Pharmaceutical advertising regulation and medical device advertising in Germany

The Unfair Competition Law Act (“Gesetz gegen den unlauteren Wettbewerb” or “UWG”) provides the general framework for fair competition between companies operating in the German market. In relation to health-related advertising it is overlaid by the EU Regulation 2017/745 on Medical Devices (“MDR”) and the German Law on Advertising in the Health Sector (“Heilmittelwerbegesetz” or “HWG”).

2.1  Medicines

• Codes of Conduct of the Freiwillige Selbstkontrolle für die Arzneimittelindustrie eV (FSA):      
  • FSA Code of Conduct on the Collaboration with Healthcare Professionals;
  • FSA Code of Conduct on the Collaboration with Patient Organisations.
• Codes of Conduct of the Arzneimittel und Kooperation im Gesundheitswesen eV (AKG):
  • AKG Code of Conduct for Healthcare Professionals;
  • AKG Code of Conduct on the co-operation with patient organisations. 

2.2  Medical devices

• Bundesverband Medizintechnologie e.V. (BVMed): Code of Conduct for Medical Devices.
• Verband der Diagnostica-Industrie (VDGH): Code of Conduct for In-vitro-Diagnostics and Medical Devices. 

Under German law, no licences/approvals/fees are required, neither for advertisements of medicines nor for medical devices. The German system is rather based on a prior self-assessment by the company responsible for the advertising. 

Yes, under German law, any advertising of prescription-only medicines to the general public is prohibited (while OTC medicines may – subject to some restrictions, see question 5 below – be advertised to the general public).

5.1 Medicines 

The advertising of prescription-only medicines is limited to healthcare professionals (doctors, dentists, veterinarians, pharmacists and persons who are allowed to trade with these medicines). Hence, the advertising of prescription-only medicines to the general public (even to nurses) is prohibited. In this regard, only communication that can be considered as non-promotional is permitted. However, as soon as a company’s campaign has a promotional purpose and/or a specific product is mentioned or allusions to it are made, the campaign risks to be seen as product-related advertising. 

Hence, only advertising of OTC medicines is in principle allowed to the general public – subject to the following main restrictions:

•  Advertising may not refer to certain diseases mentioned in Section 12 HWG and advertising may not be related to medicines which contain psychotropic active ingredients;
•  Any advertising for unauthorised medicines is prohibited, including advertising for indications or dosage forms that are not covered by an existing marketing authorisation (“off-label-advertising”);
• Comparative advertising is prohibited;
• Subject to very limited exceptions, it is prohibited to offer or give advertising gifts or other benefits to consumers in connection with the promotion of medicines (Section 7 HWG). 

Further, advertisements must comply with:

• General principles on advertising (e.g. no misleading; claims according to which medicines are attributed a therapeutic efficacy or effects must be substantiated by reliable scientific data); and
• Medicine-specific rules set out in Section 11 HWG, e.g. advertisements must not refer to recommendations or testimonials by scientists, HCPs or celebrities, as such information may encourage the consumption of medicines; claims must not use statements made by third parties, such as letters of thanks or recommendations, if this is done in a misleading manner; the use of medical case histories and references thereto is prohibited, if this is misleading or can lead to an incorrect self-diagnosis; contests, prize draws or other procedures the result of which is dependent on chance are prohibited; advertising must not be aimed predominantly at children under the age of 14.

5.2 Medical devices

Advertisements directed to the general public must comply with:

• Art. 7 MDR (e.g. no misleading claims regarding to the device’s intended purpose, safety and performance by (a) ascribing functions and properties to the device which the device does not have, (b) creating a false impression regarding treatment or diagnostics, functions or properties which the device does not have, (c) failing to inform of a likely risk associated with the use of the device in line with its intended purpose and/or (d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carriedmout); and
• General national principles on advertising (e.g. no misleading advertising; claims must be substantiated by reliable scientific data); and
• Medical device-specific rules set out in Section 11 HWG, as far as applicable beyond Art. 7 MDR (e.g. claims must not use statements made by third parties, if this is done in a misleading manner; advertising must not be aimed predominantly at children under the age of 14) and Section 7 HWG (subject to very limited exceptions, it is prohibited to offer or give advertising gifts or other benefits to consumers in connection with the promotion of medical devices). 

