OPINION OF ADVOCATE GENERAL

PIKAMÄE

delivered on 14 September 2023 (1)

Case C‑75/22

European Commission

v

Czech Republic

(Failure of a Member State to fulfil obligations – Directives 2005/36/EC and 2013/55/EU – Recognition of professional qualifications – Article 3(1)(g) and (h) – Adaptation period – Aptitude test – Determination of the status of a migrant under supervision and of the status of an applicant who wishes to prepare himself or herself for the aptitude test – Article 6(b) – Service providers – Exemption from the obligation to register with a public social security body in the host Member State – Article 45(2) – Pharmacists – Independent pursuit of activities – Supplementary professional experience)

I.      Introduction

1.        In the present case the European Commission has brought an action for failure to fulfil obligations under Article 258 TFEU against the Czech Republic, alleging that it has failed correctly to transpose several provisions of Directive 2005/36/EC, (2) as amended by Directive 2013/55/EU (3) (‘Directive 2005/36’).

2.        The Commission puts forward eight complaints. In accordance with the Court’s request, this Opinion will focus on the first, second, fourth and fifth complaints.

3.        By the first complaint, the Commission asserts that the Czech Republic has failed correctly to transpose Article 3(1)(g) and (h) of Directive 2005/36 in so far as that provision requires the competent authorities in the Member State to determine the status of persons completing an adaptation period or wishing to prepare themselves for an aptitude test.

4.        By the second complaint, the Commission alleges that the Czech Republic has failed to transpose Article 6(b) of Directive 2005/36 in respect of, first, the exemption of service providers established in another Member State from the obligation to register with a public social security body in the host Member State and, second, the obligation for service providers to inform that body.

5.        The fourth complaint relates to failure to transpose the provisions of Article 21(6) and Article 31(3) of Directive 2005/36 concerning the professional title of nurse responsible for general care.

6.        By the fifth complaint, the Commission claims that the Czech Republic has not ensured that holders of professional qualifications in pharmacy have access to the activities referred to in Article 45(2)(c), in part (e), and (f) of Directive 2005/36.

II.    Legal framework

A.      European Union law

7.        The relevant provisions in the present case are Articles 3, 6, 21, 31, 44 and 45 of Directive 2005/36.

B.      Czech law

1.      Law on recognition of professional qualifications

8.        Paragraph 13 of the zákon č. 18/2004 Sb., o uznávání odborné kvalifikace a jiné způsobilosti státních příslušníků členských států Evropské unie a některých příslušníků jiných států a o změně některých zákonů (Law No 18/2004 Coll. on recognition of professional qualifications and other skills of nationals of Member States of the European Union and of certain nationals of other States and amending certain laws; ‘Law No 18/2004’) provides:

‘(1)      “Adaptation period” means the period in which regulated activities are pursued in the Czech Republic by an applicant under the supervision of a professionally qualified natural person in order to supplement theoretical and practical knowledge in areas which form part of the education and training content leading to the issuance of a certificate of formal qualifications required in the Czech Republic and knowledge of which is necessary for the pursuit of the regulated activities. The adaptation period may also include further study or training to supplement professional qualifications.

(2)      The recognition authority shall draw up a list of areas knowledge of which is necessary for the pursuit of a regulated activity and which, according to the document submitted, are not covered by the professional qualifications of the applicant. Such areas may include both theoretical knowledge and practical competences required for the pursuit of the regulated activity.

(3)      The recognition authority shall determine in the decision referred to in Paragraph 24 the conditions in which the adaptation period is to be completed, namely:

(a)      the length of the adaptation period;

(b)      the areas referred to in subparagraph 2 in which the applicant is required to supplement his or her knowledge in the course of the adaptation period,

(c)      the method for assessing the adaptation period.

(4)      The length of the adaptation period may be no longer than three years. If the applicant intends to pursue a regulated activity in the Czech Republic and if evidence of first-level qualifications is required in order to pursue that activity, the length of the adaptation period may be no longer than two years.

(5)      On the basis of the declaration made by the professionally qualified person referred to in subparagraph 1, the recognition authority shall assess whether the objective of the adaptation period has been achieved after the expiry of the period determined in accordance with subparagraph 3(a) or, if so requested by the applicant, after half of that period and every six months thereafter. The objective of the adaptation period shall be achieved if the applicant demonstrates his or her knowledge of the areas referred to in subparagraph 3(b). In such case, the recognition authority shall recognise the professional qualifications of the applicant.’

9.        Paragraph 14 of that Law provides:

‘(1)      An aptitude test is an examination of the professional knowledge, skills and competences of the applicant with the aim of assessing the applicant’s ability to pursue a regulated activity in the Czech Republic. The aptitude test shall be taken before a recognition authority or other administrative authority or at a university or other education establishment for the purpose in question (“the examination establishment”).

(2)      The recognition authority shall draw up a list of areas knowledge of which is necessary for the pursuit of a regulated activity and which, according to the document submitted, are not covered by the professional qualifications of the applicant. Such areas may include both theoretical knowledge and practical competences required for the pursuit of the regulated activity.

(3)      The recognition authority shall determine in the decision referred to in Paragraph 24 the conditions in which the aptitude test is to be taken, namely:

(a)      the areas referred to in subparagraph 2 to be covered by an aptitude test, and

(b)      the procedure and method for assessing the aptitude test.

(4)      The recognition authority shall ensure that the applicant has the possibility of taking the aptitude test within six months of the decision referred to in subparagraph 3.

(5)      The aptitude test shall generally be composed of a written part and an oral part. The aptitude test shall generally be taken in the Czech language and its content shall take account of the fact that the applicant is a person qualified to pursue the profession in [the home Member State]. The costs associated with the aptitude test shall be borne by the candidate and may not exceed [Czech koruna] CZK 6 500. (4)

(6)      The examination establishment shall assess whether the candidate has passed or failed the aptitude test. A candidate shall pass the test if he or she demonstrates knowledge of the areas referred to in subparagraph 3(a). In such case, the recognition authority shall recognise the professional qualifications of the applicant.’

10.      Paragraph 15 of the Law states:

‘An implementing regulation or professional regulation may stipulate for individual regulated activities or a group of regulated activities, having regard to their specific features, the method for determining the length of the adaptation period and the conditions for completing and assessing the adaptation period and for taking and assessing the aptitude test, including the form, content and scope of the aptitude test.’

11.      Under Paragraph 36a of that Law:

‘(1)      An applicant who is a national of a Member State … and who, in accordance with the legislation of the Member State of origin, pursues the activity in question, which is a regulated activity in the Czech Republic, shall also be authorised to pursue that activity on a temporary or occasional basis in the territory of the Czech Republic without having to comply with the requirements relating to enrolment with, registration with, authorisation by or membership of a professional body under specific legislation and without having to apply for recognition of his or her professional qualifications …

(2)      If the activity in question is not regulated in the home Member State, the applicant must prove that he or she has pursued the activity in question in one or more Member States for at least one year during the preceding ten years or provide evidence of regulated training which prepares him or her for the activity in question in the Member State of origin ….

(3)      If a certificate of civil liability insurance for damage caused in the pursuit of a regulated activity is required in order to pursue a regulated activity in the Czech Republic, the applicant shall prove that he or she is insured to the extent and under the conditions required by special legislation.

(4)      The applicant shall, before starting to pursue the regulated activity in the territory of the Czech Republic, notify the recognition authority in writing. The notification shall contain:

(a)      the applicant’s surname(s) and first names(s), date of birth and citizenship,

(b)      the name of the regulated activity to be pursued and information on whether the activity is regulated in the home Member State or information on the activity which is most similar in content,

(c)      information on professional qualifications and also, in the cases referred to in subparagraph 2, on the pursuit of the regulated activity or training,

(d)      details of an employer established in another Member State of the European Union if the applicant is posted to the Czech Republic for the purposes of the provision of services by that employer:

1.      the first name(s) and surnames(s), date of birth, Member State of establishment and address of the place of business if the employer is a natural person, or

2.      the name, registered office and State of establishment if the employer is a legal person.

(5)      The applicant shall attach to the notification referred to in subparagraph 4:

(a)      an identity card, a document certifying the nationality of the applicant and, where necessary, a document confirming legal status as referred to in Paragraph 1(2); the provisions of the first and second sentences of Paragraph 22(6) and 22(7) shall apply mutatis mutandis;

(b)      a document certifying that the applicant is established in the home Member State and pursues the activity in question in accordance with the legislation of that Member State and that his or her authorisation to pursue the activity in question in the home Member State has not been withdrawn or temporarily suspended; the provisions of Paragraph 22(7) shall apply mutatis mutandis;

(c)      evidence of professional qualifications; the provisions of Paragraph 22(4) and (5), the first and third sentences of Paragraph 22(6) and Paragraph 22(7) and (8) shall apply mutatis mutandis;

(d)      the document referred to in subparagraph 2 if the activity in question is not regulated in the home Member State; the provisions of Paragraph 22(4) and (5), the first and third sentences of Paragraph 22(6) and Paragraph 22(7) and (8) shall apply mutatis mutandis;

(e)      a document in accordance with subparagraph 3, if proof of civil liability insurance for damage caused in the pursuit of a regulated activity is required in order to pursue a regulated activity in the Czech Republic; the provisions of Paragraph 22(7) and (8) shall apply mutatis mutandis.

(6)      The Ministry shall provide information on performance of the notification obligation by means permitting remote access.

