On 22 December 2022, the Court of Justice of the European Union (CJEU) — sitting in Grand Chamber — published its judgement in case C-530, Euroaptieka. The judgement adds further commentary to the meaning of “advertising medicinal products” in the EU and the competencies of EU Member States to restrict drug advertising activities. The judgement has particular implications for advertising “unspecified medicinal products”. No doubt, this judgement will be of interest to pharmaceutical companies and pharmacies looking at the communications activities they carry out in the EU and the risks entailed.

Background

The case concerned Euroaptieka, a group operating a network of pharmacies and companies distributing medicines in Latvia. In 2016, Euroaptieka advertised a promotion on its website and in a monthly magazine, offering retail customers (i.e., members of the public) a 15% discount off the cost of medicines, when the customer purchased at least three products (the “Euroaptieka Promotion”).

Latvian authorities banned the advertisement, citing domestic legislation that prohibits advertising medicines to the public by “encourag[ing] the purchase of the medicinal product…. on the basis of its price by announcing a special clearance sale, or by indicating that the medicinal product is sold as a bundle together with other medicinal products (including at a reduced price)…” (the “Latvian Restriction”).

The Latvian Restriction does not have a direct antecedent in EU medicines advertising legislation. It is in effect a national rule. The EU Medicines Directive (2001/83/EC) does, however, include the following provisions:

  • The definition of “advertising medicinal products” includes “any form of … canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products…” (Article 86(1));
  • Prescription-only medicines must not be advertised to the general public (Article 88);
  • All medicines advertising (including advertising non-prescription medicines to the public) must “encourage rational use” (Article 87(3)).

The referring Latvian court asked the CJEU to rule upon, in essence:

(i) whether “advertising of medicinal products” as defined under EU law included the type of activity that Euroaptieka had undertaken, notwithstanding the fact that the Euroaptieka Promotion was essentially price-promotional and did advertise any particular medicinal product or group of medicinal products; and

(ii) whether the EU Medicines Directive precludes/allows a Member State to enact legislation which extends the list of prohibited advertising methods and imposes stricter restrictions than those provided in the EU Medicines Directive; and

(iii) whether the specific Latvian Restriction, prohibiting such promotional activities, was consistent with the EU Medicines Directive.

CJEU Ruling

In summary, the Grand Chamber of the CJEU ruled that:

  1. The concept of “advertising medicinal products” may include communications that encourage the purchase of medicines through price promotions, even where the medicines being promoted are “unspecified” or “general.” In other words, where the promotional communication does not concern specific medicines but also to “unspecified medicinal products” (i.e., medicinal products in general or a set of non-identified medicinal products), it may still fall under the restrictions for “advertisement”.
  2. The EU Medicines Directive does not preclude Member States from enacting national laws such as the Latvian Restriction (i.e., restrictions against promoting non-reimbursable OTC medicines to the public using particular types of price promotion) that go beyond the prohibitions of the EU Medicines Directive.

Discussion

The meaning of “advertising medicinal products” has been the subject of various CJEU rulings in the past.[1] The Court has consistently favoured a broad definition, keeping in mind the public health implications of communications relating to health and medicines advertising. The Court has also stressed the importance of assessing the underlying intention — whether or not it is designed to encourage the prescription, sale or use of medicinal products. The Court may infer intention from the communication itself and its context, which makes the content and context key. In general, those cases have concerned situations where the reference to particular medicinal products was clear — the question at issue was whether the communication was promotional or not.

In a pair of recent cases, the CJEU discussed the definition in the context of online pharmacies.[2] In effect, the Court distinguished between medicines advertising (as conceived of in the EU Medicines Directive) and the rights of pharmacies to advertise themselves and the services they offer to patients, including the supply of medicines in general. It may have been tempting to conclude that the case law pointed to a distinction between promoting specific medicines (which clearly is “medicines advertising”) and communications about medicines generally without reference to a particular product or group of products.

The ruling in Euroaptieka suggests that distinction is rather more nuanced, when it comes to advertising or communicating about medicines in general. According to the Court here, the concept of medicines advertising (as conceived of under the EU Medicines Directive) can also cover situations where promotional activity relates to unspecified medicinal products (i.e., medicinal products in general) or the entire portfolio of a pharmacy or pharmaceutical company.

