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BCIS ACI 2019: MedTech Europe - Explaining the Rules - Fiona McDonald

An overview of the updated MedTech Europe Code of Ethical Business Practice and the direct impacts on Industry and Healthcare Professionals.

1 of 20
ACI 2019
ADVANCED CARDIOVASCULAR INTERVENTION
MedTech Europe: Explaining the Rules
Fiona McDonald
Managing Director
Millbrook Medical Conferences Ltd/ Millbrook Medical Logistics Ltd
ACI 2019
ADVANCED CARDIOVASCULAR INTERVENTION
MY CONFLICT OF INTERESTS ARE
Managing Director
Millbrook Medical Conferences & Millbrook Medical Logistics
ACI 2019
ADVANCED CARDIOVASCULAR INTERVENTION
Overview
MedTech Europe and the Code of Ethical Business Practice
Compliance regulation changes
Putting the new code into context
ACI 2019
ADVANCED CARDIOVASCULAR INTERVENTION
Introducing MedTech Europe
”
“
An alliance of Eucomed
and EDMI
ACI 2019
ADVANCED CARDIOVASCULAR INTERVENTION
Compliance Regulation Changes
REMOVAL OF DIRECT
SPONSORSHIP
EDUCATIONAL GRANTS –
PROCESS AND TRANSPARENCY
DEMONSTRATION PRODUCTS
AND SAMPLES
AGREED DEFINITIONS
GENERAL CRITERIA ON EVENTS
COMMON INDEPENDENT
ENFORCEMENT MECHANISM
ACI 2019
ADVANCED CARDIOVASCULAR INTERVENTION
Removal of Direct Sponsorship
DIRECT SPONSORSHIP
EDUCATIONAL GRANTS
OR
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BCIS ACI 2019: MedTech Europe - Explaining the Rules - Fiona McDonald

