The complaint to the European Commission

1. On 30 June 2015, the complainant, a retail pharmacist, submitted a complaint to the European Commission, claiming that the Belgian Act amending the law on medicinal products[1] (‘the Belgian Act’) was incompatible with EU law. He contended that by allowing holders of an “authorisation of preparation” to prepare medicinal products, the Act breached the exclusive right of pharmacists to prepare the same products in a pharmacy. He argued that pharmacists and the pharmaceutical industry are subject to a much stricter regulation than the holders of an “authorisation of preparation”. In particular, he argued that the Act breached the scope of Articles 2[2] and 3[3] of Directive 2001/83/EC[4], and the quality and safety assurance requirements for medicinal products prepared in pharmacies. Directive 2001/83/EC, which provides for a market authorisation for industrially produced medicinal products, excludes from its scope of application medicinal products prepared by pharmacists on the basis of (i) a doctor’s prescription (the magistral formula) or (ii) prescriptions of a pharmacopeia (the official formula) and sold directly to their customers.

2. On 8 July 2015, the complainant informed the Commission that the Belgian Constitutional Court had rejected his action for annulment of the relevant provisions of the Belgian Act[5]. He stated that the Court had held that the Belgian Act did not restrict the right of pharmacists to prepare medicinal products themselves.

The European Commission’s response to the complainant

3. On 31 May 2017, the Commission informed the complainant that it intended to close his infringement complaint. It considered that the Belgian Act did not breach Article 3 (1) and (2) of Directive 2001/83/EC. These provisions made it clear that medicinal products “prepared in a pharmacy” do not fall under the scope of the Directive and thus do not require a market authorisation if they are prepared according to the magistral and official formulas.

4. The Commission stated that the complainant had not provided any evidence to support his argument that the Belgian Act would breach the strict regulation and the quality and safety assurance requirements for medicinal products prepared in pharmacies. It noted that the conditions set out in the Belgian Act for the grant of an “authorisation of preparation” of medicinal products prepared outside of the pharmacy also aim to ensure the quality, safety and traceability of such products.

5. Regarding the application of Article 3 (1) and (2) of Directive 2001/83/EC[6], the Commission stated that the complainant had not provided any information that would show that medicinal products prepared outside of a pharmacy by holders of an “authorisation of preparation” do not comply with the magistral or official formula, and therefore should require a market authorisation for placing on the market.

6. The Commission further noted that the complainant had referred to only one individual case in which the Belgian Federal Agency for Medicines and Health Products (FAGG) decided to grant an “authorisation of preparation” to a pharmaceutical company. However, the Commission would have to prove that the failure of the Member State to correctly implement or enforce EU law at administrative level is of a systematic and persistent nature. The Commission could not review individual decisions of authorities of EU Member States, but only check whether the general administrative practice in the Member State concerned complies with EU law, and whether EU law is correctly applied. The Commission therefore referred the complainant to the national institutions, including the relevant administrative tribunals that can review the decisions by the relevant regulatory authorities.

7. On 27 June 2017, the complainant replied to the Commission, expressing his dissatisfaction with the Commission’s decision to close his complaint, emphasising that the “authorisation of preparation” meant that external laboratories, outside of the pharmacy could prepare medicinal products. In that regard, he provided an example of two medical prescriptions from 2010 for hand creams that were magistrally prepared in advance but then offered for sale via pharmaceutical wholesalers. According to the complainant, that practice amounted to commerce, and was thus in breach of Article 3 of Directive 2001/83/EC. He contended that the FAGG could in the future grant such “authorisations of preparation” to other companies as well.

8. On 18 September 2017, the Commission informed the complainant that in accordance with its Communication, “EU Law: Better Results through Better Application” (hereafter: ‘Communication’), his case should he dealt at national level since there was insufficient evidence of a general practice of a problem of compliance of national legislation with EU law or of a systematic failure to comply with EU law[7]. The complainant had mentioned only one case in which the FAGG had allegedly misapplied EU law, and there was nothing to support his argument that there could be in the future similar cases of non-compliance with Article 3 of Directive 2001/83/EC.

