How Will Europe s New Medtech Code Affect Your Meetings?
Meet the Presenters Pat Schaumann, CMP, CSEP, DMCP, HMCC Sr. Director of Healthcare Compliance Pat.schaumann@maritz.com Simon Dufaur Head of Strategy & Consulting, D4 Management Christine Sainvil Compliance Officer & Manager of the Conference Vetting System (CVS) for MedTech Europe Proprietary and Confidential 2017 Maritz 2
Next year, European medical-technology companies will be prohibited from directly sponsoring physicians to attend medical conferences. How will this affect the events industry? Proprietary and Confidential 2017 Maritz 3
The MedTech Europe Code of Ethical Business Practice The Change The change calls for the discontinuation of direct sponsorship of HCP s Independent medical education has to be supported exclusively by means of Educational Grants. Such Educational Grants can be provided to Healthcare Organizations (HCOs) or Professional Congress Organizers (PCOs or third-party meeting planning organizations. Proprietary and Confidential 2017 Maritz 4
What Is ACCME s Guidance For Cme Providers Related To Revised Industry Codes? What is their position on standards for commercial support that have been introduced by MedTech Europe, AdvaMed, and APACMed, organizations that represent the device manufacturing industry. Expectations Alignment between the revised codes and ACCME requirements Proprietary and Confidential 2017 Maritz 5
WHAT? The Medtech Europe Code of Ethical Business Practice establishes new minimum standards by which industry members will be operating in the Medtech Europe geographical area. These standards will affect all aspects of the industry s relationship with healthcare professionals and healthcare organizations. Proprietary and Confidential 2017 Maritz 6
WHAT? The Medtech Europe Code Of Ethical Business Practice Regulates all aspects of the industry s relationship with HCP s and HCO s Includes: Company-organized events Arrangements with consultants Research and financial support to medical education, amongst others Maintains an independent enforcement mechanism Proprietary and Confidential 2017 Maritz 7
WHAT? The Code should also be taken into account when planning activities that take place in the Medtech Europe geographical area, irrespective of where the healthcare professionals and healthcare organizations are registered and practicing. Proprietary and Confidential 2017 Maritz 8
What is changing? Once upon a time, member companies of MedTech Europe which started as a partnership between the medical-technology trade organization Eucomed and the European Diagnostic Manufacturers Association (EDMA) in 2012 could directly sponsor specific health-care providers (HCPs) to support their trip to a third-party organized event such as a medical meeting. But the Code of Ethical Business Practice will do away with that. Proprietary and Confidential 2017 Maritz 9
What Does It Mean? For member companies these changes, when in force, will mean: the end of the direct sponsorship of healthcare professionals attendance at third-party events new transparency and public disclosure requirements stricter rules on educational grants the use of a conference vetting system One of the key changes being brought by the new Code is the phasing out of direct sponsorship to individual healthcare professionals. Proprietary and Confidential 2017 Maritz 10
The main changes brought by the new code are: WHAT? 1. The phasing out of the direct sponsorship 2. New transparency for educational grants 3. A common chapter on general criteria for events 4. A chapter on demonstration products and samples 5. Agreed definitions 6. A common independent enforcement mechanism Proprietary and Confidential 2017 Maritz 11
How does the Direct Sponsorship Ban affect you? Member companies will not be able to provide financial or in-kind support directly to individual healthcare professionals to cover the costs of their attendance at third-party organized educational events. Third-party educational events are interpreted broadly as including activities of any type planned, budgeted, managed and executed in whole (or in part) by another entity (other than the member company) to fulfil healthcare professional medical educational needs. In practice, this includes all third-party organized educational conferences such as national, regional or specialty medical association conferences, educational conferences organized by hospitals, conferences organized by professional conference organizers, by accredited continuing medical education providers and by patient organizations. Proprietary and Confidential 2017 Maritz 12
Any New Transparency Requirements? A significant change brought by the new Code is a set of new sunshine rules that will affect the provision of educational grants. From 1 January 2018, member companies will be required to gather the data regarding the educational grants provided to healthcare organizations with a view to publicly disclosing them on 1 January 2019. Proprietary and Confidential 2017 Maritz 13
Transparency Changes The rules for the provision of educational grants have become stricter. Educational grants must be restricted. The effect is that the grant agreement between the member company and the healthcare organization must specify the intended purpose of the grant together with the rights to enable the company to verify that the grant is in fact used for such purposes. Practical examples of appropriate educational grants include support of third-party organized educational events, support for healthcare professional participation at those events, scholarships and fellowships and grants for public awareness campaigns. Proprietary and Confidential 2017 Maritz 14
