Medicines Directive interpreted by the CJEU in an interesting new ruling C-178/20

Marketing authorisations (MA) and their legal status have become increasingly interesting for anyone working in the medicinal products area. The recent CJEU ruling on July 8th in the case C-178/20 Pharma Expressz (find here), is especially so. There, the CJEU brings further clarification to the provisions of the Medicines Directive 2001/83/EC (find here) in the context of MA.

A medicinal product not subject to medical prescription in one Member State may not be placed on the market in another Member State unless that Member State, too, has granted its marketing authorisation. In the absence of such an authorisation, it still may be possible to supply that medicinal product where its use meets special medical needs in accordance with EU law.

Pharma Expressz, a Hungarian company, attempted to place its medicinal products on the market in Hungary without complying with the requirements stipulated by Hungarian law, i.e. had not applied for an MA. Consequently, the Hungarian authorities ordered the company to stop its importation of the products.

Under Hungarian law, medicinal products without an MA, issued either 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. In order to comply with the requirements, the medicinal practitioner needs to obtain from the competent governmental authorities a declaration concerning the specific use. This procedure was not followed in the case by Pharma Expressz since the medicinal products at hand were sold without prescription.

Pharma Expressz appealed the decision, refusing marketing authorisation, to the Fővárosi Törvényszék (Budapest High Court, Hungary). On appeal, Pharma Expressz claimed that the specific requirement of compliance with Hungarian law regulations was contrary to EU law because the medicinal products in question had previously been granted marketing authorisation in another Member State and the products were available without medical prescription.

In its ruling, the Court stated that the Medicines Directive (Articles 70-73) requires that an MA is granted by the competent authorities of that Member State, or under the centralized procedure established by the Commission, in order for a pharmaceutical product to be placed on the Hungarian market. Thus, a medicinal product placed on the Hungarian market needs either an MA by the Hungarian authorities, or an MA authorization through the centralized procedure of the European Medicines Agency. This requirement applies whether the medicinal product is sold under prescription or not.

The alternative procedure, namely that of mutual recognition, requires the application of strict conditions, such as the MA application for a given medicinal product in one Member State with the objective to recognize that specific MA in yet other Member States. The factual situation in the case at hand does not meet these requirements.

The Court clarified that there is no requirement under the Medicines Directive that a medicinal product granted an MA by a Member State and made available without medical prescription also to be be classified in another Member State as a medicinal product not subject to medical prescription, when the latter Member State has not prior to that time authorized placing it on the market. On the contrary, such possibility is precluded,since the product lacks an MA.

A prescription drug or not?

Finally, according to the ruling of the Court, Hungarian legislation has implemented a derogation included in the Medicines Directive, allowing for a certain flexibility when there is a need to meet specific medical needs. The implementation of this derogation is in compliance with the text of the Directive and may thus not be classified as a quantitative import restriction, or a measure that restricts the free movement of goods.

The legal framework surrounding MAs is still rather blurred, and every clarification from the CJEU is important. Apart from their formal role as gatekeeper in preventing the placing medicinal products on the market that might be dangerous or inefficient, MAs are important strategic instruments. Choices as to where and when to apply for an MA might have important consequences for patent rights (the term of SPC protection), or orphan drugs designations (whether a designation may be granted at all) and are thus elements of core value in the pharmaceutical industry’s strategic policies.