Legislation and supervision

Directive 2002/98/EC of the European Parliament and the Council of 27 January 2003, setting out standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC, is known as the Blood Directive. This directive seeks to harmonise the quality requirements for legislation and practices regarding blood services in the European Union member states.

As its name suggests, the Blood Directive addresses issues related to the safety of blood products. It issues guidance on blood donors, blood donation, the production and conservation of blood products, as well as on their distribution to hospitals. The directive also provides for the tracking of blood products from the donor to the patient and vice versa and for the quality requirements and safety standards set for blood services.

The European Commission has set up a regulatory committee of experts representing the member countries, tasked with ensuring, with the aid of directives issued by the Commission, that the detailed regulations on blood services remain up to date and that they take account of the most recent research and technology.

The Blood Services Act (197/2005) is available for reading in the Finlex Data Bank on the Finlex website. The Blood Service Decree (258/2006) is also available on the Finlex website.

In Finland, Blood Service is supervised by the Finnish Medicines Agency Fimea.

In June 2024, the EU approved a new regulation that will replace the current Blood  Directive. The goal of the SOHO regulation (substance of human origin) is to protect human health within the EU and it addresses the quality and safety of all human-derived products. The regulation has been given a three-year transition period and thus it will be implemented in Finland in 2027.