Sandoz issues proceedings against the European Commission over "rejection" of Bio-generic drug

United Kingdom

Sandoz, the generic drugs arm of Switzerland's Novartis, has issued proceedings against the European Commission over its decision to block approval of its generic version of a biotechnology drug.

The drug in question, a generic human growth hormone named Omintrop, has the support of the Committee for Proprietary Medicinal Products (CPMP) which issued a favourable opinion in June 2003 and was recommended for approval by the European Agency for the Evaluation of Medicinal Products (EMEA).  However, whilst denying it has "rejected" the drug, the Commission has uncharacteristically chosen not to ratify the EMEA's decision, citing filing irregularities.  Sandoz issued proceedings against the Commission in November, with the hearing at first instance taking place on 14 January 2004.

The legal dispute will revolve around the interpretation of Article 10(1)(a)(ii) and Annex 1 of Directive 2001/83 on the Community Code relating to medicinal products for human use, which governs "bibliographical applications" for a marketing authorisation based on well-established medicinal use of the constituents of a drug.  The Commission decision not to proceed with the authorisation of Omnitrop appears to be based on the fact that the performance of "comparability studies" implied that the legal conditions for the application of the abridged procedure were not met.  The Commission relied on the rules established by the Scotia judgment, which stated that an authority has no discretion to issue a market authorisation where the particulars and documents submitted do not satisfy community law – in this instance do not contain detailed references to published scientific literature presented in accordance with the Directive.  However, a spokesman for Sandoz has stated: "We believe that what we have got and the way we have filed it is appropriate… that is why we have filed a complaint".

Accordingly, Sandoz has entered a single plea against the Commission for infringement of article 10(1)(a)(ii), which states "applicants will not be required to provide the results of toxicological and pharmacological tests or the results of clinical trials if he can demonstrate… that the constituents of the medicinal product have a well established medicinal use, with recognized efficacy and an acceptable level of safety, by means of a detailed scientific bibliography", and procedures for bibliographic referencing set out in Annex 1.  Within this plea, Sandoz argues that the rules established by the Scotia judgement have been reversed by the Commission's own legislation and that the Commission has publicly rejected this "extremely rigid approach" in favour of a "flexible" interpretation.  Furthermore, Annex 1 expressly requires the CPMP to make a judgement on whether two products are similar, and this would be expected to require the applicant to support its data with comparability studies.  Sandoz further argues that comparability studies are fully consistent with the objective of safeguarding health and do not represent any relaxation of health protection standards.

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