Maureen O'Sullivan (Dublin Central, Independent)
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23. To ask the Minister for Health why the Health Service Executive is not engaging with the Reactions and Effects of Gardisil Resulting in Extreme Trauma, REGRET, group; if he has confidence in the human papilloma virus vaccine; and if he will engage with the group to discuss the serious illnesses suffered by over 370 girls to and address the lack of possible information on side-effects provided to parents of students receiving the vaccine. [20613/16]

Simon Harris (Wicklow, Fine Gael)
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The immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). NIAC is a committee of the Royal College of Physicians of Ireland comprising of experts in a number of specialties including infectious diseases, paediatrics and public health. The committee's recommendations are informed by public health advice and international best practice.

The HPV vaccine protects girls from developing cervical cancer when they are adults. It is available free of charge from the HSE for all girls in 1st year of secondary school.

Each year in Ireland around 300 women are diagnosed with cervical cancer. The HPV vaccine protects against two high risk types of HPV (16 & 18) that cause 73% of all cervical cancers. Vaccinated women and girls will still be at risk from other high risk types of HPV that can cause cervical cancer and will therefore need to continue to have regular cervical smear tests.

By January 2016, over 200 million doses of Gardasil had been distributed worldwide. In Ireland over 580,000 doses of Gardasil have been administered and over 200,000 girls have been fully vaccinated against HPV since it was introduced in 2010.

In Ireland, the Health Products Regulatory Authority (HPRA) is the statutory regulatory authority for medicines in Ireland. While no medicine (including vaccines) is entirely without risk, the safety profile of Gardasil has been continuously monitored since it was first authorised both nationally and at EU level. This is done by both monitoring of individual adverse reaction reports received by competent authorities across Europe (including the HPRA) and Periodic Safety Update Reports submitted by the Marketing Authorisation Holder (i.e. license holder) for the vaccine on a regular basis.

As part of its monitoring of the safety of medicines, the HPRA operates an adverse reaction reporting system, where healthcare professionals and patients are encouraged to report adverse reactions they consider may be associated with their treatment, through the range of options in place for reporting. All reports received are evaluated and considered in the context of the safety profile of the product concerned, with reports followed up as necessary for further information, that may assist in the assessment of the case.

In November 2015 the European Medicines Agency completed a detailed scientific review of the HPV vaccine. The review which the HPRA participated in, specifically focused on rare reports of two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndrome associated with heart rate increase. The outcome of the review found no evidence of a causal link between the vaccine and the two conditions examined.

On 12 January 2016 the European Commission endorsed the conclusion of the European Medicines Agency stating that there is no need to change the way HPV vaccines are used or to amend the product information. This final outcome by the Commission is now binding in all member states.

I am aware of claims of an association between HPV vaccination and a number of conditions experienced by a group of young women. It appears that some girls first suffered symptoms around the time they received the HPV vaccine, and understandably some parents have connected the vaccine to their daughter’s condition.

I want to make it quite clear that anyone who is suffering ill health is eligible to seek medical attention, and to access appropriate health and social care services, irrespective of the cause of their symptoms. The individual nature of the needs of some children may require access to specialist services.

The HSE are currently working to put in place a clinical care pathway appropriate to the medical needs of this group. I hope to be in a position to meet representatives from REGRET in the near future.