To make a medicinal product available for sale in a pharmacy without a prescription, the product must be reclassified to pharmacy only status, also known as [P] medicines, by the Medicines and Healthcare products Regulatory Agency (MHRA).

This process is triggered by an application submitted to the MHRA by a company which holds a licence for the particular product. The MHRA will consider all submitted applications, with a decision to reclassify a medicine reached following a robust evaluation of the relevant data, including evidence of the safe use and supply of the product without a prescription. The company must also demonstrate in their application that the criteria specified in relevant legislation, such as the Human Medicines Regulations 2012, have been met.

In accordance with the Human Medicines Regulations 2012, regulation 62(3), Prescription-Only Medicine status will apply where: a direct or indirect danger exists to human health, even when used correctly, if used without medical supervision; there is frequently incorrect use, which could lead to direct or indirect danger to human health; further investigation of the activity or side-effects is required; or the product is normally prescribed for parenteral administration, via injection.

Currently, United Kingdom law specifies that all products administered by injection must be subject to a prescription. The MHRA is therefore unable to reclassify the status of injections, including Vitamin B12, to [P] medicines, as this would not be consistent with the legislation.

The Department commissions research through the National Institute for Health and Care Research (NIHR). The NIHR is not currently supporting pharmaceutical companies or research specifically on injectable vitamin B12.

The NIHR welcomes funding applications for research into any aspect of human health, including injectable vitamin B12. Applications are subject to peer review and judged in open competition, with awards being made based on the importance of the topic to patients and health and care services, value for money and scientific quality.

The Department welcomes the All-Party Parliamentary Group report. We are taking steps to ensure that funders work closely together to coordinate work along the translational pathway, from the discovery and early translational science typically supported by the MRC, feeding through to the applied health and care research funded by the NIHR.

It is not usual practice to ring-fence funds for particular topics or conditions. As with other Government funders of health research, the NIHR does not allocate funding for specific disease areas. The level of research spend in a particular area is driven by factors including scientific potential and the number and scale of successful funding applications.

NIHR is taking action to help researchers develop high-quality proposals, including working with the Tessa Jowell Brain Cancer Mission on workshops and courses for applications in development. Similarly, the NIHR Research Support Service will support researchers applying for funding with expert advice, to help them develop the best funding applications.

To support healthcare professionals in the early diagnosis and management of inflammatory bowel disease, including Crohn’s disease and ulcerative colitis, the National Institute for Health and Care Excellence (NICE) has produced a range of guidance, including guidance specifically on the use of faecal calprotectin tests as a way of diagnosing inflammatory bowel disease (IBD). NICE’s IBD quality standard outlines that referral to a specialist assessment for suspected IBD should be within four weeks.

NICE guidelines represent best practice and health professionals, including general practitioners, and service commissioners are expected to take them fully into account. Guidelines published by NICE are not mandatory and do not replace the judgement of clinicians in determining the most appropriate treatment for individual patients.

In addition, NHS England’s Getting it Right First Time (GIRFT) specialty report on gastroenterology, published in September 2021, sets out actions and recommendations for the National Health Service to improve patient care and ensure consistency of care across the country.

It is the responsibility of integrated care boards to make available appropriate provision to meet the health and care needs of their local population, including the diagnosis and management of IBD.

To support healthcare professionals in the early diagnosis and management of inflammatory bowel disease, including Crohn’s disease and ulcerative colitis, the National Institute for Health and Care Excellence (NICE) has produced a range of guidance, including guidance specifically on the use of faecal calprotectin tests as a way of diagnosing inflammatory bowel disease (IBD). NICE’s IBD quality standard outlines that referral to a specialist assessment for suspected IBD should be within four weeks.

NICE guidelines represent best practice and health professionals, including general practitioners, and service commissioners are expected to take them fully into account. Guidelines published by NICE are not mandatory and do not replace the judgement of clinicians in determining the most appropriate treatment for individual patients.

In addition, NHS England’s Getting it Right First Time (GIRFT) specialty report on gastroenterology, published in September 2021, sets out actions and recommendations for the National Health Service to improve patient care and ensure consistency of care across the country.

It is the responsibility of integrated care boards to make available appropriate provision to meet the health and care needs of their local population, including the diagnosis and management of IBD.