9. On 3 and 18 October 2017, the complainant reiterated his concerns to the Commission and expressed his disagreement with the Commission’s practice to investigate only cases of systematic and persistent breach of EU law.

10. On 20 November 2017, the Commission replied to the complainant, confirming its earlier analysis and conclusions. It apologised for the time it had taken in handling his complaint, and assured him that it had carried out a thorough assessment.

11. The complainant was not satisfied with the Commission’s response and turned to the Ombudsman on 2 January 2018, arguing that the Commission had failed to correctly deal with his infringement complaint. He argued that the Commission had deliberately waited for the publication of its Communication in January 2017, before replying to him. He also complained that the Commission did not inform him about the delays in handling his complaint, contrary to its own rules. He added that case Novartis v Apozyt [8] of the Court of Justice showed that his complaint raised issues of EU-wide interest.

The European Ombudsman's findings

12. The EU Treaties confer an obligation on the Commission to oversee the application of EU law by Member States. This includes ensuring that Member States transpose and apply EU law correctly[9]. According to the settled case law of the Court of Justice, the Commission has a wide margin of discretion in deciding whether to open an infringement procedure against a Member State^[10]. The Ombudsman should not interfere with the exercise by the Commission of its discretion as long as the Commission acts within the boundaries of its legal authority. However, as a matter of good administration, the Ombudsman can check whether the Commission has explained properly how and why it has exercised its discretion.

13. In this case, the Commission did not consider that the new Belgian Act breached Article 3 (1) and (2) of Directive 2001/83/EC. It found that the complainant had not provided any evidence to substantiate his argument that the Belgian Act breached the strict rules on the quality and safety assurance requirements for medicinal products prepared in pharmacies. The Commission also pointed out that the Belgian Act sets out conditions to ensure the quality, safety and traceability of medicinal products prepared outside of the pharmacy by a holder of an “authorisation of preparation”. The complainant did not contest the Commission’s reply.

14. What the complainant did was to refer to one example where the Belgian competent authorities, the FAGG, had granted an “authorisation of preparation” to a company which allegedly sold its medicinal preparations not to the customers of a pharmacy, but to other wholesalers, in breach of Article 3 (1) and (2) of Directive 2001/83/EC.

15. It is settled case law that in order for the Commission to launch infringement proceedings, the administrative practice of national authorities that runs counter to EU law must be consistent and general in nature[11]. The Ombudsman notes that the Commission explained to the complainant that based on the information he had provided, there had not been in this case any established or systematic malpractice by the FAGG that would be in breach of Article 3(1) and (2) of Directive 2001/83/EC. In that regard, the Commission’s reference to its recent Communication and the discretion it enjoys in deciding to initiate infringement proceedings against Member States is in line not only with its previous practice, but also with the relevant case law on the matter. In that sense, the complainant’s arguments that the Commission waited first to publish its Communication and then reject his complaint is not founded.

16. The Ombudsman also takes into account the fact that the Belgian Constitutional Court has already rejected the complainant’s action for annulment of the Belgian Act. Like the Commission, the Constitutional Court also held that the rules on the grant of “authorisations of preparations” ensure that the processes carried out by holders of such authorisations still have to comply with quality and safety norms. According to the Constitutional Court, the provisions of the new Act are not disproportionate since pharmacists still have the right to prepare themselves medicinal preparations for patients served by them.

17. Therefore, the Ombudsman considers that the Commission’s explanations to the complainant are reasonable, adequate and in line with its discretionary powers.

