Post on 08-Apr-2018
transcript
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
1/26
The Patients Voice
at the
European Medicines Agency(EMA)
Dr Mary Baker, MBEPresident, European Brain Council
President, European Federation of Neurological Associations
5th European Patients Rights Day
Brussels
With grateful acknowledgement to:
Isabelle Moulon
Head of Medical Information, European Medicines Agency
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
2/26
EMA: What does that mean?
The EMA is responsible for:
The evaluation of the Marketing Authorisation
applications submitted by pharmaceutical
companies, for certain types of products
Provision of scientific advice on the development
of medicines
Coordination of pharmacovigilance at European
level (supervision of the medicines on the market)
Coordination of the inspection activities
Provision of information to the public
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
3/26
The EMA Network
EMA partners with
-More than 40 nationalcompetent authorities
-4000 EU Experts
-European Parliament
-European Commission
Relation with non-EU regulatory authorities, international health
organisations, industry academia, and the general public
A unique structure:
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
4/26
Representation of patients
at the EMA Management Board: 2 representatives of patients
organisations
Committee for Orphan Medicinal Products (COMP):2 representatives of patients organisations + 2 observers
Paediatric Committee (PDCO): 3 representatives of patients
organisations
Committee for Advanced Therapy (CAT): 2 representatives
EMA Patients and Consumers Working Party (PCWP)
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
5/26
Other participation of patients
to EMA activities
Quality-checking of product information for medicines
and EPAR summaries (European Public Assessment
Report)
Proactive involvement in guideline preparation
Responding to specific requests from EMA scientific
committees, working parties, scientific advisory groupsetc
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
6/26
EMA Patients & Consumer Working Party
4 Meetings a year
10 PCWP Members out of22 eligible Organisations
+ representatives from scientificcommittees
Co-chair elected: Nikos Dedes
1 joint meeting a year with HealthcareProfessionals Working Party
1 meeting a year with all 22 eligible
organisations
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
7/26
Criteria to be fulfilled by Patients
& ConsumersO
rganisationsinvolved in EMA Activities(EMA/14610/04/Final)
Not-for-profit
Focus on patient/consumer care
Representative of patients/consumers
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
8/26
Which are the eligible
Patients and Consumers Organisations?
Criteria
Legitimacy
Mission Objectives
Activities
Representativeness
Structure Accountability
Transparency
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
9/26
Role of the PCWP
To provide recommendations to the EMA and its Scientific
Committees from patients on all matters directly and
indirectly related to medicines:
Implementation of the recommendations and proposals for action
Provision of information on medicines
Development of appropriate communication tools
Increasing awareness of patients on the rational use of medicines
Training patients and consumers
Provision of advice to Scientific Committees
Interaction with other interested parties: e.g. healthcare professionals,
pharmaceutical industry
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
10/26
Role of the Members
Each member represents his/her organisation:
He/she is responsible for presenting the organisations
position on the topics discussed
He/she is responsible for informing his/her organisation
about the PCWPs activities
Each member fills in a declaration of interest
None of the discussions/topics is confidential
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
11/26
The PCWP Work Plan
Product information
Pharmacovigilance
Support to EC Strategy to
Strengthen the Community
System
Review of Patients leaflets and
EPAR summaries
Transparency anddissemination of information
Direct patients reporting of
adverse drug reactions
To provide input on ongoing
restructuration of the EMA website
Interactions EMA Patients
and Consumers
Organisations
Explore further involvement
Benefit/risk communicationBenefit/risk communication
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
12/26
Involvement of patients during the
evaluation processAd hocinvolvement:
Consultation of PCWP on the wording of thePackage Leaflets (e.g. NSAIDs): how to express thewarnings on cardiovascular risk.
Consultation of patients and thalidomide victimsduring the evaluation of Revlimid (lenalinomide) onthe Package Leaflet and the risk management plan.
Consultation of patients:
- during the evaluation of Tysabri (natalizumab)
- for the recall of Viracept (nelfinavir)
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
13/26
Other activities in which patients &
consumers are involved
Workshop (User Testing, Transparency)
Website design (corporate & paediatric)
EudraPharm development
Observer in the Pharmacovigilance Working
Party
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
14/26
Benefit of involving patients
They bring unique input and a different perspective
highlighting real-life implications of regulatory
decisions
Their involvement brings more transparency in theregulatory process and as a consequence helps to
build trust in the regulatory process
Their contribution is very often taken into account
and improves the regulatory outcome
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
15/26
Issues to be considered
Need to define the roles of the patients
Lack of resources in the organisations
Need for training to understand theregulatory environment
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
16/26
HTA Summer School
for patient groupsCollaboration between EFNA andLondon School of Economics:
September 2009 May 2010
June 2010
September 2010
June 2011
September 2011
Working for people living with brain disorders
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
17/26
Patient Experience Network
National Awards 2010
Criteria YourScore
Description WinnersScore
Innovation 220 Demonstrates a very high level ofinnovation and ambition, well abovethat expected in their sector
190
Transferability 244 Is easily transferable as a completeprogramme to other organisations/settings with little or no adaptationrequired.
180
The new world require more and more decision making to be evidence based by those as
close to patient care / the patient as an entity themselves. The use of material to get patients
to take such responsibility is the right way forwards.
Extract from Benchmark Scores and Judges remarks
Access to Information: Ranked Second Place
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
18/26
Societal responsibility
Understanding benefit/risk
An informed patient is a cost
effective patient (Wanless)
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
19/26
The Patients journey
Information is needed from:
Clinician - about the disease
Industry - about the medication
Patient NGOs - about fellow travellers
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
20/26
Rx
HTA review ~ 2
years
New drug application &
review
~ 2 years
Preclinical & clinical development
~ 8 years
From the bench to the bedside
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
21/26
Rx
HTA review ~ 2
years
New drug application &
review
~ 2 years
Preclinical & clinical development
~ 8 years
From the bench to the bedside
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
22/26
Rx
HTA review ~ 2
years
New drug application &
review
~ 2 years
Preclinical & clinical development
~ 8 years
From the bench to the bedside
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
23/26
Rx
HTA review ~ 2
years
New drug application &
review
~ 2 years
Preclinical & clinical development
~ 8 years
From the bench to the bedside
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
24/26
The biggest threat
Competition
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
25/26
Partnership is the only way
8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations
26/26
It is not the strongestof the species that
survives nor the most
intelligent thatsurvives. It is the one
that is most adaptable
to change.
Charles Darwin
1809 - 1882