Clare Daly (Dublin Fingal, Independent)
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443. To ask the Minister for Health the reason recommendations of the Oireachtas Joint Committee on Health and Children's report on childhood immunisation of July 2001 that legislation be drawn up to provide for a no fault national vaccine injury compensation scheme has not been implemented [24143/17]

Clare Daly (Dublin Fingal, Independent)
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445. To ask the Minister for Health the reason an ex gratia payment scheme has not been established, in view of the recommendations of the vaccine damage steering group of June 2009 regarding the need to deal with issues for retrospective cases, in instances in which persons have been awaiting a resolution of these issues for decades; and if he will make a statement on the matter. [24145/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 443 and 445 together.

I refer the Deputy to my reply to question number 379 on 16 May 2017. As I stated in my reply, my Department is considering how to implement the Programme for a Partnership Government commitment, which encompasses consideration of the implementation of the recommendations of the Vaccine Damage Steering Group. This includes the nature of any such scheme, whether it would be on a statutory or non-statutory basis, whether it would apply retrospectively, the arrangements for eligibility, the vaccines that would be included in such a scheme, the criteria for determining an adverse effect, the burden of proof required, the assessment of the level of disability and how this would be conducted, the levels of award, the mechanisms for appealing any decision and how the scheme might interact with the legal process and litigation rights. Regard is being given to the international experience with such schemes and to their potential applicability to Ireland. In the course of its considerations, my Department is engaging with other Government Departments and relevant State agencies. I hope to be in a position to finalise the consideration of options with a view making recommendations on the design and implementation of a proposed scheme in line with the commitments in the Programme for a Partnership Government.

Clare Daly (Dublin Fingal, Independent)
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444. To ask the Minister for Health if he will establish an expert medical group on the HPV vaccination along the lines of the previous group established in November 1977 on the whooping cough vaccination. [24144/17]

Michael Fitzmaurice (Roscommon-Galway, Independent)
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452. To ask the Minister for Health his views on whether it is appropriate to describe parents that are of the view their children's symptoms are a result of the HPV vaccine as scaremongers; and if he will make a statement on the matter. [24175/17]

Michael Fitzmaurice (Roscommon-Galway, Independent)
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453. To ask the Minister for Health his views on the motion recently passed by the annual conference of a union (details supplied) seeking a review of the HPV vaccination programme in post-primary schools. [24176/17]

Michael Fitzmaurice (Roscommon-Galway, Independent)
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454. To ask the Minister for Health his plans to include new warnings which would include the manufacturers leaflet in the information package being supplied to persons with regard to the HPV vaccine; and if he will make a statement on the matter. [24178/17]

Michael Fitzmaurice (Roscommon-Galway, Independent)
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455. To ask the Minister for Health his views on the fact that HPRA has received of over 1,000 reports of suspected adverse reactions associated with HPV vaccines and that the majority of these reports are consistent with the types of effects known to occur with the vaccine including chronic fatigue syndrome, post viral fatigue and auto immune disorder; and if he will make a statement on the matter. [24179/17]

Willie Penrose (Longford-Westmeath, Labour)
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537. To ask the Minister for Health if in relation to the gardasil HPV vaccine, the reason persons are being denied the details from the manufacturing company by way of the manufacturer patient information leaflet, which outlines in detail the potential side effects in relation to same, and which are not listed on the leaflet furnished by the HSE; if he will acknowledge the right of persons to have all relevant information pursuant to the doctrine of informed consent; and if he will make a statement on the matter. [24741/17]

Willie Penrose (Longford-Westmeath, Labour)
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538. To ask the Minister for Health if, in relation to the use of gardasil HPV vaccine and the significant health side effects that have been documented by a number of persons that suffered as a result of vaccination, if he will put in place an appropriate and proper investigation of persons that became ill in the aftermath of the vaccination; the steps he will take to put in place an appropriate treatment and redress plan; and if he will make a statement on the matter. [24742/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 444, 452 to 455, inclusive, 537 and 538 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.

Unfounded, false claims have been made of an association between HPV vaccination and a number of conditions experienced by a group of young women. It appears that they first suffered symptoms around the time they received the HPV vaccine and a false connection is being made between the HPV vaccine and the onset of these symptoms. This false connection has been seized upon by individuals and groups opposed to vaccination to mislead parents about the safety of vaccines and to scare them into refusing the vaccines on behalf of their daughters. 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 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.

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) credibility and content good information practices criteria.

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

I am aware from media reports that a union representing members in the educational sector passed a motion concerning the HPV vaccine at their conference recently. However, it would not be appropriate for me to comment on any motion passed at a union conference.