An Overview Of EU Rules On Consumer Advertising Of Over-The-Counter Products In The Life Sciences Sector – Media, Telecoms, IT, Entertainment -…

1. Introduction

Commentary on EU life science advertising regulation frequentlyfocuses on the rules applicable to advertisements for prescriptionproducts directed to healthcare professionals. Less iswritten about other types of products that form part of the EUhealthcare market, and the advertising restrictions that exist inrelation to the marketing of these products to consumers.While advertising restrictions on over-the-counter (OTC) productsare not, generally speaking, as detailed and stringent as thosewhich exist in relation to prescription medicines, it isnevertheless important to be aware of the regulatory framework thatapplies to consumer advertisements for such products. Thischapter is, therefore, intended to provide a summary of theoverarching EU regulatory framework for consumer advertisingof:

The European market for these OTC consumer healthcare productsis made up of over 2,000 companies.1 We summarisehere the general framework of law and industry codes of practicethat exist at EU level to regulate the advertising of thesecategories of products to consumers, with examples from nationalapproaches and commenting, where relevant, on recent developments.

At EU level, Directive 2005/29/EC on unfair commercialpractices2 (the UCP Directive) governsbusiness-to-consumer commercial practices relating to all kinds ofproducts and services including medicines, medical devices andfoods. In particular, the UCP Directive contains a broadprohibition on misleading and aggressive advertising. Forthese purposes, advertising is misleading if it contains falseinformation or in any way (including through overall presentation)deceives or is likely to deceive the average consumer (even if theinformation is factually correct) and causes or is likely to causehim to take a transactional decision that he would have otherwisenot taken. Aggressive commercial practices includeadvertising that applies undue influence, or pressure, in a waywhich significantly limits the consumer's ability to make aninformed decision. There are also restrictions on comparativeadvertising set out in Directive 2006/114/EC3 whichapply to advertising directed at consumers. The EU lawprovisions, as implemented in national laws, are enforcednationally through varying mechanisms; in some Member States it ispossible for companies to bring direct actions against competitors,whereas other countries require actions to be brought only byregulatory authorities. National laws may contain additionalrestrictions on both general and product-specific consumeradvertising.

Several pan-European industry bodies represent the interests ofmanufacturers of consumer healthcare products. These includethe Association of the European Self-Care Industry (AESGP), whichrepresents manufacturers of non-prescription medicines, foodsupplements and self-care medical devices in Europe, and theEuropean Federation of Associations of Health Product Manufacturers(EHPM), which represents specialist health product manufacturers inEurope. Individual companies may be affiliated with theseEuropean bodies directly or indirectly through nationalassociations. For example, the Dutch association representingmanufacturers of self-care products (Neprofarm) is a member ofAESGP while its trade association for operators concerned with foodsupplements (NPN) is a member of EHPM. Some national industrybodies are charged with operating self-regulatory systems ofadvertising control, and have their own enforcement mechanisms inplace. For example, in the UK, advertisements issued bycompanies who are members of the Proprietary Association of GreatBritain (PAGB) will, in the first instance, be supervised by thePAGB, whereas companies which have not agreed to abide by thePAGB's Codes of Practice will be supervised directly by theMedicines and Healthcare products Regulatory Agency. Inaddition to sector-specific enforcement agencies, advertising andpromotion of consumer health products is also subject toenforcement by bodies who enforce advertising standards generally,such as the UK Advertising Standards Agency (ASA).

The advertising to consumers of medicines not subject toprescription is regulated by the general advertising rules outlinedabove, and by Directive 2001/83/EC (the Directive) as implementedinto national laws. In addition, guidance is sometimesavailable at a national level from regulatoryauthorities,4 independent advertisingbodies,5 and industry associations.6There does not currently exist any pan-European industry code ofconduct applicable to the advertising of non-prescriptionmedicines,7 although AESGP represents the interests ofmanufacturers of non-prescription medicines at European level.

