The Government has published its response to the Health and Social Care Committee’s report of March 2018 on Brexit and medicines, medical devices and substances of human origin. The report included several questions and issues of concern for the Committee, which the Government’s response addresses. The response emphasised that a “deep and special relationship with the EU… remains the best way to promote improved patient outcomes both in Europe and globally”. It includes the following comments:
- Teams within DHSC are progressing work to assess the impact of exiting the EU on the supply chain for all medicines and medical devices used in the NHS. A cross-Government steering group, which includes all the relevant organisations including the Medicines and Healthcare products Regulatory Agency (MHRA), NHS England (NHSE) and Public Health England (PHE), has been established to oversee and contribute to this work. Ernst and Young (EY) have been appointed to carry out this work and we expect the initial phase to be concluded in late spring 2018
- The UK will continue to seek opportunities to influence through collaborations such as the International Council on Harmonisation (ICH) and similar international organisations such as the Pharmaceutical Inspection and Co-operation Scheme (PICS) and the International Medical Device Regulators Forum (IMDRF). Applications to become a full member of such organisations can take some time, and work is underway to clarify the timelines involved in these processes.
- We note the Committee’s recommendation on the breakdown of DHSC funding. At this stage we are not in a position to provide this finer detail but we can offer the Committee assurance that the funding will be used effectively not only towards achieving a successful exit from the EU for the life science sector but also for the broader health sector.
- Whatever the outcome of the negotiations we will continue to ensure that UK patients are able to access the best and most innovative medicines and be assured that their safety is protected. With regard to substances of human origin, the current regulatory framework is well established and sets high quality and safety standards for patients in the UK. The Government’s priority is to maintain the same high standards after the UK exits the EU.
- We are exploring a range of options for the future regulation of medicines and medical devices in the UK. We will discuss with the EU and Member States how best to continue cooperation in the field of medicines regulation in the best interests of business, citizens and patients in both the UK and the EU as part of the future partnership negotiations.
- DHSC is continuing to progress work to assess the impact of EU exit on the supply chain for all medicines, medical radioisotopes and medical devices used in the NHS. Due to the large volume of commercial and sensitive information that has been shared by the industry throughout this work, DHSC will be unable to publish the final report. However, we will consider publication of an executive summary of the work.”
Since publication of the Government’s response, the Committee has published a further response, again raising questions and concerns. The Committee Chair, Dr Sarah Wollaston MP, commented:
“The Government’s response to our report is full of good intentions, but does little to provide certainty for UK patients, the NHS and businesses.
Close regulatory alignment with the EU, along with an immigration regime that attracts the brightest and best scientists and healthcare professionals, are critical if UK patients are going to continue to receive timely and safe access to medicines, medical devices and substances of human origin after Brexit.”