Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
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 the reasons why tests on Primodos, which remained on the market until 1978 despite the publication of a study in 1967 indicating a causal relationship between hormonal pregnancy tests and congenital abnormalities, were not ordered by the Committee for the Safety of Medicines under the Medicines Act 1971.
Answered by Lord O'Shaughnessy
The terms of reference of the Expert Working Group on Hormonal Pregnancy Tests are focused on a scientific review of the strength of evidence for a possible association between exposure in pregnancy to hormonal pregnancy tests and adverse outcomes in pregnancy. An important part of the Group’s work 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.
Records show that the Committee on Safety of Drugs (subsequently the Committee on Safety of Medicines) carefully considered the results of the 1967 study and considered the methodology to be flawed.
In 1969, the Committee on Safety of Drugs requested the manufacturers of hormonal pregnancy tests to provide all relevant laboratory data and initiated their own long-term study of maternal drug histories in mothers of children with birth defects. In 1970, the Standing Committee on the Classification of Proprietary Medicines (the ‘MacGregor Committee’) asked Schering, the then licence holder, to remove ‘diagnosis of pregnancy’ from the indications for Primodos.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty’s Government what assessment they have made of the Sky News documentary <i>Primodos: The Secret Drugs Scandal</i>; and whether they will consider establishing a public inquiry into the alleged failure of the regulator at that time to protect public safety.
Answered by Lord O'Shaughnessy
An Expert Working Group of the Commission on Human Medicines is conducting a comprehensive scientific review on the evidence for a possible causal association between Hormone Pregnancy Tests (HPTs), including Primodos, and birth defects. Any important new evidence identified in the Sky News documentary will be reviewed by the Medicines and Healthcare products Regulatory Agency and provided to the Expert Working Group for their consideration and advice.
While the evidence for any association between HPTs and congenital defects is still under consideration it would be premature to comment on the need for a public inquiry.
The Government is not providing any funding to researchers in Cambridge or Aberdeen who are examining the composition of the drug Primodos and its likely effects on the child in the womb.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty’s Government, further to the Written Answers by Earl Howe on 26 October 2010 (HL2589, HL2591, HL2592, and HL2593) concerning the drug Primodos, and to the remarks by the Parliamentary Under Secretary of State for Health on 23 October 2014 (HC Deb 1139) concerning oral hormone pregnancy tests, and in the light of the Sky News documentary <i>Primodos: The Secret Drugs Scandal</i>, what progress has been made on the independent review of the papers and evidence relating to oral hormone pregnancy tests; what assessment that review has made of the decision by the Committee on Safety of Medicines to ask drug companies to stop promoting pregnancy test drugs to doctors in 1969 but not to advise doctors not to use such drugs until 1975; and whether that review will examine the allegations made in the Sky News documentary, in particular (1) that no toxicology or testing was undertaken prior to the drug Primodos being licensed, (2) that Primodos was being used as an abortifacient in some parts of the world whilst being sold in the UK for the purposes of pregnancy testing, and (3) that there may have been collusion between the drug manufacturer and the regulatory bodies.
Answered by Lord O'Shaughnessy
Primodos, a hormonal pregnancy test, first became available in the 1950s. At that time there were no legal requirements on companies to ensure that marketed medicines met appropriate standards of safety, quality and efficacy and a licence to market was not required. Any studies performed on a medicine prior to its use were at the discretion of the company. The Medicines Act came into force in 1971.
The terms of reference of the Expert Working Group on Hormonal Pregnancy Tests, adopted by its members and agreed with by the chair of the main patient association in her role as an ‘observer’ on the Group, are focused on a scientific review of the strength of evidence for a possible association between exposure in pregnancy to hormonal pregnancy tests and adverse outcomes in pregnancy (particularly birth defects, miscarriages and stillbirths). The Group’s terms of reference also include what lessons may be learnt for further improving existing regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy.
Asked by: Baroness Tonge (Non-affiliated - Life peer)
Question to the Department for International Development:
To ask Her Majesty’s Government what financial support they are planning to provide for family planning and sexual and reproductive health and rights in Sierra Leone over the next five years.
