New rules to deal with the unavailability of medicinal products in Belgium
An Act of 7 April 2019 has introduced new measures in Belgium to deal with the unavailability of medicinal products on the Belgian market. The first measure is that a wholesaler-distributor (also ‘full-line wholesaler’) is no longer entitled to sell medicinal products for human use outside Belgium. Second, authority is delegated to the Belgian government to define when medicinal products are considered as “temporarily unavailable” and to the Federal Agency for Medicines and Health Products (‘FAMHP’) to provide guidance on therapeutically-equivalent medicinal products in such a situation. The Act was published in the Belgian State Gazette on 8 May 2019 and thus entered into force on 18 May 2019.
The unavailability of medicinal products on the Belgian market
The Act of 7 April 2019 (‘Act’) amends the Act of 25 March 1964 on medicinal products “concerning the unavailability of medicinal products”.
The related parliamentary papers and discussions stated that the suggested measures are intended to deal with shortages of medicinal products and quotas used by the pharmaceutical companies. Shortages are said to be due not only to manufacturing problems, but also to quotas. Pharmaceutical companies often allocate stock to full-line wholesalers that is strictly necessary for Belgian patients, “because they – rightfully – fear that medicinal products intended for the Belgian market will nonetheless be exported to third countries where the sales prices are higher”. However, the allocation of stock (or quotas) in combination with sales outside Belgium sometimes leads to medicinal products eventually being unavailable for Belgian patients.
The Act tries to deal with this issue at two levels.
Export prohibition for full-line wholesalers
First, full-line wholesalers are prohibited from exporting medicinal products.
In the framework of the distribution of medicinal products, so-called full-line wholesalers fulfil an essential role in Belgium. Full-line wholesalers are the wholesalers entrusted with a public service obligation, i.e. the obligation “to guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question”.
In view of this obligation, full-line wholesalers are required at all times to have in stock a range of medicinal products to daily and regularly meet the needs of the given geographic territory/ies. To allow this, manufacturers and regular wholesalers are also obliged to supply full-line wholesalers in such a way that they can meet their obligations.
Given this essential role, the new Act now adds that full-line wholesalers can only supply medicinal products for human use to (i) other wholesaler-distributors, (ii) Belgian pharmacies, and (iii) Belgian hospitals. Apart from that, full-line wholesalers can also supply regular wholesalers, but only in the framework of a specific, previously-determined clinical trial and only to the extent that the supply of the geographical area allocated to that wholesaler-distributor is not jeopardised, and further rules can be stipulated by royal decree.
Exporting and parallel importing remain, however, possible, albeit not through the full-line wholesalers, but through regular wholesalers provided that they have an export licence.
Delivery deadline of three days to full-line wholesalers
Second, a delivery deadline of three working days can be announced as being imposed on marketing authorisation holders, regular wholesalers and parallel importers companies, and failure to comply will be considered as the product being ‘temporarily unavailable’.
When the explanatory memorandum stated that the new Act aims to ‘enhance’ the position of full-line wholesalers, it is clear that it was not referring to the above-discussed export prohibition. Instead, more likely, it referred to the fact that the new Act indeed provides that a royal decree can define ‘temporarily unavailable’ in which case the FAMHP can provide guidance on therapeutically-equivalent alternatives. This is to be able to better deal with such cases and avoid uncertainty about whether a product is legally-speaking ‘unavailable’ or not.
The royal decrees implementing the new Act have (at the time of writing) not yet been adopted. However, on 10 May 2019, the FAMHP published an update (EN / NL / FR) announcing the new rules that will be stipulated in the royal decree(s). It stated that a delivery deadline of three working days will be imposed on marketing authorisation holders, regular wholesalers and parallel importers when supplying full-line wholesalers. Failure to comply with this obligation, i.e. when the medicinal product cannot be delivered for three working days in a row, will be considered as the product being ‘temporarily unavailable’. In such a case, the supplier is required to notify the FAMHP, which can then sufficiently quickly notify the others involved and, where necessary, take additional action.
 Article 12ter, §1, twelfth section of the Act of 25 March 1964 on medicinal products (Art. 3, 2° of the Act of 7 April 2019).
 Article 12ter, §1, thirteenth section of the Act of 25 March 1964 on medicinal products (Art. 3, 1° of the Act of 7 April 2019).
 Article 6, §1sexies of the Act of 25 March 1964 on medicinal products (Art. 2 of the Act of 7 April 2019).
 The FAMHP also publishes and daily updates its database indicating the medicinal products with supply problems : https://banquededonneesmedicaments.fagg-afmps.be/#/query/supply-problem/human
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