2016 EFPIA Data Collection and Reporting Experience - Novo Nordisk A/S learnings

Transcription

1 CBI Global Transparency Reporting Congress, London 4 April EFPIA Data Collection and Reporting Experience - Novo Nordisk A/S learnings London 4-Apr-2017

2 CBI Global Transparency Reporting Congress, London 4 April AGENDA Who are we? Novo Nordisk Governance Set-Up Tricky Areas

3 CBI Global Transparency Reporting Congress, London 4 April Who are we Annika Valla Broman Senior Corp. Counsel, Novo Nordisk A/S Frederik Kibsgaard Project Manager, Compliance Operations, Novo Nordisk A/S Ekaterina S. Walløe R&D BE Compliance Specialist, Novo Nordisk A/S Prior: Dako Denmark A/S Attorney-at-Law at private law firms The Danish Association of the Pharmaceutical Industry (Lif) The Danish Ministry of Health The Danish Energy Authority Prior: Global Medical Affairs, Novo Nordisk A/S PSU Academies, Novo Nordisk A/S CMC Supply, Novo Nordisk A/S Talent Attraction, Novo Nordisk A/S Prior: Trial Execution Anchor, Novo Nordisk A/S Clinical Development, Novo Nordisk A/S Product Supply, Novo Nordisk A/S IT & Project Execution, Novo Nordisk A/S

4 Novo Nordisk at a glance Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. PRODUCTS MARKETED IN 180 COUNTRIES DIABETES 75 AFFILIATES IN COUNTRIES Novo REAL JP Nordisk - Corporate R&D CENTRESPresentatio IN CHINA, DENMARK, INDIA AND US n OBESITY EMPLOYS APPROXIMATELY 40,000 PEOPLE 4 This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. STRATEGIC PRODUCTION SITES IN BRAZIL, CHINA, DENMARK, FRANCE AND US GROWTH DISORDERS 200,000 SHAREHOLDERS SUPPLIER OF MORE THAN HALF OF THE WORLD S INSULIN 24,400,000 PEOPLE USE OUR PRODUCTS HAEMOPHILIA

5 CBI Global Transparency Reporting Congress, London 4 April AGENDA Who are we? Novo Nordisk Transparency Governance Set-Up Tricky Areas

6 CBI Global Transparency Reporting Congress, London 4 April HCP Payments Transparency: Governance setup Business Ethics Board (EVP level) Business Ethics HCP Transparency Working Group HQ Network 50 HTRs (Headquarter Tracking Responsible) Compliance Operations (BECO - HQ) Affiliate Network 100 LRRs (Local Reporting Responsible Marketing HR Medical Affairs Product Supply R&D HCP Office (India) Centre of Excellence Region Business area Affiliate

7 Communication and training Queries CBI Global Transparency Reporting Congress, London 4 April How does the LRR/HTR support network function? Compliance Operations trains super users (LRRs and HTRs) who in turn are responsible for training their respective areas When LRRs and HTRs cannot answer their users questions/issues, they request help from Compliance Operations Compliance Operations Compliance Operations Compliance Responsibles Compliance Responsibles Super users: LRR/HTR (+150 FTEs) Super users: LRR/HTR (+150 FTEs) Users ( FTEs) Users ( FTEs)

8 CBI Global Transparency Reporting Congress, London 4 April Transparency process: Plan-Track-Report process The Plan Track Report process ensures that: Novo Nordisk s internal requirements (SOPs) are followed External local law and industry code requirements are followed Plan Track Report Follow limitations on hospitality, honoraria etc. provided to HCPs/HCOs and prenotify the interaction Payments to HCPs/HCOs from selected countries must be registered in internal systems Selected affiliates publically report payments made to their local HCPs/HCOs

9 Data Quality process - Addressing Accuracy and Completeness CBI Global Transparency Reporting Congress, London 4 April Pre-event control Payment entry controls Backend controls Data Analytics Pre-disclosure audit (Samples) User enters data User enters data Pre-notification on cross border engagements (FMV validation) Input controls and central data validation Central creation of HCP/HCO vendor ID Error identification reports Data monitoring and remediation Analytical check GIA review of top risk countries

10 CBI Global Transparency Reporting Congress, London 4 April AGENDA Who are we? Novo Nordisk Governance Set-Up Tricky Areas

