14 November 2022: Raine - B

Questioning returned to issues of data not being recorded which would be considered important to know. There is an expectation that better data collection will be used after the Medicines and Medical Devices Act. An example came up about a womens’ healthcare need and it was highlighted that it was women themselves who had seen this and brought it to greater awareness. Counsel asked why it took the women themselves to get movement on the issue. Part of the problem was down to a lack of joined up information sharing.

Counsel referred to the recent evidence of Prof Iain Roberts and the opportunities for greater use of Tranexamic Acid. The witness confirmed contact via a Minister in 2018. She committed to explore this further with Prof Roberts. As a regulator, the MHRA has limited scope to change use of a medication. The witness was asked, then, who did have control sufficient to make the necessary changes. The witness spoke about the Royal Colleges and NICE.

The possibility of a product being licenced if it was known to carry a viral risk was raised. The witness said it would be hard to imagine or justify.

Finally, Counsel asked what the main changes the witness had seen over her long career in medicines regulation. “The involvement of patients” was the first response. She then briefly mentioned how uniquely important this perspective was in the regulatory process. She also mentioned the advances in technology and the capacity it provides for enhanced analysis of data. The matter of precaution and risk was a third issue raised, including the differences in the assessment of risk by clinicians compared to patients.

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