Advertising (Human Medicines)
1. Background information
The European Community and its Member States submit the advertising of human pharmaceuticals to a strict set of rules. These regimes are premised on a number of fundamental considerations regarding the markets for human medicinal products. First, the costs of medical treatments are generally absorbed by public and/or private insurance schemes. Hence, the need to maintain the overall integrity of the insurance pool may restrict the paradigm of free choice. Furthermore, the vast majority of patients do not understand the design and functioning of complex medicinal products. As a consequence, markets for medicinal products operate under pronounced information asymmetries. Finally, legislation relating to pharmaceuticals is aimed at protecting such fundamental values as physical integrity, health and life.
The European Community first assumed legislative authority over medicinal products in the 1960s when it promulgated Dir 65/65 in response to the Thalidomide tragedy. Over the years, a number of actors have entered the European stage and have influenced the Community’s pharmaceutical policies. The pharmaceutical industry’s top-level representation comprises, among others, the association of research-based pharmaceutical companies (European Federation of Pharmaceutical Industries and Associations (EFPIA)) and the association of generics manufacturers (European Generic Medicines Association (EGA)). Primary responsibility for pharmaceutical policy within the Barroso Commission (2010-2014) rests with Directorate General Health and Consumers (DG SANCO). This responsibility, however, is not exclusive. Article 168(1) TFEU/152(1) EC mandates the safeguarding of a high level of human health protection in all Community policies and activities. To this end, DG SANCO engages in a regular exchange of information with other Directorates. Stakeholder input into the legislative process was channelled through the Pharmaceutical Forum, set up by the Commission in 2005 for a three-year period. In addition to the Member States, EFTA, the Commission and the EP, representatives in the forum were drawn from all major actors in the public health sector. The forum’s advisory mandate included, inter alia, how best to ensure patient information on pharmaceuticals.
2. Sources of law
A typical medicines advertising regime lays out three to four subsets of rules: general advertising rules, specific rules for advertising directed at the public, specific rules for advertisements directed at health care professionals and special rules governing specific medicines. On the European level, rules governing the advertising of human medicines are found in Arts 88a to 100 (Title VIIIa) and Arts 86 to 88 (Title VIII) of the Directive on the Community Code Relating to Medicinal Products for Human Use (Dir 2001/83) (‘Community Code’). Unless expressly stated otherwise, these provisions entail a maximum harmonization (directive), see ECJ Case C-347/05 – Gintec [2007] ECR I‑9517, thus invalidating more restrictive or more lenient national laws. On the significance of the fundamental freedoms see ECJ Case C-143/06 – Ludwigs-Apotheke [2007] ECR I-9623. Member State laws on medicinal products advertising are identical insofar as they implement the provisions of the Community Code Directive. For the United Kingdom, see the Medicines (Advertising) Regulations (SI 1994/1932) and the Medicines (Monitoring of Advertising) Regulations (SI 1994/ 1933). For France, see Arts L5122-1 to L5122-16 and Arts R5122‑1 to R5122-34 Code de la santé publique. For Germany, see Heilmittelwerbegesetz (HWG) in der Fassung der Bekanntmachung vom 19. Oktober 1994 (BGBl I p 3068). For the Netherlands, see Hoofdstuk 9 (Geneesmiddelenreclame) of the Geneesmiddelenwet (Stb 2007, 93).
3. Basic notions
The law on the advertising of medicines builds on two basic elements: the notion of a medicinal product and the notion of advertising. Union law influences both. Whether a product is considered a medicinal product on the one hand, or foodstuff on the other, determines the applicable legal regime. Article 90(g) Community Code, for instance, prohibits advertising of medicines which suggests that the advertised medicines are foodstuff. As the delineation is of prime importance for manufacturers, it is frequently litigated before Member State courts. Article 2(d) of the General Food Law Regulation (Reg 178/2002) excludes medicinal products from the notion of foodstuff, thereby establishing the primacy of pharmaceutical legislation. For the definition of medicinal products, Art 2(d) of the General Food Law Regulation references two directives (Dir 65/65 and Dir 92/73) which had previously been repealed by Art 128(1) of the Community Code. Article 128(2) of the Community Code (Dir 2001/ 83) reinterprets this reference to non-existing directives as a reference to the Community Code itself.
