This document discusses stakeholder engagement at the European Medicines Agency (EMA). It provides an overview of EMA's engagement with patients and consumers, healthcare professionals, and academia. EMA has engaged with these stakeholders since its creation in 1995, and has developed frameworks to facilitate interaction and collaboration. Key milestones in EMA's engagement include establishing working parties for patients and healthcare professionals, and creating a dedicated department for stakeholder relations. Challenges in stakeholder engagement include finding and training suitable experts, and measuring the impact of involvement. EMA addresses these through criteria for eligible organizations, support and training resources, and transparency around its engagement activities.
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Is there patient involvement in HTA? Can patients influence HTA decision making?Kathi Apostolidis
Is HTA purely technical?
drivers for patient involvement in HTA
patient participation or tokenism
medicines do not reach patients due to delays in HTA evaluation
need for harmonized HTA
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Is there patient involvement in HTA? Can patients influence HTA decision making?Kathi Apostolidis
Is HTA purely technical?
drivers for patient involvement in HTA
patient participation or tokenism
medicines do not reach patients due to delays in HTA evaluation
need for harmonized HTA
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
How Effective is the Public in Influencing HTA Decisions?Kathi Apostolidis
Patients should be involved in HTA process to assure a robust process that embraces patients' needs, preferences, perspectives. ECPC-European Cancer Patient Coalition leverages on European Institutions for a solution to the timely authorization and reimbursement of innovative cancer medicines
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Drug development and treatment strategies may go hand in hand.EUPATI
How early in the development of a new medicine should the discussion between researchers and patients occur? Can such early strategic interaction really maximize the value of the outcome? In this EUPATI webinar, a pharmaceutical industry researcher and a patient expert will present two cases describing the research questions, their interaction and the outcome of this early collaboration. Join us in listening and discussing two very interesting experiences of successful patient involvement in the development of new medicines.
A very important result from the EUPATI project was the development, broad consultation and final release of guidances on the best approach to interaction of patients with pharmaceutical industry-led medicines R&D, regulatory authorities, ethics committees and HTA agencies. This webinar focuses on the Patient Involvement in Industry-led R&D guidance document
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
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Tripartite dimension of interaction of patients, regulators and industry, presented by Jan Geissler as a scene-setting presentation at the EUPATI Workshop on the interaction of patients, regulators and industry on 20 July 2016 in Berlin
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
How Effective is the Public in Influencing HTA Decisions?Kathi Apostolidis
Patients should be involved in HTA process to assure a robust process that embraces patients' needs, preferences, perspectives. ECPC-European Cancer Patient Coalition leverages on European Institutions for a solution to the timely authorization and reimbursement of innovative cancer medicines
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Drug development and treatment strategies may go hand in hand.EUPATI
How early in the development of a new medicine should the discussion between researchers and patients occur? Can such early strategic interaction really maximize the value of the outcome? In this EUPATI webinar, a pharmaceutical industry researcher and a patient expert will present two cases describing the research questions, their interaction and the outcome of this early collaboration. Join us in listening and discussing two very interesting experiences of successful patient involvement in the development of new medicines.
A very important result from the EUPATI project was the development, broad consultation and final release of guidances on the best approach to interaction of patients with pharmaceutical industry-led medicines R&D, regulatory authorities, ethics committees and HTA agencies. This webinar focuses on the Patient Involvement in Industry-led R&D guidance document
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
Tripartite dimension of interaction of patients, regulators and industry (Jan...jangeissler
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Introduction
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Childhood and Athletic Beginnings
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8. In the beginning…
1995
1996
EMA
created
Dialogue
with HIV
patients
Patients join
COMP as full
members
Working
group with
patients
created
Framework of
interaction
with patient
and
consumer
organisations
Ongoing…
Patients
and
Consumers
Working
Party
(PCWP)
created
Dedicated
Patients and
Healthcare
Professionals
Department
created &
framework
updated
Systematic
inclusion of
real life
experience
EMA
regulatory
output
Public
Hearing
2000 2005 2014
2003 2006 2017
Patients, Healthcare Professionals and Academia at EMA
1996
Building the foundation of the interaction between EMA and
patients
• EMA Management Board signalled of the danger of
neglecting partnership with stakeholders, public, healthcare
professions and pharmaceutical industry
• EMA started dialogue with HIV patients on the value of
surrogate markers in the approval of anti HIV drugs leading
to the early approval of protease inhibitors
9. Five years later…
1995
1996
EMA
created
Dialogue
with HIV
patients
Patients join
COMP as full
members
Working
group with
patients
created
Framework of
interaction
with patient
and
consumer
organisations
Ongoing…
Patients
