Common Ground: effective partnership for better care in rare - - PowerPoint PPT Presentation

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

• International Alliance of Patients

Organizations (IAPO) funded UCL study (published in 2014)

• “…to provide patient advocates

with background information on the issues, challenges and

• pportunities relevant to

innovation and to promote open debate and dialogue.”

• Play a greater role in setting

priorities

• Engaging on equity of access

What do we mean?

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.

EvaluatePharma - Orphan Drug Report 2014, page 19.

Innovation delivered – an update

EvaluatePharma - Orphan Drug Report 2014, page 10.

More and different innovators joining the challenge

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

• f 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

• perating 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
• ur 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

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Watch for details here

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

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Participating groups

Bechets Syndrome Society National Rheumatoid Arthritis Society Parkinson’s UK Teenage Cancer Trust 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 Bladder Foundation Independent Cancer and Patient’s Voice Rarer Cancers Foundation Hepatitis C Trust British Heart Foundation Genetic Alliance UK Breakthrough Breast Cancer Roy Castle Lung Foundation International Alliance of Patients’ Organisations RNIB Cancer Research UK AMRC CF Trust NCRI Atrial Fibrillation Association Haemophilia Society Arthritis Care INVOLVE Prostate Cancer UK Cancer 52 Arthritis & Musculoskeletal Alliance Epilepsy Society James Whale Fund for Kidney Cancer Pain UK Arrhythmia Alliance Leukaemia & Lymphoma 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.