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Conflict Of Interest Policy For Truven Health Analytics Inc.

I. Executive Summary

Truven Health is committed to providing unbiased evidence - based information on drug uses in accordance with the available medical and scientific literature. The policies and procedures outlined herein identify and help manage potential conflicts of interest for external advisors (“Advisors”) involved in the content and product development process for Truven Health.

II. Background

Truven Health draws on the expertise of a range of individuals from within and outside the company to review and evaluate the available evidence on a drug. It is essential that these individuals be impartial and unbiased.

Advisors may have affiliations with the drug sponsor or a competing drug sponsor, or may have a direct commercial interest in the drug. For example, a leading researcher in a particular field may act as a clinical trial investigator or as a consultant for the sponsor of a drug covered by a Truven Health database, or may have intellectual property and royalty rights in the drug. Where such financial relationships exist, there is the potential for a conflict of interest. The drug information contained in Truven Health products may be used by physicians to facilitate prescribing determinations, or by third - party payers or government healthcare programs to facilitate coverage or reimbursement determinations. The content that Truven Health develops thus has a potential commercial impact on drug sponsors and consequently on individuals with financial ties to the sponsors or a competing drug sponsor.

Not all financial relationships are disqualifying. Financial relationships vary in type and size, and an overly broad conflict of interest policy would inappropriately preclude individuals with critical expertise from contributing to content development. This document, therefore, sets forth a process to identify and categorize relevant financial relationships. Specific criteria are then applied for each category to determine whether disqualification or disclosure is necessary. For the remainder of this policy, a drug sponsor or competing drug sponsor will be referred to as a “Pharmaceutical Company,” meaning a company that sells and markets a pharmaceutical product.

III. Collecting Information on Financial Relationships

Before utilizing any Advisor, Truven Health will collect information on the Advisor’s financial relationships with Pharmaceutical Companies. Information will be collected on a Financial Disclosure Form (“FDF”), a copy of which is attached hereto.

The Truven Health Editorial Department (“Editorial Department”) will be responsible for ensuring that the FDFs are completed and maintained by Truven Health. FDFs will be completed upon the beginning of an Advisor’s term on an advisory board or other engagement by Truven Health, and annually thereafter.

In addition, in the case of an Advisor working on Off Label content, the Editorial Department will request the Advisor to update any financial disclosure information by completing a new FDF prior to the Advisor’s work on any new assignment such as review of a particular monograph.

If an Advisor or potential Advisor refuses to provide information about his or her financial and other relevant interests, such individual shall be disqualified from serving as an Advisor and participating in content development for Truven Health.

IV. General Rules for Identifying and Resolving Conflicts of Interest

When a new content development activity is begun such as review of a particular indication, the Editorial Department will review the financial relationship information from the Advisor and identify any financial relationships. If possible, the Editorial Department will select Advisors to assist with the content development who have not identified any pertinent financial relationships. Where that is not possible due to a limited pool of available, qualified individuals, the rules in the following sections for different types of financial relationships will be applied.

V. Domestic Partner Description

The following interests in Pharmaceutical Companies are considered to create a potential conflict of interest. In each case, the policy describes the scope of the interest and how it should be addressed. The policy is intended to cover the combined financial interests of the Advisors and the Advisor’s spouse and/or domestic partner as defined below (a spouse or domestic partner will be referred to as a “Partner.”) Someone is a domestic partner if either:

  • the domestic partnership has been registered with a governmental entity pursuant to state or local law authorizing such registration; or
  • the Advisor and domestic partner satisfy all of the following criteria:
    • are at least 18 years old
    • are not legally married to anyone else and are not the legal domestic partner of anyone else, nor have been for the preceding 6 months
    • intend to remain each other's sole domestic partner indefinitely
    • reside together in the same principal residence and intend reside together indefinitely
    • are emotionally committed to each other and share joint responsibilities for each other’s common welfare and financial obligations are not related by blood closer than would prohibit marriage in the state of residence
    • are mentally competent to enter into contracts

