The Dutch Minister of Medical Care recently sent a letter to Dutch Parliament regarding interactions between life science companies and health care professionals and the need for transparency. In the letter, the Minister proposed three measures to ensure better transparency and prevent prohibited inducement: (1) a statutory transparency register; (2) expanding the responsibility of directors of health care institutions when agreeing on financial relationships between health care institutions and pharmaceutical companies; and (3) a better legal framework for sponsoring.
Attorneys at Hogan Lovells analyzed the proposals, noting that “industry stakeholders and hospitals face an increasing risk of inspection now and in the future, making the need to comply with current regulations and developing other best practices all the more acute.”
Hogan Lovells noted that the current reporting of financial relationships is required under the self-regulatory code of conduct in relation to medical devices (GMH) and the self-regulatory code of conduct regarding pharmaceutical advertising (CGR). However, GMH and CGR are only applicable to members of umbrella organizations that have committed to the self-regulatory codes. Therefore, not all medical professionals are bound by the self-regulatory transparency requirements and not all financial relationships are required to be reported.
The Minister indicated the intent to maintain a threshold of EUR 500 per calendar year for all agreements and the idea that industry will self-report, same as the current self-regulatory codes. However, under the proposals, if transparency becomes a statutory law with a mandatory publicly accessible Healthcare Transparency Register, enforcement by the Dutch government would become possible, potentially leading to the imposition of administrative law penalties and other sanctions.
Hogan Lovells further notes that the Minister indicated intent to expand the responsibility of directors of health care providers when agreeing on financial relationships between health care providers and industry, based on recent surveillance that found the board of directors of hospitals tend to lack sufficient insight into financial relationships entered into by health care professionals that work at the hospital. Requiring the written approval of the board of directors for provider-industry relationships would bolster the self-regulatory codes, which currently require such approval as of January 1, 2024.
The third proposal of improving the legal framework for sponsorship would potentially impact grants, donations, financing of research or meetings and events, fellowships, and/or contributions to patient organizations.
As of now, these are only proposals made by the Minister and before any of them become law, draft legislation would need to be published – and then passed by Parliament. This process is likely to take some time, and may not fully materialize for another year or two. At this time, however, it sheds light on where the future of enforcement may be in the Netherlands.