The Implications for the Life Sciences Sector 30 April

Brexit: The Implications for the Life Sciences Sector

30 April 2019 Brexit: The Implications for Contents the Life Sciences Sector

Table of Contents

Introduction 3 Manufacturing and Supply 14

The Brexit Picture 4 Batch Testing and Parallel Imports 15

Timeline: 2016 – 2017 5 Patents, Supplementary Protection Certificates and Paediatric Extensions 16 Timeline: 2018 6 Trade Marks and Designs 17 Timeline: January and February 2019 7 Copyright and Database Rights 18 Timeline: March 2019 onwards 8 Data Protection and Privacy 19 Brexit Scenarios 9 People and Movement 20 Medicines 10 UK Government Support 21 Medical Devices 11 Further ahead 22 Clinical Trials 12 Glossary of Terms 23 - 24 Orphan Drugs and Minor Use Species 13

2 Brexit: The Implications for Introduction the Life Sciences Sector

Introduction

Brexit is highly fluid and subject to frequent change. Key contacts Key contributors Accordingly, the advice within this interactive Life Sciences guide (including imposed UK Government deadlines) is accurate as of 26 April 2019.

This guide assumes an Exit Date of 31 October 2019; Caroline Scott Bonella Ramsay however this is subject to change. For further information Senior Associate, Life Sciences Partner, Life Sciences T +44 (0) 131 242 5077 T +44 (0) 20 7796 6028 see Brexit Scenarios on page 9. [email protected] [email protected]

This guide is best viewed on-screen to make use of the hyperlinks within it.

For further information please contact Caroline Scott Paul Hardy Sam Mitchell or Paul Hardy. Brexit Director Trainee T +44 (0) 207 153 7099 T +44 (0) 207 153 7552 [email protected] [email protected] Click here to begin.

The Brexit Picture

Click on each time-period to see how Brexit has developed, or what it means for each aspect of Life Sciences

January and March 2019 2016-2017 2018 Brexit February 2019 onwards

2016 – 2017

2016 2017

08.12.2017 UK and EU make significant 08.06.17 30.08.17 20.11.17 progress drafting the 23.06.16 17.01.17 UK Government snap election. UK Government publishes European Medicines Withdrawal Agreement, UK Referendum. Theresa May delivers ‘Lancaster House’ Conservatives lose majority in Life Sciences Industrial Agency (EMA) announces allowing future trade UK votes to Leave the EU. speech: setting out her Brexit objectives. House of Commons. Strategy. move to Amsterdam. discussions to begin.

24.06.16 29.03.17 19.06.17 22.09.17 06.12.17 2018 David Cameron resigns UK triggers Article 50 TFEU. UK and EU begin Brexit Theresa May delivers UK Government as UK Prime Minister. negotiations. speech in Florence publishes UK Life outlining her plans for Sciences Sector Deal 1. 25.05.17 the Transition Period. Regulation 2017/745 on medical devices (EU MDR) and Regulation 2017/746 on in-vitro diagnostic medical devices (EU IVDR) enter into force, but not to apply fully until 2020 and 2016 2017 2022, respectively. Note to reader: Dates in blue reflect key dates for the Life Sciences sector.

2018

24.09.18 2018 UK Government releases technical papers 26.06.18 on what Brexit means for Intellectual The European Union (Withdrawal) Property Rights Holders. (TMs, Copyright, Act 2018 receives Royal Assent, Patents, Exhaustion of IP rights) immediately entering into force. 02.03.18 16.05.18 06.08.18 26.11.18 10.12.18 Theresa May delivers speech on Announcement of UK Life MHRA Guidance on ‘What the MHRA letter to industry on EU Court of Justice declares how Brexit can be ‘Win-Win’ for Sciences Sector record implementation period means conversion of CAP Marketing that the UK can cancel Brexit the EU and UK. turnover of £70 billion. for the Life Sciences Sector’. Authorisations. unilaterally.

2019

11.04.18 23.05.18 12.07.18 14.11.18 06.12.18 EMA completes re-distribution UK Government publishes: 12.12.18 UK Government publishes UK and EU publish • UK Government publishes of CAP Marketing Authorisations ‘Brexit, medicines and Theresa May survives White Paper on future Withdrawal Agreement. UK Life Sciences Sector to EU/EEA countries, transferring medical devices, substances Conservative party relationship between the Deal 2 and announces over 370 CAPs to new supporters of human origin’ in vote of no confidence. UK and the EU. Life Sciences as the UK’s and co-supporters (see here). response to Health and 14.09.18 The Conservatives flagship sector following Social Care Committee UK Government releases technical cannot trigger another Brexit. 4th Report. papers on regulation of medicines, vote of no confidence • UK Government publishes medical devices, batch testing for the next 12 months. EU Settlement Scheme medicines, submitting regulatory Policy paper (updated 28 information, labelling tobacco products 2018 March 2019). and ensuring the safety of blood and blood products.

