Apotheke B. (harmaceutical and cosmetic products - Medicinal products for human use - Wholesale distribution of medicinal products - Opinion) [2023] EUECJ C-47/22

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(Request for a preliminary ruling from the Bundesverwaltungsgericht (Federal Administrative Court, Austria))

(Reference for a preliminary ruling – Pharmaceutical and cosmetic products – Medicinal products for human use – Directive 2001/83/EC – Articles 77, 79 and 80 – Wholesale distribution of medicinal products – Authorisation to engage in activity as a wholesaler in medicinal products – Revocation or suspension of the authorisation)

1. In the present case, the Court has been askedby the Bundesverwaltungsgericht (Federal Administrative Court, Austria) to give a preliminary ruling. The third question referred – on which, at the Court’s request, this Opinion focuses – concerns in particular the interpretation of Articles 77, 79 and 80 of Directive 2001/83/EC, (2) as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 (3) (‘Directive 2011/83’).

2. Articles 77, 79, 80 and 118a of Directive 2001/83 are relevant to the present case.

3. Under Paragraph 62(1) of the Arzneimittelgesetz (Law on medicinal products) of 2 March 1983 (‘the AMG’), entitled ‘Operating rules’:

‘In so far as this is necessary in order to guarantee the quality of medicinal products or active substances necessary for the health and life of humans or animals and the supply of medicinal products or active substances, the Federal Minister for Health is required to lay down, by means of a regulation, operating rules for establishments which manufacture, control or place on the market medicinal products or active substances.’

‘In the establishments referred to in Paragraph 62(1), the manufacture, placing on the market and control of medicinal products or medicinal products and active substances shall be subject to an authorisation issued by the Federal Office for Safety in Healthcare.’

‘The authorisation referred to in Paragraph 63(1) or Paragraph 65(1) shall be revoked if it subsequently transpires that the conditions were not met. It must be revoked if the conditions are no longer met. Revocation may be replaced by the total or partial suspension of the authorisation if the holder of the operating authorisation is able to remedy the cause of the revocation within a reasonable period. The Federal Office for Safety in Healthcare must immediately inform the other parties to the Agreement on the European Economic Area, Switzerland and the Commission thereof.’

Facts of the dispute, the procedure in the main proceedings and the questions referred for a preliminary ruling

6. Apotheke B. (‘the appellant’) is a limited partnership established in Austria which operates a pharmacy and also holds an authorisation to engage in activity as a wholesaler in medicinal products granted in accordance with the AMG.

7. Following an inspection carried out at the appellant’s premises on 30 July 2020 and a subsequent investigation, the Bundesamt für Sicherheit im Gesundheitswesen (Federal Office for Safety in Healthcare, Austria; ‘the respondent Office’) adopted, on 8 March 2021, a decision revoking the authorisation to engage in activity as a wholesaler in medicinal products previously granted to the appellant.

8. More specifically, the respondent Office made its decision after finding that the appellant had on several occasions purchased medicinal products from other pharmacies which did not hold a wholesale distribution authorisation under the AMG and then resold them to wholesalers which did hold such authorisation.

9. The respondent Office also noted that the appellant did not have sufficient specialised and qualified staff, as the only person present during the inspection was not able to provide the relevant documents required by national law.

10. The appellant lodged an appeal against that decision before the Bundesverwaltungsgericht (Federal Administrative Court).

11. In support of its appeal, it submits, first, that the fact that it purchased medicinal products from persons who do not hold a wholesale distribution authorisation does not specifically jeopardise the safety of those medicinal products. Secondly, it takes the view that the national legislation requires only one competent person to be present in the establishment, that person not being required to remain there continuously.

12. In those circumstances, the Bundesverwaltungsgericht (Federal Administrative Court) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1) (a) Must Article 80(b) of Directive 2001/83 be interpreted as meaning that the requirement deriving from that provision is fulfilled even where, as in the main proceedings, a holder of distribution authorisation obtains medicinal products from other persons who are also authorised or entitled to supply medicinal products to the public under national law but who are not themselves in possession of such distribution authorisation or who are exempt from the obligation to obtain such distribution authorisation under the terms of Article 77(3) of that directive, and only small quantities are supplied?

(b) If Question 1(a) is answered in the negative, is it relevant to compliance with the requirement laid down in [subparagraph (b) of the first paragraph of] Article 80 of Directive 2001/83 whether a supply of medicinal products obtained in the manner described in the main proceedings and in Question 1(a) is made only to persons authorised or entitled to supply medicinal products to the public under Article 77(2) of that directive or also to those who are themselves holders of distribution authorisation?

