EU Exit Group 19 June 2018
Agenda Time Topic 09.30 Welcome and introductions Situation analysis – Political Update 09.40 Meeting leader: John Smith 10.25 PAGB update on activities and key stakeholder meetings 10.50 Update on MHRA meetings particularly deep dive Scribe: Incisive Health 11.10 Member update on any activities Timekeeper: Richard Spooner 11.25 Update on discussions with small to medium companies Gatekeeper: Gill Peckham 11.45 Member survey results 12.00 Key asks and activities next quarter July to Sept Coach: Katja Murray 12.25 Coach feedback
Situation analysis: political update Incisive Health
Recap of the process: withdrawal treaty By October / November Council Decision on 2018: legal text agreed signing based on enhanced (including transition qualified majority vote period and ‘backstop’) By 29 March 2019: Council Treaty passed to European Decision on adoption of Parliament for consent treaty based on enhanced based on a simple majority qualified majority 5
Draft withdrawal agreement – 19 March Transition EU period citizens Goods on Northern the Ireland market 6
The Brexit ‘backstop’ for NI March 2018 – January 2021 – January 2022 -> December 2020 December 2021 Temporary Permanent Implementation period customs arrangement arrangement • No tariff quotas, rules of origin or customs processes including declarations on all UK-EU trade • EU’s common external tariff at the UK’s external border “and such other parts of the Common Commercial Policy that are required to enable the temporary customs arrangement to function” • The UK would still be able to negotiate, sign and ratify free trade agreements with rest of world partners, but only implement the elements that do not affect the functioning of the temporary customs arrangement • It must be written into the legal text of the Withdrawal Agreement and apply to the whole of the UK 7
Recap of the process: future relationship Following March 2019: both October / November 2018: the Council and member June – October 2018: initial Joint Political Declaration on states must adopt Decision to negotiations take place future relationship grant Commission a negotiating mandate Council Decision on signing treaty based on consensus (ie Council Decision on the European Parliament consent unanimity) before member adoption of the treaty by to the agreement by simple states ratify through their own consensus majority processes 8
Key issues on which UK Government is yet to settle Northern Ireland 'backstop’: regulatory alignment Future relationship: Future relationship: regulatory alignment customs on goods (apart from pharmaceuticals) Future relationship: regulatory alignment on services / free movement 9
The Brexit ‘War Cabinet’ remains bitterly divided Remainers Brexiteers 10
No deal: Whitehall is preparing for the worst case scenario Contingency planning leaked • As negotiations continue, civil servants have been tasked with drawing up scenarios for leaving the EU without a deal • Three scenarios have been modelled: mild, severe, and ‘Armageddon’ • The severe scenario sees the UK hit by shortages of medicine, fuel and food within a fortnight PAGB was invited to input into DHSC’s plans and submitted a report earlier this month 11
Meanwhile in Parliament The Lords have been activated through significant amendments to the EU (Withdrawal) Bill Conservative remain rebels have put a halt to the wider legislative programme, eg Customs Bill Brexiteers are becoming more frustrated – and vocal – by lack of progress 12
Progress of the EU (Withdrawal) Bill 13
EU (Withdrawal) Bill amendments EEA membership a Meaningful vote Statement on the Charter of negotiating on Brexit customs union fundamental rights objective Good Friday Parliamentary agreement Removal of Brexit approval for incorporated into date phase 2 mandate Withdrawal Bill Limits on ministers’ Limits on changing EU Limits on Henry VIII Alignment with EU powers to deviate laws through SIs powers rules on refugees from EU law Ability for UK courts Incorporation of Provisions to continue Parliamentary to uphold EU laws environmental to apply EU law post- oversight of SIs incorporated into UK protections Brexit law 14
Progress of the Customs Bill The Government is vulnerable to losing a vote which would The Government is expected to The Customs Bill is ‘held’ before Further pressure is expected in make membership of the bring the Customs Bill back Report Stage in the Commons the Lords Customs Union a ‘negotiating before the summer recess objective’ 15