The Vetting Process How does the Conference Vetting System work? Where the educational grant is supporting an educational event, such events must comply with the Conference Vetting System. The Conference Vetting System is an independent centralized system that reviews the compliance of third-party educational conferences with MedTech Europe Code and the Mecomed Code. It determines whether it is appropriate for companies which are members of these regional associations and members of the national associations affiliated with these industry associations to sponsor healthcare professionals to participate in such conferences. Proprietary and Confidential 2017 Maritz 15
Exceptions 1. The support provided by member companies to individual healthcare professionals for attendance at procedure training meetings organized by third parties 2. The support provided to individual healthcare professionals engaged by the member companies as consultants to speak at a satellite symposium. Proprietary and Confidential 2017 Maritz 16
Guidelines On The Interaction With Hcp s And Hco s Event Programs The program should directly relate to the specialty and/or medical practice of the HCP who will attend the event Member companies are not permitted to facilitate or pay for meals, travel, accommodation or other expenses for Guests of HCP s Proprietary and Confidential 2017 Maritz 17
Where do I find the new criteria for events? The Medtech Europe Code, has consolidated the general criteria applicable to educational events into one chapter. This chapter sets out all the requirements relating to the event program; the location and venue, guests, reasonable hospitality, travel and the transparency rules. The transparency rules, in this context, refer to the need for member companies to maintain appropriate transparency by requiring prior written notification to the hospital administration, the healthcare professional s superior or other locallydesignated competent authority, fully disclosing the purpose and scope of the interaction between the company and the healthcare professional before the activity or event takes places. This is what the Code calls Employer Notification. Proprietary and Confidential 2017 Maritz 18
What Is Employer Notification? Employer Notification is required whenever a member company engages a healthcare professional or whenever it makes a financial contribution towards the healthcare professional s medical education; however, incidental interactions arising from the normal course of business such as meals associated with educational or business meetings or modest gifts related to the healthcare professional s practice do not require such notification. Proprietary and Confidential 2017 Maritz 19
What has changed in the Procedural framework and how will it be Enforced? Changes to the procedural framework are relatively minor. From 1 January 2018, the administrative charges to be imposed as part of the complaints procedure will be determined by the Chairman of the Panel. In addition, from that date onwards, information on cases that are resolved through mediation will be published in an annual summary report although the names of the companies or the individuals involved will not be disclosed. Proprietary and Confidential 2017 Maritz 20
What Do I Really Need To Know? As of 2018, EthicalMedTech will still require all meetings to be vetted through its system and only these meetings will be eligible to receive funds from Eucomed and EthicalMedTech member companies-and only through educational grants The largest change is that the burden of choosing the healthcare professionals attending the meeting will now fall onto the shoulders of the medical association. Sponsoring companies can no longer have any input or influence on healthcare professionals being chosen to attend the medical meeting, creating more work for the medical association. Proprietary and Confidential 2017 Maritz 21
What Else Do I Need To Know? It s expected that the changes will not only affect the number of international delegates attending medical meetings, but also have a ripple effect on exhibit halls. There is implications that the new Code also be adopted in Latin America and Asia Pacific Proprietary and Confidential 2017 Maritz 22
WHY? Ensures that all interactions between companies and HCPs and HCO s, such as hospitals and clinics, are ethical and professional at all times Proprietary and Confidential 2017 Maritz 23
WHEN? The MedTech Europe Code of Ethical Business Practice became binding for MedTech Europe corporate members on January 1 2017 From 1 January 2018, the end of the transitional period, member companies will not be able to provide financial or in-kind support directly to individual healthcare professionals to cover the costs of their attendance at third-party organized educational events. Proprietary and Confidential 2017 Maritz 24
