HEALTH CLAIMS REGULATION APPLIES TO COMMUNICATIONS TO HEALTH PROFESSIONALS, EU COURT RULES

In its Judgment of July 14, the Court of Justice of the EU ruled that commercial communications from food firms exclusively addressed to health professionals need to respect the rules of Regulation 1924/2006 on nutrition and health claims[1].

However, the Court did not object to food companies communicating to health professionals “objective information” about new scientific developments (including references to illnesses) if such communications are of a “non-commercial nature”[2].

The ruling generates significant legal uncertainty as it does not give any criteria to define what should be understood as “objective information”, or in which cases communications from the industry to health professionals are of “non-commercial nature”.  

Furthermore, the ruling runs counter the administrative practices of many EU countries some of which have issued guidance expressly excluding communications to health professionals[3] from the scope of application of Regulation 1924/2006, and the prevailing opinion of EU food law scholars[4].

A flawed reasoning opening the door to uncertainties and paradoxical consequences

Article 1(2) states that “[t]his Regulation shall apply to nutrition and health claims made in commercial communications, whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer”. The concept of “final consumer” is defined in Regulation 178/2002[5] as “the ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity”.

The Court has relied, basically, on a strictly literal reading of Article 1(2) of the HCR to justify the application of Regulation 1924/2006 to communications to professionals. According to the Court, the phrase “to be delivered to the final consumer” refers to the foodstuffs themselves and not to the communications in connection thereto.

According to this view, there is no difference if the advertising aims at the final consumer or professionals for as long as the products are delivered to the final consumer[6]. Therefore, Regulation 1924/2006 would not apply to anycommunications about food ingredients, as they are not intended “to be delivered as such to the ultimate consumer”.

It also follows that commercial communications to any professional, not only health professionals are caught by Regulation 1924/2006.  

These results are obviously contrary to the objectives of Regulation 1924/2006.

In fact, the reference to the concept of final consumer in Article 1(2) HCR excludes from its scope of application professionals (such as food traders, distributors, manufacturers of final products, etc.) acting within the scope of their professional activities. This dichotomy consumer vs. professional lies in the very foundations of EU consumer protection law in the EU[7], as it has been expressly acknowledged by the scholars[8]. The same principle applies to other regulated areas, such as prescription-only medicines, tobacco products or infant formulae: whilst promotion (in the form of advertising) to the general public is prohibited[9], it is allowed if addressed to professionals[10].

The judgment's cherry on the pie is the justification of why this result is in compliance with the objectives of Regulation 1924/2006: "[Health professionals] cannot be regarded as being in a position to permanently have all specialised and up-to-date scientific knowledge necessary to evaluate each food and the nutrition or health claims used in the labelling, the presentation or advertising of those foods. As stated by the Advocate General in point 49 of his Opinion, it cannot be ruled out that the health professionals themselves may be misled by nutrition or health claims which are false, deceptive, or even mendacious. Therefore, those health professionals risk forwarding, in all good faith, incorrect information on foods which are the subject of a commercial communication to final consumers with whom they have a relationship. That risk is all the more remarkable as such professionals are likely, because of the relationship of trust which generally exists between them and their patients, to exercise significant influence over the latter."

Suffice it to say in this respect that it is the deontological and professional duty of doctors to check the information that they pass onto consumers. Regulation 1924/2006 was not conceived to encroach on the medical profession rules of conduct and ethical obligations. 

Is there space to communicate to health professionals?

As stated above, the Court did not object to food companies communicating to health professionals “objective information” about new scientific developments, including references to illnesses, if this communication is of a “non-commercial nature”[11].

What does this mean in practice?

(i)     First, as to the concept of “objective information”, it would be crucial that the information is (i) sent exclusively to health professionals, that it is (ii) strictly related to their professional interest, i.e. the provision of health care services and expert advice; and (iii) of a purely scientific and factual nature. For these purposes, it would be advisable to follow recommendations contained in guidelines on principles related to publication in medical journals, as they  provide the highest standards to be achieved in the manner scientific communications should be conveyed.

(ii)    Second, and more difficult, is complying with the requisite of communications being of a “non-commercial nature”. In fact, Regulation 1924/2006 seems to be particularly restrictive as to what constitutes non-commercial communications, and, even if they should not be considered as an exhaustive list, the references to â€œdietary guidelines or advice issued by public authorities and bodies”, or “non-commercial communications and information in the press and in scientific publications” seem to exclude communications such as websites or flyers. Considering the promotional purpose (whether direct or indirect) is the main criterion to differentiate commercial from non-commercial communications and that any form of communication by a food business operator in connection to their products (including to the health professionals) could be presumed to be made with an intention to promote them (in this case, indirectly, by means of enhancing their credibility and reputation among health professionals), it will be difficult to escape the application of the Claims Regulation.
 

Therefore, it would be precisely fulfilling the criteria of the communications as described in paragraph (i) supra what could reduce the possibilities of the communication being classified as commercial.

