Written Answers Nos. 249-271
249. Deputy James Browne asked the Minister for Health the reason for the delay in admitting a person (details supplied) to the Central Mental Hospital; when they can expect to be seen and admitted; and if he will make a statement on the matter. [11129/17]
Amharc ar fhreagraAs this is a service issue, this question has been referred to the HSE for direct reply.
250. Deputy Robert Troy asked the Minister for Health the role of the HSE and his Department regarding the Gardasil vaccine; if it is proactive or reactive to the claims made by persons (details supplied); and if he will make a statement on the matter. [11130/17]
Amharc ar fhreagra251. Deputy Robert Troy asked the Minister for Health his views on the national awareness of an ever increasing number of persons whose health may have been chronically damaged in the aftermath of the Gardasil vaccine (details supplied); and if he will make a statement on the matter. [11131/17]
Amharc ar fhreagra252. Deputy Robert Troy asked the Minister for Health his views on the Health Products Regulatory Authority statements on a television programme (details supplied). [11132/17]
Amharc ar fhreagra254. Deputy Robert Troy asked the Minister for Health his views on a matter (details supplied) concerning Gardasil; and if he will make a statement on the matter. [11134/17]
Amharc ar fhreagra255. Deputy Robert Troy asked the Minister for Health his views on a statement (details supplied) concerning Gardasil; and if his Department has taken all these findings into consideration while deciding to continue with the vaccination programme. [11135/17]
Amharc ar fhreagra256. Deputy Robert Troy asked the Minister for Health his views on the numerous Gardasil safety studies including one released recently (details supplied). [11136/17]
Amharc ar fhreagra259. Deputy Robert Troy asked the Minister for Health his views on matters (details supplied) relating to the HPV vaccine. [11139/17]
Amharc ar fhreagra260. Deputy Robert Troy asked the Minister for Health his views on the role of sodium borate in the HPV vaccine. [11140/17]
Amharc ar fhreagra261. Deputy Robert Troy asked the Minister for Health his views on the role of sodium borate in the HPV vaccine; if his attention has been drawn to the fact that the US Centres for Disease Control and Prevention vaccine excipient and media summary lists four vaccines (details supplied) that contain sodium borate; and if he will make a statement on the matter. [11141/17]
Amharc ar fhreagraI propose to take Questions Nos. 250 to 252, inclusive, 254 to 256, inclusive, and 259 to 261, 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. The Health Products Regulatory Authority (HPRA) and the European Medicines Agency (EMA) in Europe continually monitor adverse events to vaccination. All relevant and appropriate information is taken into account when deciding to make changes to the State's immunisation programmes.
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. In Ireland more than 660,000 doses of Gardasil have been administered and almost 250,000 girls have been vaccinated against HPV. Over 205 million doses of the HPV vaccine Gardasil have been distributed worldwide, either as part of national immunisation programmes or by private doctors. Gardasil is currently used in over 25 European countries, the United States, Canada, Australia and New Zealand.
No medicine, including vaccines, is entirely without risk, there is therefore on-going pharmaco vigilance 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 HPRA is the statutory regulatory authority for medicines in Ireland and, along with the EMA in Europe, continually monitors adverse events to vaccination.
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. Seizures, muscle weakness, leg pain, joint pain and chronic fatigue are not mentioned as known side effects to Gardasil in the Patient Information Leaflet. There are no known long term side effects to the vaccine Gardasil. 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. The Patient Information Leaflet does not state ovarian failure, painful and chronic severe daily headaches, seizures, neurological condition, chest pain, paralyses, onset of auto immune conditions, muscle weakness, joint and leg pain, heart problems, systemic inflammation, short term memory. 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 credibility, content and 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.
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. 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. As there is no scientific evidence that the vaccine causes long term illnesses, the HPV vaccine cannot be held responsible for these illnesses. 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 and the HSE are currently working to put in place a clinical care pathway appropriate to the medical needs of this group.