The Court’s view is based on a purposive interpretation of the EU Medicines Directive, keeping in mind the Directive’s objective of protecting public health. Looking at the judgement, two aspects were particularly noteworthy in respect of communications that relate to medicines in general (as opposed to specific, identifiable products): (i) the communication was promotional in and of itself (i.e., there was an underlying intent to increase purchases by offering discounts); and (ii) the potential risks for the public health posed by advertisers encouraging the excessive or irrational use of medicines through advertising multi-buy and similar price promotions. Given both factors above, the absence of any reference to specific, identifiable medical products was not enough to suggest this was not “medicines advertising.” The risk to public health through potentially encouraging excessive use was apparent. That risk seemed particularly pronounced for OTC medicines, where the purchase of a medicine may not be intermediated by a clinician or pharmacist.

The Court also provided clarifications regarding the competencies of the EU Member States. In a previous decision, the CJEU already stated that the EU Medicines Directive does not prevent Member States from prohibiting advertising measures that promote the inappropriate use of a medicinal product and therefore endanger the public health.[3] The CJEU now decided that the EU Medicines Directive does not preclude Member State laws that prohibit the inclusion (in advertising to the general public of medicinal products that are neither subject to medical prescription nor reimbursed) of information which encourages the purchase of medicinal products by justifying the need for that purchase on the basis of the price of the products, by announcing a special sale, or by indicating that those medicines are sold together with other medicines (including at a reduced price) or with other types of products. When reading the reasoning of the judgement, the CJEU’s view appears even stricter as it states that in the interest of public health, the EU Member States even ”must prohibit” such advertising.

Practical Implications

Advertising for medicines is a constant hot topic in the practice of pharma law in the EU. With new technologies and advertising channels, the practical and legal nuances of pharmaceutical advertising become increasingly sophisticated.

There is a relatively well-established distinction in EU medicines advertising regulation between “advertising” to the general public and the legitimate provision of general, non-product-specific public information about medicinal products and treatment. On the basis of this distinction, pharmaceutical companies often carry out institutional or corporate advertising or run disease awareness campaigns. Such campaigns often encourage patients to seek diagnosis or medical treatment, in general rather than specific treatments.

In our view, this Euroaptieka judgement likely preserves the overall distinction between advertising medicines and the legitimate provision of product agnostic information. However, it does add further nuance and intricacy when communicating about medicines in general.

Actors in the pharmaceutical and healthcare space will not be able to rely on the concept that talking about medicinal products non-specifically and in general instantly takes them outside the definition of advertising. Arguably, that approach was always somewhat of a false-friend and potentially overly simplified. National medicines advertising authorities and courts in the EU rule against companies for indirect (unlawful) medicines advertising. That included cases where the company had not named specific medicinal products, but where an underlying intention to promote the unnamed medicine could be inferred.

If anything, the Euroaptieka ruling adds further nuance and breadth to indirect and portfolio advertising. However, even with this decision, there will still be practical challenges when it comes to drawing the line between indirect advertising of medicines and the many non-promotional information activities. This will be a relevant question in practice where a holistic legal assessment of the activities will remain necessary.

This CJEU judgement may nevertheless embolden national authorities to interpret the legislation yet more purposively. Where unspecified medicines are concerned, there may need to be a closer examination of whether: (i) the underlying context and intent were promotional; and (ii) whether the communication risked encouraging the irresponsible or excessive use of medicines. If so, those communications risk being viewed as advertising even if a particular product is not being advertised.

The judgement may well concentrate minds in the Marketing, Communications and Legal departments of pharmaceutical companies and other healthcare players. Companies should assess the impact of this judgement for their advertising practices and other information activities like institutional/corporate advertising or disease awareness campaigns.

The EU medicines advertising specialists of Covington & Burling LLP are always on hand to help navigate clients through this increasingly nuanced legal area.


[1] For example, MSD v Merckle, C‑316/09, EU:C:2011:275.

[2] Judgment of 1 October 2020, A (Advertising and sale of medicinal products online), C‑649/18, EU:C:2020:764; judgment of 15 July 2021, DocMorris, C‑190/20, EU:C:2021:609.

