Contributed By CMS Hasche Sigle
The main law in Germany regulating advertising on medicines is the Law on Advertising in the Health Sector (Heilmittelwerbegesetz or HWG). In addition to the Heilmittelwerbegesetz, the German Law against Unfair Competition (UWG) that, inter alia, contains advertising rules in general also applies to pharmaceutical advertising.
Pharmaceutical advertising is also the subject matter of several self-regulatory codes, such as:
FSA stands for Freiwillige Selbstkontrolle für die Arzneimittelindustrie eV (voluntary self-regulation for the pharmaceutical industry), a private industry association of which the majority of pharmaceutical companies in Germany are a member. Typically, these companies are also members of the Verband Forschender Arzneimittelhersteller (VFA), the German Association of Research-based Pharmaceutical Companies.
The Arzneimittel und Kooperation im Gesundheitswesen eV (Medicinal Products and Co-operation in the Healthcare Area, AKG) is another self-regulatory organisation. Members are typically members of the Bundesverband Pharmazeutische Industrie (BPI), the German Pharmaceutical Industry Association.
Self-regulatory codes apply to members of the self-regulatory organisation only. Membership in such associations is voluntary.
In practice, pharmaceutical companies that adhere to a self-regulatory code, such as the FSA Codes of Conduct, usually take these rules very seriously when assessing the legal boundaries for promotional activities.
In case of a breach of these rules, a proceeding according to the applicable self-regulatory code can be started. Legal consequences under the FSA Codes of Conduct are, for example, fines and – in case of a severe breach – public reproofs. Depending on the case, a breach of a self-regulatory code can also indicate (but does not necessarily entail) an act of unfair competition which enables competitors and industry and consumer associations to start civil legal actions
There is no statutory definition of advertising in the HWG. Courts usually refer to the definition in Article 86(1) of Directive 2001/83/EC on the community code relating to medicinal products for human use. According to this definition, advertising of medicinal products shall include “any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products”. This shall include, in particular:
Based on this definition, and in line with the traditional German understanding of healthcare advertising, courts usually analyse whether certain information has the purpose of promoting the sale of a medicinal product or a medical device.
German courts tend to interpret the aforementioned definition of product advertising broadly and the threshold for a communication in the life science sector to be qualified as advertising is low. This is explained by the aim of the HWG to avoid risks for individuals and the general public associated with an incorrect self-medication (irrespective of whether these risks exist in the individual case), as well as to prevent sick individuals from taking wrong decisions with regard to the use of medicinal products under the influence of inappropriate advertising. According to the German Federal Supreme Court (Bundesgerichtshof), the great value of public and individual health, as well as the importance of the risks associated with healthcare advertising, make a broad application of the Healthcare Advertising Code necessary.
Legal Exceptions for Non-promotional Information
The law itself (and similarly the FSA Code of Conduct HCPs) provides guidance on which communication shall be considered as non-promotional information: pursuant to Section 1(5) HWG, the law does not apply to correspondence and documents that do not serve a promotional purpose but that are needed to answer a specific question about a particular medicinal product. This includes the answers of a company to questions asked by patients and HCPs, even if such answers may contain a positive message regarding a specific product (so that they might have a promotional effect).
According to Section 1(8), the HWG also does not apply to the labelling of a product (Kennzeichnung), the package leaflet (Packungsbeilage), the Summary of Product Characteristics (SmPC, Fachinformation) and the health authorities’ public assessment report. However, such documents may only be made available to the general public upon request or, if the information is available on the internet, it may only be accessible to someone who is actively searching for it. And pursuant to Section 1(6) and (7) HWG, information contained in ordering forms for electronic commerce that are necessary for the ordering process, as well as sales catalogues and price lists that do not contain more information than necessary for the identification of a product, do not constitute advertising.
Separating Advertising and Non-promotional Information Communication
For all other cases, to separate between advertising falling under the Healthcare Advertising Code and lawful information, it needs to be analysed whether the communication:
Consequently, even a scientific publication from a medical journal can be advertising if a company is using it for promotional purposes.
Usually, the fact that a specific product is mentioned by its name is considered to be a strong indicator that a communication is product advertising. But even if advertising only names the active pharmaceutical ingredient or contains clear allusions of a specific product (such as its usual packaging and advertising colour and design), this may be sufficient to qualify the advertisement as being product-related so that the HWG rules apply.
Vice versa, a communication (such as a company’s website) that focuses on the company, its economic situation and prospects, including its product range (Imagewerbung), but not on one or a few specific products does not fall under the rules for pharmaceutical advertising. This is particularly relevant for investor-related information. German courts usually recognise the legitimate need of a company to provide information on its research activities and pipeline projects to existing and potential investors. However, the more a communication relates to the characteristics and functioning of a specific product, the higher the risk that it will be qualified as product advertising.
Like any other company communication, press releases can qualify as product advertising, in which case the rules for pharmaceutical advertising apply. This includes, in particular, the prohibition to promote a prescription-only product to the general public, the prohibition to advertise unauthorised medicines and the prohibition of misleading advertising.
