Long predicted, the new anti-corruption law applied to the healthcare sector was adopted last April by the German parliament. Here is what there is to know.
The law adopted by the German parliament (Bundestag) on April 14, 2016 aims to fight corruption in the healthcare sector(1): for a healthcare professional(2) to accept a benefit in return of unjustified preference to one of the market players will be punished criminally.
To avoid penalties, it is necessary to determine whether existing and future collaborations are in agreement with the new law. A very serious evaluation of each of them is therefore recommended, starting with certain forms of particularly risky cooperation. This concerns in particular the post-marketing studies and monitoring records, especially if the data produced was not required or if the remuneration granted to the healthcare professional to collect this data was not considered appropriate.
Also in focus: homecare provided to patients or set up and paid for by the pharma and medical device industries when the HCP (healthcare professional) is also involved in preventive care(3) or receives other direct or indirect benefits, to the extent that the work is partly done by the healthcare provider.
Another type of risky cooperation: patient assistance tools offered by the pharma and medical device industries through healthcare professionals, and perceived as a service from the latter. It also applies to invitations to events focused on training (international conferences, for example), when these events do not directly concern the product manufacturer or the selection of invited healthcare professionals is closely related to the use or the prescription of a product.
Active & passive corruption
Amongst other links to evaluate are services, research or consulting agreements with healthcare professionals when there is no need for a specific service or when the selection is not objective. One can also mention the participation in the profits of pharma companies, since profits distributed may encourage the use or prescription of certain products. Offer or grant benefits to healthcare professionals to send patients to programs developed by the industry (if these programs promote the use of a product), assign discounts for products (if they are not transmitted to the patient or to the health insurance) are also punishable. More generally, the grant of any form of bribes for preferential use or prescription may be punished by law.
For this new anti-corruption law, the German Criminal Act(4) has two new sections covering on the one hand, active bribery (to offer an advantage) and on the other hand, passive bribery (to accept a benefit). It thus covers all members of a healthcare profession that followed a regulated education in order to practice their profession or to use their professional title(2), and who require or accept an advantage when prescribing, buying a product or a medical device or giving unfair preference to a competitor from the market. The law makes it liable to a fine or a sentence of up to three year in prison.
(1) § 299a Strafgesetzbuch StGB
(2) Doctors, dentists, veterinarians, pharmacists, psychologists, psychotherapists, paramedical professions such as nurses, occupational therapists, speech therapists, physiotherapists.
(3) Care save money and effort
(4) Strafgesetzbuch – StGB, Sec. 299a and Sec. 299b StGB