Guiding principles of self-help for working with public bodies and private entities, organizations and commercial enterprises, particularly in the health system

Preamble

As umbrella organisations, the German National Association of Self-Help for disabled or chronically ill people and their families (BAG SELBSTHILFE), and Paritätischer Wohlfahrtsverband (Welfare Federation) with its FORUM for chronically ill and disabled persons in the PARITÄTISCHEN (FORUM) represent the interests of the member associations affiliated with them. Moreover, as the definitive, leading self-help organisations, they are tasked with representing the self-help interests of disabled and chronically ill people in general.

In order to fulfil their mission as the definitive, leading self-help organisation for disabled and chronically ill people professionally, it is essential for the self-help of chronically ill and disabled people to strictly maintain their neutrality and independence. On the basis of their neutrality and independence, BAG SELBSTHILFE and the self-help organisations affiliated with the FORUM attach great importance to working fairly and transparently with other players in the health system. They welcome the interest of commercial enterprises in such collaboration and see in it an opportunity for dialogue between equal partners.

In order to maintain their neutrality and independence and to guarantee it in the future, guiding principles common to both leading organisations for collaborating with public bodies and private entities, organisations and commercial enterprises as well as their agents are set out below.

The following guiding principles apply to BAG SELBSTHILFE and the FORUM as overarching associations as well as to self-help organisations which have given a written undertaking to BAG SELBSTHILFE and/or PARITÄTISCHER Wohlfahrtsverband, Gesamtverband e.V. to abide by these principles which are listed in the Annex. Insofar as self-help organisations have already implemented guiding principles or guidelines, their validity will remain unaffected.

BAG SELBSTHILFE and the FORUM advise the self-help organisations affiliated with them and provide them with ongoing support in putting these principles into practice.

1. General principles

a. The self-help organisations base their technical and political work solely on the needs and interests of disabled and chronically ill people and their families. Their aim is to promote the self-determination of disabled and chronically ill people.

b. The collaboration between self-help organisations and commercial enterprises must comply with and serve the statutory aims and missions of the self-help organisations. Self-help organisations do not accept any collaboration which puts at risk or even negates the charitable status of the association.

c. In all areas of collaboration with commercial enterprises, the self-help organisation must retain full control of the content of the work and maintain its independence. This applies both to financial and non-financial support and collaboration.

d. Any collaboration with and support from commercial enterprises must be designed to be transparent.

2. Percentage caps on grants

The self-help organisation must ensure that its neutrality and independence is not put at risk from financial contributions from the pharmaceutical industry, manufacturers of medical equipment or aids or from other commercial enterprises. The following principles apply:

If the percentage of financial aid from the pharmaceutical industry, manufacturers of medical equipment or aids or other commercial enterprises totals over 40% of the self-help organisation's entire revenues, the neutrality and independence of the self-help organisation is no longer guaranteed.
After establishing that the threshold has been exceeded, the responsible monitoring committee will request the self-help organisation in question to show how the proportion of funding can be reduced to under 40% within the space of a year. The committee will examine whether this proposal is viable. If this is the case, a binding agreement will be made between the committee and the self-help organisation.
If the percentage of financial aid from the pharmaceutical industry, manufacturers of medical equipment or aids or other commercial enterprises totals under 15 % of the self-help organisation's revenues, such funding does not represent any threat to its neutrality or independence.
If the percentage of financial aid from the pharmaceutical industry, manufacturers of medical equipment or aids or other commercial enterprises totals between 15% and 40% of the self-help organisation's revenues, the monitoring committees must view individual cases from an overall perspective to determine whether the neutrality and independence of the self-help organisation is at risk. In this case, the self-help organisation concerned will be obliged to inform the responsible monitoring committee of the underlying reasons why the cap of 15% has been exceeded.
A consultation will be held leading to a target agreement in order to reduce the proportion to under 15% over the long term.

3. Information and substantive neutrality

a. In collaboration with companies from the pharmaceutical industry, suppliers of medicines and aids as well as services and other companies which manufacture or distribute products for disabled and chronically ill people, care will be taken to ensure that there is a clear division between information and recommendations provided by the self-help organisation and corporate advertising. The self-help organisations will provide information about offers but will not participate in the advertising.

