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| Author | International Law Group |
On April 1, the European Court of Justice (ECJ) held that German regulations that barred imports of certain lower cost medicines from the southern Member States conflicted with EU law on the free movement of goods within the Union. The case began in 1994 when Kohlpharma GmbH unsuccessfully sought permission from Germany's medical agency to import from Italy a medication called Jumex at discount prices. The agency had declared that Jumex - used to treat Parkinson's Disease -- failed to qualify under German safety criteria. Kohlpharma went to court, contending that the agency had already cleared essentially the same drug from Finland. The big pharmaceutical companies claim the loss of about $5 billion from what is called the "parallel trading" of drugs from Members whose governments set lower prices. The exact ruling of the ECJ is: "In the case where an application for a marketing authorisation for a medicinal product is submitted with reference to a medicinal product that has already been authorised, the medicinal product which is the subject of the application is imported from a Member State in which it has obtained a marketing authorisation, the assessment of safety and efficacy carried out for the medicinal product which is already authorised can be used in the application for a marketing authorisation for the second medicinal product without any risk to public health ..." - A similar dispute is warming up in North America, where the U.S. government claims that safety factors justify the restriction on the importation of cheaper drugs from Canada and other countries.
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Citation: Judgment of the Court (Sixth Chamber) ... In Case C-112/02 ... between Kohlpharma GmbH and Bundesrepublik Deutschland [Federal Republic of Germany]; The Associated Press (online), Brussels, Thursday, April 1, 2004, at 14:25:05 GMT.
On March 9, the U.K. announced its conditional permission for the commercial planting of genetically modified (GM) maize. The Environment Secretary reported to Parliament that the government would consent "in principle" to this herbicide-tolerant maize but did not expect any to be grown for at least twelve months. In her view, there was no scientific case either for approving all the uses of GM or for a blanket ban on it. The Secretary also noted that three years of U.K. trials of gene-altered, herbicide-resistant crops showed that Bayer of Germany's T25/Chardon LL maize, a form of cattle feed, turned out better than sugar beets and rapeseed. The U.S. is the world's major producer of gene crops and has been intensively lobbying the EU to terminate its five-year ban on GM imports. It has also been trying to persuade the...
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