This section contains practical advice to help both health consumer organisations and pharmaceutical companies work together within the key principles for working together. It outlines some of the regulation and compliance requirements that will be encountered when collaborating.
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Types of relationships
Relationships between health consumer organisations and pharmaceutical companies may include one-off projects and/or longer-term relationships. In some cases, a collaboration may involve more than one health consumer organisation or pharmaceutical company, and increase the level of complexity.
Partners participating in a one-off project usually limit their participation to meeting only the needs of that project, for a fixed period of time. A one-off project typically involves a donation, sponsorship or educational grant by a pharmaceutical company to a health consumer organisation to undertake specific activities. In some cases, this support can involve no further return to the pharmaceutical company beyond an agreed acknowledgement process – for example, a reference in the health consumer organisation’s annual report.
A longer-term relationship usually takes the form of a collaboration in which a pharmaceutical company and a health consumer organisation work together on areas of common interest. Each partner makes contributions to the relationship, such as funding, the sharing of information, education, training and support. The partners benefit from working together, bringing different strengths to achieve goals that might be beyond their reach if they worked on their own.
There are many different types of relationships and some stories of working together are shared in this website.
The three stages of working together
Health consumer organisations and pharmaceutical companies may have their own governance and regulation requirements applicable to collaborations between organisations and individuals. However, a general outline of the three stages to consider when working together is provided. It describes detailed checklists containing questions that are often important in laying the groundwork for successful collaborations between health consumer organisations and pharmaceutical companies. Health consumer organisations and pharmaceutical companies will need to adapt these checklists to their particular circumstances.
|Stage 1. Laying the groundwork for working together||Contains questions and issues to consider when:
|Stage 2. Working together with a new partner||Contains questions and issues to consider when a new relationship or project is starting out.|
|Stage 3. While you’re working together||Contains questions and issues to consider during a relationship and as the relationship or project nears completion.|
Compliance with ethical standards and legislation for pharmaceutical companies, health consumer organisations and individuals
A health consumer organisation and a pharmaceutical company are often required to complete a number of compliance processes prior to agreeing upon any collaboration or activity. The compliance processes differ across companies but may include the following:
- Written agreement – signed by all parties to the collaboration, outlining the objectives, activities, outcomes and overall benefit for health consumers. The agreement will include details of the funds agreed and how/when they will be spent. In addition, with increasingly greater requirements to be transparent, an agreement will often describe how the financial support provided by the research-based pharmaceutical company should be disclosed. Sometimes referred to as ‘meaningful disclosure’, this can include a statement on all written materials related to the sponsored activity as well as a statement to an audience if the activity involves a presentation. The agreement is signed and kept on file for ongoing reference by both organisations.
- ‘Conflict of interest’ declaration – a list of questions that are answered by the health consumer organisation’s management. It aims to identify any actual, potential or perceived conflict of interest associated with the provision of funds to an organisation. It checks if the proposed payment, benefit, grant or sponsorship could be perceived to be improperly influencing decisions regarding any business being conducted by the pharmaceutical company. This allows the pharmaceutical company to assess and manage potential conflicts in a transparent manner. When a conflict is identified, it does not always mean that the project cannot proceed, but it does mean that the conflict has to be evaluated to see if it can be managed in a way that meets with compliance standards (both internal company regulations as well as national and international legislation) and can withstand public scrutiny. An example of a potential conflict and how it may be managed may be that a pharmaceutical company is providing a grant to a health consumer organisation, and the CEO of the organisation is a member of the local hospital board. In the capacity of hospital board member, the CEO is required to vote twice yearly on which medicines will be kept on the medicine list for that hospital. The conflict might be managed this way:
- Step 1. The CEO declares the conflict to the hospital board and states his or her intention to abstain from all voting related to the medicines list.
- Step 2. The CEO signs a letter to that effect.
- Step 3. The signed letter is added as an attachment to the agreement, to be kept on file.
The compliance process can take additional time to complete, however it is necessary to safeguard the integrity of sponsorships for the protection of both the health consumer organisation and the based pharmaceutical company.
For further information, visit the governance and compliance of pharmaceutical companies and regulation of pharmaceutical companies sections.