Advertising by commercial enterprises must always be labelled as such.

b. As a general rule, the self-help organisation will not recommend any individual drugs, classes of drugs, medical products, or any particular therapies or diagnostic procedures.

A recommendation can only be given if it is based on the evaluation results of recognised, neutral expert bodies. The composition of such bodies must be publicly transparent. Its results must be transparent and understandable.

Information from commercial enterprises will be labelled as such and will not be passed on uncommented upon.

c. The self-help organisation will supply information on patients' experiences with drugs, medical products, therapies and diagnostic procedures.

d. The self-help organisation will also supply information on the diversity of available products and on new developments in the fields of prevention, diagnostics, treatment and rehabilitation, and state its sources.

e. The self-help organisation is independent with respect to its professional work and not tied to any medical disciplines.

4. Communication rights

a. The self-help organisation will, if applicable, grant commercial enterprises communication rights in written agreements, such as the right to use the name or logo of the association in publications, product leaflets, on the internet, in advertising or at events. The existence and subject-matter of these agreements will be made public. The direct or indirect advertising of products, product groups or services for the diagnosis and treatment of chronic illnesses or handicaps is excluded.

Written agreements will contain clear descriptions of what partners may use the name or logo of the other party in what context, and where the lines will be drawn. A formulation in the agreement such as: "The sponsor undertakes not to take any steps injurious to the ideas and image of the self-help organisation", offers comprehensive protection for the interests of the self-help organisation.

b. The requirement for transparency dictates that in all cases reference is made to the support of the commercial enterprise as part of the joint promotion without, however, conducting advertising from a tax perspective in any active sense as defined by the principles of the Federal Ministry of Finance (BMF) governing the income tax treatment of sponsorship dated 18.02.1998 and the decree based on it issued by the Bavarian Ministry of Finance dated 11.02.2000.

c. Any use of the logo and name of the self-help organisation may only be made with the explicit written agreement of the self-help organisation. The logo must be used in a way that is faithful to the original. Variations or changes are not permitted. It may only be used for the specific purpose agreed.

The self-help organisation will also be entitled to use the logo of the commercial enterprise. Care must be taken in the process to keep any such use separate from any kind of product advertising.

d. The usual spheres of action for communication rights between commercial enterprises and self-help organisations are listed below. The list is to be understood as a non-exhaustive list of collaboration options by way of examples.

Events staged by self-help organisations
The self-help organisation will ensure that it maintains its neutrality and independence at any events which it organises and stages. This standard also applies to any organisational questions. The choice of location for the gathering and the structure of the event will be determined by the self-help organisation. As a general rule, travel expenses will be based on Federal and State laws governing travel expenses. If fees are paid, they must be set at moderate levels. To do so, the fee structure published by the German Association for Public and Private Welfare can be used. No details of participants in events will be given to commercial enterprises. In defining the contents and selecting the speakers, the self-help organisation will take particular care to ensure that facts are portrayed and treated objectively. Fundamentally, this rules out any one-sided portrayal in favour of any particular company, therapy or product. The self-help organisation will ensure that the issues dealt with are not addressed exclusively by speakers employed by, or financially dependent on the relevant sponsor.
Events staged by commercial enterprises
The self-help organisation will ensure that the neutrality and independence of the self-help organisation are also maintained at all times at any events organised by commercial enterprises. A written agreement will determine to what extent the name and logo of the self-help organisation may be used at events staged by the commercial enterprise. Advertising for a specific product, product groups or services is explicitly excluded. As a general rule, travel expenses will be based on Federal and State laws governing travel expenses. If fees are paid, they must be set at moderate levels. To do so, the fee structure published by the German Association for Public and Private Welfare can be used.
Publications by self-help organisations
If a publication has been created with the support of a commercial enterprise, reference to that support will be made in the printed matter, e.g. by use of the formulation: "with the kind support of......". The logo and lettering of the commercial enterprise can be used in the process as long as this is done without any special emphasis.
Publications by commercial enterprises
The commercial enterprise can print the self-help organisation's logo in its publications or on posters provided this has been defined in the written agreement. The agreement will forbid any direct or indirect advertising of products, product groups or services by these means.
Internet websites run by self-help organisations
The self-help organisation can refer to support from commercial enterprises on its homepage. An active link from a homepage of the self-help organisation to the homepage of a commercial enterprise is regarded by the tax authorities as active advertising and from a tax perspective represents a financial operation. Reference is made specifically to the decree issued by the Bavarian Ministry of Finance dated 11.02.2000.
Internet websites run by commercial enterprises
Commercial enterprises can refer to the self-help organisations on their websites and also set up a direct link to them. They should inform the self-help organisations of this step and also accept it if such a link is not desired. A link to the self-help organisation's download area will entail costs for the self-help organisation and the arrangements must be cemented in a written agreement.
Self-promotion by self-help organisations
Self-help organisations may refer to the support of commercial enterprises when promoting themselves. The extent and nature of such references will be defined in the written agreement. The reference will be made in such a way that it does not constitute active advertising from a tax perspective. Any connection with advertising for products, product groups or services will be excluded.
Self-promotion by commercial enterprises
Self-help organisations can offer supporting commercial enterprises to publicly document the funding provided as part of the agreements reached, and use it in its advertising.

