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Engaging with EMA methodology
- 1. An agency of the European Union Stakeholder engagement at EMA EURORDIS Summer School 2018
- 2. Who we are
- 6. EMA Stakeholder engagement EMA and patients and consumers 5
- 7. An interaction foreseen by EU Legislation EMA and its Stakeholders
- 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
- 13. EMA Stakeholder engagement EMA and Healthcare professionals 12
- 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
- 17. EMA Stakeholder engagement EMA and academia 16
- 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
- 20. EMA Stakeholder engagement Patients and consumers and healthcare professionals level of engagement 19
- 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
- 23. Increasing involvement in EMA activities 167 213 307 423 525 551 663 743 770 925 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Patients and Consumers (2008-2017) Healthcare professionals (2008-2017)
- 24. EMA Stakeholder engagement Patients and consumers, healthcare professionals and academia lessons learnt 23
- 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
- 30. Learned societies/ healthcare professional organisations Patients’ and consumers’ organisations
- 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…
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- 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.
- 25 June 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…
- 25 June 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.