The latest government technical notice was published on 12 October. The notices promise more detailed guidance from government and arm's-length bodies in the near future, and in some cases further consultations. For example the medicines, medical devices, clinical trials paper promised a Medicines and Healthcare Products Regulatory Agency (MHRA) consultation which opened on 4 October (closing on 1 Nov). This consultation seeks views on how the MHRA legislation and regulatory processes would have to be modified in the event of no-deal, and will be followed by a more comprehensive technical note. Read the government's intentions behind the publication of the technical notices.
Papers published so far cover:
Key points: what would happen in a no-deal scenario
Supply of Investigational Medicinal Products (IMPs) for clinical trials in the event of a no-deal
- Organisations running clinical trials in the UK should consider their supply chains for IMPs coming from the EU or European Economic Area (EEA) and ensure appropriate arrangements to ensure supplies in the event of any possible delays arising from a no-deal scenario after 29 March 2019.
- Contingency arrangements should be made well in advance to provide assurance for trial participants and organisers.
Providing services including those of a qualified professional if there's no deal
- The mutual recognition of professional qualifications (MRPQ) directive will no longer apply to the UK and as a result, there will be no system of reciprocal recognition of professional qualifications between the UK and the EEA states.
- Systems such as the EU-wide warning system for exchanging information between regulators will no longer be available to UK regulators.
- EEA professionals holding EEA qualifications who have already received a recognition decision in the UK, or who are awaiting a decision on exit-day, will not be affected and the decision will remain valid. They will not need to take further action.
- EEA professionals holding EEA qualifications who have not started an application for professional recognition in the UK before 29 March 2019, will be subject to future arrangements to be published in due course.
- Common Travel Area (CTA) arrangements will continue to be in force in respect of Irish and UK citizens when practising in each other's state.
- Professionals seeking recognition of their UK qualifications in an EEA member state after exit day, should check the host state national policies. If their UK qualification has already been recognised in an EEA country before exit day, this decision will not be affected.
Existing free trade agreements if there's no Brexit deal
- In the event of no deal, the UK government will seek to bring into force bilateral UK-third country agreements with non-EU countries from exit day, or as soon as possible thereafter.
- The UK government is engaging with partner countries to complete this work and replicate existing EU agreements with third countries as far as possible.
- Should such arrangements not be in place on Brexit day, trade will take place on World Trade Organisation (WTO) terms until a new arrangement is implemented.
- Businesses and organisations that trade with non-EU third countries should identify affected goods and services and make appropriate preparations.
Travelling in the common travel area if there’s no Brexit deal
- No deal will have no impact. The CTA is a long-standing arrangement between the UK, the crown dependencies (Jersey; Guernsey; Isle of Man) and Ireland. It has its origins in the 1920s and ensures that British and Irish citizens can move freely between and reside in these islands. The CTA is not reliant on membership of the EU, was formed before either the UK or Ireland were members, and is based on domestic legislation and bilateral agreements.
Travelling to the EU with a UK passport if there’s no Brexit deal
- No deal will have an impact as the UK will be a third country. UK citizens will need to make sure they have more than six months left on their passport to travel in addition to normal business or holiday travel, this could have an impact on UK citizens who travel to an EU country specifically in order to receive healthcare. If you plan to travel to the Schengen area after 29 March 2019, to avoid any possibility of your adult British passport not complying with the Schengen border code, the government suggests that you check the issue date and make sure your passport is no older than nine years and six months on the day of travel.
This technical notice does not deal with the issue of reciprocal healthcare rights, for example successor arrangements to the European Health Insurance Card (EHIC) or arrangements for access to local healthcare for UK expats living or working in an EU member state, or vice-versa.
Data protection if there’s no Brexit deal
- If there’s no deal, the EU would need to make a decision about whether the UK has adequate data standards. This has not yet been done, so those organisations (including NHS organisations) who need to transfer data after the UK leaves should investigate what legal mechanisms are currently available. The EU has an established mechanism to allow the free flow of personal data to countries outside the EU. The European Commission has stated that if it deems the UK’s level of personal data protection essentially equivalent to that of the EU, it would make an adequacy decision allowing the transfer of personal data to the UK without restrictions.
- While the government has made it clear it's ready to begin preliminary discussions on an adequacy assessment now, the European Commission has not yet indicated a timetable for this and have stated that the decision on adequacy cannot be taken until the UK is a third country. If the European Commission does not make an adequacy decision regarding the UK at the point of exit, and you want to receive personal data from organisations established in the EU (including data centres), then you should consider assisting your EU partners in identifying a legal basis for those transfers.
