Pharmacists have been told to stop selling COVID self-testing kits immediately, just days after a legal notice authorising their sale was passed into law. 

Kits cannot be sold until the Malta Medicines Authority issues a list of brands that it has certified as safe for sale, pharmacists were told on Wednesday. 

That certification process, which traditionally takes months, has been fast-tracked and is now expected to be concluded within a matter of weeks. Home kits have been available in several other EU states for months. 

On Thursday, MMA head Anthony Serracino Inglott told Times of Malta that while the authority had received applications to approve 10 different types of test kits, none of these had been approved yet. 

“We want to ensure that these tests meet the minimum standards and give peace of mind that they can be relied upon. Our first concern is that we do not want anyone, carrying the virus, to get a false negative and to come into contact with a vulnerable person,” he said. 

Serracino Inglott, a professor of pharmacy, said staff at the authority are working around the clock to certify self-testing kits as soon as possible. 

But until that happens, pharmacies caught selling the COVID self-testing kits are breaking the law and risk being fined, pharmacists were warned. 

Distributors and wholesalers who are selling the as-yet unregulated kits to pharmacies or other shops are treading on thin ice: a 2020 legal notice contemplates fines starting from €12,000 up to an eye-watering €120,000 and even jail sentences for anyone caught distributing unregulated medical devices.

“We were told to stop the sale of the kits until the MMA issues a list of approved brands,” one pharmacist told Times of Malta. 

“We’re having to turn customers away and tell them to try again in a week or two. It’s quite frustrating as people were told that they can only buy the kits from pharmacies. Now it seems we’re the only places that aren’t selling them!”

The process to legalise self-testing kits has been a rather convoluted and confusing one. 

Ten days ago, Health Minister Chris Fearne announced that self-testing kits would be made legal. 

Within days of that announcement, kits started appearing on shelves of grocery stores, supermarkets and health shops around the country. But with no law regulating their sale in place yet, most pharmacies held back from selling the kits.

That changed earlier this week, when a legal notice was passed, making it legal to sell the kits, and guidelines were issued stipulating that only pharmacists would be allowed to sell them. 

Photo: Shutterstock.

Prices range from €4 to €10

Several pharmacies immediately started selling the devices, with prices ranging from €4 to €10 each – until they were warned on Tuesday that doing so was still technically illegal.

The guidelines issued by the Superintendence of Public Health earlier this week state that a list of COVID-19 self-tests approved by the MMA will be made available on the regulator’s website. As of Wednesday afternoon, no such list was available. 

“We will just have to wait for the MMA to issue its list, and hope that the kits we have in stock are included on that list,” said another pharmacist, who asked not to be named. 

A source close to the regulator told Times of Malta that the key issue was that many self-testing kits currently being distributed are marked ‘for professional use’, meaning they must be administered by a healthcare professional.

Their concern is that the professional use kits will not properly be administered by lay people. 

The guidelines issued this week expressly prohibit such kits from being sold as self-testing kits.   

Kits being sold elsewhere

Meanwhile, retail outlets that are not pharmacies were still selling the kits as of Wednesday, despite the guidelines expressly forbidding them from doing so. 

"This is ridiculous we have these kits and we cannot sell them, even though they are already certified in the EU. And then any Tom, Dick, and Harry is selling them all over the place," an industry source said.  

The Maltese self-testing guidelines are far stricter than those in many other western countries.

Countries like the Netherlands and Germany allow the kits to be sold in supermarkets like Lidl and Aldi, while the UK government will ship eligible people a set of self-tests to their homes for free. 

Self-testing kits are considered to be less reliable than PCR or rapid antigen tests administered by a medical professional and cannot be used for travel purposes or any other form of official COVID status certification.