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Advisory Committees and Speaker Bureaux - Ensuring Compliance

September 2012 | 74 pages | ID: AA6068C1865EN

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Pharma is faced with increasing constraints on physician participation in its advisory board and speaker bureau programs. The Physician Payment Sunshine Act, which goes into effect in the US in 2013, will require public disclosure of payments made to physicians for such services. What’s more, similar rules are expected in Europe within three years, and in Asia within five.

In this new environment of transparency, Pharma will need to be proactive in educating physicians and consumers alike on the public benefit of physician consulting roles. And to meet the legal requirements of the Sunshine Act, pharma companies will have to revamp their compliance programs from the organisation’s top to bottom.

There is a substantial cost to these changes, but the new transparency also offers some exciting benefits, and smart pharma companies will learn how to capitalise on those opportunities.

Report Overview

Advisory Committees and Speaker Bureaux – Ensuring Compliance

With the Sunshine Act due to go into effect next year, FirstWord has consulted with more than 15 experts – including representatives from Pharma and the thought-leaders that are setting the new standards for Pharma participation – to create a definitive report on how the legislation will affect pharma-physician relationship programs.

The report begins with an in-depth explanation for the move to greater transparency, and follows that background with a wealth of practical guidance – on how to comply with the complex data collection and reporting mandate of the new US transparency law; how to minimize the impact on existing speakers and advisory board programmes; and alternative ways of delivering messages to doctors. The report also recommends that companies take advantage of the new public data to assess the efficacy of their own physician relationship programs and monitor their competitors’ activities and strategies.

This report includes three exclusive case studies – detailing how a major pharma company manages its physician advisory boards and speaker programmes, how a major medical centre determines what pharma relationships are appropriate for its physicians, and how a specialized consultancy audits pharma compensation to physicians to ensure payments are within the legally acceptable range.

Whether you are still unsure how to adapt, or have already begun to prepare, this report will help you to move forward with confidence.

Key Report Features
  • Overview of the changing environment for pharma-physician relationships
  • Outline of US legislation going into effect in 2013
  • Predictions for changes to European legislation
  • Redesigning pharma compliance programs for the Sunshine Act and beyond
  • Guidance for minimizing the negative impact on physician recruitment
  • Alternative peer-to-peer techniques to inform doctors
  • Positive benefits of the rich data that comes with transparency
  • Insights from the top authorities in every aspect of transparency
  • Case studies detailing best practices in Pharma-Physician relations
Key Benefits
  • Understand the ethical environment in which doctors are making decisions about their relationships with pharma companies
  • Comply with the legal requirements of the new U.S. Sunshine Act and prepare for similar transparency requirements from other countries
  • Improve recruitment of physicians for advisory boards and speaker programs by helping them mitigate any negative impact of the coming disclosures
  • Learn about alternative ways to deliver messages to doctors
  • Be prepared for press inquiries on report details
  • Ensure you are paying doctors for consulting services at a legally permissible level
  • Take full advantage of centralised data to optimise relationship programs and monitor competitors’ peer-to-peer strategies
Key Quotes
  • “By making this information publicly available, we took an important step towards improving patients’ understanding of how the pharmaceutical industry and healthcare provider work together.” Kevin G. Colgan, Vice President, GlaxoSmithKline
  • “We think it’s important that everybody knows how much we try to educate physicians on how to use the medications, particularly with new medicines.” Marjorie Powell, senior assistant general counsel, Pharmaceutical Research & Manufacturers of America (PhRMA)
  • “There are the doctors to whom it doesn't matter if you put a billboard up on the highway saying ‘Dr Smith takes money from Pfizer’; they’re going to do it anyway. I think the impact will be on sort of a middle ground physician who may see the potential transparency as being not worth the money they are getting paid.” Dr Paul Root Wolpe, director, Center for Ethics, Emory University
  • “There’s going to be an incredibly rich database available with all kinds of information that isn’t readily available right now. I think we’re going to see some creative uses of that data.” Holly Carnell, associate, McGuireWoods
Key Questions Answered
  • How do I revamp compliance programs to conform to new transparency requirements?
  • What is the potential risk if my company waits to make changes?
  • How do I minimise the negative impact of new transparency requirements on recruitment of physicians for advisory boards and speaker programs?
  • How do I set physician compensation at legally allowable levels?
  • What human and technology resources will we need to track and publish data?
  • What alternative forums can I turn to to get my peer-to-peer messages delivered?
  • What’s next for transparency in physician compensation, and how can we prepare for it?
Who Should Read This Report
  • Pharma top-level management
  • Directors and consultants in:
    • Compliance and regulatory affairs
    • Medical affairs
    • Marketing
    • Corporate Communications
    • Competitive and business intelligence
Expert Views Include:
  • Kevin G. Colgan, Vice President, GlaxoSmithKline
  • Joseph Boyd, director of marketing operations, Astellas Pharma US
  • Sharon Anglin Treat, executive director, National Legislative Association on Prescription Drug Prices, and Democrat Member of the Maine House of Representatives
  • Marjorie Powell, Senior assistant general counsel, Pharmaceutical Research & Manufacturers of America
  • Dr David Nash, founding dean, School of Population Health, Jefferson University
  • Dr Charles D. Rosen, president, Association for Medical Ethics
  • Dr Ann S. Brandt, partner, Health Care Appraisers
  • Dr Daniel Carlat, director, Pew Prescription Project
  • Dr Keith L. Ponitz, physician compliance officer, University Hospitals
  • Dr Paul Root Wolpe, director, Center for Ethics, Emory University

Pharma has a dilemma



Formal relationship codes
US federal health programmes
Stricter standards
Focus on transparency
Global impact



The new challenge
Getting the job done
The hazards of delaying
Cause for re-examining



Assessing the impact
Improving recruiting
Finding alternative message fora
Electronic alternatives
Using the data

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