(7)      If the notification or the documents attached thereto do not meet the requirements laid down in the Code of Administrative Procedure or subparagraphs 4 and 5, the recognition authority shall assist the applicant in remedying the deficiencies on the spot or immediately invite him or her to remedy them. At the same time, it will inform the applicant that he or she is not authorised to pursue a regulated activity in the Czech Republic until the deficiencies are remedied, or up to the time limit specified in Paragraph 36b(6) if a special law lays down a condition relating to verification of professional qualifications.

(8)      The applicant shall inform the recognition authority immediately of any changes to all the facts stated in the notification or the documents attached thereto, including facts which could give rise to withdrawal of authorisation to pursue regulated activities in the territory of the Czech Republic on a temporary or occasional basis. If the applicant intends to pursue a regulated activity in the territory of the Czech Republic on a temporary or occasional basis after 12 months from the date of submission of the full notification, he or she shall resubmit that notification, except in the cases referred to in Paragraph 24c(3). If he or she resubmits the notification, the applicant shall submit the documents referred to in subparagraph 5(b) to (e) only in the event of changes to the facts set out in the original notification or in the documents attached thereto.

(9)      The recognition authority shall record the details of the applicant and the facts notified by him or her in a separate register. The recognition authority shall record for each notification a registration number, the date of notification, the date of submission of the full notification to the recognition authority and information on the validity of the notification.’

2.      Law on public health insurance

12.      Paragraph 11(1) of the zákon č. 48/1997 Sb., o veřejném zdravotním pojištění a o změně a doplnění některých souvisejících zákonů (Law No 48/1997 Coll., on public health insurance and amending and supplementing certain related laws; ‘Law No 48/1997’) provides:

‘(1)      The insured person shall have the right:

(a)      to choose a health insurance fund …;

(b)      to choose a health service provider in the territory of the Czech Republic … which has a contractual relationship with the corresponding health insurance fund …;

(c)      to access in time and space reimbursed services supplied by contractual providers from the corresponding health insurance fund;

(d)      to the provision of reimbursed services to the extent and under the conditions laid down by this Law, it being understood that the provider may not receive any payment in respect of those reimbursed services from the insured person;

…’

13.      Paragraph 17(1) of that Law provides:

‘In order to ensure benefits in kind in the context of the provision of reimbursed services to insured persons, the health insurance fund (Všeobecná zdravotní pojišťovna České republiky) and the other health insurance funds shall conclude … agreements with providers on the provision and reimbursement of reimbursed services. … Agreements shall be not required in respect of the provision of

(a)      urgent treatment to the insured person,

…’

3.      Law on the conditions for acquisition and recognition of professional competences and specialised competences for pursuing the professions of doctor, dentist and pharmacist

14.      Paragraph 2(g) of zákon č. 95/2004 Sb., o podmínkách získávání a uznávání odborné způsobilosti a specializované způsobilosti k výkonu zdravotnického povolání lékaře, zubního lékaře a farmaceuta (Law No 95/2004 Coll., on the conditions for acquisition and recognition of professional competences and specialised competences for pursuing the professions of doctor, dentist and pharmacist; ‘Law No 95/2004’) states:

‘“Independent pursuit of the activity” of pharmacist means the pursuit of activities for which … the pharmacist is authorised without professional supervision and based on his or her own evaluation and assessment of the patient’s state of health and related circumstances.’

15.      Paragraph 10(2) of that Law provides:

‘After acquiring professional competences, … the pharmacist shall have the right to pursue independently activities involved in the provision of pharmaceutical care in accordance with the Law on health services, except for activities the independent pursuit of which is contingent upon acquisition of specialised competences within the meaning of Paragraph 11. The pharmacist shall also be authorised to pursue activities not classified as provision of healthcare services, namely in connection with manufacture and testing of medicinal products and storage and distribution of medicinal products at a distributor of medicinal products in accordance with Law [No 378/2007 Coll.] on medicinal products.’

16.      Paragraph 11 of that law is worded as follows:

‘(1)      Specialised qualification as a pharmacist shall be acquired:

(a)      by successfully completing specialised training attested by a certified examination … on the basis of which the Ministry issues to the pharmacist a specialist diploma in the field of specialisation concerned, or

(b)      by obtaining supplementary professional experience based on the relevant training programme at an institution accredited for the relevant field of specialised training or for the relevant field of supplementary professional experience, which will issue a certificate of completion to the applicant.

(2)      The fields of specialised training for pharmacists, evidence of qualifications and the duration of the specialised training are described in Annex 1 to this Law. …

(3)      The application for registration in respect of supplementary professional experience shall be submitted by a candidate to an accredited institution in the profession in which supplementary professional experience is required. The application shall include evidence of professional competences acquired and, where necessary, of specialised competences acquired, as well as the professional card referred to in Paragraph 23 ….

…

(5)      The Ministry shall issue a diploma of acquired specialised competences upon application by a candidate who has acquired supplementary professional experience as referred to in subparagraph 1(b). The application for a diploma of specialised competences must be accompanied by a certificate issued by the accredited institution referred to in subparagraph 1(b).

…

(7)      Acquisition of specialised competences in accordance with subparagraph 1(a) shall be a condition … for the independent pursuit of activities

(a)      related to protection of public health,

(b)      in transfusion establishments,

(c)      in the field of pharmaceutical technologies,

(d)      in the field of laboratory and analysis methods in health, and

(e)      in the field of radiopharmaceutical medicines.

(8)      Acquisition of specialised competences in accordance with subparagraph 1 in the field of practical pharmacy shall be a condition for the independent pursuit of activities related to management of a pharmacy …

(9)      Acquisition of specialised competences in the field of clinical pharmacy in accordance with subparagraph 1(a) shall be a condition for the independent pursuit of activities as a clinical pharmacist.

(10)      Acquisition of particular specialised competences in the field of hospital pharmacy shall be a condition for the independent pursuit of activities related to management of a pharmacy with specialised facilities for the preparation of particularly complex pharmaceutical forms; for the purposes of this Law, “particularly complex pharmaceutical forms” means sterile medicinal products for parenteral application prepared in specialised facilities in pharmacies.

(11)      Acquisition of specialised competences in accordance with subparagraph 1(a) in the field of radiopharmaceutical medicines or pharmaceutical technologies or acquisition of particular specialised competences in the field of hospital pharmacy shall be a condition for the independent pursuit of activities relating to the preparation of particularly complex pharmaceutical forms.

(12)      Before acquiring specialised competences, the pharmacist shall pursue the activities mentioned in subparagraphs 7 to 11 under the professional supervision of a healthcare professional who has the relevant specialised competences.’

III. Pre-litigation procedure

17.      Directive 2013/55 amending Directive 2005/36 had to be transposed no later than 18 January 2016. (5)

18.      On 25 January 2019, the Commission sent the Czech Republic a letter of formal notice concerning the measures adopted by that Member State in order to transpose Directive 2005/36. On 22 March 2019, the Czech Republic replied to that letter of formal notice.

19.      After examining that reply, the Commission sent the Czech Republic a reasoned opinion on 28 November 2019. That Member State replied to the reasoned opinion on 28 January 2020.

20.      On 18 February 2021, the Commission sent the Czech Republic a supplementary reasoned opinion to which that State replied on 16 April 2021.

IV.    Procedure before the Court and forms of order sought

21.      Since the Commission considers that, despite its explanations, the Czech Republic has failed correctly to transpose several provisions of Directive 2005/36, it brought the present action by application of 4 February 2022.

22.      The Czech Republic lodged a defence on 25 April 2022.

23.      The Commission and the Czech Republic then lodged a reply and a rejoinder respectively on 7 June 2022 and 29 July 2022.

24.      The Commission claims that the Court should:

–        find that, by failing to transpose correctly Article 3(1)(g) and (h), Article 6(b), Article 7(3), Article 21(6), Article 31(3), Article 45(2)(c), in part (e), and (f), Article 45(3), Article 50(1), read in conjunction with point 1(d) and (e) of Annex VII and Article 51(1) of Directive 2005/36, the Czech Republic has failed to fulfil its obligations under the provisions of that directive;

–        order the Czech Republic to pay the costs.

25.      The Czech Republic contends that the Court should:

–        dismiss the part of the action concerning the first, second, third, fourth, fifth and seventh pleas in law as inadmissible;

–        dismiss the action as to the remainder as unfounded, and

–        order the Commission to pay the costs.

26.      In the alternative, the Czech Republic contends that the Court should:

–        dismiss the action as unfounded, and

–        order the Commission to pay the costs.

V.      Legal analysis

A.      Preliminary remarks

27.      The Czech Republic contests the admissibility of the complaints which are the subject of this Opinion. In this regard it raises, in essence, a number of pleas of inadmissibility concerning, first, a lack of coherence and precision of the complaints put forward by the Commission during both the pre-litigation procedure and the procedure before the Court and, second, the alteration of the subject matter of the dispute.

28.      In order to enable the Court to rule on these pleas of inadmissibility, I think it necessary to recall the main features of the case-law it has developed on these points.

