FM-CFS CANADA POLICY

FM-CFS Canada Policy on Receiving Financial Support from the Pharmaceutical Industry and Medically-Related Products Industry

Adopted in 2004

BACKGROUND

FM-CFS Canada is nurturing a mutually beneficial relationship between the corporate sector and itself. Pharmaceutical companies are being asked to offer support to FM-CFS Canada programs & FM & CFS/ME. Because of possible perceptions of conflict of interest between FM-CFS Canada and pharmaceutical companies, this Policy on Receiving Financial Support from the Pharmaceutical Industry and Medically-Related Products Industry (hereinafter called the Pharmaceutical Policy) has been developed to assist FM-CFS Canada in dealing with the issues.

FM-CFS Canada considers the same policy to apply to the relationship between it and pharmaceutical companies, manufacturers and/or distributors of therapeutic devices and of non-prescription health care products, such as vitamins and dietary supplements.

Pharmaceutical companies support voluntary health agencies for several reasons: to enhance patient and professional education programs and research under the auspices of an organization that serves the needs of individuals concerned with given illnesses; and to provide a means of increasing corporate visibility outside of the normal marketing or advertising channels. In most cases, companies will support a voluntary health agency's programs if their own corporate Research & Development strategy is focussed on development of agents for treating the disease(s) that are of concern to the agency. In other cases, support will be provided simply in the spirit of good citizenship.

Support may be in the form of direct donations and/or information about a company's product and/or monetary support for educational programs, conferences, publications, fund raising events and research projects.

Benefits to FM-CFS Canada

Allowing the health care related industry (including pharmaceutical companies that produce FM & CFS/ME drugs and those who do not, manufacturers and/or distributors of therapeutic devices and of non-prescription health care products, such as vitamins and dietary supplements) to support FM-CFS Canada can aid in fulfilling the mission of the organization. Such funds can be essential in the support of programs and research that FM-CFS Canada wants to conduct but cannot support out of current funding. FM-CFS Canada will accept funds only if provided without restrictions, with control over program and research content and/or development maintained as the responsibility of FM-CFS Canada. In essence, by accepting these funds FM-CFS Canada is better able to meet the needs of people with FM & CFS/ME in support of our mission, while also gaining the benefit of being closely associated with a company working in the field of FM & CFS/ME.

Risks to FM-CFS Canada

The main risks to FM-CFS Canada of accepting support from such companies are that FM-CFS Canada may be perceived as endorsing a company's product(s) and/or be perceived by clients and/or physicians as a 'salesman' for the product(s). However, procedures can be put in place to allow for the acceptance of support for educational programs, research and fund raising events without such perceptions arising. A specific concern relating to support from companies manufacturing and/or distributing therapies that modify the course of the disease or treat specific symptoms relates to the introduction of these drugs as new treatments: By soliciting and accepting support from the companies, it may create the perception that funds provided to us for education programs and research are contributing to the price of the drug or projected availability.

Conclusion

After reviewing the situation, the positive aspects of accepting program and research funds from pharmaceutical companies outweigh the negative aspects, and will allow FM-CFS Canada to undertake programs that are compatible with its Mission and meet its ethical and social responsibilities as long as the guidelines outlined in this Policy are followed.

II OVERALL GUIDELINES

The following seven overall guidelines summarize how FM-CFS Canada should act when receiving financial support of any kind from pharmaceutical companies, manufacturers and/or distributors of therapeutic devices and of non-prescription health care products. The supplementary guidelines provide more detailed guidance for specific program areas and are an integral part of this Pharmaceutical Policy.