However, as explained in more detail under 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information, it is widely accepted that there is a legitimate interest of pharmaceutical companies to inform HCPs, investors and press and media about important developments of the company and scientific milestones. A press release that objectively informs about an important research activity, in particular about the conduct or the outcome of a relevant clinical study, may in many cases be qualified as company advertising (Imagewerbung) to which the law on pharmaceutical advertising is not applicable.
There remains a legal uncertainty, however. Care should therefore be given when publishing press releases directly or indirectly relating to prescription-only and/or unauthorised medicines. To be on the safe side, some companies publish such press releases only on secure websites granting access only to HCPs.
Comparative advertising for prescriptive and non-prescriptive medicines is not allowed if the advertising is directed to the general public. Comparative advertising addressed to HCPs is allowed but needs to observe important restrictions.
Pursuant to Section 6 of the UWG, any comparative advertising needs to fulfil a defined catalogue of criteria. Among others, the advertising must compare products intended for the same purpose; it may only compare, in an objective manner, relevant, verifiable and representative features. Furthermore, it may not take unfair advantage of the trade marks of a competitor or discredit or denigrate his or her products or business circumstances.
In addition and based on the general prohibition of misleading advertising, German courts require that a promotional claim for a medicinal product is substantiated by reliable scientific evidence. For comparative advertising, this means that the comparison needs to be based on a clinical head-to-head study. For more details for criteria clinical studies must meet, see 5.2 Reference to Data Not Included in the Summary of Product Characteristics.
Section 3a HWG, as well as Section 9 of the self-regulatory FSA Code of Conduct HCPs, forbid any advertising for an unauthorised medicinal product. This explicitly includes any advertising for indications or dosage forms that are not covered by an existing marketing authorisation (“off-label advertising”).
Therefore, providing information on unauthorised medicines or indications is only possible as long as such information is not promotional. In light of the strict standards of German courts, a company’s communication focused on a specific medicinal product risks being qualified as of a promotional nature. Such communication should therefore concentrate on general and objective information as to the company’s research activities and clinical trials, but without mentioning the name of the as-yet-unauthorised new product or otherwise focusing on a product in a way that can be interpreted as product promotion.
With regard to the prohibition of “off-label advertising”, the crucial question is whether a claim advertises a separate indication or whether it only promotes a certain (new) effect of a product. If the advertising directly or indirectly claims a certain indication, this is forbidden as long as the product has not been authorised for this indication. If the advertising only promotes a (new) effect of a pharmaceutical, this is not considered as off-label advertising as long as the advertised effect does not go beyond the authorised indication.
Courts and scholars recognise the legitimate interest of pharmaceutical companies to have a regular exchange with the scientific community with regard to recent research results. If companies inform in an objective, non-promotional manner about the outcome of clinical studies and the information does not focus on a specific product, there are good arguments that such information does not fall under the rules for pharmaceutical advertising.
However, German law does not generally exempt information provided to the scientific community from the prohibition to advertise unauthorised medicines or indications. The more a communication creates the impression that it is (also) intended to promote to future prescribers the effectiveness of a yet to be approved medicinal product, the greater the risk that it would be qualified as illicit advertising for an unauthorised medicine.
Pursuant to Section 1(5) HWG, the rules on pharmaceutical advertising do not apply to correspondence and documents that do not serve a promotional purpose but that are needed to answer a specific question about a medicinal product. Based on this rule, companies may provide scientific information regarding an unauthorised medicinal product or indications in response to specific and unsolicited queries from HCPs (ie, reactively).
However, sending information on unauthorised medicines or unauthorised indications to HCPs proactively will be considered as illicit off-label advertising.
There is no rule or principle in German law allowing companies to provide healthcare institutions with information on unauthorised medicines or indications. To the contrary, if the aim of a certain information is to prepare institutions, eg, hospitals, for the upcoming approval of a certain medicine so that the institution can prepare budgets, etc, courts and authorities might argue that the one important aim of such information is to prepare the future customers for the launch. In such a case, there is a substantial risk that such communication can be qualified as unlawful advertising for an unauthorised product.
If the information relates to specific products/APIs, the information will likely be qualified as product advertising by German courts. Such product related information on compassionate use programs (or other forms of early access) would then be illicit off-label advertising pursuant to Section 3a HWG.
However, if the communication in question is not product-related but only consists of general information about compassionate use as such and the availability of compassionate use programs, it would not fall under the rules for pharmaceutical advertising. For more details for the assessment whether a communication is product-related and thus promotional, see 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information.
Under German law, product-related advertising of prescription-only medicines is limited to physicians, pharmacists and persons who are authorised to trade in these products (“qualified HCPs”). Any advertising of prescription-only medicinal products directed at less-qualified HCPs, such as nurses, and at patients (“the general public”) is prohibited under German law (Section 10 HWG). Only non-prescription medicinal products (OTC medicines) may be advertised to the general public.
Product-related advertising activities of medicinal products, whether prescription-only or OTC medicines, have to comply with general principles on advertising as mainly set forth in the UWG. Furthermore, pursuant to Section 3 HWG, advertisements must not be misleading; ie, any promotional claims according to which medicinal products are attributed a therapeutic efficacy or effects must be substantiated with clinical data.
