News

New Policy Rules on Administrative Fines (Beleidsregels Bestuurlijke Boete) have been published in the Government Gazette (Staatscourant, Stcrt. 2023, 32190). The changes take effect from 1 January 2024.

Substantive changes

The amendments to the Policy Rules concern some substantive changes.

Suspension marketing pharmaceutical product

First, this adjustment changes the starting point for violation of section 49 paragraph 7 sub a of the Dutch Medicines Act (“DMA”) to a written warning instead of direct fining. Section 49(7)(a) of the DMA includes an obligation for marketing authorisation holders to notify the Medicines Evaluation Board (“MEB”) and other relevant pharmacovigilance authorities of the Member States of the suspension of the marketing of a medicinal product without delay, but in any case two months before the marketing of a medicinal product is interrupted and with reasons given.

Timely reporting enables the relevant bodies such as the MEB, the Healthcare and Youth Inspectorate, united in the Medicine Shortages and Defects Notification Centre, and other relevant parties to take measures to prevent possible medicine shortages. This ensures the availability of medicines, which is in the interest of patients and continuity of care.

Administrative fine

For violations of this article, the Minister of Health, Welfare and Sport may impose an administrative fine. In the annexes to the Policy Rules, it is determined for each individual violation whether a violation is immediately finable or a written warning is imposed first. Failure to report the suspension of trade in a medicine or reporting it too late can be sanctioned directly with an administrative fine.

In practice, however, many notifications are made for the sake of certainty and reports are made of temporary interruptions that do not qualify as suspension in trade. The notification is wrongly made because the notifier does not expect or foresee a suspension of trade and it turns out afterwards that there was no suspension.

This practice is problematic for two reasons. First, reporting non-suspensions is not consistent with the legislator’s intention to be able to take action on reports to counter potential shortages of medicines. Second, the legal text assumes that a suspension of trade will actually take place. In practice, it may of course occur that a suspension of marketing is anticipated, and therefore also reported to the Notification Centre, with circumstances ultimately ensuring that the suspension does not occur after all. For example, because a supplier of raw materials nevertheless delivers on time, allowing the production of medicinal products to continue unhindered, so that the marketing authorisation holder does not have to suspend the marketing of that medicinal product. However, this is a different situation from the situation of ‘certainty notifications’, where a notification is routinely made to the Notification Centre about every medicine, while no suspension of trade is foreseen.

The minister indicates than not every short interruption or temporary delay is considered a ‘suspension in trade’. A day or two delay in a release of a medicine, for example, does not mean that trade in that medicine has not continued. In the minister’s view, there is suspension of trade within the meaning of section 49(7)(a) DMA only if (part or all of) the ordered medicines cannot be delivered by the marketing authorisation holder within a period of 14 days. This means that a temporary interruption of less than 14 days does not qualify as a suspension of trade. This qualification does not affect the fact that if a marketing authorisation holder estimates for a specific medicine that even a short interruption could have a major impact on patient care, the marketing authorisation holder has a moral obligation to report this as soon as possible.

Warning

Because of this tightening and clarification of the norms on suspension of trade, it is considered appropriate to use a written warning as the starting point for violation of the statutory requirement.

Given this, being warned first gives an offender the chance to adjust his or her behaviour. With the present amendment, the starting point for violation of section 49(7)(a) DMA thus becomes written warning instead of direct fining. This amendment does not concern the other parts of this section. After all, it is clear to marketing authorisation holders when a medicine is withdrawn from the market, a request is made to withdraw a marketing authorisation or the application to renew a marketing authorisation is abandoned.

Ambulance Care Facilities Act and the Electronic Data Exchange in Healthcare Act

Second, the amended Policy Rules include an addition of two appendices to the penalty differentiation tables in connection with the enactment of the Ambulance Care Facilities Act and the Electronic Data Exchange in Healthcare Act and the administrative penalty powers included in these laws.

Technical changes

Finally, the amendment includes a number of technical adjustments. These adjustments correct slips, correct erroneous references and make textual improvements for the sake of readability and logical structure of the Policy Rules.