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Malta Among the Worst in Europe for Access to Innovative Medicines, New Data Shows

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A new wave of cancer diagnoses is expected to sweep across Europe over the next 15 years, with experts predicting a staggering 38% increase in the cancer burden by 2040. This will result in over 3.4 million new cancer cases and 1.7 million deaths annually. While scientific progress in cancer research and treatment continues to accelerate, new findings show that these breakthroughs are not reaching patients equally—particularly in smaller EU states like Malta.

According to the European Federation of Pharmaceutical Industries and Associations (EFPIA) 2024 Patients W.A.I.T. Indicator Survey published last week, the average time from European Medicines Agency (EMA) approval of a new treatment to patient access across Europe is 578 days. This delay is even longer in some regions, with wide disparities between countries. In Germany, patients typically wait as little as 4 months, while in Portugal it takes almost 2.5 years.

Between 2020 and the end of 2023, 173 innovative medicines were approved for use across the EU. Maltese patients, through the government’s national formulary, had access to just 17of these, the lowest number among all EU member states. This represents a sobering 10% of available treatments—far below the European average. 

Further analysis paints an even bleaker picture. 

An additional 35 medicines, roughly 20% of the total, were only available through the private sector, meaning patients had to pay out-of-pocket, rely on private insurance or appeal to the Malta Community Chest Fund. Furthermore, a staggering 121 of the 173 new pharmaceutical products (70%) were not available in Malta at all, either publicly or privately.

Cancer patients are among the hardest hit. Out of 56 new oncology products approved in Europe during the same period, just two were accessible in Malta. This was the lowest availability rate among the 36 European countries surveyed, making Malta’s performance especially concerning given the expected increase in the national cancer burden and the growing need for timely and effective treatment options.

Interestingly, for the first time since EFPIA started collecting this data, a separate report for small countries was commissioned. This report investigated the root causes of unavailability and delay in access to innovative medicines for patients living in countries with a population less than 4 million.

One of the most pressing issues to be addressed in smaller markets is the low investment in the healthcare sector, including chronic under-resourcing and the prioritisation of different disease areas within a limited budget. The level of government spending on healthcare as a percentage of GDP is fundamentally a policy choice. While the EU average for healthcare spending is relatively high, only a few countries in this group—like Croatia and Slovenia—exceed that benchmark. Others, including Cyprus, Estonia, Latvia, Lithuania, Malta, Montenegro, and North Macedonia, still fall below it, despite some having made notable progress in recent years.

Although economic constraints and global pressures may limit how quickly spending can increase, it would be beneficial for these countries to outline a clear plan for gradually boosting investment. Equally important is ensuring transparency about which healthcare areas will be prioritised as part of that plan.

While budget constraints are often cited as barriers, the lack of access to essential, innovative medicines, particularly in the public sector, undermines the principle of universal healthcare. The urgency of this matter is clear; Malta’s GDP per capita is the 10th highest in EU and well above the EU average, but this is not being reflected in the availability of important and innovative medicines. 

For Malta, out of the 94 products investigated only a very small number have been applied for by pharmaceutical companies and are available on the formulary. Confusingly, some medicines are available on the formulary even though no application was submitted. Thislack of transparency around the time it takes for a new medicine to become available in Maltaas well as the lack of clarity whether it is at all necessary to apply, is the major issue for companies not filing applications for inclusion in the formulary. The tender model of choosing only the cheapest drug from a class of drugs and ignoring all others is also given as a reason for not applying.

This one-drug-fits-all-patients model where alternative drugs are discarded in the pursuit of the cheapest, coupled with the low filing rate from pharmaceutical companies as well as the lengthy and convoluted process for drugs to be available on the national formulary explains in great part why Malta is doing so badly to make medicines accessible to its patients when compared to the rest of Europe. Suffice to say that Malta was not included in the calculation of the EU average for the time it takes for medicines to be made available.

As cancer and chronic disease rates rise, the cost of inaction will not just be measured in euros, but in lives lost or diminished. The country needs to explore smarter and more efficient access and procurement models used in other EU member states, such as those used in Italy,for example, to ensure the sustainability of our healthcare sector as well as increase the number of treatments available.

For patients, time is not a luxury and access to life-saving innovation should not depend on geography or income.

Sources: OECD EU Country Cancer Profile Malta 2025 / EFPIA Patients W.A.I.T. Indicator 2024 Survey / European Access Hurdles Portal & Root Cause Analysis: Smaller Markets May 2025

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