Annex III – QUERIES (Questions and Answers) on the interpretation of the Code of Practice
ARTICLE 1. MARKETING AUTHORIZATION FOR MEDICINES
7. Can a company inform Healthcare Professionals attending a congress taking place in Spain about molecules undergoing research (not yet in possession of marketing authorization) through abstracts elaborated by this same company within posters located on the walls of the company’s stand at the congress?
Informative panels about pipelines may only contain information that has been published in indexed scientific journals or approved by the appropriate scientific committee for their presentation in the congress of a scientific society.
8. In case of a communication in a scientific meeting regarding data of products in clinical development (not authorized) or of a new indication in development, what are the limits that may differentiate scientific communication from promotion?; is it acceptable to communicate scientific data of a product not yet authorized in the context of a scientific congress when delivered by a Healthcare Professional?;is it any different if this professional is a company employee (doctor)?; is it any different if the data is communicated in a satellite symposium sponsored by the company?
Legislation and authorities have developed several criteria and examples to distinguish between information and promotion of medicines and provisions of Title I of the Code are to be applied when dealing with promotion of prescription-only medicines. The data communicated or presented in the official part of a congress (oral communication, poster, abstract) under the supervision of the prestigious organizing scientific society constitutes information and not promotion, provided it is delivered in a complete form, with no modifications or additions to maintain that condition. A satellite symposium of a company taking place on occasion of a congress or a presentation delivered by a doctor hired by a company are, in principle, promotional activities, unless proven that the messages/contents delivered are purely informative both in their form and content, with no bias or modification.
The above does not prevent a company from in- forming in a balanced manner about its pipeline on occasion of a scientific congress. It shall then be the company’s responsibility to justify that the tone and scientific basis are appropriate, guaranteeing that these messages cannot be perceived as promotion of a non authorized prescription-only medicine or indication.