Supporting patient groups: a pharmaceutical company perspective Susanna Leto di Priolo Novartis Oncology Region Europe

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1 Supporting patient groups: a pharmaceutical company perspective Susanna Leto di Priolo Novartis Oncology Region Europe

2 Why pharmaceutical companies collaborate with patient groups Challenges Position on Patient Group Interaction Disclosure

3 Why pharmaceutical companies collaborate with patient groups? Close collaboration can benefit both parties Disease Awareness Help improve general awareness about a specific cancer Research Make sure that drugs that meet unmet need are developed as quickly as possible Access Ensure that drugs are made available to the people that need them in a timely manner Promote adherence to medicines Ensure that patients have access to easy-to-understand information about their medicines so that they take them correctly and side effects are minimised

4 Increasing role of companies as source of funding Commercial sector - particularly the pharmaceutical industry appears to represent the only reliable, expanding source of patient-group funding today BUT While donations and grants continue to flow from pharmaceutical companies, the money sometimes though not always comes at the expenses of the integrity of benefactor groups. Health Campaigner on Funding HSCNews International- Issue 34 - January 2007

5 Challenges: Media and Policy Makers: Pharma Influencing Patient Groups Drug companies are promoting their products through patients groups, students and Internet chat rooms to bypass the ban on advertising except to doctors. Consumers International, Branding the Cure, June 2006 All industry funding should be treated with suspicion because the intent of companies in granting funds is always to influence groups to support their agenda Many patient groups and drug companies maintain close, multimillion-dollar relationships while disclosing limited or no details about the ties. The Philadelphia Inquirer, May 2006 We are concerned about motivation of the pharmaceutical industry involvement with patient advocacy groups. The public has no way of knowing that the information from patient groups may be biased in favor of the drug companies that fund them. Sen. Grassley (R-Iowa), May 2006 A self-help or patients organisation risks its credibility if it becomes identified with one or more companies. Health Action International, Asia Pacific, March 2005 Dr. Desmond Spence, in testimony to the UK House of Commons Select Committee, October 2004 The British Medical Journal, May 2003

6 Pharma Influencing Patient Groups (2) NICE chairman cautions patient groups on drug company donations The money undermines independence Drug companies funding can destroy one s credibility, because many people think that if a company funds you, you are working to benefit them and not the patients. BBC report 14 May 2007 Barbara Mintzes BMJ 4 May 2007 South African Patient Group HSCNews Intl. January 2007

7 Phamaceutical companies face many challenges in partnering with patient groups Negative media coverage undermines corporate image Number and scope of requests for support - Impossible to support everything Regulations - National laws governing how companies can interact with patients - Self-regulation (e.g. APBI guidelines)

8 How has the pharmaceutical industry responded to these challenges? Trade associations have set down clear rules of engagement (EFPIA, IFPMA, ABPI). Individual companies have developed internal guidelines to ensure: Ethical conduct Transparency Clear agreements

9 Patient Group Interactions: The Novartis approach Strive for consistently high standard in relationship with patient groups Support appropriate relationship complying with international guidelines, as well as local laws/regulations Establish common standard for transparency in all activities with patient groups Apply globally to all Novartis associates interacting with patient groups

10 Patient Group Interaction Guidelines Activities should be mutually beneficial and fall within the objectives of both organizations The company should not interpret a relationship as an explicit endorsement of a product associated with the company Relationship can address Advice and counsel Information materials and information exchange Activities on Specific Projects Clinical research Psycho-social research Registries Business Skills Training

11 Patient Group Interaction Guidelines Governance Global Guidelines, Local Laws & Regulations In Compliance with Local Laws/Regulations of the company, as well as Patient Group by-laws The company Contact/s Should be Official Member of the Patient Group (e.g. President, Executive Director, etc.,) Interaction with legally recognized groups Distinct, legal entity with representative membership

12 Patient Group Interaction Guidelines Governance Funding Must be in hands-off form Must be publicly disclosed in Patient Group activity leaflet/brochure/etc. A drug company should not be majority funder Multiple sponsorship encouraged and requested Must be clearly documented by way of agreement that details rights and obligations of both parties

13 Patient Group Interaction Guidelines Governance Funding Establishment of Patient Groups Should be on request of a patient, relative, physician, group of.. Clear and strict guidelines for medium- and long-term funding should be incorporated into start-up structure of group Group should be encouraged to seek additional funds A pharmaceutical company should not be majority funder

14 Disclosure of sponsorship Pharma Trade group s positions: -EFPIA: Objective and scope of PAG partnership should be transparent, financial and non-financial support should be fully disclosed -PhRMA: Reviewing EFPIA standards for potential adoption -ABPI: Financial support must be declared via web/annual report Individual companies positions:* -GSK: lists all patient groups and all funds provided and their purpose -Lilly UK: posts names of patient groups and bands of funding -AstraZeneca UK: (headquarters country) lists all relationships with dates and text of their transparency agreements -BMS: lists all relationships on relevant country web site -Novartis: will post names of patients groups supported in the website (July 2007)

15 Conclusion It is acceptable for pharmaceutical companies to partner with patient advocacy groups Mutual benefits for both parties The scope and nature of the relationship should be transparent and disclosed by both parties Patients groups and pharmaceutical companies should not accept to partner if they perceive it as a threat to their independence, their credibility and their reputation.

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