The option of substation at the pharmacy
Substitutability is currently regulated by Law 221 of December 17, 2012, published in the Official Gazette No. 294 of December 18, 2012 (Development Decree), which establishes that:
“The doctor treating a patient for the first time for a chronic condition, or for a new episode of a non-chronic condition, for which multiple equivalent medicines are available, shall indicate in the National Health Service prescription the name of the active ingredient contained in the medicine or the name of a specific medicine based on the same active ingredient along with its name. The indication of the specific medicine is binding for the pharmacist if the prescription includes the non-substitutability clause, obligatorily accompanied by a brief motivation (…). The indication is also binding for the pharmacist when the indicated medicine has a price equal to the reimbursement price, without prejudice to a different request from the customer.”
In summary:
- The Doctor is required to prescribe without specifying the brand name only on the red (reimbursed) prescription, only for non-chronic use medicines or those used for the first time, and only for medicines for which a generic exists.
- The Pharmacist is required to follow the doctor’s indication only if the prescription specifies that the medicine should not be substituted, with a justification.
- The Patient can still request a particular medicine, branded or generic. If the price of the requested medicine is higher than the reimbursement price, the patient pays the difference.
When to Substitute
When the patent protection of a medicine reimbursed by the NHS expires and one or more generic medicines are authorized, the Italian Medicines Agency (AIFA) includes both the originator and the corresponding generics in a list, updated monthly, called the transparency list. In this list, the originator medicine and the corresponding generics are listed together, with the corresponding reference price. The reference price corresponds to the lowest price offered on the market for that medicine and is also the price reimbursed by the NHS.
If a medicine appears on the transparency list and the doctor does not specify in the prescription that the medicine is “non-substitutable,” the pharmacist must offer the patient the generic medicine at the reference price.
However, if the doctor marks the indication “non-substitutable” or the patient does not accept the substitution, any difference between the reference price and the retail price is borne by the patient.
Substitutability for Non-Reimbursed Medicines
The concept of substitutability has been extended to medicines not reimbursed by the National Health Service (Class C medicines, entirely paid for by the citizen), including the so-called over-the-counter (OTC) and non-prescription medicines, by DL 87/05, converted into Law 149/05. The law stipulates that even in this case, the pharmacist must inform the patient of the possible availability of generic medicines that can be purchased at a lower price. The regulation was introduced to further promote the culture of generic medicines, which is less widespread in Italy compared to other European countries, particularly in the North.