For the second time the UK and the EU27, meaning the remaining Member States of the EU after Brexit, escaped a no-deal Brexit. After the delay of Brexit on 29 March, the EU27 approved a second delay avoiding a no-deal Brexit on 31 October 2019. The third possible Brexit date is 31 January 2020. Although the UK and EU27 reached an agreement on the conditions for Brexit, a no-deal Brexit is still possible because the agreement has not yet been approved by the European and British parliament. With the general elections in the UK on 12 December 2019, there is still a lot of uncertainty. In case of a no-deal Brexit, EU law will no longer apply to the UK and there will be no transition period. Therefore, it is important to monitor the developments closely and to stay prepared for the consequences of a no-deal Brexit.

This article gives an overview of the status of the preparations for a no-deal Brexit by the Dutch government in the Dutch healthcare sector. In particular, the identification of dependencies of the Netherlands upon the UK, the legal instruments in the event of shortages, customs, the expanding capacity of relevant organizations, the actions taken to inform the sector, and the partnerships are discussed.

 

The consequences of a no-deal Brexit for the European healthcare sector

In the event of a no-deal Brexit, all existing agreements concerning medical devices and in-vitro diagnostics (IVDs) in all classifications that are included in the European legislation will expire on the date of the withdrawal. The UK-notified bodies and the Medicines & Healthcare products Regulatory Agency will no longer be recognized by the EU. As a result, the certificates issued by the UK-notified bodies will become invalid.

Furthermore, as from the withdrawal date, manufacturers located in the UK will not be able to place their (medical) products on the European market directly. Such manufactures need to appoint an authorized representative in one of the EU27 countries. The medical devices and IVDs entering the EU27 market from a UK-based manufacturer for the first time after the withdrawal date will be qualified as imported goods. This means that the WTO tariffs and quotas will be applicable to those products.

Moreover, Brexit will have consequences for the marketing authorization and the placing on the EU market of medical devices and IVDs that are produced in the UK. In the event that the medical devices or IVDs have not been placed on the EU market before the withdrawal date, such medical devices will be considered imported goods from a third country and, therefore, must comply with the European legislation applicable to imports. Consequently, where a CE mark has been applied to the device as a result of the conformity assessment carried out by the British notified body, such device will need to be marked again by a European notified body in order to comply with the European legislation.

Once the UK leaves the EU, the UK will no longer be part of the European medicines regulatory network working closely together with the European Commission and the European Medicines Agency. In order to market a medicine in the EU, the marketing authorization holder must be based in the European Economic Area. Therefore, as of the withdrawal date, the European Marketing Authorizations held by UK companies must be transferred to an EU-based company.

 

The Netherlands' preparations for a no-deal Brexit

The Dutch government considers it the sector's own responsibility to take the necessary measures to prepare for the consequences of a no-deal Brexit. The government emphasizes that preparations are necessary in any event, including if the UK and the EU succeed in making a deal. To support the sector in making itself ready for Brexit, different governmental bodies have organized meetings and seminars to inform the sector about the necessary precautions.

The Ministry of Health, Welfare and Sport ("VWS Ministry") worked together with the Dutch Healthcare Inspectorate (IGJ), the Dutch Medicines Evaluation Agency (CBG) and the Dutch Central Committee on Research Involving Human Subjects (CCMO) to draft a contingency plan for the Netherlands. The purpose of the contingency plan is to avoid and to mitigate the possible negative consequences of a no-deal scenario with regard to medicines, medical devices, medical research and body materials. The plan's core activities are described below.

Identifying dependencies of the Netherlands upon the UK

The Netherlands carried out research of potential dependencies of the Netherlands upon the UK in order to prepare alternatives to avoid shortages.

Commissioned by the Dutch government, Ernst and Young reported last year on all medicines with a license holder in the UK and/or medicines that are tested in UK labs. Based on this report, the CBG made a list with 50 'critical medicines' consisting of medicines used by patients with a life threatening decease and/or patients in a vulnerable position due to unavailable alternatives. This list is classified to prevent hoarding. The Dutch government contacted the license holders of these medicines to discuss the presence of an authorized representative in an EU27 country. By now, more and more license holders have registered in the EU and the Dutch government has an action plan available for the remaining critical medicines.

Occasionally, the Dutch government and license holders discussed the precautionary measure to keep more stock in trade. However, in general the Dutch government strongly discourages care institutions and pharmacies from doing the same because it could cause shortages instead of solving them.

The VWS Ministry requested the National Institute of Public Health and Environmental Protection (RIVM) to report with regard to medical devices and IVDs. Due to the number and diversity of products, it has been impossible to prepare an overview with critical devices/diagnostics. Therefore, the Dutch government cannot determine the risk of shortage of specific devices/diagnostics. The RIVM provided care institutions with indicators they can use to determine which devices/diagnostics they should monitor closely, for example, dedicated consumables that are supplied via or from the UK. For those products, care institutions should identify the British-notified body and assess the risk taking into account the turnover ratio, expiry date and already incurred delays.

