Changing world, changing rules?

In light of the outbreak of the coronavirus, the European Union (“EU”) and the United Kingdom (“UK”) published legislation and guidance. In the Netherlands, the Dutch Minister of Health, Welfare and Sport (“HWS”) is concerned about (possible) (temporary) export bans of China and India. Another major concern of the Dutch government is the availability of personal protective equipment (“PPE”), especially mouth masks. This, and more, in this newsletter.

Coronavirus: EU & UK

The EU has published legislation and guidance in respect of the Corona outbreak. The Official Journal of the EU of 20 March 2020 contained a Guidance note related to the implementation by member states of EU-Regulation 2020/402 making the exportation of certain products subject to the production of an export authorisation. On 1 April 2020 the EU published an overview with frequently asked questions regarding the requirements for PPE. On 3 April 2020[1] the EU announced that sanctions should not impede the delivery of essential equipment and supplies necessary to fight the coronavirus and limit its spread worldwide. The same day – 3 April 2020 – the EU published a press release with the message the European Commission postponed the application of the Medical Devices Regulation until 26 May 2021, to prioritise the fight against coronavirus. The Official Journal of the EU of 8 April 2020 included Guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak. Also in the UK the government published legislation and guidance.

Coronavirus: the Netherlands

On 31 March 2020 the Dutch Minister of HWS – Hugo de Jonge – sent a letter to the Speaker of the Dutch House of Representatives. In this letter the minister provided the House of Representatives an update on the state of affairs regarding the corona crisis.

The Dutch minister said in the letter that specific attention is paid to international market developments, such as the situation in India and China and the effect of these developments on Dutch drug supply. The minister found the situation in India worrying, because of (possible) (temporary) export bans and transport problems. The Dutch government is focussed now on the continuity of supply.

One of the major concerns of the Dutch government is the availability of PPE. The minister of HWS is working closely together with the Dutch ‘Landelijk Consortium Hulpmiddelen’ (“LCH”), the National Consortium Resources, and is doing [quote] “everything in my power” to arrange that there will be sufficient PPE available in the Netherlands. The LCH is estimating the expected demand for FFP2 masks about 4.5 million units per week. The expected demand for surgical masks is about 8 million a week. The minister explained in its letter that due to the shortage of mouth masks, not all mouth masks that become available are provided of a CE certificate issued by a European notified body. Some countries have different test standards than Europe. European Recommendation 2020/403 gave the option of temporarily serving healthcare workers non-CE marked personal protective equipment on the European market after assessment of the essential requirements by the national market surveillance authority. The crucial parameters that are tested on, in particular the stopping of particles, are equivalent. The Dutch government announced by press release of 23 March 2020 that the standards for mouth masks from China and the United States (“US”) are equivalent to European standards. The LCH briefed the minister about an order of 30 million mouth masks (FFP2). However, the minister emphasized that what has been ordered not always matches what is also supplied.

Both the Dutch Health and Youth Inspection, which is the authority on medical devices, and the Dutch Social Security and Employment Inspection, which is the authority on PPE, have provided for lenience in respect of market admission of medical devices and PPE necessary for the treatment of corona patients. This includes medical devices such as chirurgical mouth masks and FFP1-, FFP2- and FFP3-mouth nose masks. 

The requirements differ for medical devices and PPE:

– Medical devices that do not have the required CE marking can be provided to individual healthcare institutions, i.e. hospitals and clinics, provided that no similar CE marked equipment is available to the healthcare institution anymore and the healthcare institution has explicitly requested the alternative equipment. The healthcare institution will remain responsible for the use of the devices. In respect of the provision of low-risk (class I) medical devices, the manufacturer does not have to report to the Health and Youth Inspection. In respect of the provision of higher risk devices (class IIa/b and class III), a prior notification by the manufacturer to the authorities is required.

– The marketing of non-CE marked personal respiratory protective equipment (and other PPE) is temporarily permitted by the Dutch Social Security and Employment Inspection as well, under certain conditions, which basically require that the equipment must comply with the general standards, as usual, with the only exception that no CE marking is required. To this end, the Inspection has set up the LCH on PPE, which consortium collectively screens, purchases and distributes all PPE on behalf of all Dutch healthcare institutions. The process is as follows: the proposal for the provision of the PPE must be submitted via this e-mail address:, after which the consortium will assess the product and, if approved, the products will be purchased centrally by the consortium and distributed throughout the Netherlands.

Extensions of sanctions by EU & US

With Council Decision 2020/435 the EU renewed its Bosnia and Herzegovina sanctions for 1 year until 31 March 2021. On 30 March 2020 the US renewed the sanctions against those engaging in “malicious cyber‑enabled activities originating from, or directed by persons located, in whole or in substantial part, outside the United States”. On 1 April 2020 the US published a notice on the continuation of the national emergency with respect to Sudan and renewed its sanctions against the country for one year. Two days later, on 3 April 2020, the US published a similar notice with regard to on the continuation of the national emergency with respect to Somalia and renews its sanctions against the country for a year. The EU-sanctions against Libya were renewed for a period of six months, until 2 October 2020 (Council Decision 2020/458). In the same period when the EU announced the extensions of its Libya sanctions, the EU launched Operation IRINI to enforce the Libya arms embargo (Press Release EU, 31 March 2020). That same day – 31 March 2020 – the EU High Representative for Foreign Affairs and Security Policy, Josep Borrell, said that the main aim of Operation IRINI is to enforce the UN arms embargo. The goal of Operation IRINI is to stop the flow of arms to Libya and contribute to a sustainable ceasefire; the operation will deploy naval, aerial and satellite assets.

U.S. Sanctions Priorities and Approach in 2020

On 9 March 2020, David Peyman, the Deputy Assistant Secretary of State for Counter Threat Finance and Sanctions discussed in an interview the US government sanctions priorities and approach in 2020. During this interview, Peyman announced notable developments in several significant areas, such as the publication of a Global Maritime Sanctions Advisory in April 2020. The US wants to increase compliance obligations for the maritime sector. The US will impose an enhanced government sanctions compliance guidance for the US and non-US maritime industry in April 2020.

If you want more information regarding one of the topics of this newsletter, you can contact BenninkAmar Advocaten at: +31 (0)20 308 5918 or

[1], accessed on 9 April 2020.

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