Medicine-specific Advertising Rules
Advertisements directed at the general public shall, in particular, also comply with medicine-specific advertising rules that are mainly set forth in Section 11 HWG. For example, any comparison with the medicinal products of competitors according to which the promoted medicinal product corresponds to or is even superior to the competitor’s product is prohibited vis-à-vis the general public. Moreover, advertisements to the general public must not refer to recommendations or testimonials by scientists, HCPs or celebrities, as such information may encourage the consumption of medicinal products.
In addition, advertising claims must not use statements made by third parties, such as letters of thanks or recommendations, if this is done in a misleading manner. Furthermore, the use of medical case histories and references thereto are prohibited, if this is misleading or can lead to an incorrect self-diagnosis. Advertisements using contests, prize draws or other procedures the result of which is dependent on chance are also prohibited. The distribution of medicinal products, samples or respective vouchers to the general public is not compliant with German law, either. Advertising measures to the general public must not be aimed predominantly at children under the age of 14.
Finally, pursuant to Section 10(2) HWG, any promotional claims directed at the general public and relating to psychotropic active ingredients that may cause dependency and that are intended to eliminate insomnia or mental disorders are prohibited under German law.
Advertisements, regardless of whether referring to prescription-only or OTC medicines and whether directed at HCPs or the general public, must contain the following mandatory information (Pflichtangaben) as stipulated in Section 4 HWG: the pharmaceutical company’s name and registered place of business, the name of the medicinal product, its composition, therapeutic indications, contraindications as well as side effects (if any), warnings (if such warnings need to be labelled on containers and outer packaging) and the indication “prescription-only” (if applicable). According to the FSA Code of Conduct HCPs, the advertising of a medicinal product shall also state the date on which the aforementioned information was drawn up or last revised. Such mandatory information must be clearly set out, well separated from the other advertising claims and easily legible. Under German law, the price of the medicine is not such mandatory information.
In this context, the HWG provides for one exception in Section 4(6) HWG: 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 exclusively refers to the name of the medicinal product or if it refers additionally only to the pharmaceutical company’s name or trade mark or to the active pharmaceutical ingredient.
Any advertising directed at the general public 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”.
Pursuant to Section 6 of the FSA Code of Conduct Patient Organisations, companies shall respect the patient organisation’s neutrality and independence. As a result, patient organisations shall retain complete control over the content of their work when collaborating with pharmaceutical companies. Such collaborations must not involve recommendations for individual prescription-only medicinal products or groups of such products. The appearance of member companies’ representatives at patient organisations aiming at making promotional references to prescription-only medicinal products is prohibited as well.
Furthermore, any collaboration between industry and patient organisations shall proceed in a transparent and open manner (Section 8 of the FSA Code of Conduct Patient Organisations). Consequently, companies shall conclude written agreements stipulating the base elements, such as type and scope of the collaboration. This applies particularly to payments, such as sponsorships or payments for consultation, to patient organisations.
Any advertising for medicinal products (be it directed to HCPs or consumers) must – subject to few exceptions – contain mandatory information (Pflichtangaben) as stipulated in Section 4 HWG (see 4.2 Information Contained in Pharmaceutical Advertising to the General Public). In addition, pursuant to Section 6 HWG, any advertising directed at HCPs referring to scientific or medical publications (eg, articles from a medical journal on the results of a clinical study) must clearly name the authors, the time of publication and the correctly quoted reference.
Beyond these obligations, there is no obligatory content for advertising directed at HCPs. For example, German law does not require advertising to include the price of the medicine.
Scientific Evidence and Clinical Studies
It is important to note, however, that advertising claims relating to medicinal products, regardless of whether directed to HCPs or the general public, must be based upon sufficient and reliable scientific evidence. This applies in particular to promotional claims in which medicinal products are attributed a therapeutic efficacy, qualities, certain effects or other benefits. Advertising claims that are not justified by sufficient and reliable scientific evidence are likely to be considered misleading.
Scientific evidence usually means clinical studies. In order to be accepted as sufficient evidence, such studies must be designed as randomised, controlled and double-blind clinical trials with an adequate statistical analysis that has been published and is thus opened towards scientific discussions. If this “gold standard” is not met, the advertising needs to make sufficiently clear that it is based on scientific data that is not published or on scientifically limited information. This applies, in particular, to retrospective analyses, such as subgroup analyses or meta-analyses in which data generated in different studies is pooled, or for data on file. The limitations of such data need to be clearly pointed out in the advertisement
It is, from a legal perspective, not necessary to refer explicitly to data and/or clinical studies that justify the promotional claim. However, if such data and/or clinical study publications are mentioned – for example, in a footnote – this reference must be complete, correct and able to serve as scientific evidence for the promotional claim. 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, as misleading only for formal reasons, as recipients are not able to verify (based on the information presented in the advertisement) if the promotional claim made is scientifically substantiated or not.
In Germany, the content of the SmPC as approved by the competent authority gives important guidance as to the state of scientific knowledge at the time the marketing authorisation was issued. German courts therefore assume that promotional claims are in principle legitimate if they can be based on the SmPC, as long as there are no new scientific findings that prove the content of the SmPC to be outdated.
