Malta had access to the lowest number of new innovative medicines approved in the EU between 2018 and the end of 2021, according to a recent report.  

Out of the 168 pharmaceuticals to have received marketing authorisation from the European Commission, only 10 were available in Malta as of January 5, a recent report week by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and healthcare consultants (IQVIA) said. 

Of these, only four were freely available to all patients using the public health service while six were accessible without cost on a case-by-case basis, the report said.  

Meanwhile, the number of new medicines only accessible privately was four times that number, with 24% (40 products) only available to customers of private healthcare.  

In total, more than two-thirds of the 168 new pharmaceutical products were completely unavailable in the country at a proportion of 70%, or 118 products. 

What medicines are affected?

Medicines used to treat cancer were particularly affected by the lack of availability, with only one out of the 46 new products to be found in Malta this year. This was the lowest out of all 37 countries surveyed – including all 27 EU states and 10 other European countries – with Bosnia and Albania having the second and third lowest respectively, both with three.  

While only one new cancer drug was accessible using the public health service, 20 were only available privately and 25 were entirely inaccessible.  

Those classified as Orphan pharmaceuticals – used to treat, diagnose or prevent rare life-threatening or chronically debilitating diseases or those seen as commercially unviable – by the European Medicines Agency (EMA), fared slightly better, however.  

Of the 61 new Orphan drugs to receive marketing authorisation, four were widely available in Malta at the start of this year, representing one-sixth of the EU average, the report said.  

A further 15 were only available privately. None were available in Lithuania.

The time taken to access new medicines was not available for Malta, due to the relevant data only being available for two products. 

According to the EMA, an innovative medicine is one which contains one or more active substances that have not been authorised before.

How does this compare to the rest of Europe?

The data used in the study was sourced by looking at the filing of medicine pricing and reimbursement applications in various countries.  

While Germany took the top spot in all metrics, enjoying a higher level of access to medicines in all classes covered by the study and the shortest time between approval and availability, Malta consistently appeared among the bottom three EU countries surveyed. 

“The countries with the lowest percentage of products that have filed for P&R [pricing and reimbursement] are Malta (13%), Latvia (19%), Cyprus (25%), Lithuania (28%) and Croatia (31%),” the report noted.

According to the chairperson of the Malta Medicines Authority, Anthony Serracino-Inglott, the authority is “very much aware” of the issue but attributed it to Malta’s small population which, as of January 2022, stood at 520,971. Germany’s, meanwhile, was over 83 million.  

“We have difficulty with access as a number of companies consider our market too small,” Serracino-Inglott said, though he noted the responsibility for pricing and reimbursement of new medicines did not rest with the Medicines Authority.  

“In time, however, we expect the EU to move away from a completely free trade model... while attracting manufacturers to Europe,” Serracino-Inglott continued.  

“While offering incentives to manufacturers, the Commission’s proposal should also include an obligation to make medicines available in small member states,” he said, in reference to the European Commission’s plans to overhaul the bloc’s legislation for pharmaceutical products.  

In April, the Commission highlighted the lack of equal access to new medicines across the bloc and delays in reaching patients. 

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