1.      The obligation to set out the complaints in a coherent and detailed manner

29.      With regard, first, to the pre-litigation procedure, according to the Court’s settled case-law, the purpose of that procedure is to give the Member State concerned an opportunity to comply with its obligations under EU law and to avail itself of its right to defend itself against the complaints made by the Commission. (6) The proper conduct of that procedure constitutes an essential guarantee required by the FEU Treaty not only in order to protect the rights of the Member State concerned, but also so as to ensure that any contentious procedure will have a clearly defined dispute as its subject matter. (7)

30.      Furthermore, although the reasoned opinion must contain a coherent and detailed statement of the reasons which led the Commission to conclude that the Member State in question has failed to fulfil one of its obligations under the Treaty, the letter of formal notice cannot be subject to such strict requirements of precision, since it cannot, of necessity, contain anything more than an initial brief summary of the complaints. There is therefore nothing to prevent the Commission from setting out in detail in the reasoned opinion the complaints which it has already made more generally in the letter of formal notice. (8)

31.      With regard, second, to the procedure before the Court, it should be noted that, according to the Court’s case-law, the application must set out the complaints coherently and precisely, so that the Member State and the Court can know exactly the scope of the alleged infringement of EU law, a condition that must be satisfied if the Member State is to be able to present an effective defence and the Court to determine whether there has been a breach of obligations, as alleged. (9) In particular, the Commission’s application must contain a coherent and detailed statement of the reasons which have led it to conclude that the Member State in question has failed to fulfil one of its obligations under the Treaties. (10)

2.      The obligation not to alter the subject matter of the dispute

32.      It should be stated in this regard that, in an action under Article 258 TFEU, the letter of formal notice sent by the Commission to the Member State and the reasoned opinion issued by the Commission delimit the subject matter of the dispute, so that it cannot afterwards be extended. The opportunity for the Member State concerned to submit its observations, even if it chooses not to make use of it, is an essential guarantee intended by the Treaty, adherence to which is an essential formal requirement of the procedure for finding that a Member State has failed to fulfil its obligations. Consequently, the reasoned opinion and the action brought by the Commission must be based on the same complaints as those in the letter of formal notice initiating the pre-litigation procedure. (11) If that is not the case, that irregularity cannot be regarded as having been cured by the fact that the defendant Member State submitted observations on the reasoned opinion. (12)

33.      That being so, although it is true that the subject matter of proceedings is circumscribed by the pre-litigation procedure and that, consequently, the Commission’s reasoned opinion and the application must be based on the same complaints, (13) that requirement cannot go so far as to mean that in every case exactly the same wording must be used in both, where the subject matter of the proceedings has not been extended or altered. (14) Accordingly, in its application the Commission may clarify its initial complaints provided, however, that it does not alter the subject matter of the dispute. (15)

34.      It is in the light of this case-law that the pleas of inadmissibility raised by the Czech Republic should be analysed.

B.      The first complaint, concerning failure to transpose Article 3(1)(g) and (h) of Directive 2005/36

1.      Admissibility of the complaint

(a)    Arguments of the parties

35.      The Czech Republic raises two pleas of inadmissibility.

36.      First, the Czech Republic submits that the complaint put forward in the application does not correspond to the complaint made in the reasoned opinion. In this respect it asserts that the reasoned opinion related exclusively to the fact that the Czech legislation had to specify the status of the persons concerned, whereas in the application the Commission now alleges that the Czech Republic failed to introduce into national law the obligation for the competent authorities to determine the status of the persons concerned.

37.      Second, the Czech Republic submits that the complaint is not clearly set out. It asserts that in paragraph 23 of the application the Commission suggests that an act determining that status should be issued by the competent authority to each person concerned, while in paragraph 22 of the application it appears to acknowledge that the status of those persons could be laid down by law.

38.      For its part, the Commission maintains that the complaint is admissible. It submits that the subject matter of the dispute, as defined in the letter of formal notice then in the reasoned opinion, was not extended or altered in the application. It adds that the complaint clearly relates to failure to transpose Article 3(1)(g) and (h) of Directive 2005/36 in respect of the obligation for the competent authorities to determine the legal status of persons completing an adaptation period or wishing to prepare themselves for an aptitude test.

(b)    Assessment

39.      With regard to the first plea of inadmissibility, it is clear from the reasoned opinion (16) that, in the Commission’s view, the provisions of Czech law implementing Directive 2005/36 neither specify the legal status of persons completing an adaptation period or preparing themselves for an aptitude test nor provide a legal basis for the competent authorities to specify that status. It adds that such status must be sufficiently clear and precise to enable the persons concerned to be aware of their rights. In addition, according to the application lodged by the Commission, the relevant provisions of Czech law do not allow the legal status of the persons concerned to be determined sufficiently clearly and precisely.

40.      To my mind, this comparison shows that in both the reasoned opinion and the application the Commission alleges that the Czech legislation does not adequately specify the legal status of persons completing an adaptation period or preparing themselves for an aptitude test. In my view, it follows that the Commission did not alter the subject matter of the dispute at the stage of the procedure before the Court, with the result that the plea of inadmissibility raised is unfounded.

41.      With regard to the second plea of inadmissibility, concerning the obligation to set out the complaint coherently and precisely, I take the view that the Commission has not breached that requirement because, as I have already stated, it is clear from the application that the Commission unequivocally asserts that Czech law does not allow the legal status of the persons concerned to be determined. This plea of inadmissibility must therefore be rejected.

2.      Substance of the complaint

(a)    Arguments of the parties

42.      The Commission submits that the provisions of Czech law, namely Paragraphs 13 to 15 of Law No 18/2004, do not specify the legal status of persons completing an adaptation period or preparing themselves for an aptitude test.

43.      It asserts that the main objective of the provisions of Article 3(1)(g) and (h) of Directive 2005/36 is to guarantee the persons concerned a certain and sufficiently clear legal status, ensuring that they are not subject to an arbitrary decision in the Member State to which they travel.

44.      It argues that the Czech Republic fails to mention any national provision which makes it possible to clearly determine the status of the persons concerned.

45.      For its part, the Czech Republic maintains that this complaint is unfounded.

46.      It states that Member States are not obliged to transpose a provision of a directive literally. It maintains that Article 3(1)(g) and (h) of Directive 2005/36 neither mentions specific rights and obligations to be conferred on the persons concerned nor requires that a specific status be accorded to them, with the result that it is not prohibited for the status of such persons to be governed by general legislation, as in Czech law.

47.      The Czech Republic adds that Directive 2005/36 does not require national legislation to provide for a uniform system applicable to persons completing an adaptation period or preparing themselves for an aptitude test. Any such requirement would be based on the false presumption that those persons form a homogenous group that could enjoy a single specific status, whereas the status of those persons necessarily depends on their personal situation. It maintains that Czech law contains clear and precise criteria allowing the persons concerned to identify their status based on the specific circumstances of their residence.

(b)    Assessment

48.      In examining this complaint, as a first step, the exact purpose and scope of the obligation laid down in Article 3(1)(g) and (h) of Directive 2005/36 must be clarified.

49.      In this regard I note that, according to the Court’s settled case-law, in order to determine the meaning and the scope of a provision of EU law, it is necessary to consider not only its wording, but also its context and the objectives pursued by the rules of which it is part. (17)

50.      As regards the objectives pursued by Directive 2005/36, it is clear from Articles 1 and 4 of that directive that the fundamental purpose of mutual recognition is to allow the holder of a professional qualification giving access to a regulated profession in the holder’s home Member State to gain access, in the host Member State, to the same profession as that for which he or she is qualified in the home Member State and to pursue that profession in the host Member State under the same conditions as its own nationals. (18)

51.      In addition, Articles 10 to 14 of Directive 2005/36 establish a general system for recognition of evidence of training. In that system, Article 13(1) of the directive provides that the competent authority of the host Member State must permit applicants to access and pursue a regulated profession, under the same conditions as apply to its nationals, if they possess an attestation of competence or evidence of formal qualifications referred to in Article 11 of that directive, which has been issued by a competent authority of another Member State for that same purpose. That being so, the host Member State is able to make a comparison between the training requirements under its own legislation and those in the home Member State. On the basis of that examination, the host Member State has the option, under Article 14(1) of that same directive, to require, in situations exhaustively provided for, (19) compensation measures consisting in either an ‘adaptation period’ of up to three years or an ‘aptitude test’. It follows that this option, which Article 14(5) of Directive 2005/36 states must be used with due regard to the principle of proportionality, is applicable only in so far as the principle of equivalence of qualifications cannot be put into effect.

52.      It is in this context that the expressions ‘adaptation period’ and ‘aptitude test’ are defined respectively in points (g) and (h) of Article 3(1) of Directive 2005/36. It is evident from those points in particular that the detailed application of those compensation measures and the statuses of the person undergoing a period of supervised practice and of the applicant who wishes to prepare himself or herself for the aptitude test are to be [in French] ‘déterminés’ by the competent authorities (20) in the host Member State. The use of the word ‘déterminer’ seems to indicate that the authorities are required to ‘define with precision’ (21) the status of the persons to whom those provisions apply.

53.      As regards the adaptation period, moreover, Article 3(1)(g) of Directive 2005/36 states that the ‘status enjoyed in the host Member State by the person undergoing the period of supervised practice, in particular in the matter of right of residence as well as obligations, social rights and benefits, allowances and remuneration, shall be established by the competent authorities in that Member State in accordance with applicable Community law’. This addition can be explained, in my view, by the length and the characteristics of the adaptation period which, under that same article, entails ‘the pursuit of a regulated profession in the host Member State under the responsibility of a qualified member of that profession, such period of supervised practice possibly being accompanied by further training’. The status of the persons concerned does not necessarily have the same substance since the status of applicants completing an adaptation period necessarily has a wider scope than the status of applicants preparing themselves for an aptitude test. Nevertheless, this difference in content does not seem to give rise to a difference in nature as the competent authorities are required to determine with the same degree of precision both the status of migrants under supervision and the status of applicants taking the aptitude test.