January and February 2019 26.02.19

UK Government publishes 14.02.19 03.01.19 24.01.19 guidance on medical devices UK and USA sign Mutual 2019 • MHRA response to consultation on UK Government announces and further guidance on how Recognition Agreement on EU exit no-deal legislative proposals. Contingency Legislation to 01.02.19 medicines, medical devices and Conformity Assessment. • MHRA issues guidance on regulation ensure UK Legal system can EMA issues guidance for clinical trials will be regulated in of medicines, medical devices and continue to operate without Medicinal Products in a no-deal scenario. clinical trials. gaps or defects. no-deal scenario (revised 18.02.19 on 04.02.19). Group of 8 Labour MPs 16.01.19 07.02.19 01.01.19 31.01.19 resign from the Labour Theresa May survives Labour party UK and EU EMA temporarily shuts MHRA issues updated group. Further Labour vote of no confidence. No limit on re-open down services due to guidance on no-deal and Conservative the number of times Labour can Brexit talks. physical relocation. scenario. resignations followed. call this vote.

02.01.19 15.01.19 29.01.19 05.02.19 MHRA issues second letter House of Commons holds House of Commons votes UK Government 21.02.19 to CAP Holders advising on first vote on the Withdrawal against delaying Brexit publishes updated UK Government publishes guidance on conversion of CAP to UK Agreement: defeated by 432 and asks Theresa May to guidance on IP & how EU trade marks will be converted into MAs and providing Product votes to 202. renegotiate the controversial Brexit (further UK trade marks and the numbering policy Licence Numbers. Irish Backstop in the updated 02.04.19). to be used. Withdrawal Agreement.

2019

10.04.19 & 11.04.19 Life Sciences as of Exit Date: March 2019 onwards • UK and EU hold emergency summit • Deadline for (i) UK based applicants to switch to EMA applications; and to discuss Brexit. (ii) UK MAs transfer to EU holders. • Early on 11.04.19 the EU and UK • MHRA takes over EMA regulatory functions with respect to the UK. 12-14.03.19 29.03.19 agree ‘Flextension’ to delay Brexit to • EMA active in Amsterdam. 12.03.19: Second meaningful • Withdrawal Agreement defeated 31.10.19, but the EU rejected Theresa • Contingency Legislation effective. vote on Withdrawal Agreement: for the third time by the House of May’s request for an extension to defeated by 149 votes. Commons (344 votes to 286). April 08.04.19 30.06.19. 13.03.19: Commons votes will see the Commons cast further UK Parliament passed • This decision will cease to apply against no-deal Brexit (312 votes on possible Brexit options. the European Union on 31.05.19 if the UK has not held votes to 308). • The Medicines for Human Use Withdrawal Act 2019 European Parliamentary elections and 14.03.19: MPs vote 413 to (Clinical Trials) (Amendment) (‘The Cooper Bill’), obliging not ratified the Withdrawal Agreement 31.10.19 202 in favour of asking EU to (EU Exit) Regulations 2019 was Theresa May to seek an by 22.05.19. The UK Parliament does 23-26.05.19 2300 GMT: EXIT DATE delay Brexit. passed by UK Parliament. extension from the EU. not need to approve this flextension European Parliamentary (assuming an earlier Exit Date despite it being different from 30.06.19. elections to take place. has not occurred).

04.03.19 18-22.03.19 01.04.19 03.05.19* 31.05.19 MHRA publishes 18.03.19: MHRA publishes further guidance notes • UK Parliament rejects all four Brexit Deadline for MAH to Flextension expires if guidance on how on a Hard Brexit. alternatives. opt out of automatic 22.05.19 the UK has not ratified to make MHRA 19.03.19: Speaker holds that a third Brexit vote on • Annual Fee for converted CAP CAP Conversion. Deadline to ratify the Withdrawal Act or held submissions on human the Withdrawal Agreement must be ‘substantially becomes payable to MHRA. Withdrawal Agreement European Parliament medicines if there is different’ to previous votes. • Human Medicines (Amendment if the UK does not Elections: resulting no-deal. 20.03.19: Theresa May writes to Brussels etc.)(EU Exit) Regulations 2019 and intend to hold EU in a Hard Brexit on requesting extension to the negotiating period. the Medical Devices (Amendment) Parliament Elections. 01.06.19. 21.03.19: Following EU summit and subject to UK (EU Exit) Regulations 2019 passed by approval, EU agrees to delay Brexit to either the UK Parliament. General UK Position as of Exit Date: 12.04.19 (No Deal) or 22.05.19 (Deal approved). • No Transition Period if Withdrawal Agreement not ratified by UK Parliament. EMA advises that the deadline of 29 March in all • Customs/Trade Tariffs imposed.

