Asked by: Gordon Marsden (Labour - Blackpool South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the robustness of procedures to avoid conflicts of interest in the setting up of the Expert Working group led by the Medicines and Healthcare Products Agency on the effects of the drug primodos on pregnant women.
Answered by Jackie Doyle-Price
The Medicines and Healthcare products Regulatory Agency has a clearly defined, published policy on conflicts of interest for members of its scientific advisory committees and groups. This policy has been in place for a number of years and defines the level of participation of experts in the Commission on Human Medicines (CHM) and its Expert Groups.
Prior to being appointed to the CHM Expert Working Group (EWG) on Hormone Pregnancy Tests, all those invited to participate were required to complete and sign a declaration of interests form. At each meeting, experts were asked to declare any new interests. Experts with declared interests were precluded from participating in the EWG’s decision-making. Specific consideration was given to any concerns raised during the review and, in one case, led to one invited expert stepping down from the group before any scientific data were reviewed, even though the interest (a consultancy) had lapsed. All declared interests have been published.
In relation to the terms of reference of the EWG, an association between Hormone Pregnancy Tests and birth defects had long been the subject of debate, but the nature of any association remained uncertain. The EWG was formed specifically to review all the available evidence on the possible association between Hormone Pregnancy Tests during pregnancy and birth defects and reach a conclusion as to whether or not it supported a causal association. The terms of reference of the Expert Working Group on Hormone Pregnancy Tests defined the scope of the review, not the conclusion of the group, and did not change.
Asked by: Gordon Marsden (Labour - Blackpool South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what discussions his (a) Ministers and (b) officials have had with the (i) Medicines and Healthcare Regulatory Agency and (ii) members of the Expert Working Group on the review of hormone pregnancy tests (primodos) on why that Working Group changed the terms for that review from looking for an association to looking for a causal link as to the effect of the drugs concerned on the women it was given to.
Answered by Jackie Doyle-Price
The Medicines and Healthcare products Regulatory Agency has a clearly defined, published policy on conflicts of interest for members of its scientific advisory committees and groups. This policy has been in place for a number of years and defines the level of participation of experts in the Commission on Human Medicines (CHM) and its Expert Groups.
Prior to being appointed to the CHM Expert Working Group (EWG) on Hormone Pregnancy Tests, all those invited to participate were required to complete and sign a declaration of interests form. At each meeting, experts were asked to declare any new interests. Experts with declared interests were precluded from participating in the EWG’s decision-making. Specific consideration was given to any concerns raised during the review and, in one case, led to one invited expert stepping down from the group before any scientific data were reviewed, even though the interest (a consultancy) had lapsed. All declared interests have been published.
In relation to the terms of reference of the EWG, an association between Hormone Pregnancy Tests and birth defects had long been the subject of debate, but the nature of any association remained uncertain. The EWG was formed specifically to review all the available evidence on the possible association between Hormone Pregnancy Tests during pregnancy and birth defects and reach a conclusion as to whether or not it supported a causal association. The terms of reference of the Expert Working Group on Hormone Pregnancy Tests defined the scope of the review, not the conclusion of the group, and did not change.
Asked by: Gordon Marsden (Labour - Blackpool South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, for what reasons his Ministers declined to meet with members of the All Party Parliamentary Group on hormone pregnancy tests to discuss the scientific review set up to consider the effects of the drug primodos on pregnant women.
Answered by Jackie Doyle-Price
In November 2017 the Expert Working Group established by the Commission on Human Medicines to review hormone pregnancy tests concluded that the available evidence did not support a causal association with adverse pregnancy outcomes. At that time the Government made a commitment to evaluate carefully any new evidence. In February 2018 the Government asked Baroness Cumberlege to undertake a review into patients’ concerns and how these were responded to, and to advise what further action may be required.
Since then, a new ad hoc Expert Group of the Commission on Human Medicines has been convened to consider the recent meta-analysis published by Heneghan et al. of clinical studies. An independent review of this publication is also being conducted in parallel by the European Medicines Agency via a formal referral under European Union legal provisions. Both of these scientific reviews are ongoing and the conclusions will be made public when complete, likely in May.
While the review by Baroness Cumberlege into what further action may be required in the case of hormone pregnancy tests is ongoing, and pending the findings of the scientific reviews of Heneghan et al., the Government considers that it would be premature to have a further meeting with the All Party Parliamentary Group.
Asked by: Gordon Marsden (Labour - Blackpool South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what the average waiting time for patients to see their GP in the Blackpool NHS Clinical Commissioning Group has been for non-emergency appointments (a) between June and September 2018, (b) between October and December 2018, (c) in January 2019 and (d) in February 2019.
Answered by Caroline Dinenage
A table showing the time between booking an appointment with a general practice and having the appointment (in days) for Blackpool Clinical Commissioning Group (CCG) for June – September 2018 (inclusive), October – December 2018 (inclusive) and January 2018 only is attached. There are seasonal variations in the general practitioner (GP) appointment data therefore a 12-month average (February 2018-January 2019) is also presented. NHS Digital’s ‘Appointments in General Practice’ data is published monthly with a two-month time lag. Data covering February 2019 will be published on the NHS Digital website on 4 April 2019 and will include a regional breakdown by sub-region, sustainability and transformation partnership and CCG.
It is not possible to differentiate the time between booking an appointment and having the appointment by healthcare professional, therefore the data includes appointments with GPs and other practice staff. The appointments data does not differentiate between emergency and routine appointments in general practice and the ‘time from booking to appointment’ does not take into consideration that many patients will be appropriately booking ahead as part of the continuity of care they receive for long-term conditions.