54.      I infer from all these considerations that the competent authorities are not only required to define the status of the persons concerned but also to ensure its precision and clarity, so as to enable them to be certain of their legal situation, in particular with a view to facilitating the correct implementation of the compensatory measures necessary for their establishment in the host Member State. Furthermore, this twofold requirement applies irrespective of the method chosen by Member States, which remain free to determine that status either by drawing up specific provisions or by making reference to general laws. However, whichever method is used, it is necessary that the national measures allow the result prescribed by the directive to be achieved. (22)

55.      It is in the light of all these considerations that, as a second step, the substance of the complaint relied on by the Commission must be examined.

56.      It should be stated in this regard that, according to the Court’s case-law, when the Commission has adduced sufficient evidence to show that the national provisions adopted by the defendant Member State are not such as to ensure effective implementation of a directive, it is incumbent on that Member State to challenge in substance and in detail the information produced and the inferences drawn. (23)

57.      In the present case it is not disputed that Paragraphs 13 to 15 of Law No 18/2004 provide for the detailed application of the adaptation period and the aptitude test. On the other hand, as the Commission asserts, those paragraphs neither contain any provisions governing the status of the persons concerned nor make reference to other legislation for the purpose of the determination of that status.

58.      Having regard to the information communicated by the Commission, the Czech Republic relies on national rules of a general nature the application of which depends on the category into which the migrant under supervision and the applicant who wishes to prepare himself or herself for an aptitude test fall in the light of their individual situation.

59.      Nevertheless, even though the many conceivable situations could make it difficult to adopt a uniform status, this justification cannot relieve the competent authorities of their obligation to determine the legal situation of the persons concerned such that those persons have clear and precise information on this point.

60.      I take the view that, in the absence of any national rule permitting the status of those persons to be easily identified, the mere existence of those general provisions is not sufficient to ensure the correct transposition of the obligation laid down in Article 3(1)(g) and (h) of Directive 2005/36.

61.      In these circumstances, I suggest that the Court uphold the first complaint relied on by the Commission.

C.      The second complaint, concerning failure to transpose Article 6(b) of Directive 2005/36

1.      Admissibility of the complaint

(a)    Arguments of the parties

62.      The Czech Republic raises two pleas of inadmissibility.

63.      With regard to failure to transpose Article 6(b) of Directive 2005/36, the Czech Republic submits that this failure to fulfil obligations was not raised, even concisely, in the letter of formal notice and that it was not set out in a coherent and detailed manner in the reasoned opinion. It adds that the Commission did not indicate the provisions of Czech law at issue either in the letter of formal notice or in the reasoned opinion and that it was only at the stage of the application that it was able to grasp that the obligation to register with a social security body in the host Member State also had to be understood as the obligation for the provider to conclude an agreement with a public health insurance fund. It concludes that the Commission did not comply with its obligation to set out the complaint from the pre-litigation procedure and extended its subject matter at the stage of the application.

64.      Furthermore, the Czech Republic asserts that the obligation to inform in advance or, in an urgent case, afterwards, the social security body of the services provided is laid down in the second subparagraph of Article 6 of that directive. It observes, however, that the infringement of that provision was not invoked either in the letter of formal notice or in the reasoned opinion, nor was it mentioned in the application and the form of order sought. It adds that the very substance of that failure to fulfil obligations was not touched upon in the letter of formal notice with the result that the Commission has extended the subject matter of the complaint. Lastly, it asserts that the reasoned opinion did not set out that complaint clearly and coherently and concludes that the application is inadmissible in this regard.

65.      For its part, the Commission maintains that that complaint is admissible.

66.      It submits that the content of the complaint has remained the same from the time of the letter of formal notice. It claims that the responses provided by the Czech Republic to the letter of formal notice show that the latter had understood the subject matter of the complaint. The Commission asserts that in the absence of any reference by that Member State to Czech law, it was obliged itself to identify the relevant provisions of national law and the fact that those provisions were mentioned only at the stage of the application cannot therefore be regarded as an alteration of the complaint.

67.      The Commission acknowledges that, with regard to the obligation for the service provider to inform the social security body, it should have referred to the ‘second paragraph of Article 6’ of Directive 2005/36. It notes, however, that in the letter of formal notice and the reasoned opinion it pointed out the wording of that provision and that in its observations the Czech Republic responded specifically to that complaint.

(b)    Assessment

68.      With regard to the first plea of inadmissibility, I note, first, that the Commission stated in the letter of formal notice that Article 6(b) of Directive 2005/36 concerning the exemption of foreign service providers from requirements relating to registration with a social security body has not been transposed into Czech national legislation. (24)

69.      I would observe, second, that in its reasoned opinion the Commission examined the responses provided by the Czech Republic and set out that complaint in detail, pointing out that Article 6(b) of Directive 2005/36 provides that such registration is not required and that simple provision of information by the service provider to a public social security body replaces such registration for the settlement of accounts with the insurer. The Commission stated that this provision means that the fact that a doctor has provided medical services in another Member State to a patient covered by the public health insurance scheme cannot result in a refusal to reimburse the cost of treatment to the patient or the doctor on the ground that the doctor is not registered with the public health insurance scheme in the host Member State. It further asserted that Czech law does not meet these requirements. (25)

70.      It follows from the foregoing that, contrary to the assertion made by the Czech Republic, the complaint was raised in the letter of formal notice and was set out in sufficient detail in the reasoned opinion.

71.      Furthermore, it also cannot be claimed that the Commission extended the subject matter of the complaint at the stage of the procedure before the Court. The Commission simply referred, following the responses to the reasoned opinion communicated by the Czech Republic, to new provisions of Czech law in claiming that the complaint, the substance of which it did not alter, is well founded.

72.      In the light of all these factors, I take the view that the first plea of inadmissibility raised by the Czech Republic cannot be upheld.

73.      With regard to the second plea of inadmissibility, it need only be noted that in the letter of formal notice (26) the Commission recalled, in essence, the obligation for the service provider to inform the social security body and invited the Czech Republic to comply. In addition, in the reasoned opinion (27) the Commission reiterated that complaint and stated that the Czech national legislation should have imposed that obligation alone on such providers.

74.      In my view, it follows that at the stage of the pre-litigation procedure the Commission fulfilled the requirements relating to the setting out of that complaint and it cannot be alleged that it put forward that complaint only in its application.

2.      Substance of the complaint

(a)    Arguments of the parties

75.      According to the Commission, Paragraph 36a of Law No 18/2004 relied on by the Czech authorities is not sufficient to transpose correctly Article 6(b) of Directive 2005/36 because Czech law (28) makes reimbursement to the insured person subject to the existence of a contractual relationship between the service provider and a Czech health insurance fund.

76.      The Commission submits that Article 6(b) of Directive 2005/36 requires the host Member State to exempt service providers established in another Member State from registering ‘with a public social security body for the purpose of settling accounts with an insurer relating to activities pursued for the benefit of insured persons’  and, accordingly, also prohibits Member States from making reimbursement to the doctor and the patient of the cost of treatment provided in this context subject to such membership. It asserts that the objective of that article is to prohibit any unjustified restriction on the free provision of services. It states that before the entry into force of Directive 2005/36 the refusal to reimburse the cost of treatment provided without prior authorisation to patients by service providers established in another Member State was held to be contrary to Article 56 TFEU. (29)

77.      It asserts that this concept of ‘registration’ should be considered an autonomous concept of EU law which is to be interpreted in the light of the context of that provision and the objective pursued by the legislation at issue, which is to ensure respect for the free provision of services.

78.      That concept thus encompasses not only registration, in the strict sense, with the body identified by the Member State as its principal social security body but also other administrative or legal requirements having effects similar to registration which might have to be complied with in relation to other bodies of the Member State that contribute in some way to the functioning of the social security system.

79.      The Commission observes that, according to the information available to it, the Czech health insurance system is organised in such a way that if doctors have not concluded an agreement with the insured person’s health insurance fund, patients are not reimbursed the cost of treatment provided, even if they pay contributions to their insurance fund. Consequently, except in cases of urgent treatment, the patient is obliged to pay the doctor for treatment without the possibility of reimbursement from his or her health insurance fund.

80.      It observes that the conclusion of such agreements with the health insurance fund forms a complex process and that such agreement is not obtained automatically but follows a stringent selection procedure, with the result that an ad hoc agreement cannot be concluded in the context of freedom to provide services under Article 56 TFEU.

81.      It infers that this obligation to conclude an agreement with the patient’s health insurance fund must be regarded as an obligation falling under the concept of ‘registration’ for the purpose of settling accounts with insurers within the meaning of Article 6(b) of Directive 2005/36.

82.      The Commission acknowledges that EU law does not, in principle, prevent a Member State making reimbursement of the cost of treatment subject to compliance with certain requirements, but asserts that Article 6(b) of Directive 2005/36 precludes administrative requirements, like registration, which in themselves render absolutely impossible any reimbursement of the cost of services provided.

83.      It adds that, pursuant to the Court’s case-law, (30) the Czech system of reimbursement of the costs of treatment also infringes Article 56 TFEU, of which Article 6(b) of Directive 2005/36 is an expression, and that the achievement of the fundamental freedoms guaranteed by the Treaty requires Member States to adjust their social security systems.

84.      It submits that the concept of ‘public social security body’ within the meaning of Article 6(b) of Directive 2005/36 is broader than the concept of ‘insurer’ and also covers health insurance funds, since they are responsible for reimbursement of the cost of medical services provided to patients under the health insurance system.