(*) These deadlines were its guidance should be understood to be 12.04.19 • UK becomes Third Country and automatically reverts to trading on WTO terms. updated to reflect an Exit Date of until further notice. Note that given the recent • Contingency Legislation impacting wider UK industry takes effect. 12 April 2019. Given the recent changes to Exit Date (as defined changes to Exit Date the EMA now advise that the • UK/USA Mutual Recognition Agreement enters into force. herein), these dates may be revised further. date should be read as 31.10.19. • New trade deals can commence – with the US already stating it is ‘ready to deal’

Brexit Scenarios

EXIT DATE 2020 2021

26.05.20 Hard Brexit Scenarios: EU Medical Devices 1. Exit Date is 01.06.19 Regulation (Regulation Currently, the most likely UK Government fails to ratify Withdrawal Agreement 4 weeks post Exit Date* 2017/745) enters into 31.12.2020 scenario for the UK. UK before 22.05.19 and does not hold EU Parliament Deadline to name UK based force (26.05.22 for IVDs Deadline for QPPV to be businesses should be planning Elections; or point of contact for MHRA. (Regulation 2017/746)). established in the UK. for a Hard Brexit. 2. Exit Date is 31.10.19 UK Government does hold EU Parliament Elections HARD BREXIT but fails to ratify the Withdrawal Agreement.

Soft Brexit Scenarios: 1. Exit Date is Pre 22.05.19 if the UK ratifies the Withdrawal Agreement before EU Parliament 01.01.2021 Elections; or New trade deals 2. Exit Date is Post 22.05.19 but before 31.10.19 31.12.2020 commence, or, if not, UK Government does hold EU Parliament Elections Transition the Irish Backstop and subsequently ratifies the Withdrawal Agreement Period ends. comes into effect. UK enters Transition Period. Transition Period before 31.10.19. SOFT BREXIT

No Brexit Prior to any Exit Date, the UK revokes Article 50 TFEU. This is most likely to occur if a General Election is won by a political party with a manifesto EXIT DATE July 2020 pledge to remain, or Parliament agrees to legislate Previously predicted for a second referendum. This would require a longest possible further long extension. delayed Brexit date. NO BREXIT

(*) These deadlines were updated to reflect an Exit Date of 12 April 2019. Given the recent changes to Exit Date 2020 2021 (as defined herein), these dates may be revised further.

Medicines

• UK held Marketing Authorisations • MAHs will have one year from • Pre day 120 – applications • The deadline for amending • For further guidance on regulating • Companies will be expected to put (MAs) must be transferred to Exit Date to provide MHRA with in the first phase will need administrative details on the medicines click here. in place a UK based contact person holders established in the EU baseline data for converted CAPs. an independent assessment packaging and leaflets for medicinal within 4 weeks of Exit Date: before Exit Date. UK-based Two days after submission of by MHRA. products in the UK to comply with • For information on making • This is a temporary solution until applicants anticipating a MA after this data, the MAH can apply for UK requirements is the end of submissions to the MHRA, • More information on pending MAH can be changed as above. Exit Date will need to change a Certificate of Pharmaceutical 2021. As stated in MHRA guidance, click here. applications can be found here. to a non-UK based applicant Product which may be required it is likely that UK companies will • This individual must be established in the EEA/EU before for manufacturers to export not be able to comply with the Legal Presence accessible to the licencing • The abridged procedure for Exit Date. medicinal products. Further verification and authentication authority in respect of any Generic, Abridged Applications • MHRA will continue to need a guidance can be found here. requirements under the Falsified matter in relation to the MA. for UK MAs will remain in place in named individual who can: (i) be • MAs for Centrally Authorised Medicines Directive and thus these the UK; however they will require contacted in the event of a safety • Companies will have until Products (CAPs) will be • Pending CAPs will be assessed legal obligations would be removed amending as it will not be possible issue; (ii) require independent 31 December 2020 to establish automatically Grandfathered to UK depending on what stage of the in respect of all actors in the UK to rely on European reference re-testing of medicines; and (iii) a UK based QPPV. Further UK MAs on Exit Date – unless the MAH assessment timetable has been Supply Chain. The UK Government data after Brexit. The implication withdraw the medicine from the Government guidance can has opted out by notifying MHRA reached: is evaluating the options for a future of this is that generics companies market if needed. be viewed here. Government in writing before the deadline UK falsified medicines regulatory • Day 181 – outstanding issues must file a complete set of guidance on QPPVs can be found (as communicated to holders framework. More information can assessed by MHRA in a regulatory data in the UK to obtain • A UK MAH must be established in here, and on pharmacovigilance in the November 2018 letter). be found here. tailored assessment. authorisations in the UK, otherwise the UK by 31 December 2020: procedures here. The deadline has been amended generic or biosimilar products will by the Contingency Legislation and • Day 120 – either an In-Flight • UK MAs based on EU reference • A change of ownership will not be available in the UK. is expected to be 21 days from Exit Assessment (Route 1) products that have been granted/ need to be submitted to MHRA Date). See here for UK Government or Targeted Assessment are pending prior to Exit Date will to change from an EU MAH to guidance on CAPs conversion. (Route 2). remain valid after Exit Date. a UK MAH.

