Restrictions on the export and movement of medical protective clothing due to coronavirus – with exceptions and prior approval requirements
***** Update on 10 June 2020: No longer any restrictions on exporting and moving medical protective clothing *****
The restrictions on exporting and moving medical protective clothing introduced during the coronavirus pandemic have been lifted. The most recent EU-law requirements for the authorisation of the export of medical protective equipment in accordance with Implementing Regulation (EU) 2020/568 have expired and have not been extended. This requirement for authorisation is therefore not applicable.
Commission Implementing Regulation (EU) 2020/402 of 14 March 2020 imposing an obligation to submit an export authorisation for certain products expired on 26 April 2020 due to its limited period of validity of six weeks. In view of the continuing acute coronavirus pandemic situation within the European Union, the successor scheme in the form of Commission Implementing Regulation (EU) 2020/568 of 23 April 2020 introducing the obligation to submit an export authorisation for certain products entered into force on 26 April 2020. This Implementing Regulation made the export of certain types of personal protective equipment subject to an export authorisation. The Implementing Regulation provided for a period of validity of 30 days. It was not extended. Therefore, the related authorisation requirements have been lifted since 25 May 2020.
The Federal Office of Economic Affairs and Export Control (Bundesamt für Wirtschaft und Ausfuhrkontrolle, "BAFA") automatically takes into account the abolition of the authorisation requirement when deciding on all pending procedures. The Federal Ministry of Economic Affairs and Energy has not introduced any new restrictions in the form of new movement restrictions following the lifting of restrictions on foreign trade in certain goods on 19 March 2020. In the event that the coronavirus infection situation in Germany and Europe deteriorates significantly again and that there is a consequent threat of a shortage in the supply of essential medical protective equipment, the re-introduction of certain export restrictions by the EU or Germany does not appear to be precluded.
We will keep you up to date!
***** Update 20 March 2020: There are "only" restrictions for exports to non-EU countries *****
Due to Commission Implementation Regulation (EU) 2020/402, which entered into force on 16 March 2020, on 19 March 2020, the German Federal Ministry for Economic Affairs and Energy revoked its order dated 12 March 2020 (BAnz AT 19 March 2020 B11). This eliminated the remaining restrictions on exporting medical personal protection garments to other EU Member States. Now, there are “only” restrictions on exporting them to non-EU states. This means that the approach to protection is being placed at EU level, contrary to national trends which have been observed; if and to the extent that other EU Member States likewise revoke or do not enact export restrictions, the market for medical personal protection garments will probably now become larger and more flexible.
Meanwhile, the situation remains volatile. The German government has expressly reserved the right “to regularly evaluate the situation regarding not only further developments in its domestic market but also the necessary EU-wide uniform treatment”. This means that renationalisation in the form of new export restrictions is possible at any time. We will keep you updated.
We will keep you up to date!
***** Update 16 March 2020: European regulation on authorisation for exporting protective equipment *****
On 14 March 2020, the European Union issued a European prohibition on the export of medical personal protective equipment (PPE) as a protective measure against the coronavirus crisis. The corresponding Implementing Regulation (EU) 2020/402 making the exportation of certain products subject to the production of an export authorisation was published on 15 March 2020 in the Official Journal of the European Unionand entered into force on 16 March 2020. The implementing regulation provides that exporters must now apply for an export authorisation to export medical protective spectacles, visors, face shields, mouth-nose protection, protective garments and gloves to a destination outside the EU. The purpose of the implementation regulation is to enable the demand throughout the Union for medical PPE to be met despite limited production capacity in the Member States. It initially applies for six weeks.
According to information provided by the European Commission, Member States that have already passed legislation to control exports of medical PPE have stated that they will modify their national laws to conform to the implementation regulation. In the order issued by the German Federal Ministry for Economic Affairs and Energy on 12 March 2020, the grounds for the order included a statement that a national export prohibition becomes unnecessary as soon as there is a uniform procedure in the European Union. Just such uniform requirements can now be found in the implementation regulation.
The implementation regulation requires exporters to apply for an export authorisation from their national authorities. In this respect, the currently applicable practice will not change. The implementation regulation does not contain any explicit rules for issuing such export authorisations. However, the Regulation includes considerations to be taken into account in issuing an export authorisation. In particular, it shall be taken into account if the export serves to support EU concerted support actions or the activities of the WHO’s Global Outbreak Alert and Response Network or to supply foreign operations of EU Member States or if they are intended for delegations of the EU and the Member States abroad.
