Michael Healy-Rae (Kerry, Independent)
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415. To ask the Minister for Health the reason the HSE has not circulated the package information leaflet in the HPV vaccine information packs in order that parents may make an informed consent on the vaccine; and if he will make a statement on the matter. [39339/17]

Simon Harris (Wicklow, Fine Gael)
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Cervical cancer is the fourth most common cancer in women worldwide. Each year in Ireland around 300 women are diagnosed with cervical cancer and 90 die from the disease. All cervical cancers are linked to high risk Human Papillomavirus (HPV) types. In 2009 the National Immunisation Advisory Committee (NIAC) recommended HPV vaccination for all 12 year old girls to reduce their risk of cervical cancer and in September 2010 the HPV vaccination programme was introduced for all girls in first year of second level schools.

The HSE is committed to providing accurate information for parents about diseases, the vaccines to prevent them and side effects to allow them to choose whether to give consent to vaccination. All the information provided to parents about vaccination is prepared from the available licensed documentation for each vaccine, the Summary of Products Characteristics (SPC) and Patient Information Leaflet (PIL). The information is presented in clear simple language and approved by the National Adult Literacy Agency (NALA) so that it can be understood by all adults. The Health Information and Quality Authority (HIQA) Guide ‘Communicating in plain English’ (2015) developed in partnership with NALA states that “One in six people find reading and understanding everyday texts difficult: for example, reading a health leaflet, bus timetable or medicine instructions”. Therefore, like other countries providing school immunisation programmes, the Patient Information Leaflet (PIL) is replaced by this information leaflet and like other countries the HSE information leaflet provides the same information on side effects of the vaccine.

Prior to all school immunisations, parents receive an information pack in a sealed package with an information leaflet, consent form and cover letter. The information packs for all immunisations are standardised nationally. The information booklets include information on all the known side effects that can occur after each vaccination. All the known side effects of the HPV vaccine Gardasil are outlined in the information booklet given to parents. 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.

Parents are not being denied the information on the Patient Information Leaflet. The HSE parent information leaflet refers parents to the website where links to additional information including the licensing documentation, the SPC and the PIL for each vaccine can be found.

I am aware of claims of an association between HPV vaccination and a number of conditions experienced by a group of young women. An illness that occurs around the time a vaccine is given and is already known to be common in adolescence does not imply the vaccine caused the problem. 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. It is important to reassure people 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 diverse nature of these symptoms, which can have both physical and psychological causes, are shared by many conditions which has implications for both diagnostic and treatment services. The individual nature of the needs of some children may require access to specialist services and the HSE are currently working to put in place clinical care pathways appropriate to the differing medical needs of this group. As there is no scientific evidence that the vaccine causes long term illnesses, the HPV vaccine cannot be held responsible for these illnesses.

It is important that people receive accurate information from reliable sources in relation to the safety of vaccines, and to increase the uptake rates of all vaccines in the State’s immunisation programmes. The HSE recently launched their information campaign for HPV vaccination as part of the 2017/18 Schools Immunisation Programme. This launch is part of an extensive media campaign coinciding with the start of the programme in September 2017. The focus remains on providing accurate information in relation to the safety of the HPV vaccine, and to increase the uptake rate in girls as part of the schools immunisation programme. It includes a comprehensive range of materials for parents, schools and medical practitioners.

I fully support the information campaign and its aim to increase uptake of this important vaccine.