  • 1. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION MedTech Europe: Explaining the Rules Fiona McDonald Managing Director Millbrook Medical Conferences Ltd/ Millbrook Medical Logistics Ltd
  • 2. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION MY CONFLICT OF INTERESTS ARE Managing Director Millbrook Medical Conferences & Millbrook Medical Logistics
  • 3. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION Overview MedTech Europe and the Code of Ethical Business Practice Compliance regulation changes Putting the new code into context
  • 4. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION Introducing MedTech Europe ” “ An alliance of Eucomed and EDMI
  • 5. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION Compliance Regulation Changes REMOVAL OF DIRECT SPONSORSHIP EDUCATIONAL GRANTS – PROCESS AND TRANSPARENCY DEMONSTRATION PRODUCTS AND SAMPLES AGREED DEFINITIONS GENERAL CRITERIA ON EVENTS COMMON INDEPENDENT ENFORCEMENT MECHANISM
  • 6. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION Removal of Direct Sponsorship DIRECT SPONSORSHIP EDUCATIONAL GRANTS OR
  • 7. REMOVAL OF DIRECT SPONSORSHIP ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION What areas do the new rules affect?  EDUCATIONAL GRANTS – PROCESS AND TRANSPARENCY DEMONSTRATION PRODUCTS AND SAMPLES GENERAL CRITERIA ON EVENTS COMMON INDEPENDENT ENFORCEMENT MECHANISM AGREED DEFINITIONS
  • 8. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION Educational Grants: Process and Transparency - Part 1 • Educational Grants are legal agreements • Industry can only support HCPs to attend third-party organised events via an educational grant • Industry organised events are not affected by this process change • Grants can only be provided to legal entities – Healthcare Organisations (HCOs) or Professional Conference Organisers (PCOs) • The grant provider can specify criteria for the recipient, but this cannot identify one eligible individual • The grant provider cannot be aware of the individuals benefitting from the grant
  • 9. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION Educational Grants: Process and Transparency - Part 2 INDUSTRY INITIATED PROCESS  HCP INITIATED PROCESS     
  • 10. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION Educational Grants: Process and Transparency - Part 3 Transparent MedTech
  • 11. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION What areas do the new rules affect? EDUCATIONAL GRANTS – PROCESS AND TRANSPARENCY DEMONSTRATION PRODUCTS AND SAMPLES GENERAL CRITERIA ON EVENTS COMMON INDEPENDENT ENFORCEMENT MECHANISM REMOVAL OF DIRECT SPONSORSHIP   AGREED DEFINITIONS
  • 12. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION General Criteria for Events PROGRAMME LOCATION & VENUE GUESTS HOSPITALITY TRAVEL TRANSPARENCY EXHIBITION & SPONSORSHIP ITEMS DELEGATE SUPPORT EVENT MARKETING MATERIALS
  • 13. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION What areas do the new rules affect? DEMONSTRATION PRODUCTS AND SAMPLES GENERAL CRITERIA ON EVENTS COMMON INDEPENDENT ENFORCEMENT MECHANISM EDUCATIONAL GRANTS – PROCESS AND TRANSPARENCY REMOVAL OF DIRECT SPONSORSHIP    AGREED DEFINITIONS
  • 14. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION Demonstration Products and Samples GENERAL PRINCIPLES DEMONSTRATION PRODUCTS (DEMOS) SAMPLES
  • 15. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION What areas do the new rules affect? DEMONSTRATION PRODUCTS AND SAMPLES COMMON INDEPENDENT ENFORCEMENT MECHANISM AGREED DEFINITIONS GENERAL CRITERIA ON EVENTS EDUCATIONAL GRANTS – PROCESS AND TRANSPARENCY REMOVAL OF DIRECT SPONSORSHIP    
  • 16. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION Agreed Definitions
  • 17. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION What areas do the new rules affect? DEMONSTRATION PRODUCTS AND SAMPLES COMMON INDEPENDENT ENFORCEMENT MECHANISM AGREED DEFINITIONS GENERAL CRITERIA ON EVENTS EDUCATIONAL GRANTS – PROCESS AND TRANSPARENCY REMOVAL OF DIRECT SPONSORSHIP     
  • 18. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION Common Independent Enforcement Mechanism Transposition obligations Applicability of codes Dispute Resolution Principles MedTech Europe Code Committee MedTech Europe Compliance Panel Procedural principles Sanctions
  • 19. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION Overview MedTech Europe and the Code of Ethical Business Practice Compliance regulation changes Putting the new code into context
  • 20. ACI 2019 ADVANCED CARDIOVASCULAR INTERVENTION Thank you for your time Find out more: www.medtecheurope.org

