Medicines and Healthcare Products Regulatory Agency

Neil Duncan-Jordan Excerpts

Thursday 16th January 2025 Commons Chamber

[Neil Duncan-Jordan (Poole) (Lab)]

I thank the right hon. Member for Tatton (Esther McVey) for securing this important debate. My interest in the issue stems from the fact that one of my constituents, Barbara Manning, was affected by Primodos, and, along with the tireless campaigner Marie Lyon—who has already been mentioned today—has been seeking justice ever since.

For the benefit of Members who do not know this, let me explain that between 1958 and 1978, Primodos was a hormone pregnancy test that was given to about 1.5 million women in the form of pills. It was taken off the market in 1978 amid concerns about the effect on the unborn children of those who were pregnant, but the link has never been formally recognised by regulators or the manufacturer. Some research at the time suggested that there might be an association between the drug and miscarriages, and babies born with shortened limbs, abnormalities in their internal organs, brain damage and heart defects. Many of those children died before reaching adulthood, and of those still alive, some are blind, deaf and brain-damaged.

In 2017, a report from an expert working group of the Commission on Human Medicines concluded that there was no causal association between Primodos and severe disabilities in babies, but there are real concerns about the conflict of interests involving some of those on the expert working group and their connections to the big pharmaceutical companies involved in the scandal.

On 8 July 2020, Baroness Cumberlege published her in-depth findings on how the health system responds to reports from patients about harmful side effects from medicines and medical devices. On the MHRA, she said:

“A regulator must work both for patients and with them. This hasn’t been the case in the past. We are recommending that the regulator of medicines and medical devices… is overhauled. It needs to change and radically improve the way that concerns about medicines and devices are detected and acted upon. The regulation of devices in particular needs urgent change. The MHRA needs to engage more with patients and track how medicines and devices improve—or fail to improve—patients’ health and quality of life. It needs to raise public awareness of its role and it needs to ensure that patients have a core role in its work.”

The review also concluded that the state and manufacturers have a moral responsibility to provide ex gratia payments to those families who have experienced avoidable harm due to their failure to remove Primodos from the market.

The duty of the regulator was to protect women. It chose to protect the manufacturer instead. Thousands of women and unborn children were exposed to a risk that was widely acknowledged at the time. That should not have happened. It now falls to us to put right that injustice, to persuade the manufacturer to pay compensation to those affected families and to reform the regulatory system, so that it protects patients in the future.