Independence is a critical issue for Therapeutic Guidelines Limited as its reputation is staked on the integrity of its publications. Independence is relevant to Therapeutic Guidelines both at an organisational level and in the development of therapeutic information by its expert groups.
Therapeutic Guidelines’ independence as an organisation is founded on being financially self-sufficient. Therapeutic Guidelines derives an income solely from the sale of its products, and receives no direct funding from government or commercial organisations, including the pharmaceutical industry, in the production of the Guidelines. Comprehensive declaration and management of conflicts of interest is crucial to the publication of independent therapeutic advice.
Therapeutic Guidelines requires all those involved in the Company—Directors, Members of the Company, staff, members of expert groups and external reviewers—to adhere to this Conflict of Interest Policy and provide an interest statement before appointment.
Interest statements comprise declarations of any interests an individual or their associates might have relating to the role the individual is undertaking for Therapeutic Guidelines. Interests may be academic, professional, commercial or personal, and may be financial or non-financial. Relevant interests include any relationships or connections with other boards, committees or organisations, and include government or companies that stand to gain from the inclusion of any product (or its competitor) in the guidelines. Planned and current interests, as well as interests within the past five years, are to be declared if relevant. Therapeutic Guidelines provides individuals with an interest statement form to assist in providing a comprehensive declaration.
Registers of Directors’, expert group members’ and external reviewers’ declared interests are published on the Therapeutic Guidelines website.
Directors, Members of the Company and Staff
Directors, Members of the Company and staff are appointed on the basis of their expertise and interest in the core activities of Therapeutic Guidelines, in particular the promotion of quality use of medicines through the publication of independent therapeutic guidelines.
Before appointment, Directors, Members of the Company and staff must provide the Chair of the Board or the Chief Executive Officer with a written interest statement (see section above). It is the individual’s responsibility to identify and disclose any relevant changes in interests they or their associates1 might have relating to the role they are undertaking for Therapeutic Guidelines.
If a Director, including the Chair, has an interest with regard to any issue for consideration by the Board at a meeting, a statement to this effect must be provided by the relevant Director before any discussion takes place on that issue. If, in the opinion of the Chair, a conflict of interest exists that imperils the independence of the decision-making progress, the Chair may request that the Director leaves the meeting when discussing a decision related to the specific area or issue. If the Director concerned is the Chair, the remaining Directors may request that the Chair leaves the meeting during the discussion.
Directors, Members of the Company and staff must provide the Chair of the Board or the Chief Executive Officer with an updated written interest statement whenever changes occur.
The register of Directors’ declared interests is reviewed on a quarterly basis and published on Therapeutic Guidelines’ website.
Expert group members
Expert group members are appointed on the basis of their:
- clinical or academic expertise in the therapeutic area under review,
- interest in the quality use of medicines, and
- integrity in providing independent and objective advice.
When composing expert groups, Therapeutic Guidelines aims to incorporate a diversity of expertise, perspective and opinion in the therapeutic area under review. Before appointment to an expert group, individuals must provide the Chief Executive Officer with a written interest statement (see section above).
At the first expert group meeting, each member is asked to discuss their declared interests and consider how they could influence the guideline recommendations. Members must inform the expert group if there are changes to their declared interests throughout the duration of the project and these changes will be recorded in the register. Before each expert group meeting, the updated register of declared interests is circulated to members. At the start of each expert group meeting, the expert group and the Chair determine whether members have relevant conflicts of interest, and, if so, how these should be managed.
When an expert group member has an interest that is perceived to be a conflict, the member may be asked by the Chair to:
- not be involved in the writing or approval of recommendations associated with the conflict
- not take part in discussion or decision making related to the specific area or issue
- leave the expert group meeting when discussing a decision or recommendation related to the specific area or issue.
The process used to manage a conflict of interest is documented in the register of declared interests.
The member’s exclusion and the deliberations of the expert group are recorded in the minutes. If a group member is concerned that a conflict of interest has been inappropriately managed at an expert group meeting, this can be referred to the Therapeutic Guidelines Board through a confidential communication to the Chief Executive Officer.
The register of declared interests for the expert group is published on Therapeutic Guidelines’ website when the clinical content is published. In the unlikely event that members withdraw from the expert group before the completion of the project, their declared interests will still be published, but their withdrawal from the group will be noted.
The process for declaration and management of interests for external reviewers is similar to that for expert group members. If the expert group agrees that external review is required for a particular topic, then the external reviewer must submit a declaration of interests before participating in review.
 An associate refers to a family member, business associate, or professional colleague or partner.