Clare Daly (Dublin North, United Left)
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75. To ask the Minister for Health his views on the hundreds of complaints that have been received by the Health Service Executive regarding the Gardasil vaccine; and the steps he will take to address the matter. [35914/15]

Clare Daly (Dublin North, United Left)
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76. To ask the Minister for Health his plans to meet with members of a group (details supplied) who are concerned at the side effects of the Gardasil vaccine, and the need to initiate a formal review, given that such examinations are taking place in other countries. [35915/15]

Clare Daly (Dublin North, United Left)
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77. To ask the Minister for Health his plans to put in place a process to support girls who have suffered serious disabling side effects from the Gardasil vaccination. [35916/15]

Leo Varadkar (Dublin West, Fine Gael)
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I propose to take Questions Nos. 75 to 77, inclusive, together.

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.

Immunisation is regarded as one of the safest and most cost-effective of health care interventions. The HPV vaccine protects girls from developing cervical cancer when they are adults. The vaccine is available free of charge from the HSE for all girls in 1st year of secondary school. This is in accordance with the recommendation received from the NIAC which indicated that the HPV vaccine should be offered on an annual basis to all girls aged 12. The advice, based on public health considerations and supported by the cost-effectiveness analysis, is that HPV vaccines confer maximum benefit both individually and on a population basis if administered prior to HPV exposure. The 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.

In Ireland, the Health Products Regulatory Authority (HPRA) is the regulatory authority for medicines in Ireland. Gardasil^®is a medicinal product which has been authorised for use across the European Union since September 2006 following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA). With this authorisation, the vaccine can be marketed in all EU Member States. Since first authorisation the HPRA has continuously monitored the safety of Gardasil^®.

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 (PSURs) submitted by the Marketing Authorisation Holder (i.e. license holder) for the vaccine on a regular basis. The most recent EU review of cumulative global safety update data completed in December 2014 concluded that the benefit/risk profile for Gardasil^®remains positive.

Up to the 11 September 2015, the Health Products Regulatory Authority (HPRA) has received 901 reports of suspected adverse reactions/events notified in association with the use of HPV vaccines (Gardasil^®899 and Cervarix^®2). The vast majority of reports received by the HPRA regarding both Gardasil^®and Cervarix vaccines to date have been consistent with the expected pattern of adverse effects for the vaccines, as described in the product information. Vaccination related events, occurring at the time of vaccine administration, such as syncope (faints) has been among the most commonly reported effects. Other commonly reported symptoms include gastrointestinal symptoms, malaise, headache, dizziness and injection site reactions. Reports of allergic-type reactions including skin rashes, urticaria and flushing have also been received, including isolated reports of more severe hypersensitivity-type reactions.

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. All reports received through the online reporting options receive an acknowledgement and case record number on successful submission of a report. Further information is provided to reporters in respect of any questions/concerns reflected in their reports, in the context of report follow up. In accordance with its reporting obligations, the HPRA provides anonymised details of reports received to the EMA, the World Health Organisation and to the marketing authorisation (i.e. licence) holder for the medicine.

The EMA has commenced a review of the human papilloma virus (HPV) vaccine "to further clarify aspects of their safety profile," although the agency points out that this review "does not question that the benefits of HPV vaccines outweigh their risks." The review is specifically focusing on rare reports of two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndrome associated with heart rate increase. Recommendations from the first stage of this review are expected in November. The agency also notes that while the review is being carried out, no change in the use of these products is recommended.

In addition the EMA is currently evaluating data from a on the safety of human papilloma virus (HPV) vaccines, Gardasil^®and Cervarix^®. The study conducted jointly by the French medicines agency (ANSM) and the French national health insurance fund (CNAMTS) compared the incidence of autoimmune conditions in girls given HPV vaccines with the incidence in girls not given the vaccines. In the meantime, the EMA have advised healthcare professionals that available data does not warrant any change to the use of these vaccines. Healthcare professionals should therefore continue using Gardasil^®and Cervarix^®in accordance with the current product information.

As Minister for Health I consider meeting any organisation in the health area that requests to do so. However due to scheduling commitments I am not always available to meet all who request a meeting.