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Pharma Funding of Patient Groups:The building blocks of ethical and appropriate relationships
May 19, 2016
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What we will discuss
• Patient organizations: civil society• Industry: private sector• Alignment – where do interests intersect?• How relationships may create real, perceived
or potential conflicts of interest• Considerations, challenges and solutions in
Canada and globally
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Panelists
Hugh ScottInnovative Medicines CanadaExecutive Director – Strategic Alliances
Durhane Wong-RiegerCanadian Organization for Rare Disorders (CORD)President and CEO
Brian HuskinsInstitute on GovernanceSenior Fellow, Non-for-Profit Governance
Martine EliasMyeloma CanadaDirector of Access, Advocacy and Community Relations
Rosy SassoInnovative Medicines CanadaDirector, Ethics
PHARMACEUTICAL FUNDING OF PATIENT GROUPS: Governance Considerations
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How decisions are made;
How an organization is accountable to its stakeholders;
Who has a voice.
Who has the authority to make decisions; and,
GOVERNANCE…
Values Interest Structural Relationship Data
POTENTIAL AREAS OF CONFLICT
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ROLE OF THE BOARD OF DIRECTORS
• • Evaluation
• Fiduciary Responsibility
• Generative Work
• Strategic Planning
Foresight Insight
HindsightOversight
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Pharma funding of patient groups: the building blocks of ethical and appropriate relationships
Martine EliasDirector Access, Advocacy, and Community Relations
Patients principles
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Benefits of working with pharma companies
• Funding, resources and skill sharing
• access to information, educational materials, scientific data
• better and more timely understanding of regulatory and safety and access issues
• information about pipeline products
• Clinical trials – planned and ongoing
• access to networks of contacts, including access to key opinion leaders
• additional voice for lobbying policy makers
• opportunities to attend conferences and workshops
• greater understanding of options for managing health conditions. 10
Pharma’s Principles
• Interacting with patient groups in an ethical, compliant and transparent manner
• Supporting patient access in a non-promotional approach• Providing credible, relevant policy & access information on a
timely basis• Collaborating with advocacy partners to increase disease
awareness and availability of appropriate therapies• Cultivating long-term, sustainable and mutually beneficial
relationships with advocacy partners• Guidance:• EU: http://www.efpia.eu/topics/building-trust/relationships-with-patient-groups
• US:http://www.phrma.org/sites/default/files/pdf/phrma_principles_paper_20120919_final.pdf• Canada: http://innovativemedicines.ca/ethics/code-of-ethics/
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Pharma’s Criteria for engaging with patient groups
Willing to partner with Pharma companies Ability to sustain relationship Scope of activity (what are they focused on: disease awareness,
advocacy, patient submissions) Access to political influencers and decision makers Involved or interested in shaping policy Responsive/timely Truly committed to patient access (proven record) Viewed as credible Recognized by appropriate health authorities (CADTH) Reach/breadth Media Appropriate Emerging organization (have the potential of all the above)
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How to engage
Charitable contributions Program Sponsorships
Patient groups
More desirable No strings attachedLess directiveMore focused on organization’s needs
More directiveFunds cannot be transferredProgram specific
Pharma Less resources available More accountability (internal)Alignment of goals and objectives Measurable outcomes
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What is the pharma’s role in working with patient groups for HTA submissions?
• Education• Educate patient organizations about the patient input process and its
guidelines
• Facilitation• Help the patient organizations connect with patients who have
experience with the drug• Cultivate communication between patient organizations and HTA
assessment bodies
• Transparently hands off• Shine by letting the process play out
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Some of the Key issues impacting patient organizations and pharma
• HTA modernization / evolution• SEB• Pan Canadian Pharmaceutical Alliance• Innovative listing agreements• National Pharmacare• Orphan Drug Policy• Law projects – e.g. Bill C-17• Inclusion of patient voice in Clinical development trials• Real World Evidence• Federal and provincial Elections
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The players
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Durhane Wong-Rieger, PhDPresident,
Canadian Organization for Rare Disorders
May 18, 2016
Consensus Statement on Ethical Collaborations between Patients’
Organizations, Healthcare Professionals and the Pharmaceutical
Industry
18 May 2016
Patient Engagement Roles in Transition
Barbarians at the Gates
Beggars at the Table
Strange Bedfellows
Orange Patients are the
New Black
Inmates are Running the
Asylum
Developmental Progression of Patient Groups
Services to members
Acqu
isit
ion
of r
esou
rces
(B) Entrepreneurial Growth
Driving force: FundingSuccess factor: InnovationBoard: Members or ExpertServices: Professional staff
Decisions: StaffRisk: Member discontent
(D)Survival
Driving force: UnclearSuccess factor: New funding
Board: EitherServices: Staff or volunteers
Decisions: ConflictRisk: Financial collapse
