The impact of Brexit on access to medicines
The Department for Health and Social Care (DHSC) has commissioned Ernst and Young to conduct a study into the potential impact of Brexit on the supply of medicines, radioisotopes, vaccines and public health countermeasures in the UK.
Many concerns have been expressed about the impact of Brexit on access to vital medicines in the UK and the DHSC has said that it is keen to better understand the operational planning and level of preparedness of organisations to ensure the continued supply of medicines to NHS patients. As part of the study which has been commissioned, questionnaires have been circulated to drug manufacturers and other stakeholders via trade associations such as the BioIndustry Association and the Association of the British Pharmaceutical Industry. Key questions are being asked about the potential implications of the UK's withdrawal from the EU with respect to trade, border delay and product regulation, with responders prompted to consider the implications of changes to tariffs and VAT collection on supply chain, additional EU safety and security checks for goods entering and leaving the EU27 territory. They are also asked for feedback on the likely impact of any changes to the pharmacovigilance process, batch testing / batch release, contract renegotiation and Qualified Person requirements. Responders are being asked what steps they are taking and how confident they are that those steps will ensure a continuity of supply of medicines to the NHS.
An updated set of questionnaires, amended based on feedback given by various stakeholders, can be found at the links below, together with the definitions of the product type covered by each questionnaire. A relatively short timeframe was given for responses, which has now been extended to this Friday 2 March. Not least because of the confidentiality of the information being requested, we suspect that any summary of the findings will be limited, but we will keep you posted.
Links to Questionnaires
- Medicines: A drug or other preparation for the treatment or prevention of illness or disease.
- Medical radioisotopes: A version of a chemical element that has an unstable nucleus and emits radiation during its decay to a stable form. Uses include medical diagnosis, treatment, and research.
- Vaccines: An antigenic substance prepared from the causative agent of a disease or a synthetic substitute, used to provide immunity against one or several diseases purchased by Public Health England (for the National Immunisation Programmes) or the wider NHS.
- Public Health Countermeasures: Pharmaceutical products purchased by Public Health England (not for the National Immunisation Programmes) to support the response to a future UK pandemic and a Chemical, Biological, Radiological or Nuclear Incident.