Compassionate use of medicinal products

Abstract

Law 25/1990 on Medicinal Products (published in BOE n. 306, 22 December), provides in Article 37.5 “Exceptionally the Minister of Health and Consumption may grant authorization, subject to the conditions expressed in it, for the prescription and application of ‘products undergoing clinical research to patients not included in a clinical trial, when the doctor, under his exclusive responsibility and with the express consent of the patient, considers it indispensable to treat him with them and justifying the reasons for undertaking such treatment to the health authority”. Art. 8.11 that sets out the Definitions defines a Product undergoing clinical research as ‘one which is destined to be employed only by experts qualified by their scientific training and experience for research in persons or in animals on their safety and efficacy’. Art. 6.2 establishes “The legal treatment of medicinal devices will be subject to the application of this Law and its general control of substances or combinations of substances especially qualified as ‘products undergoing clinical research’ authorised for their use in clinical trials or research on animals”. The Direction General of Pharmacy and Health Products on communication 12 February 1992 wrote “In exceptional cases and in accordance with Art. 38.5 of the above-mentioned Law (on Medicinal Products) authorisation may be granted for the importing of products undergoing clinical research for patients not included in a clinical trial, when the doctor, under his exclusive responsibility and with the express consent of the patient considers it indispensable and justifies its compassionate use”. This was the first time that the phrase ‘compassionate use’ was used in an official document although always limited to products undergoing clinical research. Only three years after the Law on Medicinal Products appeared, the Royal Decree 561/1993, 16 April, establishing the requisites for undertaking clinical trials with medicinal products (published in BOE 13May), in Art. 23.1 introduced the definition of compassionate use in the following terms: “Compassionate use is understood as the employment in patients isolated and outside a clinical trial, of products undergoing clinical research, or the employment of pharmaceutical specialities for diseases or