Key Topic 1: Legitimate Business Need
Here are some examples of activities or materials where there could be a legitimate business need to include off label information:
- Advisory Boards
- Clinical trial documentation or meeting
- HTA (health technology appraisal) submission
- Development partnership
- Business development enquiry
- Market research
- Regulatory submissions
- Information for prospective employees
Some of these, such as regulatory submissions, will not require nominated signatory review. However you are likely to encounter materials related to ‘scientific exchange’, market research and provision of information for health service payers and budget holders. Market research is covered in a separate module.
In this section we will consider Scientific Exchange and Information for Payers as examples of where there is a legitimate business need.
