In response to the global outbreak of the COVID-19 virus, the EU and various member states have taken measures to ensure continuity of supply of personal protective equipment (PPE) and address shortages of healthcare equipment. The measures include export restrictions on certain PPE, and recommendations on changes in the conformity assessment and market surveillance procedures for PPE and medical devices. These measures are of a temporary nature, aiming to address the current public health crisis in the EU.
On Sunday 15 March 2020, the EU adopted Commission Implementing Regulation (EU) 2020/402 (the PPE Regulation) imposing restrictions on exports of certain PPE from the EU to third countries.
The PPE Regulation imposes the requirement for an export authorisation on certain categories of PPE, whether originating in the EU or not. The export restrictions cover five main categories of PPE items:
- Protective spectacles and visors of CN ex 9004 90 10 and ex 9004 90 90 with the following characteristics: protection against potentially infectious material; encircling the eyes and surroundings; compatible with different models of filtering facepiece (FFP) masks and facial masks; transparent lens; reusable (can be cleaned and disinfected) or single-use items;
- Face shields of CN ex 3926 90 97 and ex 9020 00 00 with the following characteristics: equipment for the protection of the facial area and associated mucous membranes (ex: eyes, nose, mouth) against potentially infectious material; includes a visor of transparent material; usually includes fixations to secure over the face (e.g., bands, temples); can include a mouth-nose protection equipment as described below; reusable (can be cleaned and disinfected) or disposable;
- Mouth-nose-protection equipment of CN ex 6307 90 98 and ex 9020 00 00 with the following characteristics: masks 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; can include a face shield as described above; whether or not equipped with a replaceable filter;
- Protective garments of CN ex 3926 20 00, ex 4015 90 00, ex 6113 00, ex 6114, ex 6210 10 10, 6210 10 92, ex 6210 10 98, ex 6210 20 00, ex 6210 30 00, ex 6210 40 00, ex 6210 50 00, ex 6211 32 10, ex 6211 32 90, ex 6211 33 10, ex 6211 33 90, ex 6211 39 00, ex 6211 42 10, ex 6211 42 90, ex 6211 43 10, ex 6211 43 90, ex 6211 49 00, ex 9020 00 00 with the following characteristics: garment (e.g., gown, suit) 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; and
- Gloves of CN ex 3926 20 00; 4015 11 00; ex 4015 19 00; ex 6116 10 20; ex 6116 10 80; ex 6216 00 00 with the following characteristics: gloves 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.
The export authorisation is granted by the export control competent authorities of the member State where the exporter is established. Member states' authorities must process the applications within the time specified by national law, which must not exceed 5 working days from the date all required information was submitted to the authorities.
If the exporter has the PPE concerned in member state(s) other than that where the application was made, the exporter should indicate this on the application and the member state concerned will contact the other member state(s) to provide this information. The other member state(s) must inform the member state where the application was made within 10 days if they have any objections to granting such authorisation.
The restrictions are directly applicable in all EU member states as from 15 March for an initial period of six weeks.
On 20 March, the European Commission adopted Implementing Regulation (EU) 2020/416, exempting certain destination countries from the above restrictions. As a result, the export ban does not apply to exports from the EU to the following countries and territories: Norway, Iceland, Liechtenstein, Switzerland, Andorra, San Marino, the Vatican City and the EU Overseas Territories listed in Annex II to the Treaty on the Functioning of the EU (Greenland, New Caledonia and Dependencies, French Polynesia, French Southern and Antarctic Territories, Wallis and Futuna Islands, Saint Pierre and Miquelon, Saint-Barthélemy, Aruba, Netherlands Antilles (Bonaire, Curaçao, Saba, Sint Eustatius, Sint Maarten), Anguilla, Cayman Islands, Falkland Islands, South Georgia and the South Sandwich Islands, Montserrat, Pitcairn, Saint Helena and Dependencies, British Antarctic Territory, British Indian Ocean Territory, Turks and Caicos Islands, British Virgin Islands, and Bermuda).
The World Customs Organisation published a reference guide for HS classification reference for Covid-19 medical supplies.
Placing on the EU market
Additionally, the European Commission published recommendations concerning conformity assessment and market surveillance procedures, aiming at ensuring availability of PPE and medical devices for adequate protection in the EU to respond to the COVID-19 outbreak. Although not legally binding, the recommendations call on companies to take all measures at their disposal to support all efforts to respond to the COVID-19 outbreak, while ensuring an adequate level of protection of all users' health and safety.
The recommendations include the following steps:
- Notified bodies conducting conformity assessments within the scope of Regulation (EU) 2016/425 on PPE should prioritise the conformity assessment activities of all newly submitted requests for PPE necessary for protection in the COVID-19 context. With respect to medical devices, the European Commission recalls the possibility for member states to authorise derogations from conformity assessment procedures when the intervention of a notified body is not required, such as for Class I medical devices.
- Relevant market surveillance authorities in EU member states should focus, as a matter of priority, on non-compliant PPE or medical devices raising serious risks to the health and safety of their intended users.
- Where market surveillance authorities find that PPE or medical devices ensure an adequate level of health and safety in accordance with the essential requirements provided in the applicable legislations, they may authorise the release of these products on the EU market, even if the conformity assessment procedures, including affixing the CE marking, have not been fully completed. Such making available on the EU market would be for a limited period of time and while such procedures are being carried out.