1. A written agreement between the supporting company and FM-CFS Canada must be developed recognizing the autonomy and independence of FM-CFS Canada and its activities separate from any influence of the supporting company. This agreement must stipulate that the supported program serves a scientific, educational or client-benefit purpose and is not for the purpose of promoting/prioritizing any product. This written agreement should include a statement that funds from a pharmaceutical company must be made payable to FM-CFS Canada. Acceptance of unrestricted funds by FM-CFS Canada should in no way be considered as an endorsement of any drugs or products manufactured or distributed by the contributing company. (See also Appendix B re additional guidelines and the use of the FM-CFS Canada corporate mark.) FM-CFS Canada initiated research projects, sponsored by pharmaceutical companies, must have formal approval by FM-CFS Canada, be ethically defensible, socially responsible and scientifically valid. Participation of FM-CFS Canada in pharmaceutical company initiated research projects must also have formal FM-CFS Canada approval. The pharmaceutical company must not influence the presentation of information by FM-CFS Canada about its product or otherwise use the presentation as an advertising vehicle for its own use. FM-CFS Canada will rely on documented scientific evidence and the advice of knowledgeable medical practitioners in presenting such information. FM-CFS Canada will acknowledge support of sponsoring companies as stated in number six below. FM-CFS Canada staff and advisors are solely responsible for the identification of needs, determination of objectives, selection of content and speakers (where such are used), educational methods and materials. Whenever possible, speakers should use generic names of products rather than trade names during educational programs. Acknowledgement of financial support by sponsoring companies must be made for all supported programs and research. However, references must not be made to specific products but only to the corporate name.
   
   
2. FM-CFS Canada volunteers and staff must not accept gifts and/or honoraria for personal use from the pharmaceutical industry.

III SUPPLEMENTARY GUIDELINES

Educational Programs

Frequently, financial support is solicited or offered in support of FM-CFS Canada educational programs which are developed for people with FM & CFS/ME, family members, caregivers or health care professionals. When such support is received the following must be adhered to:

Any monetary support must be provided in the form of an unrestricted educational grant. This means that while the company may make suggestions, it cannot determine program content, budget, selection of speakers or support material. It is acceptable for the funding source to restrict donated funds to certain elements of a program, e.g. speaker costs, travel, refreshments or materials. Speakers must be informed in advance of the requirement for a balanced presentation about the range of therapies. Speakers must present all current and new information, provide accurate and unbiased information and have the ability to answer questions about all therapies clearly and objectively. A company sales representative may not present educational material. Wherever possible, sponsorship should be obtained from more than one company to avoid the perception of undue influence or favouritism.

The explicit disclosure of the nature and extent of the support for the program and/or speakers should be made public at the meeting. Speakers should also disclose to the audience any working financial relationships they may have with sponsoring companies.

Educational Materials

Educational materials such as booklets, brochures, leaflets, newsletters, posters, videos, etc., may be written and produced with the assistance of an unrestricted educational grant from a pharmaceutical or medically related company. As with educational programs, this means that while the company may make suggestions, it cannot determine content, budget, selection of writers or illustrators. It is acceptable for the funding source to restrict donated funds to particular material(s). The company should be acknowledged in the produced material(s). (See Appendix A for examples of acceptable credit lines and disclaimers.)

Sponsorship of FM-CFS Canada Events and Other Fund Raising Activities

It is in the best interests of FM-CFS Canada to apply standard corporate sponsorship policies and guidelines to pharmaceutical and medically-linked companies. For instance, developed sponsorship categories with corresponding dollar values and key benefits (logo and corporate recognition, etc.). Written agreements/contracts must be developed specifically defining sponsor benefits as narrowly as possible, including merchandising rights, public relations/personal appearances, and future options. A request that does not fall within the national office's established sponsorship categories or guidelines would require careful consideration by the Board of Directors. Please note, acknowledgment of sponsorship support can be made only to the corporate name not to the specific product.

Confidentiality

It is the responsibility of all levels of FM-CFS Canada to maintain the confidentiality of people who have FM or CFS/ME as established in the Confidentiality Policy. FM-CFS Canada staff and volunteers are not allowed to provide company representatives with names of people who have FM & CFS/ME or family members. Mailing lists are not to be provided or shared with any external sources. Participant evaluations of educational programs must be anonymous. Participants attending programs may choose to sign a company mailing list, but if this action takes place at a FM-CFS Canada sponsored program, it must be made clear in advance that this is a personal decision and not associated with FM-CFS Canada.

