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5_ICCA Meetings Association Africa Day_How funding & Sponsorship works_Dr. Mantha Makume

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5_ICCA Meetings Association Africa Day_How funding & Sponsorship works_Dr. Mantha Makume

  1. 1. ICCA Meetings Africa Association Day - Collaboration towards an Advanced Africa 24 February 2020 Finance & Sponsorship Dr Mantha T. Makume PhD., PMP Novo Nordisk South Africa Medical Affairs
  2. 2. PRODUCTS MARKETED IN 170 COUNTRIES R&D CENTRES IN CHINA, DENMARK, INDIA, UK AND US AFFILIATES IN COUNTRIES 80 STRATEGIC PRODUCTION SITES IN BRAZIL, CHINA, DENMARK, FRANCE AND US EMPLOYS APPROXIMATELY 42,700 PEOPLE DKK122 BILLION TOTAL NET SALES GROWTH DISORDERS OBESITY HAEMOPHILIA SUPPLIER OF NEARLY HALF OF THE WORLD’S INSULIN 30million PEOPLE USE OUR DIABETES CARE PRODUCTS AMONG THE WORLD’S TEN LARGEST PHARMA COMPANIES MEASURED BY MARKET VALUE1 DIABETES Novo Nordisk at a glance Founded in Denmark in 1923 with a focus on diabetes, we have become one of the world’s leading healthcare companies. Today, we are also using our capabilities to tackle unmet needs in serious metabolic diseases, such as obesity, and in rare blood and endocrine disorders. 2
  3. 3. TOP 5 EMPLOYER In SCIENCE MAGAZINE’S TOP EMPLOYER RANKING R&D employs >5,000 PEOPLE DEVICES DIABETES OBESITY Diabetes Obesity Haemophilia Growth disorders CVD NASH 2019 R&D spend More than 2.0 BILLION EURO R&D AMBITION Innovate to improve patient outcomes and drive growth MEDICINES HAEMOPHILIA R&D at a glance 10 Global R&D sites 4 in Denmark; 3 in US, 1 in UK, China & India Therapy areas6
  4. 4. Novo Nordisk Medical Affairs- Imperatives 4 Improve patients' lives by Leading partner in the generation, interpretation and communication of scientific data with relevant stakeholders Build the scientific foundation for the next generation of products across disease areas Sustain strong scientific position of products marketed in all Novo Nordisk affiliates
  5. 5. Code of Conduct 5 IFPMA MCA Novo Nordisk BECF
  6. 6. Who? What? Why? How? Balancing Act 6 Patient
  7. 7. Definitions of Grants/Donations/Sponsorship 03/03/2020 Applies to: Sponsorships, defined as a financial or non-financial contribution: ✓ for a specific activity/project/event ✓ for the purpose of healthcare related education, information, research, scientific exchange ✓ for promotional or non-promotional purposes ✓ where Novo Nordisk receives a direct tangible benefit in return. Applies to: Grants, defined as a financial contribution: ✓ for a specific event, project or activity ✓ for the purpose of healthcare related education, information, research and/or to facilitate scientific exchange ✓ where Novo Nordisk does not provide direction on the use or implementation of the contribution ✓ where Novo Nordisk does not receive any direct tangible benefit in return ✓ where the purpose is not to promote Novo Nordisk products. Applies to: Donation, defined as a financial or non-financial contribution: ✓ for a specific or non-specified activity/project/event ✓ for charitable or other philanthropic purposes in line with Novo Nordisk’s Triple Bottom Line commitment ✓ where Novo Nordisk may have no control over the final use of the contribution ✓ where Novo Nordisk does not receive any direct tangible benefit in return ✓ where the purpose is not to promote Novo Nordisk products. Grant Donation Sponsorship 7Updated requirements for Grants, Donations, and Sponsorships
  8. 8. Definitions of Grants/Donations/Sponsorship 03/03/2020 Applies to: Sponsorships, defined as a financial or non-financial contribution: ✓ for a specific activity/project/event ✓ for the purpose of healthcare related education, information, research, scientific exchange ✓ for promotional or non-promotional purposes ✓ where Novo Nordisk receives a direct tangible benefit in return. Applies to: Grants, defined as a financial contribution: ✓ for a specific event, project or activity ✓ for the purpose of healthcare related education, information, research and/or to facilitate scientific exchange ✓ where Novo Nordisk does not provide direction on the use or implementation of the contribution ✓ where Novo Nordisk does not receive any direct tangible benefit in return ✓ where the purpose is not to promote Novo Nordisk products. Applies to: Donation, defined as a financial or non-financial contribution: ✓ for a specific or non-specified activity/project/event ✓ for charitable or other philanthropic purposes in line with Novo Nordisk’s Triple Bottom Line commitment ✓ where Novo Nordisk may have no control over the final use of the contribution ✓ where Novo Nordisk does not receive any direct tangible benefit in return ✓ where the purpose is not to promote Novo Nordisk products. Grant Donation Sponsorship 8Updated requirements for Grants, Donations, and Sponsorships
