Steve Brine MP

for Winchester & Chandler's Ford

23 FEB 2018

MP welcomes Medicines and Medical Devices Safety Review

Steve Brine has warmly welcomed a landmark review into long-standing patient concerns around sodium valproate, vaginal mesh and Primodos, announced by Health Secretary Jeremy Hunt.

All three issues will be re-examined by an independent Chair, Baroness Cumberlege, a well-known campaigner on women's health issues, with specific expertise in maternity. She will lead a nine month wide-ranging review into all three issues, and Mr Hunt has said he is determined that she has a completely free hand to examine all concerns, past processes, and evidence.

Public Health Minister Steve Brine said: "This is very good news, and I am sure that Baroness Cumberlege will conduct a thorough review.

"I am also pleased that we are taking immediate steps on each of these three issues. On Primodos, a hormone-based pregnancy test, which is claimed to have led to miscarriages and birth defects during the 1960s and 70s and was prescribed to more than 1.5 million women before it was withdrawn from use in 1978, we will be offering a full up-to-date genetic clinical evaluation to families of the Association for Children Damaged by Hormone Pregnancy Tests whose lives have been impacted by adverse pregnancy outcomes and who were given HPTs to diagnose pregnancy.

"We will also be setting up a new Working Group to advise on better ways to collect, monitor and use data on the safety of medicines during pregnancy, and make Electronic Yellow Card reporting available at the point of care, including at scanning in early pregnancy, to all those who suspect an adverse outcome of pregnancy in association with exposure to any medicine in pregnancy.

"In addition, we'll ask for regular, independent reviews by experts of all suspected adverse drug reactions in pregnancy that are reported by healthcare professionals and women in the UK to the Medicines and Healthcare products Regulation Agency, and develop specific guidance for regulators and the pharmaceutical industry, while ensuring there is stronger and more joined up messaging on safety; and providing better training and support for obstetricians in pharmacology to ensure they are best equipped to address the needs of their patients.

"On sodium valproate, the outcome of the EU review expected in March will strengthen our regulatory position but in preparation, we have tasked system leaders with delivering a rapid, coordinated response, directly responding to calls from patients, including introducing a new warning symbol on valproate packaging, updating NICE guidance on valproate, pushing for Valproate to be contraindicated for women of childbearing potential not using effective contraception, strengthening alerts across all GP systems and community pharmacy systems. In addition, for those women for whom valproate is an effective treatment, offering stronger and more tailored advice on risks and contraception."

"On vaginal mesh, the Health Secretary has asked the Chief Medical Officer for advice in light of calls for a full ban. She has been clear that clinical experts here and abroad agree that, when used appropriately, 'many women gain benefit from this intervention', and hence a full ban is not the right answer in the light of the current evidence available.

"However, we fully recognise that this is not to minimise the suffering many women have experienced, which is why Jeremy Hunt announced that we will be publishing a retrospective audit to investigate the links between patient-level data to explore outcomes, as well as investing £1.1m to develop a comprehensive database for vaginal mesh to improve clinical practice and identify issues."

The Health Secretary also said that it has become clear that too many patients struggle to have their voice heard when they attempt to raise concerns like this, so he has also asked Baroness Cumberlege to consider whether we need a new independent body to advise Ministers on the appropriate course of action in cases of patient concern, ranging from local investigations, to independent inquiries to full statutory public inquiries.

Mr Hunt said: "Too many families have had insult added to injury through a closed and defensive response to genuine concerns over many years, and I am determined that we put this right."

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Written Answers — Department of Health and Social Care: Ministry of AYUSH (25 Jul 2018)
Steve Brine: The Department has no plans to hold any such discussions and does not maintain a position on any particular complementary or alternative medicine treatments.

Written Answers — Department of Health and Social Care: Poverty: Life Expectancy (25 Jul 2018)
Steve Brine: Chapter Four of The Health Profile for England, published in July 2017, presents data comparing the life expectancy for the United Kingdom with that of other European countries for 2015. Chapter 4: European comparisons is available at the following link: https://www.gov.uk/government/publications/health-profile-fo r-england/chapter-4-european-comparisons

Written Answers — Department of Health and Social Care: General Practitioners: Waiting Lists (25 Jul 2018)
Steve Brine: The average waiting time for a general practitioner (GP) appointment is not collected or held centrally. In the 2017 GP patient survey 70.8% of respondents (who could remember whether or not they were able to get an appointment, and when they wanted the appointment) stated they saw or spoke to someone at a time they wanted to or sooner. NHS England is working with NHS Digital to consider ways...


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Call your MP in his Commons office on 0207 219 7189 or email steve.brine.mp@parliament.uk

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