- 28.02.2013 Healthcare Compliance: Challenging Transparency
A close cooperation between physicians, medical institutions and medtech companies is extremely important for medical progress and politically intended as well. The cooperation must be safe and transparent, and based on the compliance with a clear set of rules referred to as “healthcare compliance“. However, healthcare compliance may not result in preventing cooperation. This opinion was expressed in unison by experts at the fourth Medtech Healthcare Compliance Conference in Berlin. The medtech industry’s compliance efforts are not only supported by the 1997 Medical Devices Code, but also by sample contract elements or the information and provision of practical examples by the “MedTech Compass” campaign to promote transparent and good cooperation (www.medtech-kompass.deExterner Link. Öffnet im neuen Fenster/Tab.).
PressemeldungBerlin, 28.02.2013
According to BVMed Director General and Member of the Board, Joachim M. Schmitt, the main goal is to avoid being suspected of corruption. Industry experts from Johnson & Johnson and Volkswagen emphasized that, on the one hand, compliance must be part of a company’s culture, but that, on the other hand, strategies for communicating compliance rules to the staff in a simple and understandable manner had to be developed. The issue of “transparency“ is the new challenge for healthcare companies, according to attorney-at-law Dr. Peter Dieners. New statutory transparency rules increasingly ensure that the contractual relationships between medical institutions, physicians and companies must be disclosed in full.
Healthcare compliance plays a major role in everyday business. This was explained by Manfred Mieskes, managing director of the Johnson & Johnson Medical subsidiary Therakos. In his previous job, Mr. Mieskes was the Healthcare Compliance Officer for Johnson & Johnson Medical. In the meantime, many companies had established very detailed compliance programs. However, if their rules were too complicated, they were sometimes difficult to implement in everyday business. It was therefore essential to simplify and speed up processes, to improve documentation and to provide support, e.g. in the form of software programs.
“Clear and understandable compliance procedures contribute to reducing human errors and risks and, hence, will increase satisfaction“, Mr. Mieskes said. In his view, compliance is a “management issue“ and a “human resources issue“ in particular. Compliance could not be “delegated and gotten out of the way“. The management was obligated to perform preventive risk control. Furthermore, compliance involved managing values, establishing a corporate culture as well as setting reasonable goals with regard to operating results. Mr. Mieskes’ advice: the industry should further develop the compliance officer’s position to become a “compliance coach“. To ensure the future viability of healthcare compliance, it had to be changed from a rule-based to a value-based approach to provide a basis for the sustainable success of a company.
