Eamon Scanlon (Sligo-Leitrim, Fianna Fail)
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775. To ask the Minister for Health why the Health Service Executive has not put provisions in place to cater for human papillomavirus vaccination casualties given that the executive has acknowledged that no vaccine is 100% safe and the manufacturer clearly outlines more than 25 possible side effects in its patient information leaflet; and if he will make a statement on the matter. [10080/16]

Eamon Scanlon (Sligo-Leitrim, Fianna Fail)
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795. To ask the Minister for Health why the Health Service Executive is not including the manufacturer's patient information leaflet in information packs to parents when asked to sign their consent for the Gardasil human papillomavirus vaccination; and if he will make a statement on the matter. [10161/16]

Eamon Scanlon (Sligo-Leitrim, Fianna Fail)
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796. To ask the Minister for Health the critical mass number of severe adverse reactions to any new medication or vaccine that warrants an investigation into, or a suspension of, the human papillomavirus vaccination programme, including a possible connection between the mirrored symptoms of 350 girls in the Reactions and Effects of Gardasil Resulting in Extreme Trauma Group, listed in the manufacturer's patient information leaflet and the Gardasil human papillomavirus vaccine; and if he will make a statement on the matter. [10162/16]

Eamon Scanlon (Sligo-Leitrim, Fianna Fail)
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797. To ask the Minister for Health when he put fast-tracking in place under the medical card scheme, the disability benefit scheme and the carer’s allowance scheme for the persons in the Reactions and Effects of Gardasil Resulting in Extreme Trauma Group and their families, many of whom are struggling with their medical needs after several years of debilitating, chronic health issues post the Gardasil human papillomavirus vaccination; and if he will make a statement on the matter. [10163/16]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 775, 795, 796 and 797 together.

Following authorisation, all medicines, including vaccines are subject to continuous safety monitoring and ongoing evaluation to determine any change to their benefit-risk profile. The need for regulatory action is not based on numbers of reports - which may be influenced by availability on the market, the extent of use and public awareness of an issue - but is considered in the context of this continuous safety monitoring and ongoing evaluation. EU regulators continuously monitor the safety of the HPV vaccines and routine ongoing pharmacovigilance activities are in place to review any new safety signal, should they arise from the Eurovigilance database of adverse reactions, published literature, or from any other source of information. Safety monitoring includes the review, follow up and onward reporting of individual suspected adverse reaction reports submitted to national competent authorities such as the Health Products Regulatory Authority (HPRA), as well as evaluation of data from the published literature, epidemiological studies and any additional clinical trial results.

I am aware of claims of an association between Human Papillomavirus (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. As there is no scientific evidence that the vaccine causes long term illnesses, the HPV vaccine cannot be held responsible for these illnesses. 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 HSE strives to provide the appropriate care for all patients no matter what their illness. The girls and their families should seek medical advice from their family doctor in the normal manner and be referred to consultants familiar with these syndromes for diagnosis and management. A number of non health supports are referred to in these questions. As the Deputy is aware my colleague, the Minister for Social Protection, has responsibility for Disability Benefit and Carer’s Allowance Schemes.

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. Seizures, muscle weakness, leg pain, joint pain and chronic fatigue are not mentioned as known side effects to Gardasil in the Patient Information Leaflet. There are no known long term side effects to the vaccine Gardasil. 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. The website allows members of the public to contact the National Immunisation Office to ask a question if they require further information. These questions, when possible, are answered by the staff of the National Immunisation Office within one working day.

The HSE are currently working to put in place a clinical care pathway appropriate to the medical needs of this group. The Department is aware that representatives from REGRET have already met with the HSE and it would be more appropriate for them to meet with the HSE again when the care pathways and access to services has been clarified.