Legal instruments in the event of shortages

In the event of medicine shortage, the IGJ has the authority to grant dispensation for importing medicines from third countries or to accept alternative medicines. Furthermore, based on the Dutch Medicines Act, the CBG is authorized to temporarily admit medicines without EU or Dutch market authorization on the Dutch market for public health reasons if these medicines are admitted in another member state. Another instrument in the event of shortage is to make use of pharmaceutical compounding and controlled delivery. Furthermore, the government agreed with distributors that medicines will not be exported in the event of shortages.

British-notified bodies that are affiliated with notified bodies based in EU27 countries, such as the British Standards Institution and UL International, have already transferred most certificates. It is expected that the remaining British notified bodies will not transfer all certificates before Brexit. SGS UK cannot transfer all certificates because the affiliated company, SGS Belgium, does not possess sufficient expertise in all product groups. Lloyd's Register Quality Assurance (LRQA) has terminated its medical devices/IVDs section. This means that all certificates must be transferred to other notified bodies in EU27 countries. The Dutch government advises Dutch distributors and care institutions to pro-actively contact manufacturers with certificates from LRQA about the process. With regard to British medical devices, the Dutch Minister of Medical Care asked the Dutch-notified bodies to consider the patients' interests in its assessment and to give priority to medical devices in case of shortages in so far as necessary. The Dutch Minister of Medical Care regularly discusses potential bottlenecks with the notified bodies and places them on the EU agenda if necessary.

The manufacturers of medical devices or IVDs with a British CE certificate that applied for a CE certificate in an EU27 country can apply for an exemption under article 8 Medical Devices Act if the CE certificate is not yet granted at the moment of a no-deal Brexit. Such exemption allows the manufacturer 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 (https://english.farmatec.nl/exemption-notification-brexit). Manufacturers can only apply for an exemption under extraordinary circumstances, which is the case if — in case of a no-deal scenario — alternatives are unavailable and the continuation of medical care is at risk.

The Dutch government is of the opinion that exemptions on a Member-State level will result in differences in procedures, conditions and duration. This could create an unclear and potentially market-distorting situation. Therefore, the Dutch government urges the EU to arrange for a common approach on an EU level.

Customs

Dutch ports, under the name 'Portbase', have launched an online customs system called the 'Port Community System' (https://www.portbase.com/en/brexit/). The system enables everyone in the logistics chain to exchange information with each other and with governmental agencies in an efficient way. With this system, logistics parties can process documents digitally, avoiding physical border controls. In that way, transporters will hardly experience differences at the border after a no-deal Brexit.

To avoid shortages due to logistic hurdles or other border issues, customs will not detain medicines, medical devices or IVDs in case of problems with the declaration. The IGJ and customs concluded arrangements about contact in case of potential issues.

The Dutch government is also exploring unconventional measures like alternative transportation or the use of emergency services should standard transport routes be disturbed.

Expanding capacity of relevant organizations

With regard to medicine assessments, the Netherlands has set aside EUR 10 million to ensure that sufficient knowledge and capacity is available in the EU27 to offset the UK's departure.

The IGJ, CBG and CCMO hired extra employees to expand their capacity. According to the Dutch Minister of Medical Care, it is difficult to estimate the capacity need because this will depend on the number of manufacturers and distributors who will set up business in the Netherlands, additional product registrations in the Netherlands and the establishment of more notified bodies in the Netherlands due to Brexit. Furthermore, customs will expand their capacity by 928 FTE.

Informing the sector

VWS Ministry, IGJ, CBG and CCMO organize Brexit meetings and seminars to inform the sector about the status, preparations and actions. During these events they urge the sector to give substance to their own responsibility to prepare for Brexit. Furthermore, the Dutch government publishes informative documents on individual topics about potential bottlenecks, questions and requirements. In this respect, the government established the website 'Brexit Loket' (https://www.brexitloket.nl/onderwerpen/gezondheidszorg) and developed a 'Brexit Impact Scan' (https://rvo.regelhulpenvoorbedrijven.nl/brexitimpactscan/#/welkom).

Partnerships

Last of all, the Dutch government concludes partnerships to prepare for a no-deal Brexit. Representatives of VWS Ministry, CBG, IGJ and RIVM attend weekly meetings about Brexit and discuss daily if necessary. The Dutch government incorporated a coordination structure of an operational team of experts and senior decision-makers with representatives from the IGJ, CBG and CCMO in order to take immediate action if necessary after Brexit. Moreover, the VWS Ministry is part of the Coordination Unit for Contingency and Preparedness (CECP) of the Ministry of Foreign Affairs. The full-time task of the CECP is to prepare the Netherlands for a no-deal Brexit and the new relationship with the UK.

Conclusion

A no-deal Brexit will have a significant impact on the healthcare sector. The Brexit delays offer governments and the sector extra time to prepare. In order to support the Dutch healthcare sector and to mitigate any serious disruption, the Dutch government has made certain preparations. By informing the sector and concluding partnerships, the Dutch government, IGJ, CBG and CCMO aim to prepare the Dutch healthcare sector for a possible no-deal Brexit. The capacity of relevant organizations in the healthcare sector has been expanded. Under Dutch law, IGJ, CBG and other regulatory bodies have certain legal instruments to prevent the Dutch healthcare sector from medicine shortages. Furthermore, the IGJ and customs have concluded arrangements to avoid shortages in medicines, medical devices or IVDs.