Background to the measures
The FAMHP adopted and published a first version of its Decision on 1 April 2020, and provided further details about the measures in an update on its website on 2 April 2020. The FAMHP has now adopted and published a modified and consolidated version on 8 April 2020, again with further details about the measures in a new update on its website.
The FAMHP has explained in its Decision that the speed of the SARS-CoV-2 virus’ transmissibility into a pandemic was not foreseeable, and that a sudden peak in the number of contaminations has risked overloading the health care 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.
Types of therapeutically essential medicines
The FAMHP’s measures relate to medicines that the FAMHP considers as ‘therapeutically essential’ medicines. 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 as critical and essential medicines because there are no complete alternatives available. Article 1 of the Decision subdivides these medicines into: medicines that consist of a single active substance (Annex I), medicines with more than one active substance (Annex II), and raw materials (Annex III). 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 of the previous year increased up to a maximum of 50%. This applies for each medicine or raw material, regardless of the dosage, composition or packaging of the medicine. The sales referred to are those to full-line wholesalers and pharmacies.
The entities above can supply larger quantities provided (i) that this does not jeopardise the supply to other full-line wholesalers, pharmacies or hospitals, and (ii) there is prior notification to the FAMHP. Additionally, 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 of Belgium to additional conditions, in respect of which two different regimens apply:
- Supply to a different EEA member state is permitted provided that the medicine or raw material is intended for delivery or administration in that member state, and if a prior notification is sent to firstname.lastname@example.org with the following subject line: “Notificatie Export EER / Notification d’exportation EEE – [Name of MA holder] – [Name of the medicine]”.
- Supply outside the EEA is permitted if a prior notification is sent to email@example.com with the following subject line: “Notificatie Export BUITEN EER / Notification d’exportation HORS EEE – [Name of MA holder] – [Name of the medicine]”, and if the FAMHP does not object within three business days (by email). Such refusal is possible in the event of an acute or imminent shortage of the medicinal products or raw materials in question, meaning that the volumes available are insufficient to meet the needs of patients in Belgium for the following four weeks. This takes into account the availability of an equivalent therapeutic alternative, as well as the needs in the framework of the treatment of COVID-19 patients, based on present epidemiological models and taking into account standard doses.
The notifications should mention the medicines/raw materials concerned, quantities and country of destination. Templates (NL, FR, EN) for the above notifications are available on the website of the FAMHP, and, after completion, should be named pursuant to the guidance on the FAMHP’s website.
The FAMHP can grant exceptions to the above rules. The supply of the FPS Health, Food Chain Safety and Environment, in the framework of building up strategic stocks, is permitted without prior notification.
Regarding the two above exceptions, in line with Article 126 of the Agreement on the withdrawal of the UK from the EU, the “EEA” includes the UK until 31 December 2020. Additionally, although Switzerland is not part of the EEA, it is questionable whether the FAMHP intended to subject export to Switzerland to the stricter regime under point 2 above requiring an exception to be granted as it constitutes an EFTA country and a very important trade partner of the EU.
Third measure: notification and possible reallocation of large stock
Finally, 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.
Analysis under EU law of the conditional export within the EEA
The conditional export within the EEA 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 EU/EEA. This principle is one of the cornerstones of the EU's internal market but is not absolute. In specific circumstances, restrictions or even prohibitions are acceptable under Article 36 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 (for more details on this matter, please see our coronavirus Q&A).
In its coordinated economic response, the Commission has addressed the issue of several national export restrictions (on protective gear and medicines) and has emphasized 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 Commission has 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 very recent European Commission’s Guidelines of 8 April 2020 on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak. The Commission recalls that “Member States are expected to protect public health in a spirit of European solidarity. In order to achieve this objective, it is critically important that Member States lift export bans on medicines within the internal market. Whilst it is understandable that countries wish to ensure the availability of essential medicines nationally, export bans are detrimental to the availability of medicines for European patients even when they are legally justifiable. Measures leading to requisitioning of medicines, intermediates or APIs, or their production, should not be considered as an option. These measures, especially as far as they are applied to APIs or intermediates, endanger supply since they lead to a slowdown in industry output”.
It is clear that the conditional supply within the EEA is a restrictive measure that “must be notified to the Commission”. However, in the current situation, this measure seems at first sight justified and in compliance with the European standard. 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 FAMHP is used only as a surveillance mechanism and not to indirectly impose an export ban (or other export restrictions).
Analysis under EU law of the restriction on supply outside the EEA
Article 1 of 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, a member state should send a request to the European Commission, and the latter should decide, within 5 working days, to impose an export ban at EU level in order to prevent a shortage of essential products.
Article 10 of Regulation 2015/479 permits Belgium to adopt quantitative restrictions on exports if these are justified on the grounds of protection of life and human health. Against the background of Article 1, this presumably requires that urgency makes it impossible for a 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 EEA can only be refused when strictly necessary in light of immediate shortages for that product.
The modification of the Decision of 8 April 2020, no longer requiring to obtain approval for exports to the EEA but only to proceed to a notification, is clearly more in line with the principles of proportionality and international solidarity. However, if the FAMHP nevertheless decides to oppose a certain export within three business days, this export ban will still have to be very well substantiated.
The Decision’s measures are far-reaching and therefore strictly limited in time. They apply as from the first until the end of April 2020 and are renewable each month. They are part of, and contribute to, a worldwide reaction to the COVID-19 pandemic in which countries are reverting to ‘national reflexes’. Such ‘national reflexes’ are only permitted if they meet the solidarity principles of EU and international law and the fundamental principle of free movement of goods.