18. Furthermore, regarding the time taken by the Commission to reply to the complainant, the Ombudsman notes that while individuals have no right to require the Commission to adopt a particular position regarding an infringement complaint[12], they are entitled to expect that the Commission will act diligently and in accordance with the principles of good administration in whatever decisions it takes. In this context, the Ombudsman agrees with the complainant that it would have constituted good administrative practice for the Commission to inform him that the treatment of his complaint would take more than one year[13]. However, since the Commission has apologised for not doing so and for the time taken to deal with his complaint and has closed the infringement complaint, the Ombudsman does not consider that further inquiries are justified into this matter.

19. Based on the information provided by the complainant, the Ombudsman finds no maladministration in this case.[14]

 

Lambros Papadias

Head of Inquiries - Unit 3

Strasbourg, 19/12/2018

 

[1] That is, Articles 42 to 46 of the Belgian Programme Act (I) of 26 December 2013 amending Articles 6ter, §1, first indent, 12bis, 12ter, §1, and 13bis, §1 of the Belgian Act on medicinal products of 25 March 1964, available at: http://www.ejustice.just.fgov.be/cgi_loi/change_lg.pl?language=fr&la=F&cn=2013122609&table_name=loi (French version) and http://www.ejustice.just.fgov.be/cgi_loi/change_lg.pl?language=nl&la=N&cn=2013122609&table_name=wet (Dutch version).

[2] “The provisions of this Directive shall apply to industrially produced medicinal products for human use intended to be placed on the market in Member States.”

[3] “This Directive shall not apply to:

1. Any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient (commonly known as the magistral formula).

2. Any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question (commonly known as the official formula). (...)”

[4] Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ 2001 L 311, p. 67.

[5] See judgment of the Belgian Constitutional Court of 28 May 2015, judgment number 78/2015, roll number 5915, available at: http://www.const-court.be/.

[6] It stated that the Court ruled that the exception of Article 3(1) only applies to medicinal products that are prepared in accordance with a medical prescription issued before their preparation, which must be specifically for a previous identified patient. The exception of Article 3(2) only applies to medicinal products that are supplied directly to the patients of the pharmacy that has prepared them. See judgment of the Court of Justice of 16 July 2015, Abcur AB v Apoteket Farmaci AB and Apoteket AB and Apoteket Farmaci AB, Joined Cases C-544/13 and C-545/13, ECLI:EU:C:2015:481, paragraphs 54, 58-67.

[7] Communication from the Commission, EU Law: Better Results through Better Application, C(2016) 8600, 21.12.2016, p. 10.

[8] Judgment of the Court of Justice of 11 April 2013, Novartis v Apozyt, C-535/11, ECLI:EU:C:2013:226. The complainant referred to paragraph 53 of the judgment, in which the Court states regarding Article 40(2) of Directive 2001/83/EC: “It will thus fall to the referring court to ascertain, in particular, on the one hand, whether Apozyt is ‘legally authorised’ in Germany to carry out such processes and, on the other, whether those activities are in fact included within a system for the retail supply of medicinal products by pharmacies. On the latter point, the referring court will in particular have to determine whether the processes in question are carried out only on the basis of individual prescriptions that call for them to be carried out.”

[9] Article 17(1) of the Treaty on the European Union and Article 258 of the Treaty on the Functioning of the European Union.

[10] See judgment of the Court of Justice of 14 February 1989, Star Fruit v Commission, C-247/87, ECLI:EU:C:1989:58, paragraph 11.

[11] See judgment of the Court of Justice of 12 May 2005, Commission v Belgium, C-287/03, ECLI:EU:C:2005:282, paragraph 29.

[12] Judgment of the Court of Justice in Star Fruit v Commission, cited above, ECLI:EU:C:1989:58, paragraph 11.

[13] In accordance with point 8 of the Annex Administrative procedures for the handling of relations with the complainant regarding the application of European Union law to its Communication C(2016)8600, which applied since the beginning of 2017.

[14] This complaint has been dealt with under delegated case handling, in accordance with Article 11 of the Decision of the European Ombudsman adopting Implementing Provisions