That does not mean, however, that all data referred to in an advertising must be contained in the SmPC. According to the European Court of Justice (ECJ) and German courts, advertising may also refer to data and studies that are not included in the SmPC, provided that the statements used in the advertisement confirm or further clarify the information contained in the SmPC. The advertisement must be compatible with SmPC and may not distort it. For example, according to the SmPC for a diabetes mellitus medicine, the product has a proven, significant effect on the blood sugar level. If new clinical studies not yet cited in the SmPC show that the blood sugar-lowering effect is even higher than as described in the SmPC, this higher effect may be advertised without being considered as off-label promotion.
Advertising which refers to combination products or companion diagnostics that are not included in the SmPC will highly likely be qualified as illicit off-label advertising in Germany. Courts will consider such advertising as a promotion for unauthorised dosage forms and/or to be in conflict with the particulars listed in the summary of product characteristics. The Higher Regional Court of Hamburg, for example, once ruled that a promotion for a product in an authorised indication which only names that single product, although, according to the SmPC, the product is authorised only in combination with a further product, is illegal off-label advertising. Vice versa, it is very likely that a German court will find that advertising referring to combination products or companion diagnostics that are not included in the SmPC are also off-label.
There are no specific statutory rules for the distribution of journal articles to HCPs as such. However, under German law, the offer or provision of gifts or other benefits to HCPs is prohibited (see 9 Gifts, Hospitality, Congresses and Related Payments).
The FSA Code of Conduct HCPs provides for an exception: Pursuant to Section 15a of this code, informational and educational materials, such as journal articles, may be provided if such materials are inexpensive, have a direct connection with the professional activity of the respective HCP and are genuinely linked with patients’ care. If these conditions are met and if the distribution is, consequently, not intended to influence the physician’s prescribing or therapeutic decisions, there are good arguments that pharmaceutical companies may provide reprints of journal articles to HCPs. However, there is no specific statutory rule in this regard. Therefore, it should be carefully assessed in the individual case whether the aforementioned conditions are met.
MSLs to discuss scientific information on unauthorised medicines or indications with HCPs are in principle allowed as long as the MSL aims at an information exchange (and not at a unilateral provision of information from a company to an HCP) and if such exchange does not have a promotional but a scientific purpose. Otherwise, the information exchange will be considered as illicit off-label advertising.
Moreover, the MSL must observe German anti-bribery rules: There should always be a written contract in place covering and describing the consultancy services provided by the HCP and clarifying that there is no connection between the provision of services and any possible decisions on the purchase or prescription of medicinal products. Most importantly, the amount of remuneration needs to be transparent and adequate, see 9.7 Payment for Services Provided by Healthcare Professionals.
Under German law, advertising for medicines is not subject to prior authorisation from or notification to a competent regulatory authority. The German system is based on a prior self-assessment by the pharmaceutical company responsible for the advertising and a full legal review of the advertising in civil litigation, self-regulatory body or administrative proceedings.
Section 74a of the German Code on Medicinal Products (Arzneimittelgesetz or AMG) enhances the obligation of any pharmaceutical entrepreneur placing finished medicinal products on the market to appoint an information officer, who is responsible for ensuring compliance of the scientific information on the medicinal product. Advertising for medicinal products falls, inter alia, under the scope of responsibilities of the information officer.
The information officer has to have the necessary expert knowledge and reliability required to perform their activities.
In case of a violation of company-related obligations deriving from, for example, medicinal advertising law, a company’s owner can be held responsible if they have not provided for arrangements that secure compliance with the rules on medicinal advertising and if such a violation would have been prevented or hindered by such arrangements. Therefore, an owner needs at least to institute a hierarchical structure of supervisors monitoring compliance with the company-related obligations to avoid liability.
Thus, it is established practice within the German pharmaceutical industry to have in place standard operating procedures for medicinal advertising and to document the compliance with these SOPs. The review and approval process has to involve several internal functions and stakeholders – and the review/approval has to be documented. Review and approval by at least the medical department, the legal department and the information officer is necessary.
For advertising on the internet the general rules and provisions on advertising apply. However, in accordance with German case law, certain peculiarities apply:
Mandatory Information (Pflichtangaben)
Certain pieces of information have to be displayed in an advertisement for medicinal products. According to German courts, there is an exception for advertising for medicinal products on the internet. To be in compliance with the rules of the HWG, it merely has to depict a visible link that directly and without detours leads to the mandatory information and that is labelled appropriately.
Advertising Restrictions Regarding the General Public and Publication of the Package Leaflet on the Internet
According to a verdict of the ECJ, it is permissible for companies to release information on prescription drugs on their websites if such information is only accessible to someone who is actively searching and demanding for it and if such information only consists of the accurate presentation of the packaging of the medicinal product, the literal and complete reproduction of the package insert or the summary of product characteristics as approved by the authorities. Thus, information released on company websites that is subject to a selection or rearrangement by the company and that has not been released to inform on but rather to promote the company’s products is still prohibited.
Due to a lack of specific rules, the general restrictions apply. Unless an access control or access restriction is technically feasible, advertising of medicines on social media is limited to OTC products, as advertising for prescription-only medicinal products is not allowed to the general public.
