In Brief

Sweden: Country of Origin Principle Applies to On-line Marketing of Medicines

In December 2008, the Supreme Court of Sweden (Högsta domstolen) passed a judgment on a criminal case involving unlawful distribution and on-line marketing of medicines. The fundamental legal issue the Court discussed was whether the Swedish Medicinal Products Trading Act should be applied in accordance with the principle of country-of-origin or not.
The defendants had acquired and distributed medicines in EC countries but not in Sweden, where only the on-line marketing of these medications had taken place. Nevertheless, the Court held it had jurisdiction over the defendants’ operation in its entirety and found them guilty of breaking the Act.

In its reasoning, the Court first stated that the European Court of Justice (ECJ) had not considered import restrictions on medicinal products to be against Section 30 of the EC Treaty. Next, the Court set to establish whether the marketing of medicines was covered by regulation in the country it took place in or by the regulation in the countries it was directed to. These two principles of Community law, between which the Court had to choose, are termed the principle of country of origin and country of reception respectively.

To justify its decision, the Court referred to the Directive on electronic commerce (2000/31/EC), which affirmed the same principle, even though the Directive did not apply to marketing of medicines. Furthermore, a Resolution by the Committee of Ministers on the distribution of medicines by mail was grounded on the country of origin principle, too.

While granting that the scope of application of consumer law was traditionally seen to be territorially limited, the Court did not see any reason why Swedish law should only protect Swedish consumers of medicines. The Court further argued that the country of origin was much more capable of preventing illegal marketing of medicines than individual countries their marketing was directed to. Thus, the Court held that the regulation of the country of origin was applicable. (VS)

The judgment of the Supreme Court of Sweden on 5 December 2008,
case No B 3064-08:

”Resolution ResAP(2007)2 on good practices for distributing medicines via mail order which protect patient safety and the quality of the delivered medicine”:
(Adopted by the Committee of Ministers on 5 September 2007 at the 1003rd meeting of the Ministers’ Deputies [Council of Europe)