Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure the timely publication of the final results of the Mirocals trial for motor neurone disease; and what steps his Department plans to take to ensure rapid access to Proleukin for patients through NHS pathways if the trial outcomes are positive.

The Department funds research via the National Institute for Health and Care Research (NIHR). The NIHR is not a direct funder of the Modifying Immune Response and Outcomes in Amyotrophic Lateral Sclerosis (MIROCALS) trial. It was funded by the European Union’s Horizon 2020 programme, the Motor Neurone Disease Association, the Programme Hospitalier de Recherche Clinique, the My Name’5 Doddie Foundation, the Association Francaise contre les Myopathies, MND Scotland, and the Association pour la recherche sur la SLA.

The UK’s Health Research Authority recommends that summary results from clinical trials of investigational medicinal products, such as the MIROCALS study, are made available within a year of the study being complete. However, it is the study sponsor’s responsibility, in this case the University Hospital Nimes, to publish the results. Both the Department and the NIHR are committed to publishing the results from research with full transparency and in a timely manner. The Medicines and Healthcare Regulatory Agency (MHRA) does not publish data from clinical trials.

It is critical that medicines used in the United Kingdom are safe and effective and as such, medicines cannot be marketed in the UK without a marketing authorisation. These are granted by the MHRA, which assesses all medicines with regard to their quality, safety, and efficacy. Proleukin (interleukin-2, Aldesleukin) has not been licensed by the MHRA as a treatment for motor neurone disease. It is the responsibility of the company to apply to the MHRA for a relevant marketing authorisation. Should an application for it be received, the MHRA will consider this accordingly.

In England, newly licensed medicines are also appraised by the National Institute for Health and Care Excellence (NICE) to determine whether they represent a clinically and cost-effective use of National Health Service resources. If the manufacturer of Proleukin seeks a licence from the MHRA for the treatment of motor neurone disease, then the NICE will consider it through its topic selection process. If selected for evaluation, the NICE aims to issue recommendations close to the point of licensing wherever possible.