Judgment_paragraph 76 · Medac Gesellschaft für klinische Spezialpräparate mbH v European Commission (T-549/19)

76In that regard, it must be emphasised that the EU legislature attaches particular importance to the availability of medicinal products for paediatric use in the European Union. To that end, it adopted Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation No 726/2004 (OJ 2006 L 378, p. 1) which seeks, as is clear from recital 4 thereof, first, to facilitate the development and accessibility of medicinal products for use in the paediatric population, second, to ensure that medicinal products used to treat the paediatric population are subject to research of high quality, in accordance with ethical rules, and are appropriately authorised for use in the paediatric population, and, third, to improve the information available on the use of medicinal products in the various paediatric populations. In order to achieve those aims, Regulation No 1901/2006 provides a mechanism for compelling pharmaceutical companies to envisage as a matter of course the possibility of the paediatric use of the medicinal products that they develop (judgment of 14 December 2011, Nycomed Danmark v EMA, T‑52/09, EU:T:2011:738, paragraph 43). It follows that the information concerning the paediatric populations contained in the SmPCs of the medicinal products which are being compared is of particular importance, including in the analysis of whether a ‘satisfactory method’ exists within the meaning of Article 3(1)(b) of Regulation No 141/2000.

Medac Gesellschaft für klinische Spezialpräparate mbH v European Commission (T-549/19)

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