[3] CJEU, Judgment of 8 November 2007, Gintec, C‑374/05, EU:C:2007:654, marginals 51, 55 and 59.

Photo of Dr. Dr. Adem Koyuncu Dr. Dr. Adem Koyuncu

Adem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & Device” practice group and also a member of our Compliance practice. Adem is…

Adem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & Device” practice group and also a member of our Compliance practice. Adem is recognized as a “leading lawyer for pharma and medical devices law” (JUVE 2021).

Adem helps clients on a wide range of EU and German law issues, including regulatory, compliance, privacy and liability matters. He also provides strategic advice. He knows the life sciences sector also from his earlier work in the pharmaceutical industry and as a medical doctor. He represents clients before courts and authorities and assists them in contract negotiations, investigations and transactions. For years, Adem is listed in various lawyer rankings.

See some Accolades from Clients and Surveys:

  • “He is one of the most detail-oriented and client-focused partners I have ever encountered.” (Client, Chambers 2021)
  • „Great professional and human competence, good team player.“ (Client/Adverse Party, JUVE 2022)
  • “I find him to be one of the most pragmatic regulatory lawyers. He was a doctor before a lawyer, has been in-house, worked on lots of stuff that I have to handle in-house, which helps when getting advice. He is really good at saying it’s a complex situation and your best option is to do this.” (Chambers 2022)
  • “He always comes through with extremely helpful advice. He brings a unique understanding and experience to his practice as both a lawyer and medical doctor.” (Chambers 2021)
  • “Adem Koyuncu is not only a lawyer but also a doctor and has worked in industry. He knows the perspectives that also move in-house lawyers.” (Legal 500 2022)
  • “He is very sharp and quick, while at the same time having a good sense of humor and nerves of steel. Very pleasant to work with.” (Legal 500 2022)
  • He is described as “versatile competent, reliable and high quality” (JUVE 2021) and “incredibly fast.” (JUVE 2018)
  • Provides advice at “an outstanding level.” (Legal 500 2015)
  • “Very strong negotiation skills.” (JUVE 2011)
  • Clients appreciate his “very broad knowledge and long-standing expertise” (JUVE 2021/22) and that “he is approachable, knowledgeable and really easy to talk to over the various issues. He is calm and has seen most problems before.” (Chambers 2020)
  • Peer lawyers described him as “highly competent” and a “very good and pleasant lawyer” (JUVE 2014) and as “the off-label-guru, substantively very good, creative.“ (JUVE 2022)

Adem is the author of numerous publications (e.g., in leading books on pharma law, product liability and clinical trials) and frequent speaker at different events. As such, he will soon speak at following events:

  • “Medical Device Liability and Risk Transfer 2.0 | A liability issue for the Management?!,” BVMed, Webinar (3/24/2023)
  • “Data Protection Requirements and Open Issues in the Pharma Sector – Status quo,” Speech at conference, 26. Marburger Gespräche zum Pharmarecht, Marburg (3/16/2023)
  • “Vendor Oversight & Vendor (Quality) Management in the Pharma Industry,” FORUM-Institut, Online Seminar (4/19/2023)
Photo of Raj Gathani Raj Gathani

Supporting clients in the pharmaceutical, healthcare, medical device and consumer products sectors, Raj Gathani’s practice is built around EU and UK regulatory and strategic advice.

Increasingly, Raj concentrates on post market-launch projects, such as advising on advertising compliance, communications, interactions with healthcare professionals…

Supporting clients in the pharmaceutical, healthcare, medical device and consumer products sectors, Raj Gathani’s practice is built around EU and UK regulatory and strategic advice.

Increasingly, Raj concentrates on post market-launch projects, such as advising on advertising compliance, communications, interactions with healthcare professionals and patients, pricing controls and reimbursement strategies particularly in the UK and the Republic of Ireland.

Healthcare, its structure and delivery are specialist practice areas for Raj, particularly having operated healthcare and pharmacy businesses for eight years prior to joining the firm. This experience enables Raj to provide in-depth advice to healthcare clients –particularly those in the digital health space – as well as other life sciences companies whose work engages medical practice, dispensing and health-services rules.