At the pharmacy: the option of substitution

Substitution is currently regulated by law 221 of 17.12.2012, published on the Official Journal n. 294 of 18.12.2012 (“Development Decree”), which states that the Medical Doctor who visits a patient for the first time and for a chronic illness or for a new episode of a non-chronic illness where several equivalent medicinal products are available, should indicate on the National Health Insurance prescription the name of the active ingredient alone or the name of a specific medicinal product containing that active ingredient, together with the name of the active ingredient. The name of a specific product is binding for the Pharmacist unless substitution is specifically ruled out by the Doctor, with a short justification. The name of the specific medicinal product is also binding for the Pharmacist when said medicinal product is sold at the reimbursed price, unless the patient requires substitution. In summary: the Medical Doctor should not prescribe the brand name when filling the “red” (reimbursed) prescription for a medicinal product not intended for chronic use or which is used for the first time, when equivalent products are available. The Pharmacist should supply the brand name only when its substitution has been ruled out on the prescription and justified by the Doctor. The patient can always ask for a specific medicinal product, either branded or generic. If the price of the product required is higher than the reimbursed one, the patient pays the difference.

When the patent protection for a medicine reimbursed by the SSN expires and one or more equivalent medicines are authorised, the Agenzia Italiana del Farmaco (AIFA) includes both the original medicine and its equivalents in a list, which is up-dated monthly, called the “Transparency List”. In this list the original medicine and its corresponding equivalents are listed together with their reference price. The reference price corresponds to the lowest price on the market for that medicine and is also the price reimbursed by the SSN. If a medicine appears on the Transparency List and the prescribing doctor does not specify on the prescription that the medicine “cannot be substituted”, the pharmacist is obliged to offer the patient an equivalent medicine at the reference price. Should a prescribing doctor add the instruction “cannot be substituted” or should the patient not accept the substitution, the difference in price between the reference price and the retail price is borne by the patient.

The concept of substitution was also extended to medicines not reimbursed by the SSN (class C medicines, paid for completely by the patient), including the so-called “medicines available without prescription”(*) and “over the counter” medicines (OTCs), by legislative decree 87/05 converted into law 149/05. The law provides that even in this case the pharmacist must inform the patient of the availability of equivalent medicines that may be purchased at a lower price. This norm was introduced to further encourage the culture of equivalent medicines in Italy, less widespread than in the rest of Europe, especially as compared to Northern Countries.

(*)An Italian class of medicines similar to OTCs, with the only difference that no publicity to the public is allowed.