Common Ground: effective partnership for better care in rare disease Dr. Virginia Acha, Executive Director, Research , Medical & Innovation
In brief • Patient-centred care requires greater collaboration on the priorities, methods and outcomes of innovation. • Collaboration can be misperceived as collusion amongst stakeholders, and patient organisations can be challenged. • Transparency and clear rules of engagement are instrumental to establishing trust. • Active partnership and regular dialogue are necessary.
Patient-centred innovation What do we mean? • International Alliance of Patients Organizations (IAPO) funded UCL study (published in 2014) • “…to provide patient advocates with background information on the issues, challenges and opportunities relevant to innovation and to promote open debate and dialogue .” • Play a greater role in setting priorities • Engaging on equity of access
Imperative for rare diseases • According to the European Medicines Agency (EMA), between 5,000 and 8,000 distinct rare diseases exist, affecting between 6% and 8% of the population in total – Between around 27 million and 36 million people in the EU. • On average, five new diseases are described every week in the medical literature. • 80% of rare diseases have identified genetic origins, and affect between 3% and 4% of births. Other rare diseases are due to degenerative and proliferative causes. • Medical and scientific knowledge about rare diseases is lacking and not equally addressing all conditions. – According to EMA, the number of scientific publications about rare diseases continues to increase, particularly those identifying new syndromes. However, fewer than 1,000 diseases benefit from even minimal amounts of scientific knowledge. These tend to be the rare diseases that occur most frequently EMA, Medicines for Rare Diseases, access June 9, 2015. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_ 000034.jsp&mid=WC0b01ac058002d4eb,
Upward trend in innovation Biotechnology Industry Organization (BIO) – BioNow.org, March 2013.
Innovation delivered – an update EvaluatePharma - Orphan Drug Report 2014, page 19.
More and different innovators joining the challenge EvaluatePharma - Orphan Drug Report 2014, page 10.
Collaboration for research The aim of PROactive is to develop new tools that will enable patients, their doctors and clinical researchers to accurately assess the improvement or deterioration of Chronic Obstructive Pulmonary Disease (COPD). Training and workshops Publications
Collaboration for clinical research http://www.eurordis.org/content/eurordis-charter- clinical-trials-rare-diseases
Misperceptions – some familiar examples
How should we respond? Need for transparency Need for clear rules of engagement Need for dialogue and monitoring to establish trust Finding common ground…
ABPI Code of Conduct • Voluntary code of conduct for the pharmaceutical industry in the UK • Administered by the Prescription Medicines Code of Practice Authority (PMCPA) , a self-regulatory body operating at arm’s length of the ABPI. • The PMCPA is a not-for-profit body which was established by the ABPI on 1 January 1993. • Specific guidance on relationships with patient organisations is given in Clause 27. http://www.pmcpa.org.uk/thecode/InteractiveCode2015/Pages/clause27.aspx
Transparency • By being transparent about our financial relationships, we can focus our efforts to advance the collaboration it supports.
Rules of engagement • Establishing expectations is a key requirement for successful long term partnerships • Also defining what is valuable to each party • Ruling what is in and out of scope • These rules support the partners, but they also create a framework by which external parties can review the partnership. • Some notable successes: – Consensus Framework for Ethical Collaboration
Rules of engagement: an EU example • European Code of Practice – 2009 • Consistent, widely applied, common standards – 16 EU-wide patient groups endorsed the code of practice
Balancing the partnership • Establishing common ground requires fair and balanced terms of engagement and opportunities to draft these together. • ABPI and National Voices are working on a guide for collaboration for the UK • Objectives: 1. Work together to produce a clear, comprehensive guide to high standards of collaborative working between patient groups/health charities and pharmaceutical companies 2. Generate discussion between parties around collaborative working and to inform the content of the guide by consulting with patient groups, health charities and ABPI companies 3. Promote transparency and accountability and patient benefit in collaboration.
Next steps for the Guide • It has been led by a steering group, chaired by Harry Cayton CBE, Chief Executive of the Professional Standards Authority • The project included two workshops, a survey and a series of interviews to consult stakeholders and help shape the guide • The guide will be published in July 2015 Watch for details here 18
ABPI Patient Organisation Forum (POF) Brings together representatives of the pharmaceutical industry and patient and charity groups in an open forum Aims: • to identify areas of mutual interest • to promote understanding • to develop joint working on policy and practice, where appropriate By facilitating ongoing dialogue, open discussions and information sharing on issues of common interest, including healthcare policy Strong governance and co-creation • Supported by steering group of patient groups and company representatives • All meetings co-chaired by a member company representative and patient group representative • Transparency: Summaries of meetings and attendance published on the ABPI website: www.abpi.org.uk/our-work/patient-organisation-forum
Participating companies 20
Participating groups Parkinson’s UK Bechets Syndrome Society National Rheumatoid Teenage Cancer Trust Arthritis Society Child Growth Foundation Kidney Research UK Diabetes UK British Liver Trust Asthma UK Myeloma UK MS Society CML Support Group Breast Cancer Campaign Anticoagulation Europe Cystitis & Overactive Independent Cancer and Patient’s Voice Bladder Foundation Rarer Cancers Foundation Hepatitis C Trust British Heart Foundation Genetic Alliance UK Breakthrough Breast Roy Castle Lung International Alliance of RNIB Patients’ Organisations Cancer Foundation Cancer Research UK AMRC CF Trust NCRI Atrial Fibrillation Haemophilia Society Arthritis Care INVOLVE Association Prostate Cancer UK Cancer 52 Arthritis & Epilepsy Society Musculoskeletal Alliance James Whale Fund for Pain UK Arrhythmia Alliance Leukaemia & Lymphoma Kidney Cancer Research 21
Meeting topics 2014/15 • February NICE and value based assessment • Industry & patient groups working together • May Unlocking data for medical research, drug development and better healthcare • Evidence of barriers to patient access to medicines • September Health policy in the pre-election political landscape • Early Access to Medicines Scheme • Guide for collaboration between patient groups and industry • November Not an optional extra: patient involvement in clinical research and development • March Specialised commissioning
Looking forward • Finding common ground to advance patient-centred innovation in medicines and patient care is not difficult if we focus on what brings value to the patient . • Collaboration is our best way forward to achieving this aim, but we need to take collaboration seriously. • We need to focus on: – Transparency – Clear rules of engagement – Active partnership and regular dialogue • ABPI and its member companies look forward to continuing to work with you to improve and develop partnerships with patient organisations and health charities.
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