For the medical technology industry, collaboration with healthcare professionals (HCPs) is an absolute must. HCPs are prime users of new technology and play an instrumental role in the successful diffusion of innovative medical devices throughout Europe. In fact, HCPs often bring the ideas to the table that lead to the development of new devices and inspire continuous incremental improvements to existing technology. Close collaborations and partnerships between HCPs and industry can only last if both parties respect high ethical standards.
In a move to increase transparency, HCP relationships with pharmaceutical and medical device companies have been the subject of considerable scrutiny in many jurisdictions. The German Federal Supreme Court of Justice (Bundesgerichtshof, “Supreme Court”) addressed the issue of whether private practitioners who treat patients insured by public sick funds should be considered public officials (Amtsträger) or “agents” (Beauftragte) for the purposes of the German Criminal Code (Sec. 331 et seq. and Sec. 299, respectively). This case has reignited discussion on a closely-watched issue both inside and outside Germany.
The Judgment
The Grand Senate for Criminal Matters of the Bundesgerichtshof, in a press release on 22 June 2012, provided clarification on this much disputed issue of the status of private practitioners under the German Criminal Law.
To this question, the Supreme Court decided that private practitioners who treat patients insured through the public sick funds are subject neither to Sec. 331 German Criminal Code (i.e. the prohibition of bribery of public officials) nor to Sec. 299 of the German Criminal Code (i.e. the prohibition of commercial bribery).
While the Supreme Court clearly sees the practice of providing monetary and other benefits to private practitioners as harmful to the healthcare system, because the Criminal Code does not classify private practitioners as public officials or agents, the Supreme Court was compelled to exclude applicability of criminal liability to this context. Correspondingly, the Supreme Court suggested that the legislature may wish to enact new legislation which would prohibit potentially criminal activity arising from suspect interactions between industry and private practitioners.
Practical consequences
The medical technology industry has been waiting for this decision from the Supreme Court. By clearly denying the applicability of criminal anti-corruption laws to interactions between the industry and private practitioners, the Supreme Court has now provided much needed legal certainty to this previously unclear area of law.
Of course, this does not mean that companies are free from restrictions in interacting with German private practitioners. There are other criminal laws which could be applicable to private practitioners in their interactions with the pharmaceutical and medical device industries, such as fraud or breach of trust. In addition, there are many civil laws and a professional code of conduct for physicians which ensure appropriate behavior. Finally, the European medical technology industry has affirmed their commitment to the highest standards of ethical behavior in the form of codes of conduct at national and European levels. These provide a thorough framework of rules which aim to emphasise the critical importance of the HCP-Industry relationship for the continuous delivery of modern, safe and effective care to patients —a relationship that must be built on trust, transparency and ethical interactions.
While other countries are broadening the scope of their anti-bribery laws, it is still not clear how the legislature will respond to this decision. This is especially so with respect to the fact that the governing parties, in reference to the upcoming decision of the Supreme Court, recently postponed a proposal from the opposition which would have explicitly made private practitioners criminally liable for corrupt behavior.
Will the governing parties renew their confidence in the self-regulation of HCP-Industry relationships in Germany or will it prefer to draft a new anti-bribery law specifically directed at healthcare professionals?
The industry may want to consider these options and weigh the consequences, and in doing so also take into account the experiences from other countries, such as the recently enacted sunshine Act in France.
Personally, I believe that legislative power would be put to better use in promoting the full implementation of the existing legal framework as well as in supporting the effective self-regulation of the medtech and pharmaceutical industries, who have already taken wide-ranging measures to uphold the highest ethical standards.
– Peter Dieners, Head of Global Healthcare, Life Sciences and Chemicals Sector Group, Clifford Chance
