Annex III – QUERIES (Questions and Answers) on the interpretation of the Code of Practice
ARTICLE 2. INFORMATION ON MEDICINES TO BE MADE AVAILABLE
10. What aspects should pharmaceutical companies take into account in terms of information and promotion in the case of new medicines or new indications?
A distinction should be made between information and promotional activities.
Current legislation does not establish limits on the right of pharmaceutical companies to inform about scientific and technical advances, including those that are directly related to new medicines or new indications. In this regard, there are certain activities which, lacking the purpose envisaged in the definition of advertising, are considered by the health authorities themselves to be informative (non-promotional) activities, such as, for example:
- The delivery of the summary of product characteristics or any other type of public information published on the official website of the European Medicines Agency (EMA) or the Spanish Agency of Medicines and Medical Devices (AEMPS in its Spanish acronym).
- The provision of originals, offprints or literal translations of scientific articles or their abstracts published in scientific sources of recognised prestige or at congresses, provided that they are not modified and do not include promotional elements.
With regard to the right of pharmaceutical companies to promote new medicines or new indications, current legislation requires them to have the corresponding marketing authorisation issued by the European Commission, following the opinion of the EMA, in centralised procedures, or by the AEMPS, in other cases.
In addition, Royal Decree 1416/1994 of 25 June 1994, which regulates the advertising of medicinal products for human use, also requires advertising to include the retail price, the reimbursement conditions of the National Health System (SNS in its Spanish acronym), where applicable, and, where possible, the estimated cost of the treatment.
In cases where, following marketing authorisation, a resolution on financing and price is pending in the SNS, the promotion of a new medicine or a new indication does not constitute an infringement of the Code provided that the advertising aimed at persons authorised to prescribe or dispense medicines includes information on this circumstance.