On July 8, 2021, the European Court of Justice ("ECJ") ruled on the interpretation of Directive 2001/83/EC (hereinafter the "Medicines Directives") in case C-178/20. The ECJ stated that, according to the Medicines Directive, if a medicinal product has not been issued marketing authorization ("MA") either by the relevant authorities of the Member State in which it is offered for sale or by the EU Commission, following the centralized procedure, it may not be placed on the market in that State. This rule applies even if that same medicinal product may be sold in another Member State without a medical prescription.
Furthermore, the ECJ clarified that Article 5 of the Medicines Directive allows for derogation whenever it is necessary to meet special medical needs certified by a practitioner. Therefore, the transposition of this derogation into national legislation cannot be considered a quantitative import restriction or a measure having an equivalent effect with regard to the principle of the free movement of goods under Article 34 TFEU.
The principles stated by the ECJ in this judgment are not surprising, since the judgment confirms the general rules for marketing medicines in Europe. What is notable about the judgment is that it addresses the case of online sale of medicines to patients located in a Member State other than the one where the medicines are offered for sale.
- The case at issue and the matter referred for a preliminary ruling
An Hungarian company, Pharma Expressz (Applicant) placed on the Hungarian market medicinal products that were authorized and available without medical in another Member State (but not in Hungary).
However, according to Hungarian legislation, MA granted by another Member State is not sufficient for these purposes. Indeed, medicinal products that are not authorized by either the Hungarian authorities or the EU Commission may be placed on the market in Hungary only on a doctor's request for special medical needs and with the approval of the regulatory authorities.
In this context, the Hungarian authorities ordered Pharma Expressz to refrain from selling those medicinal products on the Hungarian market, as doing so was in violation of national legislation (Art. 12/A Ministerial Regulation 44/2004). The Applicant appealed to the Budapest High Court, which issued a stay in the proceedings and referred the matter to the ECJ for a preliminary ruling. The ECJ was asked whether Articles 70 and 73 of the Medicines Directive indicate that the authorization and classification of a medicinal product provided by one Member State are sufficient for another Member State to sell that product under the same conditions on its own market, regardless of whether the latter has granted authorization. Then the ECJ was asked to clarify whether what is prescribed by Hungarian law should be considered a quantitative import restriction and, therefore, could be justified as a means of protecting public health under Article 36 TFEU.
- On the possibility of selling medicines without national authorization
The ECJ began to answer the first question by citing Article 6 of the Medicines Directive, which states that placement of any medicinal product on the market of a Member State is subject to authorization either by the authorities of that Member State or by the Commission. The Court went on to reference Article 5 of the same directive, which provides the possibility of derogating from the aforementioned authorization in case of special medical needs.
Therefore, to interpret Articles 70 and 73, it is necessary to refer first to Articles 5 and 6, as it would be irrelevant to discuss the classification of medicinal products where there is no authorization or special need. Medicinal products can be classified only if they are authorized or in exceptional circumstances . Furthermore, mutual recognition between Member States is subject to strict conditions, above all the request of the holder of MA to have a certain medicine recognized in another State. However, that was not the scenario in this case.
In light of the above, Articles 70 and 73 must be interpreted as precluding the sale of an unclassified and unauthorized medicines, even if they are not subject to prescription in another Member State. Again, Article 5 represents the only exception to the need of MA in each Member State.
- On possible exceptions
Article 5 waives the authorization requirement when special medical needs exist. Hungarian law handles this exception by requiring a formal application by the attending physician to the appropriate authority, followed by the latter's issuance of a statement replacing the missing authorization. This transposition, which responds to the obligation of each Member State to implement directives, cannot and must not be considered a form of quantitative restriction on importation or a measure of equivalent effect. The formalities required by Hungarian law are in line with Article 5, which states that special medical needs must be certified by an order "formulated in accordance with the specifications of an authorized health-care professional and for use by an individual patient under his direct personal responsibility."
- Consideration on the online sale of medicines
To support its claim, the Applicant pointed out that Hungarian patients may purchase medicines online only.
However, this argument failed to persuade the ECJ. Indeed, the Court noted that e-commerce is also subject to the governance of Article 6 and, therefore, only medicines authorized in the particular Member State where the patient is located may be purchased in both physical and online markets. Furthermore, medicines offered to patients in a certain Member State must comply with the regulation in effect in that Member State.
Also from such perspective, this judgment appears to be in line with another case, recently decided by the ECJ, where the Court ruled on the legality, under EU law, of certain restrictions set forth by a Member State where medicines were sold by an e-commerce service provider based in a different Member State1. Once again, the legislation of the country where patients receiving medicines are located results to be the one to be complied with when a medicine is offered for sale online.
1 Please refer to our article here: https://portolano.it/en/blog/life-sciences/e-commerce-of-medicinal-products-according-to-the-court-of-justice-a-foreign-pharmacy-may-be-subject-to-the-restrictions-in-force-in-member-states-where-it-sells-medicines-online
Thanks to Eleonora Vita for collaborating on this article
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