The HPRA which monitors the safety of all medicines in Ireland has received 1072 spontaneously reported adverse reactions and events associated with use of the HPV vaccines from doctors and members of the public since 2006. The vast majority of reports received by the HPRA have been consistent with the expected pattern of short term and self limited adverse effects for the vaccines, as detailed above from the Patient Information Leaflet. Though the Irish media report that anti-vaccine groups report there are several hundred girls suffering chronic fatigue like conditions adverse events after the HPV vaccine, the HPRA has received less than 30 reports of chronic fatigue like conditions and autoimmune disease together and one report of suspected premature ovarian failure after HPV vaccine administration since 2006. These numbers are much less than the estimated prevalence of chronic fatigue syndrome likes conditions and premature ovarian failure occurring by chance among a population of almost 250,000 Irish girls who have received the vaccine. One would expect to see at least 300 cases of chronic fatigue syndrome like conditions and more than 20 cases of premature ovarian insufficiency reported in a group this size. However this has not been seen despite all the media attention given to this vaccine. This HPRA surveillance data provides evidence supporting the good safety profile of the HPV vaccine and is consistent with data from international regulatory bodies. Consequently, there is no scientific biological or epidemiological evidence of the HPV vaccine causing chronic medical conditions.
The focus for the HPV programme in 2017 is to counter misinformation in relation to the safety of the HPV vaccine, and to increase the uptake rate in girls as part of the schools immunisation programme. 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.
253. Deputy Robert Troy asked the Minister for Health if he has indemnified the manufacturers of the Gardasil vaccine. [11133/17]
Amharc ar fhreagraMy Department has contacted the HSE who have confirmed that as the Gardasil vaccine has been approved for use in the European Union by the European Medicines Agency there is no requirement for indemnity.
257. Deputy Robert Troy asked the Minister for Health his views on a report (details supplied). [11137/17]
Amharc ar fhreagraThis question refers to a paper published in an academic journal. All relevant information is taken into account by my Department.
258. Deputy Robert Troy asked the Minister for Health if the manufacturer of the HPV vaccine failed to inform the US Food and Drug Administration and the European Medicines Agency regarding Gardasil vaccine research omitting data concerning ovarian failure and its implications for the current HPV vaccination programme administered by the HSE on behalf of his Department. [11138/17]
Amharc ar fhreagraIn 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. Gardasil is the HPV vaccine used in the HSE schools immunisation programme its safety profile has been continuously monitored since it was first authorised. In Ireland more than 660,000 doses of Gardasil have been administered and almost 250,000 girls have been vaccinated against HPV. Over 205 million doses of the HPV vaccine Gardasil have been distributed worldwide, either as part of national immunisation programmes or by private doctors.
The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. The EMA granted market authorisation for Gardasil on 20 September 2006. I am not privy to interactions between vaccine manufacturers and the EMA so cannot answer the Deputy's question in that regard.
The Food and Drug Administration (FDA) is a federal agency of the Government of the United States of America and has no role in the approval of vaccines for use in the EU.
262. Deputy Robert Troy asked the Minister for Health if his attention has been drawn to an issue (details supplied). [11142/17]
Amharc ar fhreagraI am not familiar with the website referenced or its content.
263. Deputy Robert Troy asked the Minister for Health if his attention has been drawn to the fact that the toxicity of borate compounds has been studied in laboratory animals with most studies using either borax or boric acid (details supplied). [11143/17]
Amharc ar fhreagraI understand the question refers to a report released by the United States Forest Service which is an agency of the United States Department of Agriculture. Other than the Deputy's question, it has not been drawn to my attention, but my Department will now consider whether any further examination of this matter is required.
264. Deputy Niall Collins asked the Minister for Health the legislative proposals published by his Department between 2011 to 2016 that underwent a regulatory impact assessment; the legislative proposals published by his Department that did not undergo a regulatory impact assessment; and if he will make a statement on the matter. [11154/17]
Amharc ar fhreagra265. Deputy Niall Collins asked the Minister for Health if regulatory impact assessments for legislative proposals published by his Department include impacts (details supplied); the impact categories not included; and if he will make a statement on the matter. [11169/17]
Amharc ar fhreagraI propose to take Questions Nos. 264 and 265 together.