As a result of the different effects of directives and regulations on Member State law, it is difficult to systematically integrate this chain of reference. Ambiguous products are subject to the medicinal products regime, see Art 2(2) Community Code and ECJ Case C-211/03 – HLH Warenvertrieb and Orthica [2005] ECR I-5141. The actual definition of medicinal products is provided by Art 1(2) of the Community Code. Where a substance or a combination of substances is presented as treating or preventing diseases in human beings, that presentation alone makes it a medicinal product (see Art 1(2) first alternative). It is generally irrelevant whether such a presentation originates from the manufacturer or a third party, see ECJ Case C‑219/91 – Ter Voort [1992] ECR I-5485. A substance that is not designated as a measure of disease prevention or treatment qualifies as a medicinal product if it is intended to be used for a medical diagnosis or for influencing physiological functions (see Art 1(2) second alternative).
Article 86 Community Code defines advertising as any activity designed to promote the prescription, supply, sale or consumption of medicinal products. The main element is the promotion of product supply as set out in Art 2(a) Misleading and Comparative Advertising Directive (Dir 2006/114). The notion of advertising as defined by Art 86 may encompass information about a medicine’s positive properties disseminated by a third party acting independently, de jure and de facto, from the manufacturer, see ECJ Case C-421/07 – Damgaard [2009] ECR I-2629.
4. Ban on prescription medication advertising
Article 88 of the Community Code prohibits the advertising to the general public of medicinal products which are available only by prescription. Article 88 aims to protect the integrity of the relationship between physicians and their patients and reflects an almost worldwide consensus. The United States is a prominent exception. Empirical studies on prescription medication advertising in the United States reach differing conclusions. Advertising expenditures, sales numbers and the consumption levels of advertised medicines are frequently cited variables. The absence of a ban on prescription medication advertising generates an additional layer of problems in liability cases, see eg Perez v Wyeth Labs, 734 A.2d 1245 (NJ 1999). In Europe, on the other hand, the existing ban means that illegal prescription medication advertising must be distinguished from permissible information about human health or diseases. The Community-wide ban on prescription medication advertising is firmly rooted and is not going to change anytime soon, see recommendation 1.6 (Final Conclusions and Recommendations of the High Level Pharmaceutical Forum). Consequently, the discussion gravitates around the notion of patient information. Currently, Community Code Art 86(2) bans any reference to medicinal products, direct or indirect, in informational material.
5. Further rules
Pursuant to Community Code Art 89(1)(a), advertising to the general public must be set out in such a way that it is clear that the message is an advertisement. The general community law ban on misleading advertising is reiterated specifically for medicinal products by Art 87(3) of the Community Code, see recital 42. Article 90(a)-(d),(f)-(h),(j),(k) target specific instances of misleading advertising to the general public. Article 90(b) prohibits advertising which guarantees a certain outcome or the absence of adverse reactions upon consumption of the medicine. Furthermore, advertising may not suggest that a consumer’s health can be enhanced by taking the medicine, Art 90(c). Medicinal products and the human organisms with which they interact are highly complicated. In light of this fact, many advertisements of the sort targeted by Art 90 (b),(c) would otherwise obfuscate the risks inherent in medicinal products.
Unlike in the case of a regular sales contract, damages resulting from a misleading promise cannot be recouped from the manufacturer – bodily harm may be irreversible. Patients must be fully aware of the risks they assume when consenting to treatment. Pursuant to a similar rationale, Art 90(g) mandates that Member States prohibit advertising which suggests that a medicinal product is a foodstuff, cosmetic or other consumer product. Article 90(g) is complemented by Art 89(1)(a), which mandates that an advertised medicine be clearly identified as a medicinal product. Article 90(f) prohibits advertising which incorporates recommendations by scientists, health professionals or other persons who could encourage the consumption of the medicine. Unlike healthcare professionals, the general public ordinarily lacks the medical sophistication needed to independently assess third party recommendations.
Product samples are a common method of advertising. Pursuant to Art 96(1) Community Code, free medicinal samples may be provided on an exceptional basis only to persons qualified to prescribe them, and only under narrow conditions. Article 96(2) allows for further restrictions by a Member State. Any form of promotional distribution of medicines to the public must be forbidden (Art 88(6)). The Community Code also restricts the use of comparative advertising. Article 90(b) prohibits advertisements targeted at the general public which suggest that the effects of a particular medicine are better than, or equivalent to, those of another. Comparative advertising is admissible, however, when targeted at professionals.
