The company Chiesi Farmaceutici SpA ('Chiesi') produces and markets a medicinal product Jumex in Italy under an Italian marketing authorisation. That medicinal product is manufactured from the active ingredient selegiline hydrochloride. The company Orion Pharma GmbH ('Orion') produces and markets the medicinal product Movergan in Germany under a German marketing authorisation. Movergan is manufactured using the same active ingredient as that in Jumex.
The active ingredient used by Chiesi and Orion is supplied by Chinoin Pharmaceutical and Chemical Works Co. Ltd ('Chinoin'), established in Hungary. While Chiesi has a licensing agreement with Chinoin, Orion receives its supplies, either directly or through Finland, under a supply agreement between Chinoin and Orion Corp. Finland.
Kohlpharma applied to the Bundesinstitut fur Arzneimittel und Medizinprodukte (Federal Institute for Medicinal Products, the 'Bundesinstitut') for marketing authorisation for the medicinal product Jumex, for the purpose of importing it into Germany. It referred to the medicinal product Movergan, which is already authorised in Germany, and requested that the marketing authorisation for that medicinal product be extended to Jumex.
The Bundesinstitut rejected that application, citing the judgment in Case C-201/94 Smith & Nephew and Primecrown [1996] ECR I-5819. That judgment, the Bundesinstitut argued, established that the extension to an imported medicinal product of a marketing authorisation already issued to another medicinal product in the state of importation is subject to the condition that the two medicinal products have a common origin, i.e. that their manufacturers are part of the same group of undertakings or, at the very least, that they produce those medicinal products under agreements with the same licensor.
Kohlpharma appealed against that rejection decision, arguing that the medicinal product to be imported and that already authorised in the Member State of importation could not be required to have a common origin. In the case law relating to parallel imports, it submitted, the ECJ did not establish the condition of identity of origin as a binding principle but merely took it into account, since the conditions of identity of products and of origin were in fact both satisfied in the cases which had been referred to it.
The German national court referred the matter to the ECJ for a preliminary ruling on this point.
The ECJ took as a basis the premise that, for the purposes of assessing their safety and efficacy, the two medicinal products in question did not differ significantly.
The question was therefore whether, if the assessment carried out on the safety and efficacy of the medicinal product that was already authorised could be applied to the second product without any risk to the protection of public health, Articles 28 and 30 EC precluded the competent authorities from refusing to grant marketing authorisation to the second medicinal product with reference to the first solely on the ground that the two medicinal products did not have a common origin.
The ECJ considered that it is for the competent national authorities, before they issue a marketing authorisation, to ensure that the primary objective of Community legislation, namely the safeguarding of public health, is fully complied with. If this is the case, then the second medicinal product cannot be refused a marketing authorisation on the grounds of protecting public health if that refusal is based solely on the fact that the two medicinal products do not have the same origin.
In such a situation, the problem confronting the competent authorities as regards marketing authorisations for medicinal products is whether, as was claimed by the applicant for marketing authorisation, the safety and efficacy assessment carried out for the medicinal product which has already been authorised can be applied to the application for marketing authorisation from the second medicinal product without any risk to the protection of public health. Therefore the common origin of two medicinal products may constitute an important element in establishing that such is the case. However, the absence of common origin does not in itself constitute a ground for refusing marketing authorisation to the second product.
In the circumstances outlined above, the applicant for the second medicinal product may, for the purpose of assessing its safety and efficacy, demonstrate by means of available or accessible information that the medicinal product to be imported does not differ significantly from the medicinal product which is already authorised.
Comment
The outcome of the Kohlpharma case has been awaited with a considerable amount of interest, following the publication of the Advocate General's opinion in September 2003. Unsurprisingly, the ECJ has followed that opinion and concluded that a lack of common origin by itself where the products are not significantly different will not prevent the authorisation of the parallel import.
This decision has the effect of increasing the opportunities for parallel imports in that there is no longer a requirement for any link between the products, other than that they are sufficiently similar to satisfy the criteria set down in earlier cases. Common origin will remain a relevant but not conclusive factor in determining the criteria of similarity, but a lack of common origin will no longer be a bar to authorisation of the second product.
The effect of this will be to blur further the distinction between generic products and parallel imports. If the common origin link is removed, it is possible that producers of generic products will seek registration of those products as parallel imports, needing only to demonstrate a marketing authorisation in the Member State of export and an appropriate level of similarity to a reference product in the Member State of import. No doubt, we can expect to see more clarification of these issues in future cases.
For further details please contact Zelda Pickup at zelda.pickup@cms-cmck.com or on +44 (0) 207 367 2043 or David Marks at david.marks@cms-cmck.com or on +44 (0) 207 367 2136.
