The unavailability of certain medicines in Belgium is nothing new, and this situation is certainly not unique in Europe. However, with shortages of 428 products reported at the end of April 2019, there is nonetheless real cause for concern. In order to resolve this issue, Belgium has passed new legislation on the distribution of medicinal products, to be followed by implementing decrees, in order to ensure the uninterrupted supply of medicinal products to the Belgian market.
1. The Act of 7 April 2019
The new act (the "Act") was published in the Moniteur belge/Belgisch Staatsblad on 8 May 2019 and contains two important new provisions.
a) Definition of "temporary interruption" For some time, there was no clear definition for the concept of a "temporary interruption" in supply, interpreted by some as a complete stockout while the Federal Agency for Medicines and Health Products (FAMHP) believed that it referred to a temporary interruption in supply (regardless of the available stock levels).
The Act authorises the executive to clearly define the circumstances in which a temporary interruption will be found and empowers the competent minister to issue, in the event of a temporary interruption, provisional recommendations on medicinal products with an equivalent therapeutic effect.
b) Prohibition on export by wholesale distributors
The role of wholesale distributor is deemed incompatible with the export of medicinal products, as the products supplied to wholesale distributors are intended exclusively for the Belgian market.
The idea is to combat the unavailability of medicinal products due not, for example, to a production problem but rather caused by the export of medicines abroad.
It should be noted that wholesale distributors are entrusted, by the Medicinal Products Act of 25 March 1964, with a public service mission, namely to guarantee the security of supply for pharmacies and hospitals. They must be able to supply at all times a range of medicinal products corresponding to the needs of a given geographic territory and be able to ensure supply at short notice for the entirety of this territory.
Manufacturers had already taken certain measures to limit exports, such as the allocation of stocks of medicinal products per country (otherwise known as quotas), i.e. supplying only the quantities strictly necessary for Belgian patients. However, this practice sometimes had the effect of threatening the availability of medicines in Belgium.
The legislature thus decided to act.
Wholesale distributors will henceforth only be authorised to supply (public or hospital) pharmacies and other wholesale distributors. A notable exception is made for clinical trials, in which context a wholesale distributor can supply a regular wholesaler but only at the conditions to be determined by royal decree.
Regular wholesalers may, for their part, still export medicinal products (provided they have a license to do so).
2. Forthcoming royal and ministerial decrees
The Act will soon be accompanied by royal and ministerial decrees in order to complete the legislative package intended to fight against the unavailability of medicinal products.
The FAMHP has announced an implementing decree that will introduce an obligation for manufacturers to supply wholesale distributors (as well as pharmacies and hospitals) within a period of three working days.
Entry into force
The Act will enter into force on 18 May 2019, with the implementing decrees expected to be adopted shortly thereafter.