Belgium – Royal Decree Enables Use of Unauthorised Medicines to Treat COVID-19 Patients
On 26 June 2020, the Belgian Official Journal published a Royal Decree of 23 June 2020 (the RD) which introduces an exemption from the marketing authorisation requirement to account for shortages in authorised medicinal products to treat COVID-19 patients.
The RD confers on the Minister of Social Affairs and Public Health, or her representative, the Administrator General of the Federal Agency of Medicines and Health Products (FAMHP), the requisite powers to authorise the supply to COVID-19 patients of unauthorised medicinal products from Belgium’s strategic national stockpile if (i) the FAMHP determines that the medicinal products which are authorised in Belgium for the treatment or the adjunct treatment of COVID-19 are unavailable; and (ii) there is no authorised alternative available either. While the unauthorised medicines are in principle intended for use by hospitals, the RD provides that, upon the request of community pharmacies and subject to the production of a medical prescription, the Minister or her representative can also deliver an unauthorised alternative to community pharmacies. Strict safety reporting obligations apply.
Interestingly, it follows from the Council of State’s opinion on the draft RD that the authorities entertain some doubt as to whether the exemption from the marketing authorisation requirement is compatible with EU law. In particular, the question arises whether the exemption falls within the scope of Article 5(1) and/or Article 5(2) of Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use (Directive 2001/83/EC). Article 5(1) of Directive 2001/83/EC exempts from the need for a marketing authorisation medicinal products which are supplied to satisfy special needs “in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility”. Article 5(2) of Directive 2001/83/EC, in turn, allows EU Member States to “temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm”.
In view of these doubts, the Council of State strongly recommended that clarifications be sought from the European Commission (the Commission) on the occasion of the RD’s notification to the Commission pursuant to Directive 2015/1535. This Directive requires Member States to advise the Commission and other Member States of the technical regulations which they intend to introduce for products and for Information Society services before their adoption. While such regulations are in principle subject to a mandatory standstill period of at least 3 months, Directive 2015/1535 provides for an exception to this standstill requirement in the case of, amongst others, “urgent reasons occasioned by serious and unforeseeable circumstances relating to the protection of public health”.
In view of the urgent need to protect public health, the main provisions of the RD apply retroactively from 13 March 2020. They will expire once the coronavirus COVID-19 pandemic is over in Belgium and at the latest on 31 March 2021.
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