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General Court distinguishes “active substance” from “medicinal product”


The General Court of the European Union has delivered judgment in Case T‑80/16 Shire Pharmaceuticals Ireland Ltd v European Medicines Agency in which it provides important guidance as to the approach which ought to be taken by the European Medicines Agency ("EMA") in respect of applications for designation as an “orphan medicinal product” pursuant to the terms of Regulation (EC) No 141/2000 (the "Orphan Regulation"). The Orphan Regulation provides a series of incentives designed to foster the research and development of medicinal products intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect no more than 5 in 10,000 people in the European Union.

At issue was the EMA’s refusal to validate an application for orphan designation relating to a new medicinal product intended for the treatment of MPS II, an extremely rare, life-threatening disease that mainly affects male children and young adults, drastically shortening their lives. 

The Applicant, Shire Pharmaceuticals Ireland Limited ("Shire”) currently markets another orphan medicinal product (Elaprase) for the treatment of patients with MPS II.  Shire’s application in respect of the new product was based on the premise that it would be of significant benefit in the treatment of MPS II compared to existing treatments, including Elaprase. This is because while Elaprase contains the same active ingredient as the new product, the active ingredient is unable to cross the blood-brain barrier and reach a therapeutic level in the brain. The consequence is that Elaprase cannot be used to treat the cognitive disease from which many patients with MPS II also suffer. By contrast, the new product is able to reach therapeutic level in the brain, and therefore offers a treatment for cognitive disease in MPS II where previously there was none.

The General Court concluded that the EMA’s refusal to validate the application in respect of the new product was unlawful. In particular, it held that the EMA could not refuse to validate the application for the new product on the basis that Shire had obtained an earlier marketing authorisation for Elaprase. The Court held that it was properly the task of the specialist Committee on Orphan Medicinal Products to assess whether the characteristics of the new product are likely to be of “significant benefit” to patients suffering from the condition at issue, taking into account the relevant scientific evidence, in accordance with the terms of the Orphan Regulation.

The judgment can be viewed here.

David Anderson QC and Malcolm Birdling appeared for the Applicant, instructed by Covington & Burling LLP.