Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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340. To ask the Minister for Health if there is significant under reporting of HPV vaccine adverse reactions to the Health Products Regulatory Authority, HPRA; his plans to provide an advertising campaign to draw the attention of families that may be suffering in silence to contact the HPRA (details supplied); and if he will make a statement on the matter. [38558/16]

Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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341. To ask the Minister for Health if there is significant under reporting of HPV vaccine adverse reactions to the Health Products Regulatory Authority, HPRA, by doctors and consultants failing to report suspicions of side effects even when parents had pointed out the connection; his plans to investigate the stage at which the medical profession consider reporting the conditions of the girls as listed on the HPRA website; and if he will make a statement on the matter. [38559/16]

Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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342. To ask the Minister for Health his views on the safety of the Gardasil HPV vaccine (details supplied); his plans to follow the Danish model or if the HSE will deal with the issue; and if he will make a statement on the matter. [38560/16]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 340 to 342, inclusive, 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 papillomavirus (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.

Gardasil is the HPV vaccine used in Ireland in the context of the HSE schools immunisation programme. By January 2016, over 200 million doses of Gardasil had been distributed worldwide. In Ireland over 620,000 doses of Gardasil have been administered and over 220,000 girls have been fully vaccinated against HPV since it was introduced in 2010.

The European Medicines Agency (EMA) is a decentralised agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. It would not be appropriate to comment on data submitted by manufacturers of a medicinal product to the EMA as part of their market authorisation processes or monitoring of its safety following authorisation for use.

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 both nationally and at EU level. In Ireland, the Health Products Regulatory Authority (HPRA) is the statutory regulatory authority for medicines in Ireland. The HPRA and the European Medicines Agency (EMA) in Europe continually monitor adverse events to vaccination.

As part of its monitoring of the safety of medicines, the HPRA operates an adverse reaction reporting system, with healthcare professionals and patients encouraged to report adverse reactions they consider may be associated with their treatment, through the range of options in place for reporting. All reports received are evaluated and considered in the context of 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.

In addition, pharmaceutical companies are obliged, as a condition of the authorisation to market a medicine, to submit reports of adverse reactions received directly, to the HPRA. At EU level, regulators continuously monitor this cumulative reporting experience as part of the ongoing assessment of the safety of HPV vaccines. In accordance with its reporting obligations, the HPRA provides anonymised details of reports received to the EMA, the WHO and to the relevant pharmaceutical companies.

The fact that a suspected adverse reaction has been reported does not necessarily mean that the vaccine has caused the observed effect, this may also been caused by a new disease the patient developed. Further data are usually needed to complete the picture. In the context of monitoring the safety of vaccines, new information on a possible risk is called a signal. Signals may arise from various data sources, including spontaneous reports, clinical trials and epidemiological studies. Once a signal has been identified, investigations are undertaken to consider the likelihood that a medicine may have caused or contributed to the effect, try to identify risk factors and estimate the frequency of occurrence. Following the assessment, a decision on the most appropriate regulatory action is taken by the competent authorities. The regulatory action is communicated to healthcare professionals, patients and the general public through established channels, and timelines reflect the degree of urgency.

The EMA completed its detailed scientific review in November 2015 of the evidence surrounding reports of two conditions. In line with its initial recommendations, the EMA confirms that the evidence does not support a causal link between the HPV vaccine sand development of the two conditions studied. Therefore there is no reason to change the way the vaccines are used or to amend the current product information. The Agency’s Committee for Medicinal Products for Human Use concurred that the available evidence and did not recommend any changes to the terms of licensing or the product information for these medicines. On 12 January 2016 the European Commission endorsed the conclusions of the EMA, that there is no change to the way HPV vaccines are used, or to amend the current product information. This final outcome by the Commission is now binding in all members states.

The review recognised that, at that time, more than 80 million girls and women worldwide have now received these vaccines, and in some European countries they have been given to 90% of the age group recommended for vaccination. Use of these vaccines is expected to prevent many cases of cervical cancer (cancer of the neck of the womb, which is responsible for over 20,000 deaths in Europe each year) and various other cancers and conditions caused by HPV.

I am aware of claims of an association between 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. 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.

I am aware of media reports that the authorities in Demark and Japan have taken some measures concerning HPV immunisation in their countries. However, it would be inappropriate for me to comment on the arrangements put in place by the health authorities these countries.

The benefits of HPV vaccines outweigh the known side effects. The safety of these vaccines, as with all medicines, will continue to be carefully monitored and will take into account any future new evidence of side effects that becomes available. I encourage the parents of all eligible girls to ensure that their daughters receive this important cancer preventing vaccine.