5th european patients rights day / mary baker, european federation of neurological associations

8/7/2019 5th European Patients Rights Day / Mary Baker, European Federation of Neurological Associations

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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


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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


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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:


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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)


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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


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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


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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


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Which are the eligible

Patients and Consumers Organisations?

Criteria

Legitimacy

Mission Objectives

Activities

Representativeness

Structure Accountability

Transparency


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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


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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


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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


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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)


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Other activities in which patients &

consumers are involved

Workshop (User Testing, Transparency)

Website design (corporate & paediatric)

EudraPharm development

Observer in the Pharmacovigilance Working

Party


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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


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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


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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


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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


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Societal responsibility

Understanding benefit/risk

An informed patient is a cost

effective patient (Wanless)


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The Patients journey

Information is needed from:

Clinician - about the disease

Industry - about the medication

Patient NGOs - about fellow travellers


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Rx

HTA review ~ 2

years

New drug application &

review

~ 2 years

Preclinical & clinical development

~ 8 years

From the bench to the bedside


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Rx

HTA review ~ 2

years


review

~ 2 years


~ 8 years



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Rx

HTA review ~ 2

years


review

~ 2 years


~ 8 years



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Rx

HTA review ~ 2

years


review

~ 2 years


~ 8 years



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The biggest threat

Competition


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Partnership is the only way


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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

5th european patients rights day / mary baker, european federation of neurological associations

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