Question to the Department of Health and Social Care:

To ask Her Majesty’s Government what is their assessment of the efficacy of the drug lanosterol in reducing cataracts.

The drug Lanosterol is not licensed for human use in the United Kingdom.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the licensing of medicinal products according to legislation set out in European Directive 2001/83 EC. The MHRA's primary aim is the protection of public health, for which an important objective is assessing the safety, quality and efficacy of medicines, and authorising their sale or supply in the UK for human use.

A medicine can only become licenced if an application is made to the MHRA for a licence, usually by the manufacturer, demonstrating that the product meets the required standards of safety, quality and efficacy. In their role as a regulator, the MHRA is not in a position to hold product licences or to solicit for new product licence applications.

There has been no evidence submitted to MHRA to support the use of Lanosterol in humans at present. There have been no applications for UK clinical trials or marketing authorisations for this product.

Under their terms of service, general practitioners and hospital doctors are allowed to prescribe any medicinal product, including any unlicensed medicinal product, which they consider necessary for the treatment of their patients and under their clinical responsibility. They should always satisfy themselves that the medicinal products or other substances they consider appropriate for their patients can be safely prescribed, that patients are adequately monitored and that, where necessary, expert hospital supervision is available. We would expect clinicians to also seek informed consent from their patients on the basis that there are risks associated with using an unlicensed medicine as well as potential therapeutic benefit(s). Patients should also be informed that the licensing assessment of the medicine for unlicensed use will not have taken place.