Given the fact that any advertising for prescription-only medicines is limited to HCPs under German law, it is necessary to restrict access to websites which refer to prescription-only medicines. The HWG does not provide for a specific mechanism to restrict access. However, restricting access by providing a simple tick-box question (eg, “Are you a healthcare professional?”) would not be accepted as sufficient by courts. In practice, established access control systems with registration requirements (such as DocCheck) are used by most companies in Germany
Online disease awareness information aimed at patients is allowed as long as it informs generally about a certain condition as well as prevention and a variety of treatment options.
However, as soon as the information qualifies as product advertising by naming or describing, explicitly or implicitly, a specific product, or by focusing on statements that products to treat the condition are available, it clearly risks being seen as product advertising to the public.
There is no statutory law specifically regulating online scientific meetings. In the absence of any specific rules, the general rules apply. See rules on sponsoring of scientific meetings, online or offline, in 9.3 Sponsorship of Scientific Meetings.
For any information materials provided at international virtual conferences (which are attended by participants from different countries) German law is applicable, if a noteworthy number of German HCPs attend the meeting. In this case the materials aimed at German HCPs are likely considered to have an effect on the German market. There is no publicly available German case law determining a fix number of German participants necessary.
German law contains general anti-bribery rules contained in the German Criminal Code (Strafgesetzbuch or StGB) that may also apply to interactions between pharmaceutical companies and HCPs and specific rules for the pharmaceutical sector. Regarding the latter, statutory law provisions and self-regulatory provisions exist.
For the legal risk analysis there are important differences between the public and private sector. In essence, for the interaction with HCPs qualifying as public officials, the standards are very strict, while for privately employed or self-employed HCPs, slightly more leeway seems possible.
Section 331 StGB stipulates that a public official or a person entrusted with special public service functions who demands, allows themself to be promised or accepts a benefit for themselves or for a third person for the discharge of an official duty shall be liable to imprisonment not exceeding three years or a fine. The offence of offering or giving such bribes is inversely contained in Section 333 StGB. Fulfilling Section 331/333 StGB does not require a concrete action or omission taken by the public official.
By contrast, Section 332 StGB stipulates that a public official or person entrusted with special public service functions who demands, allows themselves to be promised or accepts a benefit for themselves or for a third person in return for the fact that they performed or will perform an official act and thereby violated or will violate their official duties shall be liable to imprisonment from six months to five years. This offence, which is mirrored in Section 334 StGB for the person giving such a bribe, is stricter than the general bribery provision.
HCPs Qualifying as Public Officials, etc
HCPs can qualify as public officials or persons entrusted with special public service functions. In essence, from a practical perspective, HCPs employed by publicly owned hospitals or medical institutions, such as a university hospital or a municipal hospital, may often qualify as such public official. The interaction between pharmaceutical companies and such HCPs should be closely monitored.
For the private business sector, Section 299 StGB prohibits the taking and giving of bribes in commercial practice. According to Section 299(1) StGB, whosoever, as an employee or agent of a business, demands, allows themselves to be promised or accepts a benefit for themselves or another in a business transaction as consideration for according an unfair preference to another in the competitive purchase of goods or commercial services shall be liable to imprisonment not exceeding three years or a fine. Section 299(2) StGB mirrors the prohibition for the person giving such bribe.
This general anti-bribery rule may typically apply to interactions with HCPs or other members of the healthcare profession who are employed by a private hospital or medical institution.
The responsibility for violations of these criminal law provisions always falls on a human being. An organisation cannot be held liable under German criminal law. However, in practice this does not mean that providing illicit benefits to organisations may not be covered by criminal law provisions. In such cases, the competent authorities and courts typically hold liable the person acting on behalf of the company or institution or the person in a management or monitoring function.
As regards sector-specific anti-bribery rules, the German legislator introduced in 2016 a new provision in the Criminal Code according to which also self-employed HCPs, eg, physicians in private practice, can commit bribery according to the general rules.
Under Section 299a of the Criminal Code, liability is found in any HCPs requiring state-organised training to carry out their profession or to bear a specific professional title who – in pursuing their profession – demand, allow themselves to be promised or accept a benefit for themselves or another as consideration for according an unfair preference to another in domestic or foreign competition by prescribing medicinal products, remedies and therapeutic products or medical devices; by purchasing medicinal products or therapeutic products or medical devices intended for direct application by the members of the healthcare profession or their assistants; or by referring patients or specimens for testing.
Conversely, under Section 299b it is a criminal offence to offer, promise or grant such benefit to any of the above-mentioned persons. Whereas under Section 299a, only persons belonging to the group of people mentioned in that provision can be criminally liable, under Section 299b any person can be an offender (eg, employees of companies dealing in pharmaceuticals, medicinal products or biotechnology or wholesale companies co-operating with HCPs). The list of healthcare professions is long and includes doctors and pharmacists, as well as physiotherapists and nurses.
The entry into force of the new regulations has marked a turning point for the practice of law. Since then, for activities that were not previously criminal offences and were therefore often tolerated, the risk profile has considerably changed for members of the healthcare profession and the life sciences industry.
