Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

571. To ask the Minister for Health if he will consult with members of a group (details supplied) regarding the human papilloma virus; and if he will make a statement on the matter. [21076/16]

Michael Healy-Rae (Kerry, Independent)
Link to this: Individually | In context | Oireachtas source

625. To ask the Minister for Health if the Health Service Executive will commence an awareness campaign for parents of young girls who are being given the vaccine Gardasil so that they can be fully informed of the potential dangers; and if he will make a statement on the matter. [21310/16]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 571 and 625 together.

In Ireland the National Immunisation Advisory Committee (NIAC) makes recommendations on vaccination policy. Their recommendations are based on the epidemiology of the disease in Ireland and international best practice in relation to immunisation. 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. NIAC recommended that the human papilloma virus (HPV) vaccine be given to all girls aged 12-13 in 2009 and in September 2010 the HPV vaccination programme was introduced for all girls in first year of second level schools.

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. 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. My Department is aware that representatives from REGRET have already met with the HSE and I hope to be in a position to meet with them in the near future.

The HSE provides information for parents about diseases, the vaccines to prevent them and side effects to allow them to choose whether or not to give consent to vaccination. All vaccination information provided to parents is prepared from the available licensed documentation for each vaccine, the Summary of Products Characteristics and Patient Information Leaflet. The information booklets include information on the most common adverse events that can occur after each vaccination. The information is presented in clear simple language and approved by the National Adult Literacy Agency so that it can be understood by all adults as the average reading age in Ireland is 12 years of age. Parents are also given contact details for their local immunisation office and advised to speak to a member of the school immunisation team if they have any further questions. Should parents require additional information about vaccines the immunisation leaflet refers to the HSE’s national immunisation website (). The national immunisation website has been accredited by the World Health Organisation for credibility, content and good information practices.

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. 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.