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Sweden: Administrative Court Upholds Prohibition on Sale of COVID-19 Test Kits

(May 8, 2020) On May 4, 2020, the Administrative Court of Uppsala ruled that sales of Zandcell AB’s COVID-19 test kits were prohibited in Sweden because the producer had not proven that the product met the legal requirements for medical devices under Swedish and European Union law. (Uppsala Administrative Court, Decision No. 240-20 (May 4, 2020), on file with author.)

The Swedish Medical Products Agency (Läkemedelsverket) had previously issued a prohibition on the sale of the product, coupled with an injunction and monetary fine of 10,000 Swedish kronor (about US$1,000) for each subsequent violation. Since then the Swedish Medical Products Agency has prohibited several other vendors from selling products with similar properties.

In its appeal of the Swedish Medical Products Agency’s prohibition on the sale of the product, Zandcell AB argued that they were not selling a product with the name “COVID-19 Test Kit” and that the prohibition was therefore not precise enough. (Decision No. 240-20 at 2–3.) The court, however, found that the because the Agency had referred to the website where the product was sold and Zandcell AB had admitted that it sold only one product that could test for COVID-19, the injunction was sufficiently specific for the company to be able to comply with the injunction. (Decision at 8–9.) The court also concluded that an immediate injunction was warranted in light of the urgent public interest in protecting public health during an ongoing pandemic. (Decision at 11.)

The Administrative Court of Uppsala went on to find that the prohibition of the sale of the product was lawful because, even though the tests at issue do not need to have preliminary approval before sale, they but must be CE-labeled and hold a certificate from a “designated agency” that the product meets the requirements for being sold on the Swedish market. (8 § 1 p LVFS 2001:7.) The court found that Zandcell AB had been unable to prove that the COVID-19 test kits met these requirements. (Decision at 12.) Thus, the sale of the COVID-19 test kits continues to be prohibited. (Decision at 13.)