Medical Devices

• Following Exit Date, all medical • The UK will give UK Notified • CE Marks approved by an • Under the MDR, from 26 May 2020 devices, active implantable Bodies an on-going legal status EU based Notified Body will there will be increased requirements medical devices, In-Vitro and continue to recognise continue to be recognised in the for clinical evidence, including an Diagnostics Medical Devices certificates granted by UK-based UK for a limited (unspecified) expectation for higher risk devices (IVDs) and custom-made devices Notified Bodies prior to Exit Date, period: no separate marking by that clinical investigations specific to will need to be registered with allowing products authorised by a UK established Notified Body the device in question are conducted. the MHRA to be placed on the UK Notified Bodies to continue to is required. UK market. There is a grace be placed on the UK market. • MHRA will continue to perform period for complying with these • The UK will continue to comply market surveillance of medical additional requirements – • CE marks approved by a UK-based with all key elements of the devices on the UK market. see ‘Registrations’ section of Notified Body will no longer be Medical Devices Regulation Government guidance. valid in the EU/EEA on Exit Date, (MDR) and the In-Vitro • Formal UK presence at EU meaning the devices they have Diagnostics Regulations (IVDR) committees in respect of devices • New devices being placed on the certified will no longer be able entering into force in the will cease at the beginning UK and/or EU market following to be placed on the EU market. EU from May 2020 and 2022 of the Transition Period or Exit Date should be authorised by UK exporters of CE marked goods respectively. The key elements following no-deal. an EU Notified Body. to the EU should put measures in in the MDR and IVDR will be place for re-authorisation of such transposed into the Contingency • UK Government guidance on products by a Notified Body in an Legislation. regulating medical devices (updated EU/EEA Member State. 19 March 2019) can be found here.

Clinical Trials

• UK clinical trials will continue to • The current EU position is that • Clinical trials are governed by • The new EU Clinical Trials be managed nationally by the from Exit Date, sponsors based the Medicines for Human Use Regulations 536/2014 (CTR) MHRA. The UK will continue to in the UK may no longer sponsor (Clinical Trials) Regulations 2004. will likely not be in force on Exit recognise existing approvals – trials conducted in the EU. UK These regulations will remain Date. Therefore, they will not be no need to re-apply. sponsors running a trial in the in force, albeit amended by incorporated into EU law under EU must, from Exit Date, ensure Contingency Legislation. the EUWA and will not apply to • MHRA will require trial sponsors that the sponsor or a legal the UK. UK Government guidance to be based in the UK (or on an representative is established in has stated that the UK will align approved list – to include EU/EEA the EU27. Further EU guidance ‘where possible’ with the new CTR countries) following Exit Date. can be found here. once it enters into force. Further guidance can be found here and here.

Orphan Drugs and Minor Use Minor Species (MUMS)

• Orphan Drug Designations held • The EMA has provided a checklist • The UK will offer market exclusivity • MUMS/limited market by a UK entity/individual must for sponsors on the transfer and full or partial refunds classifications attach to a veterinary be transferred to a sponsor of Orphan Drug Designations, for Marketing Authorisations product/indication, but do not established in the EEA by Exit Date. guidelines and templates. Further as incentives to encourage transfer automatically on transfer information can be found here. development of medicines in rare of the related MA to a new MAH. • Transfers are free of charge, but a diseases. Original sponsor/applicant must separate application is required for • A new UK system for re-assessing write to the EMA regarding the each designation. the orphan status of rare disease • The UK Government will consult on transfer of the classification of medicinal products at the point the treatment of orphan drugs in the product and the MUMS/ • Proof of EEA establishment must of applying for an MA will be in the UK. For further information on limited market classification to a be submitted if there is a change force following Exit Date (using the orphan drugs, click here. sponsor/applicant established in of legal entity. This is likely except current EU criteria as a base and the EEA. This letter should state where a designation is held by adding UK-specifics). • A MUMS/limited market the document reference number an individual and that individual classification held by a UK sponsor/ of the MUMS outcome letter changes residency to remain applicant must be transferred to a confirming the MUMS classification. in the EEA. sponsor established in the EEA.

