The regulation of medicinal products, an analysis of the impact on pharmaceutical innovation, consumer safety and legal redress

The adverse consequences of the use of thalidomide in the 1950s and 1960s by pregnant women, instigated law reform in the United Kingdom and Europe, in relation to product liability and the regulation of medicinal products. In this Thesis, it is suggested that a legislative framework should balance three elements: consumer safety, legal redress and pharmaceutical innovation. Chapter Three examines the development of the legislative framework in the United Kingdom following thalidomide and considers the impact of the Medicines Act 1968, the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 and the Consumer Protection Act 1987, together with European legislation, on medicinal products. This Chapter also examines the role of regulatory bodies such as the Medicines Control Agency, the Committee on Safety of Medicines, the European Agency for the Evaluation of Medicinal Products and the Committee on Proprietary Medicinal Products. Chapter Four analyses the three above mentioned elements and, in particular, discusses: the centralised and decentralised licensing procedures; the definition of "relevant medicinal product"; the regulation of homeopathic products, herbal products and medical devices; conflicts of interest; transparency of licensing procedures; the legal status of medicinal products; promotion by the pharmaceutical industry; information supplied to patients; pharmacovigilance; and the development risks defence. The Author concluded that the legislative framework had struck an appropriate (albeit imperfect) balance between the elements of pharmaceutical innovation, consumer safety and legal redress. The Author further concluded that issues such as patents, prescribing errors and legal aid, which are outwith the control of the Medicines Act 1968 and the Consumer Protection Act 1987, impact on the balance of these three elements. In the future, the Author suggested that research should be conducted in areas such as transparency of regulatory action, the regulation of herbal products, and the improvement of prescribing and dispensing practices.The adverse consequences of the use of thalidomide in the 1950s and 1960s by pregnant women, instigated law reform in the United Kingdom and Europe, in relation to product liability and the regulation of medicinal products. In this Thesis, it is suggested that a legislative framework should balance three elements: consumer safety, legal redress and pharmaceutical innovation. Chapter Three examines the development of the legislative framework in the United Kingdom following thalidomide and considers the impact of the Medicines Act 1968, the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 and the Consumer Protection Act 1987, together with European legislation, on medicinal products. This Chapter also examines the role of regulatory bodies such as the Medicines Control Agency, the Committee on Safety of Medicines, the European Agency for the Evaluation of Medicinal Products and the Committee on Proprietary Medicinal Products. Chapter Four analyses the three above mentioned elements and, in particular, discusses: the centralised and decentralised licensing procedures; the definition of "relevant medicinal product"; the regulation of homeopathic products, herbal products and medical devices; conflicts of interest; transparency of licensing procedures; the legal status of medicinal products; promotion by the pharmaceutical industry; information supplied to patients; pharmacovigilance; and the development risks defence. The Author concluded that the legislative framework had struck an appropriate (albeit imperfect) balance between the elements of pharmaceutical innovation, consumer safety and legal redress. The Author further concluded that issues such as patents, prescribing errors and legal aid, which are outwith the control of the Medicines Act 1968 and the Consumer Protection Act 1987, impact on the balance of these three elements. In the future, the Author suggested that research should be conducted in areas such as transparency of regulatory action, the regulation of herbal products, and the improvement of prescribing and dispensing practices