  9. 9. • 7.4. Sponsorships • Applies To • Sponsorships, defined as a financial or non-financial contribution: • for the purpose of healthcare related education, information, research, scientific exchange • for a specific activity/project/event • for promotional or non-promotional purposes • where Novo Nordisk receives a direct tangible benefit in return. • Typical examples: • Support for congress and other third party organised meetings • Novo Nordisk sponsored satellite symposia at a congress • ‘Walks’ or similar activities/events arranged by organisations within Novo Nordisk therapeutic areas, e.g. national diabetes or haemophilia foundations • Team Novo Nordisk • Contributions to patient organisations. • These activities are not Sponsorships: • Funding in response to an unsolicited request for support to a specific activity for the purpose of healthcare related education, information, research, scientific exchange, where the value of any tangible benefit in return is significantly less than the funding being sought - this follows the requirements for Grants • Covering the costs for an individual healthcare professional to participate in an event or similar activity follow the requirements in sub-section ‘Delegate Support’, in section ‘Interactions w/ HCPs & HCOs’ • Fee for service engagements, see sub-section ‘Engagement of HCPs’ in the ‘Interactions w/ HCPs & HCOs’ section. • Novo Nordisk organised activities/projects/events see section ‘Interaction w/ HCPs and HCOs’ and/or ‘Interaction w/ Public Officials’ • Activities/projects/events where Novo Nordisk or a third party under Novo Nordisk’s control exercises significant influence on the programme (e.g. on presenters, faculty, audience) or the execution of the activity. In these cases, see section ‘’Interactions w/ HCPs & HCOs’ and/or ‘Interactions w/ Public Officials’ and/or ‘Interactions w/ Patients & Patient Organisations’ or could be in scope for TPR requirements, see section ‘Interactions w/ Third Party Representatives’. • Interactions with Patients and Patient Organisations, see section ’Interactions w/ Patients & Patient Organisations’. • Requirements • Accountability, Review and Approval: Local management of global functions or affiliates must ensure a robust review and approval process. This includes: • Clear definition of who is responsible and accountable, including for the budget • Commercial or non-commercial functions can be accountable for decisions and budget as deemed relevant locally depending on the purpose of the Sponsorship • Criteria for determining whether or not to provide a Sponsorship, including (see non-mandatory ‘Sponsorships checklist’ [link_7.4.1]): • Appropriate recipient (considering prior experience and publicly available information, e.g. annual reports, website, internal or external exclusion lists, or recent media coverage) • Valid purpose • Appropriate commercial value • Appropriate venue, hospitality, no entertainment, and travel arrangements in line with Novo Nordisk requirements • Local Legal/Compliance review in case of cross-border Sponsorships • Cross-border Sponsorships: Where the Sponsorship is provided to a recipient in another country, review must be performed from Local Legal/Compliance in the affiliate of that country to ensure proper application of any local requirements. Remember that compliance with corporate requirements is the responsibility of the HQ function or affiliate providing the Sponsorship. • Sponsorships by HQ for international congresses targeting an international audience, e.g. ADA, IDF, EASD, EOS, ICO, WHO, ISPAD, WFH, ISTH, ESPE, FEND, do not require approval by Local Legal/Compliance in the receiving country of the Sponsorship. Please note that requirements for global and local review and approval of the underlying Novo Nordisk activities at the respective congresses as per existing processes, and local HCO payment tracking requirements must be complied with. • The following criteria must be fulfilled when providing a Sponsorship: • Appropriate recipient: Sponsorships must only be provided to appropriate, reputable recipients (considering prior experience and publicly available information, e.g. annual reports, website, internal or external exclusion lists, or recent media coverage):, • not to individuals - e.g. Healthcare Professionals, Patients, political party officials, candidates for political office • Exception: In limited circumstances it is acceptable to sponsor Patient role models for sporting events, provided that this support is ad hoc and of a value that is appropriate to the type of event, and such engagement is approved by Local Legal/Compliance. • not to political parties or political campaign efforts • Tangible benefit: Novo Nordisk must receive a direct tangible benefit in return. • Typical examples: booth space, symposia timeslot, free registrations at congresses or membership rights, recognition as ‘sponsor’, advertisement space (in paper, electronic or other format, e.g. t-shirts, bags, and similar), Novo Nordisk-sponsored satellite symposia at a congress, membership rights in an organisation • Appropriate value: Novo Nordisk must determine if the value of the sponsorship is appropriate (and not excessive) for the purpose in light of all circumstances, e.g. the benefits provided to Novo Nordisk and the commercial value and reach of the organisation. The rationale for the amount/value must be documented. • Written agreement: If approved, a written agreement