You can read more detailed information here about how we work.

Working with pharmaceutical companies

Background

Tuberous Sclerosis Australia’s vision is a world where every family affected by Tuberous Sclerosis (TSC) is empowered by the best treatment, information and support.

Pharmaceutical companies are one key party in the search for better treatments, and eventually a cure, for TSC. Working with pharmaceutical companies that manufacture and market drugs and treatments gives us important background knowledge and provide positive networking opportunities.

Pharmaceutical companies are also willing to sponsor and fund certain activities we undertake. TSA, as a charitable organisation, relies on the generosity of its members and donors and on fundraising events to fund our activities. TSA also seeks grants from commercial organisations, government and philanthropic funds. We are committed to developing a variety of long term dependable income sources to fund our work.

However, pharmaceutical companies are not charitable organisations and have different interests from our own, including a direct commercial interest in TSC. We also acknowledge that in many cases, 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 our 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. These will ensure that our activities are not in any way influenced by the commercial interests of the for-profit companies we work with.

Policy Review

The TSA Committee will review this policy annually

Principles

  • 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 Tuberous Sclerosis treatments for the betterment of our members.

Practice

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 reports of TSA.

c.        TSA will acknowledge financial support for projects with a statement similar to “This project was funded by an unrestricted grant from <company name>. This company had no influence over the outcomes of this project”.

d.      TSA will maintain a register of all involvement with pharmaceutical companies which will be available on request the TSA members and the community.

e.      The TSA Committee will encourage members to raise any concerns about TSA relationship with pharmaceutical companies. These questions and concerns will be discussed at the next committee meeting.

2.       Funding of Projects

a.       All relationships with pharmaceutical companies will be documented in signed memoranda of understanding (MOU). This MOU will have agreed roles and responsibilities 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. Projects that are initiated by a pharmaceutical company will be approved by the TSA Committee before they proceed.

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.

d.      TSA will attempt to fund projects by other sources first and only accept money from pharmaceutical companies where other funding requests are unsuccessful or unlikely to be successful.

3.       Promotion

a.       TSA will not endorse any specific drug or treatment. Where possible, when discussing treatments, TSA will refer to a class of drugs (e.g. “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.

4.       Education

a.       TSA will keep our 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 are reviewed by the TSA medical advisors, who are independent clinicians.

5.       Representing TSC Families

a.       TSA understands that in its role as representing the families affected by TSC in Australia and New Zealand 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.

6.       Other

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.

 

References

1.       Herxheimer, A. 2003, ‘Relationships between the pharmaceutical industry and patients organisations’, BMJ, Vol 326, pp 1208-1210

2.       Kent, A. 2007, Should patient groups accept money from drug companies? Yes, BMJ 2007;334:93

3.       Consumers’ Health Forum & Medicines Australia 2005, Working together. A guide to relationships between health consumer organisations and pharmaceutical companies, Consultation, https://www.chf.org.au/pdfs/fac/fac-Working-together-guide-2008.pdf

4.       Breast Cancer Care (UK), Policy on working with Pharmaceutical Companies, http://www.breastcancercare.org.uk/sites/default/files/files/pdf/pharmaceutical_policy_sept09.pdf

5.       Arthritis Victoria, Relationships with Pharmaceutical Companies Policy, http://www.arthritisvic.org.au/pages.asp?d=5A4C5A717251477C7008060B0E0800

6.       Cancer Voices Australia, Policy on Collaboration with the Pharmaceutical Industry, http://www.cancervoicesaustralia.org.au/pdfs/policy/pharmaceutical.pdf

Privacy

Background

Tuberous Sclerosis Australia’s vision is a world where every family affected by Tuberous Sclerosis (TSC) is empowered by the best treatment, information and support.

In working towards this vision, TSA collects personal information about individuals, including:

  • Information that can identify an individual
  • Information that could be considered health information, such as whether the individual is affected by Tuberous Sclerosis

TSA supports the importance the community places on personal and sensitive information. TSA also faces significant challenges caused by a geographically distributed team that is primarily voluntary, with varying degrees of experience in handling personal information. The purpose of this policy is to provide clear principles and guidance about how TSA collects, stores and disposes of information.

Policy Review

The TSA committee will review this policy annually. This review will be the responsibility of the Secretary.

Principles

  • TSA will attempt to achieve best practice in handling personal information, meeting or exceeding our legal obligations
  • TSA  will adhere to the national privacy principles
  • The policy will be implemented in various processes, forms and tools that TSA uses
  • The policy will be followed by all TSA staff and volunteers, including committee members and regional contacts

Definitions

1.    The National Privacy Principles (NPPs)

The NPPs set minimum standards for:

  • collection, use and disclosure of personal information which could identify a person;
  • quality, security and storage of that information;
  • giving an individual access to their information;
  • transferring information offshore;
  • special categories of information such as ‘sensitive’ information and ‘health’ information.