While advertising to the general public of prescription-onlymedicines is prohibited under the Directive, there is no suchrestriction in relation to non-prescription medicines.Provided they have a valid marketing authorisation and do notcontain any narcotic or psychotropic substances, non-prescriptionmedicines (including non-prescription herbal medicines) may,therefore, be advertised both to healthcare professionals and thegeneral public if they comply with the advertising requirements setout in the Directive, and with any further requirements containedin national law (discussed below). In addition to complyingwith the Directive's advertising rules applicable toprescription medicinal products, advertisements of non-prescriptionmedicines to the general public must also:

Advertisements for herbal medicinal products authorised by atraditional herbal registration must be accompanied by a noticestating "traditional herbal medicine for use in specificindication(s) exclusively based on long-standing use".

Homeopathic medicinal products must comply with the general EUlaw advertising requirements applicable to non-prescriptionmedicines, subject to additional limitations on the informationthat may be included in such advertisements. For example,advertisements for homeopathic medicines must include a statementthat the products are "without approved therapeuticindications".

Further restrictions on non-prescription medicines advertisingto consumers may be set out under national law and/or industrycodes. For example, French law prohibits advertising ofnon-prescription medicines to the general public where themedicines are reimbursed under the national social securityschemes. National industry codes of practice frequently setout detailed requirements specific to consumer advertising ofnon-prescription medicines. While compliance with such codesis not legally mandated, it is encouraged and represents industrybest practice. Compliance with the codes, which typicallyreflect and often elaborate on the legal requirements, is usually agood indication of compliance with legal requirements and thereforehelps to minimise enforcement action.

In some European countries, there is a requirement to obtainpre-approval from a regulatory body (e.g., the ANSM in France) oran industry body (e.g., the PAGB in the UK, where membercompanies' advertisements to consumers are concerned) beforeadvertisements for non-prescription medicines may be issued.Obtaining such approval further reduces the risk of enforcementaction for improper advertising.

There is little by way of EU law specifically directed towardsmedical devices advertising. Under the Medical DeviceDirective, only products that are CE-marked may be marketed inEurope, and only in accordance with their intended use. Theseprinciples extend to claims made in advertisements: to make amedicinal claim in an advertisement for a self-care medical device,the device must be CE-marked and the claim must be within the scopeof the device's intended use. Enforcement actions takenat national level in relation to self-care medical devices oftenconcern advertising that has made unauthorised use of medicinalclaims.

The Medical Devices Regulation8 introduces a specificprohibition on advertising that may mislead in relation to adevice's intended purpose, safety and performance.

The position under national laws is patchy, with some countrieshaving introduced laws to further regulate medical deviceadvertising (including, in some cases, laws that specificallygovern the advertising of self-care medical devices) beyond that ofthe EU-wide legislation.

In the context of industry self-regulation, it is important tonote that the Code of Ethical Business Practice issued by theEuropean medical device industry representative body, MedTechEurope, does not govern advertisements directed to consumers.However, several countries have issued national codes of conduct tothis effect; for example, the UK's PAGB Medical DevicesConsumer Code which is applicable to member companies'advertisements concerning self-care medical devices (those thattreat or prevent a self-treatable condition).

Food supplements are regulated as foods under EU law.Regulation (EC) No 1924/20069 (the Claims Regulation),which is directly effective in Member States, places strictcontrols on the use of nutrition and health claims on foodlabelling and in advertising. Under the ClaimsRegulation:

Under the Claims Regulation, only nutrition claims that arelisted in the Annex to the Regulation, and/or health claims thathave been authorised by the European Commission following aEuropean Food Safety Authority scientific review arepermitted. The only exception to these requirements is inrelation to claims that are trade marks (or brand or"fancy" names) and general, non-specific health claims(e.g., "good for you"). These claims may be usedwithout prior approval, provided they are "accompaniedby" an approved claim (which, in the case of a general healthclaim, must be an authorised specific health claim, such as thecalcium example given above).

