On July 29, 2015, the German government adopted a draft Act
against corruption in the health care system (Entwurf eines
Gesetzes zur Bekämpfung der Korruption im Gesundheitswesen,
the "Draft Act"). The Draft Act marks a significant step
in the fight against corruption in Germany's health care
system. At the same time, it raises a number of issues due to its
broad wording. The Draft Act will certainly result in protracted
discussions in the German Parliament, but however these discussions
develop, it is highly probable that an act ultimately will be
adopted. Thus, life sciences companies should examine their
compliance procedures for interactions with health care
professionals in Germany.
Why the Draft Act?
The German Federal Court of Justice held in 2012 that
self-employed health care professionals are not subject to the
existing anti-corruption rules: they are neither public officials
nor representatives of the public health insurers. While corruption
in the health care system is already sanctioned under professional
regulations and regulations on promotion of medical products, the
German legislature determined that criminal sanctions were required
Who is Affected?
The Draft Act purports to cover both the giving and taking of
benefits. On the taker's side, all health care professionals
that work in a regulated profession are affected. This means not
only doctors and pharmacists but also nurses, physiotherapists, and
other health care professionals, whose education is regulated or
who may carry a professional title only subject to regulated
license. On the giver's side, the Draft Act applies to anyone
involved with health care products or services: pharmaceuticals,
medical devices, and other medical products, as well as the
treatment of patients or laboratory analysis. The Draft Act
utilizes categories from both product regulation and social
security regulation in relation to reimbursement (e.g., by listing
both "medical devices," which is a category under product
regulations, and "medical aids," which is a term under
reimbursement law, comprising medical devices from a product
regulation perspective). But the product categories are in general
well defined by prior case law, except perhaps for the those on the
fringes of other medical products.
How is "Corruption" Defined?
The Draft Act defines "corruption" based on two
elements. First, there has to be a benefit given or taken, promised
or requested. "Benefit" is defined broadly to include
both material and intangible benefits. Benefits may include
invitations to conferences or even consideration payable (at
arm's length) under a service contract, and benefits to
designated third parties (e.g., a family member of the health care
professional) are also covered. Second, there must be a nexus with
a sought or offered advantage, which is a key factor. The Draft Act
considers two scenarios: (i) the product or service being preferred
unfairly over competitors, or (ii) a violation of professional
ethics rules on independence of medical choices from benefits. At
the same time, the Draft Act confirms that legitimate cooperation
in the health care sector and the resultant compensation remain
unaffected. Considering the highly cooperative nature of the health
care sector, where specialists interact among themselves and with
industry and service providers, it will be challenging to
distinguish legitimate cooperation from illegal benefits.
Violations will be pursued only if a complaint is filed. The
public health care insurers have created task forces for combating
corruption under earlier legislation. It is likely that such task
forces will file such complaints if they are apprised of apparent
The proposed penalties are monetary fines or imprisonment of up
to three years and, in certain serious cases, of between three
months and five years of imprisonment.
The political discussion will resume after the summer break.
However, industry should proactively examine its relationships with
health care professionals in Germany, particularly in relation to
any incentives to prescribe or purchase a pharmaceutical or medical
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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