85.      The Czech Republic asserts that the second complaint is unfounded.

86.      It maintains that the obligation under Czech law to conclude an agreement with a health insurance fund cannot be treated as equivalent to an obligation to register with a public social security body in accordance with Article 6(b) of Directive 2005/36 and refers in this regard to the judgment in Commission v Spain. (31)

87.      It submits that the Commission’s assessment is not supported by the wording of Article 6 of Directive 2005/36, which distinguishes between (i) the public social security body, with which registration cannot be required, and (ii) the insurer to which the services provided are charged. The health insurance fund in question is an insurer within the meaning of that provision and not the public social security body within the meaning thereof.

88.      It observes that a social security scheme under which the cost of treatment other than urgent treatment is reimbursed only to contractual partners is quite common in the European Union and affords the scheme its financial security and quality and ensures the proximity of medical care.

89.      It also refers to recital 38 of Directive 2005/36, which, in its view, confirms its assessment that the directive does not relate to the provision of health services and their reimbursement.

(b)    Assessment

90.      Before examining the substance of this complaint, it is necessary to define its subject matter precisely. It should be noted in this regard that, in essence, the Commission alleges that the Czech Republic has failed to transpose Article 6(b) of Directive 2005/36 in respect of, first, the exemption of service providers established in another Member State from the obligation to register with a public social security body in the host Member State and, second, the obligation for service providers to inform that body.

91.      In my view, it follows that in these infringement proceedings the compatibility of the national measures adopted by the Czech Republic may be assessed having regard to that article alone and not having regard to other provisions of EU law, such as Article 56 TFEU. Accordingly, the arguments developed by the Commission based on that latter article are not relevant.

92.      Having said that, in order to understand the meaning and the scope of the provisions of Article 6(b) of Directive 2005/36, regard should be had, first, to the objectives of that directive and the system it establishes for the provision of services.

93.      As far as the objectives of Directive 2005/36 are concerned, recital 4 thereof states that the directive seeks to facilitate the free provision of services by introducing specific rules aimed at extending the possibility of pursuing professional activities under the original professional title.

94.      Within that framework, Directive 2005/36 establishes, in Title II thereof, (32) a simplified recognition procedure for service providers. That system, which is based on the principle of the free provision of services, (33) is related to the specific feature of such provision which, under Article 5(2) of the directive, corresponds to the temporary and occasional pursuit of a profession in the host Member State. (34)

95.      That being said, the directive reconciles the principle of the free provision of services with the interests of the host Member State. Thus, while exempting the provider from the qualifications recognition mechanism, that directive authorises Member States, under Article 7(1) thereof, to require a declaration made in advance (35) of the first provision of services, the purpose of which, particularly in the case of professions that have public health or safety implications, is to make a limited check of the provider’s professional qualifications. Following that check, the competent authority must, no later than one month after receipt of the declaration, (36) take the decision to allow the provision of services or to require an aptitude test.

96.      It is in the context of this system that, in order to limit obstacles to the free provision of services, Article 6 of Directive 2005/36 provides that the host Member State is to exempt service providers established in another Member State from the requirements which it places on professionals established in its territory relating to, in point (a) thereof, ‘authorisation by, registration with or membership of a professional organisation or body’ and, in point (b) thereof, ‘registration with a public social security body for the purpose of settling accounts with an insurer relating to activities pursued for the benefit of insured persons’. Under that article, ‘the service provider shall, however, inform in advance or, in an urgent case, afterwards, the body referred to in point (b) of the services which he has provided’.

97.      The judgment in Commission v Spain, which is relied on by the Czech Republic, could cast light on the interpretation of Article 6(b) of Directive 2005/36. In that case, the Commission, which had brought an action before the Court for failure to fulfil obligations, alleged that the Kingdom of Spain had failed to transpose Article 18 of Directive 93/16/EEC, (37) the provisions of which are equivalent (38) to those in Article 6(b) of Directive 2005/36. The Commission’s arguments were essentially based on the fact that Spain’s legislation made reimbursement of the cost of health services subject to a doctor’s membership of the national health system.

98.      In rejecting that complaint, the Court held, first, that neither Article 18 of Directive 93/16 nor any other provision of that directive seeks to eliminate all obstacles that might exist in the Member States relating to the reimbursement of the cost of medical services by an insurance body to which the doctor established in another Member State does not belong. (39) The Court held, second, that such an obligation would go beyond the bounds of a directive on the mutual recognition of diplomas and would, in addition, not be consistent with the 22nd recital of Directive 93/16, according to which that directive does not affect the power of the Member States to organise their national social security schemes. (40)

99.      It is thus clear from that judgment that the Court draws a distinction between the obligation for the host Member State to exempt the service provider from registration with a public social security body and that State’s organisation of its system of reimbursement of the cost of health services.

100. It seems that, contrary to the assertion made by the Commission, the Court’s reasoning in the judgment in Commission v Spain is still relevant in assessing the substance of the complaint at issue.

101. In this regard, it is clear from the wording of Article 6(b) of Directive 2005/36 that reimbursement of the cost of medical services supplied by a service provider cannot be made subject to the provider’s registration with a public social security body. It cannot therefore be inferred from the wording of that provision that, beyond the exemption laid down therein, the provider would not be required to complete the charging formalities for health services inherent in the organisation of the social security system of the host Member State. It follows, in my view, that that provision does not regulate the detailed arrangements for reimbursement of the cost of health services laid down in the national legislation of a Member State.

102. This interpretation is corroborated, moreover, by recital 38 of Directive 2005/36, according to which ‘the provisions of this Directive do not affect the powers of the Member States as regards the organisation of their national social security system and determining the activities which must be pursued under that system’. Following this logic, the directive does not provide for a general mechanism to organise the relationship between recognition of qualifications and national social security systems. I therefore find it hard to see how the pursuit of a profession in the host Member State, even on a temporary or occasional basis, entails the right to have health services covered by the social insurance funds of that Member State, without the need to complete the formalities required by national legislation.

103. In these circumstances, as the Court has already pointed out in the judgment in Commission v Spain, I doubt that, in enacting Article 6(b) of Directive 2005/36, the EU legislature intended to confer on the exemption from registration with a public social security body such scope that it would affect the organisation of the social security system of a Member State. In other words, I consider that that provision cannot be given such a broad interpretation and, in actual fact, has no purpose in the system established by the directive other than setting aside the registration formality expressly provided for in that provision.

104. In the light of all these considerations, I take the view that the Commission is not justified in claiming that the obligation for the host Member State to exempt service providers from registration with a public social security body entails the obligation to exempt service providers from the duty to conclude an agreement with the patient’s health insurance fund.

105. Accordingly, I propose that the Court reject the second complaint, concerning failure to transpose Article 6(b) of Directive 2005/36.

D.      The fourth complaint, concerning failure to transpose Article 21(6) and Article 31(3) of Directive 2005/36

1.      Admissibility of the complaint

(a)    Arguments of the parties

106. The Czech Republic raises three pleas of inadmissibility.

107. First, it submits that the fourth complaint did not appear in the operative part of the reasoned opinion and that such omission is not reparable because it results in a fundamental discrepancy between that operative part and the form of order set out in the application. It adds that this irregularity, which was not remedied in the supplementary reasoned opinion, deprived it of any certainty as to the precise extent of the infringement of EU law alleged by the Commission.

108. Second, the Czech Republic submits that in the application the Commission altered the subject matter of the complaint compared with the pre-litigation procedure. It claims in this regard that at the stage of the reasoned opinion and the letter of formal notice this complaint related only to the title of the profession of ‘nurse practitioner’ under Czech law, which creates a likelihood of confusion with the profession of general nurse, corresponding to ‘nurse responsible for general care’ within the meaning of Directive 2005/36. It concludes that this complaint is distinct from the complaint raised in the application since it now concerns the precise scope of the activities of nurse practitioners.

109. Third, the fourth complaint was not set out coherently and precisely, in particular in so far as in paragraph 115 of the application the Commission summarises the analysis of that complaint solely by reference to the title of the profession of nurse practitioner, without mentioning the overlap between the activities of the professions in question.

110. For its part, the Commission maintains that this complaint is admissible.

111. With regard to the first plea of inadmissibility, it asserts that the omission of the complaint from the operative part of the reasoned opinion, which it characterises as a ‘clerical error’, did not affect the rights of defence of the Czech Republic, as the Czech Republic submitted observations on that complaint.

112. As far as the second and third pleas of inadmissibility are concerned, the Commission submits that it neither altered nor extended the subject matter of that complaint as defined in the reasoned opinion because from the time of letter of formal notice it has claimed a failure to fulfil the obligation referred to in Article 21(6) and Article 31(3) of Directive 2005/36. It asserts that at the stage of the pre-litigation procedure it stated that that directive did not prevent certain activities of the profession of nurse also being pursued by other less qualified persons, but that there should be no ambiguity regarding the differing levels of training and competences of the professionals concerned.

113. In addition, in their response, the Czech authorities did highlight the differences between the activities of the professions of ‘general nurse’ and ‘nurse practitioner’ and therefore understood perfectly clearly that the Commission’s complaint concerned the coexistence of those professions.