The Claims Regulation is enforced at national level, andnational regulators have to date taken varying approaches in theirinterpretation of its requirements. A recent decision by theEuropean Court of Justice Case C-524/18Schwabe,10 which followed a referral from aGerman court, has helpfully clarified the meaning of the ClaimsRegulation's use of the phrase "accompaniedby". The European Court held that the concept of"accompanying" includes both a substantive and a visualdimension. The substantive element requires that the contentof the "general" health claim and the specific healthclaim match, meaning that the former is fully supported insubstance by the latter. In relation to the visual element,the Court held that this normally requires "spatial proximityor immediate vicinity" but that, exceptionally, a clearreference, such as an asterisk, between the two claims may suffice(e.g., in cases where the packaging of a food supplement contains areference to general, non-specific health benefits of a nutrient orfood on the front of the packaging, whereas the specific healthclaim intended to accompany it appears only on the back of thatpackaging). This is a more restrictive approach than thatwhich was preferred by the Advocate General,11 but willnevertheless help to inform a more uniform application of therelevant rules across Europe.

Also of importance to food supplements advertising in the EU isDirective 2002/46/EC (the Food Supplements Directive), whichprovides for specific marketing requirements relating to foodsupplements. These include that the labelling, presentationand advertising of food supplements:

There has been a recent flurry of activity by nationalregulators in some European countries in response to advertisementsfor food supplements that purport to prevent or treat infectionwith coronavirus/COVID-19. Such advertisements are contraryto the prohibition on medical claims contained in the FoodSupplements Directive, as implemented in national laws. Forexample, the Finnish Food Authority issued a statement in April2020, noting that marketing of foods (including food supplements)for the purpose of preventing or treating coronavirus had increasedsignificantly on the internet and social media, that these mustimmediately cease, and reminding commercial entities of their legalduties in this regard.13 In the UK, the ASA hasissued several recent decisions which uphold complaints made inrelation to advertisements claiming that various marketed vitamins,minerals and amino acids could help prevent or treatCOVID-19. For example, statements such as "Help protectand prevent against the new strand of virus (known as theCoronavirus) with a REVIV Megaboost IV Therapy containing ahigh dose of Vitamin C" were determined to be contrary to theapplicable regulatory requirements and the advertiser was orderedto remove the material, and refrain from making unauthorisedmedicinal claims going forward.14

Footnotes

1. (Hyperlink) [Accessed 20 May 2020].

2. Directive 2005/29/EC of the European Parliament and ofthe Council of 11 May 2005 concerning unfair business-to-consumercommercial practices in the internal market and amending CouncilDirective 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/ECof the European Parliament and of the Council and Regulation (EC)No 2006/2004 of the European Parliament and of theCouncil.

3. Directive 2006/114/EC of the European Parliament andof the Council of 12 December 2006 concerning misleading andcomparative advertising.

4. For example, the UK Medicines and Healthcare productsRegulatory Agency (MHRA) "Blue Guide".

5. For example, the UK Advertising Codes applied by theAdvertising Standards Authority (ASA).

6. For example, the UK PAGB's Advertising Codes forMedicines.

7. The European Federation of Pharmaceutical Industriesand Associations (EFPIA) Code of Practice does not apply toactivities relating solely to non-prescriptionmedicines.

8. Article 7 of Regulation (EU) No 2017/745 of theEuropean Parliament and of the Council of 5 April 2017 on medicaldevices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002and Regulation (EC) No 1223/2009 and repealing Council Directives90/385/EEC and 93/42/EEC.

9. Regulation (EC) No 1924/2006 of the EuropeanParliament and of the Council of 20 December 2006 on nutrition andhealth claims made on foods.

10. Case C-524/18, Dr. Willmar Schwabe GmbH &Co.KG v Queisser Pharma GmbH & Co. KG (30 January2020).

11. Opinion of Advocate General Hogan delivered on 12September 2019.

12. Articles 6(2) and 7 of Directive 2002/46/EC of theEuropean Parliament and of the Council of 10 June 2002 on theapproximation of the laws of the Member States relating to foodsupplements.

13. (Hyperlink) [Accessed 20 May2020].

14. ASA Ruling on REVIV UK Ltd (22 April 2020).Similar decisions were issued by ASA on the same day in relation toadvertisements by the Private Harley Street Clinic and CosmeticMedical Advice UK Ltd t/a Dr Rita Rakus Clinic.

Originally published by ICLG.com.

The content of this article is intended to provide a generalguide to the subject matter. Specialist advice should be soughtabout your specific circumstances.

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An Overview Of EU Rules On Consumer Advertising Of Over-The-Counter Products In The Life Sciences Sector - Media, Telecoms, IT, Entertainment -...