Answered by Lord Bates
DFID is working with the Government of Sierra Leone, NGOs and the UN to tackle the high levels of maternal mortality and teenage pregnancy in Sierra Leone. This is a top priority of our £150million Saving Lives Programme which, over the next five years, aims to save the lives of 2,000 women and provide family planning for more than 134,000 women and girls. Activities include upgrading obstetric facilities, training nurses and midwives, developing a teenage pregnancy reduction strategy and providing essential life-saving drugs. We are also setting up adolescent-friendly sexual and reproductive health services; and working with communities to increase the use of family planning services.
Asked by: Baroness Tonge (Non-affiliated - Life peer)
Question to the Department for International Development:
To ask Her Majesty’s Government what support the UK will provide to Sierra Leone over the next five years to promote women and girls' sexual and reproductive health and rights.
Answered by Lord Bates
DFID is working with the Government of Sierra Leone, NGOs and the UN to tackle the high levels of maternal mortality and teenage pregnancy in Sierra Leone. This is a top priority of our £150million Saving Lives Programme which, over the next five years, aims to save the lives of 2,000 women and provide family planning for more than 134,000 women and girls. Activities include upgrading obstetric facilities, training nurses and midwives, developing a teenage pregnancy reduction strategy and providing essential life-saving drugs. We are also setting up adolescent-friendly sexual and reproductive health services; and working with communities to increase the use of family planning services.
Asked by: Richard Burgon (Labour - Leeds East)
Question to the Ministry of Justice:
To ask the Secretary of State for Justice, how many prison officers have taken long-term sick leave and for what reasons in each of the last five years.
Answered by Sam Gyimah
Dedicated prison staff work in an extremely challenging environment in which, on a daily basis, they face unique circumstances unlike most others in the public sector.
We have announced a major shake-up of the prison system with 2,500 extra prisons officers and new security measures to tackle drones, phones and drugs and help make prisons places of safety and reform.
The safety, welfare and wellbeing of our staff is a top priority and we will always ensure prisons have enough staff to run safely and securely.
Long-term sick leave is defined within the Civil Service as periods of absence of more than 28 calendar days. The number of Band 3-5 prison officers to have taken long-term sick leave between 2010/11 and 2014/15 is available in the answer to PQ 37734. Data for 2015/16 is provided below.
Instances1,2 of Long Term Absence Amongst Band 3 to 5 Prison Officers
2015/16
International Classification of Diseases Category | 2015/16 |
Mental and Behavioural Disorders | 852 |
Musculoskeletal System | 500 |
Injury and Poisoning | 344 |
Digestive System | 102 |
Circulatory System | 84 |
Nervous System and Sense Organs | 44 |
Genitourinary System | 28 |
Infective and Parasitic Diseases | 43 |
Respiratory System | 38 |
Neoplasms | 32 |
Pregnancy Complications | 25 |
Skin and Subcutaneous Tissue | 18 |
Eye and Adnexa | 8 |
Endocrine, Nutritional and Metabolic Diseases | 4 |
Ear and Mastoid Process | 9 |
Symptoms Ill-Defined | 627 |
|
|
Blank / Unknown3 | 220 |
Total Cases | 2,978 |
Notes:
1 Where an officer has two or more periods of absence for the same reason within a year they are counted as one, where the reasons differ they are counted separately.
2 absences that straddle two years are counted in each year.
3 also includes reasons where small numbers (2 or fewer) would otherwise be supressed for data protection reasons.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty’s Government, further to the Written Answer by Earl Howe on 3 December 2014 (HL2977), (1) what records are maintained by the Human Fertilisation and Embryology Authority (HFEA) regarding (a) any drugs given during the follicular and implantation phases or early pregnancy, (b) the use of EmbryoScope or other forms of time-lapse video microscopy, (c) the use of EmbryoGlue, (d) the use of calcium activation, and (e) the use of intracytoplasmic morphologically selected sperm injection; (2) whether additional powers are required to enable the HFEA to collect the data necessary to protect patients and embryos and, if so, what steps they plan to take to remedy this; and (3) how the HFEA ensures that additional interventions do not lead to epigenetic errors and future health risks.
Answered by Baroness Chisholm of Owlpen
As stated in the Written Answer by Earl Howe on 3 December 2014 (HL2977), the Human Fertilisation and Embryology Authority (HFEA) does not regulate the administration of drugs and, therefore, does not collect such data. However, the HFEA does collect information on whether stimulation was used in in-vitro fertilisation, intracytoplasmic sperm injection and donor insemination treatment cycles. The HFEA currently collects information on whether assisted hatching was used.
