Manufacturing medicines and placing them on the market without an authorisation is prohibited in the EU1. As an exception to this principle, a pharmacy has the right to manufacture and dispense a medicine without an authorisation if "the medicines are prepared and dispensed on a small scale in a pharmacy"; this is commonly known as the "magistral formula" or "pharmacy preparation"2.
This right of the pharmacy has been fully harmonised in the EU by Article 3(1) of the Directive 2001/83/EC (Medicines Directive), which The Netherlands has implemented into the Dutch Medicines Act (the Act).
The Inspectorate for Health and Youth Care (the Inspectorate) is the administrative body that supervises compliance with the Act. The Inspectorate examines on a case by case basis whether the pharmacy preparations are permitted and can take enforcement action.
The term "on a small scale" is not defined in the Medicines Directive nor in the Act itself. The Dutch legislative history states that the most important criterion in determining if the manufacturing is on a small scale is whether the medicines are intended for direct supply to the normal patients of the pharmacy (which automatically implies limitations on the production scale).
The manufacturing of medicines in a pharmacy may not exceed the size of its normal patients3. Other relevant factors mentioned are the production scale, the presence of quantities of pharmaceutical raw materials that exceed the normal production of the pharmacy, the production techniques and associated investments4.
CJEU 16 July 2015 (Abcur AB v Apoteket)
The CJEU ruled in the case Abcur AB v Apoteket (C-545/13) on 16 July 2015 that Article 3 of the Medicines Directive must be interpreted strictly, like all provisions which are exceptions to a principle (par. 54).
According to the CJEU medicines are covered by the exception referred to in Article 3(1) Medicines Directive "only if they have been prepared in accordance with a medical prescription issued before their preparation, which must be specifically for a previously identified patient" (par. 71). The patient must be identified before the medicine is produced and it must be produced specifically for that patient (par. 61).
Council of State, 1 May 2013 (Regenboog Apotheek)
In a 2013 case before the Council of State5 (the supreme administrative court in The Netherlands), there was a pharmacy named Regenboog Apotheek that provided 20.000 tablets methylphenidate per month to 300 patients.
This represented 0.25% of the total number of patients in The Netherlands who used methylphenidate. The Dutch distributor of the registered version of methylphenidate requested the Inspectorate to take enforcement action. The Inspectorate replied that the methylphenidate tablets were manufactured and dispensed on a small scale by the pharmacy and therefore allowable.
Due to the fact that the 300 patients lived scattered all over The Netherlands and a large proportion of them did not use the services of pharmacy (other than for the methylphenidate tablets they prepared) the Council of State ruled that the pharmacy preparations could not be regarded as for their own patients of the pharmacy.
Another relevant factor was that the pharmacy used mixing vessels and a tableting machine for the preparation of the methylphenidate tablets. This led the Council to conclude that the pharmacy preparations were not "on a small scale", referring to legislative history in its decision-making process.
Dutch Minister's letter, 8 April 2019
In an attempt to reduce the expenses for medicines incurred by the government, the Minister of Medical Care drafted a letter on 8 April 2019 which informed the parliament of how the Inspectorate will deal with pharmacy preparations.
More precisely, the Minister explained that the Inspectorate will consider pharmacy preparations to be dispensed on a small scale (and therefore allowable) if they are for:
- around 50 unique patients per month who need the medicine for a long term
- around 150 unique patients per moth who need the medicine on a short term.
The Minister stated that the criteria mentioned in the legislative history of the Act, such as the number of patients of a normal pharmacy and the production techniques, are no longer up-to-date or distinctive. Therefore, they can no longer be decisive for the assessment of whether pharmacy preparations are permitted.
According to the Minister, pharmacy preparations take place in hospital pharmacies with a different and larger patient base than public pharmacies. As a result, the number of patients of a normal pharmacy is no longer a significant criterion for determining whether a pharmacy preparation is intended for dispensing on a small scale.
In our opinion, the Minister interprets the criterion "the number of normal patients of the pharmacy" incorrectly – as if it were an absolute number, that of ‘a normal’ (ie average) pharmacy. The legislative history clearly indicates that it refers to the normal patients of the pharmacy in question.
This is also confirmed in the decision Regenboog Apotheek by the Council of State. In addition, the absolute numbers given by the Minister do not serve society as pharmacies may differ in the size of their patient base. The small pharmacies will not be able use the full space of the amount given by the Minister while for the big pharmacies it will not be enough to serve their own normal patients.
Furthermore, from a democratic point of view, the Minister cannot reject criteria that were formulated in the legislative history and subsequently formulate its own.
Pharmacy preparations are fully harmonised in the EU so it is ultimately up to the CJEU to decide if the new policy of the Inspectorate is in accordance with the Medicines Directive.