The New Belgian Act on Medicinal Product Shortages
On 3 February 2020 the Act of 20 December 2019 amending various legal provisions concerning shortages of medicinal products was published in the Official Gazette. Except for Articles 2 and 4, which entered into force on 31 January 2020, the act’s provisions entered into force on 13 February 2020. In our view, the new legislation does not prevent pharmaceutical companies from applying quotas, provided that they do not affect the public service obligation of wholesaler-distributors (also known as full-line wholesalers. In addition, we also consider that the act arguably imposes no general obligation on pharmaceutical companies to supply retail pharmacies directly. Several of the act’s provisions are to be implemented by royal decrees which are not yet available.
The new act follows a previous attempt by the legislature to address medicinal product shortages, which was annulled by the Constitutional Court. The act amends the Medicines Act of 25 March 1964 and the Health Insurance Act of 14 July 1994.
Wholesalers should supply medicinal products within three working days to:
- full-line wholesalers to the extent that it concerns a delivery within the framework of their public service obligation; and
- pharmacists (Article 4).
A royal decree will implement this obligation and its control mechanism.
The interruption of the supply to a full-line wholesaler or pharmacist or the lack of a complete supply of the amounts requested within the framework of the full-line wholesaler’s so-called ‘public service obligation’ are now considered a ‘temporary shortage’ (Article 2(2)). Full-line wholesalers must:
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 the event of a temporary shortage, the marketing authorisation holder (MAH) must notify the Federal Agency for Medicines and Health Products (FAMHP) of the exact reason for the shortage. Failure to do so is considered a lack of notification (Article 2(1)).
In addition, a temporary export ban can be applied to medicinal products for which a shortage is notified or established (Article 3), and the MAH will be required to compensate any additional costs relating to the unavailability of a medicinal product (Article 6). A royal decree will implement the procedure and conditions for both provisions.
If there is a medicinal product shortage, as reported to and published on the FAMHP’s website, pharmacists may deliver a substitute medicinal product with the same active substance or combination of active ingredients, the same strength, the same method of administration and the same frequency of administration, provided that the FAMHP’s guidelines are complied with and the healthcare practitioner has made no therapeutic objection (Article 7). A royal decree will further supplement this article.
Finally, if the medicinal product continues to be unavailable beyond the first day of the twelfth month following the start of the unavailability, it will no longer be reimbursed (Article 5).
Impact on pharmaceutical companies active in Belgium
Can pharmaceutical companies continue to use quotas?
The explanatory memorandum of the new act’s first draft referred to quotas of pharmaceutical companies per medicinal product per country as one of the causes of shortages. Several legal provisions of that draft act directly or indirectly referred to tackling such quotas in an attempt to remedy shortages.
The adopted legal provisions no longer contain such references, and it is our view that a quota system does not necessarily violate the act. Rrather, a pharmaceutical supplier should consider whether or not a full-line wholesaler’s order is part of its public service obligation. The pharmaceutical supplier should avoid preventing full-line wholesalers from fulfilling such an obligation, but no more than that. It is not required to supply a full-line wholesaler with products that are intended for export or to supply wholesalers that have no public service obligation.
Should pharmaceutical companies supply pharmacists directly?
The new act stipulates that wholesalers must deliver their medicinal products within three working days not only to full-line wholesalers, but also to pharmacists. However, the Belgian supply chain is based on delivery to full-line wholesalers, which in turn supply pharmacists. Does the new act now oblige all wholesalers to deliver directly to all pharmacists? Arguably, it does not.
The same ‘obligation’ was already stated in the Medicines Royal Decree of 14 December 2006. In fact, the explanatory memorandum of the act states that the purpose of this provision is to enshrine in the Medicines Act the obligations that already exist under that royal decree, so not much appears to have been changed. A general obligation to deliver directly to pharmacists would also impose a huge burden on pharmaceutical companies, disregard the specific cascade system and obviate the need and position of wholesaler-distributors. It would be irrelevant for dealing with shortages, which remains the aim of the new act. The explanatory memorandum confirms the exceptional nature of such direct supply and states that it:
goes without saying that, in cases of urgency, companies can supply directly to the pharmacist, without having to go through the wholesaler (distributors) channel. However, it is not the intention to supply publicly accessible pharmacies on a daily basis.