On 14 April 2016 the German Bundestag (Parliament) passed the long-announced anticorruption law specifically addressed and aimed at fighting corruption in the health care sector (§ 299a Strafgesetzbuch – StGB): the acceptance or grant of a benefit as a consideration for the HCP's having given concrete unfair preference to a competitor will be criminally sanctioned once the new law takes effect, which is assumed to be May or June this year.
What should I do now?
Existing and future collaborations with healthcare professionals (HCP) should be closely reviewed to determine their permissibility with the new law. Especially the following forms of collaboration pose risks and should be legally assessed:
- Post market surveillance studies and monitoring registries, in particular if the data generated might not be needed or if the compensation to the HCP for collecting the data might not be deemed appropriate;
- Homecare services rendered to patients or organized and paid for by the pharma/devices industry, in particular if the HCP also involved in the care save money and effort or receives other direct or indirect advantages, given that their work is partially performed by the healthcare service provider;
- The offer by the pharma/devices industry of valuable patient support/tools through the HCP, in particular if the patients perceive the support/tool as a service from the HCP;
- Invitations to educational events (e.g. international congresses), in particular if the educational event does not relate closely to the product of the respective pharma/devices manufacturer or if the selection of the invited HCP is closely linked to the use or prescription of a product;
- Conclusion of service, research or consultancy agreements with HCP if there is no need for the specific service or if the selection of the HCP is not done in an objective manner, even despite the fact that the consideration paid reflects fair market-value;
- Company participation of and profit-sharing with HCP, in particular if the distributed profit may induce the HCP to use or prescribe certain products;
- Offering or granting benefits to HCP for referring patients to patient programs in the industry, in particular if such a program fosters the use of a product;
- The granting of discounts to HCPs for products designated for patients if the discount is not passed on to the patient or its sick fund
- And, of course, any form of kick-back for the preferred use or prescription of a product.
What does the new law say exactly?
Active bribery (offering a benefit) and passive bribery (accepting a benefit) are proposed to be covered in two new sections of the German Criminal Act (Strafgesetzbuch – StGB), Sec. 299a and Sec. 299b StGB. The new law will state the following in Sec. 299a StGB:
Any member of a healthcare profession who is subject to having a state-regulated professional education in order to practice his profession or use his professional title, who requests, allows himself to be promised or accepts a benefit for himself or for a third party whilst practicing that profession, in order to,
1. when prescribing pharmaceuticals, remedies, aids or medical devices or
2. at the purchase of pharmaceuticals, remedies, aids or medical devices which are intended for direct application by the member of healthcare profession or its professional assistant or
3. when assigning patients or test materials,
unfairly give preference to another in national or foreign competition shall be liable to imprisonment of up to three years or to a fine.
Sec. 299b StGB is the counterpart to Sec. 299a StGB and covers the offering, promising or granting of a benefit under the above-mentioned circumstances.
What do the legal terms mean?
The new law will not only cover resident doctors but "all healthcare professionals who are subject to having a state-regulated professional education in order to participate or use their professional title". This definition includes both "academic HCP" (such as physicians, dentists, veterinarians, pharmacists, psychological psychotherapists and psychotherapists for children and teenagers) and "paramedical professions" such as nurses, occupational therapists, speech therapists and physiotherapists. Thus, almost all HCPs are covered by the new law – irrespective of whether they are employed or self-employed and irrespective of whether they provide their services to patients with public health insurance or with private health insurance.
Benefit is defined in a very broad manner and includes any material or immaterial advantage to which the HCP is not legally entitled and which improves his economic, legal or personal situation. A benefit could even include the prospect of concluding a certain agreement and thus receiving an adequate payment for certain permissible activities (e.g. concluding a speaking agreement, even if the consideration is of fair-market value). Invitations to congresses or reimbursement for the participation in observational studies may qualify as a benefit, and accepting, offering or granting any such benefit may lead to criminal liability, provided that a special "corruptive agreement" was concluded ("Unrechtsvereinbarung").
The benefit must have been accepted and granted as a consideration for the HCP's having given concrete unfair preference to a competitor. This means that a concrete corruptive agreement must be proven to establish criminal liability. The courts ruled that, for a corruptive agreement, it is sufficient that the donor and receiver reach concurrence of will, so that there is a connection between the benefit and the HCP's undue action. Of course, also offering a benefit with corruptive intent is already an act of violating the law.
The penalties range from fines to imprisonment and vary substantially, depending on the nature and seriousness of the illegal conduct.
According to the new law, an individual may be liable to imprisonment for up to three years or a fine – similar to the already existing fines for corruption in the private sector. In very serious cases, an offender shall be liable imprisonment from three months to five years (Sec. 300 StGB). A very serious case typically occurs if the criminal action relates to a major benefit or the offender acts on a commercial basis. It should be noted that acting for a commercial company may already be deemed acting on a commercial basis.
It follows that if an individual acts on behalf of a corporate body, the corporation itself may be imposed with a fine, with severe financial sanctions of up to € 10 million in fines, plus any profits made through the corruptive practice and any pecuniary advantage gained. Further, the manager(s) of an undertaking/company can be fined for intentionally or negligently omitting necessary supervisory measures designed to help prevent criminal offences within its undertaking, i.e. omitting to set up and run an appropriate compliance system.