Longevity clinics in Europe

How is longevity medicine regulated across Europe?

Europe has a supranational layer for products and none for clinics. The European Union authorizes advanced therapies centrally and governs diagnostic tests through a regulation that applies directly in every member state, while the founding treaty reserves the licensing and organization of health services to each country. A longevity clinic in Europe is therefore licensed nationally, and there is no European clinic category.

An advanced therapy medicinal product, the class that covers stem cell, gene and engineered tissue therapies, needs a single European marketing authorization granted centrally. It cannot be authorized market by market. Article 28 of the same regulation carves out products prepared on a non-routine basis and used inside one member state's hospital system, and each member state writes that carve-out into its own law, so the exemption's scope differs from country to country.

European Parliament and Council; European Medicines Agency, Regulation (EC) No 1394/2007 on advanced therapy medicinal products, applicable from December 30, 2008. Primary source .

In vitro diagnostic tests, the class most longevity blood panels and biomarker assays fall in, are governed by one regulation that applies directly in every member state with no national transposition. Article 5(5) exempts a test that a health institution makes and uses in house, on conditions that include an accredited quality system and a documented finding that no equivalent test is available on the market.

European Parliament and Council, Regulation (EU) 2017/746, the In Vitro Diagnostic Regulation, applicable from May 26, 2022. Primary source .

There is no European clinic license and no European longevity facility category. The founding treaty requires Union action to respect each member state's responsibility for the definition of its health policy and for the organization and delivery of health services and medical care. Authorization to open and operate a clinic is granted under national law, and it differs from one country to the next.

European Union, Treaty on the Functioning of the European Union, article 168(7), in force December 1, 2009. Primary source .

High confidence. Both regulations and the treaty article are read from EUR-Lex, and each of the three facts is the text of the instrument rather than a characterization of it.

This is the European Union layer only. Several of the countries the Atlas maps in Europe sit outside the Union: the United Kingdom, Switzerland, Norway and Iceland. How much of this law reaches them, through the European Economic Area or through any other route, was not checked in this pass. Each of those markets is governed by its own national regime, and where one has been researched it is carried on that country's page.

For how individual markets in Europe compare, see Longevity Clinic Regulation, Market by Market .