Prof. Guido Rasi EMA Nominated Executive Director EMA-EuropaBio Information Day, London 15 October 2015

EMA - focus on the future

Trends and strategic goals

EMA tools to support innovation

Focus on patients

1

1 - Trends and strategic goals

2

Global environmental changes / trends

Costs for R&D are increasing

Cost of innovative medicines are increasing

Investments are moving away from Europe

Ageing population will drive up consumption of medicines

Number of expiring patents steadily decreasing

Supply chain is increasingly complex, medicines shortages in some areas

3

0

200

400

600

800

1000

1200

1400

1600

1800

2007 2008 2009 2010 2011 2012 2013 2014

Phase I

Phase II

Phase III

Phase IV

Clinical Trials in Europe

4

SCADENZA DIRITTI BREVETTUALIITALIA 1996-2017

0

10

20

30

40

50

60

70

80

90

100

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

ANNO SCADENZA BREVETTO

NU

MER

O P

RIN

CIPI

ATT

IVI

“Innovation”/Patent expiration

Expiry of patents - Italy 1996-2017

5

Strategic considerations (EU regulatory network challenges)

Sustainability

Health systems (medicines cost, NCAs/EMA)

R & D (patient access to innovation, Europe competitiveness)

Quality

Scientific opinions (complexity)

Medicines (safety, efficacy, availability)

6

Strategic priorities for EMA & the Network

Optimising the operation of the network of national authorities and EMA

o Common strategy to 2020 o Common telematics governance strategy o Network training centre o Multinational teams

Access to innovation

o Adaptive pathways o PRIME

7

Strategic priorities for EMA & the Network, cont..

Global regulatory environment o Data integrity o Global capacity building o Convergence of global standards

Transparency and communication

8

s Sustainability Quality

Some of the initiatives Health systems (medicines cost,

HTA/payers, NCAs/EMA)

R & D (patients access, competitiveness)

Scientific opinions

(legal, procedural complexity)

Medicines (pharmacovigilance, inspections, supply chain/shortages)

Network Training Centre

Multinational teams

Telematics

PRIME

Adaptive licensing

Clinical data publication

Joint advice (HTA/Payers)

Fee impl rules

Big data

9

Hub of expertise for the centralised and national assessment

Hub for local industry (National scientific advice and link with the centralised advice)

Hub for pharmacovigilance and market surveillance capabilities

Link to HC systems, Health Care Professionals and patients

Hub for post marketing data generation (HTA/payers)

Strong EU Regulatory Network for sustainability and quality

10

2 – EMA tools to support Innovation

11

Facilitating medicines research and development

EU Regulatory pathways

Research & Development support

Medicines & Technology

Horizon scanning

Cost of Development

Adaptive pathways/ Best evidence generation

SA /Parallel HTA Orphan /Paediatric

ATMP/SME PRIME

Innovation Task Force /Innovation Network/

Business Pipeline

Innovative Medicines Initiative (PPP)/ Horizon

2020/…

12

3 – Focus on Patients

13

1996

Dialogue with HIV patients

2000

Patients members of COMP

2005 Framework of interaction with patients’ and consumers’ organisations

2006 Patients and Consumers Working Party (PCWP)

2014… - Real life experience routinely embedded in EMA regulatory output

- Dedicated Patients and Healthcare Professionals Department created

EMA interaction with patients:

The journey … so far

14

0

200

400

600

20072008

20092010

20112012

20132014

76 167 213 307 423 525 551 586

Number of cases of patient involvement in EMA activities

(2007–2014)

Increasing number of patients in EMA activities

15

Orphan

Designation

Scientific

Advice

Paediatric

Investigation

Plan

PRESUBMISSION

COMP

PATIENT INPUT

COMP

PATIENT INPUT

COMP

PATIENT INPUT

EVALUATION

Marketing

Application

Evaluation

CHMP

CAT

PRAC

PATIENT INPUT

SAG

PATIENT INPUT

Post Marketing

Authorisation

CHMP

PRAC

PATIENT INPUT

SAG

PATIENT INPUT

RE

GU

LA

TO

RY

PR

OC

ED

UR

E

DO

CU

ME

NT

S

FO

R T

HE

PU

BLIC

CO

MM

ITT

EE

ES

AN

D W

OR

KIN

G

PA

RT

IES

POST AUTHORISATION

Package Leaflets (PL)

EPAR summaries

PATIENT INPUT Safety

Communications

PATIENT INPUT

Opportunities for involvement throughout medicines lifecycle

Thank you for your attention

European Medicines Agency

30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom

Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555

Send a question via our website www.ema.europa.eu/contact

Further information

Follow us on @EMA_News