Précis

On 16 July 2015, the European Court of Justice issued a judgment on an application for a preliminary ruling made by the Stockholm Tingsrätt (the Stockholm District Court in the dispute between Abcur AB (“Abcur”), on the one hand, and Apoteket AB (“Apoteket”) and Apoteket Farmaci AB (“Farmaci”) on the other, concerning the production and distribution by Apoteket of medicinal products, Noradrenalin APL and Metadon APL.

The requests referred to the Court concerned whether the medicinal products at issue in the main proceedings might be covered by the so called “pharmacy exemption”, as provided for by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use (the “Directive”).

Background

Abcur is a Swedish pharmaceutical company which manufactures and distributes the following drug products:

  • Metadon DnE, a narcotic which is used to treat opiate addiction, and which may only be prescribed by a doctor with a special authority to prescribe narcotic medicinal products; and
  • Noradrenalin Abcur, a pharmaceutical preparation for infusion which is mainly used to treat acute low blood pressure in emergency and intensive care units and which is not available on prescription to individual patients.

Apoteket is a company owned by the Swedish State. Until 1 July 2009, when Sweden reorganised its regulatory framework of pharmacies, Apoteket had the sole and exclusive right to retail medicinal products in Sweden. Before that date, it marketed Metadon APL and Noradrenalin APL, both produced by the Apoteket group company responsible for magistral formulae (any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient), Apoteket Produktion och Laboratorier AB (“Apoteket PL”), and then supplied through another Apoteket’s company, Apoteket Farmaci

Noradrenalin Abcur was first authorised for sale as a medicinal product in Sweden on 3 July 2009. Before that date, there was no Swedish noradrenalin medicinal product authorised for sale, the needs in Sweden being met by using Noradrenalin APL, then ordered by health care institutions from Farmaci on the basis of the relatively immediate needs of those institutions known in advance.

Metadon DnE was first authorised for sale as a medicinal product on 10 August 2007. Before that date, there was no authorised methadone product in Sweden and needs in Sweden were met solely by using Metadon APL, also prepared by Apoteket PL and marketed in Sweden by Apoteket between 2000 and 2011.

Noredrenalin APL and Noregrenalin Abcur contain the same active substance, they are used in the same dosage and have the same pharmaceutical, the same applies to Metadon APL and Metadon DnEThe only difference between the Apoteket and Abcur products is the sugar and alcohol content and the taste.

Abcur brought a legal action against Apoteket and Farmaci before the Stockholm Tingsrätt claiming that they infringed the Swedish legislation in having advertised Noradrenalin APL and Metadon APL without having obtained a marketing authorisation from the competent authority. Abcur also claimed damages.

The defendants claimed that the Directive should not apply to the products in question and the Stockholm Tingsrätt stayed the proceedings and referred the Court for a preliminary ruling concerning the scope of the Directive and, in particular, the scope of the so called “pharmacy exemption”.

In particular, the Stockholm Tingsrätt asked the Court to state if the prescription-only medicinal products for human use, such as those involved in the proceedings, for which no marketing authorisation has been granted and which are marketed and supplied in the circumstances and under the conditions described in the proceedings, may be covered by any of the exceptions contained in Article 3(1) or (2) of Directive 2001/83. In particular, where there is another authorised medicinal product containing the same active substance being used in the same dosage and having the same pharmaceutical form.

What

The question referred to the Court essentially deals with exemption contained in Directive 2001/83/EC, hereafter referred to as the “pharmacy exemption”, pursuant to which the Directive does not apply to magistral formul or to any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question ("officinal formula").

The Court firstly notes that the main aim of any legislation concerning the medicinal products for human use is to safeguard the public health and that, as a consequence, any exception to the general principles provided for in such legislation shall be interpreted restrictively. This also applies to Article 3 and to the conditions to be fulfilled in order for the medicinal products to caught by the Directive.

The Court then turned to examine whether the pharmacy exemption may apply to drug products such as those at issue in the main proceedings.

