Panel Discussion MINI SUMMIT XIII: global fair market value update

Transcription

1 Panel Discussion MINI SUMMIT XIII: global fair market value update

2 Introduction Panel Swee Kheng Khor, MD, Associate Director, Office of Ethics and Compliance, Middle Eastand Pakistan, AbbVie BioPharmaceutical GmBH, Dubai, United Arab Emirates Dr. Marcel Koerting, Senior Legal and Compliance Counsel, Novo Nordisk Health Care AG, Zurich, Switzerland Dr. Gudula Petersen, Chief Compliance Officer Europe and Australia, Grunenthal Pharma, GmbH & Co. KG, Aachen, Germany Peter Dieners, Esq., Partner, Clifford Chance, Düsseldorf, Germany Andy Bender, President and Founder, Polaris, Amsterdam/New York Opinions expressed by the panel are personal opinions, and do not reflect the opinion of AbbVie Inc, UC Berkeley, Grünenthal, Novo Nordisk or Polaris 2

3 Challenges implementing global FMV Finding a consistent methodology that can be applied across the globe Obtaining buy in from local management Finding reliable data sources Dealing with issues like travel, multiple specialties in one adboard Compensation of international HCPs from countries with substantial income differences Cross border Getting large group of local management to buy into consistent methodology Dealing with outliers Managing differences between current and propose pay Etc. Exception process Updating rates Dealing with high inflation and exchange rate differences Etc. 3

4 Global Fair Market Value Update Grünenthal s approach to define service fees for HCP Methodology List of fair market values for services by HCP per country is available where Grünenthal is present Currently different approaches per country how to define the local fair market value per hour/day or per service degree of expertise is respected by giving a range or as a multiplier of the fees differentiation between national and international activities by using multiplier or respecting the range Local Compliance person to be involved in any cross-border transaction with HCP/HCO in their countries Any deviation from the defined standard FMV need to be justified by the requestor and approved by local Compliance GRÜNENTHAL Name der Präsentation Datum Page 4

5 Global Fair Market Value Update Challenges and Issues How to validate that our company fees are within the normal range? How to define values in countries / regions where Grünenthal is not present? How to define fees in joint meetings (e.g. if activity is organized with other companies)? How to deal with different fees for the same service (e.g. members of an advisory board from different countries/ regions)? How to respect travel time (esp. with intercontinental flights) and attendance in meetings without an active part? How to justify a significant higher fee for a consultant who seems to be a stand-alone expert? GRÜNENTHAL Name der Präsentation Datum Page 5

6 6 Purpose & Definition Fair market fees are essential not only to be fair and reasonable, but also to avoid any suspicion that with such payments a hidden consideration for any other unauthorized service is made. In order to meet this obligation it is necessary to have a sound approach for establishing a documented Fair Market Value (FMV) compensation standardized across the company that is supported by current and reliable data sources. The Law and EFPIA rules are in general silent but make reference to a FMV only: EFPIA code: it is permitted to use healthcare professionals as consultants and advisors, whether in groups or individually, for services such as speaking at and chairing meetings, involvement in medical/scientific studies, clinical trials or training services, participation at advisory board meetings, and participation in market research where such participation involves remuneration and/or travel. The compensation for the services is reasonable and reflects the fair market value of the services provided. In this regard, token consultancy arrangements should not be used to justify compensating healthcare professionals. NN defines FMV as a: Reasonable and customary rate for services provided where neither party is under any compulsion to pay or perform the services or buy or sell the object.

7 7 CHALLENGES Even with a methodology in place it is a case by case FMV assessment in each single case pure local project (less difficult) vs. global projects (more difficult) Cross-country indication/local purchase power Which factors matter or is more important than others (e.g. education and experience of the HCP, level of effort and intensity of the activity/service, local knowledge, etc.)? FMV is sensitive and subjective! Due to circumstances of place, time, existence of comparable precedents, education, expertise level, customs, national and international framework, and the evaluation principles of each involved person Internal/external pressure: we need this HCP we have paid this x Euro amount for years now if we can not pay y Euro amount the HCP will go somewhere else Competition law issues when sharing data: An industry association, cannot be a platform for an exchange of confidential information between independent entrepreneurs being members of the association. Confidential information is in particular information about prices offered by members of the association.

8 8 to be considered (1) Does local law require a min. or max. rate? Germany: The German federal law states that the reimbursement of services of physicians in providing written expertise may not exceed an amount of EUR 17,49 for each 20 minutes of work and may be multiplied with a factor of 1 up to a maximum of 2,3. This regulation has been the basis of a court decision of the FSA (a German pharmaceutical industry organisation, which has established not only a general accepted Business Ethics code, but also an internal jurisdiction), where they stated that this regulation shall also be the Fair-Market-Value of expert-services of physicians contracted by pharmaceutical enterprises. So this leads to a hourly rate in the range of 52 EUR to 120 EUR.

9 9 to be considered (2) Cross-country indication/local purchase power

10 Why is FMV Important? And why is it difficult? Important because: Greater scrutiny around payments to Health Care Professionals (HCPs) Excessive fees may be perceived as a kickback / inducement Transparency requirements, e.g. US and France Difficult because: No official guidance on what s FMV (either from Govt or Pharma associations) Any collaboration at trade association level faces anti trust issues Rather difficult to determine what criteria is important, multipliers/weightage and data sources 10

11 Broad Strategies Per hour, or per engagement? Adjust for preparation work, or not? If yes, should there be a ratio, e.g. 4:1? Adjust for travel, or not? Should there be a difference between specialties, or not? Should there be a difference between countries, or not? Adjusting for GDP or inflation? Should there be a difference between type of service, or not? E.g. is an AdBoard more complex than Speaking, and therefore deserves higher pay? Should there be a cap, or not? If a cap, per engagement or per year? 11

12 Possible Criteria CLINICAL EXPERIENCE Years of Experience in Specialty Leadership in hospitals or healthcare settings Leadership/Membership in Professional & Scientific Society Leadership/Membership in Guideline Committees or Official Committees Board Certification or Additional Academic Degrees or Fellowships RESEARCH Number of Peer Reviewed Publications Number of Peer Reviewed Presentations Leadership/Membership in Research Institution Leadership/Membership in Editorial Boards of Journals / Periodicals ACADEMIA Years of Experience in Teaching Leadership in Universities or Teaching Institutions Supervision of Graduate / Post Graduate Students NUMERATING THESE METRICS Leadership highest, or current? Number, or value of publications? What about Number of Citations instead? 12

13 FMV in a Box Design the Grid and Calculator Use the criteria proposed previously Obtain data from various sources: Ministry of Labour? Ministry of Finance? Self reported physician salaries? Consultation fees per hour? (although this is weak) Careful of privacy laws and physician push back Owner: Medical Affairs. Process: decide internally before communicating to HCPs Caveat: PSA / proof of service is important. FMV calculation should be clearly defined in PSA. What I like: per hour rate, including reasonable preparation time, with no travel adjustment, with caps per engagement and per year (depending on sophistication of your Finance system). 13

14 Questions for the panel What are the key principles for developing and applying a FMV methodology globally? What are some of the unique challenges in establishing FMV rates globally? Why is FMV relevant to global transparency and compliance reporting? In addition to FMV for HCP engagements, what other areas does FMV apply to? How do we get buy in from local management? How do you deal with the lack of available data for determining FMV? How do you account for differences between public and private sector compensation when calculating FMV rates? Are there differences in international HCP FMV rates based on specialties? 14