Annemiek Van Rensen Dutch College Medicines Evaluation Board, Nertherlanfs

Patient involvement in the Regulatory Agencies, the Netherlands, for 2017 European Patients' Rights Day in Brussels

Patient involvement at the
Medicine Evaluation Board (MEB-CBG)
Annemiek van Rensen, Ph.D
Senior advisor patient participation (PGOsupport, Utrecht, NL)
Member of the Dutch Medicine Evaluation Board (MEB-CBG)

• Focus on the entire life cycle
of a medicinal product
• Patient is important
stakeholder
• Aim: Exchange knowledge and
experience with patients to
strengthen the connection to
the user’s practice
• Transparency on how MEB
operates and create support for
regulatory decisions
Strategic Business Plan of MEB
2014-2018

• Since 2004 “Overleg CBG patiënt & consument”
– 4 meetings per year
– Minutes published on the MEB website
– Different subjects discussed: product issues, regulatory
guidelines, development in medicine regulation, product
information, substitution
• Theme-meetings: biosimilars, patient information,
PROMs, registries
• Questions from (individual) patient organisations
• Specific (joint) actions in response to events
– e.g. Thyrax, medicinal products for ADHD, new safety
information
Goal: Inform Inform and listen
Currently at MEB

• 2013-2014: Pilot on presence of patient
representatives during Board meetings
• Since Oct. 2015 – Annemiek van Rensen - Board
member with focus on patient- and consumer
perspective
Patient involvement in decision making process

5
Future
MEB wants to strengthen the connection with patient
organisations, and involve patients in the decision making
process
- Regulatory guidelines
- Scientific Advice, esp. ‘tailored advice’
- Risk Communication Material
- Patient expertise consultation on a (group of) diseases,
specific topics (e.g. endpoint selection)
Consultation with patient and consumer organisations
http://english.cbg-meb.nl/human/for-patients-and-consumers

The document summarizes the European Patients' Academy on Therapeutic Innovation (EUPATI) project. EUPATI aims to (1) develop and disseminate education on medicines research and development to patients and the public, (2) build competency among patient advocates, and (3) create a public library on patient information. By empowering patients, EUPATI seeks to facilitate greater patient involvement in research and development to support various stakeholders. Running from 2012 to 2017, EUPATI's consortium of 29 members is funded by the Innovative Medicines Initiative to develop objective and credible educational resources.

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This document discusses patient involvement in science, industry, and research. It describes how the Irish Platform for Patient Organizations, Science and Industry (IPPOSI) brings together patient experts and organizations to encourage dialogue and influence decision making. IPPOSI members include patient experts in science and industry. The document also discusses the European Patients' Academy on Therapeutic Innovation (EUPATI) which provides training for patient experts through courses and educational materials. EUPATI aims to facilitate greater patient involvement in research and development.

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This document discusses guidance created by EUPATI for patient involvement in regulatory processes. It provides background on why such guidance is needed, as existing regulations only generally address collaboration and communication but not the specific processes. It describes the process used to develop the guidance, including extensive consultation. It then highlights some key points from the guidance, such as a history of patient involvement at regulatory agencies like the FDA and EMA. It also gives examples of patient involvement at national regulatory authorities in countries like France, Switzerland, and others. Finally, it lists some of the documentation and resources available on patient involvement in regulatory processes.

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The document provides an overview of EUPATI guidance for patient involvement in health technology assessment (HTA). It describes the process used to develop the guidance, which included reviewing literature, holding workshops, and a public consultation. The guidance defines key terms, outlines best practices for involving patients in HTA, and provides resources and references. It aims to support meaningful and ethical collaboration between patients, patient organizations, and HTA bodies.

This document discusses increasing patient involvement in medical research and development. It notes that the medical landscape is transforming rapidly through innovations like personalized medicine and biomarkers. While this benefits patients, it also means smaller trial populations and a need for more post-marketing data. The document advocates for increasing patient involvement in areas like clinical trial design, setting research priorities, measuring quality of life, and pharmaceutical policy. It highlights the European Patients' Academy (EUPATI) project, which aims to empower patients through education on medical research and development processes in order to facilitate greater patient engagement.

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Good practices in patient involvement in HTA

Patients and caregivers have unique knowledge and perspectives about living with an illness that can help inform health technology assessments (HTA). Their involvement is recommended at every stage of the HTA process, from topic selection to disseminating results. However, challenges exist in ensuring patient views are representative and not biased. Different countries in Europe are implementing patient involvement in HTA to varying degrees, with some holding training programs and allowing patient groups to initiate research or contribute to appraisals. Ongoing efforts are needed to strengthen patient involvement through resources, training, and embedding it in all new HTA processes.

