Paddy Burke (Fine Gael)
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I welcome the Minister for Health, Deputy Varadkar, to the House. I call Senator Mooney to speak on his commencement matter. He has four minutes.

Paschal Mooney (Fianna Fail)
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I thank the Cathaoirleach for taking this matter, which I raised on the Order of Business some weeks ago. I am also grateful that the Minister for Health has taken the time out from his busy schedule to be with us.

I want to put on the record straight away that, in the context of this motion, I am not calling for a suspension of the vaccination programme. What I am looking at, however, are those mothers and their daughters - specifically a growing number of daughters in this country - who, in my opinion, are not being treated in a holistic manner for the traumatic physical and mental side-effects that have hit them, coincidentally or otherwise, within a couple of days of receiving this vaccination.

We are also here today in the shadow of High Court proceedings that are being taken by the mother of a girl who received the HPV vaccine. She is asking for an order restraining the Health Products Regulatory Authority, HPRA, which monitors health products in Ireland, from proceeding with the use of gardasil in any vaccine programme.

She is also saying that within 24 hours of receiving the vaccination in October 2011, her 11-year-old daughter presented with severe flu-like symptoms. Her daughter became extremely fatigued and suffered severe nausea which led to weight loss and muscle wastage. Her daughter also missed days at school, was hospitalised with bilateral pneumonia the following year, and was on antibiotics for six weeks.Her daughter is now disabled to the point that she needs to be cared for on a permanent basis. This was reported in yesterday's edition of The Irish Times. I cite that example as one of the many that can read on the website of REGRET, a support group set up by a group of parents. There is growing concern internationally about the use of gardasil, which I hope the Minister will acknowledge. To date, Japan has suspended its vaccination programme. Denmark has asked the European Medicines Agency to review the vaccine and it has been decided that the Danish child vaccination programme will switch from using gardasil to cervarix. A presentation has been made to the Scottish petitions committee on the points that I have made and it has been asked to accede to a request for a round-table discussion to be held at Edinburgh between scientists and medical professionals from both sides of the HPV vaccine safety debate.

According to Merck's own statistics, some 183 million doses of gardasil have been distributed worldwide. Using its clinical trial percentage, this means there could be more than 6 million girls around the world suffering autoimmune conditions that could influence their health for the rest of their lives. According to the World Cancer Research Foundation, in 2012, 528,000 cases of cervical cancer were diagnosed worldwide. This presents the question of whether it is worth the risk.

There should be some acknowledgement by the Irish health authorities that there is something medically wrong with over 100 girls who have now been identified by REGRET as having developed similar symptoms within days of receiving the vaccination. The medical establishment and the Department of Health have decided against having any discussion or investigation of this. They say it will happen anyway and that every medication and vaccination has side effects and this is within the tolerable level. When one looks more deeply, there are parents spending huge sums of money on trying to get treatment for their daughters and there should be some recognition of the financial crisis that many of them face as a result of this. They genuinely believe that it is as a direct result of the vaccination.

Everything I have said so far on the record is factual. This is not about scaremongering. The Danish Government has given 7 million kroner for an independent investigation, the Japanese have suspended its use, and an evaluation of gardasil and cervarix by the EMA has been initiated by the French Government. These are not isolated cases. There is a growing body of international opinion that suggests that something is wrong somewhere. HPRA is engaged in the current EMA evaluation. I hope there will be some recognition by the Irish health authorities of the trauma being suffered by these children and that they get some financial benefit. They could be granted medical cards, which has happened in the case of other conditions in previous years. There should be some recognition that there is something wrong somewhere along the line. The parents genuinely believe that it is a direct result of the HPV vaccination.

I reiterate that this is not about a suspension of the programme but an acknowledgement that there is something going on. The Irish health authorities should not turn their face away from a growing body of international opinion that is beginning to acknowledge that there is something there. We should join that growing chorus. I do not believe it will go away.

