Primodos: Research
(asked on 5th November 2024) - View Source
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 13 September 2024 to Question 4203 on Primodos: Research, when he expects the Medicines and Healthcare products Regulatory Agency to complete that review; and what steps he is taking to (a) manage potential conflicts of interest and (b) ensure transparency during the review process.
The Medicines and Healthcare products Regulatory Agency (MHRA), together with the wider Government, are committed to reviewing any new scientific evidence since the conclusions of the 2017 independent Expert Working Group, convened by the Commission on Human Medicines (CHM).
As per the commitment to reviewing any new scientific evidence, the MHRA has reviewed the publication by Danielsson et al. For full transparency, the MHRA will present their review at the November 2024 CHM meeting. The meeting will have a number of invited experts, including the papers authors, who are invited to give a presentation on their paper and address any questions from the CHM. Mrs Marie Lyon has also been invited to participate as an expert patient, as a representative of the Association For Children Damaged by Hormone Pregnancy Tests. The CHM will give their opinion, and the MHRA will then act upon the CHM’s advice if required. Both the MHRA and the CHM have codes of conduct in order to manage potential conflicts of interest.
The MHRA have a Dealing with Staff Conflicts of Interest Policy, where staff must declare all relevant interests on appointment, when they arise and annually, so that they can be discussed, mitigated, or disposed of, or both, as required. Staff cannot hold direct financial interests in the pharmaceutical industry or healthcare, specifically medical device, industries.
The CHM has a Code of Practice on conflicts of interest which applies to chairs, members, co-opted members, and invited observers and experts. The annual declaration of interests made by all chairs and members are published on GOV.UK website. Declarations from members for the day, invited experts, and patient experts are published in the same way as permanent members of the CHM, on the GOV.UK website, and in the committee minutes for transparency reasons. Further information is available on the GOV.UK website, at the following link:
The minutes and outcome of the November CHM discussion will be communicated and made publicly available through the GOV.UK website, at the earliest opportunity.