However, exporting relevant medical PPE from Germany to a destination outside the EU remains subject to the export prohibition in the German Federal Government’s order dated 12 March 2020.
We will keep you up to date!
***** Update 12 March 2020: Extension of exceptions and possibilities for approval *****
The Federal Ministry for Economic Affairs and Energy has already repealed its order of 4 March 2020 again – but only to replace it with its order of 12 March 2020. The new order extends both the exemptions from the general ban and the possibilities of obtaining approval, but nevertheless still has a very restrictive approach. Following the structure of the order, a distinction has to be made between three levels:
- The group of protective products that are subject to export and movement restrictions has not changed.
- In addition to the exemptions already existing, no approval is now necessary for exports and movements products including those listed below: relating to (i) supplies for German overseas missions, overseas assignments of the German Armed Forces, German members of international police missions or international civilian peace missions, and assignments of the European Border and Coast Guard Agency FRONTEX; (ii) protective clothing which is only a “subordinate component of another item” or “supplied for use for another item”; (iii) movements of the goods referred to in Part I; (iv) re-exports of (in customs law terms) non-EU goods. The exemption referred to under (ii) in particular still appears to need clarification and certainly still has potentially varying interpretations.
- Although the possibilities for allowing possible export and movement are still limited, something has nevertheless been extended. One aspect that should particularly be stressed is that approvals can be issued if this “is necessary for the operation of foreign subsidiaries or foreign branch offices or establishments of companies domiciled in Germany”. The authority responsible for issuing the approval, the Federal Office of Economics and Export Control, also published an information sheet concerning applications on 12 March 2020.
The new order dated 12 March 2020 and the information sheet can be found here (in German).
***** News of 05.03.2020 *****
Coronavirus SARS-CoV-2 has triggered a global epidemiological crisis situation. Demand for medical protective clothing is correspondingly high almost everywhere. Germany itself does not have sufficient production capacity to meet the existing demand or at least the expected demand. In addition, there is a heavy drop in previous imports, partly due to export bans in the countries concerned. In view of this, the German federal government also sees itself forced to generally keep domestically produced supply in Germany.
Against this background, the Federal Ministry for Economic Affairs and Energy, which is responsible in this respect, banned on 04.03. the export of various protective clothing to third countries and its transfer to EU countries, namely as follows (see in detail with detailed product descriptions here): protective glasses/visors, face shields, mouth and nose protection products (surgical masks), Class 2 filtering facepiece (FFP2) masks, class 3 filtering facepiece (FFP3) masks, protective gowns, protective suits, corresponding gloves.
The prohibition is based on the first sentence of section 6(1) in conjunction with section 4(1) no. 5 of the German Foreign Trade and Payments Act, according to which individual interventions in the fundamental freedom of foreign trade and payments are possible in order to ‘counteract any danger to the coverage of vital needs in Germany […] and thereby to protect the health and life of human beings […]’. EU law allows such national responses for the purpose of health protection, at least in principle (Article 36 TFEU); whether the specific prohibition is actually lawful would require closer examination.
The ban does not apply: (i) to travellers carrying reasonable quantities for their own private use; (ii) mostly to medical personnel for the exercise of their profession; and (iii) in reasonable quantities for the provision of first aid or for other urgent cases in buses, trains, aircraft or ships in international traffic.
There is also the possibility of granting exemptions. The Federal Ministry for Economic Affairs and Energy cites several case constellations, including concerted relief efforts, appeals for assistance from the World Health Organisation's Global Outbreak Alert & Response Network, and many more. In this respect, the view goes beyond national borders and continues to make it possible to provide assistance where help is needed, for example because own production capacities are too small and medical protective clothing is no longer available on the world market.
The fact that the German authorities are also enforcing the ban became clear on 07.03.: Customs apparently prevented a truck of a Swiss company with a load of 240,000 protective masks from exporting to Switzerland. According to the Swiss government, which protested to the German government against the export ban, this was not an isolated incident. Against this background, we urgently recommend that, in the event of such efforts, exemption certificates be applied for and, if necessary, cooperation with the embassy of the recipient country be sought instead of violating the export ban.
Any questions? Please contact: Bärbel Sachs, Johannes Schäffer and Carl-Wendelin Neubert
Practice group: Regulatory & Governmental Affairs