In its cabinet session on 21 January 2015, the German government adopted the draft bill on combating corruption1 of the Ministry of Justice and Consumer Protection. The bill is intended to reform the German Criminal Code in order to accommodate the mandatory requirements imposed by the European Council and the United Nations Convention Against Corruption of 31 October 2003. Preventing and combating corruption in all its forms is regarded as one of the state's central tasks by the German government, including the effective fighting of cross-border corruption. The government is also working on a draft bill on active and passive corruption in the healthcare sector.
Draft bill on combating corruption
The new bill tightens the penalties on passive and active corruption in business transactions, now a criminal offence. Corruption in business transactions means that an employee or agent of a commercial undertaking is bribed, by contrast to the bribing of public officials which is an offence as well. Under the current law, bribing an employee or agent of a company is only a criminal offence if it is done in order to buy an undue advantage in competition; by way of example, the purchasing manager in a company is paid bribe money by a supplier and in return awards the contract to the supplier rather than a less expensive competitor. If there is no distortion of competition, corruption is currently not a criminal offence.
Based on the EU Council Framework Decision2, however, corruption that does not involve a distortion of competition but a breach of duty in relation to the employer shall also be an offence. The new, extended Sec. 299 StGB (German Criminal Code) also covers cases where bribe money buys a breach of duty by an employee or agent of a company outside of any competition context. These are duties that the employees or agents owe to the business proprietor, which may in particular be grounded in law or in contract. Merely accepting the advantage or merely withholding the fact of the benefit from the employer, in other words a breach of the company's compliance policies, is not sufficient to constitute such a breach of duty. The advantage rather has to manifest itself in some sort of return service for the breach of duty committed in the briber's interest, involving the receipt of goods or services. Breaches of duty that only cause internal disruptions are not an offence by this definition, as they are not duties involving the receipt of goods or services. The bill explains the reasoning behind the amendment of Sec. 299 StGB as follows: Sec. 299 serves not only to protect the functioning of competition but also to safeguard the employer's interests where the exchange of goods is concerned. The amendment more strongly protects the employer's interest in the loyal and uninfluenced discharge of duties by his employees and agents relating to the exchange of goods and services. An "advantage" per the legal definition exists where the receiver has no legal claim to receive the benefit.
Corruption in the healthcare sector
Ever since a 2012 decision of the Enlarged Criminal Panel of the Federal Court of Justice (to be discussed below), the political parties in Germany largely agree that corruption in the healthcare sector should be combated more seriously by means of a legislative reform. So far, opinion was divided on how and especially in which act of legislation the amendment should be crafted. On 15 January 2015 the state of Bavaria submitted a bill for an act combating corruption in the healthcare sector.3
The Enlarged Criminal Panel of the Federal Court of Justice decided in March 20124 that for purposes of SHI doctor services, physicians in their own practice – as opposed to physicians working in public hospitals – are neither public officials nor agents of the health insurance funds within the meaning of Sec. 299 StGB. In the case decided by the FCoJ, a drug representative working for a pharmaceutical enterprise was practicing a bonus system under the name "prescription management" for doctors who prescribed the drugs she was selling. The physician was to receive 5% of the manufacturer's price as a reward for prescribing drugs made by her employer. The payments were documented as fees for fictitious scientific lectures. Based on this bonus system the accused handed out cheques to different SHI doctors in 16 cases, for a total sum of EUR 18,000. The lower court had convicted the accused of corruption in business transactions. The FCoJ overturned the judgment.
Under the old law (which is currently still in force), the giving of benefits to doctors working in their own practice to encourage them to prescribe specific drugs or drugs from a particular pharmaceutical company was and is not a criminal offence in Germany, be it under Sec. 299 StGB or as an offence committed in public office under Sec. 331 ff. StGB (active and passive corruption in public office).
In the previous legislative period, the Hamburg senate introduced a draft bill for a new offence "passive and active corruption in the healthcare sector", to be added to the Criminal Code as new Sec. 299a, to the German Bundestag5, but the bill was thrown out.
The federal government's counter-bill6 would have introduced a criminal offence to the Fifth Book of the Social Security Code (SGB V), modelled on the corruption offences defined in the Criminal Code with a focus on the special characteristics of statutory health insurance. The clause would have imposed penalties on anyone who unlawfully accepts or gives advantages. Depending on the severity of the offence, a corrupt service provider would have faced either a fine or imprisonment of up to three years. The new legislation was to apply not only to doctors but to all occupational groups in the healthcare system. The draft bill did not make it past the Bundesrat, where the opposition parties referred it to the Mediation Committee shortly before the end of term.