JUDGMENT OF THE COURT (Third Chamber), of 14 July 2016 in Case C‑19/15, Verband Sozialer Wettbewerb eV v Innova Vital GmbH

[1]            

  Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ L 404/9 of 30.12.2006 - corrected by OJ L 12/3 of 18.01.2007 - as last modified by Regulation (EC) No 109/2008 of the European Parliament and of the Council of 15 January 2008 amending Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (OJ L 39/14 of 13.2.2008).

[2]              See paragraphs 50-53 of the Judgement.

[3]              See, inter alia, Food Standards Agency Guidance to compliance with Regulation (EC) 1924/2006 on nutrition and health claims made on foods, of November 2011: "While the Regulation applies to claims made in commercial communications about foods it is our opinion that it will not control claims made in communications within trade (business to business), to doctors or other health professionals, or to their organisations, whether the claim is in the labelling, advertising or other presentation of the food. This is provided that the recipients are acting within the scope of their professional activities and that they are not being addressed as final consumers of the foods. It therefore follows that if the information were, at any time, conveyed to final consumers within a commercial context, any claims made would need to comply with the requirements of the Regulation".

[4]              See, for example, Holle (Health Claims Kompakt, 2007), who holds that the HCR is exclusively applicable to final consumers, Teufer (ZLR 2009, 581), Ballke (“Nutrition and health claims in b2b communications”, EUFFLR 3, 2011) and Romero & Timmermans (“But what is it, Doc?” – Health Care Professionals under Regulation 1924/2006”, EUFFLR 5, 2010). Finally, Meisterernst and Haber (Meisterernst/Haber, Praxiskommentar Health&Nutrition Claims, 2008, art. 1 margin note 64 et seq.) had in the past doubted that non-consumers were exempted from the scope of the HCR, but have since embraced the opposite view (see Health and Nutrition Claims. Commentary on the Health HCR, Lexxion Verlagsgesellschaft, 2010).

[5]                           Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31/1 of 1.2.2002).

[6]              Paragraph 31.

[7]              See to this effect Council Directive 85/577/EEC of 20 December 1985 to protect the consumer in respect of contracts negotiated away from business premises (OJ L 372/31 of 31/12/1985), Article 1(2)(a); Council Directive 90/314/EEC of 13 June 1990 on package travel, package holidays and package tours (OJ L 158/59, of 23.6.1990), Article 2(4); Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95/29 of 21.4.1993), Article 2(b); Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts (OJ L 144/19 of 04/06/1997), Article 2(2); Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on consumer protection in the indication of the prices of products offered to consumers (OJ L 80/27 of 18.3.1998), Article 2(e); Directive 1999/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the sale of consumer goods and associated guarantees (OJ L 171/12 of 07/07/1999), Article 2(a); Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (OJ L 178/1 of 17.07.2000), Article 2(e); Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services and amending Council Directive 90/619/EEC and Directives 97/7/EC and 98/27/EC (OJ L 271/16 of 9.10.2002), Article 2(e); and Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (OJ L 149/22 of 11.06.2005), Article 2(a).

[8]              According to the scholars, the various definitions referred to in the above mentioned acts share common characteristics which can be summarized as comprising all physical persons acting outside their professional duties, who receive goods or services for their final use or consumption, with the objective to meet personal or family needs. See, in this sense, González Vaqué, “La noción de consumidor normalmente informado en la jurisprudencia del Tribunal de Justicia de las Comunidades Europeas: la Sentencia Gut Springenhedie”, Derecho de los Negocios, nº 103 (April 1999), Palao Moreno, "La protección de los consumidores en el ámbito comunitario europeo" in Reyes López, Derecho de Consumo, Tirant lo Blanch, Valencia, 2002, p. 39-40; Tenreiro, “Un Code de la consommation ou un Code autour du consommateur? Quelques réflexions critiques sur la codification et la notion du consommateur” in Krämer, Micklitz y Tonner, Law and diffuse Interests in the European Legal Order - Liber amicorum Norbert Reich, Nomos, Baden-Baden, 1997, p. 348.

[9]              A fortiori, in case of food products, it is not prohibited, but strictly limited by the HCR.

[10]             Directive 2001/83 prohibits the advertising to the general public of medicinal products available on medical prescription-only, but allows advertising them to professionals (“persons qualified to prescribe or supply such products”) (Article 88). Also, whilst Directive 2003/33/EC of 26 May 2003 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products (OJ L 152/16 of 20.6.2003) prohibits the advertising of tobacco products in the print media (newspapers and other publications), information society services and radio broadcasting, it can be done so in publications intended exclusively for “professionals in the tobacco trade” (Article 3). Along the same lines, Article 14 of Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L 401/1 of 30.12.2006) prohibits the advertising to the general public of the former type of products, but allows it in “publications specializing in baby care and scientific publications”, subject to certain conditions (e.g. such information shall not imply or create a belief that bottle feeding is equivalent or superior to breast feeding) and to the fact that it contains only information of a scientific and factual nature.

[11]             See paragraphs 50-53 of the Judgment.