Brendan Ryan (Dublin Fingal, Labour)
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1182. To ask the Minister for Health if all patient information leaflets published by the HSE regarding the HPV vaccine gardasil contain all known side effects; and if he will make a statement on the matter. [27204/17]

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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1186. To ask the Minister for Health if the manufacturer product information leaflet for the human papillomavirus vaccine which lists certain adverse effects not listed on the HSE leaflet is being made available to parents and children before consent is being given for administration of the vaccine; and if not, the reason therefor. [27215/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 1182 and 1186 together.

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. One in four has difficulties in real world maths from simple addition and subtraction to the calculation of averages”. 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 immunisation parents receive an information pack in a sealed package with an information leaflet, consent form and cover letter. The information packs for all immunisation 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 national immunisation website www.immunisation.ie where links to additional information including the licensing documentation, the SPC and the PIL for each vaccine can be found at: www.hse.ie/eng/health/immunisation/pubinfo/schoolprog/HPV/HPV/.

The website allows members of the public to contact the National Immunisation Office (NIO) to ask a question if they require further information. These questions, when possible, are answered by the staff of the NIO within one working day. The NIO website has been accredited by the World Health Organisation (WHO).

Brendan Ryan (Dublin Fingal, Labour)
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1183. To ask the Minister for Health if he will put in place an investigation into the use of the HPV vaccine gardasil and its impact on young girls and women that have received the vaccine; and if he will make a statement on the matter. [27205/17]

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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1187. To ask the Minister for Health if an investigatory body will be put in place to examine the cases of children that have displayed adverse effects after receiving the HPV vaccine; and if he will make a statement on the matter. [27216/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 1183 and 1187 together.

Immunisation is regarded as one of the safest and most cost-effective of health care interventions and the importance of vaccination is acknowledged by all the major international health organisations. The World Health Organisation estimates that up to 3 million lives are saved each year as a result of vaccination and the scientific evidence is clear that benefits of vaccines outweigh the known side effects.

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. All relevant and appropriate information is taken into account when deciding to make changes to the State's immunisation programmes.

The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines that are licensed in Ireland. While no medicine is entirely without risk, the safety of vaccines, as with all medicines, is carefully monitored and any new evidence concerning side-effects is taken into account. The HPRA and the European Medicines Agency continually monitor adverse events to vaccination.

A number of unsubstantiated claims have been made of an association between HPV vaccination and a number of conditions experienced by a group of young women. 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 causes of their symptoms. The diverse natures of these symptoms, which can have both physical and psychological causes, are shared by many conditions which have 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 is working to put in place clinical care pathways appropriate to their differing medical needs.

As there is no scientific evidence that the vaccine causes long term illnesses, the HPV vaccine cannot be held responsible for these illnesses. However, this misinformation relating to unsubstantiated claims has led to a significant drop in uptake rates of the HPV vaccine. This means that a large cohort of girls is now at risk of developing cervical cancer later in their lives.

This misinformation is causing real harm to those unvaccinated children and adults who develop vaccine preventable diseases, and to people who seek inappropriate treatments for real conditions that are not caused by vaccines. Any parent who has doubts or questions about vaccination should talk to their family doctor, or alternatively to visit the National Immunisation office website. These sources of information are clear and accurate and will answer any queries you may have about the benefits or risks of vaccination. Vaccination is the best way for parents to make sure their children are healthy and protected from preventable diseases.

I have no plans to set up an investigation along the lines suggested by the Deputies as the safety and efficacy of these vaccines continues to be monitored by regulatory agencies at both national and European level.