(2) (a) Must Articles 79(b) 80(g) [of Directive 2001/83], in conjunction with point 2.2 of the [Guidelines on Good Distribution Practice of medicinal products for human use of 5 November 2013], be interpreted as meaning that the staffing requirements are fulfilled even where, as in the main proceedings, the responsible person is (physically) absent from the premises for a period of four hours but can be contacted by telephone during that time?

(b) Must Directive 2001/83, in particular [Article 79 and subparagraph (g) of the first paragraph of Article 80] thereof, in conjunction with the first paragraph of point 2.3 of the [Guidelines on Good Distribution Practice of medicinal products for human use of 5 November 2013], be interpreted as meaning that the staffing requirements provided for in those provisions and guidelines are met where, as in the main proceedings, in the event that the responsible person is absent as described in Question 2(a), the staff present on the premises are not able, in particular in the event of an inspection by the competent authority of the Member State, to provide information themselves on the written procedures relating to their respective areas of responsibility?

(c) Must Directive 2001/83, in particular [Article 79 and subparagraph (g) of the first paragraph of] Article 80 thereof, read in conjunction with point 2.3 of the [Guidelines on Good Distribution Practice of medicinal products for human use of 5 November 2013], be interpreted as meaning that, in assessing whether an adequate number of competent personnel is involved in all stages of the wholesale distribution activities, account must also be taken of activities outsourced to third parties (or activities carried out by third parties on behalf of the establishment), as occurred in the case in the main proceedings, and does that directive preclude or even require the obtaining of an expert report for the purposes of that assessment?

(3) Must Directive 2001/83, in particular [Article 77(6) and Article 79] thereof, be interpreted as meaning that the authorisation to engage in activity as a wholesaler in medicinal products must also be revoked where it is established that a requirement under Article 80 of that directive is not fulfilled – for example, medicinal products are obtained in a manner contrary to [subparagraph (g) of the first paragraph of] Article 80 of that directive, as may be the case in the main proceedings – but that requirement is then once more complied with, in any event at the time of the decision by the competent authority of the Member State or the court before which the matter is brought? If not: what other requirements for that assessment exist under EU law, and, in particular, when must the authorisation be (merely) suspended instead of revoked?’

13. Written observations were submitted by the appellant, the respondent Office, the Austrian, Czech and Polish Governments and the European Commission.

14. By its third question, the referring court seeks to ascertain, first, whether Article 77(6) and Article 79 of Directive 2001/83 must be interpreted as meaning that it is not necessary to revoke the authorisation to engage in activity as a wholesaler in medicinal products in the case where one of the requirements laid down in Article 80 of that directive, which was initially no longer met, is once again met.

15. Secondly, and if the answer is in the negative, the referring court asks what other requirements of EU law must be taken into consideration in order to assess which of the two penalties should be imposed. (4)

16. In the light of those questions, it should be noted at the outset that, under Article 77(1) of Directive 2001/83, medicinal products benefiting from a previously granted marketing authorisation may be distributed wholesale only where an authorisation to engage in that activity is granted by the Member States. (5)

17. In that regard, the EU legislature established in Articles 79 and 80 of that directive, respectively, a non-exhaustive list of requirements which applicants for authorisation to engage in activity as a wholesaler in medicinal products are to fulfil in order to obtain such authorisation and a non-exhaustive list of requirements which holders of such authorisation must fulfil once the authorisation is granted to them, with checks being carried out during the period in which the authorisation is held to ensure that those conditions are satisfied. (6)

18. Where the conditions laid down in Articles 79 and 80 cease to be met by the holder of the authorisation to engage in activity as a wholesaler in medicinal products, the Members States are required, under Article 77(6) of Directive 2011/83, to suspend or revoke that authorisation and forthwith to inform the other Member States and the Commission thereof.

19. Article 77(6) forms part of the rules governing the wholesale distribution of medicinal products for human use laid down in Title VII of Directive 2001/83 and contributes to the attainment of the objectives pursued by that directive, in particular those relating to the protection of public health, the removal of barriers to trade in medicinal products within the European Union and the need to exercise control over the entire chain of distribution of medicinal products. (7) It therefore contributes to the functioning of the control mechanism for which the EU legislature has provided at all stages of the life of medicinal products, from their manufacture through to their distribution to the public. (8)

20. That said, it should be observed that the EU legislature, by means of Article 77(6) of Directive 2001/83, carried out only a minimum harmonisation limited to the determination of measures which may be taken when the conditions laid down in Articles 79 and 80 of that directive cease to be met. It should also be noted that Article 77(6) of that directive does not merely specify those measures but also provides that the Member State which has suspended or revoked the authorisation is forthwith to inform the other Member States and the Commission thereof. It follows, in my view, that the EU legislature essentially wished to approximate the laws in order to strengthen the effectiveness of the system for monitoring authorisations to engage in activity as a wholesaler in medicinal products.