(C)Opportunistic Balance
Driving force: Clients & fundersSuccess factor: Strategic
planningBoard: Expert
Services: Professional staffDecisions: Staff with members
Risk: Bureaucratization(A)Missionary
Driving force: Member needsSuccess factor: Participation
Board: Members/ClientsServices: Volunteers
Decisions: CollaborativeRisk: Increased demand
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Potential Patient Partner RolesConsultee, Informant
Input thru Council, Task Force, Collect Info: Survey, Poll, Focus
GroupForm of Info: Answers, Opinions,
DeliberationImpact: Advise, Discretionary
Examples: NICE Citizens Council, IQWiG, Ontario Citizens Council
Patient Representative
Input thru Committee, Board, Council
Collect Info: Experts, DeliberationForm of Info: Analytical, Guidelines
Impact: Varied, Based on Guidelines
Examples: NICE, AU MASC, CEDAC, pERC Ontario CED
Individual Patients
Input thru Clinical Trials, TestimonyCollect Info: QoL, PROs, Impact
StatementForm of Info: Ratings, Qualitative Impact: Varied, Emotional Suasion
Examples: SMC, IQWiGQuebec conseil, BC Pharmacare,
Patient Groups
Input: SubmissionCollect Info: Written, Oral,
MeetingsForm of Info: Qualitative Statement
Degree of Impact: ResponseExamples: NICE, SMC AU MASC,
CADTH, pCODR, Ontario CED
Patient Representativeness
Part
i ci p
atio
n in
Sys
tem
May 2016
May 20162121
Consensus Framework
Support / signatories: International Alliance for Patients’ Organizations (IAPO) International Council of Nurses (ICN) International Federation of Pharmaceutical Manufacturers and
Associations (IFPMA) International Pharmaceutical Federation (FIP) World Medical Association (WMA)
Common interest: Ensuring that the relationship between patients, healthcare
professionals, the pharmaceutical sector, and their organisations, are ethical and foster evidence-based decision making
May 201622
Consensus Framework
Four overarching principles:putting patients firstsupporting ethical research and
innovationensuring independence and ethical
conductpromoting transparency and
accountability
May 201623
Consensus Framework
In order to endorse the framework: Demonstrate a public commitment to ethical conduct,
shared values and will promote the Consensus Framework with internal and external stakeholders
Additional actions that can be considered: Issuing a public statement endorsing the framework Having or striving to have established internal guidelines
similar to the Consensus Framework that guide ethical interactions and collaborations with external partners
Engaging with partners and contributing to activities that support the roll-out and the implementation of the Consensus Framework at the national level
May 201624
Thank You!
Durhane Wong-Rieger, PhDPresident
Canadian Organization for Rare Disorders
www.raredisorders.ca(416) 969-7435
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May 201625
• Canadian association of more than 50 companies that discover, develop and deliver new medicines and vaccines
• The voice of the innovative pharmaceutical industry in Canada since 1914
• Last year we marked our 100th anniversary
• Investments of more that $1 billion per year in Canada
• Contribute more than $3 billion per year to GDP
• Anchor vibrant life sciences clusters across the country
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INNOVATIVE MEDICINES CANADA: WHO WE ARE
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OUR MEMBERS
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INDUSTRY CHALLENGES
accessvendor-credentialing price-freezes
private-plans PMPRBinvestment
regulatory barriers
queuingPCPAHTACADTH
regulatory barrierstransparency
reputationshortages
Consensus Framework: Fostering Partnership with National Level
English Español
中文 日本語Français
Canada
Mexico
UK
Austria
Thailand
China
Japan
Philippines
Russia
Belarus
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THE CANADIAN CONSENSUS FRAMEWORK FOR ETHICAL COLLABORATION
Developed by leading Canadian health organizations to create a set of ethics standards to
help guide collaboration between healthcare professionals, patient organizations and the
Canadian pharmaceutical industry.
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THE CANADIAN CONSENSUS FRAMEWORK
• Aims to enhance credibility, dialogue, trust and respect between organizations, professionals, institutions and the healthcare system and ultimately to improve health outcomes.
• Established to demonstrate the common commitment to professional integrity and appropriate ethical interactions that the signatory partners hold.
• Is based on the shared values and principles currently found in the Codes and Guidelines of each signatory partner and are characterized by four overarching principles:
• Ensures patients best interests are at the core of our activities• Promotes Transparent and Accountable Conduct• Sets clear rules on gifts, funding and conferences, continuing
professional education and clinical research• Guides National Ethical leadership
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EMBRACING ETHICS AND TRANSPARENCY
• Developed in 1988
• Governs interaction with ALL stakeholders
• Promotes Reputation and Trust
• Guides us to live by the high standards we set for ourselves as an industry
• Code available at www.innovativemedicines.ca
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Canadian Cancer Survivor Network Contact Info
Canadian Cancer Survivor Network1750 Courtwood Crescent, Suite 210Ottawa, ON K2C 2B5Telephone / Téléphone : 613-898-1871E-mail [email protected] or [email protected] Web site www.survivornet.caBlog: http://jackiemanthornescancerblog.blogspot.com/Twitter: @survivornetcaFacebook: www.facebook.com/CanadianSurvivorNet Pinterest: http://pinterest.com/survivornetwork/
