ECJ confirms "well-established use" medicine can serve as reference product

In a judgment of 23 October 2014, the EU Court of Justice (ECJ) confirms that a human medicinal product authorised under the "well-established use" (WEU) procedure of Article 10a of the Human Medicines Directive (2001/83) can be used as a reference product to issue a marketing authorisation (MA) for a generic version of it to another manufacturer. The ECJ also holds that EU law gives the holder of an MA for a reference product, including a WEU-approved product, the right to oppose the granting of an MA to another company for a generic version of the reference product.

The ECJ observes that the WEU procedure does not provide for a relaxation of the safety and efficacy requirements which must be met by every medicinal product in the EU, but simply reduces the preparation period for an MA application. The applicant is not required to submit the results of preclinical tests and clinical trials, but can instead demonstrate the product's safety and efficacy with scientific literature. The dossier for the WEU-approved product will thus contain all information and documents necessary to demonstrate safety and efficacy. In the Court's view, nothing therefore precludes a WEU-approved medicinal product from being used as a reference product for generic versions.

The Court further confirms that the holder of an MA for an original product has the right to challenge the decision of an authority to authorise a generic using the original product as a reference product. Although the Human Medicines Directive does not refer to such a right, the Court holds that the MA holder enjoys a fundamental right to an effective remedy which is laid down in Article 47 of the Charter of Fundamental Rights of the EU. This means that the MA holder of a reference product authorised under the abridged WEU procedure can oppose the authorisation and sale of a generic until the eight- and ten-year periods of data and marketing exclusivity have elapsed.

The ECJ's analysis and conclusions are entirely in line with the Opinion delivered by Advocate General Wahl in this case earlier this year (C-104/13, Olainfarm). For a detailed discussion of this Opinion, please see our June 2014 newsletter.

Please click on the links below for the other articles in the November 2014 EU life sciences and regulatory newsletter:

• Simplified authorisation procedure applies to double importation of plant protection products
• Advocate General explains Specific Mechanism for parallel imports of medicines
• ECJ concludes EU Commission respected the limits of its implementing powers
• EU General Court annuls ECHA decision imposing manifestly disproportionate administrative charge
• EU Commission interpretation of extended market exclusivity for non-patented orphan medicine cannot be challenged in court
• New actions before the EU Courts