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15 April 2020
On 8 April 2020 the Federal Agency for Medicines and Health Products (FAMHP) adopted a consolidated version of its decision to take the following urgent measures for certain listed medicines (and raw materials) to avoid medicine shortages during the COVID-19 pandemic:
The above measures apply until the end of April 2020 but may be renewed on a monthly basis. This article discusses the measures and their legality under EU law in more detail.
On 1 April 2020 the FAMHP adopted and published a first version of its decision, and provided further details about the measures in an update on its website on 2 April 2020. On 8 April 2020 the FAMHP adopted and published a modified and consolidated version and provided further details about the measures in an update on its website.
In its decision, the FAMHP explained that the speed of COVID-19's transmissibility into a pandemic was unforeseeable, and that a sudden peak in the number of contaminations has risked overloading the healthcare system with serious consequences for public health. Given the unequal stock distribution between different actors and the sudden increase in demand for certain medicines used in the treatment of COVID-19 patients, certain medicines or raw materials are no longer available at some pharmacies, hospitals and wholesalers, or risk becoming unavailable in the near future in the absence of urgent measures.
The FAMHP's measures relate to medicines that it considers 'therapeutically essential'. A first category concerns potential or promising treatments of COVID-19, as discussed in the interim clinical guidance for COVID-19 patients. A second category concerns medicines that are applied for the treatment of hospitalised COVID-19 patients that are not antivirals, but provide the necessary care and treatment of complications, such as antibiotics, benzodiazepines and curarizing agents.
The listed medicines are considered critical and essential medicines because there are no complete alternatives available. Article 1 of the decision subdivides these medicines into:
Almost all of the medicines are for intravenous use.
First measure: supply quota for wholesalers, full-line wholesalers and manufacturers
Article 2 of the decision orders wholesalers, full-line wholesalers and manufacturers to limit their sales of medicines and raw materials to an amount that corresponds with their sales for the same period in 2019 increased up to a maximum of 50%. This applies to each medicine or raw material, regardless of dosage, composition or packaging. The sales referred to are those to full-line wholesalers and pharmacies.
The entities above can supply larger quantities provided that:
Further, the FAMHP may order wholesalers to supply in accordance with a specific supply ratio or other specific instructions.
Second measure: conditional supply to recipients outside Belgium
Article 3 of the decision subjects the supply to entities established outside Belgium to additional conditions, in respect of which two different regimens apply:
The notifications should mention the medicines or raw materials concerned, quantities and the country of destination. Dutch, French and English templates for the above notifications are available on the FAMHP website and, once completed, should be named pursuant to the guidance found thereon.
The FAMHP can grant exceptions to the above rules. In the interests of building up strategic stocks, supplies to the Federal Public Service Health, Food Chain Safety and Environment are permitted without prior notification.
Regarding the two above exceptions, in line with Article 126 of the Agreement on the withdrawal of the United Kingdom from the European Union, the "EEA" includes the United Kingdom until 31 December 2020. Further, although Switzerland is not part of the European Economic Area, it is questionable whether the FAMHP intends to subject exports to Switzerland to the stricter regime under the second bullet point above, which would require an exception to be granted, as it constitutes a European Free Trade Association country and an important trade partner of the European Union.
Third measure: notification and possible reallocation of large stock
Article 4 of the decision orders hospitals to notify the FAMHP of stocks of medicines (or raw materials for compounding) that exceed a volume corresponding to the sales for the same period of the previous year increased by a maximum of 50%. This notification serves to identify where stock reallocation may be necessary.
The FAMHP's conditional export within the Euopean Economic Area of Article 3 constitutes a possible restriction on the fundamental free movement of goods principle, under which all goods (including medicines) must be able to move freely and without any hindrance within the European Union and the European Economic Area. This principle is one of the cornerstones of the European Union's internal market, but is not absolute. In specific circumstances, restrictions or even prohibitions are acceptable under Article 36 of the Treaty on the Functioning of the European Union (TFEU) when serving important purposes, such as the protection of the environment or human health, and if they respect the principle of proportionality and necessity.
In this respect, in its coordinated economic response, the European Commission has addressed the issue of national export restrictions (on protective gear and medicines) and has emphasised in this regard that:
Any national restrictive measure taken under Article 36 TFEU to protect health and life of humans must be justified, i.e. suitable, necessary and proportionate to such objectives by ensuring an adequate supply to the relevant persons while preventing any occurrence or aggravation of shortages of goods, considered as essential, such as personal protective equipment, medical devices or medicinal products. Any planned national measure restricting access to medical and protective equipment must be notified to the Commission, which is to inform the other Member States thereof.
In Annex 2 of its communication, the European Commission added that:
Measures regulating the concerned markets with adequate mechanisms to channel essential goods where they are needed the most both within the Member States and to qualified buyers in other Member States, can be a positive contribution to the overall coordinated European approach to help saving lives.
The same principles are confirmed in the recent European Commission Guidelines of 8 April 2020 on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak.
Conditional supply within the European Economic Area is a restrictive measure that "must be notified to the [European] Commission". However, in the current situation, this measure seems at first sight justified and in compliance with EU standards. The aim seems to be in line with the European Commission's main priority to "channel essential goods where they are needed the most within the Member States". Nevertheless, it is important that the notification procedure before the FAMHP is used only as a surveillance mechanism and not to indirectly impose an export ban (or other export restrictions).
Article 1 of EU Regulation 2015/479 on common rules for exports states that export to non-EU countries "shall not be subject to any quantitative restriction, with the exception of those restrictions which are applied in conformity with this Regulation". In principle, an EU member state should send a request to the European Commission, and the latter should decide within five working days whether to impose an export ban at the EU level in order to prevent a shortage of essential products.
Article 10 of EU Regulation 2015/479 permits the Belgian authorities to adopt quantitative restrictions on exports if these are justified on the grounds of protecting life and human health. Against the background of Article 1, this presumably requires that urgency makes it impossible for an EU member state to consult with the European Commission. Moreover, such an export ban requires compliance with the overarching principles of proportionality and international solidarity, so that a request for the export of a product outside the European Economic Area can be refused only when strictly necessary in light of immediate shortages for that product.
The modification of the FAMHP's decision of 8 April 2020 (ie, export to another EEA member state is permitted only if the medicine or raw material is intended for delivery or administration in that member state and prior notification is given to the FAMHP) is clearly more in line with the principles of proportionality and international solidarity. However, if the FAMHP nevertheless decides to oppose an export within three business days, this export ban will still have to be very well substantiated.
For further information on this topic please contact Kirian Claeyé or Hanne Baeyens at ALTIUS by telephone (+32 2 426 1414) or email (firstname.lastname@example.org or email@example.com). The ALTIUS website can be accessed at www.altius.com.
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