharmaceuticals Professionals Association (EFPIA). The last WAIT Report published in May this year indicates that some medicines take five years more to be available in Malta when compared to mainland Europe. The situation is particulary concerning when it comes to oncology treatments where Malta scores at just two per cent availability of medicinces available when compared for instance with Germany (96%) according to the WAIT report. 

The new rules, set to become law in phases starting in 2028, will empower Maltese authorities and importers to request pharmaceutical companies to supply new products to Malta overcoming in part Malta’s restrictions due to its smaller market size. According to the new negotiated text, if pharma companies do not comply with Malta’s request for new products, they could lose their patent protection. 

“These are two giant leaps forward for Maltese patients thanks to our direct intervention in Brussels. It is now up to government authorities to ensure that these provisions deliver on their expected results for the benefit of Maltese patients. 

“We now need to see that these measures enter into effect without delay and without disruptions in supply due to the end of the Brexit derogation which we are asking to be extended until these new measures enter into force. I will stand ready to do my part on this and other issues as an elected MEP for Malta and Gozo," said Agius.