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Impact of Brexit – an

industry perspective

Dr. Isabelle Stöckert

Head RA EMEA

Pharmaceuticals

Bayer AG

21st DGRA Annual Congress

May 2019

The story continues…

Industry Readiness for Brexit

Reflection on Current State of Play

Future Challenges

UK Perspective - New Opportunities and Risks

Concluding Remarks

/// BREXIT Update DGRA /// May 20192

3www.efpia.eu

External Voice – Priority of Actions Required

EU urged to safeguard post-Brexit medical supplies from UK

European pharmaceutical leaders have called on EU member states to do more to safeguard the supply of medicines post-Brexit, suggesting

they had shown a “lack of focus” by prioritising the protection of industries

such as fisheries and finance.

“…we have been concerned by a certain lack of focus, outside of our industry,

on protecting medicines supply.”

Steps should be taken “to prioritise medicines, active pharmaceutical ingredients,

raw and clinical trial materials”…

[industry preparations] “in what is one of the biggest supply-chain logistics

challenges our industry and our health service partners have ever faced”

…“positive action” by the EU in areas such as fisheries, transport and financial services but more

needed to be done to protect public health and ensure drugs continued to reach patients

Bayer was and continues to remain ready for Brexit

Bayer`s Readiness for Brexit today

/// Impact of Brexit from an Industry Perspective /// June 20184

CP Rapporteur-ships

reassigned

DCP procedures with

UK RMS transferred

MAH transfers

completed (MT)

New SKUs for IE/MT

developed

Notified Body move to

NL: Artwork amended

Regulatory

Oversight

Portfolio

Review

Import &

Export

Clinical Trials

Portfolio review started

Q1 2017

EMA pipeline meeting

2018

Baseline dossier

preparation for CP

products

MHRA Portal training/

registration and inflight

MAA meeting

EU QPPV / UK

alignment

Additional UK

warehousing secured

3 months additional

stock imported into

UK

UK WDLs amended

to prepare for UK

Responsible Person

New UK stock

management

systems

Review of UK studies

conducted – critical

studies closely

managed (e.g.

radioactive materials)

deletion of QC testing

in UK for IMPs

UK storage site

warehousing with QP

oversight registered

Additional stock ready

for dispatch to site or

warehouse

NB = Notified Body

WDLs = Wholesales Dealers and importation Licence

5www.efpia.eu

EFPIA Brexit Survey – Readiness as of March

Survey responses n = 38 (survey as of March 12th 2019)

95%Companies putting in placeBrexit business continuity plans

50%Companies with products having post March 29th

approval timelines for Brexit-related changes

95%

Companies with ongoing submissions andregulatory procedures with regulatory agencies

Up to€100M

Financial spend and investments made by companies on business continuity plans

45%

Companies with supply and other mitigations inplace where post March 29th approval timelines exist

Sum

mar

yP

roce

du

res

%’s shown represent percentage of companies

Sum

mar

yP

roce

du

res

(per company)

(95% of the above 50% of companies)

Mit

igat

ion

s

Mit

igat

ion

s

Regulatory Activities – Reflection on Current State of Play

/// BREXIT Update DGRA /// May 20196

Amsterdam is welcomed as new home for EMA

First feedback on EMA interim building/meeting facilities

Very positive to see 75% of staff seems to stay on board

Product related work in general ongoing without disruption

Redistribution of CP work to other agencies

Redistribution of MRP/DCP work from MHRA

Mixed industry feedback

Positive experience within Bayer

Uncertainty will remain – need to mitigate portfolios for a no-deal Brexit

Readiness for Brexit – is uncertainty our future?

/// BREXIT Update DGRA /// May 20197

23 May 2019

31 December 2020

31 October 2019

UK participates in EU EP Elections and

avoids no deal Brexit on 1st June 2019

Deal

• Mrs May’s deal

• Amendment?

• Art 50 further extension

No deal• No deal Brexit

• Revoke Brexit

Political Change

• General election

• Second Referendum

New EU budget: acceptability of

continued uncertainty to EU ?

UK political debate

and voting continues

to try to resolve

impasse

?Further extension

cannot be ruled out

UK parliamentary

impasse will have to be

broken

If agreement on deal

can be reached and

ratified, earlier exit into

transition period

possible

Currently all possible

options remain on the

table including

UK not exiting

UK exiting without a

deal

UK ratifying existing

deal

Bayer plans for both a deal and no-deal Brexit

What future should we plan for?

/// BREXIT Update DGRA /// May 20198

Preferred option remains a Deal:

What will long-term MHRA / EU Network relationship be?

