Annex III – QUERIES (Questions and Answers) on the interpretation of the Code of Practice
ARTICLE 2. INFORMATION ON MEDICINES TO BE MADE AVAILABLE
9. Can physicians be informed about approval of a new product once marketing authorization has been granted, even if the decision of the Ministry of Health, Social Services and Equality on reimbursement and price is still pending? And when a new indication is approved for a product already marketed, but the price and re- imbursement conditions for the new indication are pending?
The approval of a new medicinal product and the content of the corresponding summary of product characteristics are public information which, in the case of a centralized procedure, are published in the web page of the European Medicines Agency (EMA), and whose dissemination is, according to the law, the responsibility of the authorization holder. The Spanish Agency of Medicines and Medical Devices also publishes in the Internet the summaries of product characteristics.
On the other hand, the law establishes that once a medicinal product is authorized and registered, the State shall decide, before the product is marketed, whether it is included in the pharmaceutical benefits of the Social Security and, if so, the maximum price will be fixed. The regulations also require that any promotional material (printed, digital or electronic, etc.) must include, among other things, the selling price to the public, the reimbursement conditions under the National Health System, if applicable, and, when feasible, an estimation of the cost of treatment.
Thus, mere transmission to Healthcare Professionals of the summary of product characteristics, with no other type of commercial claim, message or explanation of a promotional nature is not considered a breach of the Code. However, in such cases a clear warning must be present indicating that the product is not yet available in the market due to a pending administrative decision on reimbursement and price.
For a new indication, an express warning that the new indication is not reimbursed until the appropriate administrative decision is made should be add- ed, and it should also be stated that the price may be reviewed if and when the new indication obtains its reimbursement conditions.