Editor's Notes

  1. Thank you I’m Fiona McDonald, MD - MMC have worked closely w/ NHS/ Industry +25 years MD - MML 2018 spec provide a compliant organisl service 4 HCPs wishing to attend educt mtgs thru ind grant funding
  2. Next 10 mins – provide an overview of …. Presentation prepared to explain the changes in way industry interact HCPs Changes not implemented by industry but independent body with whom industry must comply
  3. MedTech Europe set up 2012 - alliance 2 Assoc. - Eucomed & European diagnostics manuf industry Acting as the Voice of the European med technology ind, number of responsib which INCLUDE EU health related policies and legis. Research & dvpt of new techno. Ensuring highest ethical standards are maintained in our sector 17/18 - phase in of the new code ethical bus practice. Important 2 understand regs not intro to inhibit educ in our sector - but rather to ensure that trans & honest procedures take place Number of reasons for new regs. Eucomed/ EDMA codes out of date, confusing and needed aligning, public & regulatory demand 4 greater transparency of relationship btwn industry & HCPs, wish to promote responsib. Ind image – gone are the days when we could use luxury hotels and destinations.
  4. We’re going to look at the 6 key areas that the new rules affect starting with removal of direct sponsorship
  5. 1st Jan 18 saw the removal direct spons by med ind to Healthcare Professionals - prob the change affect everyone most HCPs no longer rcv direct support from ind to attend third party organised ed mtgs Adit ind r prohib from arranging conf attendance for HCPs direct trav agencies Doesn’t mean funding cannot provided - simply means diff process must now be followed That process is intro of ed grants
  6. Moving on to the edu grant
  7. Ed grants forms a legal agreement and must be accurate, transparent, disclose finance breakdown, set clear criteria of intent but not identify individuals. Any comps provid finance 4 HCPs attend 3rd party organised ed conf must process funds as ed grant Point out at this stage, changes do not include industry org events Ed grants only provided to legal entit ie Healthcare Organisations or Professional Conference Organisers – known as HCOs & PCOs. To assess grant requests, providers must have in place an internal independent process based on objective criteria The grant provider IS permitted specify certain criteria for the allocation monies: benif hospitals, specialty, years HCP practice, number of publications, clinical trials. However detailed info must not shape individual The Code stipulates that the grant provider should not be aware of the individuals benefiting from the grant before or during the event and that following the event these details may only be shared 4 legal purposes. What this does means though, is that we’re in better position to focus on getting the right people to right meetings  
  8. So how do you go about obtain funding to attend ed conf? Whilst HCP cannot directly request ed grant from cos. for themselves, they can send written request to cos. on behalf of their hospital. This should simply state number of attendees wishing to attend/conference details. If support is offered, the Grant then process through finance dept, not the individual. The HCP can also approach an independent PCO (such as Millbrook) who can reach out to companies. If the PCO already holding a grant, they will cross check your details against criteria received from the grant provider. Or the HCP can approach the organisers of the conf they wish to attend, who may already be holding grants for distribution or dtls of PCOs handling such grants. Whilst no guarantee of grant being awarded via these 3 methods, these are the most proactive ways to seek funding.
  9. Regardless of the process followed, it is mandatory for cos. to annually disclose details of grants on “Transparent MedTech” - Ethical MedTech’s publicly available online portal As well as finance details of ed events, this platform also publishes details of contributions to scholarships, fellowships & public awareness campaigns.
  10. Moving on, specifics surrounding org of educational events
  11. So, anyone thinking of org ed conf should be aware that there are new regulations that need to be adhered to that address the issue of perceived image and appropriateness. Most aspects of conf org have updated regulations. All sponsored confs are subject to approval by the Ethical MedTech’s newly intro Conference Vetting System. The CVS is the most significant change in this area and ind sponsorship will not provided without this approval.
  12. Products and samples
  13. Companies are still permitted to provide single and multi use products and samples for demo and training but now required to keep detailed records re no charge, delivery, receipt and return of goods. Also required to write to recipient re no fee arrangement. When providing single use samples, quantity provided must not exceed amount reasonably nec to require adequate experience or training in dealing with that product
  14. Agreed Definitions
  15. Clear definitions are now included at the end of code removing confusion and vagueness of previous codes.
  16. What are consequences if these new regulations are not followed?
  17. New code includes CIEM. Members that do not comply with code may face audit by the MedTech Europe Compliance Panel. Sanctions range depending on severity of fault from publication of infractions, financial penalties to exclusion of membership Onus falls on member companies to fully adhere to code. MedTech Europe’s Code Committee offers support 2 companies with integrating the new regulations into working practice.
  18. So, at the end of day, we must acknowledge regulations have been introduced to protect reputation health service in general and that the money that industry invests in ed meetings is spent prudently and appropriately whilst ensuring that cos. get best value for investment. Already covered specific areas that affect conference organisers and industry. The overall message is that the ethos must be to respect high ethical standards and values. Conf Org’s acknowledge importance managing/ organising ed meetings and that this must be done in appropriate manner and that our Responsibility of governing and financing of meetings must be done in accordance with new code. Likewise industry acknowledges that new regs introduced by MedTech Europe benefit education and training and as such welcomes opportunity provide ethically compliant workplace.
  19. Full code available on MedTech Europe site. Please speak to me in person for more detailed info. Thank you for listening.