Trade Controls in the EU: COVID-19 Measures at a Glance - Jones Day
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
WHITE PAPER May 2020 Trade Controls in the EU: COVID-19 Measures at a Glance In response to the novel coronavirus (“COVID-19”) pandemic, the European Union (“EU”), various Member States and the United Kingdom have adopted trade control mea- sures aimed at avoiding shortages and ensuring the availability and quality of certain essential medicines and medical equipment. Specifically, at the EU level, the European Commission adopted a Regulation making the export of certain products subject to an export authorisation. The Member States have implemented this export licensing require- ment, as well as the United Kingdom. In addition, a number of Member States have introduced further trade control measures on an individual basis, including export bans, notification requirements for exports, import requirements to ensure product safety and the power to seize goods.
TABLE OF CONTENTS
EU 1
Belgium 1
France 3
Germany 3
Italy 4
The Netherlands 5
Spain 5
United Kingdom 6
Lawyer Contacts 6
Jones Day White PaperEU
Regulatory /
Legislative Measure Type of Measure Product Scope Competent Authority Application Form
Commission Implementing Export restriction: Protective Personal Competent Member Yes. The license
Regulation (EU) 2020/568 Equipment (“PPE”): State Authority application is contained
• Licensing requirement
of 23 April 2020 making in Annex II to the
• Protective spectacles
the exportation of certain Regulation
and visors
products subject to the
production of an export • Mouth-nose-protection
authorisation equipment
• Protective garments
BELGIUM
Regulatory /
Legislative Measure Type of Measure Product Scope Competent Authority Application Form
Commission Implementing Export restriction: PPE: Belgian Federal Ministry Yes. License application
Regulation (EU) 2020/568 of Economy available (in French):
• Licensing requirement • Protective spectacles
of 23 April 2020 making https://economie.fgov.
and visors
the exportation of certain be/fr/themes/politique-
products subject to the • Mouth-nose-protection commerciale/licences/
production of an export equipment licence-dexportation-de
authorisation • Protective garments
Ministerial decree on Inter alia, export ban to PPE and Belgian Federal Ministry N/A
special measures in the non-EU third countries medical devices: of Economy
context of the SARS-
Inter alia, potential • Surgical masks
CoV-2 pandemic, based
export restrictions • Screening material
on Chapter XVIII of the
to EU countries • Disinfectant wipes for
Economic Law Code
medical use
(In French):
• Ventilation equipment
• Arrêté ministériel and related aids and
portant des mesures accessories
particulières • Single use blood
• dans le cadre la pressure cuffs
pandémie de SRAS- • Self-adhesive ECG
CoV-2 basées sur le electrodes
• livre XVIII du Code de • Tools used for
droit économique bronchoalveolar lavage
• Aerosolization chamber
and disposable
bronchoscope mask
• FFP2 masks
• FFP3 masks
• Protective aprons,
permeable or not
• Protective
glasses and masks
• Gloves (nitrile),
long sleeve, at
least 300 mm
• 12% hydrogen
perioxide and
nebulizers (nocospray)
contined on next page
Jones Day White Paper
1Regulatory /
Legislative Measure Type of Measure Product Scope Competent Authority Application Form
Royal Decree of 24 March Export restriction: Certain medicines and Belgian Federal Agency Notification to be
2020 on special measures raw materials, as listed for Medicines and sent by email to:
to combat the shortage of • Notification in the Annex to the Health Products coronashortages@
requirement for sales
medicines in the context of Decision of the FAMHP fagg-afmps.be
within the European
the SARS-CoV-2 pandemic
Economic Area (“EEA”)
(In French): • Notification
requirement with
• Arrêté royal du 24 mars
potential refusal for
2020 relative à des
exports outside the
mesures spéciales de
EEA
lutte contre la pénurie
de médicaments dans le
contexte de la pandémie
de SARS-CoV-2
• Implementing measure:
• Decision of the Federal
Agency for Medicines
and Health Products
(“FAMHP”) General
Administrator on various
urgent measures
concerning specific
medicines to combat the
shortage of medicines
in the context of the
SARS-CoV-2 pandemic,
as amended
(In French):
• Décision de
l’Administrateur général
de l’AFMPS relative
à diverses mesures
urgentes concernant
des médicaments
spécifiques pour lutter
contre la pénurie de
médicaments dans le
contexte de la pandémie
de SARS-CoV-2
• Décision de
l’Administrateur général
de l’AFMPS modifiant
les diverses mesures
urgentes concernant
des médicaments
spécifiques pour lutter
contre la pénurie de
médicaments dans le
contexte de la pandémie
de SARS-CoV-2
Jones Day White Paper
2FRANCE
Regulatory /
Legislative Measure Type of Measure Product Scope Competent Authority Application Form
Commission Implementing Export restriction: PPE: French Economy Yes. License application
Regulation (EU) 2020/568 Ministry, specifically available (in French) at:
• Licensing requirement • Protective spectacles
of 23 April 2020 making French customs: dual https://sbdu.entreprises.