and
Consumers
Working
Party
(PCWP)
created
Dedicated
Patients and
Healthcare
Professionals
Department
created &
framework
updated
Systematic
inclusion of
real life
experience
EMA
regulatory
output
Public
Hearing
2000 2005 2014
2003 2006 2017
Patients, Healthcare Professionals and Academia at EMA
Observers
Young
people
Oral
explanations
10. Framework and working party
Working
group with
patients
created
Framework of
interaction
with patient
and
consumer
organisations
Ongoing…
Patients
and
Consumers
Working
Party
(PCWP)
created
Dedicated
Patients and
Healthcare
Professionals
Department
created &
framework
updated
Systematic
inclusion of
real life
experience
EMA
regulatory
output
Public
Hearing
2005 2014
2003 2006 2017
Patients, Healthcare Professionals and Academia at EMA
Patients’ and Consumers’ Working Party (PCWP)
11. A framework of interaction based on five critical elements
1. A network of European patients and consumers
organisations
2. A forum of exchange: EMA Working Party with
Patients and Consumers’ organisations
3. A pool of patients acting as experts in their disease
and its management
4. Interaction with the EU Regulatory Network
5. Capacity-building focusing on training and raising
awareness about EU regulatory system
10
12. Collaboration with patients: the EMA journey
1995
1996
EMA
created
Dialogue
with HIV
patients
Patients join
COMP as full
members
Working
group with
patients
created
Framework of
interaction
with patient
and
consumer
organisations
Ongoing…
Patients
and
Consumers
Working
Party
(PCWP)
created
Dedicated
Department
created &
framework
updated
Systematic
inclusion of
real life
experience
EMA
regulatory
output
Public
Hearing
Involvement
of young
people
2000 2005 2014
2003 2006 2017
11
14. Healthcare professionals and EMA
EMA recognised the importance of bridging the regulatory and real-life clinical practice worlds.
Healthcare professionals are part of:
• Management Board
• Scientific committees
• Working parties
• Expert groups
• Also as individual experts
15. Healthcare professionals – who are they?
14
• General practitioners and family physicians
• Hospital pharmacists
• Pharmaceutical group
• Nurses (specialised or general)
• Specialists (e.g. diabetes, oncology, epilepsy, geriatrics, paediatrics…)
16. Framework
Framework of interaction
with healthcare professionals
Action plan
The framework aims to:
• Support access to best possible independent expertise in clinical practice,
• Contribute to a more efficient and targeted communication to healthcare
professionals,
• Enhance understanding of the role and activities of the EU medicines
Regulatory Network.
Recognises:
• Importance of involving healthcare professionals in the field of clinical
practice foresees the establishment of pools of experts
• Need to stimulate areas of shared interest with academia
• Further strengthen the established collaboration with patient and consumer
organisations
18. EMA and academia
• There has always been an interaction between
academia and regulators
• No direct mention of academia in regulations - many
references to regulatory decisions based on scientific
evidence
17
• Framework created supporting interaction and dialogue between EMA, academia and
broader EU scientific communities
• Revised healthcare professionals framework focused primarily on clinical practice
• Academia framework focuses on research and education
• Common objectives shared in both frameworks
19. Academia pages on EMA website
The framework objectives are:
•Raise awareness of the work of the European medicines
regulatory network
•Promote and further develop the regulatory support to
academic research
•Support timely and effective evidence generation, regulatory
advice and guidance
•Work in collaboration with the regulatory network in developing
regulatory science
Framework of collaboration
with academia
Academics and researchers and the EMA
Action plan
21. • Management Board
• EMA Scientific Committee Members
Representing their
community
• Working Party (PCWP or HCPWP)
• EMA consultations
• Workshops
Representing their
organisations
• Scientific Advice / Protocol Assistance Procedures
• Scientific Advisory/ad hoc expert Groups
• Scientific Committee consultations
• Review of documents
Individual experts
Patients and consumers and healthcare professionals:
Representation within EMA
Patients, Healthcare Professionals and Academia at EMA
22. Involvement along the medicine lifecycle at EMA
CHMP
PRAC
Post Marketing
procedures
Expert
mtg
POST AUTHORISATIONPRE-SUBMISSION
COMP
CAT
CHMP
SAWP
PDCO
Designation &
Classification
Scientific
Advice
Paediatric
Plan
EVALUATION
CHMP
CAT
PRAC
COMP
Marketing Authorisation
Evaluation
Expert
mtg
Product
information
Product
information
Safety
Communications
HCP input
Public
Summaries
of Opinion
Patient input
Patients, Healthcare Professionals and Academia at EMA
25. Challenges for patients
24 Patients, Healthcare Professionals and Academia at EMA
• Finding suitable patients (e.g. language barrier, availability)
• Ensuring comprehensive, tailored training to facilitate and enhance
participation
• Provide a clear definition of patients role in the different activities /
committees to manage expectations from all angles
• Managing potential conflicts of interest
• Representativeness
• Measuring the value / impact of patients
26. • Maintaining interest and levels of participation in EMA activities
• Ensuring consistency in provision of feedback
• Providing contextualised information of EMA activities
• Striking the right balance between clinical practice and academic/research interests
• Expanding outreach
• Research how to collect and use the wealth of information available from healthcare
professionals in post-marketing phase
Patients, Healthcare Professionals and Academia at EMA
Challenges for healthcare professionals
27. Challenges for academia
• Building of an effective working model for enhancing and fostering collaboration
• Creation of a space of convergence that would allow for changes in the modus operandi
on both sides while balancing between the constraints of regulation and the free breathing
space of research and innovation.