Accessing public sector contracts if there’s no Brexit deal
- In the event of a no-deal scenario, UK organisations will need to post notifications on a new UK portal. Contracting authorities and entities would need to ensure their contract notices are published on the UK e-notification service rather than the Official Journal of the European Union (OJEU) or Tenders Electronic Daily (TED).
The technical note states that: "The requirement to advertise in Contracts Finder, MOD Defence Contracts Online, Public Contracts Scotland, Sell2Wales and eTendersNI would remain. Those contracting authorities and entities who are currently working with a third party such as an e-sender or e-publisher to publish to OJEU/TED should be able to continue to work with their provider to publish on the UK e-notification service.”
The notice does not discuss whether or not the UK may wish to make changes in future to procurement/contracting rules – it deals purely with the practicalities of where and how to advertise contracts.
European Regional Development Funding and European Structural Funding
- As before, funding is guaranteed by HM Treasury. In July 2018, the government extended the guarantee so that it would cover all projects, including European regional development fund projects, that would have been funded by the EU under the 2014-2020 programme period. The extension means that the Ministry of Housing, Communities and Local Government, the Devolved Administrations, and HM Government of Gibraltar, will continue to sign new projects after EU-exit until programme closure. Organisations should continue applying for and delivering funding under current arrangements, confident that the funding guarantee applies if there is no negotiated agreement between the UK and the EU.
- In a no-deal scenario, there are no expected financial implications or impacts for citizens or businesses operating in the UK (whether UK or EU-based) in regard to workplace rights. Employment rights remain unchanged, including the employment rights of those working in the UK on a temporary basis, except for some implications in relation to European Works Councils and the insolvency of some employers.
- With regards to employer insolvency, in a no-deal scenario, people living and working in the UK for a UK or EU employer will continue to be protected under existing law. UK and EU employees who work outside the UK in an EU country for a UK employer may still be protected under the national guarantee fund established in that country. However, this may not always be the case, as there are variations in how each EU country has implemented the guarantee required by EU law.
Medicines, medical devices, clinical trials, batch testing medicines, regulatory systems
- The MHRA would perform functions related to approval and marketing of medicines in the UK, including approving new applications, and pharmacovigilance.
- Regulatory information (for example, on medicines safety, clinical trials) currently submitted to EU networks and portals will need to be submitted directly to the MHRA. Separate applications will need to be made to EU bodies, such as for medicines marketing authorisation, but the MHRA will wherever possible continue to accept EU forms, standards and processes, to minimise burdens.
- Medicines already authorised for use in UK will continue to be authorised.
- The UK will continue to accept batch testing of medicines carried out in the EEA and other named countries.
- The UK will continue to recognise EU-approved medical devices.
- The UK will align where possible with incoming EU rules on clinical trials.
- Further information and instructions in the coming months (mostly aimed at industry).
Blood, organs and tissues
- Current quality standards will not change and will be carried over into UK law
- The availability of organs should not be affected, as current EU law already allows for third country organ and tissue exchange.
Areas of concern for NHS
Patients travelling from the UK to the EU: Would have to ensure at least six months of validity on their passport before travelling, in the event of no deal. It’s not yet clear how their rights to receive healthcare in EU countries would be affected.
Data sharing: Possible problems transferring data between the UK and EU, for example patient data for clinical trials or treatment. NHS organisations may need further guidance on the legal practicalities of doing this.
Drugs precursors: A no-deal Brexit scenario could delay the trade of certain drug precursors (chemicals used for the production of medicines, cosmetics and fragrances) by up to 15 days, if companies have to meet third country rules on imports and exports post-Brexit.
Medicines authorisation: The UK will have to authorise medicines separately from EU in future, which will work, but could lead to delays.
Rare diseases: There may be particular concern regarding orphan medicines (treatments that aren’t commercially viable for the UK market alone) as to whether such medicines will even reach the UK market. This will have implications for the treatment of rare diseases.
Pharmacovigilance: If the UK chooses not to mirror the pharmacovigilence rules in the rest of the EU, UK-approved medicines may not find a welcome market in the EU27.
Sponsorship of clinical trials: The technical notices are vague about what happens regarding sponsors based in the UK/EU.
Blood and tissues: As a third country, the UK will need new written agreements for import/export with existing EU partners of blood, organs and tissues.