EU Exit Group 19 June 2018 Agenda Time Topic 09.30 Welcome and - - PowerPoint PPT Presentation

EU Exit Group

19 June 2018

Agenda

Meeting leader: John Smith Scribe: Incisive Health Timekeeper: Richard Spooner Gatekeeper: Gill Peckham Coach: Katja Murray

Time Topic 09.30 Welcome and introductions 09.40 Situation analysis – Political Update 10.25 PAGB update on activities and key stakeholder meetings 10.50 Update on MHRA meetings particularly deep dive 11.10 Member update on any activities 11.25 Update on discussions with small to medium companies 11.45 Member survey results 12.00 Key asks and activities next quarter July to Sept 12.25 Coach feedback

Situation analysis: political update

Incisive Health

5

Recap of the process: withdrawal treaty

By October / November 2018: legal text agreed (including transition period and ‘backstop’) Council Decision on signing based on enhanced qualified majority vote Treaty passed to European Parliament for consent based on a simple majority By 29 March 2019: Council Decision on adoption of treaty based on enhanced qualified majority

6

Draft withdrawal agreement – 19 March

Transition period EU citizens Goods on the market Northern Ireland

7

The Brexit ‘backstop’ for NI

• 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
• nly 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

Implementation period Temporary customs arrangement Permanent arrangement March 2018 – December 2020 January 2021 – December 2021 January 2022 ->

8

Recap of the process: future relationship

June – October 2018: initial negotiations take place October / November 2018: Joint Political Declaration on future relationship Following March 2019: both the Council and member states must adopt Decision to grant Commission a negotiating mandate Council Decision on signing treaty based on consensus (ie unanimity) before member states ratify through their own processes Council Decision on the adoption of the treaty by consensus European Parliament consent to the agreement by simple majority

9

Key issues on which UK Government is yet to settle

Future relationship: customs Future relationship: regulatory alignment

• n goods (apart from

pharmaceuticals) Future relationship: regulatory alignment

• n services / free

movement

Northern Ireland 'backstop’: regulatory alignment

10

The Brexit ‘War Cabinet’ remains bitterly divided

Brexiteers Remainers

11

No deal: Whitehall is preparing for the worst case scenario

• 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

Contingency planning leaked

PAGB was invited to input into DHSC’s plans and submitted a report earlier this month

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

Meanwhile in Parliament

13

Progress of the EU (Withdrawal) Bill

14

EU (Withdrawal) Bill amendments

Meaningful vote

• n Brexit

Statement on the customs union EEA membership a negotiating

• bjective

Charter of fundamental rights Good Friday agreement incorporated into Withdrawal Bill Parliamentary approval for phase 2 mandate Removal of Brexit date

Limits on changing EU laws through SIs Limits on ministers’ powers to deviate from EU law Limits on Henry VIII powers Alignment with EU rules on refugees Incorporation of environmental protections Parliamentary

• versight of SIs

Provisions to continue to apply EU law post- Brexit Ability for UK courts to uphold EU laws incorporated into UK law

15

Progress of the Customs Bill

The Customs Bill is ‘held’ before Report Stage in the Commons The Government is vulnerable to losing a vote which would make membership of the Customs Union a ‘negotiating

• bjective’

The Government is expected to bring the Customs Bill back before the summer recess Further pressure is expected in the Lords

16

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

17

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 EMA as a priority to mitigate impact of fallout from Brexit “John Smith, Chief Executive of over-the- counter trade body PAGB, told us that while large companies will be able to cope with whatever happens, an early, fixed end date for leaving the EU could be very severe for some SMEs.” “We received evidence from companies

• n an appropriate timescale between

two and five years.”

18

Next on the agenda EU Council meeting on 28

• 29 June

Chequers 'away day' in July Publication of Brexit White Paper

PAGB update on Q2 activities and key stakeholder meetings

Donna Castle and John Smith

Tactics

Member survey Medical devices infographic Facts and figures briefing 'No deal' preparations report

Stakeholder engagement Intelligence updates EU (Withdrawal) Bill

Q2 Ongoing

EU (Withdrawal) Bill engagement

EU (Withdrawal) Bill engagement

Amendment debated in House of Lords Blog published in Pharmacy magazine Meeting with the Minister secured

New collateral shared with stakeholders

New collateral shared with stakeholders

Member survey

Member survey

Q2 results to come later…

56%

have ‘some confidence’ with the Government’s handling of negotiations to date

44%

have ‘some confidence’ with the Government’s ability to

• btain a ‘good’ deal for the

consumer healthcare industry

63%

feel that the consumer healthcare industry’s views are being ‘taken into account to a small extent’ by government

50%

are planning for the UK to ‘crash out’ of the EU with no deal

Almost 25%

feel that a transition period longer than two years is needed (but more than 75% do not)

Over 25%

estimate ongoing costs of more than £1m per year as a result of leaving the EU

Points to note:

• Baseline from which future results marked against
• Shared with key stakeholders
• Reminder: high response rate is vital

Key stakeholder meetings

Ed Jones (Special Adviser to Jeremy Hunt)

26 April 2018 with John Smith and David Barnett 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 O'Shaughnessy (Health Minister)

30 April 2018 with John Smith, Chris Mummery and Donna Castle 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 Changing Europe (influential think tank)