Pharmaceutical Company Displays and Materials

It is illegal in Canada for pharmaceutical companies to advertise prescription drugs directly to consumers. Therefore, pharmaceutical companies cannot set up a display booth to promote the company's prescription drugs at any FM-CFS Canada organized program or event. The company can act as a sponsor and be offered the opportunity to be recognized in meeting programs, on signs and through oral acknowledgement. Only the name of the company can be used, not the product.

It is acceptable to have available at a workshop or educational session, company brochures or other hand-outs providing the information is restricted to describing the company's information or product support telephone lines and web sites. Such materials can be made available to individuals who wish to have them (for example, placed on a table in the room), but should not be distributed to each participant. It is not acceptable for the company to attempt to sell their drug product at a workshop or educational session.

The direct participation of company information and product support telephone line staff at a workshop or educational session is discouraged. If they are invited to attend, they should not present information, but only answer direct questions.

Therapeutic devices and non-prescription health care products can be promoted to the general public since these devices do not claim to treat or cure a disease or condition. Therefore, display booths of such products as wheelchairs, walkers and other equipment can be set up at FM-CFS Canada programs or events and can be acknowledged in meeting programs, on signs and through oral acknowledgement.

IV PROCESS WITHIN FM-CFS CANADA

As stated in the Corporate Solicitation Policy (see below) the solicitation of businesses, corporations and foundations is the responsibility of the national office. The FM-CFS Canada Board will review FM-CFS Canada proposed contacts with companies falling within the Pharmaceutical Policy and will review the outcomes of those contacts on a yearly basis. In addition, the committee will have the responsibility for reviewing questions, as they may arise, of appropriate agreements or ethical issues and providing guidance. Staff support for the committee will be the executive director.

Corporate Solicitation Policy

The solicitation of businesses, corporations and foundations is the responsibility of the National office. National will use whatever methods are appropriate to solicit donations or sponsorships, including direct mail, telephone, and person-to-person contact.

APPENDIX A

Credit Lines and Disclaimers The following are examples of acceptable credit lines: For FM-CFS Canada originated and printed material:Publication of this (booklet) (pamphlet) was made possible by an unrestricted educational grant from the XYZ company. (Company logo can be used). For FM-CFS Canada produced audio-visual material:Produced by FM-CFS Canada, supported by an unrestricted educational grant from the XYZ company. (Company logo may be used). If FM-CFS Canada is involved in the preparation of material about FM & CFS/ME for a company, FM-CFS Canada's assistance can be publicly acknowledged. However, the content should not include product identification:Prepared with technical assistance from FM-CFS Canada. In addition to the credit line, a disclaimer is also required on publications and other materials. The following are examples of acceptable disclaimersAcceptance of this unrestricted educational grant by FM-CFS Canada does not constitute endorsement by FM-CFS Canada of any product(s) of XYZ Company. FM-CFS Canada does not approve, endorse or recommend any specific product or therapy but provides information to assist individuals in making their own decisions. FM-CFS Canada is an independent, voluntary health agency and does not approve, endorse or recommend any specific product or therapy but provides information to assist individuals in making their own decisions.

APPENDIX B

Guidelines regarding the potential linking of FM-CFS Canada corporate mark (logo) and commercial products To overcome any perception of endorsement, any action to link FM-CFS Canada corporate mark (logo) with a particular product or company must first be reviewed and approved by the Board of Directors and must meet the following recommended guidelines:

FM-CFS Canada and the company shall ensure that all advertising is balanced, accurate and fair. The company must say that FM-CFS Canada has not endorsed its product if FM-CFS Canada has not. The company cannot claim that the product is superior to or preferable to competitors' products unless the statement is true and FM-CFS Canada agrees it is true. Advertisements must clearly and conspicuously disclose if the company has paid for the use of the FM-CFS Canada's name or corporate mark (logo). Advertisements must be true, accurate and informative to the public as to how buying the company's product will affect charitable contributions.

Advertising partnerships between a company and FM-CFS Canada should avoid exclusive product sponsorships.