In recent days, both the EU and certain EU Member States have imposed new export licensing requirements on the export of certain types of medical equipment and medicines, in light of the COVID-19 outbreak. We summarize those measures below. The new measures are relevant for any companies who may export medical equipment or medicines from the EU or the United Kingdom—including life sciences companies, as well as other companies such as for example those that may wish to export the items in question for the use of their global affiliates.
The status of the new EU and Member State measures may change rapidly in the days and weeks ahead. Moreover, there are reports of similar measures being considered or implemented in other jurisdictions. Consequently, companies that wish to export medical equipment and medicines relevant to the treatment of COVID-19, or protection against COVID-19 infections, should be continually attentive to emerging export controls licensing requirements.
EU Measures
On 15 March 2020, the European Commission issued Commission Implementing Regulation No. 2020/402 (the “Regulation”). The Regulation imposes licensing requirements on exports, from the EU, of personal protective medical equipment, as listed in Annex I to the Regulation. While issued by the Commission, the Regulation also applies in the United Kingdom, and should continue to do so at least until 31 December 2020 under Brexit-related transition legislation (unless the Commission revokes the Regulation in the interim).
Annex I to the Regulation includes types of the following items, meeting certain specifications set forth in Annex I and in associated EU CN tariff codes (which are cross-referenced in Annex I):
- Protective spectacles and visors;
- Face shields;
- Mouth-nose-protection equipment;
- Protective garments; and
- Protective gloves.
The Regulation includes details concerning the licensing process for exports of the foregoing items, as well as a set of licensing criteria which Member States must consider in determining whether to grant licenses. The Regulation applies for a period of six weeks (i.e., through 26 April 2020), although the Commission may determine to extend the duration of the Regulation.
The Regulation is supplementary to pre-existing export controls on certain medical equipment, as set forth in the EU Dual Use Regulation. Category 1 of the EU Dual Use List, in particular, includes controls on a range of chemicals and goods that are relevant to the life sciences sector. Those controls have not, however, themselves been expanded, thus far, as a consequence of the COVID-19 outbreak.
EU Member State Measures
The Regulation was prompted by unilateral export controls that had been implemented by a number of Member States. Some Member States—such as Germany and France—have now lifted most or all of their national measures following implementation of the Regulation. Certain other Member States are, however, reported to have implemented national controls on the exports or intra-EU transfers of certain items, including Bulgaria, Poland, and the Czech Republic. Those measures include controls both on certain types of medicines as well as medical equipment.
The scope and status of the foregoing controls are evolving on a day-to-day basis. It is, therefore, important for EU parties seeking to export, or even transfer within the EU, medicines and medical products to assess both the EU regime (including Regulation 2020/420 and the Dual Use Regulation) as well as any potential unilateral Member State measures.
If you have questions concerning the material discussed in this client alert, please contact the following members of our International Trade practice.
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