The HWG in principle forbids giving incentives or advertising gifts to doctors. Pursuant to Section 7(1) HWG, it is, subject to certain exceptions, prohibited to offer or give advertising gifts or other benefits to consumers or HCPs in connection with the promotion of medicinal products or medical devices. It is also prohibited for HCPs to accept these advertising gifts or benefits.
Section 7(1) HWG states some exceptions to this prohibition. In particular, it is acceptable to provide low-value advertising gifts or benefits. According to applicable case law, the value acceptable is widely considered to be EUR1. Moreover, Section 7 HWG allows a company to grant a volume-related discount in kind or in money, but only subject to the following conditions: rebates in kind are prohibited for all kinds of pharmacy-only pharmaceuticals, which means that they are only possible to medical devices and pharmaceuticals that may be sold outside pharmacies. Rebates in money are prohibited if they are granted against the German Ordinance on Pharmaceutical Prices (Arzneimittelpreisverordnung).
Breaches constitute an administrative offence and can be punished with fines of up to EUR50,000 a case by the competent administrative authorities. This applies not only to the doctor, but also to the company offering the incentive. Civil law cease and desist claims asserted by competitors constitute a further risk.
Professional Code of Ethics
Doctors are subject to the Medical Association’s professional code of conduct, which contains detailed rules governing co-operation with third parties, such as pharmaceutical companies. Under this code, doctors may not demand or accept gifts or other benefits if this were to give the impression that the independence of the doctor’s decision has been influenced.
If a doctor breaches the professional code of conduct, he or she faces disciplinary measures that can result in serious penalties, including a formal warning, a maximum fine of EUR50,000 and the declaration of unworthiness to exercise their profession in the most serious cases.
The latter can lead to the doctor's licence to practise medicine being revoked.
The involvement of pharmaceutical companies in a breach of a professional code of conduct committed by a doctor (eg, by providing gifts or payments) can trigger civil law cease and desist claims asserted by competitors). This aspect should not be underestimated as it seems that pharmaceutical companies have become increasingly aware of this issue.
Manufacturers may not give doctors any incentives in connection with prescribing medical devices (Section 128(2) Fifth Book of the Social Code). If a doctor also breaches his or her duties while acting for the healthcare service, he or she could face disciplinary proceedings before the National Association of Statutory Health Insurance Physicians. Depending on the gravity of the misconduct, disciplinary measures can include a warning, a fine of up to EUR10,000 or a suspension of the doctor’s practice certificate for up to two years.
Industrial Codes of Conduct
The pharmaceutical industry has put in place strict regulations for co-operation with doctors. For example, pursuant to the FSA Code of Conduct HCPs, a doctor may not receive a fee or any other non-cash benefit for prescribing or recommending a drug to patients. For any breach of this rule, the FSA’s arbitration board can impose fines and administrative fines of up to EUR400,000.
For the legal risk analysis of concrete measures in the interaction between pharmaceutical companies and HCPs, the standard to assess whether a practice is still permissible or already illicit varies depending on the legal qualification of the HCP. In essence, for the interaction with HCPs qualifying as public officials, the standards are very strict, while for privately employed or self-employed HCPs, slightly more leeway seems possible.
For any form of commercial interaction with HCPs, and in particular for the grannting of any sort of benefit, it is highly recommended to adhere to the four basic principles of healthcare compliance, namely the principles of documentation, transparency, separation and equivalence should always be respected. Moreover, it is highly recommended, if not required, to ask the HCP to provide an authorisation of the employer or administration.
Offering gifts to HCPs bears a considerable legal risk. Gifts in the form of cash will very likely be considered unacceptable by authorities and the courts, irrespective of the amount. Providing gifts to HCPs qualifying as public officials also bears the risk of triggering a suspicion of violation of Section 331 StGB and of criminal proceedings being started. Moreover, the HWG does not allow the offer or supply of gifts or other benefits – or the acceptance of such gifts or benefits. However, it foresees a limited number of exceptional rules, eg, with regard to promotional gifts of minor value.
In addition, the Professional Rules for German Physicians prohibit the acceptance of any gifts or benefits that might influence their prescribing or therapeutic decisions or which could be considered as a reward for such previous decisions. Furthermore, the FSA Code of Conduct HCPs generally prohibits the provision and acceptance of any kind of benefits with respect to hospital physicians that is granted in the context of their work, especially as consideration for carrying out purchasing or prescription decisions.
The provision of samples is limited pursuant to Section 47, paragraphs 3 and 4 of the AMG. Pharmaceutical companies may provide samples of medicinal products to HCPs, but only in small numbers and upon their written request. Samples may be provided with a maximum amount of two packages per year, it is understood that the packages must be of the smallest commercially available size and be labelled as samples. The supply of such samples must be recorded by the company. In addition, samples may only be provided accompanied by a professional information sheet according to Section 11a AMG.
In the absence of concrete stipulations in German statutory law, authorities and courts often make reference to the FSA Code of Conduct HCPs, which contains specific rules for financial support of scientific meetings or congresses. If these rules are respected, a company has good reasons to argue that it complied with the industry standards and did not provide inappropriate inducement to the organiser or the participating HCP, which could otherwise be considered an indication of bribery.
The FSA Code of Conduct HCPs differentiates between in-house scientific events or seminars and external scientific events.
