LUXEMBOURG (CN) — Just because one country has made a medication available without a prescription doesn’t mean it can be sold without one in another, the EU’s highest court ruled Thursday.
In a ruling that was not immediately available in English, the European Court of Justice found that Budapest was within its rights to order a pharmaceutical company to stop selling several medications without a prescription in Hungary, even though they could be sold over the counter in other European Union member states.
The case was referred to the Luxembourg-based court by the Budapest High Court after the Hungarian pharmaceutical company Pharma Expressz challenged a 2019 government order to stop selling medications without a prescription.
Under Hungarian medical regulations, medicines that do not have an authorization issued by the Hungarian authorities or by the European Commission, the EU's executive branch, can only be sold with a prescription from a doctor. Pharma Expressz had been importing drugs from other EU countries, where they were available without a prescription, and selling them online directly to consumers.
Pharma Expressz contested the Hungarian government’s demand that the company stop selling the drugs, arguing the order is unduly restrictive and violated the bloc’s internal market rules that allow for the free movement of goods and services.
The Court of Justice said that according to EU regulations that govern medicinal products within the 27 member states, no medication can be sold in a country without approval from the relevant authorities
"Pursuant to the ‘Medicines Directive’, no medicinal product may be placed on the market of a Member State unless an MA [marketing authorization] has been issued by the competent authorities of that Member State or, under the centralized procedure established to that end, by the Commission," an English press release from the court states.
It adds, "Therefore, if a medicinal product does not have an MA issued by the competent authorities of the Member State in which it is offered for sale or an MA issued following the centralized procedure, it may not be placed on the market in that State, regardless of whether that same medicinal product may be sold in another Member State without a medical prescription."
However, the court did note that in some special cases, exemptions can be made. In the present case, however, there was no special need that would require such an exception.
The European Medicines Agency is responsible for drug approval in the EU, but approval from the organization doesn’t mean a medication is automatically available in every member state. Countries still have a say in what is available within their borders and drug makers still must get approval from national health bodies for medication to be included as part of national health insurance schemes.
Follow @mollyquell
Subscribe to Closing Arguments
Sign up for new weekly newsletter Closing Arguments to get the latest about ongoing trials, major litigation and hot cases and rulings in courthouses around the U.S. and the world.
Additional Reads
-
Denmark aims to rebuild historic stock exchange after blaze April 24, 2024 -
