Outgoing Health Minister Bruijn (VVD) foresees “very drastic and possibly life-threatening consequences” for more than 60,000 patients if two medicines are no longer allowed to be imported from abroad. These are medications prescribed to patients with bipolar disorder. The Zeeland-West-Brabant court ruled that exceptions to the import ban are not lawful, but Bruijn continues with this anyway.
To overcome the medicine shortage, pharmacies were allowed to market medicines containing lithium carbonate and promethazine from abroad under a so-called exemption decision. A Brabant pharmacy chain has been objecting to this for years. The preliminary relief judge agreed to that objection on Tuesday and suspended the two exemption decisions.
Bruijn has decided not to comply with that ruling wrote he told the House on Wednesday. He has again instructed the Health and Youth Inspectorate (IGJ) not to take enforcement action to combat shortages of these medicines.
1What’s going on here?
In principle, lithium carbonate and promethazine may only be obtained abroad in exceptional cases upon request of a doctor, but there are situations that allow a generic exemption. It has been this way since 2020 (lithium carbonate) and 2022 (promethazine). But the Zeeland-West-Brabant court ruled in summary proceedings that the IGJ can no longer turn a blind eye to the import of medicines for which a marketing authorization requirement applies, as is the case with these two products.
The judge follows a Brabant pharmacy chain that initiated summary proceedings against two exemption decisions. Regenboog Apotheek Bavel manufactures medicines based on individual prescription, also known as pharmaceutical preparation. This pharmacy will be “irreversibly” affected if a ban on importing is not enforced, the judge said.
The statement is striking. Last September, a change in the law came into effect that should give IGJ broader options to intervene in the event of shortages. But the exemption decisions are “probably” unlawful, the judge now rules.
Because the exemption decisions must be assessed in substantive proceedings, the preliminary relief judge did not go so far as to ban new decisions in advance. The minister then immediately introduced new exemption decisions for lithium carbonate and promethazine on Wednesday. The ministry therefore does not want to talk about ignoring a court decision, according to a spokesperson.
2Who wants to stop imports and why?
Regenboog Apotheek Bavel often conducts lawsuits against health insurers and the IGJ, among others. The company has challenged the way in which the Netherlands allowed the medicines in question to be imported from abroad under the guise of shortages, all the way to the Council of State. According to Jan-Pieter Dupon of Regenboog Apotheek Bavel, today’s challenged exemption decisions amount to “old wine in new bottles”. When the amendment to the law was adopted last fall, “we already said: this is not possible. We will be proven right again.”
The pharmacist states that the preparation capacity in the Netherlands is being eroded. “They reason incorrectly,” says Dupon. “If the compounding pharmacists in the Netherlands collapse, you will really have the puppets dancing. Then you will be completely dependent on foreign countries.” Dupon calls Minister Bruijn’s view of shortages “exaggerated”. According to him, the resources are available. “Only health insurers will not reimburse them if they come cheaper from abroad.” He calls the fact that the IGJ allows foreign medicines through exemptions the “success of the health insurance lobby”.
3How dangerous is the situation in the event of a shortage?
Jelmer Weijs, an addiction doctor affiliated with Jellinek, calls lithium carbonate a good mood stabilizer and “the first choice for many patients to protect against extreme mood swings in bipolar disorder.” “If this is stopped acutely, rapid decompensation can occur. This causes mood disruption, which can ultimately lead to a manic disorder or major depression.” Promethazine has several uses, but is used ‘off label’ in psychiatry to counteract an acute arousal state.
Pharmacists’ organization KNMP, Royal Dutch Society for the Promotion of Pharmacy, says it is “pleased” that “these medicines remain available while a structural solution is being worked on.” A spokesperson does not want to comment on the litigation by Regenboog Apotheek Bavel, which is affiliated with the KNMP.
Outgoing Minister Bruijn looks forward to the further course of the procedure with confidence. “The main purpose of the European medicines directive is to protect public health,” Bruijn’s spokesperson emails. “This provides sufficient room for exemption in the event of a medicine shortage.”
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