With reference to the Article 3 (1) of the Directive, the Court noted that it implied the patient must be identified before the medical product is produced, the purpose of that provision being to enable pharmacies to produce, on a small scale, tailor-made products for individual patients. It follows that, the key issue in answering the question of the Swedish Court was, whether the medicinal products at issue in the main proceedings were manufactured after an individual patient was identified.

In that regard, it appeared clear to the Court that Noradrenalin APL was ordered by the hospitals before an individual patient was identified and that Metadon APL was supplied on subscription, i.e. without an individual prescription in every instance. Thus, none of the said products fall into the scope of the said article. Therefore, since one of the conditions for the application of Article 3 (1) of the Directive was not satisfied, that provision could not apply in the case at issue.

With regard to the Article 3, point 2, of the Directive, the Court noted that it implied that the medicinal products must be prepared in a “pharmacy”, “in accordance with the prescriptions of a pharmacopoeia” and “intended to be supplied directly to the patients served by the pharmacy in question”. Nonetheless, the Court noted that no definition of “pharmacy” is contained in the Directive. In the absence of any pharmacy definition, the Court decided to follow the definition proposed by the Commission in their observations submitted to the Court, pursuant to which a pharmacy is a physical facility with the right to sell, supply, monitor and prepare in small quantities, medicinal products. Thus, according to the Commission, the main phases of preparation of a pharmaceutical product must take place in a pharmacy. A laboratory cannot, as such, be considered as a pharmacy. As a consequence, if it cannot be established that both the production site and the dispensing site are situated in the same physical facility, the criterion is not fulfilled.

Since Noradrenalin APL and Metadon APL were both prepared at separate geographical sites from the one where they are dispensed, the Court concluded that none of themfall into the scope of the pharmacy exemption.

So what?

The key points of the decision rendered by the Court can be summarised as follows:

  • medicinal products for human use, such as those at issue in the main proceedings, issued in accordance with a medical prescription and for which no marketing authorisation has been granted by the competent authority, may be covered by the exception referred to in Article 3, point 1, of the 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; and
  • the same products may be covered by the exception referred to in Article 3, point 2, of the Directive, only if they are delivered directly to patients supplied by the pharmacy which prepared them.

The decision in comment is interesting as:

  • this was the first case in which the European Court of Justice defines what a “pharmacy” is under European law.
  • the Court clarified the precise scope of the pharmacy exemption, in particular stating that, in order to fall within the exceptions set forth in Article 3, points 1 and 2, of the Directive, the medicinal products shall be prepared and sold at the same facility.

In its decision, the Court followed the approach of the Advocate General. In the Advocate General’s opinion, he called the Court’s attention on the fact that it is clear from the wording of Article 3 that the medicinal products shall be intended to be supplied directly to the patients served by the pharmacy in question. Therefore, if it cannot be established that both the production site and the dispensing site of those products are situated in the same pharmacy, Article 3 of the Directive cannot apply, regardless any other reason of practical convenience.

The decision, and in particular, the new approach concerning the pharmacy exemption, is likely to have significant consequences on the preparation and distribution of magistral and officinal formulae, in particular of those magistral and/or officinal formulae prepared by the hospital pharmacies, which had benefited from the Article 3 exemption, even though the preparation and supply of them physically did not take place at the same location.

Indeed, the concept of pharmacy was not defined in the Directive and there was no formal requirement that the preparation should have occurred at the same place where the product was supplied to the patient. Moreover, many courts (e.g. the UK courts) were used to broadly interpret the pharmacy exemption basing their interpretation on the argument that it could actually be safer and more convenient to keep the preparation of the medicines separate from the supply to patients.

We can therefore expect that, following the decision of the Court in comment, situations such as those described above and other situations concerning the use, preparation and distribution of magistral and officinal formulae, which were usually included within the scope of the pharmacy exemption, and therefore excluded from the scope of the Directive and its authorisation regime, could now be reconsidered in light of the new approach.

The decision of the Court also seems to be coherent with the recent regulatory trend to limit, as far as possible, the circulation of medicinal products whose preparation and circulation cannot be properly controlled.