European Court of Justice provides clarity on the marketing authorisation requirements of medicinal products

In July 2021, the European Court of Justice (the “Court”) issued its judgement in Case C-178/20, concerning the interpretation of Directive 2001/83/EC (the “Medicines Directive”)[1] in relation to the placement on the market of medicinal products which are not subject to medical prescription in one Member State where a marketing authorisation has been granted by competent authorities.

The case developed from a preliminary ruling request from the Budapest High Court, Hungary (the “Hungarian Court”) which was made in the proceedings in the names of Pharma Expressz Szolgáltató és Kereskedelmi Kft. (“Pharma Expressz”) and the Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (National Institute of Pharmacy and Nutrition, Hungary).

Background to the proceedings before the Hungarian Court

Pharma Expressz, a Hungarian company operating in the medicinal market, was ordered by the Hungarian authorities to halt its practice of putting medicinal products on the market in Hungary without complying with the formalities stipulated in the relevant Hungarian laws.

According to the Hungarian legislation, medicinal products without a marketing authorisation issued by the Hungarian authorities or the European Commission may be placed on the market only where their use for medical purposes is notified to those authorities by a medical practitioner prescribing medicinal products, who must obtain from those authorities a declaration concerning that same use.

In light of the circumstances, Pharma Expressz appealed the decision and proceeded to institute proceedings against the Hungarian authority’s decision. It was argued that the competent authority’s interpretation of Hungarian law amounted to a quantitative import restriction that was incompatible with EU law. Such import restrictions refer to specific limits on the quantity or value of goods that can be imported or exported during a specific time frame. In addition, Pharma Expressz also argued that the requisites for such a declaration are disproportional especially when a Member State of the European Economic Zone had already approved the medicinal product in question and classified it in the category which does not require a medical prescription to acquire, in conformity with regulations of the European Union.

The Hungarian Court referred the matter to the Court to clarify whether it is not contrary to EU law to require compliance with the mentioned formalities for the placing on the market, in Hungary, of medicinal products which have been granted marketing authorisation by one Member State and which are available without medical prescription.

Marketing authorisation of medicinal products

The Medicines Directive constitutes the main European legislation regulating medicinal products for human use and provides the necessary framework for marketing authorisation in the EU. The Medicines Directive provides, as a general rule, that no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State or, under the centralised procedure established to that end, by the European Commission. It is further noted that same Medicines Directive provides for certain medicinal products to be excluded from the obligation of acquiring marketing authorisation.

With a view to achieving mutual recognition of medicinal products, marketing authorisation for a medicinal product which is granted by a competent authority in one Member State ought to be recognised by the competent authorities of the other Member States unless there are serious grounds for supposing that the authorisation of the medicinal product concerned may present a risk to public health.

When marketing authorisation is granted, the competent authorities shall specify the classification of the medicinal product into either (i) a medicinal production subject to medical prescription; or (ii) a medicinal product not subject to medicinal prescription. The Medicines Directive stipulates that medicinal products shall be subject to medical prescription where they –

  • are likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision; or
  • are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health; or
  • contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation; or
  • are normally prescribed by a doctor to be administered parenterally

In an event of disagreement between Member States with regards to either the safety, quality or efficacy of medicinal product, a scientific evaluation shall be conducted adhering to community standards, leading to a single decision on the area of disagreement binding on the Member States concerned.

Opinion of the Advocate General of the Court

In the opinion delivered by the Advocate General of the Court in May 2021, it was suggested that the Court should find that the relevant Articles of the Medicines Directive in question be interpreted as meaning that that a medicinal product, which can be purchased without any medical prescription in one Member State, may be supplied without prescription in another Member State.

Referral to the Court

The Court in its ruling, clarified and confirmed pursuant to the Medicines Directive, that if a medicinal product does not have a marketing authorisation issued by the competent authorities of the Member State in which it is offered for sale or a marketing authorisation issued following the centralised procedure, it may not be placed on the market in that respective Member State, regardless of whether that same medicinal product may be sold in another Member State without a medical prescription.  Therefore, a medicinal product placed on the Hungarian market needs either a marketing authorisation by the Hungarian authorities, or a marketing authorisation through the centralised procedure of the European Medicines Agency.

The alternative procedure, namely that of mutual recognition, takes place under strict conditions and is conditional on a request by the marketing authorisation holder for a given medicinal product in a Member State with a view to recognising the same marketing authorisation in other Member States. The factual situation in the case at hand did not meet these mentioned requirements.

Consequential to the mentioned clarifications, the Court stipulated in a press release issued on 8 July 2021 that:

“not only does the ‘Medicines Directive’ not require that a medicinal product which has been granted marketing authorisation by a Member State as a medicinal product available without medical prescription also be classified as a medicinal product not subject to medical prescription in another Member State which has not authorised its placing on the market but, on the contrary, it precludes such a possibility.”

Finally, the Court found that the formalities arising from Hungarian legislation appear to transpose into Hungarian law a derogation provided for by the Medicines Directive, allowing medicinal products to be placed on the market in a Member State even when no marketing authorisation has been approved by this same Member State or by the Commission, to satisfy special medical needs. However, since in adopting these formalities, Hungary correctly transposed the mentioned derogation, those formalities cannot be classified as quantitative import restrictions or as a measure having equivalent effect with regard to the principle of the free movement of goods.

Concluding comments

The legal framework surrounding marketing authorisation of medicinal products in the European Union is still rather vague, and every clarification from the Court will ensure that in due course the desired and necessary clarity is acquired. Marketing authorisation of medicinal products plays a very important role in the market and this by filtering medicinal products which may be considered dangerous or inefficient. Such authorisation procedures constitute a core procedural element in the pharmaceutical industry and decisions relating to when and where to apply a marketing authorisation will have long lasting implications for those individuals which are in need of the same medicinal products.

This article was first published in the Malta Independent. 

[1] Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012