Every form of medicinal advertising must be accompanied by a minimum level of information. These information obligations are not to be confused with Arts 54 ff on the labelling of medicines packaging and package leaflets. Article 89(1)(b) Community Code establishes three basic obligations for advertisements targeted at the general public. Such advertisements must include: the name of the medicine; an express, legible invitation to carefully read the instructions on the package leaflet or the outer packaging; and the information necessary for correct use of the medicinal product. Correct use of a medicine is not possible without knowledge of its indications, which is therefore part of the obligatory information. The ingredients, on the other hand, do not have to be disclosed. Article 89(2) specifically relates to public reminder advertising. Such reminders are advertisements designed to keep a brand name alive and remind consumers of a product’s existence. A common example in the pharmaceutical sector are ballpoint pens imprinted with drug names and logos. At the discretion of national legislatures, reminder advertising is exempt from the information requirements laid down in Art 89(1)(b). Article 91(1) lists the information requirements for advertising to qualified professionals. Article 91(2) contains a discretionary exception for reminder advertising.
6. Enforcement
Articles 97–100 prescribe in general terms a framework which is to ensure the effective enforcement of the Community Code across all Member States. The Community Code aims at establishing equivalent, though not uniform, measures within the Community. Notably, Art 97(1) mandates the availability of private enforcement: anyone with a legitimate interest in prohibiting non-compliant advertising as defined by national law must have power to institute judicial or administrative control. Article 97(2), (3) lays down additional requirements specifically with regard to misleading advertisements: national laws must allow for cessation or prohibition orders against misleading advertisements regardless of actual losses and regardless of intention or negligence on the part of the advertiser (Art 97(2)). Claimants or petitioners must be able to demand cessation or prohibition of misleading advertisements under accelerated procedures (Art 97(3)). Self-regulation may only complement, not substitute, the above-mentioned procedures, see Art 97(5). Article 98 contains a set of information, cooperation, record-keeping and compliance obligations directly aimed at enterprises authorized to market pharmaceuticals.
7. Conformity with primary Union law
The Community Code is subject, like any Community act, to the limitations drawn by primary Union law. Based on Art 114 TFEU/95 EC, the Community Code is a harmonizing instrument designed to promote the internal market. Article 152(4)(c) EC, however, excludes harmonizing instruments in the sphere of public health. After the ECJ’s consideration of the conflict between Arts 95 and 152(4)(c) in its tobacco advertising decisions (advertising (tobacco products)), it remains doubtful whether the Community Code is within the bounds of competence, especially with regard to the strict ban on prescription medication advertising. The Treaty on the Functioning of the European Union (TFEU) promises to resolve this legal uncertainty in that harmonizing instruments pertaining to the advertising of medicines will no longer be subject to a ban on harmonization, read Art 168(4)(c) with Art 168(5) TFEU. Finally, medicinal advertising regulation on the European level raises similar questions of fundamental rights as discussed within the Member States. The ban on prescription medication advertising, the restrictions on the advertising of OTC medicines and the mandatory information regime may abridge the economic liberty of the affected enterprises.
Literature
Yvonne Lau, ‘Is Banning Direct to Consumer Advertising of Prescription Medicine Justified Paternalism?’ (2005) 2 Journal of Bioethical Inquiry 69; John Lisman and Carla Schoonderbeck, An Introduction to EU Pharmaceutical Law (2005); Kurt Faßbender, ‘Der grundrechtliche Schutz der Werbefreiheit in Deutschland und Europa’ [2006] GRUR Int 965; Andreas Hasman and Søren Holm, ‘Direct-to-Consumer Advertising: Should There be a Free Market in Healthcare Information?’ (2006) 15 Cambridge Quarterly of Healthcare Ethics 42; Luis González Vaqué, ‘La sentencia “Ludwigs-Apotheke” (TJCE 2007, 307) relativa a la publicidad de los medicamentos: ¿Dónde estás “Keck y Mithouard”?’ (2008) 25 Revista española de Derecho Europeo 67; Michael Trebilcock, ‘Direct-to-Consumer Prescription Drug Advertising: Testing the Limits of Legal Paternalism’ in Michael Faure and Frank H Stephen (eds), Essays in the Law and Economics of Regulation in Honour of Anthony Ogus (2008) 177; Peter Bülow and Gerhard Ring, Heilmittelwerbegesetz (4th edn, 2011).
