In response to COVID-19 emergency, the Commission has taken first measures to protect the availability of supplies of personal protective equipment , by adopting an Implementing Regulation foreseeing that exports of such equipment outside of the European Union shall be subject to an export authorisation by Member States.
In the context of the COVID-19 epidemiological crisis, demand for personal protective equipment (“PPE”) has increased significantly and is expected to continue increasing in the near future, with related shortages occurring in several Member States. Production of PPE, such as mouth-protection masks, in the Union is indeed concentrated in a limited number of Member States, and despite efforts to increase production, the current production levels of the European Union are not sufficient to meet the relevant internal demand.
Consequently, in order to remedy and prevent a critical situation, on March 14, 2020, the Commission adopted Implementing Regulation No. 2020/402 (“Regulation”), stating that for a period of six weeks the export of these goods outside of the European Union shall be subject to an export authorization granted, within five working days, by the competent authority where the exporter is located (in Italy, the Ministry of Foreign Affairs and International Cooperation), regardless of their EU origin. If the relevant PPEs are located in one or more Member States other than the one where the application for export authorization has been filed, that shall be indicated on the application form in order to allow the competent authorities of that/those Member State(s) to assess local needs and potentially raise objections. Therefore, Member States may grant export authorizations for such products when there is no threat posed to their availability on their markets or elsewhere in the Union.
According to Article 2 of the Regulation, when deciding whether to grant an export authorization, Member States shall take into account all relevant considerations, including, where appropriate, whether the export serves, inter alia: (i) to fulfill supply obligations under a joint procurement procedure in accordance with Article 5 of Decision No. 1082/2013/EU of the European Parliament and of the Council of October 22, 2013 on serious cross-border threats to health; (ii) to support concerted support actions coordinated by the Integrated Political Crisis Response Mechanism (IPCR), the European Commission, and other Union institutions; to respond to requests for assistance from third-party countries or international organizations addressed to and handled by the UPCM (Union Civil Protection Mechanism) and to enable the provision of emergency supplies in the context of humanitarian aid; (iii) to support the statutory activities of support companies abroad that enjoy protection under the Geneva Convention, insofar as they do not impair the ability to work as a national support company; (iv) to support the activities of the World Health Organization (WHO) Global Outbreak Alert & Response Network (GOARN); and (v) to supply foreign operations of EU Member States, including military operations, international police missions, and/or civilian international peacekeeping missions, or for the supply of EU and Member State delegations abroad.
The Regulation was further amended on March 19, 2020 to exempt the export to EFTA States as well as the overseas countries and territories listed in Annex II of the Treaty and the Faroe Islands, Andorra, San Marino, and Vatican City from export authorization requirements. Finally, on March 20, 2020 the Commission also issued a Guidance note to support Member States in the implementation process.
Following the six weeks period, the Regulation has now been replaced by Implementing Regulation no. 2020/568 which entered into force on April 26, 2020 for an additional 30 days period and extends the exemption to some additional non- EU countries.
Similar measures have also been implemented in Italy by the Ministry of Health with its Circular No. 4373 of February 12, 2020 (“Circular”), which sets forth that export of specific PPE (among others, mouth-protection masks/model FFP2 and sanitary gloves) is banned absent the prior authorization of the Department of Civil Protection, requiring companies producing or distributing such products to communicate the number and type of products. Detail has been added to the Circular via Decree No. 639 of February 25, 2020 of the Civil Protection Department, which determined that prior authorization is also required for other medical devices (e.g., invasive and non-invasive ventilation tools and devices). In this last respect, on April 24, 2020 a new Order no. 667 was adopted by the Civil Protection Department excluding from the export ban invasive and non-invasive ventilation tool devices in line with products considered by the EU implementing Regulation above quoted.