After the elections on 22 September 2013, CDU and SPD in their coalition talks agreed to set forth a new regulation in the Criminal Code, defining a new, separate offence.7 A proposal by the Federal Ministry of Justice and Consumer Protection (BMJV) was coordinated with the Federal Ministry of Health in early 2015 and published on 5 February 2015. The draft introduces a specific offence of active and passive corruption in the healthcare sector (Sec. 299a StGB-E).
The state ministers of justice have already adopted a resolution on combating corruption in the healthcare sector. The state of Bavaria submitted a draft bill for an act on combating corruption in the healthcare sector on 15 January 2015. The bill was put before the Bundesrat on 6 February 2015. The BMJV bill will not differ significantly from the Bavarian bill. The definition of the possible perpetrators will be different, and an offence shall only be prosecuted on request under the BMJV bill. The coalition will likely have to reach an agreement on which bill will finally be adopted as the federal cabinet's bill.
New criminal offence in Sec. 299a StGB
The draft provision is set out below:
"§ 299a Passive and active corruption in the healthcare sector
- Whosoever as a member of a healthcare profession for which professional organisations are established throughout Germany requests, accepts the promise of, or accepts an advantage for himself or for a third party, while practicing that profession, in order to, in purchasing, prescribing, administering or dispensing medicinal products, therapeutic remedies or appliances or medical devices or in referring patients or test material,
- unfairly give preference to another in national or foreign competition or
- otherwise breach his professional duties,
shall be liable to imprisonment of no more than three years or a fine.
- Anyone offering, promising or giving to a member of a healthcare profession within the meaning of paragraph (1), while practicing that profession, an advantage for himself or for a third party in order to, in purchasing, prescribing, administering or dispensing medicinal products, therapeutic remedies or appliances or medical devices or in referring patients or test material,
- unfairly give preference to him or another in national or foreign competition or
- otherwise breach his professional duties,
shall be liable to the same penalties."
According to the bill's explanatory notes, the definition of a new offence is necessary as the legislator has been using the medical community widely as demand managers for commercial enterprises. By laying down in the law that medical treatment has to be given by a physician (Sec. 15 SGB V) and that specific medicinal products are subject to prescription (Sec. 48 AMG, German Medicinal Products Act), the legislator turned medical professionals into key figures for many other players in the healthcare marketplace, entrusting them with considerable decision-making power. Thus, the risk is high of exposure of these persons to unlawful forms of influence and of cooperation arrangements between doctors and other healthcare service providers that adversely affect others. The central position of medical professionals is also perceived by the manufacturers of pharmaceutical products, encouraging them to focus their advertising efforts for pharmaceutical products on the healthcare professionals, especially physicians and pharmacists who control the prescription and dispensation of their products. However, the bill emphasises that this alone does not permit the conclusion that any collaboration between medical professionals should be put under general suspicion or sanctioned with far-reaching criminal penalties. On the other hand, any abuse has to be prevented.
A number of initiatives emerged in the past in order to more clearly define the lawful forms of partnership between doctors and the industry and to clearly keep them away from any criminality, while on the other hand determining what forms of improper influence cross the line to unlawfulness. For example, the professional codes for doctors prohibit particular forms of cooperation so as to safeguard the physician's independence in working with others. In particular, a doctor is not permitted to accept transfers of value in order to prescribe particular medicinal products, therapeutic remedies or appliances or medical devices, or to accept excessive benefits in any contractual collaboration (see Sec. 31 - 33 Model Professional Code for Physicians (MBO-Ärzte); Sec. 2 (7) and (8) Model Professional Code for Dentists (MBO-Zahnärzte); Sec. 12 (8) Model Professional Code for Veterinarians (MBO-Tierärzte); for pharmacists, see Sec. 10, 11 Pharmacy Act (ApoG) and for example Sec. 11 (2) of the Bavarian Professional Code for Pharmacists). In the law governing the statutory health insurance, Sec. 73(3) SGB V explicitly prohibits doctors from accepting the promise of or accepting, or promising or giving, any remuneration or other economic benefit for the referral of patients. In addition, Sec. 33(2) Regulation on the Licensing of SHI Doctors prohibits practicing associations designed to circumvent this prohibition of Sec. 73(3) SGB V. Sec. 128 SGB V also controls benefits for and inadmissible relationships between SHI physicians and other service providers in the supply with therapeutic remedies and appliances. However, the currently available penalties, especially under professional regulations, are seen as insufficient because they do not consider and compensate for the ethical reprehensibility of corruption in the same way as a criminal penalty would.
