How new EU incentives will help all patients get the best treatments

Pharmaceutical manufacturers have historically focused on large, high-value markets, leaving those in smaller countries struggling to find the latest drugs. New EU legislation is designed to correct this imbalance.

Medical advances can bring about life-changing improvements, especially for those suffering from long-term conditions. Every year new treatments are discovered that work better or have fewer side effects.

But not everyone can benefit from these changes. Often the priority for distribution is large, high-value markets, at the expense of those living in smaller inhabited areas.

Waiting for new treatments in Malta

Wayne Zammit lives in Malta. When he was a boy, he had a dream.

\”I grew up loving cars,\” he says. \”One of the things I always wanted was to work at something I love. But unfortunately, due to the condition of my skin, my eczema, dust, and the things you do are all very messy, and it\’s very easy to get infections and stuff like that. It\’s something I had to give up very quickly.\”

Wayne was diagnosed with severe eczema when he was 4 years old. Problems soon piled up.

\”When I went to get my first passport, at that point, I was pretty young,\” he says. \”In my picture, my lips were completely broken. So I was like a mini-wild card, to an extent. And I had a lot of flare-ups around my eyes. Also a cracked eyelid. And my ears were very swollen and red. And of course they wouldn\’t want to take a picture for identification purposes; and for me too. This is a disease that affects the skin, it\’s our largest organ. I\’ve had days where I couldn\’t move my neck around. I\’ve had days where to get out of a chair, I wanted to cry. I have days where my clothes are stuck to my skin, from open wounds\”

A cocktail of medicines now keeps the disease at bay. But periodically they cause such side effects as nausea and high blood pressure. When Wayne stops them, his body ignites again.

However, there is no prescription of injectable medicines available in Malta which doctors believe are most effective for him.

“I want to know why I have to wait so long for something I need so badly,” Wayne says.

Approved drugs not available

The treatment that could help Wayne has already been approved by regulators in Malta and is eligible for free administration to patients. Yet it is nowhere to be found in pharmacies across the country, unlike those in other European Union members.

The consequences are dire for Wayne and other patients with severe eczema, says his dermatologist Michael Boffa.

\”The fact that these drugs are not available means that patients will have to be treated with other drugs, which are less effective and perhaps carry risks of important side effects that could be avoided by using better drugs,\” says Michael Boffa, who is chairman of the Department of Dermatologist of Mater Dei Hospital and President of the Malta Eczema Society. \”Patients should certainly not be discriminated against because of the disease they are unfortunate enough to have.\”

A size problem

Bureaucracy, Brexit, Covid, the global supply crisis and the war in Ukraine help explain the situation. But Malta also has a structural problem: its tiny size.

As the smallest member state of the EU, the country seems less attractive for pharmaceutical developers.

A warehouse houses all the medicines used by Malta Social Security. It looks full, but statistically Malta lags behind other member states when it comes to full public availability of approved medicines. Of the 160 medicines approved by the EU between 2017 and 2020, only 11 were available in Malta compared to 147 in Germany, according to the EFPIA Patients WAIT Indicator 2021 Survey. The figures have been updated as of July 2022, but as Malta has not completed its entire data set, they are only an indicative indicator.

The man in charge of Malta\’s Medicine Supply Unit says they are working hard to find solutions.

“If there are high numbers, the industry registers a product and we don\’t have a problem,” says Karl Farrugia, managing director of the Central Procurement And Supplies Unit. \”But when there are few patients, and Malta obviously is a small country, so you get these treatments where few patients need them, then the government comes in. For registration, we do the translation, we do the serialization.\”

EU to provide incentives

To further help small countries like Malta, the European Commission\’s reform of EU pharmaceutical legislation has proposed rewarding developers who launch a medicine in all member states within two years of authorisation. According to the EC, this alone would increase access by 15%.

Further proposals such as the simplification of authorization procedures or the introduction of multinational packaging have been welcomed by the Maltese pharmaceutical industry.

\”The pharmaceutical industry in its best effort has to try to make products a little more affordable for smaller countries,\” says Mark Mallia, pharmaceutical industry representative in Malta. \”And we need to see inventory, drug depots available for small countries. And a multilingual package could help that, because you have a depot that would serve 6 or 7 or 8 countries when needed.\”

Wayne hopes all the actors will soon work together to help him.

\”I think we\’ll get there,\” he says. \”Especially if you do the necessary and if people help each other.\”

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