Tony McLoughlin (Sligo-Leitrim, Fine Gael)
Link to this: Individually | In context | Oireachtas source

454. To ask the Minister for Health his views on the findings of the European Commission which endorsed the conclusion of the European Medicines Agency on 12 January 2016 that there is no need to change the way Gardasil HPV vaccines are used or to amend the product information, considering the current concern here in regard to over 400 young girls who are suffering side effects from this drug; and if he will make a statement on the matter. [29690/16]

Marc MacSharry (Sligo-Leitrim, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

455. To ask the Minister for Health if he will meet representatives of an organisation (details supplied); and if he will make a statement on the matter. [29694/16]

Marc MacSharry (Sligo-Leitrim, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

456. To ask the Minister for Health if he will arrange for a State-funded free independent medical assessment for each girl suffering illnesses that they associate with the HPV vaccine; and if he will make a statement on the matter. [29695/16]

Martin Kenny (Sligo-Leitrim, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

467. To ask the Minister for Health if he is satisfied that the Gardasil vaccine is totally safe; and the reason the information from Gardasil is not included as part of the information to parents before vaccination (details supplied). [29772/16]

Martin Kenny (Sligo-Leitrim, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

469. To ask the Minister for Health his views on the fact that up until 2012, reporting of suspected vaccine reactions including Gardasil vaccine here depended on the voluntary submission of a report from a doctor, consultant or medical professional (details supplied); and his views on whether the incidence of adverse reactions is under-reported in view of the fact that most doctors will not acknowledge any connection between a vaccine including the Gardasil vaccine and a subsequent serious medical condition that manifests in the weeks or months afterwards. [29774/16]

Michael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source

471. To ask the Minister for Health if he is satisfied that the human papilloma virus Gardasil vaccine is totally safe; and if he will make a statement on the matter. [29791/16]

Michael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source

472. To ask the Minister for Health his views on whether the information from Gardasil vaccine makers should be provided as part of the information package provided by the HSE to parents; and if he will make a statement on the matter. [29792/16]

Michael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source

473. To ask the Minister for Health his views on the claims made by the HSE which state that the Gardasil HPV vaccine is the safest and most cost effective of health care interventions available currently and that it is the best way to prevent most disease due to human papilloma virus, HPV; and if he will make a statement on the matter. [29793/16]

Michael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source

476. To ask the Minister for Health his plans to arrange training for general practitioners in dealing with girls who have received the Gardasil HPV vaccine and the reported side effects. [29796/16]

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

494. To ask the Minister for Health the number of adverse effect reports received by the HPRA regarding a drug (details supplied) since that drug was licensed for use here. [29877/16]

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

495. To ask the Minister for Health if his Department has performed any lifetime analysis of the cost of support to persons reporting serious adverse effects following the administration of a drug (details supplied). [29878/16]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 454 to 456, inclusive, 467, 469, 471 to 473, inclusive, 476, 494 and 495 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.

Each year in Ireland around 300 women are diagnosed with cervical cancer. The HPV 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. NIAC recommended that the human papilloma virus (HPV) vaccine be given to all girls aged 12-13 in 2009 and in September 2010 the HPV vaccination programme was introduced for all girls in first year of second level schools.

By January 2016, over 200 million doses of Gardasil had been distributed worldwide. In Ireland over 580,000 doses of Gardasil have been administered and over 200,000 girls have been fully vaccinated against HPV since it was introduced in 2010.

No medicine, including vaccines, is entirely without risk, there is therefore on-going pharmacovigilance and monitoring of medicinal products once they are authorised for use. The safety profile of Gardasil has been continuously monitored since it was first authorised.

In Ireland, the Health Products Regulatory Authority (HPRA) is the statutory regulatory authority for medicines in Ireland. 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.

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. The national adverse reaction reporting programme in Ireland has been in place since 1968, initially operated by the HPRA's predecessor organisations, the National Drugs Advisory Board (NDAB) and the Irish Medicines Board (IMB). This reporting system has continuously evolved over the years to encourage increased participation across healthcare professional groups as well as patients/consumers. A variety of methods are in place to facilitate reporting such as on-line reporting tools, or submitting a form by post, email or reporting by telephone. The HPRA website includes a dedicated section on reporting for healthcare professionals as well as members of the public and regularly highlights reporting recommendations in its Drug Safety Newsletter. In addition, a number of leaflets have been issued by the HPRA to highlight patient awareness around taking medicines safely and advising patients of reporting options. These leaflets have been distributed to the public through a number of channels, including being made available in GP surgeries.

Reporting rates in Ireland for suspected adverse drug reactions associated with HPV vaccines have been high since the introduction of Gardasil into the Schools Immunisation Programme in 2010. This level of reporting reflects the very positive response to calls from the HPRA for reporting of national experience associated with use of the vaccine. All reports of suspected adverse reactions submitted to the HPRA are reviewed and followed up as necessary to ensure all relevant information is available, prior to onward reporting to relevant stakeholders, including the European Medicines Agency (EMA). At EU level, regulators continuously monitor this cumulative reporting experience as part of the ongoing assessment of the safety of HPV vaccines.

In terms of overall reporting rates, the HPRA actively participates in the WHO Collaborating Programme for International Drug Monitoring. Information on reporting rates from countries in the WHO programme is published on the centre's website and Ireland was ranked as the thirteenth highest reporter across 121 participating countries during the period 2011-2015.

I am aware of claims of an association between HPV vaccination and a number of conditions experienced by a group of young women. 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 individual nature of the needs of some children may require access to specialist services. The HSE are currently working to put in place a clinical care pathway appropriate to the medical needs of this group.

In November 2015, the European Medicines Agency completed a detailed scientific review of the HPV vaccine. The review, which the HPRA participated in, specifically focused on rare reports of two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndrome associated with heart rate increase. The outcome of the review which was carried out by the EMA Pharmacovigilance and Risk Assessment Committee (PRAC) found no evidence of a causal link between the vaccine and the two conditions examined. The European Medicines Agency has advised healthcare professionals that available data does not warrant any change to the use of HPV vaccines as there are no new safety concerns regarding HPV vaccines. Healthcare professionals should therefore continue using the vaccines in accordance with the current product information.

On 12 January 2016, the European Commission endorsed the conclusion of the European Medicines Agency stating that there is no need to change the way HPV vaccines are used or to amend the product information. This final outcome by the Commission is now binding in all member states.

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. 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 (www.immunisation.ie).The national immunisation website has been accredited by the World Health Organisation for content and for 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.

No specific training was provided to GPs when HPV vaccine was introduced in 2010 other than as part of the information sent in the regular Immunisation newsletters. Recent updates to GPs have included updated information in national immunisation newsletter, a letter sent to all GPs with copies of a HPV information leaflet and the information leaflet given to parents, collaboration with ICGP in production of 2 e-learning modules on HPV vaccine and the development of workshops on HPV vaccine which will take place shortly. In addition the HSE immunisation website (www.immunisation.ie)is constantly updated with the latest information.

My Department is aware that representatives from REGRET have already met with the HSE and I hope to be in a position to meet with them in the near future.