and visors
the exportation of certain use division (services gouv.fr/fr/actualites/
products subject to the • Mouth-nose-protection des biens à double covid-19-autorisations-
production of an export equipment usage (“SBDU”) d-exportation-des-biens-
authorisation • Protective garments de-protection-medicale
See also Advice to the
Operator (NOR: ECO I
2008235) (in French):
https://sbdu.entreprises.
gouv.fr/files_sbdu/files/
actualites/avis_aux_
operateurs_export.pdf
Decree n° 2020-314 of Export ban outside the Medicines: French Health Ministry N/A
25 March 2020 modifying French national territory
• Pharmaceutical
Decree n° 2020-293 of (ban does not apply
specialties containing
23 March 2020 to any French oversea
the association of
territory including New
lopinavir/ ritonavir or
Caledonia)
hydroxychloroquine
GERMANY
Regulatory /
Legislative Measure Type of Measure Product Scope Competent Authority Application Form
Commission Implementing Export restriction: PPE: The Federal Ministry for
Applications can be
Regulation (EU) 2020/568 Economic Affairs andsubmitted via the
• Licensing requirement • Protective spectacles
of 23 April 2020 making Energy (“BMWi”) is the
ELAN-K2 Export Portal.
and visors
the exportation of certain competent ministry. Further information
products subject to the • Mouth-nose-protection and the application
equipment The Federal Office for
production of an export form are available at:
• Protective garments Economic Affairs and
authorisation https://www.bafa.de/
Export Control (“BAFA”) DE/Aussenwirtschaft/
is the competent agency Ausfuhrkontrolle/
for issuance of export Coronavirus_
licenses for medical Schutzausruestung/
and personal protective coronavirus_
equipment. schutzausruestung_
node.html;jsessionid=3B
0CE54C0F1B06F9A5D80
9E33E9760CB.1_cid387
Export ban-related
questions can be sent
to: schutzausruestung@
bafa.bund.de
Order of the Federal Withdrawal of previous
Ministry of Economics and national export ban.
Technology (“BMWi”) of Thus, currently, no
19 March 2020 (BAnz AT coronavirus-related
19.03.2020 B11), vgl. https:// national bans on the
www.bmwi.de/Redaktion/ export and movement
DE/Downloads/B/ of medical protective
bundesanzeiger- equipment.
aufhebung-
Only the EU export ban
beschraenkungen.
applies (see above).
pdf?__blob=
publicationFile&v=4
Jones Day White Paper
3ITALY
Regulatory /
Legislative Measure Type of Measure Product Scope Competent Authority Application Form
Commission Implementing Export restriction: PPE: Italian Ministry of N/A
Regulation (EU) 2020/568 Foreign Affairs, DG of
• Licensing requirement • Protective spectacles
of 23 April 2020 making the European Union,
and visors
the exportation of certain Unit X Markets Access
products subject to the • Mouth-nose-protection and Trade Defence, Ms.
production of an export equipment Gabriella De Stradis
authorisation • Protective garments
E-mail: dgue10@esteri.it
(Ministero degli
affari esteri e della
cooperazione
internazionale, DG per
la Politica commerciale,
Ufficio X Accesso ai
mercati esteri e difesa
commerciale)
Order of the Head of Export restriction: PPE: Presidency of the N/A
the Department of Council of Ministers:
• Licensing requirement • Protective spectacles
Civil Protection No 639
• Power to seize and visors • Department of Civil
of 25 February 2020;
concerned goods • Mouth-nose-protection Protection
Note of the Ministry of
Health Number No 4373 equipment at least
of 12 February 2020; of type FFP2
and Note of the Italian • Protective garment
Customs No 93201/RU type Tychem C
of 17 March 2020 • Gloves
Law Decree No 18 of Power to seize Any type of product Presidency of the N/A
17 March 2020, Article 6 concerned goods necessary to address Council of Ministers:
the COVID-19 emergency
• Department of Civil
Protection
Jones Day White Paper
4THE NETHERLANDS
Regulatory /
Legislative Measure Type of Measure Product Scope Competent Authority Application Form
Commission Implementing Export restriction: PPE: The Health and Youth Yes. License application
Regulation (EU) 2020/568 Care Inspectorate available (in Dutch)
• Licensing requirement • Protective spectacles
of 23 April 2020 making (Inspectie Gezondheids at: https://www.