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This document discusses Romania's progress toward establishing a national EUPATI platform. It notes that patients are currently represented in law debates regarding the health system and hospital ethics committees, but not in committees for the Romanian Drug Agency or health technology assessment meetings. It then outlines the initial steps taken to form a national EUPATI liaison team, including identifying trainees, academic representatives, media partners, and representatives from healthcare professional bodies. The document concludes by describing how EUPATI can benefit patients and advocates in Romania by increasing health literacy and facilitating greater participation in clinical trials and health policy decisions.

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This document summarizes the discussion from Break-Out Group 1 at the EUPATI 2015 Workshop regarding implementing EUPATI at the national level. Some key benefits of establishing a national EUPATI partner (ENP) include having a central point of contact for health policy questions, connecting diverse stakeholders, and facilitating multi-sectoral cooperation. National partners could include patient organizations, academics, regulatory authorities, healthcare professionals, and pharmaceutical companies. Strategic priorities for ENPs include disseminating EUPATI training and strengthening partnerships. Success would involve raising awareness, securing institutional support and sustainable funding, and becoming a go-to resource. ENPs should focus on building relationships, learning from more established programs, and leveraging partnerships

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The document discusses the EUPATI Patient Expert Training Course. It aims to educate and empower patients to be actively involved in all stages of medicine research and development from drug discovery through regulatory approval. The course includes 150-175 hours of online learning over 6 modules, along with two in-person meetings. It covers topics like clinical trials, ethics, regulations, health technology assessments, and more. The goal is to train independent and knowledgeable patient advocates who can partner with academics, industry, and regulators. Over 300 patients applied for the first class of 50-50 trainees, showing high interest. The course materials were developed by experts from different stakeholders and underwent extensive review.

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The document discusses setting up a National Learning Team (NLT) to establish a European Patients' Academy (ENP) in their country to implement the EUPATI program before the end of 2015. Key points discussed include finding champions in patient organizations, academia, and industry; creating effective partnerships between these stakeholders; developing strategic links and growing networks; and emphasizing the benefits EUPATI can provide like training opportunities and access to resources to promote patient public involvement.

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This document discusses patient involvement in health innovation and research. It introduces IPPOSI, a patient-led organization that advocates for improved patient access to health innovation and meaningful patient involvement in health research and policy. IPPOSI runs various patient-led activities and provides training to educate patient communities. The EUPATI program also trains "expert patients" on medicines research and development to take on leadership roles advising organizations. While challenges remain, patient involvement can provide different perspectives to improve research quality by ensuring methods and outcomes important to patients are considered. Education and training of both patients and researchers is key to furthering patient involvement.

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This document provides guidance on using social media and communication tools effectively for patient organizations. It discusses how to create an online voice, examples from successful patient ambassadors, lessons from their experiences, and techniques for working smart with limited resources. Specific strategies and examples are provided for creating a meaningful brand difference, positioning an organization, running typical awareness and advocacy campaigns, and leveraging tools like social media, websites, videos, and crowdfunding campaigns.

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This document discusses patient involvement at the Medicines Evaluation Board (MEB) in the Netherlands. It makes three key points: 1. The MEB focuses on involving patients throughout the entire life cycle of a medicinal product to ensure the patient perspective is considered. Meetings are held 3-4 times per year and minutes are published online. 2. Strategies for patient involvement at the MEB include having a board member represent the patient perspective, consulting patient organizations on regulatory decisions and guidelines, and creating an online portal for patients. 3. Eliciting individual patient preferences could help identify subgroups with similar preferences to better tailor regulatory decisions and highlight situations where regulator and patient values differ requiring improved communication.

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This document discusses the importance of interaction and partnership between patients, regulators, and industry in medicine research and development. It acknowledges that patient involvement enhances the quality of research, evidence, transparency, and mutual respect. The document outlines some challenges to interaction, including siloed thinking and lack of trust, and notes that EUPATI has helped improve collaboration but long-term sustainability is key. The objectives of the event are to share experiences of pilot projects involving these stakeholders and ensure their interaction is understood and trusted.

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This document discusses the information available to patients once a medicine is authorized, including the product information and European Public Assessment Report (EPAR). It outlines the involvement of patients and consumers in reviewing elements of product information like package leaflets and EPAR summaries. The review process aims to ensure information is clear, understandable, and meets public needs. Patient and consumer organizations provide input on draft documents to assess language use, explanations, and identify unnecessary or missing information from a lay perspective. Their comments notably differ from other reviews and often lead to text changes or revisions for future documents.

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The NICE Office for Market Access provides opportunities for companies to engage with NICE at any stage of product development and adoption. Through tailored engagement and expert advice, the Office helps companies optimize their journey through NICE. The Office offers bespoke packages including early engagement meetings to discuss evidence requirements and managed access approaches, as well as portfolio reviews and multi-stakeholder safe harbor meetings. These collaborative safe harbor meetings bring together companies, NICE, and other key stakeholders to explore issues in a confidential environment, with the goal of helping companies develop patient- and healthcare system-focused market access plans. Feedback from pilots of these meetings highlighted their value in providing a breadth of stakeholder input and fostering open discussions.

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