VI. Rules for Specific Financial Relationships

A. Employment or Leadership Positions
  • An Advisor who currently or within the past six months (a) is or was an employee, or (b) holds or held a position as a director, officer of, or a partner in, any pharmaceutical company shall be excluded from content development .
  • Where the Advisor’s Partner is an officer or director of, or a partner in, any pharmaceutical company, the Advisor shall be excluded from content development.
B. Equity or Stock Ownership
  • This section applies only to stock or equity ownership in a pharmaceutical company where the Advisor or the Advisor’s Partner has direct control over the disposition of that ownership interest. It does not include an interest in stock held via a diversified fund, such as a mutual fund, which is under the control of another.
  • Where the combined value of the stock or equity ownership in any single pharmaceutical company held by the Advisor and/or the Advisor’s Partner totals $25,000 or less, the Advisor shall be allowed to participate in content development.
  • Where the combined value of the stock or equity ownership in any single pharmaceutical company held by the Advisor and/or the Advisor’s Partner is greater than $25,000 but le~ss than $100,000, the Advisor shall be allowed to participate in content development and the Advisor’s interest shall be disclosed.
  • Where the combined value of the stock or equity ownership in any single pharmaceutical company held by the Advisor and/or the Advisor’s Partner is greater than $100,000, the Advisor shall not be permitted to participate in content development.
C. Advisory/Consulting Role; Lecture/Speaking and Expert Witness Fees and Payments of Other Sorts
  • This section addresses fees and payments for an Advisor’s or their Partner’s service as an advisor, consultant or expert witness for a pharmaceutical company, and lecture fees and other honoraria from a pharmaceutical company.
  • Where the Advisor and/or the Advisor’s Partner has received payments with a combined value of less than $25,000 from any single pharmaceutical company within the past twelve (12) months, the Advisor shall be allowed to participate in content development.
  • Where the Advisor and/or the Advisor’s Partner has received payments with a combined value of more than $25,000 but less than $100,000 from any single pharmaceutical company within the past twelve (12) months, the Advisor shall be allowed to participate in content development and the Advisor’s interest shall be disclosed.
  • Where the Advisor and/or the Advisor’s Partner has received payments with a combined value of more than $100,000 from any single pharmaceutical company within the past twelve (12) months, the Advisor shall not be permitted to participate in con tent development.
D. Research Funding
  • Where an Advisor or an Advisor’s Partner has received research funding as a principal investigator in the past twelve (12) months from any pharmaceutical company, the interest shall be disclosed.
  • No Advisor may be permitted to participate in the review of their own or their Partner’s research.
E. Patents or Royalties
  • Where an Advisor or an Advisor’s Partner holds a patent or other intellectual property or royalty rights in a drug that is the subject of the current content development, or that is related to the current content development, the Advisor shall not participate in content development. The determination of whether a drug is related to the current content development will be made by the Editorial Department.
  • Where the Advisor or the Advisor’s Partner holds a patent or other intellectual property or royalty rights on an unrelated product and receives payments from any pharmaceutical company based on those rights, the following rules shall apply:
    • Where the Advisor and/or the Advisor’s Partner has received payments with a combined value of less than $25,000 from any single pharmaceutical company within the past twelve (12) months the Advisor shall be allowed to participate in content development.
    • Where the Advisor and/or the Advisor’s Partner has received payments with a combined value of more than $25,000 but less than $100,000 from any single pharmaceutical company within the past twelve (12) months, the Advisor shall be allowed to participate in content development and the Advisor’s interest shall be disclosed.
    • Where the Advisor and/or the Advisor’s Partner has received payments with a combined value of more than $100,000 from any single pharmaceutical company within the past twelve (12) months, the Advisor shall not be permitted to participate in content development.

VII. Disclosures

The Truven Health website at www.truvenhealth.com will be the central location for the disclosure of all pertinent financial relationships that need to be disclosed for the Truven Health publications. This disclosure shall identify the name of the Advisor, the name of the Pharmaceutical Company or companies, and the general nature of the financial relationship (e.g., consultant, grant recipient, equity ownership).

VIII. Waivers and Exceptions

In some circumstances, it may be appropriate to deviate from the basic conflict of interest rules set forth above, either to grant a waiver from a financial relationship that otherwise would require disqualification or disclosure, or to require disqualification or disclosure where otherwise not applicable. For example, an otherwise disqualified Advisor who possesses unique expertise in a particular field that is unavailable from other sources will be a valuable contributor to content development and could be used if necessary with an appropriate disclosure.

Truven Health reserves the right to limit, on any basis, any Advisor’s participation in content development, including for financial relationships otherwise permissible under the terms of this policy.

All waivers and exceptions must be reviewed and approved in writing by the Editorial and Legal Departments. Changes may be made to this Conflict of Interest policy at the sole discretion of Truven Health.