Government Response

The Government responded to this petition on Thursday 14th May 2020

The Government is working to ensure that UK patients can access the best and most innovative medicines and participate in clinical trials, whatever the result of negotiations with the EU.

We recognise the devastating impact that cancer has on the lives of patients up and down the country. It is essential to get the best cancer treatments to UK patients as soon as possible and we are working to ensure this.

The Government is working alongside the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health Research (NIHR), the Health Research Authority (HRA), and others to ensure that UK patients can access the best and most innovative medicines and participate in clinical trials, whatever the result of negotiations with the EU on our future trading relationship. The Medicines and Medical Devices Bill will play an important role in ensuring that the legal frameworks around medical devices, human medicines, veterinary medicines and clinical trials can be updated to reflect new innovative practices and protect patient safety.

As the UK’s regulator of medicines and medical devices, the MHRA brings world-leading expertise in many areas including clinical trials regulation, which we believe already provides significant benefit to patients. Clinical trials are currently approved nationally by the MHRA; this approach would continue at the end of the transition period. The MHRA will implement future regulatory approaches which ensure that UK patients have access to safe and effective, new and innovative medicines.

Through the NIHR, the Government invests over £1 billion a year in health research. This provides direct funding for clinical trials, as well as for the skills, facilities and infrastructure needed to undertake clinical trials in the health and care service. NIHR funding for cancer research has risen from £101 million in 2010/11 to £132 million in 2017/18, making it the largest investment in a disease area. Through the NIHR Clinical Research Network, the proportion of patients entering cancer clinical trials and studies is more than double that in any other country for which data exists, including the United States.

As part of the Life Sciences Sector Deals, we have implemented a new streamlined MHRA and HRA approval process. It is now possible for efficient clinical trials to be set up in the UK within 100 days from first regulatory application to first participant recruited. We are further improving this, with MHRA and HRA working together through a Combined Ways of Working Pilot, delivering approvals in parallel rather than in sequence.

The ‘UK approach to Negotiations’, published on 27 February 2020, shows that we are seeking to collaborate with our European partners on pharmaceuticals. This is subject to the outcome of negotiations with the EU and what is best for both the UK and the EU. In his Written Ministerial Statement on 3 February 2020, the Prime Minister said that any agreement with the EU must respect the sovereignty of both parties and the autonomy of our legal orders. It cannot, therefore, include any regulatory alignment, any jurisdiction for the CJEU over the UK’s laws, or any supranational control in any area. At the end of the transition period, the UK’s participation in the European Medicines Regulatory Network will cease and the MHRA will take on the functions currently undertaken by the EU for human medicines on the UK market. Our approach will always be one that prioritises delivering the best outcomes for UK patients.

Department of Health and Social Care