Sex as a variable in medicines assessment reports for licensing in the European Union. Can gender bias be excluded?

PURPOSE: To analyse publically available official reports on the evaluation of European Union (EU) registration of new medicines (aimed at diseases affecting both sexes) in order to address the possibility of gender bias. METHODS: Descriptive study reviewing two types of assessment reports corresponding to different EU registration procedures: European Public Assessment Reports (EPARs) for the centralised procedures (399 reports considered from 2001 to 2002 and 2008 to 2009) and Mutual Recognition or Decentralised Public Assessment Reports (MPARs) for the mutual recognition and decentralised procedures (2,704 reports, totality until 2009-inclusive). RESULTS: Two hundred and twenty-four EPARs fulfilled the study criteria. It can be deduced from those EPARs that women participated in at least one clinical trial in 215 (78.5 %) of the reports. In 49(17.9 %) of the EPARs, the study population is explicitly evaluated according to sex, ten (3.6 %) presenting results disaggregated by sex. Most sex-related differences are in safety and pharmacokinetics; six of the 22 cases (72.7 %) of safety differences and nine of the 23 cases (60.9 %) of pharmacokinetic differences are not discussed. In relation to MPARs, only 2,704 out of 15,621 registries (17 %) were published, which casts doubts on the representativity of the available reports. Those published reflect less participation by women than in the EPARs. CONCLUSIONS: From the incomplete sex-related data made public, it is difficult to conclude on the existence of gender bias in the evidence used for the evaluation of new medicines. It certainly cannot be excluded. It is therefore recommended that compliance with existing guidance for publication of reports is increased, so as to transparently reassure on the issue.

Legislación sobre autorización de genéricos / Regulation about generics approval

Objetivo: Analizar la legislación vigente referida a medicamentosgenéricos y actualizar su conocimiento.Método: En este trabajo se ha revisado la normativa europeay nacional respecto a los procesos de autorización y los procedimientosque garantizan la calidad, seguridad, y eficacia de losmedicamentos genéricos.Resultados: Los países pertenecientes a la Unión Europeahan desarrollado, a través de la Agencia Europea de Medicamentos(EMEA), una homogeneización en materia de autorización demedicamentos y exclusividad de los datos, ordenado en la Directiva2004/27 y el Reglamento 726/2004, normativas que se recogela Ley 29/2006 de Garantías y Uso Racional de los Medicamentosy Productos Sanitarios.Conclusiones: Aunque los mecanismos de regulación delprecio y la política de financiación son diferentes en los estadosmiembros, en casi todos los países se han desarrollado medidaspara contener el crecimiento del gasto farmacéutico, siendo unamedida importante para ello el uso de medicamentos genéricos,de menor coste que los medicamentos innovadores

Objective: To analyze current legislation referring to genericdrugs and to update knowledge concerning these drugs.Method: In this paper Spanish and European regulations havebeen reviewed in relation to the authorisation and procedures thatguarantee the quality, safety and efficacy of generics.Results: The countries belonging to the European Union haveestablished, through the European Medicine Agency (EMEA), uniformcriteria for authorisation and data exclusivity, regulated byDirective 2004/27 and Regulation 726/2004, which are beingimplemented in our country through Law 29/2006 of Guarantyand Rational Use of Medicines and Medical Devices.Conclusions: Although mechanisms of price regulation andfinancing policy are different throughout the member States, mostcountries have introduced measures to reduce the increase inexpenditure on medicines, with generic products being an importantaspect since they are less expensive than innovating medicines

[Regulation about generics approval]. / Legislación sobre autorización de genéricos.

OBJECTIVE: To analyze current legislation referring to generic drugs and to update knowledge concerning these drugs. METHOD: In this paper Spanish and European regulations have been reviewed in relation to the authorisation and procedures that guarantee the quality, safety and efficacy of generics. RESULTS: The countries belonging to the European Union have established, through the European Medicine Agency (EMEA), uniform criteria for authorisation and data exclusivity, regulated by Directive 2004/27 and Regulation 726/2004, which are being implemented in our country through Law 29/2006 of Guaranty and Rational Use of Medicines and Medical Devices. CONCLUSIONS: Although mechanisms of price regulation and financing policy are different throughout the member States, most countries have introduced measures to reduce the increase in expenditure on medicines, with generic products being an important aspect since they are less expensive than innovating medicines.