Manufacturing and Supply

Manufacturing • Manufacturers placing a medical Supply Chains • Non-UK based device device on the UK market must • If EU-UK trade reverts to WTO manufacturers must designate a first register with the MHRA. terms, EU to UK imports will be ‘UK Responsible Person’ to act on its The ‘UK Responsible Person’ can subject to import tariffs, clearance behalf from Exit Date; a new role to assume the manufacturer’s role procedures and delays. The supply be created under the Contingency as the MHRA will only register risk profile will depend on the Legislation. No labelling changes manufacturers with a registered nature of the supply chain (UK-EU, will be required to reflect this place of business in the UK. UK-third country, UK domestic) new role. Guidance on this role is and the product being imported available here. • UK based authorised and distributed: representatives for medical • Human medicines manufactured devices/IVDs cease to be • For example, import logistics for in the UK will continue to require recognised in the EU post Exit drugs with particular storage a UK based QP. Human medicines Date. Manufacturers will need conditions and shelf lives (e.g. manufactured and directly to establish a new authorised insulin, highly sensitive to light imported into the UK from a representative in an EU country. and hot or cold temperatures) country not on the MHRA QP List must be managed to account (currently this includes all EEA • The UK-US Mutual Recognition for likely delays that could countries: see here) will require a Agreement, signed February 2019 result in degradation and UK based QP to ensure compliance (entering into force on Exit Date) consequently loss of stock. with the MHRA. See also further is intended to streamline processes • Existing wholesalers importing information under Batch Testing. for GMP inspection and monitoring QP certified medicines should by the FDA and MHRA/Veterinary refer to the Government • API Certificates authorised by Medicines Directorate. When guidance for details on the UK stating that products in force it will apply to a broad complying with the licensing manufactured in the UK comply range of human and veterinary regime and assurance system with GMP must be transferred to a pharmaceuticals, biologicals, so they can continue to import holder established in the EU. IMPs, APIs and medicated feeds. medicines that have been QP Similar MRAs are being agreed with certified in the EU/EEA. other countries.

Batch Testing and Parallel Imports

Batch Testing and of human medicines, and batch • For products subject to Official • The UK Government are issuing QP Certification testing of IMPs carried out in the Control Authority Batch Release Parallel Import Licences (PILs) • Immediately following Exit countries on the MHRA QP list (OCABR) testing (immunological as a replacement for Parallel Date, medicines regulation and imported into the UK, without medicinal products or medicinal Distribution Notices (PDNs) in case in the EU will be the same as further clarification. An imported product derived from human blood of a Hard Brexit: the UK, and so batch testing device from the EU into the UK or plasma), if the UK ceases to for compliance does not need will be treated as a new placing be part of the Official Medicines • PDN holders need to opt in to duplication in the UK in respect on the market so requirements Control Laboratory (OMCL) this process; failing to do so of imports from the EU, thereby such as registering the device network, either a MRA needs to be means that the product will no facilitating the movement of with the MHRA and ensuring in place or the UK National Institute longer be licensed in the UK medicines into the UK. The UK there is a UK Responsible for Biological Standards and following Exit Date. PDNs holders Government has advised that Person in place will apply. For Control will need to certify batches have 4 weeks (beginning on Exit these measures shall continue government guidance, click here. before the medicine can be placed Date) to opt in. Following this until the UK Government onto the market. Any products period, a new application for a considers that further change • Human medicines manufactured where the OMCL is in the UK will PIL will be necessary. is necessary. However, the EU and certified in a third country need to change from Exit Date • For PDN holders issued by has not yet reciprocated these on the MHRA QP List will be regards OCABR release for the EEA. the EMA in respect of CAPs, provisions meaning re-testing for recognised if conducted by a QP where the UK is listed as the compliance may be needed in the based in the listed country, without Parallel Imports destination country, this process EU in respect of imports from the further clarification. • Parallel importing from the EU into will be automatic (subject to the UK to the EU. the UK will remain possible for an provision of certain information • Human medicines manufactured initial period, as the UK has agreed to the MHRA by 21 April 2019). • MHRA to set out a list of countries and imported into the UK from to recognise the EU exhaustion Click here for further guidance. (MHRA QP List). On Exit Date this a country not on the MHRA QP regime. However, this position has list will include EEA countries List will require a UK based QP to not been reciprocated, meaning • PIL holders will need to and those countries with whom ensure compliance. parallel imports from the UK to the be located in the UK by the EU has a mutual recognition EU may not be possible. 31 December 2020, and should agreement (MRA). The list can appoint a contact person within be found here. The UK will 4 weeks of Exit Date in any continue to accept batch testing event.

Patents, SPCs and PEs

• The UK is a signatory to the European Patent • Additional contingency legislation, the Patents into force) will have exclusive jurisdiction over Convention and European Patent Organisation (Amendment) (EU Exit) Regulations 2019 SPCs based on patents granted by the EPO. (EPO); EU membership is not a pre-requisite (SI 2019/801), will amend UK law to create a Additional information on patents and SPCs can for either. UK Supplementary Protection Certificate (SPC) be found here. system. SPC grant is conditional on having a valid • The majority of UK patent law will not be effected UK patent and a MA allowing sale of the product • Equivalent provisions for Paediatric Extensions by Brexit. Applicable EU patent law is already in the UK; this remains unchanged. (PEs) will be introduced into the Human contained in the Patents Act 1977 (as amended) Medicines Regulations 2012. Procedures will and the Patent Rules 2007. For example: • Granted SPCs will remain in effect/come in to essentially remain the same but new applicants force as normal subject to the above condition will not need to provide evidence of the MA • the Bolar exemption (allowing use of a and any CAPs being converted to UK MAs. covering the product across EEA. Granted patented product to obtain approval for After Exit Date, the duration of SPCs will be PEs still require this evidence if challenged or, a generic medicine); and based on the first authorisation to place the if pending, for grant of the PE. • Patenting of biotechnology inventions. product on the market in the UK or the EEA. The Unified Patent Court (UPC) (if it comes