The HFEA has advised that as it does not regulate the administration of drugs, surgical procedures or laboratory equipment, it does not collect data on the interventions listed in the noble Lord’s question.
The HFEA has also advised that it has sufficient powers to collect the data necessary to perform its regulatory functions, as set out in the Human Fertilisation and Embryology Act 1990.
The HFEA’s Scientific and Clinical Advances Advisory Committee regularly reviews the evidence of effectiveness and safety of a number of interventions, commonly described as treatment add-ons.
Asked by: Robert Flello (Labour - Stoke-on-Trent South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, with reference to the Care Quality Commission report, British Pregnancy Advisory Service, BPAS-Richmond, Quality Report, published in November 2015, what steps his Department is taking to improve safety in abortion clinics.
Answered by Jane Ellison
The termination of pregnancies is a regulated activity. All providers of regulated activities must be registered with the Care Quality Commission (CQC) and must meet all of the relevant Regulations under the Health and Social Care Act 2008, including meeting the fundamental standards of quality and safety, which includes independent sector termination of pregnancy providers and managers. The CQC is responsible for monitoring and, where appropriate, inspecting providers in relation to their ongoing compliance with meeting those requirements. Independent sector providers are also required to comply with the Department’s Required Standard Operating Procedures which the CQC inspect against.
The CQC has made a public commitment to undertake inspection of all independent providers of termination of pregnancy services using their new inspection approach and will continue to respond to risk as appropriate and take regulatory action as required.
On the issue of whether the Department plans to issue guidance to abortion clinics on consultation on disposal arrangements following termination, I refer the hon. Member to the answer I gave on 11 April 2016 to Question 32357.
We have no plans to issue guidance to abortion clinics on the administration of drugs. The administration of drugs is managed through the CQC’s fundamental standards and through inspection visits.
Asked by: Robert Flello (Labour - Stoke-on-Trent South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, with reference to the Care Quality Commission report, British Pregnancy Advisory Service, BPAS-Richmond, Quality Report, published in November 2015, whether his Department plans to issue guidance to abortion clinics on consultation on disposal arrangement following terminations.
Answered by Jane Ellison
The termination of pregnancies is a regulated activity. All providers of regulated activities must be registered with the Care Quality Commission (CQC) and must meet all of the relevant Regulations under the Health and Social Care Act 2008, including meeting the fundamental standards of quality and safety, which includes independent sector termination of pregnancy providers and managers. The CQC is responsible for monitoring and, where appropriate, inspecting providers in relation to their ongoing compliance with meeting those requirements. Independent sector providers are also required to comply with the Department’s Required Standard Operating Procedures which the CQC inspect against.
The CQC has made a public commitment to undertake inspection of all independent providers of termination of pregnancy services using their new inspection approach and will continue to respond to risk as appropriate and take regulatory action as required.
On the issue of whether the Department plans to issue guidance to abortion clinics on consultation on disposal arrangements following termination, I refer the hon. Member to the answer I gave on 11 April 2016 to Question 32357.
We have no plans to issue guidance to abortion clinics on the administration of drugs. The administration of drugs is managed through the CQC’s fundamental standards and through inspection visits.
Asked by: Robert Flello (Labour - Stoke-on-Trent South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, with reference to the Care Quality Commission report, British Pregnancy Advisory Service, BPAS-Richmond, Quality Report, published in November 2015, whether his Department plans to issue guidance to abortion clinics on the administration of drugs.
Answered by Jane Ellison
The termination of pregnancies is a regulated activity. All providers of regulated activities must be registered with the Care Quality Commission (CQC) and must meet all of the relevant Regulations under the Health and Social Care Act 2008, including meeting the fundamental standards of quality and safety, which includes independent sector termination of pregnancy providers and managers. The CQC is responsible for monitoring and, where appropriate, inspecting providers in relation to their ongoing compliance with meeting those requirements. Independent sector providers are also required to comply with the Department’s Required Standard Operating Procedures which the CQC inspect against.
The CQC has made a public commitment to undertake inspection of all independent providers of termination of pregnancy services using their new inspection approach and will continue to respond to risk as appropriate and take regulatory action as required.
On the issue of whether the Department plans to issue guidance to abortion clinics on consultation on disposal arrangements following termination, I refer the hon. Member to the answer I gave on 11 April 2016 to Question 32357.
We have no plans to issue guidance to abortion clinics on the administration of drugs. The administration of drugs is managed through the CQC’s fundamental standards and through inspection visits.