5. Funding

a. Self-help organisations may accept funding. In doing so, the self-help organisation will not become dependent on certain commercial enterprises or on any particular person. When receiving support from commercial enterprises and private individuals, the self-help organisation will pay particular attention to ensuring that any termination of the support cannot endanger its continued existence nor the core area of its work in accordance with its statutes.

b. The self-help organisation will also conclude sponsorship agreements with commercial enterprises, where applicable. Sponsorship in this context is understood to mean the granting of money, benefits in kind, material grants or intellectual support by companies to support the self-help organisation if in doing so the companies' own advertising or public relations aims are being pursued. The self-help organisation will secure its independence from sponsors by ensuring that sponsorship agreements which focus to a not inconsiderable extent on grants, are defined in writing, making the grants transparent.

If a sponsorship agreement is concluded with a company, current tax regulations, in particular with respect to the charitable status of associations, must be observed as well as its unambiguous assignment to the relevant sphere of activity.

c. If over half of the required material resources and finance for any project of a self-help organisation are provided by one or more commercial enterprises, this will be publicly disclosed in a suitable manner.

d. The self-help organisation will provide information in a suitable manner on any of its representatives who receive payments from commercial enterprises beyond their role as members of the general assembly of members.

6. Support for research

a. The self-help organisation welcomes any research efforts aimed at improving the situation of chronically ill and disabled people.

b. As a general rule, the self-help organisation is prepared to contribute its professional expertise to such research programmes, particularly clinical studies, and to report on such research programmes, particularly clinical studies in order to facilitate the participation of test subjects in research programmes or studies through its member associations. Any such support presupposes, however, that information about the design of the research and studies and the ongoing results from the research programmes or studies are fully disclosed to the self-help organisation. Furthermore, the self-help organisation regards it as warranted that the companies concerned assume the costs for the specified measures of support. In particular, the self-help organisations will support studies registered with clinical trial registries in which the design and results of the study are made publicly accessible.

c. The self-help organisation will for its part try to influence company policy (study designs, product characteristics, marketing, etc.) in the interests of chronically ill and disabled people.

7. Monitoring

a. BAG Selbsthilfe and PARITÄTISCHE Wohlfahrtsverband with its FORUM actively advise new members in connection with signing the guiding principles, and other members, too, on the objectives and scope of the principles.

b. Representatives of both organisations will come together at least once a year in order to consult on their experiences in applying the guiding principles in practice and any refinements required. The results of such professional dialogues will be published.

c. In the event of breaches of the guiding principles, the organisations concerned will be actively addressed by their umbrella organisation and invited to a consultative meeting. The agreements reached in the consultation will be documented and communicated in the professional exchanges of views.

d. The self-help organisations will regularly advise and inform their affiliated subsidiary organisations (self-help groups), e.g. at suitable events and through publications in order to familiarise main members and honorary members with the required procedural rules.

e. Self-help organisations which have signed up to these guiding principles will be collated in an overview. The latest version of this overview will be published in a suitable manner.

Self-help organisations will be given a transitional period until 31.12.2007 to bring any divergent rules of their own into line.

Any further-reaching rules of self-help organisations will continue to apply.

These guiding principles were adopted by the general assembly of BAG SELBSTHILFE on 29.04.2006 and last updated in 2012.