In this webinar, our panelists explored ethics, transparency, resources, alignment and conflicts in the important relationships between companies and patient groups. This webinar presented perspectives from subject matter experts from the innovative medicines industry, governance experts, and patient advocates. Panelists: Hugh Scott, Executive Director, Strategic Alliances at Innovative Medicines Canada. Rosy Sasso, acting Director, Ethics and Compliance at Innovative Medicines Canada. Brian Huskins, the Senior Fellow of Not-For-Profit Governance at the Institute on Governance. Martine Elias, Director of Access, Advocacy & Community Relations with Myeloma Canada. Dr. Durhane Wong-Rieger, PhD, President and CEO of the Canadian Organization for Rare Disorders. Moderator: Bill Dempster, 3Sixty Public Affairs

1. Pharma Funding of Patient Groups:
The building blocks of ethical and
appropriate relationships
May 19, 2016

2. 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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3. Panelists
3
Hugh Scott
Innovative Medicines Canada
Executive Director – Strategic Alliances
Durhane Wong-Rieger
Canadian Organization for Rare
Disorders (CORD)
President and CEO
Brian Huskins
Institute on Governance
Senior Fellow, Non-for-Profit
Governance
Martine Elias
Myeloma Canada
Director of Access, Advocacy and
Community Relations
Rosy Sasso
Innovative Medicines Canada
Director, Ethics

4. PHARMACEUTICAL FUNDING OF
PATIENT GROUPS:
Governance Considerations

5. 5
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…

6. Values Interest Structural Relationship Data
POTENTIAL AREAS OF CONFLICT
6

7. ROLE OF THE BOARD OF DIRECTORS
•
• Evaluation
• Fiduciary
Responsibility
• Generative
Work
• Strategic
Planning
Foresight Insight
HindsightOversight
7

8. Pharma funding of patient groups: the building
blocks of ethical and appropriate relationships
Martine Elias
Director Access, Advocacy, and Community Relations

9. Patients principles
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10. 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.
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11. 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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12. 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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13. How to engage
Charitable contributions Program Sponsorships
Patient
groups
More desirable
No strings attached
Less directive
More focused on organization’s
needs
More directive
Funds cannot be
transferred
Program specific
Pharma Less resources available More accountability
(internal)
Alignment of goals and
objectives
Measurable outcomes
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14. 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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15. 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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16. The players
16

17. Durhane Wong-Rieger, PhD
President,
Canadian Organization for Rare
Disorders
May 18, 2016
Consensus Statement on Ethical
Collaborations between Patients’
Organizations, Healthcare Professionals
and the Pharmaceutical Industry

18. May 201618
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

19. Developmental Progression of
Patient Groups
Services to members
Acquisitionofresources
(B)
Entrepreneurial Growth
Driving force: Funding
Success factor: Innovation
Board: Members or Expert
Services: Professional staff
Decisions: Staff
Risk: Member discontent
(D)
Survival
Driving force: Unclear
Success factor: New funding
Board: Either
Services: Staff or volunteers
Decisions: Conflict
Risk: Financial collapse
(C)
Opportunistic Balance
Driving force: Clients & funders
Success factor: Strategic planning
Board: Expert
Services: Professional staff
Decisions: Staff with members
Risk: Bureaucratization
(A)
Missionary
Driving force: Member needs
Success factor: Participation
Board: Members/Clients
Services: Volunteers
Decisions: Collaborative
Risk: Increased demand
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20. Potential Patient Partner Roles
Consultee, Informant
Input thru Council, Task Force,
Collect Info: Survey, Poll, Focus Group
Form of Info: Answers, Opinions,
Deliberation
Impact: Advise, Discretionary
Examples: NICE Citizens Council, IQWiG,
Ontario Citizens Council
Patient Representative
Input thru Committee, Board, Council
Collect Info: Experts, Deliberation
Form of Info: Analytical, Guidelines
Impact: Varied, Based on Guidelines
Examples: NICE, AU MASC, CEDAC,
pERC Ontario CED
Individual Patients
Input thru Clinical Trials, Testimony
Collect Info: QoL, PROs, Impact
Statement
Form of Info: Ratings, Qualitative
Impact: Varied, Emotional Suasion
Examples: SMC, IQWiG
Quebec conseil, BC Pharmacare,
Patient Groups
Input: Submission
Collect Info: Written, Oral, Meetings
Form of Info: Qualitative Statement
Degree of Impact: Response
Examples: NICE, SMC AU MASC,
CADTH, pCODR, Ontario CED
Patient Representativeness
20 May 2016

21. May 201621
21

22. 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

23. Consensus Framework
Four overarching principles:
putting patients first
supporting ethical research and innovation
ensuring independence and ethical
conduct
promoting transparency and accountability
May 201623

24. 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

25. Thank You!
Durhane Wong-Rieger, PhD
President
Canadian Organization for Rare Disorders
www.raredisorders.ca
(416) 969-7435
durhane@gmail.com
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May 201625

27. • 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
27
INNOVATIVE MEDICINES CANADA: WHO
WE ARE

28. 28
OUR MEMBERS

29. 29
INDUSTRY CHALLENGES
accessvendor-credentialing price-freezes
private-plans
PMPRB
investment
regulatory barriers
queuing
PCPAHTA
CADTH
regulatory barriers
transparency
reputation
shortages

30. 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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31. 31
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.

32. 32
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
• PromotesTransparent and Accountable Conduct
• Sets clear rules on gifts, funding and conferences, continuing
professional education and clinical research
• Guides National Ethical leadership

33. 33
EMBRACING ETHICS ANDTRANSPARENCY
• 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

34. 34

35. Canadian Cancer Survivor Network
Contact Info
Canadian Cancer Survivor Network
1750 Courtwood Crescent, Suite 210
Ottawa, ON K2C 2B5
Telephone / Téléphone : 613-898-1871
E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca
Web site www.survivornet.ca
Blog: http://jackiemanthornescancerblog.blogspot.com/
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