Substitution and exchange are different concepts that should not be mixed. The definition that BioSim includes in its Decalogue it is enlightening.
"Substitution is understood as the dispensing by the pharmacist of a different medication from the one prescribed by the doctor without prior consultation with the latter. In Spain, by law, in pharmacies (or street pharmacies), the substitution of a medicine of biological origin for another is not authorized, the biosimilar or the original. In hospitals where Pharmacy and Therapeutics Commissions are the decision-making body, it is essential that a consensus be reached with doctors regarding the selection of biological drugs”.
On the other hand, the expression “automatic replacement” refers to the practice by which the pharmacist is obliged to dispense a medicine for another equivalent, and interchangeable, due to national or local requirements.
There is no European legal framework on substitution. The “no substitution” policy is decided by each member state. Therefore, it is about national laws that vary from country to country. There are debates about the scope of these rules and it would be convenient to reach a European consensus on the matter.
