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Referrals to the Constitutional Court: if there are grounds for believing that a law or regulation that should be applied in a particular case is unconstitutional, the court suspends the proceedings and, taking into account the competence of the Constitutional Court, asks the latter to rule on the constitutionality of the law or regulation.

The Supreme Administrative Court of Lithuania (SACL) by a ruling adopted on October 2, 2024, referred to the Constitutional Court a request to examine whether Article 17(13) of the Law on Pharmacy, by which the Minister of Health is entrusted with the task of establishing other requirements related to parallel imports and other obligations of the holder of a parallel import permit, while also establishing the grounds for the revocation of the validity of such a permit, does not contravene the hierarchy of legal acts, as encompassed by the Constitutional principle of Rule of Law, Article 5(2) and 46(1) of the Constitution.

This question arose before the extended panel of Judges of the SACL, which was hearing a normative case concerning the compliance of sub-paragraph 42.4 of the Rules on parallel import of medicinal products approved by the Order of the Minister of Health of the Republic of Lithuania No V-228 of 30 March 2007 "On the Approval of the Rules for the Parallel Import of Medicinal Preparations" with the constitutional principle of the rule of law and with the provisions of Article 3(4) of the Law on Public Administration.

Pursuant to sub-clause 42.4 of the Rules on parallel import of medicinal products, the State Medicines Control Authority shall revoke the validity of a parallel import authorisation if, following the issue of a parallel import authorisation, the parallel imported medicinal product has not been placed on the market for a period of 3 years or if a parallel imported medicinal product which has already been placed on the market is not available for a period of 3 years in a row.

The extended panel of Judges noted that the sub-legislative act thus establishes the essential conditions for the economic activity of pharmaceuticals and amounts to a restriction of the freedom and initiative of a person in his economic activity. Having assessed the nature of this legal regulation and its impact on the individual's freedom of economic activity, the extended panel of Judges held that the regulation of this economic activity, which includes restrictions on its exercise (grounds for the revocation of a parallel import authorisation), should, in accordance with the Constitution and the official constitutional doctrine, be established by a law and not by a sub-legislative act approved by the Minister.

Thus, the legal regulation established in Article 17(13) of the Law on Pharmacy, insofar as it allows the Minister of Health to impose other obligations on the holder of a parallel import permit, which de facto imply grounds for the revocation of the validity of a parallel import permit required for the exercise of an economic activity that are not derived from the requirements of the Law on Pharmacy, is inconsistent with the constitutional grounds for limiting the freedom of economic activity and is in conflict with the constitutional principle of rule of law. In the opinion of the extended panel of Judges, by disregarding the constitutional prohibition to lay down the essential conditions for the restriction of the freedom of economic activity in a law, the legislator also violated the provision of Article 5(2) of the Constitution that the powers of the government are limited by the Constitution.

For these reasons, the Chamber of Advanced Judges concluded that it was necessary to ascertain whether the regulation laid down in Article 17(13) of the Law on Pharmacy was constitutionally justified.

Administrative case No. eI-10-525/2024