The legislator especially has an eye on cases of "pharma marketing" – activities intended to foster sales of medicinal products. For example, the activities include discounts given by drug manufacturers to pharmacists in order to promote sales of specific (more expensive) drugs. The draft bill also refers to activities by which drug manufacturers seek to encourage a doctor to prescribe their products. This can be done under the cover of non-interventional trials (Sec. 67(6) s. 1 AMG), in other words trials designed for systematically collecting knowledge and experience with the use of a particular drug. As soon as the manufacturer pays the doctor a fee which clearly exceeds the value of the service, i.e., of the documentation effort, it at least stands to reason that this is intended to influence the prescription practices and to motivate the doctor to employ the particular drug. For this reason, Sec. 67(6) s. 3 AMG expressly provides that the type and amount of any remuneration paid to a doctor for participating in such a trial shall be so as to create no incentive for any preferential prescription or recommendation of a specific medicinal product (complemented by Sec. 33 of the Model Professional Code for Physicians). In general, this concerns agreements between pharmaceutical enterprises and physicians which, at the end of the day, grant a remuneration in the shape of a discount, refund, kickback or other benefit to the doctor for prescribing a medicinal product from a specific enterprise.
In terms of perpetrators, the draft bill in Sec. 299a(1) refers to members of healthcare professions for which professional organisations are established throughout all of Germany (special offence). These are (at present) physicians, dentists, veterinarians, pharmacists, non-medical psychotherapists and child and adolescent psychotherapists – the so-called academic health professions. This limitation of the addressees is said to account for the fact that these occupational groups have a particularly central steering and distributive function in the healthcare market. Physicians exercise these functions in questions of medical treatment, while pharmacists do so in questions of due and proper drug supply. Medical professionals decide as part of their medical consulting and treatment activities whether any members of non-medical health professions will be involved in the therapy. As a result, they widely act as demand managers for other players in the healthcare market and are exposed to particular risks of unlawful influence. By contrast, occupational therapists, speech therapists and physiotherapists are not covered by 299a(1) but only fall under the active corruption variant of Sec. 299a(2) StGB-E in their capacity as givers of benefits. The resultant protection against corruption in the healthcare sector is reinforced by the provisions of the Health Products Advertising Act (Heilmittelwerbegesetz, HWG), which largely prohibit any acceptance of benefits in all health professions on pain of fines (see Sec. 2, 7(1), 15(1) No. 4a HWG). For persons outside these occupational groups, such as business managers or clerks working in hospitals or nursing homes who handle the purchase of medicinal products, therapeutic remedies or appliances or medical devices, corruption offences remain subject to Sec. 299 StGB.
Only acts undertaken by the healthcare professionals "in practicing their profession" are offences by the new law. This qualification is intended to make it clear that private acts outside the professional occupation (for example, purchasing drugs for private use) do not constitute an offence under Sec. 299a(1) of the new bill.
The perpetrator has to request, accept the promise of, or accept an advantage for himself or for a third party. "Accepting" means the actual physical taking of the benefit, "accepting the promise of" is accepting the offer of an advantage to be provided in the future, and "requesting" means the perpetrator's (express or implied) declaration that he seeks an advantage in return for his acting. Similar to Sec. 299 StGB, an advantage under Sec. 299a StGB-E generally includes everything which materially or immaterially improves the receiver's situation and which he is not entitled to. By way of example, a direct payment of money would be an advantage, or a discount on the purchase of medicinal products and laboratory services, or an invitation to a holiday trip. This includes benefits granted to the perpetrator as well as to third parties.
As with all corruption offences in general, at the core of the offence lies the "wrongful agreement", that is to say the requesting, accepting the promise of, or accepting of advantages for oneself or for another in return for the health professional's engaging in a particular (unlawful) act. It is an offence to demand something in return for giving the advantage, specifically, a breach of duty in purchasing, prescribing, administering or dispensing medicinal products, therapeutic remedies or appliances or medical devices or referring patients or testing material. Thus, in the first place, the legal definition refers to a breach of duty in purchasing, prescribing, administering or dispensing medicinal products, therapeutic remedies or appliances or medical devices. The wrongful agreement can refer to any procurement whatsoever, or passing on of these products and remedies to patients. The relevant activities cited in the law are purchasing, prescribing, administering and dispensing. The wrongful agreement may also concern the referral of patients or testing material. Referring a patient means any act by the bribed person which is causal for the patient engaging the services of a particular, different doctor, pharmacist, laboratory or other health services provider. These are mainly referrals to other physicians, a hospital and to medical specialists, but it can also mean a recommendation to see and employ the services of a specific service provider.
