# C_2011145EN.01000902.xml

| 14.5.2011 | EN | Official Journal of the European Union | C 145/9 |
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Reference for a preliminary ruling from the Korkein hallinto-oikeus (Finland) lodged on 24 February 2011 — Marja-Liisa Susisalo, Olli Tuomaala, Merja Ritala

(Case C-84/11)

2011/C 145/13

Language of the case: Finnish

Referring court

Korkein hallinto-oikeus

Parties to the main proceedings

Applicants: Marja-Liisa Susisalo, Olli Tuomaala, Merja Ritala

Other parties: Helsingin yliopiston apteekki, Lääkealan turvallisuus- ja kehittämiskeskus FIMEA

Questions referred

| 1. | Is Article 49 TFEU, which deals with the right of establishment under EU law, to be interpreted to mean that it precludes application of the provisions of Finland’s Law on Medicines with respect to the pharmacies operating licence scheme, for the reason that conditions set for Helsinki University Pharmacy to set up branch pharmacies differ from the conditions set for private pharmacies as follows:
(a)
By a licence granted by Finnish Medicines Agency (‘FIMEA’) on the basis of Paragraph 52(1) of the Law on Medicines, a private branch pharmacy may be set up in an area which (because of the sparseness of its population) cannot be regarded as having adequate operational prerequisites for an independent pharmacy, but where (for the availability of medicines) a pharmacy business is required; and a private pharmacist may, on the basis of a separate licence granted for each branch pharmacy, operate a maximum of three branch pharmacies. On the other hand, a branch pharmacy of Helsinki University Pharmacy may be set up by a licence granted in each case by FIMEA on the basis of Paragraph 52(3) of the Law on Medicines, and discretion in the granting of such a licence is not limited by the provisions of the Law on Medicines or by other national regulations in any way other than that Helsinki University may have a maximum of 16 branch pharmacies. (b)
When determining the place of establishment of a private branch pharmacy, FIMEA must take account of the location of the pharmacy. There is no corresponding regulation regarding the places of location of Helsinki University Pharmacy branch pharmacies, and these branch pharmacies are located in various parts of Finland. | (a) | By a licence granted by Finnish Medicines Agency (‘FIMEA’) on the basis of Paragraph 52(1) of the Law on Medicines, a private branch pharmacy may be set up in an area which (because of the sparseness of its population) cannot be regarded as having adequate operational prerequisites for an independent pharmacy, but where (for the availability of medicines) a pharmacy business is required; and a private pharmacist may, on the basis of a separate licence granted for each branch pharmacy, operate a maximum of three branch pharmacies. On the other hand, a branch pharmacy of Helsinki University Pharmacy may be set up by a licence granted in each case by FIMEA on the basis of Paragraph 52(3) of the Law on Medicines, and discretion in the granting of such a licence is not limited by the provisions of the Law on Medicines or by other national regulations in any way other than that Helsinki University may have a maximum of 16 branch pharmacies. | (b) | When determining the place of establishment of a private branch pharmacy, FIMEA must take account of the location of the pharmacy. There is no corresponding regulation regarding the places of location of Helsinki University Pharmacy branch pharmacies, and these branch pharmacies are located in various parts of Finland. |
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| (a) | By a licence granted by Finnish Medicines Agency (‘FIMEA’) on the basis of Paragraph 52(1) of the Law on Medicines, a private branch pharmacy may be set up in an area which (because of the sparseness of its population) cannot be regarded as having adequate operational prerequisites for an independent pharmacy, but where (for the availability of medicines) a pharmacy business is required; and a private pharmacist may, on the basis of a separate licence granted for each branch pharmacy, operate a maximum of three branch pharmacies. On the other hand, a branch pharmacy of Helsinki University Pharmacy may be set up by a licence granted in each case by FIMEA on the basis of Paragraph 52(3) of the Law on Medicines, and discretion in the granting of such a licence is not limited by the provisions of the Law on Medicines or by other national regulations in any way other than that Helsinki University may have a maximum of 16 branch pharmacies. | | | | |
| (b) | When determining the place of establishment of a private branch pharmacy, FIMEA must take account of the location of the pharmacy. There is no corresponding regulation regarding the places of location of Helsinki University Pharmacy branch pharmacies, and these branch pharmacies are located in various parts of Finland. | | | | |

| 2. | If the Court of Justice takes the view that, in the light of the answers to the questions set out above, Article 49 TFEU precludes the branch pharmacy licence scheme as it applies to Helsinki University Pharmacy, the Supreme Administrative Court requests a preliminary ruling from the Court Of Justice on the following questions:
(a)
is the restriction on the freedom of establishment stemming from Helsinki University Pharmacy’s branch pharmacy licence scheme justified by overriding reasons in the general interest arising from its particular tasks relating to pharmacological services and pharmacy teaching, which are necessary and in accordance with the principle of proportionality, taking account of the fact that no corresponding particular tasks are laid down in the case of its branch pharmacies? (b)
do the particular tasks, explained above, laid down in law with respect to Helsinki University Pharmacy mean that it may be regarded as an undertaking providing services of general economic interest as referred to in Article 106(2) TFEU, and if so, does the said TFEU provision give entitlement to derogate from the requirements regarding administrative advance authorisation set by Article 49 TFEU and by the case-law of the Court of Justice in the case of Helsinki University’s branch pharmacies, taking account of the fact that no corresponding particular duties are stipulated in the case of Helsinki University Pharmacy branch pharmacies? | (a) | is the restriction on the freedom of establishment stemming from Helsinki University Pharmacy’s branch pharmacy licence scheme justified by overriding reasons in the general interest arising from its particular tasks relating to pharmacological services and pharmacy teaching, which are necessary and in accordance with the principle of proportionality, taking account of the fact that no corresponding particular tasks are laid down in the case of its branch pharmacies? | (b) | do the particular tasks, explained above, laid down in law with respect to Helsinki University Pharmacy mean that it may be regarded as an undertaking providing services of general economic interest as referred to in Article 106(2) TFEU, and if so, does the said TFEU provision give entitlement to derogate from the requirements regarding administrative advance authorisation set by Article 49 TFEU and by the case-law of the Court of Justice in the case of Helsinki University’s branch pharmacies, taking account of the fact that no corresponding particular duties are stipulated in the case of Helsinki University Pharmacy branch pharmacies? |
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| (a) | is the restriction on the freedom of establishment stemming from Helsinki University Pharmacy’s branch pharmacy licence scheme justified by overriding reasons in the general interest arising from its particular tasks relating to pharmacological services and pharmacy teaching, which are necessary and in accordance with the principle of proportionality, taking account of the fact that no corresponding particular tasks are laid down in the case of its branch pharmacies? | | | | |
| (b) | do the particular tasks, explained above, laid down in law with respect to Helsinki University Pharmacy mean that it may be regarded as an undertaking providing services of general economic interest as referred to in Article 106(2) TFEU, and if so, does the said TFEU provision give entitlement to derogate from the requirements regarding administrative advance authorisation set by Article 49 TFEU and by the case-law of the Court of Justice in the case of Helsinki University’s branch pharmacies, taking account of the fact that no corresponding particular duties are stipulated in the case of Helsinki University Pharmacy branch pharmacies? | | | | |

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