Leo Varadkar (Dublin West, Fine Gael)
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I thank Senator Mooney for giving me the opportunity to update the House on this important matter. I acknowledge the concerns of families who believe their daughters have experienced adverse reactions and health issues after receiving the HPV vaccine. The vaccine protects against two high-risk types of HPV that cause 73% of all cervical cancers. It is estimated that the HPV vaccination will save 60 lives annually in this country.The vaccine used in the school immunisation programme is gardasil, a fully tested vaccine which was licensed by the European Medicines Agency in 2006. Following this, the national immunisation advisory committee recommended that the vaccine should be offered to all girls aged 12 years on an annual basis.

The Health Products Regulatory Authority, HPRA, is the 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 nationally, and at EU level. Decisions on the supply of vaccines are undertaken by specific expert agencies rather than being the responsibility of the Minister of the day. This is as it should be as it ensures that decisions are made solely on scientific information and expert advice, rather than being implemented by political pressure or lobbying.

As part of its monitoring of the safety of medicines, the HPRA operates an adverse reaction reporting system, where health care professionals and patients are encouraged to report adverse reactions they consider may be associated with their treatment. All reports received are evaluated and considered for the safety profile of the product concerned, with reports followed up as necessary for further information that may assist in the assessment of the case. I have been informed by the HPRA that up to 9 October it had received 921 reports of suspected adverse reactions or events notified in association with the use of HPV vaccines. The vast majority have been consistent with the expected pattern of adverse effects for the vaccines, as described in the product information, such as gastrointestinal symptoms, malaise, headache, dizziness and soreness or a rash at the injection site. These are short-lived.

As is the case for all licensed medicines, the safety of these vaccines is monitored by the pharmacovigilance and risk assessment committee, an EU-level drug safety committee, where the authority is represented and actively contributes. I am aware that the European Medicines Agency has commenced a review of the HPV vaccine "to further clarify aspects of their safety profile", although the agency points out that this review "does not question that the benefits of HPV vaccines outweigh their risks". The HPRA is participating in the review, which aims to clarify aspects of their safety profile and is specifically focusing on rare reports of two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndrome. In the meantime, the European Medicines Agency has advised health care professionals that available data does not warrant any change to the use of HPV vaccines. Health care professionals should therefore continue using them in accordance with the current product information. Any changes to this advice will be made following the outcome of the review.

Paschal Mooney (Fianna Fail)
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I thank the Minister and I am glad that he has put on the record that there are 921 reports of suspected adverse reactions. He said the symptoms he outlined in the same paragraph are short-lived. He should tell that to the parents of the over 100 people who have been experiencing much more serious medical, emotional and mental conditions for two, three and four years after getting the vaccination at 11 and 12 years of age, citing the current court case. All I have asked, and it has not been forthcoming, is for some acknowledgement, at least, that there is something going on regarding this.

In providing the pack to parents under the vaccination programme, why does the HSE not provide the patient information leaflet that is provided by Merck itself? It provides a different information package. I have read the information leaflet that accompanies the HPV gardasil vaccine and it makes for frightening reading. I also know anecdotally that there are GPs around the country who are not recommending this vaccination as a result of this growing concern about the efficacy of gardasil and its possible side-effects. They are issues the Minister cannot ignore. Is he happy that the information leaflet provided by Merck, which manufactures gardasil, is not given to parents before they sign the consent form?

Leo Varadkar (Dublin West, Fine Gael)
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I am advised that all the information provided to parents about the vaccination is prepared from the available licensed documentation for each vaccine. This is the summary of product characteristics, SPC, and the patient information leaflet. 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 lower than the adult age. 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 and the information booklets include information on the most common adverse events that can occur after each vaccine.For schools vaccines, parents are also given the contact details of their local immunisation office and advised to speak to a member of the school immunisation team if they have any further questions. Each information leaflet also refers patients to the national immunisation website, immunisation.ie, where additional information, including the licence documentation, the summary of product characteristic, SPC, and the patient information leaflet, PIL, for each vaccine are found. The national immunisation website has been accredited by the World Health Organization for credibility, content and good information practices. The website allows members of the public to contact the national information office to ask any question if they require further information. These questions, when possible, are answered by the staff of the immunisation office within one working day.