Definitions
Generic Medicines
As specified in the Spanish law of July 2006 that refers to the Guarantees and Rational Use of Medicines and Sanitary Products (LGURMPS), a generic medicine “is any medicine that has the same qualitative and quantitative composition and active substance, the same pharmaceutical form and its bioequivalence with the originator product has been demonstrated with the appropriate bioequivalence studies”.
A generic medicine contains the same active medicinal substance as an originator pharmaceutical product. Because it acts in the same way in the human body, it is interchangeable with the originator product. Generic medicines are launched when the originator product’s patent has expired.
EFG
Acronyms for "Equivalente Farmacéutico Genérico" (Pharmaceutical Generic Equivalent). Generic medicines have to be designated with the Spanish official active substance denomination (DOE) or, if it does not exist, with the common international denomination (DCI). If it this does not exist either, with the common or usual scientific denomination of the substance, accompanied, in this case, by the manufacturers brand or name. They will have to be identified with the letters EFG (Pharmaceutical Generic Equivalent). In the EU a generic medicine is identified either by a company name plus its International Nonproprietary Name (INN), or by its own invented brand name.
Bioequivalence
Bioequivalence demonstrates the interchangeability between a generic medicine and the originator medicine in terms of quality, security and efficacy. Bioequivalence studies are done to prove that the generic medicines are equivalent and interchangeable with the originator product in terms of therapeutic efficacy.
Reference Prices
This is the maximum amount that health authorities are willing to pay for the medicines included in a group. The reference price is the amount that will finance the different medicines included in the different therapeutic groups, however these medicines have to be prescribed and dispensed through the official medical receipt of the National Health System (SNS).
Therapeutic Group
Total number of financed medicine presentations that have the same active substance and that have, at least, one generic medicine amongst them, excluding the “innovative pharmaceutical forms”.
The Reference Price (PR) for each therapeutic group will be the minor cost/treatment/day of medicine presentations in that group, for each administration route according to the Defined Daily Dosage (DDD).
Substitution by the pharmacist
When prescribing a medicine that is part of the group and has a higher price than the reference one, the pharmacist will have to substitute it for the one that has lower in price and has identical qualitative and quantitative composition of active substance, pharmaceutical form, administration route, dosage and presentation, than the prescribed medicine. In the cases where the prescription is by active substance and is submitted to the reference price system, the pharmacist will dispense the medicinal product with the lower price.
Generics