Development of the Labour Party’s position Labour has shifted its position towards a ‘softer Brexit’: calling for ‘shared institutions’ and ‘common standards’ The party remains too divided to agree Norway-style model: many MPs in leave-backing seats Whipped to abstain on EEA amendment to the EU (Withdrawal) Bill Proposed “full access to the internal market of the EU” instead 16
Select Committees PAGB referenced in BEIS committee report into impact of Brexit on the pharmaceutical sector: BEIS recommends that the Government secure continued membership of “John Smith, Chief Executive of over -the- EMA as a priority to counter trade body PAGB, told us that while mitigate impact of fallout large companies will be able to cope with from Brexit whatever happens, an early, fixed end date for leaving the EU could be very severe for some SMEs.” “We received evidence from companies on an appropriate timescale between two and five years.” 17
Next on the agenda EU Council Chequers Publication of meeting on 28 'away day' in Brexit White - 29 June July Paper 18
PAGB update on Q2 activities and key stakeholder meetings Donna Castle and John Smith
Tactics Medical Facts and 'No deal' Member Q2 devices figures preparations survey infographic briefing report EU (Withdrawal) Bill Ongoing Stakeholder engagement Intelligence updates
EU (Withdrawal) Bill engagement Amendment debated in House of Lords EU (Withdrawal) Bill engagement Blog published in Pharmacy magazine Meeting with the Minister secured
New collateral shared with stakeholders New collateral shared with stakeholders
Member survey 63% 44% 56% feel that the consumer have ‘some confidence’ with have ‘some confidence’ with healthcare industry’s views Member survey the Government’s ability to the Government’s handling of are being ‘taken into account obtain a ‘good’ deal for the to a small extent’ by negotiations to date consumer healthcare industry government Almost 25% 50% Over 25% feel that a transition period are planning for the UK to estimate ongoing costs of longer than two years is ‘crash out’ of the EU with no more than £1m per year as a needed (but more than 75% deal result of leaving the EU do not) Points to note: • Baseline from which future results marked against • Shared with key stakeholders • Reminder: high response rate is vital Q2 results to come later…
Key stakeholder meetings Ed Jones 26 April 2018 with John Smith and David Barnett (Special Adviser to Jeremy Hunt) Secured following dissemination of OTC medicines supply chain graphic DHSC is aware of issues around regulation and supply chain – they are advocating on these issues within government; they see keeping people ‘safe and well’ as part of the top priority in contingency planning (security at the border) Lord 30 April 2018 with John Smith, Chris Mummery and Donna Castle O'Shaughnessy (Health Minister) Secured via engagement with Baroness Jolly DHSC is keen for MHRA to have associate membership of EMA and understand need for regulatory alignment; within transition period there will be continued recognition of batch testing and NB, but MHRA will not be rapporteur for EMA processes; particularly interested in hearing information on companies’ contingency plans The UK in a 9 May 2018 with Donna Castle Changing Europe Secured following dissemination of OTC medicines supply chain graphic (influential think tank) Offered to brief PAGB members at seminar / webinar if helpful; invited PAGB to Brexit and industry conference planned for October; requested PAGB submit a blog to publish on their website
No deal scenario planning Following anonymised interviews with five member companies, a report with two sets of recommendations has been shared with government to inform their contingency plans: Recommended government actions ahead of withdrawal date : 1. Be clear about the unilateral actions the UK Government will take in the event of no deal 2. Publish and consult on their own contingency plans for a ‘no deal’ situation 3. Confirm how the UK will treat countries with which the EU has mutual recognition agreements (eg Canada, Japan etc) Recommended government actions on or after withdrawal date : 1. Taking all action possible to facilitate the flow of goods through the border 2. Minimising any visa requirements for those involved in transporting goods. 3. Ensuring that tariffs on healthcare-related products are reduced to the minimum levels possible consistent with World Trade Organization (WTO) rules 4. Prioritising healthcare-related products at the border
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