21. However, it is in no way apparent from the wording of Article 77(6) of Directive 2001/83 that the EU legislature intended to define the criteria governing the implementation of those measures and to specify the way in which those criteria are to be applied by the national authorities.

22. It follows, in my view, that, although the Member States are obliged to adopt measures – including at the very least revocation or suspension measures – applicable in the event of infringement of Articles 79 and 80 of Directive 2001/83, that directive leaves it to the national legislature to determine the parameters for the application of each of those measures. In such a situation, it is for the national authorities to determine in concreto the most appropriate measure on the basis of the criteria laid down by national law and in the light of the factual circumstances of each case.

23. In the present case, it is common ground that the provisions of Article 77(6) of Directive 2001/83 have been transposed into national law by Paragraph 66a of the AMG. In addition to that transposition relating to the adoption of suspension and revocation measures and the information provided to the other Member States, Paragraph 66a of the AMG sets out the criteria for assessing the measure to be adopted. To that end, that paragraph provides, in essence, that authorisation for the wholesale distribution of medicinal products is to be revoked if the conditions are no longer met and that the revocation may be replaced by the total or partial suspension of the authorisation if the holder thereof is able to remedy the cause of the revocation within a reasonable period.

24. It is apparent from the request for a preliminary ruling and from the written observations submitted by the parties to the proceedings that the dispute in the main proceedings concerns the determination of the most appropriate measure and, more specifically, the question as to the conditions under which the measure revoking authorisation to engage in activity as a wholesaler in medicinal products is to be preferred to the measure suspending that authorisation. In that context, the referring court does not question whether the revocation and suspension measures laid down in Paragraph 66a of the AMG are proportionate in the light of the requirements of Directive 2001/83, but rather whether the criteria laid down in that paragraph to govern the choice between those measures are applicable.

25. In that regard, it should be noted that, contrary to what the Commission maintains in its written observations, (9) Article 118a(1) of Directive 2001/83, under which the penalties applicable to infringements of the national provisions adopted pursuant to that directive must be ‘effective, proportionate and dissuasive’, plays no role in the assessment of the proportionality of the implementation of those penalties. That article, which is a general provision inserted into Title XI entitled ‘Supervision and sanctions’, is applicable only when the sanctions to be adopted by the Member States in the context of that directive are established.

26. In the light of this, I do not consider that article to be relevant to the present case. First, the Austrian legislature has laid down in its national law the suspension and revocation measures provided for in Article 77(6) of Directive 2001/83 and the dispute in the main proceedings does not concern the transposition of those measures. Secondly, since those measures have been enacted in national law by virtue of the harmonisation of legislation carried out by the EU legislature, it seems to me that the conditions laid down in Article 118a of Directive 2001/83, which governs the penalties which national law is free to lay down provided that they are effective, proportionate and dissuasive, do not apply to the implementation of those same measures.

27. The fact remains that the Court could consider, on the basis of Article 49(3) of the Charter of Fundamental Rights of the European Union (‘the Charter’), (10) that it is necessary to determine the proportionality of the system of penalties provided for by national law. (11) That said, apart from the undeniable difficulty in classifying the suspension and revocation measures provided for in Paragraph 66a of the AMG as ‘criminal penalties’, (12) the national legislation would still have to fall within the scope of the Charter.

28. In that regard, it should be recalled that the field of application of the Charter is defined in Article 51(1) thereof, according to which the provisions of the Charter are addressed to the Member States only when they are implementing EU law. To that end, the fundamental rights guaranteed in the legal order of the European Union are applicable in all situations governed by EU law, but not outside such situations. Thus, where the provisions of EU law in the area concerned do not govern an aspect of a given situation and do not impose any specific obligation on the Member States with regard thereto, the national rule enacted by a Member State as regards that aspect falls outside the field of application of the Charter and the situation concerned cannot be assessed in the light of the provisions thereof. In that case, the Court therefore does not have jurisdiction and any provisions of the Charter relied upon cannot, of themselves, form the basis for such jurisdiction. (13)

29. On that point, it is clear from the foregoing that, through the provisions of Article 77(6) of Directive 2001/83, the EU legislature did not intend to define the criteria governing the implementation of measures for the suspension and revocation of authorisation to engage in activity as a wholesaler in medicinal products or to specify the way in which those criteria are to be applied by the national authorities.