• Capacity and financial resources represent a major challenge for academics
• Communication and engagement are key areas
Patients, Healthcare Professionals and Academia at EMA26
28. How to address the challenges
•Who to interact with?
• Creating a diverse group of stakeholders to consult
• Criteria for organisations
• Individual experts
•How to interact?
• Methodologies for engaging stakeholders
• Support and training
• Develop appropriate content and ensure targeted communication
•Transparency
•Monitoring and reporting
Patients, Healthcare Professionals and Academia at EMA27
29. Who do we work with?
Through a network of eligible organisations fulfilling the following criteria:
Legitimacy
Mission/activities
Representation
Structure
Accountability
Transparency
31. Who do we work with?
• Any organisation representing EU patients or consumers may express an interest
to work with the Agency, however they must meet the defined eligibility criteria
(application form on the EMA website)
• List of eligible patients & consumers organisations published on the EMA website
• Individuals can also register to be involved
30
All images hyperlinked
32. How does EMA engage?
Face
to
Face
In
writing
Surveys
Preference Elicitation
Committee
meetings
Patients, Healthcare Professionals and Academia at EMA
Conference
calls
33. What support and resources are available?
Annual
training
day
Webpages
One-to-one
personalised supportVideos; EMA basics Info-sheets
34. Information to stakeholders
It is important to provide targeted information to
the right stakeholder group
Involve them in the review of the documents
Training resources also available:
• Leaflets and information sheets
• Short videos explaining the role of EMA and its
activities
33
35. Transparency
• Declarations of Interest – publication of declarations and CVs of individual experts
• Eligibility criteria for organisations and publication of funding
• Publication of agendas, minutes, highlights of committees
• Civil society members in committees
• Proactive publication of clinical trial data
• Public Hearing
Patients, Healthcare Professionals and Academia at EMA34
36. Monitoring and measuring
• Questionnaires sent to patients who participate
• Proposals for improvements included in the next work-plan
• Annual report to EMA Management Board
Feedback
• Meeting minutes
• Thank you acknowledgement
• Comments taken into account
Annual reports
with
summaries of
feedback
35
37. • Engagement with stakeholders:
Brings the aspects of researching, living with a disease into the scientific
discussions and helps bridge the gap between clinical trial data and real world data
Improves transparency and trust
Increases understanding and dissemination of EMA outcomes
• ALL perspectives are crucial and have ultimately resulted in more meaningful
decisions for all concerned.
Importance of engaging with stakeholders in EMA
36
38. Any questions? Maria Mavris
Patient Liaison
Public Engagement Department
maria.mavris@ema.europa.eu
www.ema.europa.eu
European Medicines Agency
30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5550
Send a question via our website www.ema.europa.eu/contact
37
Editor's Notes
EMA is a scientific body;
It is a decentralised agency of the European Union established in 1995 to evaluate medicines for use in people and animals in the EU;
EMA brings together the best scientific expertise on medicines from across the whole of the EU;
EMA works with seven scientific committees who evaluate medicines along their life cycle from early stages of development, through marketing authorisation to the safety monitoring once they are on the market; the committees are supported by 28 working parties;
All of this is underpinned by a network of over 4000 scientific experts who are made available to EMA by the national competent authorities (more about the network in the next slide). At EMA’s London headquarters, there are around 890 staff members; EMA staff help to support, coordinate and facilitate the work of the committees;
EMA is a guardian of public health in the EU.
EMA is a scientific body;
It is a decentralised agency of the European Union established in 1995 to evaluate medicines for use in people and animals in the EU;
EMA brings together the best scientific expertise on medicines from across the whole of the EU;
EMA works with seven scientific committees who evaluate medicines along their life cycle from early stages of development, through marketing authorisation to the safety monitoring once they are on the market; the committees are supported by 28 working parties;
All of this is underpinned by a network of over 4000 scientific experts who are made available to EMA by the national competent authorities (more about the network in the next slide). At EMA’s London headquarters, there are around 890 staff members; EMA staff help to support, coordinate and facilitate the work of the committees;
EMA is a guardian of public health in the EU.
