1 Case T-301/12 Laboratoires CTRS v. European Commission, Judgment of the General Court (Fifth Chamber) of 4 July 2013.

2 Directive 2001/83/EC of the European Parliament and Council on the Community Code Relating to Medicinal Products for Human Use, OJ 2001 L 311/67, as amended.

3 Regulation (EC) No 726/2004 of the European Parliament and of the Council on the Community Procedures for the Authorisation and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency, OJ 2004 L 136/1, as amended.

4 Regulation (EU) No 182/2011 of the European Parliament and of the Council Laying Down the Rules and General Principles Concerning Mechanisms for Control by Member States of the Commission's Exercise of Implementing Powers OJ 2011 L 55/11.

5 Article 17(1) of the Treaty on the European Union (“TEU”).

6 Regulation (EC) No 141/2000 of the European Parliament and of the Council on Orphan Medicinal Products OJ 2000 L 18/1, as amended. The holder of the 2002 designation is now CTRS. See Commission Decision relating to the designation of medicinal product “Cholic acid” as an orphan medicinal product C(2002) 5453 of 18 December 2002. In 2009, the Commission designated again cholic acid as an orphan medicinal product but with slightly different indications. See Commission Decision C(2009)8521 of October 2009. The holder of this designation is now FGK Representative Service GmbH, which in effect acts as the representative of the U.S. company Asklepion Pharmaceuticals. Importantly, Special Products Ltd. was Asklepion Pharmaceuticals’ former licensee in Europe.

7 Case C-440/93 Scotia Pharmaceuticals Ltd, [19995] ECR I-12851, paras. 19–22.

8 These exceptional circumstances include: (i) indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence, (ii) in the present state of scientific knowledge, comprehensive information cannot be provided, or (iii) it would be contrary to generally accepted principles of medical ethics to collect such information.

9 Annex I – Reasons for the Decision to Refuse the Marketing Authorisation, accompanying a European Commission Proposal for a Commission Implementing Decision Refusing a Marketing Authorisation under Regulation (EC) 726/2004 of the European Parliament and Council for “Orphacol – Cholic Acid”, an Orphan Medicinal Product for Human Use, C (2013) 3306.

10 Case T-12/12 Laboratoires CTRS v. European Commission, Judgment of the General Court (Fifth Chamber) of 4 July 2012.

11 Compare Articles 5 and 6 of Regulation (EU) 182/2011 with Article 5 of the repealed Council Decision 1999/468/EC, which stated that “If within that period the Council has indicated by qualified majority that it opposes the proposal, the Commission shall re-examine it. It may submit an amended proposal to the Council, re-submit its proposal or present a legislative proposal on the basis of the Treaty.”

12 Case T-301/12 Laboratoires CTRS v. European Commission, Judgment of the General Court (Fifth Chamber) of 4 July 2013, para. 53.

13 Id., para 36. See C-185/10 Commission v. Poland, Judgment of the Court (Third Chamber) of 29 March 2012, para. 30.

14 Case T-301/12, para. 38.

15 Id., para. 39.

16 Id., para. 48.

17 Id., para. 49.

18 Id., para. 50.

19 Id., paras. 41 to 45.

20 Rapport sur les préparations pharmaceutiques à l’hôpital et à l’officine, available on the Internet at (http://www.ladocumentationfrancaise.fr/var/storage/rapports-publics/Q640005Q3/0Q0Q.pdf) (which states at page 2, “le code communautaire du médicament ignore la préparation hospitalière, mais traite ou évoque d’autres catégories de médicaments, dont les préparations magistrales et les préparations officinales,” and at page 30, “[l]’élargissement de la production des préparations hospitalières aux établissements pharmaceutiques des établissements de santé, au détriment des exigences du décret du 26 mai 1997, ne correspondait pas à des considérations de sante publique, mais à des demandes de ces établissements d’échapper aux procédures d’AMM [in English, “marketing autorisation application”] et d’ATU [ in English, “temporary authorisation of use”; this is the autorisation given in France since 2007 for the use of cholic acid in the relevant indication] . Il faut maintenant gérer ce regrettable état de fait, car il est sans doute inopportun de revenir dessus.”)

21 Case T-301/12, para. 65.

22 Id., paras. 68–69. Note that there is no “and” nor “or” between the two indents.

23 Regulation (EC) No. 190/2006 on Medicinal Products for Paediatric Use, OJ 2006 L 378/1.

24 Case C-185/10 European Commission v. Republic of Poland, Judgment of the Court (Third Chamber) of 29 March 2012, paras. 33–35.

25 Opinion of Advocate General Jääskinen in Case C-185/10 European Commission v. Republic of Poland of 29 September 2011, para. 34. In that case, however, the Court did seem to put some emphasis on individual products as it repeatedly referred to “individual situations,” “individual patients,” and “medicinal product.” See Case C-185/10 European Commission v. Republic of Poland, paras. 33–36.

26 Case T-301/12 Laboratoires CTRS v. European Commission, Judgment of the General Court (Fifth Chamber) of 4 July 2013, para. 36.

27 Case C-440/93 Scotia Pharmaceuticals Ltd, [1995] ECR I-2851; C- 127/95 Norbrook Laboratories Ltd v. Ministry of Agriculture, Fisheries and Food, [1998] I-01531, para 84.

28 Case T-301/12 Laboratoires CTRS v. European Commission, Judgment of the General Court (Fifth Chamber) of 4 July 2013, para. 70.

29 European Medicines Agency Decision P/191/2010 of 15 October 2010 on the Acceptance of a Modification of an Agreed Paediatric Investigation Plan for Cholic Acid (EMEA-000651-PIPO1-09-MO1) in accordance with Regulation (EC) No. 1901/2006 of the European Parliament and Council, EMA/478331/2010, available on the Internet at (http://www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500095066.pdf).

30 See the Opinion of Advocate General Sharpston in Case C- 535/11 Novartis Pharmaceuticals v. Apozyt GmbH of 31 January 2013, para. 11 (“The result [of the history of EU medicines legislation] has been that piecemeal changes have often been ‘bolted on’ to the existing legislation in a manner that has not always been entirely coherent.”).

31 It is noteworthy that in a recent case concerning the deliberate release of genetically modified organisms into the environment, the General Court warned that the Commission cannot keep delaying the comitology procedure. While in a different context and subject to the different procedure of regulatory procedure with scrutiny of Decision 1999/468/EC, the Court stated that “Commission cannot, in a dilatory manner, repeatedly request opinions from EFSA pending the arrival of new scientific data and thereby justify its failure to submit the proposal to the Council.” See Case T-164/10 Pioneer Hi-Bred International, Inc. v. European Commission, Judgment of the General Court (Seventh Chamber) of 26 September 2013, para. 71.