News
Draft bill to combat corruption in the healthcare sector published
10.02.2015
The Federal Ministry of Justice and for Consumer Protection (Bundesministerium der Justiz und für Verbraucherschutz – BMJV) last week published its long-awaited draft bill which makes corruption in the private healthcare sector a criminal offence.
The draft bill is a reaction to a judgement handed down by the German Federal Court of Justice in March 2012 (BGH GrS St 57, 202), in which it negated a criminal liability of doctors in private practice for corruption offences on the grounds that these were not to be considered either public officials or employees or agents of a commercial company. Benefits granted to doctors in private practice in order to influence their issuing of presciptions could therefore not be qualified as giving bribes in commercial practice (Section 299 of the German Criminal Code (Strafgesetzbuch – StGB)) or as bribery of public officials (Sections 331 ff. of the German Criminal Code). The recently published draft bill is designed to remedy this situation. While the Bundesrat, the upper house of the German parliament, had already accepted a draft bill in the last legislative period, due to the upcoming general election it was no longer possible to enact the bill. Since the two governing parties stated their clear intention in the Coalition Agreement to regulate this issue quickly, the draft bill which has now be published in no surprise. A draft bill was originally announced for December 2014.
In future, the offering, promising or granting of benefits to a healthcare professional is a criminal offence if such are consideration for the fact that the healthcare professional unfairly gives preferential treatment to another person or party, or in any other way breaches his or her professional obligations, with respect to the procurement, prescription or dispensing of drugs and medical products or the referral of patients or test material. The requesting, receiving, or accepting the promise, of such a benefit by a healthcare professional is likewise a criminal offence.
Compared to the draft bill tabled during the last legislative period, criminal liability has fortunately been limited. Where in accordance with the original draft bill allowing oneself to be unfairly influenced in any way was sufficient to trigger criminal liability, unfair preferential treatment in domestic or foreign competition or a breach of professional obligations by the healthcare professional is now required. Therefore the requirements for criminal liability are made much higher.
Healthcare professionals as defined by the present draft bill include, besides the classical academic healthcare professions such as doctors, dentists, psychotherapists, chemists etc., also “paramedical healthcare professions” such as nurses, speech therapists or physiotherapists. It therefore differs considerably to the draft of the Bavarian State Government submitted to the Bundesrat the week before last because this was limited to the academic healthcare professions. It is rather likely that the draft bill presented by the Federal Ministry of Justice and for Consumer Protection will be successful. A key issue which has, for example, already been discussed in the legislative process is that a limitation to doctors is specifically not desired by the professional associations concerned.
Irrespective of which draft bill will ultimately be passed, it remains clear that the usual addressees of pharmaceutical marketing activities and referral bonuses, namely doctors, dentists and pharmacists, will in any event be covered by this legislation. This new criminal offence definition will therefore have a considerable impact on compliance practice in the pharmaceutical and medical products industries and lead to the fact that invitations, marketing, fees for speeches and remuneration for participation in drug studies will have to be reassessed in future.
The draft bill is a reaction to a judgement handed down by the German Federal Court of Justice in March 2012 (BGH GrS St 57, 202), in which it negated a criminal liability of doctors in private practice for corruption offences on the grounds that these were not to be considered either public officials or employees or agents of a commercial company. Benefits granted to doctors in private practice in order to influence their issuing of presciptions could therefore not be qualified as giving bribes in commercial practice (Section 299 of the German Criminal Code (Strafgesetzbuch – StGB)) or as bribery of public officials (Sections 331 ff. of the German Criminal Code). The recently published draft bill is designed to remedy this situation. While the Bundesrat, the upper house of the German parliament, had already accepted a draft bill in the last legislative period, due to the upcoming general election it was no longer possible to enact the bill. Since the two governing parties stated their clear intention in the Coalition Agreement to regulate this issue quickly, the draft bill which has now be published in no surprise. A draft bill was originally announced for December 2014.
In future, the offering, promising or granting of benefits to a healthcare professional is a criminal offence if such are consideration for the fact that the healthcare professional unfairly gives preferential treatment to another person or party, or in any other way breaches his or her professional obligations, with respect to the procurement, prescription or dispensing of drugs and medical products or the referral of patients or test material. The requesting, receiving, or accepting the promise, of such a benefit by a healthcare professional is likewise a criminal offence.
Compared to the draft bill tabled during the last legislative period, criminal liability has fortunately been limited. Where in accordance with the original draft bill allowing oneself to be unfairly influenced in any way was sufficient to trigger criminal liability, unfair preferential treatment in domestic or foreign competition or a breach of professional obligations by the healthcare professional is now required. Therefore the requirements for criminal liability are made much higher.
Healthcare professionals as defined by the present draft bill include, besides the classical academic healthcare professions such as doctors, dentists, psychotherapists, chemists etc., also “paramedical healthcare professions” such as nurses, speech therapists or physiotherapists. It therefore differs considerably to the draft of the Bavarian State Government submitted to the Bundesrat the week before last because this was limited to the academic healthcare professions. It is rather likely that the draft bill presented by the Federal Ministry of Justice and for Consumer Protection will be successful. A key issue which has, for example, already been discussed in the legislative process is that a limitation to doctors is specifically not desired by the professional associations concerned.
Irrespective of which draft bill will ultimately be passed, it remains clear that the usual addressees of pharmaceutical marketing activities and referral bonuses, namely doctors, dentists and pharmacists, will in any event be covered by this legislation. This new criminal offence definition will therefore have a considerable impact on compliance practice in the pharmaceutical and medical products industries and lead to the fact that invitations, marketing, fees for speeches and remuneration for participation in drug studies will have to be reassessed in future.
Contact
Arbitration
Life Sciences
Compliance & Investigations
Share
Insights
