Key Topic 8 - Subtopic 3: Working with Patient organisations
Pharmaceutical companies may interact with patient organisations but they must always respect their independence. Work with patient organisations should be covered by suitable contracts/agreements.
Examples of working with patient organisations include:
- Sponsorship of specific projects e.g. meetings
- Provision of background information to enable patient organisations to contribute to health technology assessments
- Advisory boards e.g. on clinical trial design
- Use of expert patients in training of staff e.g. sales representatives
In all cases the company’s involvement in activities with patient organisations must be made clear.
In many countries companies are required to make publicly available details of their support for patient organisations (see value transfer module for more detail).
Consider this example
In the UK Sanofi voluntarily admitted breaching the regulations with respect to its conduct and disclosure of interactions with patient organisations in 2013 and 2014.
The issues were:
- There was no written agreement to cover relationships with a number of patient organisations
- The company had also failed to certify sponsorship arrangements with a number of patient organisations
- There were failures to disclose and certify ‘fee for service’ arrangements with a number of patient oprganisations
For one organisation Sanofi had not accurately disclosed the amount paid and the information given was not sufficient for the reader to understand the significance of the support given.
Sanofi’s sponsorship of health professional’s meetings organised by patient associations had not been publicly declared as interactions with the relevant associations.
Ruling
These matters were taken extremely seriously by the Panel who noted the sensitivities surrounding the pharmaceutical industry working with patient organisations; robust agreements setting out the arrangements, and certification of agreements were important steps in ensuring compliance. They stated that “The systemic failure with respect to the whole process of working with patient organisations was of grave concern.”
Sanofi were found to have breached several parts of the UK Code and were also found to have brought discredit upon, and reduced confidence in the pharmaceutical industry. They had to undergo an audit of their procedures by the Authority and a public reprimand was issued.