11 Master data setup CBI Global Transparency Reporting Congress, London 4 April 2017 Slide no 11 John Schmidt Finance Invoices 1 HCP Tag WUK Housekeeping rules 1 Tag HCP/HCO vendors Standardise approach Centralise efforts 2 3 Keep strict naming format HCP Portal John Schmidt 2 Second ID layer (unique ID) John Schmidt Manuel 3 rd Party 1 HCP Tag 3 Second layer quality control

12 CBI Global Transparency Reporting Congress, London 4 April Tracking HCP/HCO payments to EFPIA categories If a transfer of value (ToV) to an HCP/HCO is in scope for EFPIA Disclosure, it seen either as R&D ToV or non-r&d ToV In Novo Nordisk it is not an organisational set-up that defines the type of ToVs provided (R&D vs non-r&d), but the nature and purpose of HCP/HCO engagement. An R&D department can provide both R&D and non-r&d ToVs to EFPIA HCPs/HCOs.

13 CBI Global Transparency Reporting Congress, London 4 April Exercise: EFPIA categories for reporting In your group distribute the below listed ToVs between the 2 categories to the right: 1. ToV related to epidemiological studies based on external databases and registries 2. ToV related to retrospective non-interventional studies 3. ToV related to contribution to an individual HCP to cover the cost of non-consultancy related event (e.g. conference/congress/symposia registration fees or related travel and accommodation) 4. ToV related to service/consultancy associated with clinical development 5. Grant associated with clinical development 6. Donation 7. ToV related to non-clinical research collaboration with an HCO 8. ToV related to service/consultancy associated with prospective non-interventional studies 9. Sponsorship to an HCO 10.Financial contribution to an Investigator Sponsored Study (ISS) R&D ToVs Non-R&D ToVs

14 PowerPoint toolbox 14 Obtaining and managing initial consents HCP Consultants HCP Delegates Challenges Disclosure wording included in all contract templates Mandatory delegate consent letter included with invitations Primarily for information purposes NN allows No consent Decentralised contracting NN does not allow partconsent No centralised repository for managing consents Master data challenges

15 CBI Global Transparency Reporting Congress, London 4 April Obtaining and managing final consents How to handle? Pre-disclosure consent collection Individual affiliates reach out to all HCPs prior to disclosure to re-confirm consent Pros Accurate data Relationship mgmt. Cons Highly manual Lower consent rates

16 CBI Global Transparency Reporting Congress, London 4 April HCP vs. HCO How to track? Can an HCO travel? Are all university faculties HCOs?

17 CBI Global Transparency Reporting Congress, London 4 April Grants, Donations & Sponsorships What is the difference? Is it R&D ToV or non-r&d?

18 CBI Global Transparency Reporting Congress, London 4 April Registration Fees to Congresses Are the registration fees reportable? What if employees participate?

19 CBI Global Transparency Reporting Congress, London 4 April Devices? Main rule: Not reportable What about integrated products?

20 VAT reporting with or without? CBI Global Transparency Reporting Congress, London 4 April

21 European EFPIA Disclosure Program 13/04/2017 Slide no 21 NN reflections on inclusion/exclusion of VAT Include Exclude Simple communication: What 1. VAT not split on activity 1. No local ToV VAT calculation 1. Complex Cross-Border we pay is what we disclose (Balance sheet acc.) requiring required (all balance sheet calculation per invoice 2. Consistent local ToV VAT calculation accounts can be excluded) (difficult to separate VAT for 2. Potentially low TPR data quality 2. Real perceived value some invoiced payments) 3. Difficult to know if VAT has disclosed 2. Re-training of all suppliers been included for cross border 3. Some countries have and NN employees doing 4. Examples of HCPs not always difficulties handling VAT due manual postings/uploads including VAT when invoicing to local accounting principles 3. Total ToV is not reflected 4. Lower numbers disclosed

22 CBI Global Transparency Reporting Congress, London 4 April Research Publications Are co-author fees reportable? How to calculate ToV split (HCP co-authoring with employees)?

23 EFPIA Training 28-May Capturing Transfers of Value (ToV) Provided to identifiable HCPs/HCOs by Novo Nordisk or by 3 rd parties on our behalf ToV Hospital/clinic University Association HCO ToV ToV 3 rd party HCP ToV - in scope for tracking

24 CBI Global Transparency Reporting Congress, London Slide no 24 Thank you for contributing to knowledge sharing during this presentation!