The health professional's return service for the benefit under Sec. 299a(1) No. 2 StGB-E may also involve the health professional otherwise breaching his duties to properly practice his profession. The legislator seeks to prevent breaches of professional duties that compromise the objectivity and independence of medical decisions. The professional duties are set forth in the special laws for each healthcare profession (for example, the Federal Medical Practitioners Act, Federal Veterinarians Act, Dentistry Act, Psychotherapists Act, Pharmacy Act), the state laws on healthcare professions and organisations and the professional codes based on them, as well as the rules of the Fifth Book of the Social Security Code. Of special importance are the rules governing the exchange of goods and services in the healthcare market and the cooperation and interaction with other players in the healthcare sector (such as Sec. 31-33 MBO-Ärzte, Sec. 2 (7) and (8) MBO-Zahnärzte, Sec. 12 (8) MBO-Tierärzte, Sec. 10, 11 ApoG, Sec. 73 (7), 128 SGB V).
Under the mirror image provisions of Sec. 299a(2) StGB-E, the granting of advantages to any of the persons in paragraph (1) is a criminal offence. Anyone can be a perpetrator.
Bill of the Federal Ministry of Justice and Consumer Protection of 5 February 2015
On 5 February 2015, the BMJV submitted its own ministerial bill on combating corruption in the healthcare sector.8 The bill also proposes introducing a new criminal offence of active and passive corruption in the healthcare sector and very closely follows the earlier Bavarian bill. The proposed new offence shall be added to the Criminal Code as Sec. 299a StGB.
Unlike the Bavarian bill, the federal bill addresses both the academic health professions requiring training regulated by the law and medical licensing regulations (physicians, dentists, veterinarians, psychotherapists, child and adolescent psychotherapists and pharmacists), as well as the related specialist professions such as nurses, occupational therapists, speech therapists and physiotherapists, whose training is regulated by law as well. In other words, the list of possible perpetrators is not limited to those working in academic healthcare professions. In its explanatory notes, the Ministry states that non-academic health professionals are not involved in the allocation of expenditures in the healthcare sector to the same degree as physicians and pharmacists are. In particular, their economic importance for other service providers is not the same as that of doctors and pharmacists. Thus, the general risk of unfair influence being exerted on decisions of non-academic health professionals should be somewhat less serious. However, this does not permit the conclusion that active and passive corruption offences involving members of non-academic health professions are punishable to a lesser degree. On the contrary, the services rendered by non-academic health professionals to patients and thus for healthcare purposes in general are equally important and necessary. It has to be ensured by way of the means available under criminal law that these services are provided without any undue influence as well.
The federal bill expressly sets forth that there shall be no de minimis limit. A low-value, customary promotional gift or small present from a patient, however, is not suited to influence a specific decision by a healthcare professional and is regarded as a socially adequate benefit that does not fulfil the criteria of the offence (similar to Sec. 299 StGB). The Bavarian bill shares this view. Not socially adequate are benefits which, when accepted, suggest that the independence of the medical decision is being influenced; such a benefit is also contrary to professional ethics (Sec. 32 MBO). A benefit may also take the shape of a congress invitation, the coverage of the cost of continued medical education, or the granting of business shares or profit-sharing rights. A contract providing for obligations owed to the perpetrator also can be a benefit, even if they are only the reasonable consideration for obligations owed in turn by the perpetrator under the contract. Thus, the participation in a paid non-interventional trial may also be seen as a benefit.
Contrary to the Bavarian bill, the federal bill provides that the offence of active and passive corruption will only be prosecuted on request (through Sec. 301 StGB). According to the current Sec. 301(1) StGB, active and passive corruption in business transactions under Sec. 299 StGB is only prosecuted on request. A request for prosecution may be filed by those who are harmed by a corruptive arrangement. These are the competitors in the cases of Sec. 299a(1) No. 1 and (2) No. 1 StGB. Patients have the right to request prosecution as well. Under the proposed new law, a request to prosecute may also be filed by competitors' professional associations having legal capacity, the statutory health and nursing care insurance funds, and private health and nursing care insurers. The professional associations having legal capacity in particular include professional associations organised under private law that are engaged in representing and promoting the interests of specific professions. The medical associations of which the perpetrator is a member shall have the right to request prosecution as well.
Due to the renewed legislative initiatives from several different sides, it is likely that a bill on combating corruption in the healthcare sector will be adopted during the current legislative session. The language in the current draft bills being very generalising, there is a risk that forms of cooperation which are actually welcome could constitute an offence as well. One example is aftercare planning to ensure seamless patient care, where cooperation between service providers and hospitals is regarded as indispensable. The new law should not obstruct and impede the welcome and necessary forms of collaboration in the healthcare market. Companies are advised to check if their internal guidelines and policies on relationships with healthcare professionals have to be revised and amended.