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12 December 2018 / news

Life Sciences Bit: AMC is allowed to produce an equivalent of CDCA if the used resources meet the quality standards

On the 28th of November, the Dutch Health and Youth Care Inspectorate (‘Inspectorate’) published the results of its investigation into the practice of the Academic Medical Centre Amsterdam (‘AMC’) of the pharmaceutical compounding of an alternative to the medicine CDCA.

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Leadiant, the pharmaceutical company which owns the rights to the production of CDCA, had filed an enforcement request against AMC. CDCA is a medicine which is used to treat the medical condition called “CTX” (metabolic disorder). CDCA was the only medicine available for treatment of this condition in the Netherlands.

AMC had started production of an alternative medicine to CDCA after Leadiant significantly increased the price of this medicine, in April 2018 (please refer to our earlier bit about this). Leadiant objected to this action, claiming that AMC was not allowed to produce its medicine. Leadiant brought forward that the law stipulates that AMC needs a marketing authorization to produce the medicine and that the production process itself did not comply with legal standards. Furthermore, Leadiant argued that AMC had wrongfully advertised its medicine and that the raw materials used for production by AMC did not meet a regulatory quality standard. Finally, Leadiant argued that AMC should enter into negotiations about the price of CDCA with Leadiant instead.

In its decision, the Inspectorate concludes that AMC has the rights to produce an alternative medicine to CDCA. The Inspectorate did not order AMC to enter into negotiations with Leadiant. Furthermore, it found that AMC is allowed to produce the medicine through pharmaceutical compounding. This decision entails that, in principal, pharmaceutical compounding of alternatives to CDCA by (hospital) pharmacies for individual own patients is allowed.

Although Leadiant’s main complaint, that AMC infringes upon its production rights, was dismissed, the Inspectorate did issue two warnings to AMC:

  1. Firstly, raw materials used for the production of medicine must meet the quality requirements described in the European Pharmacopoeia. The Inspectorate found that the resources used by AMC did not meet these quality standards. AMC has ceased production of the medicine. It may restart production once the standards of the European Pharmacopoeia are met.
  2. Secondly, the Inspectorate found that AMC had advertised its medicine. It explicitly promoted the medicine in a press release, published on its website. In doing so, AMC acted against regulation on the advertising of medicines. By Dutch law, it is not allowed to advertise medicinal products for which no marketing authorization has been issued.

Leadiant has criticized the decision. It disagrees with the Inspectorate’s interpretation of pharmaceutical compounding and argues that it goes against the European pharmaceutical system to allow the pharmaceutical compounding of unregistered alternatives to registered pharmaceuticals. It remains to be seen whether Leadiant will take further steps against AMC.

Do you have any questions regarding pharmaceutical compounding or the decision by the Inspectorate? Please do not hesitate to contact your regular Loyens & Loeff adviser or Aurélie Mingels.

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