Belgium - Medicine Shortages - Constitutional Court Suspends Statutory Provision Limiting Exports For Benefit of Local Patient
Yesterday the Constitutional Court suspended Article 3, 2° of the “Law of 7 April 2019 modifying the Law of 25 March 1964 on medicines as regards the unavailability of medicines” (Wet tot wijziging van de wet van 25 maart 1964 op de geneesmiddelen voor wat de onbeschikbaarheden van geneesmiddelen betreft / Loi modifiant la loi du 25 mars 1964 sur les médicaments en ce qui concerne les indisponibilités de médicaments) (the “Law”). Pursuant to Article 3,2°, wholesalers (“WS”) with a public-service WS status (groothandelaar-verdeler/grossiste-répartiteur) are no longer allowed to supply medicines to customers of their choice and should limit their supplies to specific customer categories, namely (a) other WS with a public-service WS status; (b) community pharmacists; and (c) hospitals recognised under applicable rules (see, Van Bael & Bellis Life Sciences Newsflash of 8 May 2019 and of 17 May 2019).
The Constitutional Court suspended this provision at the request of a number of regular wholesalers (the “Plaintiff Wholesalers”) who claimed that the new rule had cut off a major source of supplies - WS with a public-service WS status - which they had not been able to replace. The Plaintiff Wholesalers showed, first, that they were able to put forward weighty arguments against the challenged provision and, second, that they would suffer serious harm that would be difficult to undo if the challenged provision were not suspended.
While the Plaintiff Wholesalers put forward four different sets of arguments, the Constitutional Court focused on the compatibility of the challenged provision with the rules of the Treaty on the Functioning of the European Union (“TFEU”) which guarantee the free movement of goods. The Constitutional Court considered that the Plaintiff Wholesalers could no longer source supplies from the WS with a public-service status which, in turn, reduced their ability to export medicines from Belgium. According to the Constitutional Court, the challenged provision therefore amounted to a measure of equivalent effect as a quantitative restriction on exports in breach of Article 35, TFEU. The Constitutional Court added that such a measure can be justified on the grounds of the protection of health and life of humans as provided for by Article 36, TFEU and that, in theory, making sure that medicines are in sufficient supply on the Belgian territory to serve the patients on that territory would qualify as an objective protected by Article 36, TFEU.
However, the Constitutional Court went on to affirm that for two reasons the challenged provision was not suitable to achieve that objective. First, the file did not show that the export activities of regular WS actually had an adverse influence on the availability of specific medicines in Belgium. Moreover, the government had not been able to dispel that impression with fresh evidence. Second, WS with a public-service WS status are only allowed to furnish medicines to regular WS if they are sure to be in a position to meet their public-service obligations. The Constitutional Court concluded that Article 36, TFEU could not come into play and that, as a result, there were weighty arguments in favour of a suspension on the basis of Article 35, TFEU.
Serious Harm Difficult To Undo
The Constitutional Court found that the Plaintiff Wholesalers had been deprived of a major source of supply and had not been able to find alternative supply channels, such as direct purchases from the marketing authorisation holders. The Constitutional Court also noted that Parliament had failed to create a reasonable transition period, thus exacerbating the predicament of the regular WS to a point where a number of these WS found themselves on the edge of bankruptcy.
According to the Constitutional Court, all of these findings justified the suspension of Article 3, 2°.
Yesterday’s judgment puts a spanner in the works by compromising part of the outgoing government’s recent efforts to reduce medicine shortages. While the Constitutional Court was not impressed with the evidence produced to justify the export restriction, the new federal government will probably have to pursue similar and possibly better documented avenues to remedy some of the existing medicine shortfall problems. The Constitutional Court could still reach a different conclusion when reviewing the action for annulment against Article 3,2°, but the chances of this happening would seem remote.
The judgment of the Constitutional Court is attached.
Related insightsSign up for updates