Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 20 December to Question 88624 and the Answer of 28 February 2022 to Question 127264 on Coronavirus: Ivermectin2, what the decision making process was for the Ivermectin being (a) entered into the PRINCIPLE clinical trial and (b) made the subject of monitoring by the Therapeutics Taskforce; and for what reason it an application for licensing authorisation for the use of Ivermectin in the treatment of patients with covid-19 has to be made to the MHRA before it (i)conducts a safety, efficacy and quality review and (ii) consults the Commission on Human Medicines.

Ivermectin has been a controversial drug throughout the pandemic, with many clinicians prescribing globally with no clear evidence to demonstrate there is a benefit. Taking this into consideration and the need to generate evidence on ivermectin’s efficacy in the treatment for COVID-19, the PRINCIPLE trial investigators determined that its inclusion would provide further information. Many of the outcomes of clinical trials, such as RECOVERY, have shown that such treatments are ineffective, which informs our understanding.

Should the ivermectin arm of the PRINCIPLE trial produce positive outcomes, an application may be submitted to the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA must assess the company’s compliance with Human Medicines Regulation requirements, including pre-clinical and clinical trials, manufacturing and pharmacovigilance legislation requirements and the manufacture of a product to determine its safety, quality, or efficacy, including input from the Commission on Human Medicines. A marketing authorisation application for the license of a medicinal product must be submitted by a legal entity registered with Companies House, as holding a marketing authorisation includes legal responsibilities.