The Medtech Europe Countries With National Associations Austria * The Netherlands Belgium * Norway Bulgaria * Poland Czech Republic * Portugal Denmark * Romania Finland * Russia France * Slovakia Germany * Spain Hungary * Sweden Ireland * Switzerland Italy * Turkey * The United Kingdom Countries covered by Mecomed, the Middle East Medical Devices and Diagnostics association, are in the scope of the Disclosure Guidelines. Proprietary and Confidential 2017 Maritz 25
WHEN? Member companies had a one-year transitional period ( phase-out period ) to get ready to cease direct sponsorship. The Code does not prevent, however, member companies from providing support to such events in other ways that are considered appropriate, such as via educational grants or other types of funding such as grants and charitable donations. Proprietary and Confidential 2017 Maritz 26
HOW? The information to be disclosed will be the aggregate amount of all the grants provided to each healthcare organization during the previous reporting year. It is anticipated that this information will be disclosed in the Medtech public platform currently being built for this purpose. Proprietary and Confidential 2017 Maritz 27
WHO? Medtech Europe is an alliance of the European Diagnostic Manufacturers Association (EDMA) and Eucomed, representing respectively the European in vitro diagnostic industry and medical devices industry. Proprietary and Confidential 2017 Maritz 28
ACCME Responds To New Code The ACCME applauds the changes the associations have introduced in the codes ethical business practices since they bring industry standards in closer alignment with those that have existed in the United States. Many of the principles espoused in the revised codes are aligned with the ACCME s Standards for Commercial Support Standards to Ensure Independence in CME activities. These standards have been recognized internationally as a benchmark for independent medical education. Proprietary and Confidential 2017 Maritz 29
Standards For Commercial Support Apply Internationally As has always been the case, organizations accredited in the ACCME System can accept financial support for their educational activities from commercial entities such as medical device manufacturers under the revised codes and successfully maintain independence from industry by adhering to ACCME s Standard 3. The ACCME s Standard 3 allows accredited organizations to accept funds from commercial interests, with the express understand that the accredited organization will: Proprietary and Confidential 2017 Maritz 30
Standard 3 Rules Make all decisions regarding the use of the support independent of any company or companies Have assigned written agreement with the company that includes the specific terms and conditions of the support Use the funds only for the educational activity and to offset the cost of participation to the learners as a whole Not pay for travel, lodging, honoraria, or personal expenses for non-teacher or non-author participants of the supported education activity Disclose to learners the source and (if in-kind) the nature of the commercial support. Proprietary and Confidential 2017 Maritz 31
These expectations apply to any activities that an accredited provider offers, regardless of where the activity is held. Proprietary and Confidential 2017 Maritz 32
These expectations to follow ACCME standards also applies to organizations that are acting as agents of the accredited organization offering the activity, such as firms that provide meeting planning services, nonaccredited joint providers, or other stakeholders in an educational event. Proprietary and Confidential 2017 Maritz 33
Resources Resource section MedTech Europe Code of Ethical Business Practice The Conference Vetting System Toolkit for PCOs, HCOs and Educational grant templates Code Hotline ethics@medtecheurope.org ACCME info@acme.org Proprietary and Confidential 2017 Maritz 34
Maritz A Certified Trusted Partner Of Medtech Europe Maritz is in the process of becoming Certified and a Trusted Partner of MedTech Europe which is the official certification of meeting planning organizations that demonstrate understanding and commitment to the new regulations. We will be able to: Assist in the administrative process of completing and submitting standardized education grant request and the application processes. Manage compliant destination and venue selection With our subject matter experts we can make the process easy, seamless while adhering to all compliance regulations. Proprietary and Confidential 2017 Maritz 35
Our Partner - Polaris Polaris fully supports MedTech Europe and its Code of Ethical Business Practices. That is why we created our Global MedTech Solution. Our goal is to assist clients in implementing an end-to-end tool that ensures complete, accurate and efficient capture and reporting of information related to all HCP/O payments or transfers of value without overburdening the organization including: Automating the grant request submission and approval process Automatically generating the pre-notification for Educational Grants to third party events to HCOs to the Conference Vetting System (CVS), using HCP eligible groups Post reporting formatting for grants per transparency reporting Proprietary and Confidential 2017 Maritz 36
CONTACT MARITZ Pat Schaumann, CMP, CSEP, DMCP, HMCC Senior Director of Healthcare Compliance Maritz Global Events Pat.Schaumann@maritz.com For healthcare-related white papers, surveys, updates, and to download our webinar Proprietary and Confidential 2017 Maritz 37
QUESTIONS? Proprietary and Confidential 2017 Maritz 38