1. Summary

On 1 April 2020, the Belgian Federal Authority for Health and Medicinal Products (“FAMPH”) adopted a Decision to avoid shortages of medicines and raw materials used in the treatment of COVID-19.  It applies for one month from 1 April, renewable.  On 2 April 2020, the authority provided further details in a news post on its website.  The decision implies:

  • An export ban to countries outside the European Economic Area (EEA).  Exceptions must be expressly requested from the FAMPH.
  • Exports to EEA countries are prohibited unless notified beforehand to the FAMPH.
  • Sales quota for wholesalers.
  • Notification and possible reallocation of large stocks.

We briefly explain these measures, and review their lawfulness under EU law.

2. Medicines and raw materials covered

The Decision applies to medicines and raw materials mentioned in the Annexes.  Here are some examples:

  • Annex I: medicines with a single active substance (e.g. intravenous diazepam and lorazepam, fentanyl, epinefrin…);
  • Annex II: medicines with more than one active substance (e.g. lidocainehydrochloride – methylprednisolon…);
  • Annex III: raw materials  (e.g. amoxicillin, chloroquine, morfinehydrochloride…);
  • Annex IV lists medicines with a single active substance for non-intravenous use that are excluded (e.g. diazepam…).

3. Export notification to EEA countries

Article 3 (1st and 2nd indent) of the FAMHP Decision states that it is prohibited to supply medicines to anyone other than wholesalers established in Belgium, entities established in Belgium authorized to distribute medicines, or hospitals established in Belgium.  Similarly, raw materials may only be supplied to wholesalers established in Belgium and entities established in Belgium authorized to distribute medicines.

As an exception to this general principle, supplies to another EEA member state are permitted if (1) the medicine or raw material are intended to be supplied in that member state, and (2) if a notification is sent beforehand to the FAHMP at coronashortages@fagg-afmps.be .  The subject line should read: “Notification export EEA – Name of MA holder – Name of the medicine.”  Under article 126 of the EU-UK withdrawal agreement, for the purposes of the FAMHP Decision, “EEA” should include the UK until 31 December 2020.

Under the current circumstances, the Belgian notification requirement likely complies with EU law given that it allows the FAHMP to monitor product flows.  In this regard, Commission Guidelines of 16 March 2020 on COVID-19 and border management measures state at point 6 that: “Member States should preserve the free circulation of all goods. In particular, they should guarantee the supply chain of essential products such as medicines, medical equipment, essential and perishable food products and livestock. No restriction should be imposed on the circulation of goods in the Single Market, especially (but not limited to) essential, health-related and perishable goods, notably foodstuffs, unless duly justified….”

Close follow-up is required so that the Belgian notification requirement should not – in practice – amount to an intra-EEA export ban.

4. Export ban to non-EEA countries

As mentioned above, the FAMHP contains a general export ban.  For non-EEA countries, the Decision did not provide for a specific procedure to request an exception.  The news post on the FAMHP website of 2 April clarifies this.  It states that an exception can be requested via email to coronashortages@fagg.be. The subject line should read: “Request Export outside the EEA – Name of MA holder – Name of the medicine.”  The country of destination and the quantities should be mentioned.

The export ban is in a tense relationship with EU law.  Article 1 of Regulation 2015/479 states that “[t]he exportation of products from the Union to third countries shall be free, that is to say, they shall not be subject to any quantitative restriction, with the exception of those restrictions which are applied in conformity with this Regulation.”   Therefore, in principle, a Member State should request the European Commission to impose an export authorization at EU-level in order to prevent a shortage of essential products.  In March, the Commission adopted such measures for protective equipment (see our alert here).  When a member state makes such a request, the Commission should decide within 5 working days.  It is unclear whether Belgium has consulted with the European Commission.  Regulation 2015/479 and Belgium’s duty of loyalty to the EU interest (article 4(3) TEU) seem to require this kind of (prior?) consultation.

Article 10 of Regulation 2015/479 does permit Belgium to adopt quantitative restrictions on exports if these are justified on grounds of public health.  Presumably this requires that due to urgency, it is not possible for member state to consult with the European Commission.  Moreover, the export ban requires compliance with the principle of proportionality.  Thus, when a company’s request for non-EEA export is refused, EU law no doubt requires that this is specifically motivated in light of shortages for exactly that product.  A general reference to public health risk is not likely sufficient.

5. Supply quota

Pursuant to article 2 of the FAMHP Decision, manufacturers, wholesalers, wholesalers-distributors must limit sales of medicines and raw materials to an amount equal to the sales of the previous year for that period, increased with a coefficient of maximum 50%. Larger quantities may be supplied on prior notification to the FAHMP.  Wholesalers may receive specific instructions for deliveries from the FAHMP.  These measures too, must be checked for compliance with EU free movement principles on a case-by-case basis.

6. Re-allocation of large quantities of stock

Hospitals and entities authorized to distribute medicines that hold stocks of more than one month of sales volume (or raw materials for the preparation of sales volume of officinal or magistral preparations) must notify this stock to the FAHMP with the goal of possible reallocation.  The sales volume is calculated based on sales of last year for the same period, increased with a coefficient of 50%.