and visors
the exportation of certain org en Jeugd) is the belastingdienst.nl/
products subject to the • Mouth-nose-protection competent authority wps/wcm/connect/
production of an export equipment under Article 1(1) of bldcontentnl/
authorisation • Protective garments Regulation 2020/402. berichten/nieuws/
douane/aanvraag-
License applications are uitvoervergunning-
processed by Customs persoonlijke-
Central Import and beschermingsmiddelen-
Export Office (“CDIU”) beschikbaar
(Centrale Dienst In- en
Uitvoer). Applications
are submitted by
email to the CDIU at:
douane.dgr.cdiu.pbm@
belastingdienst.nl
SPAIN
Regulatory /
Legislative Measure Type of Measure Product Scope Competent Authority Application Form
Commission Implementing Export restriction: PPE: Subdirección General Yes. The model export
Regulation (EU) 2020/568 de Comercio de license form is set out
• Licensing requirement • Protective spectacles
of 23 April 2020 making Mercancías de la in Annex II to Regulation
and visors
the exportation of certain Dirección de Política 2020/402.
products subject to the • Mouth-nose-protection Comercial del Ministerio
equipment A sworn statement may
production of an export de Industria, Comercio
• Protective garments also be presented by
authorisation y Turismo
the exporter that the
License applications are goods concerned are
submitted by email to: not included in Annex I
vigilanciasiderurgica@ of the EU Regulation No
mincotur.es 2020/402. This negative
declaration should be
indicated by code Y975
in box 44 of the SAD.
Order SND/233/2020, There is no restriction on PPE and Diagnostics: Spanish The obligation to send
15 March, establishing the export or import of Ministry of Health information under this
certain information the concerned products. • Mouth-nose-protection Order shall be fulfilled
equipment
obligations in accordance by the reporting parties
However, there is an • COVID-19 diagnostic
with the provisions of completing the model
obligation to submit PCR kits and their
Royal Decree 463/2020, declaration in the Annex
information to the consumables
of 14 March, declaring of the Order.
Spanish Ministry • Swabs
the state of alert for the
of Health on the This form shall be
management of the health • Protective glasses
possession of medical available on the website
crisis situation caused
equipment and devices. • Nitrile gloves, with and of the Ministry of Health.
by COVID-19 without powder
• Disposable and
waterproof gowns
• Hydroalcoholic solution
• Invasive mechanical
ventilation
(“VMI”) devices
• Sanitary alcohols
• Chlorhexidine
Jones Day White Paper
5UNITED KINGDOM
(UK Guidance Update 29 April 2020)
Regulatory /
Legislative Measure Type of Measure Product Scope Competent Authority Application Form
The UK Government Export restriction: PPE: Department of Health Yes. License application
has implemented and Social Care available at: https://www.
Commission Implementing • Licensing requirement • Protective spectacles gov.uk/government/
and visors
Regulation (EU) 2020/568 publications/
of 23 April 2020 making • Mouth-nose-protection personal-protective-
the exportation of certain equipment equipment-ppe-export-
products subject to the • Protective garments control-process/
production of an export personal-protective-
authorisation equipment-ppe-export-
control-process
LAWYER CONTACTS
Renato Antonini Armelle Sandrin-Deforge Javier Moya
Brussels Paris Madrid
+32.2.645.14.19 +33.1.56.59.39.47 +34.91.520.3959
rantonini@jonesday.com asandrindeforge@jonesday.com jmoya@jonesday.com
Cristiana Spontoni Holger Neumann Rick van ’t Hullenaar
Brussels Frankfurt Amsterdam
+32.2.645.14.48 +49.69.9726.3939 +31.20.305.4223
cspontoni@jonesday.com hneumann@jonesday.com rvanthullenaar@jonesday.com
Eva Monard Christian B. Fulda Byron Maniatis, an associate in the
Brussels Munich Brussels Office and Martin J. Wortmann,
+32.2.645.15.10 +49.89.20.60.42.200 an associate in the Frankfurt Office,
emonard@jonesday.com cfulda@jonesday.com contributed in the preparation of this
White Paper.
Jones Day publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general
information purposes only and may not be quoted or referred to in any other publication or proceeding without the prior written consent of the
Firm, to be given or withheld at our discretion. To request reprint permission for any of our publications, please use our “Contact Us” form, which
can be found on our website at www.jonesday.com. The mailing of this publication is not intended to create, and receipt of it does not constitute,
an attorney-client relationship. The views set forth herein are the personal views of the authors and do not necessarily reflect those of the Firm.
© 2020 Jones Day. All rights reserved. Printed in the U.S.A.You can also read
