Written Answers Nos. 385-404
385. Deputy Bernard J. Durkan asked the Minister for Health the progress to date in the determination of a medical card application by a person (details supplied); when the application is likely to be finalised; and if he will make a statement on the matter. [9527/19]
Amharc ar fhreagraAs this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.
386. Deputy Bríd Smith asked the Minister for Health further to Parliamentary Questions Nos. 322 and 331 of 19 February 2019, the details of the comprehensive and co-ordinated set of preparations to ensure continuity of health service post-Brexit; and the work undertaken by the HSE with regard to same to date. [9534/19]
Amharc ar fhreagraMy Department continues to work intensively with other Government Departments on all aspects of Brexit planning particularly the Department of the Taoiseach and the Department of Foreign Affairs and Trade. The Department is represented at all relevant sectoral working groups and is cooperating fully with colleagues across Government.
The Irish and UK Governments are committed to maintaining access to health services currently available under the Common Travel Area for both Irish and UK residents. Work is currently ongoing between Irish and UK officials on the preservation of access to health services which have been facilitated by the Common Travel Area.
There has been extensive engagement between Department of Health officials in Ireland and the UK to scope out the extent of reciprocal healthcare arrangements that are to be maintained post-Brexit. Working Groups on reciprocal healthcare and cross-border healthcare have facilitated discussions on the maintenance of healthcare arrangements. A number of key meetings have been held between officials from my Department, Northern Ireland and the UK to advance this.
Separately, officials from my Department continue to work closely with the HSE which has facilitated the identification of healthcare arrangements that are likely to be impacted by Brexit. This engagement has also led to the development of a number of statistical reports for the Department on the activity and spend levels associated with the EU Treatment Abroad Scheme and the EU Cross-Border Directive.
In addition, a significant body of work has been undertaken by my Department to determine the necessary legislative changes that may be required to maintain access to healthcare arrangements in the event of a no-deal Brexit.
The Government, on Friday 22 Feb 2019, published the ‘Withdrawal of the United Kingdom from the European Union (Consequential Provisions) Bill 2019’.
Part 2 of the Bill deals with healthcare arrangements with the UK post-Brexit and contains provisions to allow me to make Orders and Regulations to enable necessary healthcare arrangements to be maintained between Ireland and the UK in a no-deal scenario, including those existing arrangements which enable access to health services in the UK for persons in the State.
Intensive work is currently underway within my Department to draft the necessary statutory instrument(s), that may be required in the event of a no-deal Brexit.
I have asked the HSE to respond directly to the Deputy in relation to the work undertaken by the HSE.
387. Deputy Bríd Smith asked the Minister for Health the procedures in place for persons who access treatment under the EU cross-Border directive in the UK; and if he has requested an arrangement with the UK to replace same. [9535/19]
Amharc ar fhreagra388. Deputy Bríd Smith asked the Minister for Health if persons who may have to travel to other EU countries, thus accruing higher travel costs than if they travelled to the UK, for medical treatment under the EU cross-Border directive post-Brexit will receive financial assistance for travel costs. [9536/19]
Amharc ar fhreagraI propose to take Questions Nos. 387 and 388 together.
The HSE operates the EU Cross Border Directive (CBD) in Ireland. Patients in Ireland can seek to be referred to another EU/EEA member state, including the UK, for medical treatment that is available in the public health service in Ireland. The patient may access the overseas service in either the public or private health sector of the EU/EEA member state they choose to receive the service in. The patient pays for the treatment and claims reimbursement from the HSE at the cost of that treatment in Ireland or the cost of it abroad, whichever is the lesser.
It is important to note that reimbursement is confined to the costs of the care itself, and all other costs associated with accessing care abroad, including travel costs, under the CBD are not reimbursed by the HSE.
There are currently no plans to introduce financial assistance for travel costs incurred under the CBD.
It is also important to emphasise that at present there are no changes to patient care in the UK under the CBD, as the UK continues to be a full member of the EU. Indeed until the UK formally withdraws from the European Union, it remains a full Member with all of its existing rights and obligations.
Nevertheless, the Irish and UK Governments are committed to maintaining access to health services currently facilitated by the Common Travel Area for both Irish and UK residents to ensure that, insofar as possible, there is minimum disruption to health services and that essential services are maintained on a Cross-Border, all-island and Ireland-UK basis post-Brexit.
In this regard, the Government's 'Withdrawal of the United Kingdom from the European Union (Consequential Provisions) Bill 2019' published last Friday contains provisions to allow me to make Orders and Regulations to enable necessary healthcare arrangements to be maintained between Ireland and the UK in a no-deal scenario, including those existing arrangements which enable access to health services in the UK for persons in the State.
389. Deputy Pearse Doherty asked the Minister for Health the processing times for cross-Border directive refunds; the measures put in place to reduce waiting times; and if he will make a statement on the matter. [9538/19]
Amharc ar fhreagraThe HSE operates the Cross Border Directive in Ireland. Patients in Ireland can seek to be referred to another EU/EEA country for medical treatment that is available in the public health service in Ireland. The patient may access the overseas service in either the public or private health sector of the country they choose to receive the service in. The patient pays for the treatment and claims reimbursement from the HSE at the cost of that treatment in Ireland or the cost of it abroad, whichever is the lesser.
