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In response to the growing impact of the COVID-19 Coronavirus in Europe, a number of EU countries have implemented national controls to restrict the export of medicines and medical equipment, such as face masks, gloves, and protective clothing.
Over the weekend, the EU Commission reviewed actions taken by Member States and, while it has discouraged Member States from adopting measures which would limit intra-EU trade, it has introduced a temporary export ban on exports of certain medical/protective equipment to destinations outside the EU.
EU wide controls under Commission Implementing Regulation (EU) 2020/402
On Sunday 15 March 2020 the Commission published an Implementing Regulation that prohibits the export of the personal protective equipment listed in Annex I to the Implementing Regulation, whether or not originating in the EU, to destinations outside the EU, unless a licence is first obtained from a Member State. The Implementing Regulation was made pursuant to Article 5 of Regulation (EU) 2015/479, which permits the Commission to adopt temporary export control measures in order to prevent or remedy critical situations arising from shortages of essential products.
Annex I to the new Regulation covers a range of items (including mouth-nose-protection equipment, gloves, and other protective garments) for the protection of the wearer against potentially infectious material and for the protection of the environment against potentially infectious material spread by the wearer, as well as covering protective spectacles and visors, and face shields. For full categories and descriptions, and corresponding customs codes that correspond to or which can include these items, please see the table in Annex I.
An application for an export authorisation can be made to Member States using the form set out in Annex II to the Implementing Regulation.
The Regulation entered into force immediately on publication yesterday (15 March 2020), and will apply for a period of six weeks. Within 12 working days of the measure entering into force, the Commission must decide whether to adopt longer-lasting restrictions (which could include quantitative restrictions on exports, as well as licensing requirements).
The Commission is also expected to publish guidance on the restrictions on exports of protective equipment during the course of today.
EU dual-use export controls
The EU's existing dual-use export control regime will also continue to apply to any items that are listed in the EU dual use list (Annex I to Regulation 428/2009, as amended). These are specifically intended to capture more sophisticated items with both a civil application and a military or WMD application (consumer or civil grade equipment is less likely to be covered by these controls).
In particular, 1A004 covers, inter alia, full face masks (i.e. gas masks including powered air purifying respirators), filter canisters and decontamination equipment (and specially designed components) therefor, designed or modified for defence against… "biological agents"; and protective suits, gloves and shoes, specially designed or modified for defence against… "biological agents". For these purposes, "biological agents" means pathogens or toxins, selected or modified (such as altering purity, shelf life, virulence, dissemination characteristics, or resistance to UV radiation) to produce casualties in humans or animals, degrade equipment or damage crops or the environment. Further advanced protective equipment for biological manufacture and handling is also listed under 2B352.
National controls in EU Member States
In addition, a number of Member States have also introduced national export bans of medical equipment:
The Czech Republic has adopted measures under which manufacturers, distributors and importers of personal protective equipment, are prohibited from selling certain personal protective equipment (chiefly class FFP3 respiratory protection masks and medical veils) other than to the state of the Czech Republic and its organisational units or to distributors of personal protective equipment that are incorporated or established in the territory of the Czech Republic (and which in turn may resell or transfer personal protective equipment only to the state or other state suppliers). The restrictions continue to evolve rapidly, and an initial exception allowing for sales to hospitals and healthcare and social care providers has been removed in the most recent restrictions.
In France, the Government has requisitioned stocks of FFP2 respiratory protection masks held by any public and private legal entities, as well as stocks of anti-projection masks (surgical masks) held by distributors or manufacturers of these products (under Decree No. 2020-190, dated 3 March 2020). FFP2 type masks, as well as respiratory masks, produced between the publication of the decree (4 March 2020) and 31 May 2020 have also requisitioned.
Poland adopted measures on 5 March, limiting export and intra-community transfer from the territory of Poland of medicinal products and medical equipment that may become unavailable on the Polish market. These include (amongst others) medicinal products used against flu, as well as other medical equipment, including masks, injection needles, medical caps, surgical gowns, and other surgical garments. Export of these products is allowed only subject to the consent of the Main Pharmaceutical Inspector.
German intra-EU transfer restrictions by governmental Decree (Anordnung) of 12 March 2020
In Germany, the restrictive measures adopted in response to the Coronavirus crisis were so far limited to export restrictions for medical equipment. A general decree issued on 4 March 2020, and updated on 12 March 2020, prohibited the export and intra-EU transfer of specific type of medicinal protective gear (transits of the goods listed through Germany continue to be allowed). The decree has been repealed on 19 March 2020, but may be reinstated anytime according to the German government. Companies have to apply for export licences under the EU Implementing Regulation through domestic authorities.
The adoption of Implementing Regulation (EU) 2020/402 by the Commission of 14 March 2020 had not changed the continued existence of the German governmental Decree of 12 March 2020 until 19 March 2020. The EU Implementing Regulation takes precedence over any overlapping national export restrictions due to the primacy of European law. To the extent that the national Decree contained provisions going beyond the EU Implementing Regulation, such as the ban on intra-EU transfers, it continued to apply. Exports of medical protective equipment were thus restricted on the basis of the EU Implementing Regulation, while the transfer of medical protective equipment from out of Germany was restricted based on the national Decree.
The German government had amended the national Decree on 12 March 2020 so as to exempt specific exports and transfers from the prohibition and to provide for a licensing procedure based on specific exceptional grounds. Since, the intra-EU transfer of gear by persons for their personal use and by medical personnel for their professional use inter alia is exempt from the restrictions as a whole. Based on the Decree, companies could apply for a transfer licence if the domestic demand of the medical goods was satisfied. A licence could be granted inter alia where necessary for the maintenance of the business operations of foreign subsidiaries of companies based in Germany, and where the lack of supplies was below vital demands in another EU or EFTA country with a view to protecting the health and lives of people. The decree also provided for a hardship clause, based on which the German Bundesamt für Wirtschaft und Ausfuhrkontrolle (BAFA) could grant licences in exceptional cases.
Russian export ban and export controls
Russia has introduced a temporary ban on the exportation of 17 types of medical equipment, including face masks, plastic shoe covers, gloves, surgical scrubs, gas masks, protective suits, etc., under Governmental Decree No. 223 dated 2 March 2020. The ban shall remain effective from 2 March 2020 until 1 June 2020. The ban will apply both to goods which were placed under the customs procedures prior to entering into force of Decree No. 223 and to goods whose actual export from the customs territory of Russia is carried out after the entry into force of Decree No. 223. The ban does not apply to the export of listed goods: (i) for rendering international support to the foreign states based on the decisions of the Russian Government or (ii) by the individuals for personal use.
Under the Russian export control legislation certain complicated medical equipment may also be subject to export restrictions set out under Federal law No. 183-FZ "On export control" dated 18 July 1999. For example, export of full-face protective masks, isolated laboratories, certain biological protective boxes will be subject to the license authorisation of the Federal Service for Technical and Export Control of Russia.
We will continue to monitor bans and export controls on medicines and medical supplies as governments react to the pandemic, and will provide further updates accordingly.
See original article - https://www.bakermckenzie.com/en/insight/publications/2020/03/new-eu-national-export-controls-medical-equipment