The Netherlands
On 1 January 2022, a new provision will be added to the chapter in the GMH* Code regarding transparency.
This provision relates to the clarifying note that the GMH foundation publishes annually at the time of publication of the reports by the Transparency Register (Transparantieregister Zorg). This clarifying note further analyses a number of interactions as reported by the medical devices sector to the Transparency Register. The purpose of this is to provide a better insight into a number of existing forms of cooperation in the sector in relation to legislation and self-regulation and to identify points of attention and trends. Now that this clarifying note has become established practice, the GMH foundation considered it desirable to also give it a legal basis in the code of conduct. Therefore, a new Article 27 has been added: Making documents available for clarification.
For the purpose of further clarification of the interactions reported annually to the Transparency Register, the GMH can request companies to share the documentation on which these reports are based. This documentation includes, for instance, the agreements preceding a service provision.
Medical device companies are obliged to cooperate with such a request.
*GMH: Gedragscode Medische Hulpmiddelen
Source: GMH_nieuwsbrief_december_2021_-_Aanpassing_GMH_Code.pdf