As we say in Dutch: the day that you knew that would come is finally here. The legislative proposal to grant the Healthcare Inspectorate (IGZ) IGZ enforcement powers in the field of industry/HCP interactions (the “Wet van 17 mei 2017 tot wijziging van wetgeving op het terrein van de zorg in verband met het invoeren van een wettelijke regeling voor gunstbetoon bij medische hulpmiddelen en enkele bepalingen over transparantie tussen beroepsbeoefenaren en bedrijven op het terrein van geneesmiddelen en medische hulpmiddelen” – yes, we like very long descriptive titles for laws in the Netherlands) that was a long time in the making has finally been finally published. It amends the Act on Medical Devices and the Act on Healthcare Professions.
The aim of the law is twofold:
- enable similar controls for the IGZ in the field of medical devices as it has regarding industry/HCP interactions in the field of medicinal products and allow the IGZ to use these controls only in excessive cases where the current self-regulation under the GMH Code does not provide for sufficient control.
- implement a legal basis for mandatory Sunshine type transparency reporting (which currently happens on a self-regulatory basis under the GMH Code).
A novelty is that contravention of the industry/HCP interactions rules is now subject to criminal enforcement in the Netherlands, and not only for industry but also for the persons accepting unlawful hospitality, i.e. HCPs but also healthcare insurance fund staff and employees of the purchasing department of healthcare institutions.
The scope of the law is not identical to that of the GMH Code. An important difference is that the law defines ‘hospitality’ (gunstbetoon), which the GMH Code deliberately does not do because of its special connotation as relevant to the medicinal products field. This is obviously not ideal, because it provides for a bad interface between the GMH Code and the law. Yet, the explanatory memorandum to the act says that the intention is that the act intends to follow the substantive provisions of the GMH Code. The act seeks to capture that entire scope regarding hospitality in one single short and rather generally worded article addressing:
- meeting attendance (necessary costs)
- consultancy (reasonable in relation to the work)
- gifts (minor value and relevant to the practice)
- purchase related bonuses / rebates
While the article is very general, there is of course a limitation in its generality and that is none of the preciseness of the GMH Code reflected in the amounts and hourly rates that industry can pay has found its way to the law. That means that the IGZ could theoretically have a completely different idea of what is necessary, reasonable or minor and relevant. It is expected however that the government will publish further policy regarding interpretation by the IGZ, so we will need to see how this will land in the end.
The act will enter into force at a date to be determined by implementing act, which no doubt will take place soon.
Companies already diligently implementing the GMH Code for the Netherlands (likely) will not see any substantive changes (we hope) as a result of this law and companies that do not have some additional compliance implementation work to look forward to.