Primodos

Department of Health written question – answered on 6th April 2017.

Alert me about debates like this

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

To ask Her Majesty’s Government, further to the Written Answer by Lord O’Shaughnessy on 28 March (HL6261), whether they will meet with Marie Lyon and representatives of the Primodos victims support group.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

To ask Her Majesty’s Government, further to the Written Answer by Lord O’Shaughnessy on 28 March (HL6261), whether the Expert Working Group on Hormonal Pregnancy Tests will review (1) the terms of reference of (a) the Committee on the Safety of Medicines, and (b) the Metabolic Research Unit, when determining what lessons may be learnt for further improving existing regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy, (2) the need to assemble and assess reports of adverse reactions to drugs trials, and (3) how ministers should be advised of the outcomes of those trials.

Photo of Lord O'Shaughnessy Lord O'Shaughnessy The Parliamentary Under-Secretary of State for Health, Lord in Waiting (HM Household) (Whip)

One of the terms of reference of the Expert Working Group on Hormonal Pregnancy Tests is to consider what lessons may be learnt for further improving existing regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy. The regulatory, legal and social landscape has changed significantly since hormonal pregnancy tests were on the market; many of these changes have been driven by previous experience. The Group will consider the processes and tools that were available to the United Kingdom regulator when hormonal pregnancy tests were on the market and make recommendations for any changes necessary to further improve the capability of current regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy. This will include all aspects of medicines regulation, from the assessment of safety pre-authorisation to communication of an identified risk.

There has been continued engagement with the Association for Children Damaged by Hormonal Pregnancy Tests throughout the Expert Working Group review process. I am meeting the All Party Parliamentary Group on Hormone Pregnancy Tests and representatives of the Association in the near future.

Does this answer the above question?

Yes0 people think so

No0 people think not

Would you like to ask a question like this yourself? Use our Freedom of Information site.