with the recipient is required prior to the Sponsorship starting, specifying: • the support (amount/quantity – if non-financial, the type of contribution and its value) • purpose of the support • tangible benefits for Novo Nordisk • that the recipient is not aware of any conflict of interest which would prevent the recipient from accepting the Sponsorship • that the recipient will be transparent about the receipt of financial support from Novo Nordisk. • Sponsorship applications for congresses may take place on web based platforms according to pre-defined terms and conditions (which should be reviewed for acceptability) or based on Novo Nordisk terms in a purchase order/statement of work in case it is not possible to conclude a separate written agreement between Novo Nordisk and the congress organiser/recipient of the Sponsorship. A printout of the confirmed Sponsorship application must be archived according to the general rules on archiving • Patient Organisations: Novo Nordisk must not require that it be the sole funder of the Patient Organisation or any of its programmes. • Follow-up: Appropriate follow-up documentation must be obtained evidencing that the Sponsorship has been used for its intended purpose, e.g. sponsorship package, Novo Nordisk logo and/or name on website, budget record, event/project material, reports, or pictures. The level of follow-up should be proportionate to the associated risk considering the recipient and the significance of the support. For different types of Sponsorships, Local Legal/Compliance should assess what follow-up documentation is appropriate. • Appropriate documentation: • Value rationale (e.g. written explanation in ‘Sponsorship checklist’, or in the meeting minutes relating to the approval of the sponsorship). • Fully executed written agreement or Sponsorship application including date of Sponsorship being provided • Follow-up documentation • Tracking requirements: Sponsorships provided to Healthcare Organisations or Patient Organisations may be in scope for transparency (transfer of value disclosure) requirements. The person responsible for executing the Sponsorship must follow any applicable transparency requirements. See sub-section ‘Transfers of value to HCPs and HCOs’ in the ‘Interactions w/ HCPs & HCOs’ section, and sub-section ‘Transfers of value to Patients, Caregivers, Patient Representatives and Patient Organisations’ in the ‘Interactions w/ Patients & Patient Organisations’ section How do we fund and provide sponsorship? 9
  10. 10. Groundwork- Where the real work is PowerPoint Presentation Date 10 DGS Committee RegulatoryMarketing Legal & Compliance Medical Congress Organiser
  11. 11. 11 Accountability, Review and Approval Appropriate recipient Tangible benefit Appropriate value Follow-up Written agreement Tracking requirements How do we fund and provide sponsorship?
  12. 12. 12 Accountability, Review and Approval How do we fund and provide sponsorship? • Local management of global functions or affiliates must ensure a robust review and approval process • Clear definition of who is responsible and accountable, including for the budget • Criteria for determining whether or not to provide a sponsorship
  13. 13. 13 Appropriate recipient How do we fund and provide sponsorship? • Sponsorships must only be provided to appropriate, reputable recipients • Not to individuals • Not to political parties or political campaign efforts
  14. 14. 14 Tangible benefit How do we fund and provide sponsorship? Novo Nordisk must receive a direct tangible benefit in return • booth space, symposia timeslot, free registrations at congresses or membership rights, recognition as ‘sponsor’, advertisement space (in paper, electronic or other format, e.g. t-shirts, bags, and similar), Novo Nordisk-sponsored satellite symposia at a congress, membership rights in an organisation.
  15. 15. 15 Appropriate value How do we fund and provide sponsorship? • Novo Nordisk must determine if the value of the sponsorship is appropriate (and not excessive) for the purpose in light of all circumstances, e.g. the benefits provided to Novo Nordisk and the commercial value and reach of the organisation • The rationale for the amount/value must be documented
  16. 16. 16 Written agreement How do we fund and provide sponsorship? • If approved, a written agreement with the recipient is required prior to the Sponsorship starting, specifying: • the support (amount/quantity – if non-financial, the type of contribution and its value) • purpose of the support • tangible benefits for Novo Nordisk • that the recipient is not aware of any conflict of interest which would prevent the recipient from accepting the Sponsorship • The recipient will be transparent about the receipt of financial support from Novo Nordisk
  17. 17. 17 Tracking requirements How do we fund and provide sponsorship? • The person responsible for executing the Sponsorship must follow any applicable transparency requirements Follow-up • Appropriate follow-up documentation must be obtained evidencing that the Sponsorship has been used for its intended purpose
  18. 18. Thank you 18

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