Further, advertising for medical devices may not refer to certain diseases mentioned in Section 12 HWG.

The following main restrictions apply to the advertising of medicines (be it prescription-only or OTC) and medical devices:

• Promotional claims must be based on sufficient and reliable scientific evidence (this applies in particular to claims in which medicines and /or its active ingredients or medical devices are attributed a therapeutic efficacy, certain effects or other benefits and to superiority claims);
•  If the data/study that justifies the claim is mentioned (e.g. in a footnote), this reference must be complete, correct and able to serve as scientific evidence (if the reference does not justify the claim, German courts will consider the claim, regardless of whether it can be scientifically substantiated by another study not cited, as misleading only for formal reasons);
• Pursuant to Section 7 HWG it is, subject to very limited exceptions, prohibited to offer or give advertising gifts or other benefits to healthcare professionals in connection with the promotion of medicines or medical devices.

Further, any advertising for unauthorised medicines is prohibited, including advertising for indications or dosage forms that are not covered by an existing marketing authorisation (“off-label-advertising”). 

7.1 Medicines

Advertisements, regardless of whether referring to prescription-only or OTC medicines, must contain the following mandatory information (Pflichtangaben): the pharmaceutical company’s name and registered place of business, the name of the medicine, its composition, therapeutic indications, contraindications as well as side effects (if any), warnings (in so far as such warnings need to be labelled on containers and outer packaging) and the indication “prescription only” (if applicable). Such mandatory information must be clearly set out, well separated from the other advertising claims and easily legible. Only advertisements that are intended solely as a “reminder” (Erinnerungswerbung) do not have to contain the aforementioned mandatory information. An advertisement is intended as a reminder if it refers exclusively to the name of the medicine and/or only to the company’s name or trade mark or the active pharmaceutical ingredient.

In addition, any advertising referring to scientific or medical publications must clearly name the authors, the time of publication and the correctly quoted reference (Section 6 HWG). 

7.2 Medical devices

Neither the MDR nor the HWG does provide any mandatory information in advertisements for medical devices (irrespective of whether directed to healthcare professionals or to the general public).

8.1 Medicines 

Advertisements directed to the general public must contain the following mandatory information (Pflichtangaben): the name of the medicine, its therapeutic indications and warnings (if any). Such mandatory information must be clearly set out, well separated from the other advertising claims and easily legible. 

The advertising must also contain – well separated from the other advertising claims and easily legible – the following advice: “For further information on risks and side effects, please read the package leaflet and consult your physician or pharmacist.” Only advertisements that are intended solely as a “reminder” E( rinnerungswerbung) do not have to contain the aforementioned mandatory information (see question 7 above). 

In addition, any advertising referring to scientific or medical publications must clearly name the authors, the time of publication and the correctly quoted reference (Section 6 HWG). 

8.2 Medical devices

See point 7.2 above.

9.1 Medicines

German courts do consider a clinical study to be sufficient evidence to support a promotional claim (including comparative advertisement, see question 10 below) if the study fulfils the recognised “gold standard”: it must be designed as a prospective randomised, controlled and double-blind clinical trial with an adequate statistical analysis that has been published and is thus opened towards scientific discussions. If the study does not meet these criteria (e.g. in case of retrospective analyses of clinical studies, such as subgroup analyses or meta-analyses in which data generated in different studies is pooled, or in case of data on file), the promotional claim needs to make sufficiently clear that it is – as the case may be – based on scientific data that is not published (data on file) or that it is based on data with certain limitations (with naming the limitations the indirect evidence is subject to). 

9.2 Medical devices

If the “gold standard test”, as developed for medicines (see above), also applies for medical devices or if a deviating standard should be adopted, given the peculiarities of medical devices with an often lower hazard potential, is not answered uniformly by German courts. However, the more concrete, harder and defined effects of medical devices are claimed, the stronger requirements are to be placed on scientific proof. This is particularly true if the medical device is advertised with curative effects and for comparative advertising (see below under 10).

