Jett Foundation's Guidelines for Engagement with Pharmaceutical Companies

Version 1.0, July 1, 2015

Introduction

Jett Foundation is a 501(c)(3) non-profit organization supporting medical research, education and communication for those afflicted by the rare genetic condition, Duchenne muscular dystrophy (DMD). Our mission is to fund research to find treatments and/or a cure for Duchenne muscular dystrophy while supporting individuals and their families through education, awareness, programs and advocacy. Our vision is build a "lifetime" for those diagnosed with Duchenne.

In support of our mission, Jett Foundation engages in dialogue and collaboration with pharmaceutical companies. Jett Foundation seeks the highest level of ethical conduct in our partnerships with pharmaceutical companies. Jett Foundation's goal in engaging pharmaceutical companies is to enable development of therapies to meet patient needs while maintaining our independence as a patient organization.

Our approach to interacting with pharmaceutical companies is informed by the European Federation of Pharmaceutical Industries and Associations (EFPIA) “Code on Interactions between Pharmaceutical Companies and Patient Organizations” and the Pharmaceutical Manufacturers of America (PhRMA) “Principles on Interactions with Patient Organizations.”

The principles outlined in this document are intended to guide Jett Foundation, including board members, staff, committees, ambassadors, representatives, and interested Duchenne national organizations, in engagement with the pharmaceutical industry.

1.0 Identifying and Engaging Companies

Jett Foundation desires mutually beneficial dialogue and information exchange with pharmaceutical companies developing potential therapies for Duchenne.

1.1. 1.2.

Jett Foundation will actively seek contact with companies that show interest or activity in drug discovery, preclinical research, or clinical research in Duchenne.

Jett Foundation will collaborate with companies, at Jett Foundation's discretion, which are conducting ethical, high-quality research in a responsible manner, according to industry and international regulatory standards.

1.3. Jett Foundation will seek insight into the company’s objectives, plans, and the potential drug being evaluated and will provide companies with community-wide insight and perspective as needed and appropriate.

1.4. Jett Foundation reserves the right, at our discretion, but not limited to, disengage with any pharmaceutical company or any employee of a pharmaceutical company if the company or individual are not behaving in an ethical, responsible matter in accordance with industry and international regulatory standards.

 

2.0 Patient Engagement

We encourage and enable direct dialogue between patients and pharmaceutical company representatives for the purposes of promoting disease awareness and sharing patient perspective, according to the following principles:

  1. 2.1.  We believe direct interactions between patients and pharmaceutical companies are best arranged with the involvement of Jett Foundation, a Duchenne representative, and/ or the relevant national Duchenne organization. Including a patient organization in these interactions can:

    • ensure fairness and transparency within the patient community;

    • ensure that the patient community is well and adequately represented to the

      pharmaceutical company;

    • allow for access to experts and professional advisers who can inform the dialogue;

    • help avoid misunderstanding in the conversation;

    • ensure the protection of patient privacy in any data collection activities; and

    • allow the patient organization to better understand the needs of both the patient

      and the pharmaceutical company.

  2. 2.2.  We believe that disease insight can best be provided by an advisory group rather than via individual input. An advisory board format helps ensure that the community is adequately represented and that work is not unduly requested of one individual.

  3. 2.3.  We recommend that learnings and outcomes from any interaction be shared in an open manner.

  4. 2.4.  We recommend that personal health data are not recorded by the company without proper informed consent, and that patient identifiers are not recorded at all.

  5. 2.5.  Jett Foundation leaders (e.g., board members, ambassadors) or individuals representing the Duchenne community may be invited by pharmaceutical companies to speak about Duchenne and Jett Foundation at internal company meetings, public events hosted by the company, or in meetings with regulatory agencies. This should be done for the purposes of disease education or awareness in a manner consistent with the points outlined in this document.

 

3.0 Financial Contributions

Strong and healthy patient organizations are vital partners to pharmaceutical companies developing drugs for Duchenne. Financial resources are a key need for the growth and maintenance of a patient organization. Demands on the organization are increased by drug development activities in the clinical and commercial stages. We receive pharmaceutical company donations according to the following principles:

  1. 3.1.  Financial contributions from a pharmaceutical company should be initiated by a written request from the patient organization, on the organization’s letterhead, stating the organization’s mission, activities, and reason for the request.

  2. 3.2.  It is ideal to receive a single, unrestricted donation from any given pharmaceutical company in a year, rather than multiple smaller donations, however it is recognized that this is not always practical or possible.

  3. 3.3.  Donations from pharmaceutical companies must be given in a named manner; i.e., we do not accept anonymous donations from pharmaceutical companies.

  4. 3.4.  It is ideal that any financial contribution be made either as (1) an unrestricted grant or (2) sponsorship of a specific activity initiated by the patient organization to support it’s stated mission.

  5. 3.5.  Patient organizations and their leadership should not operate as paid service providers to a pharmaceutical company.

  6. 3.6.  Leaders of a patient organization (e.g., board members, presidents) should not receive honoraria to speak on behalf of their organization.

  7. 3.7.  Travel expenses incurred to participate in advisory board meetings or disease- awareness activities may be reimbursed directly to the individual or the organization.

 

4.0 Clinical Trial Communication

Jett Foundation, through various means and committees, including the ambassador program, serves as a conduit for information about clinical trials, according to the following principles:

4.1. Jett Foundation shares information about clinical trials with the community to ensure that patients and families are aware of clinical trials and have the opportunity to make informed decisions about participating. The choice to participate in any given trial is an individual one; Jett Foundation does not seek to influence that choice, but rather to ensure informed decisions can be made.

 

  1. 4.2.  Jett Foundation disseminates accurate and fair-balanced clinical trial information that it receives from a pharmaceutical company. Jett Foundation shall not provide additional commentary or opinion that may influence an individual’s decision to participate in a clinical trial or that may change the meaning of the information.

  2. 4.3.  In order to support optimal trial design and communications, Jett Foundation provides pharmaceutical companies with community-wide observations, needs and barriers to participation.

  3. 4.4.  Jett Foundation does not encourage the sharing of individual clinical trial experiences in social media, for reasons of individual privacy and maintaining the integrity of the clinical trial. However, the choice to share information is personal and Jett Foundation shall not dictate what clinical trial participants do or do not share in public forums.

  4. 4.5.  Jett Foundation board and committee members have a responsibility to represent Jett Foundation in their conduct. Information about clinical trials that is accessible to the community via social media, including in personal blogs or other forms of communication, should adhere to the principles outlined in this document.

 

5.0 Patient Privacy

  1. 5.1.  In order to ensure patient privacy, Jett Foundation does not disclose the town or state in which a patient lives as this can uniquely identify a patient with a disease as rare as Duchenne.

  2. 5.2.  The collection of personal health information by a pharmaceutical company for research purposes shall be guided by a protocol and reviewed by an ethics committee.

  3. 5.3.  A pharmaceutical company should not collect and store patient identifiers.

 

References

EFPIA Code http://transparency.efpia.eu/uploads/Modules/Documents/code_po2011.pdf PhRMA Principles:

http://www.phrma.org/sites/default/files/pdf/phrma_principles_paper_20120919_final.pdf