In its cabinet session on 14 April 2016, the German government adopted a bill on combating corruption in the healthcare sector. Before, the committee of consumer protection and justice that was in charge for the bill enacted major changes in comparison to the draft bill. Ever since a 2012 decision of the Enlarged Criminal Panel of the Federal Court of Justice, the political parties in Germany largely agreed that corruption in the healthcare sector should be combated more seriously by means of a legislative reform. On 13 May 2016 the bill on combating corruption in the healthcare sector (“Gesetz zur Bekämpfung von Korruption im Gesundheitswesen”) also passed the Federal Council of Germany. The new law will soon come into effect.

New criminal offence in Sec. 299a and Sec. 299b Criminal Code (“Strafgesetzbuch” – StGB)

The provision is set out below:

Ҥ 299a Corruptibility in health care

Any member of a health care profession requiring state-regulated training in order to practice or to hold a professional title who, in connection with the practice of their profession, demands, accepts the promise of or directly accepts a benefit for themselves or a third person as compensation in return for

  • the prescription of medicinal products or other health care services and products or of medical devices,
  • the procurement of medicinal products or other health care products or of medical devices that are intended for direct use by the health care professional or one of his supporting staff, or
  • for the referral of patients or test materials

in such a way as to give unfair preference to another in domestic or foreign competition shall be punished by up to three years’ imprisonment or a fine.

§ 299b Bribery in health care

(1) Whoever offers, promises or grants a member of a health profession in terms of § 299a subsection 1 or a third person a benefit as compensation for

  • their prescription or dispensing of medicinal products, other health care services and products or medical devices, or
  • the procurement of medicinal products or other health care products or of medical devices that are intended for direct use by the health care professional or one of his supporting staff, or for the
  • the referral of patients or test materials

in such a way that the health care professional gives unfair preference to himself or another in domestic or foreign competition shall be punished by up to three years’ imprisonment or a fine.”

Major changes in comparison to the draft bill

Perpetrators

In terms of perpetrators, the draft bill referred to members of healthcare professions for which professional organisations are established throughout all of Germany (special offence). Therefore, physicians, dentists, veterinarians as well as pharmacists, non-medical psychotherapists and child and adolescent psychotherapists (the so-called academic health professions) were included. However, the final version of the bill does no longer address pharmacists because dispensing decisions by health care providers were dropped from the definition of the offence.

Offence - § 299a Corruptibility in health care

In addition, the procurement decisions by health care providers included in subsection 2 of the Federal Government’s draft law are restricted to those medicinal products or other health care products or medical devices that are intended for direct use by the health care professional or one of his supporting staff. The particular variant of the offence described in § 299a subsection 1 number 2 StGB – the violation of the health care professional´s obligation to maintain professional independence – was dropped. Now, the three types of health care decisions connected to criteria for the described offence are arranged as new numbered clauses.

In variance to prescribing, dispensing and referral decisions, procurement decisions shall not be criminal because the specific criteria of corruption or an undermining of public confidence in the integrity of health care decisions is absent. Instead, the criminal procurement decisions are now restricted to the procurement of medicinal products or other health care products or medical devices that are intended for direct use by the health care professional or one of his supporting staff. According to the explanation of the changes, the legal interests of fair competition and the integrity of medical decisions could also be criminally violated in these cases by the granting of advantages in connection with procurements decisions.

The scope of the procurement activity relevant extends to those medicinal products or other health care products and medical devices which are not (primarily) prescribed, but instead are used directly in treating the patient, for example prostheses, implants and such medicinal products applied directly by the health care profession. In those cases where the health care professional first procures product using a prescription and then afterwards uses the product directly in treating the patient, as it is common practice in outpatient oncological treatment or when physicians prescribe narcotics for substitution treatment, the wrongful agreement and the criminal nature thereof will normally be associated with the initial prescribing decision. Such prescribing decisions include all activities associated closely with the prescription process, for example the transmission of the prescription to another service provider. The product does not necessarily need to be applied or used by the health care professional himself. It is sufficient that the product is applied or used by supporting staff that are organizationally involved in the activities of the health care professional and are bound by the same health care professional’s instructions, and so act on his behalf. Such acts are not punishable when the health care profession accepts the rebates and other benefits in connection with the procurement decision for the benefit of the patient or the responsible payor in order to directly transfer these benefits to them.

Agreements between a local general practitioner and the sole specialist located nearby or the only clinic located in the general vicinity of the general practitioner’s practice will also commonly be considered to be competitive activity. As with § 299 StGB, where the particular definition of the term “competition” derives from § 2 subsection 1 number 3 of the Law against unfair competition (UWG), the criteria for establishing the fact of a competitive environment should not be too stringent. Furthermore, when the granting of benefits is intended to foster long-term patient commitment and to deter market entry of potential competitors and the increase of competition, then this would constitute competitive activity, analogous to the marketing of a new medicinal product or medical device.

Offence - § 299b Bribery in health care

Analogous to § 299a StGB, § 299b StGB defines the criminality of active bribery. The changes corresponding to those made to § 299a StGB were made here, i.e. the dispensing decisions were dropped and the procurement decisions were limited to those pertaining to certain medicinal products or other health care products and medical devices. The same criteria apply to procurement decisions as to prescribing and referral decisions.

Outlook

Due to the changes made during the legislative procedure – in particular the offence variant contained in the original draft legislation in subsection 1 number 2 concerning the violation of the obligation to maintain professional independence was dropped – inconsistencies were solved. The amendment intends to address concerns related to the ambiguity and heterogeneity of some of the referenced professional codes. The new law will raise awareness of pharmaceutical companies in regard to cooperation with physicians in private practice because a breach of the new provisions will have consequences under criminal law. Companies are advised to check if their internal guidelines and policies on relationships with physicians have to be revised and amended.