In-house Training Events
Generally speaking, pharmaceutical companies may invite HCPs to their own training events who are particularly concerned with said companies’ research areas, pharmaceuticals and their therapeutic indications (in-house training events). The company may only pay reasonable travel and accommodation costs for the invited physicians if the job-related, scientific character of the in-house training event clearly takes centre stage. During such training events, reasonable hospitality arrangements for the participants are also possible. However, the company must neither finance nor organise any entertainment and leisure time programmes for the participants.
The participation of the invited persons and the event programme must be documented. Accommodation and hospitality must not exceed reasonable limits and must be of minor importance in relation to the job-related, science-orientated purpose of the in-house event. The selection of the conference location and conference venue as well as the invitation of HCPs must be made exclusively based on factual criteria. For instance, the leisure offerings of the conference venue do not qualify as such a reason. Further, the companies are to avoid conference locations that are known for their entertainment value or are considered extravagant.
Third-party Job-related Training Events
With regard to job-related training events of any third party (external training events), it is recognised that pharmaceutical companies may invite HCPs to attend such events. Also in this regard the FSA Code of Conduct HCPs contains provisions that reflect industry standards: the invitation may only include reasonable travel expenses, necessary accommodation (if necessary, including hotel breakfast) and participation fees charged by said third party if the scientific character of these events clearly takes centre stage and if the company has a relevant interest in such a participation.
The company may only assume the costs if the event provides a link to the member company’s field of activities as well as a link to the expertise of the event participant. Member companies must not support directly or indirectly any entertainment programmes by paying participation fees for HCPs.
If the HCP also acts as a speaker (active participation), the pharmaceutical company may in addition pay an appropriate honorarium compensating for the services rendered.
Pharmaceutical companies must neither finance nor organise any entertainment or other non-scientific events in relation to scientific conferences (eg, theatre, concert or sports events).
It is widely recognised that, as an exception to the general rule for the provision of gifts and other benefits to HCPs or institutions, a company may grant donations to healthcare institutions if these donations are made:
The FSA Code of Conduct HCPs contains some more specific rules in this regard. According to its Section 25, donations (monetary or donations in kind) as well as other unilateral monetary benefits or benefits in kind to institutions, organisations or associations, whose members are HCPs (eg, medical–scientific associations) and/or perform medical services or research (eg, hospitals or university clinics), need to comply with the following requirements (besides the compliance with relevant other legal requirements): serve the aims of healthcare or comparable aims (including, for example, the aims of research, teaching and further training), are correctly documented, whereby this documentation is to be kept for a minimum period of five years after the contractual relationship has ended and are not misused as an incentive to influence therapy, prescription or procurement decisions. Donations to individual HCPs are not permissible.
In essence, these rules apply to monetary donations and donations of equipment and services. For equipment and services, it will in practice be harder to justify, though, how the donation was appropriate because there is a close link to the sale of the pharmaceutical product. Thus, at least a violation of Section 7 HWG needs to be carefully considered.
Section 7 HWG contains specific rules defining whether and to what extent rebates may be granted to HCPs and institutions, see 8.1 General Anti-Bribery Rules Applicable to Interactions between Pharmaceutical Companies and Healthcare Professionals. In essence, for medicinal products subject to price ordinance, it is not possible to grant rebates. For other medicinal products and devices, rebates in kind and in money are in principle permissible.
There are different legal considerations to make with regard to paying HCPs for the service they render. In principle, it is allowed under German law and in line with the codes of conduct to receive services from a HCP – such as consultancy, speaker or study services – and to pay for such services. However, to avoid any misunderstandings and suspicion from the outset, it is crucial to ensure that for any service rendered by a HCP, the applicable principles and rules are respected. From a formal point of view, there should always be a written contract in place covering the service.
The services should be described in sufficient detail and the agreement should contain language clarifying that there is no connection between the provision of services and any possible decisions on the purchase or prescription of medicinal products. Most importantly, the amount of remuneration needs to be transparent and adequate. An hourly fee calculated on the basis of the medical fee schedule (Gebührenordnung für Ärzte) leads to an hourly rate of approximately EUR120. Agreeing compensation on this level would likely only pose a low risk. Exceeding the threshold – eg, by arguing that the HCP in question is very competent and recognised – can be argued, but poses a certain risk with regards to anti-bribery provisions.
It is recommended, if not required, to ask the HCP to provide an authorisation of the employer or administration. This is essential if the receiving HCP qualifies as a public official. For HCPs employed by a private hospital or institution, it is also highly recommended for reasons of transparency to obtain such approval by the management.
German statutory law does not contain provisions that would oblige pharmaceutical companies publicly to disclose the transfer of value to HCPs or institutions. Thus, pharmaceutical companies active on the German market are in principle not required to make the transfer of value to HCPs or institutions public.
Different rules apply to those pharmaceutical companies that are members of the FSA. They have voluntarily agreed to a Transparency Code. According to the Transparency Code, all payments in kind by the pharmaceutical industry to physicians and other HCPs are to be made public. The FSA member companies have to document all direct and indirect payments, and benefits in kind, made to HCPs or organisations of the healthcare system from the areas of:
The figures are published once a year.