9 May 2018 with Donna Castle Secured following dissemination of OTC medicines supply chain graphic 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

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 Following anonymised interviews with five member companies, a report with two sets of recommendations has been shared with government to inform their contingency plans:

Response to ‘no deal’ paper

26

Would PAGB members welcome a time-limited commitment to unilateral recognition? Further details on settlement scheme to be announced Problems at the border are likely to be due to France’s reaction

Regulatory update on key meetings

Katharine Mason

Key meetings

Medicines Industry Liaison Group 25 Apr Medical Devices Industry Liaison Group 26 Apr MHRA Cross trade “deep dive” 14 May FDF EU Exit Roundtable 23 May CMDh Interested Parties meeting 29 May

Key meetings coming up

FDF EU Exit Roundtable 19 June 'BREXIT: What does it mean for the Life Sciences?' Summit 20 June MHRA Cross trade “deep dive” 9 July Medicines Industry Liaison Group 17 July Medical Device Industry Liaison Group 5 Sept

MHRA Cross trade “deep dive”

The MHRA consider the following as “confirmed” regarding the Implementation Period:

market access would not change firms could continue to batch release and QP certification mutual recognition of manufacturing, distribution and associated inspections mutual recognition with UK and third country authorities agreed by the EU would remain in place marketing Authorisation Holders could continue to be in the UK Notified Bodies can continue to be in the UK

MHRA Cross trade “deep dive”

However the role of the Regulator would change and MHRA would:

have no formal role in legislation updates a restricted role in meetings not be able to lead new assessment work as Rapporteur, RMS

Industry representatives noted that the EMA’s stance was that the MHRA would have no role.

CMDh Interested Parties

CMDh confirmed that it cannot comment on implementation period because everything depends on the outcomes of negotiations EMA and CMDh made clear onus is on industry to be prepared e.g.

Medicines for Europe highlighted 1/6 of companies currently blocked from switching RMS because of an

• ngoing regulatory process

Challenge for industry is there are very few “windows” to switch RMS CMDh rejected solution suggested

PAGB member updates on any activities

Update on discussions with small-medium sized companies

John Smith

Small-medium companies

• PAGB adding value
• Very positive
• Therapy session
• Incisive Health invaluable
• Trying really hard to influence
• Other comments
• Taking more and more company effort
• Anxious about possible outcome
• Looking for guidance to navigate Brexit
• Get through Brexit unscathed
• MRA only possibility

Small-medium companies

• Additional assistance
• Identify 3rd party consultants re QPs and QPPVs
• Guidance re timing of application
• Change from UK to EU – can applicant choose effective date?
• Active communication when things are really changing
• Do we have to log in every time?
• More guidance on medical devices
• Could we invite a Notified Body to a meeting?
• Are we linked with ABHI?

Member survey results

Incisive Health

Overall response rate

Q1: 17 (40%) Q2: TBC (TBC%)

Confidence in Government handling of negotiations

56%

have ‘some confidence’ with the Government’s handling of negotiations to date

Q1 HOLD Q2 statistic

Confidence in Government’s ability to

• btain a good deal for consumer health

44%

have ‘some confidence’ with the Government’s ability to obtain a ‘good’ deal for the consumer healthcare industry

Q1 HOLD Q2 statistic

Extent to which consumer health views are being taken into account

63%

feel that the consumer healthcare industry’s views are being ‘taken into account to a small extent’ by government

Q1 HOLD Q2 statistic

Scenarios members are preparing for

50%

are planning for the UK to ‘crash out’ of the EU with no deal

Q1 HOLD Q2 statistic

Length of the transition period

Almost 25%

feel that a transition period longer than two years is needed (but more than 75% do not)

Q1 HOLD Q2 statistic

Estimated costs of leaving

Over 25%

estimate ongoing costs of more than £1m per year as a result of leaving the EU

Q1 HOLD Q2 statistic

Key asks and activities for Q3: July to September

Incisive Health and John Smith

Agreed strategic approach

Be the expert: position PAGB as the ‘go-to’

• rganisation
• n consumer

healthcare- related EU exit issues Be vocal: use existing (and create new)

• pportunities

to make the case for our priority asks

Priority asks

Ensure appropriate mutual recognition agreements are in place to allow OTC / self care products manufactured in the UK to continue to be exported to the EU and vice versa Secure a simple transition process to any new arrangements, which is at least two years but ideally five years, and during which there is no divergence from EU regulations

Ask Progress

Ensure appropriate mutual recognition agreements are in place to allow over-the-counter / self care products manufactured in the UK to continue to be exported to the EU and vice versa Secure a simple transition process to any new arrangements, which is at least two years but ideally five years, and during which there is no divergence from EU regulations

Progress on asks

Proposed activities Q3 2018

Be the expert

• Ongoing intelligence-

gathering

• Repeat of members’

survey

• Food supplements supply

chain

• Position paper on

devolution of EU powers

• European consumer

healthcare map

Be vocal

• Select Committee

engagement – call for investigation into no deal planning

• Continuation of

stakeholder meeting programme (eg Brexit Health Alliance)

• Response to the EU Exit

White Paper

• Secure further blog
• pportunity

EU Exit Seminar

• Benefit to members?
• Key topics / contents?
• Objective?

Coach feedback