Lord Alton of Liverpool – 2016 Parliamentary Question to the Department of Health
The below Parliamentary question was asked by Lord Alton of Liverpool on 2016-04-26.
To ask Her Majesty’s Government, further to the Written Answer by Earl Howe on 17 March 2015 (HL5319) and by Lord Prior of Brampton on 25 April (HL7391), how the incidence of ovarian hyperstimulation syndrome (OHSS) has been substantially reduced as a result of changes introduced by the HFEA since the publication of the McCracken Report in accordance with recommendations 10 and 11 and in the light of paragraphs 4.40 and 4.44; and what assessment they have made of the extent to which the lack of reporting by the HFEA of any adverse incidents to the Medicines and Healthcare products Regulatory Agency has mitigated the risks of OHSS.
Lord Prior of Brampton
The Human Fertilisation and Embryology Authority (HFEA) has advised that Ovarian HyperStimulation Syndrome (OHSS) is primarily a matter for clinical judgement and professional standards. The responsibility for reporting adverse reactions in accordance with the Human Medicines Regulations 2012 rests with clinics and the treating clinician. The number of serious adverse incidents of OHSS reported to the HFEA in each of the three years 2010-2012 was approximately 60. In 2013 it was 46, and in 2014 it was 42. Figures for 2015 will be published in September 2016.
Where the HFEA is made aware of information relevant to the regulatory functions of the Medicines and Healthcare products Regulatory Agency, the information is shared between the two organisations.
Recommendations 10 and 11 of the McCracken Report relate to a variety of issues not just OHSS. The HFEA has advised that its strategy for 2014–2017 fulfils these recommendations.