Trade Marks and Designs

• All existing EU trade marks (EUTMs) • International trade marks (IRs) • The UK will remain a member of and registered community designs designating the EU and pending the Madrid and Hague Systems, will continue to be valid in the EU. EU designations of IRs will be enabling international protection of On Exit Date, existing EU rights treated in materially the same way trade marks and industrial designs. holders will automatically be in the UK as EUTMs and EUTM Note that design registrations granted an equivalent UK trade applications, thus also resulting in under the Hague system will be mark or registered design right, equivalent UK rights and the right treated as registered community though owners can opt out in to file applications claiming priority designs and granted an equivalent limited circumstances. Advice on etc. This includes trade mark UK right. the numbering system for the new registrations protected under the UK rights can be found here. Madrid Protocol. • Detailed government guidance on these changes can be found here. • The equivalent UK rights will be • Unregistered Community entirely independent from the Design rights are an EU right, EU right i.e. they can be disputed providing 3 years of protection before UK courts, or assigned and completely distinct to the UK and licensed separately from the Design Right. The UK Government corresponding EU rights. is creating a new ‘Supplementary Unregistered Design Right’. This • All pending EUTM applications will mirror the characteristics of the need to be re-filed with the UK IPO. existing EU right and all existing For a period of 9 months following disclosed EU unregistered designs Exit Date, the UK Government will will continue to be protected in recognise filing dates, claims to the UK for the remaining period priority and UK seniority in the earlier of protection. No action is needed EU applications. UK applicants will by rights holders, providing the still be able to apply for EU protection unregistered design is disclosed in under an EU right in the future. the UK.

• The UK and EU are parties to the main international • Sui generis database rights: copyright treaties – the Berne Convention and WIPO • under a Hard Brexit: treaties. The rules therein underpin copyright legislation in • EU-wide right only arises for database makers established in all Member States and will be unaffected by Brexit. the EU (which will cease to include the UK); • UK-established database makers will have database right • There are certain unique EU rights where UK users will lose protection for UK only; reciprocal protection in the EU, but these mainly affect the media sector and are unlikely to be relevant in a life sciences • under the Withdrawal Agreement, the EU-wide database right shall context (e.g. portability of online audio-visual content). be extended to cover the UK following Exit Date, and UK-established database makers shall benefit from that ‘EU + UK’ database right.

• In event of a Hard Brexit, UK database owners should plan alternative strategies to continue enforcing/protecting rights in their databases in the EU: e.g. restrictive licences, trade secret protection, and copyright where applicable.

• Further government guidance on copyright and database rights can be found here.

Data Protection and Privacy

• In a Soft Brexit, the Withdrawal Agreement • A Hard Brexit will have the following the ‘one-stop-shop’ regime for cross-border maintains the status quo for the duration of the consequences from Exit Date: processing, and face dual UK/EU oversight on Transition Period. During transition: data protection. • Immediate restrictions on the transfer • GDPR directly applicable in the UK and of personal data from the EU to the • In the immediate term, the data protection the UK treated as a Member State for UK (although not vice versa) – practical legal framework will remain materially the the purposes of GDPR. consequence is the need for businesses same in the UK as in the EU – the UK will to adopt an appropriate safeguard in transpose the GDPR into national law, making • No restrictions on the transfer of personal respect of these transfers, which will often certain technical changes in order to create data from the EU to the UK (or vice versa). mean ‘re-papering’ existing contractual a ‘UK GDPR’ (to work in conjunction with • ICO (UK data protection regulator) continues arrangements to incorporate the standard the Data Protection Act 2018) which closely to be a competent supervisory authority. contractual clauses. mirrors the EU GDPR, but which recognises that the UK will no longer be a Member • ICO no longer a competent supervisory State of the EU (for example, references to authority (for example, for lead supervisory ‘EU or Member State law’ are changed to authority purposes). This also means ‘UK law’). businesses lose the benefit of

