Impact of Brexit on UK and EU Drug Regulation and Patient Access.

The chronology of the United Kingdom (UK) leaving the European Union (EU) is presented together with its implications for medicines regulation, including the move of the European Medicines Agency from London (UK) to Amsterdam (the Netherlands). The legal and political options for the UK and the EU are discussed, which at the time of writing (October 2018) are both uncertain. Of importance is the response of the pharmaceutical industry and the possible consequences for UK patients, including delays in access to innovative medicines and an increase in drug costs.

Regulatory Consequences of "Brexit" for the Development of Medicinal Products.

The United Kingdom voted in a referendum in June 2016 to leave the European Union (EU) after 45 years of membership. Among the many political, social, and scientific consequences are those for the regulation of health care products. No longer will the efficacy, safety, and quality of medicines in the United Kingdom be subject to an EU regulatory framework.

After thalidomide - do we have the right balance between public health and intellectual property.

The current European regulatory and consumer protection legal framework is the legacy of Thalidomide. The disaster led to the introduction of systematic biological and clinical data to endorse the safety and efficacy of new medicines. The European Medicines Directive outlined the pre-clinical, clinical data and product information to evaluate an appropriate benefit.

The Imperfect Intellectual Bridge Between a Master Medicinal Product and Its Associated Custom-Made Medicinal Products.

To obtain a license to be placed on the marketplace, a medicinal product must be accompanied by data on quality and data from preclinical studies and studies of clinical safety and efficacy. At the time of first production, a custom-made medicinal product will have data on quality but will not be accompanied by data from preclinical studies or from studies of clinical safety and efficacy. To span the gap in data, an "imperfect intellectual bridge" between data for a custom-made medicinal product and data for its master medicinal product is described.