On 4 February 2015, the German Ministry of Justice published a new draft law specifically aimed to combat corruption in the healthcare sector. Key element of the draft legislation will be a newly defined criminal offence that will be inserted as a new Section 299a of the German Criminal Code (StGB). This new criminal offence sanctions active and passive bribery of a wide range of healthcare professionals – not only of medical doctors.

The envisioned new § 299a StGB would significantly sharpen the German anti-corruption laws as far as interactions between life sciences companies with medical doctors and other healthcare professionals are concerned. The criminal culpability would apply to both the healthcare professional that accepts a bribe and the company representative that pays a bribe.

The new § 299a StGB is crafted very broadly and appears like a “catch-all” rule. It sanctions the improper influencing of a healthcare professional’s decision-making on the use or prescription of a certain product. Further, the new rule would also sanction “violations of professional duties” by healthcare professionals if induced by bribes from a company. However, the law does not define which “professional duties” are meant and will become subject to the law. Obviously, the broad term “professional duties” leaves room for interpretation and uncertainty that increases the legal risks for all stakeholders.

This new legislation was originally supposed to fill a gap in the German Criminal Code after in 2012 the German Federal Supreme Court (BGH) found that doctors licensed in the statutory healthcare system (Vertragsärzte) do not fall under the existing anti-corruption laws. In the case decided by the court in 2012, sales representatives of a drug company had made revenue-based payments to doctors to incentivize the prescription of their drugs. However, the now presented draft clearly goes beyond the “gap” that the court had once identified.

In conclusion, the new law bears the clear risk that many legitimate types of collaborations may be criminalized. The new law can particularly create challenges to pharmaceutical and – probably even more – for medical devices companies.

The draft legislation proposal also includes further legal amendments in the Social Security Code V that are complementary to the new § 299a StGB. The Social Security Code V is the legal basis for the German statutory health insurance system and covers approximately 90% of the German population. The envisaged amendments of the Social Security Code V aim to intensify the cooperation between health insurance funds and medical doctor associations with state prosecutors. These amendments would further intensify the control mechanisms to detect unlawful misconduct in the healthcare system. They will also impose pressure on the health insurance funds and medical doctor associations to effectively implement adequate controls and sanctions.

Overall, the new legislation proposal will now be subject to political deliberations in Germany which will take place over the next months. Pharmaceutical and medical device companies as well as other stakeholders potentially affected by the new laws should carefully monitor this process and its outcome.

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Photo of Dr. Dr. Adem Koyuncu Dr. Dr. Adem Koyuncu

Adem is a life sciences industry advisor with more than 25 years of professional experience. He has a broad practice that cuts across regulatory, compliance, IP, privacy and liability matters. Adem also provides strategic advice. He knows the life sciences sector also from…

Adem is a life sciences industry advisor with more than 25 years of professional experience. He has a broad practice that cuts across regulatory, compliance, IP, privacy and liability matters. Adem also provides strategic advice. He knows the life sciences sector also from his earlier work in the pharmaceutical industry and as a medical doctor. He represents clients before courts and authorities and assists them in contract negotiations, investigations and transactions. For years, Adem is listed in various lawyer rankings.

See some Accolades from Clients and Surveys:

  • “Adem Koyuncu is one of the most intelligent lawyers I know.” (Legal 500 2023)
  • “He is one of the most detail-oriented and client-focused partners I have ever encountered.” (Client, Chambers 2021)
  • “Great professional and human competence, good team player.” (Client/Adverse Party, JUVE 2022)
  • “I find him to be one of the most pragmatic regulatory lawyers. He was a doctor before a lawyer, has been in-house, worked on lots of stuff that I have to handle in-house, which helps when getting advice. He is really good at saying it’s a complex situation and your best option is to do this.” (Chambers 2022)
  • “He always comes through with extremely helpful advice. He brings a unique understanding and experience to his practice as both a lawyer and medical doctor.” (Chambers 2021)
  • “He is an excellent dispute resolution lawyer and advises at the highest level, including, in particular, strategic advice.” (Legal 500 2023)
  • “He is very sharp and quick, while at the same time having a good sense of humor and nerves of steel. Very pleasant to work with.” (Legal 500 2022)
  • He is described as “versatile competent, reliable and high quality” (JUVE 2021) and “incredibly fast.” (JUVE 2018)
  • Provides advice at “an outstanding level.” (Legal 500 2015)
  • “Very strong negotiation skills.” (JUVE 2011)
  • Clients appreciate his “very broad knowledge and long-standing expertise” (JUVE 2021/22) and that “he is approachable, knowledgeable and really easy to talk to over the various issues. He is calm and has seen most problems before.” (Chambers 2020)
  • Peer lawyers described him as “highly competent” and a “very good and pleasant lawyer” (JUVE 2014) and as “the off-label-guru, substantively very good, creative.” (JUVE 2022)

Adem is the author of numerous publications (e.g., in leading books on pharma law, product liability and clinical trials) and frequent speaker at different events. As such, he will soon speak at following events: