Scientific Exchange
There is no official definition of ‘scientific exchange’, but the term has been used by regulatory authorities to acknowledge that exchange of information during the development of a product needs to be allowed for certain ‘legitimate’ reasons. In addition the term ‘exchange’ implies a two way process in terms of sharing information. This does not preclude the one way provision of off label information, but this should not be the only part of the process.
It is important to distinguish scientific exchange from medical education, because medical education does not allow for sharing of off label information. In medical education the purpose is to add to the knowledge or skills of the target audience in some way through a teaching or training process. In scientific exchange there is a sharing of knowledge without a ‘training’ or ‘teaching’ element.
Consider this example
This is an example of where the line between medical education and scientific exchange became blurred in the US leading to severe consequences for AstraZeneca:
In 2010 AstraZeneca in the US had to pay fines of $520 million to resolve allegations of off label promotion of Seroquel. The report stated that AstraZeneca “promoted the unapproved uses by unduly influencing the content of, and speakers, in company sponsored continuing medical education programs. The company also engaged doctors to give promotional speaker programs on unapproved uses for Seroquel.”
Learned Society
A learned society is an organization that exists to promote an academic discipline or profession, or a group of related disciplines or professions. Examples are The American Society of Hematology (ASH) and the European Association for the Study of the Liver (EASL)
This can be a difficult area so if you are unsure about whether an activity is medical education or can be classed as scientific exchange consult a senior nominated signatory and consider taking advice from compliance and/or legal colleagues.
Here are some examples of allowable types of scientific exchange – click on each for more information
Discussion at a congress
of a learned society
Advisory
Boards
Clinical research/
investigator meetings