(b)    Assessment

114. As I have already stated, the Court has consistently ruled that the reasoned opinion and the action brought by the Commission must be based on the same complaints as those in the letter of formal notice initiating the pre-litigation procedure. Even though that requirement cannot go so far as to mean that in every case exactly the same wording must be used in both, the fact remains that the subject matter of the dispute cannot be extended or altered during the procedure before the Court. (41)

115. In the present case, it is clear from the letter of formal notice (42) and the reasoned opinion (43) that at the stage of the pre-litigation procedure the Commission stated that Czech law provides for a profession of ‘general nurse’, members of which may lay claim to the professional title of ‘nurse responsible for general care’ as defined in Directive 2005/36. The Commission noted that Czech law has also established the profession of ‘nurse practitioner’ and that access to that professional title entails training the level of which does not satisfy the minimum requirements laid down in Article 31(3) of that directive. The Commission asserted that the terms ‘general’ and ‘practitioner’ give rise to a likelihood of confusion between those two professions for patients and professionals in the Member States. It concluded that it is necessary to modify the professional title ‘nurse practitioner’, adding the word ‘assistant’, and the conditions of training for that profession.

116. At the stage of the procedure before the Court, the Commission submits that its complaint is essentially based on the fact that the activities of the two professions of ‘general nurse’ and ‘nurse practitioner’ are, to a large extent, highly comparable, with the result that the Czech Republic was not able to create a parallel profession without calling into question the effectiveness of Directive 2005/36 and circumventing its requirements. In support of this argument, the Commission makes a detailed comparative analysis of the activities allocated to each of those professions.

117. It follows that, even though it seeks an identical finding of infringement of Article 21(6) and Article 31(3) of Directive 2005/36, the complaint as set out in the application now relates essentially to the precise nature of the activities of nurse practitioners and the detailed examination of their comparability with the activities of general nurses, whereas the letter of formal notice and the reasoned opinion concerned the likelihood of confusion caused by the titles of those two professions.

118. It would appear that, in doing so, the Commission did not confine itself to clarifying that complaint but substantially altered its subject matter by shifting the debate to a question on which arguments were not exchanged between the parties during the pre-litigation procedure. In those circumstances, it seems that the Czech Republic was deprived of the opportunity to avail itself of its right to defend itself against the complaint relied on by the Commission.

119. It should be observed, moreover, that the complaint put forward in the application is particularly technical in nature in that it requires a detailed examination of the activities allocated to the professions of ‘general nurse’ and ‘nurse practitioner’ respectively. However, I take the view that in so far as this point was not discussed during the pre-litigation procedure, the Court will not be able to make an informed decision.

120. Accordingly, I propose that the Court declare the fourth complaint to be inadmissible.

2.      Substance of the complaint

121. As I have explained, the procedural defect prevents the merits of this complaint from being assessed. In these circumstances, I do not think it is possible to make a finding on its substance.

E.      The fifth complaint, concerning failure to transpose Article 45(2) of Directive 2005/36

1.      Admissibility of the complaint

(a)    Arguments of the parties

122. In support of the pleas of inadmissibility raised by it, the Czech Republic submits that the Commission failed to indicate coherently and precisely the alleged infringement of EU law.

123. In particular, the Commission did not identify clearly in the reasoned opinion the provisions of Czech law which it considered to be contrary to Article 45(2) of Directive 2005/36 or even the precise nature of the infringement which it alleged the Czech Republic had committed.

124. Furthermore, the application itself also does not allow the scope of the infringement to be defined precisely in so far as it refers sometimes to Article 45(2) of Directive 2005/36 in its entirety and sometimes only to points (c), (e) and (f) of that provision.

125. In addition, at the stage of the proceedings before the Court, the Commission no longer invokes the provisions of Czech law which it mentioned in the letter of formal notice and now refers to other provisions of Czech law. The Czech Republic concludes that the Commission has extended the subject matter of that complaint.

126. For its part, the Commission maintains that the fifth complaint is admissible.

127. It asserts that from the time of the letter of formal notice it has alleged that the Czech Republic has failed adequately to transpose Article 45(2) of Directive 2005/36 and that it had mentioned Decree No 187/2009 Sb. (44) because it did not transpose certain obligations under EU law, not because it infringed EU law. It does not therefore matter that that Decree was no longer cited in the application.

128. It then referred to Law No 95/2004 in the reasoned opinion in the light of the observations on the letter of formal notice communicated by the Czech Republic.

129. The Commission adds that, following the Czech Republic’s observations on the letter of formal notice, it eventually limited the scope of the complaint to Article 45(2)(c), in part (e), and (f) of Directive 2005/36 in the reasoned opinion and that this is also the scope of the complaint in its application.

(b)    Assessment

130. With regard to the plea of inadmissibility alleging alteration of the subject matter of the dispute, I note that the Commission did state in the letter of formal notice (45) that Czech law, namely Paragraph 4(2) of Decree No 187/2009 Sb., fails to transpose Article 45(2) of Directive 2005/36 in so far as it does not mention the activities referred to in points (c), (f) and (h) to (j) of that provision and mentions only some of the activities referred to in point (e) of that provision.

131. In its observations on the letter of formal notice, (46) the Czech Republic stated that Paragraph 4(2) of Decree No 187/2009 regulates the minimum requirements for acquiring the professional competences necessary to pursue the profession of pharmacist. It added that Paragraph 10(2) of Law No 95/2004 governs the activities which a pharmacist has the right to pursue independently.

132. In the reasoned opinion (47) the Commission examined the relevant provisions of those two laws and noted that Czech law makes the independent pursuit by a pharmacist of the activities referred to in points (c) and (f) and some of the activities referred to in point (e) of Article 45(2) of Directive 2005/36 contingent upon acquisition of supplementary specialised training. It concluded that, by failing to mention those activities among those which may be pursued by a pharmacist with basic training, the Czech Republic has failed to fulfil the obligations under that article. This argument was then taken up and developed in the application.

133. Accordingly, from the time of the letter of formal notice the Commission has claimed that Czech law does not guarantee pharmacists access to some of the activities referred to in Article 45(2) of Directive 2005/36. Subsequently, in the reasoned opinion and the application, the Commission developed this complaint in the light of the provisions of national law cited by the Czech Republic in its observations on the letter of formal notice. It would seem that, in referring to new provisions of Czech law, the Commission did not extend the complaint as set out in the letter of formal notice, but clarified its subject matter in the context of the exchange of arguments inherent in the proper conduct of the adversarial procedure.

134. I also take the view that it cannot be alleged that the Commission failed to set out the complaint precisely and coherently both at the stage of the pre-litigation procedure and in the proceedings before the Court. It follows from the above arguments that, both in the reasoned opinion and in the application, the Commission presented the reasons why it considers that the provisions of Czech law, which it has identified precisely, infringe the obligations under Article 45(2)(c), in part (e), and (f) of Directive 2005/36.

135. In these circumstances, I consider that the Czech Republic is not justified in claiming that the fifth complaint is inadmissible.

2.      Substance of the complaint

(a)    Arguments of the parties

136. The Commission states that Article 45(2) of Directive 2005/36 requires that Member States guarantee pharmacists who satisfy the basic conditions relating to professional qualifications laid down in Article 44 of that directive access to the activities mentioned in Article 45(2) thereof, subject only to the requirement, where appropriate, of supplementary professional experience. It follows that a Member State may not impose a restriction on the pursuit of those activities other than relating to this requirement of supplementary professional experience.

137. The Commission submits that the Czech Republic has failed to transpose this provision in respect of some of the activities referred to in Article 45(2) of Directive 2005/36 by making the independent pursuit of those activities contingent upon supplementary specialised competences. More specifically, the Commission asserts in particular that the provisions of Czech law in Paragraph 11(7) to (11) of Law No 95/2004 require supplementary specialised training for the independent pursuit of the following activities:

–        pharmaceutical technologies,

–        laboratory and analysis methods in health,

–        radiopharmaceutical medicines,

–        practical pharmacy,

–        clinical pharmacy,

–        hospital pharmacy.

138. The Commission also observes that under Paragraph 11(12) of that Law, before acquiring those specialised competences, a pharmacist may pursue the activities mentioned in subparagraphs 7 to 11 of that provision only under the professional supervision of a healthcare professional who already holds those competences.

139. According to the Commission, those activities correspond to the activities mentioned in Article 45(2)(c), in part (e), and (f) of Directive 2005/36.

140. The Commission maintains that the conditions imposed by Czech law relating to supplementary specialised training or professional supervision are not consistent with the objective and the scheme of Section 7, entitled ‘Pharmacist’, of Directive 2005/36. It asserts that pharmacists whose professional training satisfies the harmonised minimum conditions must have the ability to pursue all the activities mentioned in Article 45(2) of that directive, subject only to the requirement, where appropriate, of supplementary professional experience. It concludes that the supplementary restrictions imposed by Czech law constitute a infringement of that article and an obstacle to free movement.

141. For its part, the Czech Republic maintains that this complaint is unfounded.

142. First, it submits that Article 45(2) of Directive 2005/36 does not cover the activities for which Czech law requires specialised qualifications from pharmacists. It asserts that, in using the words ‘at least’ in that provision, the EU legislature recognised that there may be other activities requiring a particular specialisation to which pharmacists who possess basic qualifications for the purposes of Directive 2005/36 may not gain access. It states that in highly specialised fields of pharmacy, a lack of experience and an absence of professional supervision are likely to have huge repercussions on the lives and health of a large number of people.

143. The Czech Republic maintains that the activities referred to in Paragraph 11(7) to (11) of Law No 95/2004, which it presents in detail, fall within this category and do not correspond to the ‘usual’ activities listed in Article 45(2)(c), (e) and (f) of Directive 2005/36.

144. Second, the Czech Republic submits that those specialised qualifications relate only to the independent pursuit of the activities in question and that under Paragraph 11(12) of Law No 95/2004 each pharmacist may pursue all the activities for which specialised qualifications are required under the professional supervision of a health professional who holds those qualifications. This approach is fully consistent with Article 45(2) of Directive 2005/36, as that provision requires only that the holders of evidence of professional training in pharmacy are able to access and pursue certain activities. On the other hand, that provision does not require that the activities referred to therein must be pursued independently.

