Dáil Éireann Debate, Tuesday - 25 October 2016
453. Deputy Clare Daly asked the Minister for Health if the recent complaint by a centre (details supplied) regarding maladministration at the European Medicines Agency, EMA, in regard to a drug has been noted by his Department; and if he will make a statement on the matter. [31879/16]
View answerThe HPV vaccine, which was introduced in 2010, protects girls from cervical cancer when they are adults. It is available free of charge from the HSE for all girls in the first year of secondary school. Each year in Ireland around 300 women are diagnosed with cervical cancer and there are approximately 70 deaths per year. The HPV vaccine protects against two high risk types of HPV that cause 73% of all cervical cancers.
I am aware of claims of an association between HPV vaccination and a number of conditions experienced by a group of young women. I want to provide assurances to these young women and their families that they are eligible to seek medical attention and to access appropriate health and social care services, irrespective of the cause of their symptoms. The HSE are currently developing a care pathway for young people who are experiencing these types of symptoms and will be in a position to facilitate access to specialist services tailored to the needs of each individual.
It appears that some girls first suffered symptoms around the same time that they received the HPV vaccine, and understandably some parents have connected the vaccine to their daughter's condition.
The vaccine used in the school immunisation programme is Gardasil and over 220,000 girls have received this vaccine since its introduction. Gardasil is a fully tested vaccine which was licensed by the European Medicines Agency in 2006.
While no medicine, including vaccines, is entirely without risk, the safety profile of Gardasil has been continuously monitored since it was first authorised nationally and at EU level.
In November 2015 the European Medicines Agency (EMA) completed a detailed scientific review of the HPV vaccine. The review, in which the Health Products Regulatory Authority participated, focused on two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndrome. The review found no evidence of a causal link between the vaccine and the two conditions. On 12 January 2016 the European Commission endorsed the conclusion of the EMA stating that there is no need to change the way HPV vaccines are used or to amend the product information which is now binding in all member states.
In relation to the issue referred to by the Deputy it concerns a complaint made by the Nordic Cochrane Centre concerning the EMA. The EMA is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. It would be inappropriate for me to comment on any complaint made by a third party concerning an EU agency.
Health care professionals are advised to continue using HPV vaccines in accordance with the current product information and I would encourage all young women to receive this important cancer preventing vaccine.
