THE EQUIVALENT MEDICINE

An equivalent medicine is a medicine that contains the same quantity of active ingredient and has the same bioavailability as a branded medicine with an expired patent.

DEFINITION

An equivalent medicine is a medicine that contains the same quantity of active ingredient and has the same bioavailability as a branded medicine with an expired patent. The protection offered by a patent allows a company, which has carried the costs of research, development and launch of a new product, to maintain its monopoly in the sale of this product for several years. At the end of this period of protection provided by the patent, a medicine may then be produced by other pharmaceutical companies and offered on the market at a lower price.

GENERICS BECOME EQUIVALENT MEDICINES

The definition of an equivalent medicine is contained in Article 10, subsection 5, Letter b of the Legislative Decree 219 of 2006, which states: "generic medicinal product: a medicinal product having the same qualitative and quantitative composition in terms of active ingredient and the same pharmaceutical form of a reference medicinal product and which bioequivalence to the reference medicinal product has been demonstrated by appropriate studies".

WHAT THE LAW SAYS

La definizione della nozione di farmaco generico è contenuta nell'Articolo 10 Comma 5 Lettera b del Decreto Legislativo 219 del 2006, che così recita in proposito: "medicinale generico: un medicinale che ha la stessa composizione qualitativa e quantitativa di sostanze attive e la stessa forma farmaceutica del medicinale di riferimento nonché una bioequivalenza con il medicinale di riferimento dimostrata da studi appropriati di biodisponibilità".

THE CONCEPT OF BIOEQUIVALENCE

Two medicinal products are defined as bioequivalent when their bioavailability, i.e. the quantity of active ingredient that is released into the bloodstream, and the rate at which it is released are equivalent. In practice, the concept of equivalent medicine is based on the assumption that, in the same subject, equal active substance plasma concentrations over time will produce an equal concentration of the substance at the site of action and, therefore, an equal therapeutic effect. This is why the Agenzia Italiana del Farmaco (AIFA - Italian Medicines Agency) grants authorisation to produce and market an equivalent medicine on condition that the quality of the product is documented and that its bioequivalence to the original medicine is demonstrated.

WHY IT COST LESS

An equivalent medicine costs less in comparison to the original because the costs of research have been recovered during the period in which the product was under patent. It is well known that to demonstrate the efficacy and safety of a new medicine it is necessary to test the product on hundreds or even thousands of subjects. Such testing takes months and has high costs.

On the contrary, a company that produces and markets an equivalent medicine does not have to prove its therapeutic efficacy: if its active ingredient reaches the same blood levels as those obtained with the original medicine (i.e. if it is bioequivalent) it therefore has the same therapeutic efficacy. Demonstrating bioequivalence to a medicine that is known to be safe and effective requires much less time and greatly reduced costs, and so the equivalent medicine can be marketed at lower price.

THE ROLE OF THE DOCTOR

Generic drugs have been available in Italy for more than ten years now and the General Practitioner (GP) has learned how to use them better. Nevertheless, in the everyday clinical practice, some critical points still appear that directly involve the peculiar relationship between the GP and the patient: the GP is the cornerstone of the healing process and the patient has trust in this relationship.

The widespread availability of drugs based on the same active ingredient and for which patent protection has expired may generate confusion: the prescription of a generic drug, though already accepted as far as efficacy and safety are concerned, needs to be supported by specific information to patients who, in the general medicine setting, are often elderly and fragile and who may have memorized some peculiar element of branded drugs (such as commercial name, packaging, color of the tablets etc.). In the prescribing choice, the GP needs to manage the possible objections not only arising from the patient but also from other health professionals such as the Specialist (it may for instance happen that the patient is recommended to take a branded medicinal product at hospital discharge) and the Pharmacist, who can substitute the generic product prescribed by the GP with a different one.

The GP has a mean to grant both the therapeutic choice and the patient: add to the prescription the ban to substitute in all cases where this is considered appropriate, avoiding therefore the chance of repeated substitutions among different generic products, potentially confounding for the patient. Furthermore, the note "not-substitutable" allows the GP to evaluate the results of the therapy, i.e. check in time whether a specific product generates the expected benefit for the patient, which is an essential factor for drugs intended to heal chronic illnesses, where efficacy needs to be verified in time.

GLOSSARY

Active ingredient

The term active ingredient indicates the substance that possesses therapeutic activity in a medicine. The remaining components of a pharmaceutical form are called excipients and are utilised to improve its stability, storage and administration or to modify the release rate of the active ingredient.

AT THE PHARMACY: THE OPTION OF SUBSTITUTION

The concept of substitution is closely connected to that of bioequivalence; if a medicinal product is bioequivalent to a reference medicinal product the patient can obtain the latter without paying the price difference.

Definition

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.

THE ROLE OF THE PHARMACIST

The pharmacist has a pivotal role to play in the development and dissemination of the use and culture of equivalent medicines. Since 2001, by law, the pharmacist is obliged to inform the patient of the availability of an equivalent medicine corresponding to the original medicine and to inform the patients about the difference in price and the amount of money they have to pay if they decide to buy the original.

The pharmacist also has the important task of reassuring the patient about the quality of the equivalent medicine, the similarity of its therapeutic activity and of the incidence of its side effects compared to those of the original product.

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