145. Third, the Czech Republic asserts that pursuant to Article 45(2) of Directive 2005/36 Member States may require acquisition of supplementary professional experience in order to gain access to certain activities of a pharmacist. It observes in this regard that under Paragraph 11(1) of Law No 95/2004 the specialised competences at issue may be acquired either by specialised training or by supplementary professional experience. It concludes that this provision offers a choice between two methods of acquiring specialised competences, which means that a pharmacist is not obliged to follow specialised training in order to be able to pursue activities requiring specialised competences.

(b)    Assessment

146. As a preliminary point, it should be recalled that Directive 2005/36 establishes, in Chapter III of Title III thereof, a system of automatic mutual recognition for seven professions, including pharmacist. (48) The system is based, first, on the definition of minimum training requirements with which all Member States must comply and, second, on the automatic recognition of all diplomas satisfying those requirements.

147. Within that framework, Articles 44 and 45 (49) of that directive define the training standards applying to pharmacists and the activities open to them on the basis of those qualifications. More specifically, Article 45(2) of that directive provides that ‘the Member States shall ensure that the holders of evidence of formal qualifications in pharmacy at university level or a level recognised as equivalent, which satisfies the requirements of Article 44, are able to gain access to and pursue at least the following activities, subject to the requirement, where appropriate, of supplementary professional experience’. Those activities include, under point (c) of that provision, testing of medicinal products in a laboratory for the testing of medicinal products, under point (e), supply, preparation, testing, storage, distribution and dispensing of safe and efficacious medicinal products of the required quality in pharmacies open to the public (50) and, under point (f), preparation, testing, storage and dispensing of safe and efficacious medicinal products of the required quality in hospitals.

148. In the case at issue, Paragraph 11 of Law No 95/2004 makes the independent pursuit of certain activities as a pharmacist contingent upon acquisition of specialised competences such that, before they are acquired, the pharmacist may pursue those activities only under the supervision of a healthcare professional who holds those competences.

149. In order to assess the substance of this complaint, it is necessary, in a first step, to determine whether the requirement under Czech law relating to acquisition of specialised competences complies with the stipulations of Article 45(2) of Directive 2005/36, which permits Member States to make access to activities in pharmacy contingent only upon supplementary professional experience.

150. In this respect it should be observed that under Article 3(f) of Directive 2005/36 ‘professional experience’ means the actual and lawful pursuit of the profession concerned in a Member State. (51) In my view, it is clear from this definition that such experience must be practical and genuine so as to allow the pharmacist to pursue the activity concerned following practical experience.

151. In addition, as is apparent from the wording of Article 45(2) of Directive 2005/36, that experience can only be supplementary to training previously completed by a pharmacist under the conditions laid down by that directive. A Member State cannot require professional experience which, in reality, constitutes supplementary training leading to a qualification without circumventing the system of mutual recognition of qualifications regulating the profession of pharmacist.

152. I note that, under Paragraph 11(1) of Law No 95/2004, specialised competences of a pharmacist are acquired either by successfully completing specialised training attested by a certified examination or by obtaining supplementary professional experience.

153. It is clear that the first condition relating to successful completion of specialised training does not satisfy the definition of ‘supplementary professional experience’ which I propose be adopted by the Court.

154. As regards the second condition, I consider that, despite its wording, it also fails to satisfy that definition. In this regard I note that under Paragraph 11 of Law No 95/2004 (52) the application for registration in respect of supplementary professional experience must be submitted to an accredited institution and that, at the end of that period of training attested by a certificate, the Ministry must issue a diploma of specialised competences. It would seem that in the light of these conditions, supplementary professional experience as regulated by Czech law can be regarded as supplementary specialised training.

155. That being so, this finding alone is not sufficient to substantiate the complaint put forward by the Commission.

156. It is necessary, in a second step, to determine to what extent a host Member State is entitled to require, for certain professional activities of pharmacists, acquisition of specialised competences going beyond the requirement of supplementary professional experience within the meaning of Article 45(2) of Directive 2005/36.

157. In this regard, I think that a textual analysis of that provision provides helpful guidance as to interpretation. It is clear from its wording that, provided they satisfy the training requirements under Directive 2005/36, pharmacists must be able to gain access to at least the activities referred to in that provision. The use of the expression ‘at least’ would seem to indicate unequivocally that Article 45(2) of that directive requires Member States only to guarantee access to the activities referred to therein, subject, where appropriate, to supplementary professional experience. (53) It is clear, by the same token, that those States enjoy full discretion in making access to other activities not mentioned in that provision subject to more stringent training requirements. (54)

158. This interpretation is supported, moreover, by a reading of recital 25 of Directive 2005/36, according to which, going beyond a minimum range of activities to which pharmacists who satisfy basic training conditions should have access, the Member States remain free to impose supplementary training conditions for access to activities not included in that minimum range. (55)

159. In addition, I note that recital 44 of that directive states that ‘this Directive is without prejudice to measures necessary to ensure a high level of health and consumer protection’. This wording would seem to reflect the EU legislature’s intention to allow Member States, in order to achieve this objective, the possibility to require specialised training for certain activities needing a high level of expertise.

160. It is in the light of that guidance as to interpretation that it must be determined whether the activities for which the Czech legislation requires acquisition of specialised competences fall within the scope of Article 45(2)(c), in part (e), and (f) of Directive 2005/36.

161. As regards, first, the field of laboratory and analysis methods in health under Paragraph 11(7) of Law No 95/2004, I would observe that Article 45(2)(c) of Directive 2005/36, on which the Commission relies, refers to testing of medicinal products in a laboratory for the testing of medicinal products. It can be inferred both from the description of this field and from the clarifications provided by the Czech Republic that these methods concern techniques relating to laboratory tests. In so far as this field is distinct from testing of medicinal products in a laboratory for the testing of medicinal products, it does not, in my view, fall within the minimum range of activities provided for in Article 45(2) of the directive.

162. As regards, second, the field of clinical pharmacy, it should be noted that, according to the Court’s settled case-law, it is for the Commission to prove the existence of the alleged infringement and to provide the Court with the information necessary for it to determine whether the infringement is made out, and the Commission may not rely on any presumption for that purpose. (56) In the present case, it must be stated that the Commission does not explain how this field might come under any of the activities referred to in Article 45(2) of Directive 2005/36 and simply asserts that the Czech Republic’s arguments do not make any relevant reference to Czech legislation. It follows that the existence of that infringement has not been demonstrated to the requisite legal standard.

163. As regards, third, hospital pharmacy, pharmaceutical technologies and radiopharmaceutical medicines, I note that, under Paragraph 11(10) and (11) of Law No 95/2004, those activities are related to the preparation of particularly complex pharmaceutical forms, which are defined, for the purposes of that Law, as sterile medicinal products for parenteral application prepared in specialised facilities in pharmacies. In my view, if Article 45(2)(f) of Directive 2005/36 is not to be construed too broadly, (57) such activities cannot be treated as equivalent to the preparation of safe and efficacious medicinal products of the required quality in hospitals. Contrary to the assertion made by the Commission, the fact that point (f) does not draw a distinction based on the degree of complexity of medicinal products prepared in hospitals would not seem to be a crucial criterion for interpretation. Following the logic which I propose be adopted by the Court, this difference seems, conversely, to justify fully the non-inclusion of the preparation of pharmaceutical forms which, in the light of their definition, have a high level of technicality in the minimum range of activities provided for in Article 45(2) of the directive.

164. As regards, fourth, the field of practical pharmacy, reference should be made to the wording of Paragraph 11(8) of Law No 95/2004, according to which acquisition of specialised competences in that field is a condition for the independent pursuit of activities related to management of a pharmacy. It is undeniable that supply and distribution of medicinal products in pharmacies open to the public, as mentioned in Article 45(2)(e) of Directive 2005/36, necessarily entail the performance of activities related to management of a pharmacy and form an essential part of them. In these circumstances, I consider that this field, which, moreover, is part of the usual pursuit of the profession of pharmacist, falls within the range of the activities referred to in Article 45 of that directive.

165. For all the above reasons, I propose that the fifth complaint be upheld only in respect of this latter point.

F.      Summary of the analysis

166. The analysis of the action leads me to conclude that the first complaint and, in part, the fifth complaint are well founded. The action should be dismissed as to the remainder.

VI.    Conclusion

167. In the light of the above considerations, I propose that, with regard to the first, second, fourth and fifth complaints, the Court should:

(1)      declare that:

–        by failing to adopt the necessary measures to determine the status of migrant under supervision and the status of applicant who wishes to prepare himself or herself for the aptitude test, the Czech Republic has failed to fulfil its obligations under Article 3(1)(g) and (h) of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications, as amended by Directive 2013/55/EU of the European Parliament and of the Council of 20 November 2013, and,

–        by making the independent pursuit of activities related to management of a pharmacy contingent upon acquisition of specialised competences, the Czech Republic has failed to fulfil its obligations under Article 45(2)(e) of Directive 2005/36, as amended by Directive 2013/55.

(2)      dismiss the action as to the remainder.

1      Original language: French.

2      Directive of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ 2005 L 255, p. 22).

3      Directive of the European Parliament and of the Council of 20 November 2013 (OJ 2013 L 354, p. 132).

4      Approximately EUR 270.

5      In this regard Article 3(1) of Directive 2013/55 provides: ‘Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 18 January 2016.’

