Keywords
Summary

Keywords

Free movement of goods – Quantitative restrictions – Measures having equivalent effect – National rules prohibiting the importation of blood products provided from donations that were not entirely unpaid – Justification – Protection of public health – Unlawful

(Arts 28 EC and 30 EC; European Parliament and Council Directive 2002/98, Arts 20(1), and 21)

Summary

Article 28 EC, read in conjunction with Article 30 EC, must be interpreted as precluding national legislation that provides that the importation of blood or blood components from another Member State is permitted only on the condition, which is also applicable to national products, that the donations of blood on which those products are based were made not only without any payment being made to the donors but also without any reimbursement of the costs incurred by them in connection with those donations.

Such legislation which has the aim, first, of ensuring that blood and blood components marketed in the Member State at issue satisfy the criteria of high quality and safety and, second, of attaining the objective enshrined in Article 20(1) of Directive 2002/98 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, that is, encouraging voluntary and unpaid blood donations, addresses human health concerns such as those acknowledged in Article 30 EC. Therefore, those objectives are, in principle, capable of justifying a restriction of the free movement of goods.

However, considered in isolation, the obligation that the blood donation should have been made without any of the costs incurred by the donor having been reimbursed is not necessary in order to ensure the quality and safety of the blood and the blood components. That conclusion is supported by the fact that neither Directive 2002/98 nor Recommendation No R (95) 14 of the Committee of Ministers to the Member States of the Council of Europe, to which that directive refers, requires donations to be completely unpaid but provide that small tokens, refreshments and reimbursements of travel costs connected with the donation are compatible with voluntary, non-remunerated donation, with the result that those elements cannot be considered as liable to compromise the quality and safety of those donations or the protection of human health.

Such legislation therefore goes beyond what is necessary to attain the objective pursued, that is, to ensure the quality and safety of the blood and of the blood components.

(see paras 33, 43-46, operative part)