31 October is fast approaching and while a hard Brexit scenario may have become less likely, governments in the EU-27 have been ramping up preparations in case the UK would leave the EU by the end of the month (or any later date) without a deal. Industry has done its own share of preparing for hard Brexit. The additional time allowed by the first extension of the Brexit deadline has meant that overall authorities and companies are now in a better place than in March 2019: However, increasing costs (aggravated by Brexit delays and continued uncertainty) and issues over grace periods for labelling changes are continuing to require the attention of industry and follow up with regulators in the relevant Member States.
The Netherlands and Belgium are particularly exposed to any hard Brexit scenario because of their historic trade relations with the UK. Here below we give a small summary of preparations that have been going on in these countries to mitigate the risks of a no deal departure:
(1) Dutch and Belgian health authorities have been working with EMA and HMA (Heads of Medicines Agencies) to put out guidance to inform marketing authorisation holders of medicines authorised in the EU about the consequences of Brexit and actions to be taken to avoid disruptions after Brexit. Separately, the competent authorities have been putting out guidance including areas such as medical devices and clinical trials.
Please find latest versions of guidance here:
- EMA: https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/brexit-related-guidance-companies HMA: https://www.hma.eu/535.html
- HMA: https://www.hma.eu/535.html
- Dutch Ministry of Health, Welfare and Sports: https://www.rijksoverheid.nl/onderwerpen/brexit/brexit-en-de-zorgsector
- Belgian FAMHP: https://www.famhp.be/en/brexit_information_for_the_professional ; https://www.famhp.be/en/brexit_information_for_the_public
As a result, all but 3 centrally authorised medicinal products were reported to be compliant in June of 2019, a 80 % of nationally authorised products are reported to be on track for compliance by 31 October. Despite the fact that it is reported that most UK certified medical devices were well on track to be transferred to EU notified bodies and progress is tracked by Member States and the European Commission the picture is however less clear for medical devices (data derived European Commission Communication on finalising Brexit preparations dd 4 September 2019 – COM(2019) 394 final).
(2) With a view to avoid shortages, Dutch and Belgian health authorities have conducted an analysis of medicines available on their markets and their dependency towards the UK. Such national efforts have been undertaken alongside European wide efforts. Special focus has been placed on critical medicines, pro-actively reaching out to marketing authorisation holders of such products to encourage contingency planning and looking into possible alternative medicines. Lists are not published to prevent hoarding but it is reported that for most products meanwhile a solution is found.
For medical devices such exercise is more challenging due to the number and wide variety of products available on the market. Instead, the authorities have been issuing recommendations to hospitals to pro-actively monitor availability of medical devices, to contact manufacturers and ask about contingency planning, contact distributors to be informed about stock levels and investigate alternatives.
(3) Both Dutch and Belgian health authorities have refrained from legally imposing stock requirements. They encourage actors such as distributors and hospitals to hold sufficient stocks to get through a first critical period but leave discretion to what that means to each actor. Any such discretion should however be considered against a background of general supply obligations that exist under national frameworks. Manufacturers, wholesalers, distributors and hospitals have privately been ramping up stocks to deal with a no deal Brexit costing the industry a fortune on warehousing. Health authorities in both the Netherlands and Belgium remain available to closely work with stakeholders for any product for which a problem may occur after Brexit.
(4) Considering the high number of medical devices that historically have been assessed by UK notified bodies and the fact that in case of hard Brexit the certificates issued by such notified bodies are no longer valid has raised real concerns about shortages of medical devices in the EU-27. Such issues are aggravated by the fact that notified body capacity is squeezed further to the transition to the new medical devices regulations requiring notified bodies to be re-accredited against more stringent regulatory requirements. This has led a number of national authorities including the Dutch authorities to publish details on an exemption regime for medical devices based on national derogations in the EU Medical Devices, Active Implantable Medical devices and Invitro Diagnostics Directives.
In the Netherlands, if a manufacturer of a medical device or IVD with a British CE certificate applied for a CE certificate in a EU27 country which is not yet granted at the moment of a no-deal Brexit, they can apply for an exemption under article 8 of the Dutch Medical Devices Act to be allowed to continue to trade their medical devices on the Dutch market. The exemption is a one-time option for a maximum period of 6 months. The manufacturer can submit an application on Farmatec’s website (http://english.farmatec.nl/exemption-notification-brexit). However, the exemption is only available under extraordinary circumstances, which is the case if – in case of a no-deal scenario – alternatives would be unavailable and the continuation of medical care is at risk.
The transparent and coherent use of such national derogations is being coordinated by the European Commission working closely with the Member States to avoid any fragmentation of the Single Market.
Significant efforts have been undertaken to mitigate the consequences on public health of a hard Brexit and further efforts are ongoing. However, preparations are not 100 % complete. Costs are rising.
Hard Brexit may not materialise at least not for now considering PM Johnson’s extension request. However, with the political situation in flux, companies remain advised to be prepared for hard Brexit and monitor developments on the political stage.