New EU pharma rules could be a big win for medicines availability in Malta

EU lawmakers have approved revised pharmaceutical rules that could lead to a much broader spread of medicines being available in Malta.

MEP Peter Agius, who negotiated amendments that made it into the final deal, said the new rules were a big win for Maltese patients.

One major change is that the new rules will include a digital multilingual electronic code for patient information. That, Agius, said, will make it possible for the government to procure pharmaceuticals from across the EU, instead of being restricted to sourcing them from English-speaking markets.

“Suddenly our market will expand from Ireland and the UK to all the 26 other Member States of the EU,” he said.

Agius sits on the European Parliament Health Committee and submitted amendments to the rules as part of his work on the committee.

MEP Peter Agius. Photo: Facebook

Another key change is a requirement that will oblige pharmaceutical producers to supply smaller markets like Malta. Companies that refuse to do so risk losing patent protection.

Malta consistently ranks towards the bottom of EU rankings in terms of medicines availability – a result of its small market size, geographic isolation and language restrictions.

A Europe-wide metric used to measure delays in accessing innovative treatments, the WAIT Indicator, found that Maltese patients contend with significantly less access to innovative treatments than the EU average.

The problem is especially acute when it comes to innovative drugs to treat cancers: out of 56 new oncology products approved in Europe between 2020 and 2023, just two were accessible in Malta – the EU’s lowest rate.

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

Agius said he would be pushing for the EU to extend a Brexit derogation that allows Malta to source medicines from the UK until the new rules come into effect.

The EU’s new set of rules for the pharma sector must be voted on by MEPs and then signed off by ministers before they can come into effect. But given that the European Parliament, European Commission and European Council have agreed on most of the details, that is not expected to be a stumbling block.

It will be the first major overhaul of EU pharma rules in over 20 years.

Among other things, the negotiated set of rules will give new medicines an eight-year data protection period and one year of market protection, extendable to two years in some cases. Generic versions of out-of-patent medicines will be available on day one following the expiration of intellectual property rights.  

Pharma companies will also be incentivised to develop new antibiotics, with each company getting one voucher that will grant them an extra year of patent protection on a drug of their choice, provided the drug clocks up sales of less than €490 million over four years.

If approved, the new rules will start being phased in starting from 2028.