EMA - focus on the future · EMA - focus on the future Trends and strategic goals EMA tools to...
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Prof. Guido Rasi EMA Nominated Executive Director EMA-EuropaBio Information Day, London 15 October 2015 EMA - focus on the future
Transcript of EMA - focus on the future · EMA - focus on the future Trends and strategic goals EMA tools to...
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
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1 - Trends and strategic goals
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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
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2007 2008 2009 2010 2011 2012 2013 2014
Phase I
Phase II
Phase III
Phase IV
Clinical Trials in Europe
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SCADENZA DIRITTI BREVETTUALIITALIA 1996-2017
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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
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CIPI
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“Innovation”/Patent expiration
Expiry of patents - Italy 1996-2017
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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)
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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
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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
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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
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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
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2 – EMA tools to support Innovation
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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/…
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3 – Focus on Patients
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1996
Dialogue with HIV patients
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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
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20072008
20092010
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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
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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
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DO
CU
ME
NT
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FO
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HE
PU
BLIC
CO
MM
ITT
EE
ES
AN
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OR
KIN
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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
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