De verkoop van medicijnen in de interne markt - achtergronden (en)

The European Commission has published a Communication clarifying how the principle of free movement of goods within the EU applies in practice to parallel imports of medicinal products. Parallel imports are products imported into one Member State from another and placed on the market in the destination Member State, outside the manufacturer's or its licensed distributor's formal channels. In the case of medicines, such imports are allowed if the product imported is identical or sufficiently similar to one already authorised for sale in the Member State of destination. Aiming to help businesses and national administrations take full advantage of the Internal Market in medicinal products, the Communication covers the rights and obligations of the parties concerned and the guarantees to which they are entitled according to EU law.

Internal Market Commissioner Frits Bolkestein said: "This Communication makes clear to national administrators the conditions under which parallel imports of medicinal products must be allowed and to those marketing medicinal products how they must proceed if they wish to undertake such parallel imports. The ultimate aim is to ensure patients and healthcare providers can benefit from parallel imports, without taking any risks with patient safety."

Parallel importing of a medicinal product is a lawful form of trade within the Internal Market under EC Treaty rules on the free movement of goods (Article 28), subject to the exceptions regarding the protection of human health and life and the protection of industrial and commercial property (Article 30 of the EC Treaty).

The Commission's Communication updates a 1982 Communication on the same subject. It provides a comprehensive reference to recent judgements of the European Court of Justice.

Since the 1982 Communication, the Court has addressed many issues regarding parallel imports of medicinal products. In particular it has confirmed that Member State authorities should grant licences to market parallel-imported medicinal products on the basis of a simplified procedure relative for example to that applied to new medicines being marketed in the EU for the first time - when the information necessary for the purpose of protecting public health is already available to them.

This is the case when the product in question is already authorised for sale in the Member State from which it is to be exported and is sufficiently similar to a product (known as the "reference product") authorised in the Member State of destination. Parallel importing of a medicinal product is still possible even when the authorisation for the reference product has been withdrawn and the parallel import licence may not be revoked unless such a measure is justified by reasons relating to the protection of public health.

A further development that has significantly contributed to legal certainty and thus to the smooth functioning of the Internal Market, is the series of rulings delivered by the Court regarding repackaging of a product imported in parallel. The Court has clarified that the protection of a trade mark is not without limits, noting in particular that it may not contribute to the artificial partitioning of the Internal Market. Therefore, the parallel importer may repackage a proprietary medicinal product and reaffix the trade mark or indeed replace it with the trade-mark used in the market of destination, provided that repackaging does not adversely affect the original condition of the product or the reputation of the trade mark and its owner. Further conditions confirmed by the Court are that the new packaging states by whom the product has been repackaged and that the trade mark proprietor receives notice before the repackaged product is put on sale.

The full text of the Communication is available at:

http://www.europa.eu.int/comm/internal_market/en/goods/art2830.htm

See also MEMO/04/7.