This Policy was last updated on 15 September 2021. This Policy is reviewed regularly. We invite your comments by email to [email protected].
TSA’s vision is that together we can create a better life and more hopeful future for every individual living with TSC. We want to live in a world where every person affected by Tuberous Sclerosis Complex (TSC) is empowered by the best treatment, information and support.
Collaboration between TSA (Tuberous Sclerosis Australia) and pharmaceutical companies may deliver significant benefits for our TSA members enhancing current and potential development of new treatments to produce better health outcomes. TSA has an important role to play in increasing TSC research and development capacity in Australia. TSA recognises that relationships with pharmaceutical companies should be subject to clear guidelines to ensure openness, independence, transparency and impartiality.
Pharmaceutical companies are also sometimes willing to sponsor and fund certain activities we undertake. Pharmaceutical companies are not charitable organisations and have different interests and objectives from TSA’s. We acknowledge that in many cases, when we work with pharmaceutical companies the partnership is not equal, in that the pharmaceutical company has many more resources at its disposal than TSA. For these reasons, we take particular care in how our organisation works with pharmaceutical companies and other for-profit health care providers.
We also acknowledge that, because there are a limited number of treatments for TSC, there are a limited number of pharmaceutical companies with an interest in TSC. TSA is also committed to supporting research that leads to new treatments for TSC.
The purpose of this Policy is to provide clear principles and guidance about how TSA works with pharmaceutical companies to achieve our objectives, without compromising our integrity and our ability to support our members. Adherence to this Policy will ensure that our activities are not in any way influenced by the commercial interests of any for-profit companies we work with.
The TSA Committee will review this policy every two years.
- TSA will independently set its own priorities, policies and plans.
- TSA is committed to total transparency in all dealings with pharmaceutical companies.
- TSA will not endorse individual pharmaceutical products or suppliers of health care services.
- TSA will seek to develop relationships with multiple pharmaceutical companies, so as not to develop a special relationship with only one company.
- TSA will engage in dialogue with pharmaceutical companies about TSC treatments.
1. Openness and Transparency
a. This Policy will be published on the TSA website.
b. A full list of donations and grants received from pharmaceutical companies will be published in the annual report of TSA in the year in which the money is received.
c. TSA will acknowledge financial support for projects with a statement similar to “This project was funded by a grant from <company name>.”
2. Funding of Projects
a. All relationships with pharmaceutical companies will be documented in writing. The agreed roles and responsibilities will be clearly defined for all parties.
b. TSA will only encourage funding for projects that have been identified as priorities in the regular TSA planning process. These will be projects that align with TSA’s mission and objectives. Funded projects that are not research trials and are initiated by a pharmaceutical company will need to be approved by the TSA Committee before they proceed. TSA will not accept support from any pharmaceutical company that is attempting to influence its policy or direction for commercial advantage.
c. Funding will only be accepted from pharmaceutical companies where the project has a fixed timeframe and outcome. Funding will not be accepted for ongoing costs of operating TSA.
a. TSA will not endorse any specific drug or treatment. Where possible, when discussing treatments, TSA will refer to a class of drugs (eg “mTOR inhibitors”) rather than a specific drug or brand name.
b. TSA will not accept or distribute promotional products provided by a pharmaceutical company and will not allow distribution of such products at TSA events.
a. TSA will keep its key staff and volunteers informed on TSC research, the drug development process and the way the pharmaceutical industry operates.
b. TSA will work with other members of TSC International and learn from their experiences of working with pharmaceutical companies.
c. TSA will seek ensure that all medical information it publishes is reviewed by the TSA medical advisors, who are independent clinicians.
5. Representing Families affected by TSC
a. TSA understands that in its role as representing the families affected by TSC in Australia that it may be asked to review patient information material to ensure that it has validity and understanding for its audience. TSA will not accept any fee for this service. TSA representatives may, however, be reimbursed for any out of pocket expenses associated with this activity.
a. The TSA Committee will review any offer of hospitality, including travel and accommodation that is provided or funded by a pharmaceutical company.
b. The TSA logo and name cannot be used by any pharmaceutical company to promote a product.