The Government cannot comment on individual legal cases, but we are committed to access to justice at proportionate cost. There are several mechanisms that can reduce the legal costs involved in pursuing a civil claim. Whether any are available to a claimant would depend on the specifics of the claim.

Claimants may be able enter into an agreement with a lawyer using a Conditional Fee Agreement or Damages Based Agreement, or with a third party funder using a Litigation Funding Agreement. Such agreements usually mean that a claimant will not have to pay all or part of their own legal costs unless they win their case.

Claimants may be able to take out Legal Expenses Insurance and After the Event insurance to mitigate some of the financial risks associated with litigation. Such insurance would usually cover adverse legal costs, where the losing party in a claim is ordered to pay the legal costs of the other side.

Fixed Recoverable Costs are also applicable to most civil cases in the Fast and Intermediate Tracks. These allow parties to know in advance what adverse costs they would be liable for if they lose a case. This can help claimants make an informed decision about whether or not to pursue litigation.

Our sympathies remain with those who believe they were harmed by hormone pregnancy tests, such as Primodos.

Recommendation 4 of the Independent Medicines and Medical Devices Safety Review, also known as the Cumberlege Review, specifically mentions hormone pregnancy tests, recommending that separate redress schemes be set up for each of the interventions examined by the Review, namely hormone pregnancy tests, sodium valproate and pelvic mesh. As a follow up to this recommendation, the Patient Safety Commissioner was asked to investigate and provide advice on options for redress for those affected by sodium valproate and pelvic mesh. The Government is carefully considering the Patient Safety Commissioner’s recommendations.

The Patient Safety Commissioner was not asked to look at Primodos as part of this work, because the available scientific evidence does not support a causal association between the use of hormone pregnancy tests such as Primodos and adverse outcomes in pregnancy. The Government is committed to reviewing any new scientific evidence which may come to light.

The review referenced in Question 31168 considered the 2023 publication by Danielsson et al only. The Medicines and Healthcare products Regulatory Agency’s (MHRA) assessment of this publication focussed on new data, which concerned transient embryonic hypoxia and teratogenicity in relation to oral hormone pregnancy tests (HPTs), and has been published at the following link:

https://assets.publishing.service.gov.uk/media/68b0696bf31f3b16cee0e937/Evaluation_of_review_of_transient_embryonic_hypoxia_and_teratogenicity_in_relation_to_oral_hormone_pregnancy_tests__including_Primodos.pdf

This MHRA assessment was considered by the Commission on Human Medicines (CHM) in November 2024. A copy of the minutes of this CHM meeting is attached.

The study referenced by Mr Roland Moyle on 26 May 1978 is titled Maternal drug histories and congenital anomalies, and is authored by Greenberg G, Inman WHW, Weatherall, JAC et al. This was published in the British Medical Journal in October 1977, and is available at the following link:

https://www.bmj.com/content/2/6091/853.abstract

The original Expert Working Group (EWG) convened by the United Kingdom’s CHM to review all available evidence on the possible association between HPTs and adverse outcomes in pregnancy considered the study by Greenberg G referenced above as part of their review.

The EWG reported its findings in November 2017 and concluded that the totality of the available scientific data does not support a causal association between the use of HPTs during early pregnancy and adverse pregnancy outcomes. The EWG report on the use of HPTs and adverse effects relating to pregnancy, including possible birth defects, is published online, at the following link:

https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-hormone-pregnancy-tests

The MHRA remains committed to reviewing any new scientific data which becomes available following the conclusion of the EWG.

A total of £469,613.30 in legal costs, as of the end of May 2025, excluding VAT, has been incurred by the Department of Health and Social Care via the Government Legal Department representing them on the Wilson and others v Bayer Pharma and others case. Another matter, Forshaw, was litigated at the same time where the costs were included within the billing for Wilson, but it is not possible to split the costs on these cases because that data is not available in that format.

Four legal representatives on behalf of the Department and the Medicines and Healthcare products Regulatory Agency (MHRA) attended the hearing in May 2023 at the Royal Courts of Justice, namely a senior Government Legal Department lawyer accompanied by a legal executive, and two Counsel, a King's Counsel and a barrister. There were no attendees from the Department of Health and Social Care or the MHRA.

An Expert Working Group (EWG) of the Commission on Human Medicines reviewed the available evidence on the possible association between hormone pregnancy tests and adverse outcomes in pregnancy. Its review considered all available scientific evidence, including information collected from a public call for evidence.

The purpose of the EWG was to ascertain whether the available data could establish a causal association between the use of hormone pregnancy tests during early pregnancy and adverse pregnancy outcomes.

One publication by Briggs was considered as part of the review of non-clinical evidence of reproductive and developmental toxicity for norethisterone acetate and ethinylestradiol and is therefore referenced on page 97 of this review. This publication is not cited within the text of the report as it did not contribute towards the final paper and its conclusions.