30. It follows, in my view, that Paragraph 66a of the AMG, in so far as it specifies the criteria determining the choice between measures for the revocation and suspension of the authorisation to engage in activity as a wholesaler in medicinal products, cannot be regarded as implementing EU law, with the result that that paragraph does not fall within the field of application of the Charter.

31. In the light of all of the foregoing considerations, I am of the opinion that the referring court’s questions relate only to the interpretation of the national provisions for determining which of the penalties of suspension or revocation of the authorisation to engage in activity as a wholesaler in medicinal products is the most appropriate. It is settled case-law that the Court has no jurisdiction to rule in the context of proceedings under Article 267 TFEU on the interpretation of national laws or national regulations, but only on the interpretation of EU law. (14)

32. In those circumstances, I propose that the Court declare that it has no jurisdiction to answer the third question referred for a preliminary ruling by the Bundesverwaltungsgericht (Federal Administrative Court).

33. In the light of the foregoing considerations, I propose that the Court declare that it has no jurisdiction to answer the third question referred for a preliminary ruling by the Bundesverwaltungsgericht (Federal Administrative Court, Austria).

2 Directive 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).

4 With the aim of removing any ambiguity which might affect the interpretation of the question referred, I would point out that, under Title VII of Directive 2001/83, the term ‘requirements’ should be used only where it is necessary to refer to the conditions which must be satisfied by an applicant wishing to obtain authorisation for the wholesale distribution of medicinal products in accordance with Article 79 of that directive and those which must be satisfied by the holder of that authorisation under Article 80 of that directive. For that reason, to my mind it seems to be preferable, in order to avoid any confusion, to use the term ‘requirements’ only when the conditions laid down by those articles are at issue.

5 Under Article 77(3) of Directive 2001/83, possession of a manufacturing authorisation automatically includes authorisation to engage in activity as a wholesaler in medicinal products.

8 See, to that effect, recital 35 of Directive 2001/83, in accordance with which ‘it is necessary to exercise control over the entire chain of distribution of medicinal products, from their manufacture or import into the Community through to supply to the public’.

9 I refer to paragraph 36 of the written observations submitted by the Commission.

10 Under that provision, ‘the severity of penalties must not be disproportionate to the criminal offence’.

11 See, to that effect, judgment of 4 October 2018, Link Logistik N&N (C‑384/17, EU:C:2018:810, paragraphs 40 to 45 and the case-law cited).

12 In that regard, according to the case-law of the Court resulting from the judgment of 5 June 2012, Bonda (C‑489/10, EU:C:2012:319, paragraph 37), three criteria are relevant. The first criterion is the legal classification of the offence under national law, the second is the very nature of the offence, and the third is the nature and degree of severity of the penalty that the person concerned is liable to incur. In the light of the information contained in the request for a preliminary ruling, none of those criteria seems to me to be met. In the first place, I note that it is apparent from the order for reference that the revocation and suspension measures are classified as ‘administrative’ measures under national law. Secondly, those measures are not intended to punish non-compliance, but to safeguard the integrity of the distribution chain of medicinal products intended for the public. In the third place, the revocation measure does not prevent the exercise of other professional activities in the same field of expertise, as the present case shows, as the appellant may continue its activity as a pharmacy.

13 Judgment of 20 October 2022, Curtea de Apel Alba Iulia and Others (C‑301/21, EU:C:2022:811, paragraphs 72, 74 and 75 and the case-law cited).

14 See, to that effect, order of 18 November 2022, mBank (Invalidity of unfair and unlawful terms) (C‑138/22, not published, EU:C:2022:915, paragraph 27 and the case-law cited).

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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Apotheke B. (harmaceutical and cosmetic products - Medicinal products for human use - Wholesale distribution of medicinal products - Opinion) [2023] EUECJ C-47/22_O (16 March 2023) URL: http://www.bailii.org/eu/cases/EUECJ/2023/C4722_O.html Cite as: ECLI:EU:C:2023:225, [2023] EUECJ C-47/22_O, EU:C:2023:225

Court of Justice of the European Communities (including Court of First Instance Decisions)