People and Movement

• UK nationals in the EU: 30 June 2021 if the UK leaves • Applicants with pre-settled • Post 31 December 2020, a new 2020 and beyond, provided • Visa-free travel: Regulation (EU) The Withdrawal Agreement the EU with a deal. status can remain in the UK and UK skills-based immigration the relationship began before 2019/592 of the EU Parliament and provides for continued freedom of apply for settled status once regime will apply regardless this date and still exists at time Council has now been published • A new EU Settlement Scheme movement for UK nationals in the they achieve 5 years’ continuous of whether there is a deal or a of application. in the Official Journal to grant is open for applications until EU until the end of the Transition residence. Hard Brexit, to any individuals UK nationals visa-free travel to the 30 June 2021 if there is a deal, • If there is a Hard Brexit, EU Period. After which, the rights to wishing to come to live and EU following Exit Date for short or 31 December 2020 if there is • For applicants arriving in the UK citizens with pre-settled and remain are regulated. Importantly, work in the UK for the first time stays of up to 90 days in any 180 day a Hard Brexit. after Exit Date: settled status will be able the rights to remain are regulated from 1 January 2021. period. This is conditional on the to be joined by close family at the national level and it will • This scheme will allow EU • Permission to enter and UK granting reciprocal and non- • Family members will have members until the deadline therefore be for each Member State nationals already in the UK, remain will be required if discriminatory visa-free travel for all different rights to live in the of 29 March 2022, provided to decide on UK nationals’ rights or those who start living in wishing to stay for longer than EU citizens. This will apply from the UK and rights will also differ the relationship existed before to remain. In the event of a Hard the UK by 31 December 2020 3 months; day following that on which Union depending on whether the Exit Date and continues to Brexit, the rules of each Member (or, if there is a Hard Brexit, • Subject to checks, leave to Law ceases to apply in the UK. More UK leaves with a deal or there is exist when the family member State will apply from that date. Exit Date) and have 5 years’ remain will be granted for 36 information is available here. a Hard Brexit: applies. If a relationship with continuous residence in the months, including permission an EU citizen with settled • Key dates and implications for EU/ UK to claim ‘settled status’ and to work and study; and • If there is a deal, under the • For further guidance on the EU status comes into existence EEA and Swiss nationals in the UK: remain in the UK indefinitely, • After 36 months, EU citizens EU Settlement Scheme, Settlement Scheme Statement of after Exit Date, the deadline or ‘pre-settled status’ if they do must apply under the new EU citizens with pre-settled Intent (21 June 2018) see the Policy • For EU nationals who is 31 December 2020. After not have 5 years’ continuous skills-based immigration and settled status, who paper on citizens’ rights in the are resident in the UK by these deadlines, the new residence. regime if they wish to remain are already in the UK may event of a no-deal Brexit (issued 31 December 2020, rights and UK skills-based immigration in the UK. be joined by close family 6 Dec 2018, updated 28 March status will remain the same until regime will apply. members up to 31 December 2019). See here.

UK Government Support

• In December 2017 and 2018 the UK • Deal 1 included close to £500 million • SMEs based in the UK may still access financial Government published the Life Sciences Sector of UK Government support for major new and administrative assistance under SME Deals 1 & 2 respectively, demonstrating its research programmes and over £1 billion of Regulation (Commission Regulation (EC) commitment to the life sciences sector: new industry investment. No 2049/2005) as a non-EEA based company.

• The UK Government to increase public • A world first – commitment to sequence • EMA SME guidance (see here and here) investment to £12.5 billion for 2021/22. 1 million whole genomes in the UK in for non-EEA based companies suggests the next 5 years, and provision of whole • Continued commitment to increase establishing a legal entity in the EEA genome sequencing as part of routine investment in R&D to 2.4% of GDP by 2027. or indirectly benefiting through an EEA clinical care for NHS patients with rare established SME regulatory consultancy • The life sciences sector is named as the UK’s diseases and cancer. as solutions. flagship sector following Brexit. • £79 million commitment by the UK Government to the new ‘Accelerating detection of disease’ challenge.

• The Wellcome Trust has committed £250 million to their Leap Fund for high risk, high reward pioneering science.

Further ahead

• The UK Life Sciences industry is consistently ranked in the top • The UK position on Brexit is pragmatic, with the UK global life science hubs, alongside Boston and San Francisco. Government committing to minimising disruption to ensure ‘business as usual’. • Investment in the UK Life Sciences sector remains upbeat, with Astrazeneca and GSK committing to the UK, with • All challenges create opportunities and DLA Piper has the the former in the midst of developing its £500+ million combination of political policy and legal know-how, as well global headquarters and R&D hub in Cambridge. Other UK as global coverage, to provide the highest level Brexit and Government industry partners such as GW Pharmaceuticals, trade advice. Roche, Celgen, IQVIA Ltd and Oxford Biomedica have committed over £200 million of new investment.

• A forecasted weakening of the pound coupled with attractive private and public sectors may be a positive draw for foreign investors when deciding whether to enter the UK market or enlarge an existing footprint.