Setting the scene …
EMA serves a market of over 500 million people living in the European Union;
EMA protects public and animal health in 28 Member States (+ EEA countries) by ensuring that all medicines available on the EU market are safe, effective and of high quality;
The medicines EMA recommends for marketing authorisation account for 27% of global pharmaceutical sales.
First and foremost, EMA protects human and animal health;
EMA facilitates medicines development by giving scientific advice and providing guidance to developers of medicines, including on the development of medicines for children, The Agency has a specific programme in place to facilitate the development of medicines for rare diseases (orphan designation programme);
EMA carries out robust scientific evaluations of medicines for human and veterinary use; the outcomes of our evaluations are the basis of the European Commission’s decision on whether a medicine can be authorised for marketing throughout the EU. The company which produces the medicine can only market the medicine once it has received a marketing authorisation from the Commission;
EMA monitors the safety of medicines in the EU after they have been authorised;
EMA provides information on human and veterinary medicines to healthcare professionals and patients.
In 2004, Regulation 726/2004 stated that ‘appropriate contacts’ should be developed with industry, consumers, patients and health professionals…
02 July 2018
02 July 2018
02 July 2018
02 July 2018
02 July 2018
The ultimate goal is to bring on board organisations that represent different fields of clinical expertise and practitioners in Europe (e.g. doctors, pharmacists, nurses; generalists or specialists), active within the broad spectrum of health care, including primary care.
02 July 2018
Now we come to the EMA and academia, and the interactions of regulators with academia have also existed since the creation of EMA…
While other frameworks were created – interactions with academics did not become formalised until very recently
Use text from slide…
02 July 2018
The different ways that patients and healthcare professionals can be involved in EMA activities –
Patients and HCP are involved in the management board and in EMA scientific committees in the capacity of representing their communities i.e. they represent all patients organisations or all HCP organisation
On the working parties and in EMA consultations or workshops they are there in the capacity of representing their own organisation
Whereas in cases where they are invited to contribute to Scientific Advice or Scientific Advisory Groups, committee medicine-specific consultations or when they review documents – they do so as individual experts, even if they have been identified via an organisation.
This is a visual representation of where stakeholders are involved all along the lifecycle of a medicine…
In this figure we show that patients and HCP are involved all along the medicines lifecycle from pre-submission to evaluation to authorisation as members of committees or in expert meetings or in the review of documents..
Here we see the increasing numbers of these stakeholders across the years, which reflects not only the increase in involvement of these stakeholders but is also reflective of the increase in the diversity of activities where they are involved…
The process of working with patients has been a mutual exchange and learning.
The challenges for this stakeholder group are different (and similar) to those for patients…
We need to ensure that we can demonstrate the value to them of their participation in EMA activities and part of this is achieved by providing feedback and outcomes..
While we do not necessarily ‘train’ the HCP, we do need to provide tailored information that puts regulatory concepts into the right context
It is also important to remember that many healthcare professionals wear ‘two hats’ and may also be classified as academics or researchers, therefore striking the right balance between clinical practice and research interest is key to maintaining their interest…
As mentioned, there is a diversity in who is encompassed by the term healthcare professionals … and we need to continue to reach out to groups such as specialised nurses and family doctors in addition those with whom we already interact…
Finally, similarly with patients, we need to look into how best to collect and use the information that is available once a medicine is on the market and being prescribed and used in order to ensure the safety of the medicine and the best use of this information…
Some of the challenges surrounding the involvement of academia include first defining who we refer to when we use the term academia…
Then go through the list in the slide…
Implement the EMA framework for collaboration with academia in light of their role in pharmaceutical innovation and seeding SMEs creation. 6. Guide academic sponsors to seek scientific advice early in development and review opportunities for fee incentives. New Academia 2018-2019
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/05/WC500228736.pdf
Over the years of interaction – different challenges have presented themselves – solutions can be found be engaging with the stakeholders to better understand their needs and addressing these within the remit of the Agency…
We work with a network of organisations who must fulfill certain criteria… their logos are displayed on the website…
All the eligible organisations based on criteria from previous slide… and 20 of each of these selected to join…
Many engagement methodologies exist and have been used… will describe each of these
It is important to provide support and access to resources – providing information in a language and format that is accessible and relevant to each stakeholder and at times to each individual….
When addressing different stakeholder groups – it is important to consider the audience and tailor the information for them.
EMA also involves patients and healthcare professionals in review of documents destined for that particular audience group.
Training/Resource material is also needed to help people understand the role of EMA and its activities and to see where they can be involved.