Introduction

Corruption is set to become a criminal offence for most individuals working in the healthcare sector. This development will affect the assessment of business practices and the importance of industry compliance. In particular, significant changes to the medical device sector can be expected.

Until now, corruption in the healthcare sector was a criminal offence only for doctors employed in state hospitals who accepted gifts or other benefits. Doctors in private practice and other persons working in the healthcare sector were not subject to criminal law on corruption offences. Doctors involved in corruption were regulated only by the Medical Professional Code.

As a result, the healthcare industry developed a number of marketing methods which would have been impossible without the legislative gap. However, this approach has been criticised heavily. In 2012 the Federal Court of Justice ruled that a pharmaceuticals representative could not be sentenced for bribing doctors to prescribe medicinal products, since a corresponding penal provision was missing from the criminal code.

Proposed changes

On July 29 2015 the government introduced a draft bill which aims to amend the Criminal Code. The amended code is expected to enter into force at the end of 2015 or early 2016. The new Section 299a will close the gap and make corruption a criminal offence for anyone with a job in healthcare if that job requires state-regulated education. The new law will cover doctors and other healthcare professionals, including dentists, psychotherapists, pharmacists, physiotherapists and nurses. Moreover, according to Section 299b, the person granting the benefit will commit a criminal offence if he or she bribes such persons. This affects representatives of medicinal product and medical device manufacturers, as well as laboratories and other industry members. The penalties for such criminal offences vary from fines to imprisonment for up to three or even five years in severe cases.

However, the new criminal provisions will not change all existing marketing methods. Typical industry marketing tools (eg, invitations to training or post-marked studies in medicinal products and medical devices) will not be subject to the new provisions.

Comment

Looking at the compliance of other industries with corruption developments, it was only a question of time until the healthcare sector followed suit. Healthcare companies should consider carefully the extent to which the changes will affect their businesses, especially their established marketing methods.

For further information on this topic please contact Marc Pussar at SKW Schwarz Rechtsanwälte by telephone (+49 69 630 001 0) or email (m.pussar@skwschwarz.de). The SKW Schwarz Rechtsanwälte website can be accessed at www.skwschwarz.de.

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