- PPE or medical devices not bearing the CE marking may be assessed and be part of a purchased by the relevant member state authorities, so long as such products are made available only to healthcare workers for the duration of the current health crisis.
Market surveillance authorities should inform the European Commission and other EU member states of any temporary measures granted to PPE or medical devices.
Key member states' measures
Further, certain member states have adopted national measures and restrictions with respect to PPE items, as follows:
- Belgium: On 25 March 2020, the Belgian federal government published the Royal Decree of 24 March 2020 regarding special measures to combat drug shortages in the context of the SARS-CoV-2 pandemic. The Royal Decree provides that the Minister of Health may adopt measures which are necessary and proportionate to combat the SARS-CoV-2 virus, to contain the spread of the SARS-CoV-2 virus, or to limit the consequences of the SARS-CoV-2 virus. According to Article 4 of the Royal Decree, the Minister of Health may, for example, adopt measures to restrict or prohibit the export of a drug or raw material. The Minister of Health may also requisition stocks of a drug or raw material for redistribution or order that stocks of medicinal products held by wholesalers may only be sold or delivered in accordance with instructions of the Belgian Federal Agency for Medicines and Health Products (AFMPS).
- France adopted on 3 March 2020 exceptional measures through Decree no. 2020-190 allowing the Government to requisition stocks FFP2 face masks held in France, and of projection masks held by companies that are manufacturing or producing those items. Further, Decree no. 2020-247 of 13 March extended the requisition to other types of masks (FFP2, FFP3, N95, N99, N100, P95, P99, P100, R95, R99, R100 masks as well as anti-projection masks). The requisition covers stocks of anti-projection masks (surgical masks) held by distributors or manufacturers of those products for key health workers and those suffering from COVID-19. The measures will be in place until 31 May 2020.
- Germany had imposed a ban on all exports of PPE from Germany to non-EU states, as well as all transfers to EU and EFTA states on 4 March, through Ordinance BAnz AT 04.03.2020 B1. Transfers through Germany remained unaffected. Upon intervention of other European states, the ordinance was amended on 12 March to allow transfers to EU and EFTA states in urgent cases subject to export authorisations. Covered PPE included safety glasses and visors, face shields made of clear plastic, respiratory masks, gloves, and protective gowns and suits. Following the adoption of the PPE Regulation, Germany lifted the ban on 19 March, but reserved the right to re-impose it if needed.
- Italy adopted Law Decree No 18 of 17 March 2020 whereby enacting exceptional measures on the expropriation or requisition, as well as on the manufacture, importation and commercialisation of protective masks and other PPE, also derogating on a temporary basis on the compliance with certain regulatory requirements. The measures include:
- Prohibition of exportation of PPE: By Order of the Presidency of the Council of Ministries (DPCM) issued on 25 February 2020, the Italian Government has prohibited the exportation of the PPE listed in the circular of the circular of the Ministry of Health prot. n. 4373 of 12 February 2020. According to that DPCM Order, companies producing or distributing PPE must communicate the number and type of available products on a daily basis. The DPCM Order has been amended in order to include in the list invasive and non-invasive ventilation medical devices. Further, the relevant acts provide that orders of PPE from the Civil Protection Department must take absolute priority. The measures also provide for the possibility to exempt imported PPE items from customs duties and VAT. The DPCM Order has been recently implemented by the Italian Customs Agency with the Note No. 93201/RU of 17 March 2020. Special regulations apply to customs clearance of surgical masks to be used as PPE and other goods, including instruments and apparatus intended for medical research, medical diagnoses or medical treatment that are donated either by a charitable or philanthropic organisation or by a private individual to health authorities, hospital departments or medical research institutions;
- The possibility for the Head of the Civil Protection Department to confiscate from any public or private entity medical products or other goods of any kind, to the extent needed to face the COVID-19 emergency for the supply to the hospitals and healthcare facilities located in the national territory, as well as for increasing the number of beds dedicated to the assistance of COVID-19 patients. The measure is intended to last for a maximum of 6 months or the end of the emergency (without prejudice to prolongation);
- The possibility for manufacturers and importers of surgical masks to derogate from compliance with the medical devices regulation, by submitting to the Istituto Superiore di Sanità (ISS) a self-certification that the surgical mask's technical characteristics comply with all the safety and quality requirements set out in current legislation, which must be assessed within 3 days. The same procedure applies for PPE, where the submissions and the clearance is performed by the Istituto Nazionale Assicurazione Infortuni sul Lavoro (INAIL). If the surgical masks or PPE are found to be non-compliant, the manufacturer and importer shall immediately cease the manufacture and commercialisation. Within the national territory, it is allowed to use filtering masks without CE mark in derogation to the regulatory requirements for such products.
- Spain: Pursuant to the Royal Decree 463/2020 of 14 March, manufacturers and importers of certain PPE, such as masks, diagnostic kits and protective goggles, as well as the companies with a capacity to develop such items were required to submit information on their "available units" and "daily units" manufactured or imported by the Ministry of Health.
With respect to the UK, as of 31 January 2020 it is no longer an EU member state, pursuant to the Withdrawal Agreement concluded between the EU27 and the UK. A transition period for the complete withdrawal of the UK started on 1 February 2020 and is set to last until 31 December 2020, unless extended. EU law will continue to be applicable to and in the UK during the transition period and, as a result, the export restrictions on PPE apply to the UK as well.
The above measures reflect the situation in the EU on 24 March 2020. Companies affected by these measures should remain vigilant to any further developments.