Aim for MHRA to be an active member of the EU Network

No deal scenario results in MHRA sovereign regulator:

MHRA issued technical guidance on new processes

Targeted assessment based on CHMP opinion (67 days)

Accelerated assessment and faster national routes (<150 days)

Rolling review in development to better manage risk

MHRA advice on “in flight” submissions to aid transition

Emphasis is on continued alignment with EU, simplified processes and

consultation with Industry

Regulatory Activities – Future Challenges for Industry

/// BREXIT Update DGRA /// May 20199

Ongoing applications for Innovative products

Still unclear if and when UK MHRA would start own assessment

EMA back to standard operations by January 2020

25% new talents, new hires => takes some time to train and learn

Deletion of Procedural Manager role - leaves companies to rely fully on

one PTL – high responsibility, need for continuous availability

EU Regulatory System – some delays in Assessment Reports observed =>

less time for applicant, no flexibility on industry timelines

10www.efpia.eu

85%Companies making changes to andimplementing alternative supply chains

Regulator capacity

Sup

ply

C

hai

ns

Ch

alle

nge

s an

d C

on

cern

s

Time to transfer

Border disruption

Supplier readiness

Medical devices

Clinical trials

Supply chainCompanies identifyingwhere key challengesor concerns remain(testing and release)

40%

25%

60%

25%

15%

35%

25%

Survey responses n = 38 (survey as at March 12th 2019)

%’s shown represent percentage of companies

Sup

ply

C

hai

ns

Ch

alle

nge

s an

d C

on

cern

s

EFPIA Brexit Survey – Future Challenges

11www.efpia.eu

Quality control test: Flexibility acknowledged by EU Commission

…a high level of preparedness

of the sector.

However, … there may be objective reasons beyond control of the marketing authorisation holders that

may prevent timely transfer … by the withdrawal date.

…competent authorities may allow marketing authorisation holders, for a limited period of time, as

a justified case, to rely on quality control testing performed in the United Kingdom…

(conditions apply)

Letter from European Commission DG Sante to European Medicines Agency (EMA) and EU-27 Heads of

Medicines Agencies (HMA). Temporary exemption from batch testing requirements now available.

March 18th 2019

12www.efpia.eu

Medical Devices: Patchwork of policies within the internal marketThe Commission has not yet developed an EU-wide contingency plan for ensuring the supply of medtech

products certified by U.K. notified bodies

March 18th 2019

UK Perspective – New Opportunities and Risks from Brexit

/// BREXIT Update DGRA /// May 201913

Opportunities:

MHRA/NICE joint assessment

MHRA role on global stage,

Co-operation with other NCAs, and

groups (ICH, ICMRA IMDRF…):

Implementation of innovative

access schemes (AAC) or

authorisation schemes (rolling

dialogue)

increased influence

Risks depend on outcome and timing:

Remaining in EU Network without

significant Assessment Role

Long transition period to

becoming sovereign Regulator or

Sovereign Regulator national

routes slowly implemented, long

assessment times or unaligned

requirements

loss of expertise and decreased

influence

NICE = National Institute for Health and Care Excellence CH = International Conference on Harmonisation

ICMRA= International Coalition of Medicines Regulatory Authorities IMDRF = International Medical Device Regulator Forum

AAC = Accelerated Access Collaborative CTR = Clinical Trial Regulattion

Concluding remarks

/// BREXIT Update DGRA /// May 201914

Industry has prepared for no-deal scenario or is using the extension of Article

50 to complete the necessary work

EMA / EU Network slowly recovering from consequences of Article 50:

Relocation of EMA and move of work to other HA

Resources/expertise loss not yet compensated

Loss of MHRA still being felt

Need to end uncertainty and allow MHRA to move forward as either:

A sovereign Regulator with its own international standing or

As an active contributing part of the future EU Network

OUTLOOK: NOW IS THE TIME TO SHAPE A WORLD

CLASS EU REGULATORY SYSTEM

ELEVATEmulti-stakeholder

engagement

ENSUREa competitive world-class

regulatory system

EVOLVEthe framework for

innovation

EXPANDglobal

convergence

EFPIAs RSC

4e to 2023

Vision

To drive for an agile, competitive and world-class regulatory system in

Europe and beyond that embraces advances in science, technology

and medicines, accelerating access to innovative healthcare solutions

and optimised patient outcomes.

3

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Time to work

together UKEU-27

EMA

UK Perspective – Accelerated Access Collaboration

/// BREXIT Update DGRA /// May 201917

Registration: by Company on HealthTech Connect or UK PharmaScan platforms

Time line: Up to 10 years before availability to NHS

Support: NICE hosts secretariat

Products: medicines, therapeutic, medical technologies, digital, diagnostic

Requirements: evidence of clinical and cost effectiveness, addressing significant unmet need,

application to large populations or high budget impact, enabling a novel mode of action or

enabling significant changes to the care pathway

Support: dedicated case management offering optimised processes, running processes in

parallel and smoother transition between steps in the journey to adoption including:

Generation of real world evidence in addition to RCT

Potential for flexible and confidential commercial arrangements

Pathway transformation funding to drive adoption into the NHS