6      See, inter alia, judgments of 8 December 2005, Commission v Luxembourg (C‑33/04, EU:C:2005:750, paragraph 70); of 31 May 2018, Commission v Poland (C‑526/16, not published, EU:C:2018:356, paragraph 49); and of 18 October 2018, Commission v Romania (C‑301/17, not published, EU:C:2018:846, paragraph 32).

7      See judgment of 19 September 2017, Commission v Ireland (Registration tax) (C‑552/15, EU:C:2017:698, paragraphs 28 and 29 and the case-law cited).

8      Judgment of 26 April 2018, Commission v Bulgaria (C‑97/17, EU:C:2018:285, paragraphs 18 and 19 and the case-law cited).

9      Judgment of 8 March 2022, Commission v United Kingdom (Action to counter undervaluation fraud) (C‑213/19, EU:C:2022:167, paragraph 133 and the case-law cited).

10      See judgment of 11 July 2018, Commission v Belgium (C‑356/15, EU:C:2018:555, paragraph 34 and the case-law cited).

11      Judgment of 22 September 2016, Commission v Czech Republic (C‑525/14, EU:C:2016:714, paragraph 17 and the case-law cited).

12      Judgment of 25 April 2013, Commission v Spain (C‑64/11, not published, EU:C:2013:264, paragraph 14 and the case-law cited).

13      Judgment of 2 March 2023, Commission v Poland (Forest management and good practice) (C‑432/21, EU:C:2023:139, paragraph 32 and the case-law cited).

14      Judgment of 21 December 2016, Commission v Portugal (C‑503/14, EU:C:2016:979, paragraph 16 and the case-law cited).

15      Judgment of 30 April 2020, Commission v Romania (Exceedance of limit values for PM10) (C‑638/18, not published, EU:C:2020:334, paragraph 49 and the case-law cited).

16      See paragraph 3.1 of the reasoned opinion, in particular the arguments developed on page 155 of that opinion.

17      Judgment of 22 December 2022, Les Entreprises du Médicament (C‑20/22, EU:C:2022:1028, paragraph 18 and the case-law cited).

18      Judgment of 3 March 2022, Sosiaali- ja terveysalan lupa- ja valvontavirasto (Basic medical training) (C‑634/20, EU:C:2022:149, paragraph 34 and the case-law cited).

19      That article states, in essence, that the Member State is entitled to require compensation measures if training covers substantially different matters than those covered by the evidence of formal qualifications required in the host Member State or if the scope of the professional activities open to the profession is broader in the host Member State than in the home Member State.

20      Under Article 3(1)(d) of Directive 2005/36, competent authority means: ‘any authority or body empowered by a Member State specifically to issue or receive training diplomas and other documents or information and to receive the applications, and take the decisions, referred to in this Directive’.

21      This definition of the word ‘déterminer’ (determine) is given in the ninth edition (in publication) of the Dictionnaire de l’Académie française. The other language versions of Directive 2005/36 are consistent as regards this requirement. See, with regard to paragraphs (g) and (h) of Article 3(1) of that directive respectively, in German ‘festgelegt’; in Estonian ‘kehtestab’ and ‘määrab’; in English ‘shall be laid down’ and ‘shall be determined’; in Italian ‘sono determinati’ and ‘sono determinate’; and in Czech ‘stanoví’.

22      I note in this respect that although national authorities are competent as regards the form and methods to achieve the result prescribed by a directive, the implementing measures, in order to satisfy the requirements of legal certainty, must be sufficiently precise and clear. See, to that effect, judgment of 12 May 2022, U.I. (Indirect customs representative) (C‑714/20, EU:C:2022:374, paragraphs 57 to 59 and the case-law cited).

23      Judgment of 6 May 2010, Commission v Poland (C‑311/09, not published, EU:C:2010:257, paragraph 34 and the case-law cited).

24      See paragraph 2.2.2. of the letter of formal notice.

25      See paragraph 3.3. of the reasoned opinion.

26      See paragraph 2.2.2 of the letter of formal notice.

27      See paragraph 3.3 of the reasoned opinion.

28      The Commission refers to Paragraphs 11(1) and 17(1) of Law No 48/1997.

29      The Commission refers to the judgments of 28 April 1998, Decker (C‑120/95, EU:C:1998:167) and Kohll (C‑158/96, EU:C:1998:171).

30      The Commission refers to the judgments of 16 May 2006, Watts (C‑372/04, EU:C:2006:325) and of 27 October 2011, Commission v Portugal (C‑255/09, EU:C:2011:695).

31      Judgment of 16 May 2002 (C‑232/99, EU:C:2002:291; ‘the judgment in Commission v Spain’).

32      That title encompasses Articles 5 to 9 of Directive 2005/36.

33      This expression is the heading for Article 5 of Directive 2005/36.

34      According to the second paragraph of that article, the ‘temporary and occasional nature of the provision of services shall be assessed case by case, in particular in relation to its duration, its frequency, its regularity and its continuity.’

35      Under Article 7(2) of Directive 2005/36, Member States may require that the declaration be accompanied by documentation. Without mentioning all the documents listed exhaustively in that article, the purpose of producing them is to allow States to check the provider’s professional qualifications and experience and to satisfy themselves, in the field of public health in particular, that the provider presents sufficient guarantees related to his or her probity and knowledge of the language of the host Member State.

36      This being so, that decision may be deferred under the conditions laid down in Article 7(4) of Directive 2005/36.

37      Council Directive of 5 April 1993 to facilitate the free movement of doctors and the mutual recognition of their diplomas, certificates and other evidence of formal qualifications (OJ 1993 L 165, p. 1).

38      Under Article 18 of Directive 93/16, ‘where registration with a public social security body is required in a host Member State for the settlement with insurance bodies of accounts relating to services rendered to persons insured under social security schemes, that Member State shall exempt nationals of Member States established in another Member State from this requirement, in cases of provision of services entailing travel on the part of the person concerned. However, the persons concerned shall supply information to this body in advance, or, in urgent cases, subsequently, concerning the services provided.’

39      Judgment in Commission v Spain, paragraph 52.

40      Judgment in Commission v Spain, paragraph 53.

41      See points 32 and 33  of this Opinion.

42      See paragraph 2.4.3 of the letter of formal notice.

43      See paragraph 3.5.3.1 of the reasoned opinion, it being noted that this complaint is not addressed in the supplementary reasoned opinion.

44      Vyhláška č. 187/2009 Sb., o minimálních požadavcích na studijní programy všeobecné lékařství, zubní lékařství, farmacie a na vzdělávací program všeobecné praktické lékařství (Decree No 187/2009 Sb. on minimum requirements for study programmes in general medicine, dentistry and for the training programme for general medical practitioners).

45      See paragraph 2.4.6 of the letter of formal notice.

46      See paragraph 2.4.6 of the observations on the letter of formal notice.

47      See paragraph 3.5.1 of the reasoned opinion.

48      The provisions relating specifically to pharmacists are in Section 7 of that chapter.

49      Articles 44 and 45 of Directive 2005/36 reproduced Articles 1 and 2 of Council Directive 85/432/EEC of 16 September 1985 concerning the coordination of provisions laid down by Law, Regulation or Administrative Action in respect of certain activities in the field of pharmacy (OJ 1985 L 253, p. 34). More broadly, the provisions of Directive 2005/36 are intended to consolidate and simplify the system under Directive 85/432. See, to that effect, Proposal for a Directive of the European Parliament and of the Council on the recognition of professional qualifications (COM/2002/0119 final) (OJ 2002 C 181 E, p. 183).

50      It should be pointed out that, as far as Article 45(2)(e) of Directive 2005/36 is concerned, the Commission mentions in support of its action only the activities of supply and distribution of medicinal products.

51      See, to that effect, judgment of 5 April 2011, Toki (C‑424/09, EU:C:2011:210, paragraph 28).

52      I refer in particular to subparagraphs 3 and 5 of that provision.

53      If those provisions are not to be rendered ineffective, such a guarantee necessarily means that a pharmacist who satisfies the minimum requirements relating to professional qualifications may pursue fully independently the activities mentioned in Article 45(2) of Directive 2005/36.

54      It should be noted that under Article 3 of Directive 85/432 the Commission had to submit to the Council of the European Union appropriate proposals on specialisations in pharmacy and in particular hospital pharmacy. It follows that, going beyond the basic training requirements and the range of activities that is open based on these qualifications governed by Articles 1 and 2 of that directive, the legislature had reserved the existence of specialised training. In so far as those provisions are reproduced, in essence, in Articles 44 and 45 of Directive 2005/36, it seems that the system under that directive, like that under Directive 85/432, merely seeks to establish a minimum range of activities to which pharmacists holding basic qualifications must have access.

55      According to recital 25 of Directive 2005/36, ‘holders of qualifications as a pharmacist are specialists in the field of medicines and should, in principle, have access in all Member States to a minimum range of activities in this field’. This being so, ‘the provisions of this Directive are without prejudice to the possibility for the Member States to impose supplementary training conditions for access to activities not included in the coordinated minimum range of activities. This means that the host Member State should be able to impose these conditions on the nationals who hold qualifications which are covered by automatic recognition within the meaning of this Directive’.

56      Judgment of 17 December 2020, Commission v Hungary (Reception of applicants for international protection) (C‑808/18, EU:C:2020:1029, paragraph 112 and the case-law cited).

57      I note in this regard that, as far as paragraph (e) of Article 45(2) of that directive is concerned, the Commission does not mention in support of its action the activity of preparation of medicinal products.