Under German law, comparative advertising for medicines (whether prescription-only or OTC) is not allowed if it is directed to the general public. By contrast, comparative advertising for medicines addressed to HCPs or for medical devices (irrespective of whether addressed to the general public or to HCPs) is – subject to the following restrictions – allowed: 

General Rules 

Pursuant to Section 6 UWG the advertisement must, inter alia, compare products indented for the same purpose; it may only compare, in an objective manner, relevant, verifiable and representative features of the goods concerned. The advertising may not take unfair advantage of the marks of a competitor or discredit or denigrate the competitor’s goods or business circumstances. 

Special Rules for Medicines and medical devices 

German courts require that a promotional claim for medicines or medical devices is substantiated by reliable scientific evidence. Any comparative advertising must be based on sufficient head-to-head data. At least for medicines, this requires a clinical head-to-head study. Such “head-to-head studies” are clinical studies which are designed to compare two or more medicines within the same patient population and in view of clearly pre-defined criteria. If a comparative advertisement cannot be backed-up by head-to-head data, sufficient disclaimers need to be used in the advertisement to explain this lack of data to avoid dissemination of any misleading information. 

When it comes to the question of what “reliable scientific evidence” is required for comparative advertising for medical devices, German courts are – at least for comparative claims on the efficacy of medical devices – guided by the principles developed for medicines, for which clinical head-to head studies are required. 

The question whether such clinical head-to-head data is also required for the comparative advertising of medical devices, or whether a different standard should be adopted, given the peculiarities of medical devices with an often lower hazard potential than medicines, has not been answered uniformly by the German courts. One argument offered for taking a different approach in respect of medical devices is the fact that in medical device law it is sufficient to demonstrate the suitability of a medical device for its intended use by means of a clinical evaluation, whereas a clinical trial is automatically required for the authorisation of a medicine. Adopting a different approach for medical devices has been discussed, at least for situations in which the proof of a device’s effectiveness can be measured objectively and there is no risk of the study results being distorted due to subjective perceptions of the study participants. However, the more concrete, harder and defined the claims being made for the effects of medical devices, in particular in the context of a comparative advertisement, the stronger the requirement for scientific evidence.

There are no specific legal provisions for advertisements on the internet/in social media postings. However, the general restrictions apply (with certain peculiarities): 

Access Restrictions on Websites
 

Since advertising for prescription-only medicines is limited to HCPs, it is necessary to restrict access to comply with German law (if prescription-only medicines are involved). German law does not provide for a specific mechanism to restrict access. However, restricting access by providing a tick-box question (“Are you an HCP?”) is not sufficient. In practice, most companies use access control systems with registration requirements (such as DocCheck). 

Mandatory Information (Pflichtangaben) 

In advertisements for medicines, whether prescription-only or not, the mandatory information must be displayed (see question 7 above). However, on the internet and in social media postings a visible link that directly and without detours leads to such information is considered sufficient by German courts.

Social Media: Only OTC medicines 

In practice, the advertising on social media is limited to OTC medicines and medical devices (as advertising for prescription-only medicines is not allowed to the general public and an access restriction, as used for websites, is technically not feasible on social media). 

• In Germany, the rules on advertising for medicines and medical devices are primarily enforced by civil courts. If a company allegedly violates a provision of the HWG, such violation is at the same time an act of unfair competition. As a consequence, many alleged HWG violations are pursued among competitors or by industry and consumer protection associations. In light of the usually high time-pressure in advertising cases, many of the court cases are interim injunction proceedings. In such civil litigation courts can grant injunctive relief by issuing a cease-and-desist order (Unterlassung), which is the most important remedy in practice.
• The rules of the Heilmittelwerbegesetz may also be enforced by public authorities through administrative offence proceedings (Ordnungswidrigkeitenverfahren), which, however, rarely happens in practice.
• Finally, there are arbitration boards established by self-regulatory industry associations that adjudicate on violations of industry codes of conduct. However, such boards are only competent for infringements committed by the voluntary members of the corresponding association.
• Further, in very rare circumstances, an offence against the prohibition of misleading advertising under Section 3 HWG can lead to criminal proceedings initiated by the locally competent state prosecutors.

No.