Glossary of Terms (1)

API(s): Active Pharmaceutical Regulations 2019 (SI 2019/774). Exit Date: 31 October 2019 at Grandfathered: The automatic Member State(s): The individual Ingredient(s). 23:00 GMT or possibly earlier, conversion of MAs for CAPs into UK 28 nations making up the EU, currently EEA: The European Economic Area depending on which scenario occurs MAs on Exit Date. Austria, Belgium, Bulgaria, Croatia, Brexit: The United Kingdom’s made up of EU countries and Iceland, as set out on page 9 of this guide. Republic of Cyprus, Czech Republic, departure from the European Union, Liechtenstein and Norway. Hard Brexit: The UK leaves the EU Denmark, Estonia, Finland, France, to take place on Exit Date. GDPR: General Data Protection with no trade deal and becomes a Germany, Greece, Hungary, Ireland, EMA: European Medicines Regulation 2016 (Regulation (EU) Third Country on Exit Date. Italy, Latvia, Lithuania, Luxembourg, CAP(s): Centrally Authorised Product(s): Agency. See here for EMA’s Brexit 2016/679). Malta, Netherlands, Poland, Portugal, benefit from a single MA authorised website. Note: 29 March deadline ICO: Information Commissioner’s Romania, Slovakia, Slovenia, Spain, by the EMA that is valid in all Member in EMA guidance now refers to Generic/Abridged Applications: Office (UK). Sweden and (currently) the UK. States, Iceland, Liechtenstein and 31 October 2019. Application for a MA for generics/ Norway. hybrid abridged/biosimilars which IMPs: Investigational Medicinal MHRA: Medicines and Healthcare EU: The European Union. does not require full pre-clinical or Products. products Regulatory Agency. See here Contingency Legislation: Legislation clinical studies. for MHRA’s guidance on a Hard Brexit. passed by powers granted under European Parliament: The MA(s): Marketing Authorisation. the EUWA to amend current UK parliamentary institution of the EU GMP: Good Manufacturing Practice; Notified Body: An organisation law to reflect that the UK ceases that has a significant role in the EU the minimum standard that a MAH: A Marketing Authorisation designated by an EU country to assess to be a member of the EU. For Life budget and legislation. Elections are medicines manufacturer must meet in Holder is a company, firm or non- the conformity of certain products Sciences, three key pieces are: Human due to be held on 23-26 May 2019. its production process. profit organisation that has been before being placed on the market. Medicines (Amendment etc.) (EU granted a Marketing Authorisation. Exit) Regulations 2019 (SI 2019/775); EUWA: The European Union Paediatric Extension (PE): A 6 month The Medical Devices (Amendment) (EU (Withdrawal) Act 2018. extension that can be added to SPCs Exit) Regulations 2019 (SI 2019/791); under current EU legislation. and The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit)

Glossary of Terms (2)

QP: Qualified Person who is legally TFEU: The Treaty on the Functioning Further Useful Links MHRA Guidance and Publications on responsible for quality assurance of of the European Union (Consolidated a no-deal Brexit: https://www.gov. DLA Piper’s dedicated Brexit site: medicines and GMP. version 2016 OJ C 202, 7.6.2016). uk/government/collections/mhra- https://www.dlapiper.com/en/uk/ guidance-and-publications-on-a- focus/brexit-legal-impact/overview/ QPPV: Qualified Person for Third Country: A country not a possible-no-deal-scenario Pharmacovigilance. The individual member of the EU and not subject EMA Brexit Guidance: https:// (typically employed by a to its rules or the jurisdiction of the Contingency Legislation covering www.ema.europa.eu/en/about-us/ pharmaceutical company) who is European Court of Justice. regulation of medicines and uks-withdrawal-eu/brexit-related- personally responsible for the safety of medical devices: https://www.gov. guidance-companies the human pharmaceutical products Transition Period: From Exit Date to uk/government/news/contingency- marketed by that company in the EU. 31 December 2020 (or later agreed legislation-covering-regulation-of- IP and Brexit: https://www.gov.uk/ date if Exit Date is delayed) whereby medicines-and-medical-devices-in-a- government/publications/ip-and- Soft Brexit: Where the UK and the the UK remains in the EU and EU no-deal-scenario brexit-the-facts/ip-and-brexit EU negotiate and agree a deal (as laws continue to apply. described on page 9 of this guide) and the UK enters a Transition Period. Withdrawal Agreement: The deal agreed with the European Union SPC(s): Supplementary Protection that governs the terms of the UK’s Certificate(s) – a form of intellectual departure from the EU (published property that extends the protection on 14 November 2018). It is still in of patented active ingredients draft as it is yet to be agreed by the present in pharmaceutical or plant UK Parliament. protection products.

The Brexit Picture 2016-2017 2018 Jan & Feb 2019 March 2019 onwards Brexit Scenarios Medicines Medical Devices Clinical Trials Orphan Drugs & MUMS Mfg & Supply Batch Testing & Para Imp. Patents & SPCs & PEs Trade marks & Designs Copyright & DB Rights Data Prot & Privacy People & M’ment UK Government Further Ahead Glossary 24 Support DLA Piper is a global law firm operating through DLA Piper LLP (US) and affiliated entities. For further information please refer to www.dlapiper.com. Note past results are not guarantees of future results. Each matter is individual and will be decided on its own facts. Attorney Advertising. www.dlapiper.com Copyright © 2019 DLA Piper LLP (US). All rights reserved. | APR19 | A00065