The transparency rules do not contain any exceptions for COVID-19 incidences (eg, cancelled events).
The requirements apply to those pharmaceutical companies that are members of the FSA, irrespective of whether they are based in Germany or abroad, and irrespective of whether they have products on the market or not.
The HWG is a federal administrative law that as such is enforced by the competent authorities in the 16 federal states (Bundesländer).
In practice, however, the rules on advertising and inducement are primarily enforced by civil courts. According to longstanding and established case law, if a company (allegedly) violates a provision of the HWG, such violation is at the same time an act of unfair competition under Sections 3 and 3a of the UWG. As a consequence, many (alleged) HWG violations are pursued among competitors or by industry and consumer protection associations (such as the Zentrale zur Bekämpfung unlauteren Wettbewerbs) out of court and through civil litigation. In light of the usually high time pressure in advertising cases, many of the court cases are interim injunction proceedings.
Enforcing HWG Rules at Civil Law Level
In fact, there has been a long tradition of enforcing the HWG rules at a civil law level and the vast majority of court decisions in the field of pharmaceutical advertising are judgments of the German Regional Courts (Landgerichte), Higher Regional Courts (Oberlandesgerichte, acting as courts of appeal) and the Federal Supreme Court (Bundesgerichtshof).
Moreover, an offence against the prohibition of misleading advertising under Section 3 HWG can – under particular circumstances – also lead to criminal proceedings. In these rare cases, the competent bodies to initiate an investigation are the locally competent state prosecutors. Judgments are pronounced by the local district or the regional court.
Finally, there are arbitration boards established by self-regulatory industry associations that adjudicate on violations of industry codes of conduct. A famous example is the Schiedsstelle of the FSA.
If a company (allegedly) violates a provision of the HWG, such violation is at the same time an act of unfair competition under Sections 3 and 3a of the UWG. This law gives companies the possibility to bring cease and desist claims as well as damages claims directly against their competitors and to pursue these claims in civil courts. A cease and desist claim can also be brought by industry associations as well as consumer protection associations against companies. However, action may not be taken by individuals.
In case of a breach of an industry code, companies, associations and individuals can initiate proceedings against members of the relevant self-regulatory organisation before the organisation’s arbitration board. The company initiating the arbitral proceeding does neither have to be a member of the organisation nor have subjected itself to the rules of the organisation.
Depending on the individual case, a breach of a self-regulatory code can also indicate an act of unfair competition under the UWG. This allows competitors as well as industry and consumer protection associations to bring a civil law claim against the member of the self-regulatory organisation. Whether a breach of a self-regulatory code is indeed “unfair” in terms of the UWG is ultimately to be evaluated by the civil court.
Furthermore, companies, associations and individuals can direct themselves to the competent health authorities and inform them about (alleged) advertising infringements. It will be up to the authority to decide whether it will start administrative proceedings or not. In case such proceedings end with an administrative decision against the advertising company, this company may go on to appeal before the competent administrative court
In civil litigation based on an infringement of the UWG, courts can grant injunctive relief by issuing a cease and desist order (Unterlassung), which is the most important remedy in practice. The court can also impose remedial action by the defendant (Beseitigung), including a seizure of any infringing advertising material and the publication of corrective statements, and allow the plaintiff to publish the court decision if he or she is able to demonstrate a legitimate interest in this respect. Finally, the plaintiff may claim an account of any profits made by the infringer and if they are able to prove that he or she suffered any measurable damages from the unlawful advertising (which is rarely the case), the court may award damages.
The arbitration boards of self-regulatory bodies can impose the sanctions provided for in their code of procedure or the code of conduct. The board of currently the most relevant self-regulatory body for the pharmaceutical industry, the FSA, for example, may grant injunctive relief (cease and desist orders) and issue fines of EUR5,000 up to EUR200,000 and, in exceptional cases, an additional financial sanction of EUR5,000 up to EUR200,000 (in second instance, EUR400,000) to be donated to a charitable organisation. In cases of a severe or repeated violation of the FSA rules, the board of second instance may issue a public rebuke.
Finally, the rules of the HWG may also be enforced by the public authorities through administrative offence proceedings (Ordnungswidrigkeitenverfahren), which rarely happens in practice. Negligent or wilful violations of the advertising rules can lead to fines of up to EUR50,000. If the violation is committed through a misleading advertisement, the sanctions are different: an intentional violation is a criminal offence punishable by imprisonment of up to one year or by a fine; in case of negligence, misleading advertising can be punished by an administrative fine of up to EUR20,000.
A competitor is free to bring action before a civil court and an arbitration body of a self-regulatory association. The proceedings before a court and before an arbitration body can take place independently from each other. Likewise, the authorities may initiate administrative proceedings irrespective of whether there is or has been any civil court or self-regulatory action.
Experience shows, however, that companies often choose between filing a complaint with a self-regulatory body or bringing a civil law claim and do not pursue both paths in parallel. Breaches of the self-regulatory code by way of inappropriate gifts and inducements are often brought to the arbitration bodies of self-regulatory associations such as the FSA, whereas cases of misleading or off-label advertising as well as advertising to the general public are often the subject matter of civil court proceedings.
There are no particularly relevant enforcement trends in Germany at the moment.