The NPPs are:

  • NPP1 Collecting information
  • NPP2 Using and disclosing information
  • NPP3 Data quality
  • NPP4 Data security
  • NPP5 Openness
  • NPP6 Access and correction
  • NPP7 Identifiers
  • NPP8 Anonymity
  • NPP9 Transborder data flow
  • NPP10 Sensitive information

2.    What is personal information?

  • Information or an opinion about an individual whose identity is apparent or can be ascertained from that information or opinion.
  • This includes names, addresses, telephone numbers, age and e-mail address.

3.    What is sensitive information?

This includes information about:

  • Racial or ethnic origin;
  • Political opinion or association;
  • Trade union or professional association membership;
  • Religious beliefs or philosophical beliefs;
  • Sexual preferences;
  • Criminal record;
  • Health information.

4.    Volunteers

Volunteers include committee members, regional coordinators and all other people that assist with TSA activities in a voluntary capacity.

Practice

1.    Collecting Information

a.     When collecting information about an individual TSA will only collect information that is necessary to provide services to the individual and for other activities that TSA carries out.

b.    Where possible, TSA will provide services to individuals that only wish to provide a smaller amount of information about themselves.

c.     Collection will be undertaken by a method which is fair, lawful and not unreasonably intrusive.

d.    Individuals from whom personal information is collected are to be made aware of:

i.    the contact details of TSA;

ii.    the primary purpose for which the information is collected;

iii.     any possible secondary purpose for which the information may be used;

iv.    the names of the organisations or types of organisations to which we disclose information of any nature (if any);

v.    the ability of individuals to access the information held on themselves.

This will be done by providing them will a copy of the TSA privacy policy or instructions on where to obtain a copy.

e.     Where reasonable, TSA will collect information about an individual from that individual.

2.    Using and Disclosing Information

a.     Information will only be used or disclosed for the primary purpose for which it was collected. In some instances, information provided by individuals may be used to keep them better informed about TSA activities and services, such as by way of a newsletter. Individuals have the right to opt out of receiving such additional communications at any time.

b.    Personal information about an individual will not be used or disclosed for a secondary purpose unless:

i.    the purpose is closely related to the primary purpose and the individual would reasonably expect the information to be used in that way; or

ii.    the information is health information and its use is necessary for records or statistical analysis relevant to public health; or

iii.    the individual has consented; or

iv.    TSA has a legal obligation to disclose personal information which overrides the provisions of the primary legislation.

c.     TSA will never sell or exchange or release personal information about an individual for commercial gain.

 

3.    Data quality

a.     Reasonable steps will be taken to ensure information collected and used is complete, accurate and up-to-date.

 

4.    Data security

a.    TSA will take reasonable steps to protect personal information from misuse, loss, unauthorised use, modification or disclosure. Specifically:

i.    Secure internet technologies will be used for the exchange of personal and financial details of members and donors.

ii.    Personal information will be centralized on a secure server, and offline copies will only be used for back up or temporary use. Offline backup copies to be stored in a secure location, which may be the residence of a volunteer.

iii.    Personal information will never be emailed.

iv.    Staff and volunteers will be discouraged from printing personal information. If personal information is printed it will be destroyed securely e.g. by shredding.

b.    Personal information will be destroyed or permanently de-identified when it is no longer needed for the purpose for which it was collected

 

5.    Openness:

a.     TSA will publish this privacy policy. This will be available on the TSA website, at all TSA events and also to any person who asks for it.

b.    On request by a person, TSA will take reasonable steps to let the person know, generally, what sort of personal information it holds, for what purposes, and how it collects, holds, uses and discloses that information.

 

6.    Access and Correction

a.     TSA will make information held on an individual is accessible to them on request (except where frivolous and vexatious). This will be available free of charge.

b.    If an individual informs TSA that information TSA holds is not accurate, complete or up to date, TSA will take reasonable steps to ensure the information provided is accurate and up-to-date.

c.     Requests should be sent to membership@tsa.org.au

 

7.    Identifiers

a.     Identifiers used on personal information will be unique to TSA.

 

8.    Anonymity

b.    Individuals have the option of not identifying themselves when dealing with TSA.

c.     This is practicable when TSA staff and volunteers are offering support or advice or in making a financial contribution to TSA. This is not practicable when registering for TSA events or in becoming a member of TSA.

 

9.    Transborder data flows

d.    TSA will not sell, exchange or release personal information

 

10.  Sensitive information

e.     TSA does not collect sensitive information about individuals unless:

i.        we have the consent of the individual; or

ii.        the information is collected in the course of TSA activities where the individual is in regular contact in relation to those activities and the individual understands that the information will not be disclosed without consent.

 

References

1.    Information Sheet (Private Sector) 1A: National Privacy Principles, Office of the Australian Information Commissioner, http://www.privacy.gov.au/materials/types/infosheets/view/6583. Accessed on 16 March 2012.

2.    Cancer Council Australia Privacy Policy, Cancer Council Australia, http://www.cancer.org.au/PrivacyPolicy.htm. Accessed on 16 March 2012.