The EWG reported its findings in November 2017 and concluded that the totality of the available scientific data does not support a causal association between the use of hormone pregnancy tests during early pregnancy and adverse pregnancy outcomes.

The Medicines and Healthcare products Regulatory Agency remains committed to reviewing any new scientific data which becomes available following the conclusion of the EWG.

An Expert Working Group (EWG) of the Commission on Human Medicines (CHM) reviewed the available evidence on the possible association between hormone pregnancy tests and adverse outcomes in pregnancy. Its review considered all available scientific evidence, including information collected from a public call for evidence.

The purpose of the EWG was to ascertain whether the available data could establish a causal association between the use of hormone pregnancy tests during early pregnancy and adverse pregnancy outcomes. The EWG reported its findings in November 2017 and concluded that the totality of the available scientific data does not support a causal association between the use of hormone pregnancy tests during early pregnancy and adverse pregnancy outcomes.

The Medicines and Healthcare products Regulatory Agency (MHRA) committed to review any new scientific data which became available following the conclusion of the EWG. Accordingly, two new CHM EWGs were established to review two new studies of hormone pregnancy tests published in 2018. The reviews concluded that they did not present evidence that was sufficient or robust enough change the scientific position since the report of the EWG was published. The MHRA also sought a further independent scientific opinion on these two studies from the European Medicines Agency's Committee for Medicinal Products for Human Use, who concluded that they have no clinical implications.

In November 2024, the publication by Danielsson et al was reviewed by the MHRA and advice has been sought from the Government’s independent advisory body, the CHM. Following their review, the CHM concluded that a further review by an ad hoc EWG was not warranted at this time and supported the MHRA’s conclusion that no new evidence, with respect to a possible association between hormone pregnancy tests and adverse outcomes in pregnancy, was identified.

The MHRA remains committed to reviewing any new scientific evidence which may come to light.

The Government is sympathetic to the families who believe that they have suffered because of using hormone pregnancy tests.

An Expert Working Group of the Independent Commission on Human Medicines (CHM) reviewed the available scientific evidence in 2017 and concluded that the evidence does not support a causal association between the use of hormone pregnancy tests during early pregnancy and adverse pregnancy outcomes. Following a review of the more recent evidence, the CHM concluded in November 2024 that it does not provide any new scientific evidence demonstrating that the medicinal components of hormone pregnancy tests could disrupt a pregnancy.

It is not currently the Government’s intention to review the findings of the Expert Working Group, however we are committed to reviewing any new scientific evidence which may come to light.

Because a causal link between hormone pregnancy tests and adverse outcomes in pregnancy has not been demonstrated, the previous administration did not ask the Patient Safety Commissioner to look at redress for hormone pregnancy tests as part of the Hughes Report.

The Government is hugely sympathetic to the families who believe that they or their children have suffered following the use of hormone pregnancy tests.

The previous administration did not ask the Patient Safety Commissioner, Dr Henrietta Hughes, to look at redress for hormone pregnancy tests as part of the Hughes Report, because a causal link between hormone pregnancy tests and adverse outcomes in pregnancy has not been demonstrated. An Expert Working Group of the independent Commission on Human Medicines reviewed the available scientific evidence in 2017 and concluded that it does not support a causal association. This position was reaffirmed in its most recent review in November 2024. However, we are committed to reviewing any new scientific evidence that comes to light.

The Government is carefully considering the valuable work done by the Patient Safety Commissioner and the resulting Hughes Report, which set out options for redress for those harmed by valproate and pelvic mesh. This is a complex area of work, involving several Government departments, and it is important that we get this right. We will be providing an update to the Patient Safety Commissioner’s report at the earliest opportunity.

The Patient Safety Commissioner was not asked to look at redress for hormone pregnancy tests as part of her recent report. The causal link between the use of hormone pregnancy tests during pregnancy and adverse outcomes in pregnancy has not been demonstrated. However, we are committed to reviewing any new scientific evidence that comes to light.

We remain hugely sympathetic to the families who believe that they or their children have suffered following the use of hormone pregnancy tests.

The Medicines and Healthcare products Regulatory Agency (MHRA), together with wider Government, has committed to reviewing any new scientific evidence which comes to light.

The new publication by Danielsson et al has been reviewed by the MHRA, and advice has been sought from the Government’s independent advisory body, the Commission on Human Medicines (CHM), who have provided their independent expert advice on our assessment of whether the findings of the latest publication justify a further review. The MHRA will consider the recommendations given by the CHM before deciding whether any further action is warranted.

The minutes of the November CHM meeting will be made publicly available through the GOV.UK website at the earliest opportunity.