Medical devicemakers doing business with doctors in Germany will need to exercise extra caution if a proposed anticorruption law goes into effect.
The German government has introduced a draft legislative proposal in Parliament to fight corruption in the healthcare sector. Entwurf eines Gesetzes zur Bekämpfung der Korruption im Gesundheitswesen is designed to ensure fair competition in the sector and maintain patient confidence in the integrity of decisions made by healthcare practitioners, explains Hans-Hermann Aldenhoff, the international head of dispute resolutions at Simmons & Simmons.
If enacted, healthcare workers could face fines and imprisonment of up to five years if they accept bribes to prescribe medical devices.
Device sales representatives could be pursued on bribery charges, and punished by fines and imprisonment up to three years.
Under parliamentary rules, second and third readings of the draft are required. It then will be forwarded to the Federal Council, which may or may not raise an objection. If it is ultimately signed by the federal president, it then will be published in the Federal Law Gazette. Laws take effect the day after publication.
The impetus for the measure was a controversial March 2012 decision by the German Federal Supreme Court, which found self-employed healthcare practitioners were not public officials and not subject to criminal prosecution under the German Criminal Act for accepting devicemaker incentives.
Aldenhoff says Germany doesn’t have a database similar to that set up by the U.S. Centers for Medicare & Medicaid Services to track device industry gifts to physicians. However, he doesn’t rule out enactment of a sunshine act in the future, as there such systems are in place in France, Denmark and elsewhere in the EU.