Bills published between 2011 and 2016 are shown in the following table.
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Bills published between 2011 and 2016 |
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Public Health (Tobacco) (Amendment) Bill 2011 |
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Medical Practitioners (Amendment) Bill 2011 |
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Health (Provision of General Practitioner Services) Bill 2011 |
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Health Insurance (Miscellaneous Provisions) Bill 2011 |
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Clotting Factor Concentrates and Other Biological Products Bill 2012 |
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Health (Pricing and Supply of Medical Goods) Bill 2012 |
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Health Service Executive (Governance) Bill 2012 |
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Health and Social Care Professionals (Amendment) Bill 2012 |
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Health Insurance (Amendment) Bill 2012 |
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Public Health (Tobacco) (Amendment) Bill 2013 |
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Health (Alteration of Criteria for Eligibility) Bill 2013 |
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Health (Amendment) Bill 2013 |
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Protection of Life During Pregnancy Bill 2013 |
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Health (Alteration of Criteria for Eligibility) (No. 2) Bill 2013 |
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Health Insurance (Amendment) Bill 2013 |
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Health Identifiers Bill 2013 |
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Health Service Executive (Financial Matters) Bill 2013 |
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Public Health (Sunbeds) Bill 2013 |
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Health (General Practitioner Service) Bill 2014 |
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Public Health (Standardised Packaging of Tobacco) Bill 2014 |
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Health (Miscellaneous Provisions) Bill 2014 |
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Medical Practitioners (Amendment) Bill 2014 |
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Health Insurance (Amendment) Bill 2014 |
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Misuse of Drugs (Amendment) Bill 2015 |
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Health (General Practitioner Service) Bill 2015 |
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Public Health (Alcohol) Bill 2015 |
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Health Insurance (Amendment) Bill 2015 |
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Misuse of Drugs (Amendment) Bill 2016 |
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Health (Amendment) Bill 2016 |
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Health Insurance (Amendment) Bill 2016 |
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Health (Miscellaneous Provisions) Bill 2016 |
RIAs were published for the following Bills:
- Health (Pricing and Supply of Medical Goods) Bill 2012
- Public Health (Sunbeds) Bill 2013
- Public Health (Standardised Packing of Tobacco) Bill 2014
- Public Health (Alcohol) Bill 2015
A RIA was also published for the General Scheme of the Health Information and Patient Safety Bill in November 2015.
The Deputy will appreciate that for various reasons a RIA was not always necessary in regard to the Bills published during this time period, for example a number of Bills made technical amendments to existing legislation, dealt with urgent matters or implemented budgetary measures. In these cases a RIA was not carried out.
When carrying out RIAs for legislative proposals my Department takes account of the RIA Guidelines as issued by the Department of the Taoiseach. The approach taken is dependent on the nature of the proposal and the extent to which particular impacts are relevant.
266. Deputy Michael D'Arcy asked the Minister for Agriculture, Food and the Marine when a person (details supplied) in County Wexford will be paid a single farm payment grant in view of the fact all documentation has been provided; and if he will make a statement on the matter. [10777/17]
Amharc ar fhreagraThe person named submitted three 2016 Transfer of Entitlements applications to my Department seeking the transfer of entitlements by lease. As the herd number shown had been changed from an individual to a Company name after the submission of the 2016 Basic Payment Scheme application, it was necessary to have a Declaration of Undertaking form completed in order to allow the transfer applications to be processed.
A letter issued with a Declaration of Undertaking form to the person named on 12 November 2016. The completed Declaration of Undertaking form was subsequently returned to my Department and processed. However, as there were multiple transfers involved in this case it was necessary for my Department to revert to the person named again to clarify issues pertaining to the transfers. These issues have now been clarified and payment will issue shortly.
