As previously reported on this blog, on 1 April 2020 Belgium adopted a complete ban on exports of certain medicines and raw materials to non-EEA countries to avoid shortages during the COVID-19 outbreak. On 8 April 2020, Belgium reversed this ban, and instead installed a system of export controls. Coincidentally or not, the same day the European Commission also issued guidelines to the member states on the rational supply of medicines.
Below I discuss the new approach to exports within and outside the EEA from Belgium.
1. Total export ban under the Decision of 1 April 2020
Article 3 of the Decision of the Federal Agency for Medicines and Health Products (“FAHMP”) of 1 April 2020 (“old Decision”) was drafted as a total export ban within and outside the EEA. By way of exception, EEA exports were lawful subject to prior notification to the authority. It did not provide for an exception for exports outside the EEA. It was the news article on the FAHMP website of 2 April 2020 that stated that exceptions could be requested for exports outside the EEA. This approach was highly questionable under EU law.
Article 3 of the FAHMP Decision of 8 April 2020 (“new Decision”) has essentially reversed the total export ban.
2. Non-EEA exports under the Decision of 8 April 2020
Pursuant to article 3(1), exports outside the EEA are now in principle permitted, subject to prior notification and insofar the Minister or the FAHMP have not opposed the export within three working days “after” the notification. The opposition will be communicated by email to the notifying wholesaler. The language of this provision suggests that if a company has not heard of the FAHMP within that period, the non-EEA export can go ahead.
The Decision states that the export outside the EEA can be refused if there is an “acute or imminent shortage of the relevant medicines or raw materials, insofar the available volumes are insufficient to fulfill the needs of patients in Belgium during the upcoming four weeks. The availability of an alternative, therapeutic equivalent alternative is taken into account, as well as the needs for the treatment of COVID-19 patients, on the basis of current epidemiological models and taking into account standard dosages.”
This new approach is likely compliant with EU law. Exports are in principle allowed, and the authority gives clear public health criteria that could be a ground for refusal. In general terms, three working days also appears a reasonable time-period, unless the planned export is itself particularly urgent given the global health emergency.
3. Exports within the EEA under the Decision of 8 April 2020
Article 3(2) has been redrafted to reflect that exports to the EEA are in principle permitted. Other than that, the requirements are identical as under the old Decision: prior notification is required, and the medicine or raw material must be destined for supply or administration in the EEA member state of destination.