Guidance for reviewing/approving market research materials
Purpose of this programme
The purpose of this programme is:
- To provide an understanding of the basis, scope and purpose of the BHBIA Legal and Ethical Guidelines, in particular their inter-relationship with the ABPI Code of Practice
- To make clear the distinction between market research and other activities such as clinical research, promotion, PR and selling
- To allow those inputting to market research to do so more confidently and efficiently, and to make better informed decisions and comments.
Clauses 24 and 25 of the ABPI Code of Practice deal with market research:
Clause 24.1 Contracted Services
24.1 Health professionals, other relevant decision makers or their employers on their behalf, healthcare organisations, patient organisations, individuals representing patient organisations, and members of the public including patients and journalists may be used as consultants and advisors, whether in groups or individually, for services such as speaking at and chairing meetings, involvement in medical/scientific studies, clinical trials or training services, writing articles and/or publications, participation at advisory board meetings, and participation in market research where such participation may involve remuneration and/or hospitality.
Clause 25 Relationships with Health Professionals, Other Relevant Decision Makers, Healthcare Organisations and Patient Organisations
25.4 Market research activities, clinical assessments, post-marketing surveillance and experience programmes, post-authorisation studies (including those that are retrospective in nature), and the like must not be disguised promotion. They must be conducted with a primarily scientific or educational purpose.
Clause 25 Supplementary Information
Clause 25.4 Market Research Market research is the collection and analysis of information and must be unbiased and non-promotional. The use to which the statistics or information is put may be promotional. The two phases must be kept distinct.
Attention is drawn to the Legal & Ethical Guidelines for Healthcare Market Research produced by the British Healthcare Business Intelligence Association.
Market research material should be examined to ensure that it does not contravene the Code.
Where market research is carried out by an agency on behalf of a pharmaceutical company, the agency must reveal the name of its client to the PMCPA when requested to do so. When commissioning market research, a company must take steps to ensure that its identity would be made known to the Authority should a request for that information be made.
The guidance included in this training module is provided by the BHBIA for information purposes only and is not intended and should not be construed as regulatory or legal advice. It does not cover all legislative and regulatory requirements and whilst every reasonable effort is made to ensure the information is accurate, no responsibility for its accuracy or for any consequences of relying on it is assumed by the authors. Organisations are urged to consult their own legal advisers to reflect their approach to compliance.
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