267. Deputy Michael Healy-Rae asked the Minister for Agriculture, Food and the Marine the reason for the refusal of a GLAS payment for a person (details supplied); and if he will make a statement on the matter. [10779/17]
Amharc ar fhreagraThe person named was approved into GLAS 2 with a contract commencement date of the 1 January 2016.
The holding of the person named was selected for a ground inspection which took place on the 9 December 2016. It was during this inspection that the person named was deemed non-compliant in respect of the Geese and Swans (Whole of parcel) action. A letter issued on the 6 February 2017 notifying the person named of the non-compliances found on inspection and giving the right to request a review of this decision within 20 working days.
A review request was received from the Agricultural Advisor of the person named and it is currently being considered. The person named will be notified in writing of the outcome of this review once a decision has been made.
268. Deputy Clare Daly asked the Minister for Agriculture, Food and the Marine the role played by Horse Sport Ireland in overseeing the welfare of horses used by hunt clubs. [10783/17]
Amharc ar fhreagraThe Hunting Association of Ireland is an affiliate body of Horse Sport Ireland (HSI). HSI does not have any overseeing role in relation to the welfare of horses used by hunt clubs. However HSI has informed me that as an organization it is committed to ensuring that the welfare of horses is never compromised in the pursuit of sporting excellence or commercial gain. It expects that all its affiliates would adhere to the highest standards of animal welfare and that these standards are maintained at all times. It would be normal for all hunts to have a close relationship with veterinary surgeons in their area of operation, in this regard.
269. Deputy Eamon Scanlon asked the Minister for Agriculture, Food and the Marine the amount it costs to remedy a recent design fault in the newly designed category four high containment laboratory at the Backweston facility in County Kildare; and if he will make a statement on the matter. [10806/17]
Amharc ar fhreagraMy Department in collaboration with the Office of Public Works is currently developing a high containment laboratory at Backweston to enhance our National capability in the laboratory diagnosis of exotic viral diseases of farmed animals. An outbreak of Foot and Mouth disease in the UK in 2007 attributable to an escape of live virus from Pirbright was the prompt for us to upgrade a pre-existing laboratory space within the Backweston Laboratory Complex to the highest attainable international standard. A specialist US engineering firm was contracted to ensure the integrity of the design and to have confidence that the project would deliver a facility to the required certified standard. The tendered cost of the main building works were € 4.9 million excluding VAT.
During the construction works an underlying issue in the fabric of the original building was discovered. Although this does not affect the stability of the structure, it had the potential to compromise containment. The engineering solution to rectify this problem and the associated project delays have cost an additional €219,572. Building works are currently scheduled to be completed in early May 2017. On completion we will have the laboratory infrastructure required for safe, rapid and reliable laboratory diagnosis of exotic viral disease – this self-reliance constitutes a critical support for our expanding, export-dependent livestock sectors.
270. Deputy Mary Butler asked the Minister for Agriculture, Food and the Marine when Bord na gCon secured finance to build Limerick greyhound stadium at Greenpark in 2010; the greyhound stadia here that were used as collateral; and if he will make a statement on the matter. [10835/17]
Amharc ar fhreagraBord na gCon is a commercial State body, established in 1958, under the Greyhound Industry Act, 1958, chiefly to control greyhound racing and to improve and develop the greyhound industry.
Bord na gCon has informed me that bank loans relating to the Limerick Stadium were agreed with Allied Irish Bank on June 24th 2009. These facilities involved granting security to Allied Irish Bank over assets held at Waterford, Limerick and Shelbourne Park in Dublin.
271. Deputy Mary Butler asked the Minister for Agriculture, Food and the Marine his plans to reduce the €21 million debt currently owed by Bord na gCon; and if he will make a statement on the matter. [10836/17]
Amharc ar fhreagraBord na gCon is a commercial State body, established in 1958, under the Greyhound Industry Act, 1958, chiefly to control greyhound racing and to improve and develop the greyhound industry.
Bord na gCon has informed me the bank debt has been reduced by circa €2.0m between 2015 and 2016 and that they have recently entered negotiations with Allied Irish Bank to restructure the remaining loan facility.