The HSE's target for reimbursing patients for healthcare accessed abroad under the CBD is a maximum of 20 working days from receiving all the completed documents. However, the HSE confirmed that it currently takes approximately 64 days to process reimbursements. The HSE have confirmed the increase in processing times is due to a significant increase in the amount of applications received for the CBD.
Nevertheless, the HSE informs me that it remains committed to monitoring and reviewing this situation and providing reimbursement to CBD patients in a timely manner given the resources it has available.
390. Deputy Gino Kenny asked the Minister for Health the progress made to date on the proposed cannabis access programme; if potential suppliers have been identified; and the timeframe for the implementation of the programme. [9540/19]
Amharc ar fhreagra391. Deputy Gino Kenny asked the Minister for Health the number of licences issued to date for medical cannabis. [9541/19]
Amharc ar fhreagra392. Deputy Gino Kenny asked the Minister for Health if an importation licence has been granted to a company that will supply cannabis for the cannabis access programme. [9542/19]
Amharc ar fhreagraI propose to take Questions Nos. 390 to 392, inclusive, together.
Quality Standards for medical cannabis products
The Medical Cannabis Access Programme aims to facilitate access to certain cannabis-based products which have not been authorised as medicines by a statutory Medicines Competent Authority. This means that the product manufacturers have not applied for an authorisation to market their products as medicinal products. This is because these products are unlikely to meet the same rigorous safety, quality and efficacy standards that authorised medicines must meet before being placed on the market, nor are the production processes likely to meet the same level of regulatory requirements as the marketing authorisation holders for authorised medicines.
However, whilst efficacy and safety data are not available for these products, it is crucially important that patients and prescribers can be assured, as far as possible, of the quality of these products. Department officials are working to ensure that appropriate procedures are put in place to facilitate this requirement in relation to cannabis-based products that will be permitted for medical use in Ireland.
Access to Medical Cannabis
Availability of cannabis products that are of an appropriate quality standard and are affordable to patients is clearly critical in establishing the access programme. To the Department’s knowledge only two countries, Canada and the Netherlands, currently permit export of such cannabis products, which meet acceptable quality control standards, beyond their borders. The Netherlands permits exports of cannabis dried herb, but does not permit commercial export of their oil-based cannabis formulations, which is the formulation preferred by the clinical community.
Department officials are working intensively on finding solutions to the supply of appropriate quality assured products for Irish patients, in parallel to their ongoing work on other significant projects. Department of Health officials are in regular contact with their counterparts in other countries, including Denmark, UK and Canada.
However, the Department of Health has no control in relation to business decisions taken by commercial product manufacturers and has no powers to compel companies to supply their products to the Irish market.
Ministerial Licence
Pending full operation of the Access Programme, doctors may continue to utilise the Ministerial licensing route to prescribe medical cannabis for their patients. Thirty-two licences have now been granted in respect of sixteen individual patients.
As the Deputy has stated, until suitable medical cannabis products are made available in Ireland, prescribers and their patients are sourcing the prescribed product from a pharmacy in The Netherlands, on foot of their medical prescription.
It is intended that the Ministerial licence application scheme will continue to operate in parallel with the Cannabis for Medical Use Access Programme, after the programme becomes operational, for exceptional cases only where there is an unmet clinical need.
Importation Licence:
One licence has been granted to an entity for the importation of products containing medical cannabis.
Department of Health website:
Information on the situation regarding medical cannabis is available on the Department of Health website. The medical cannabis section is continually updated.
394. Deputy Brendan Griffin asked the Minister for Health his views regarding the provision of a youth worker in a location (details supplied) in County Kerry; and if he will make a statement on the matter. [9545/19]
Amharc ar fhreagraAs this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
395. Deputy Éamon Ó Cuív asked the Minister for Health the number of persons waiting to be admitted to the National Rehabilitation Hospital; the average waiting time for persons waiting for a bed; his plans to reduce these waiting times; and if he will make a statement on the matter. [9548/19]
Amharc ar fhreagraThe Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives.
This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.
As the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.
398. Deputy Éamon Ó Cuív asked the Minister for Health the breakdown of funds received by his Department or channelled through his Department from EU funds in 2017; and the programmes these funds supported. [9573/19]
Amharc ar fhreagraIn 2017, the Department did not receive any funds from EU funding but €153,000 was paid out of subhead E.4 to the Special EU Programmes Body (SEUPB).
This was match funding from the Department of Health to support projects funded by the SEUPB under the INTERREG V EU Funding Programme
399. Deputy Clare Daly asked the Minister for Health the way in which the Health Products Regulatory Authority plans to monitor the safety of the HPV vaccine Gardasil 9 as a black triangle product; if it is to be administered to girls and boys here simultaneously with other vaccines as proposed by HIQA in its health technology assessment on extending the HPV vaccination to boys; and if he will make a statement on the matter. [9582/19]
Amharc ar fhreagraThe Health Products Regulatory Advisory (HPRA) has advised that Gardasil 9 was authorised by the European Commission to be placed on the market for use across the European Union (EU) in 2015 and as you have noted, is one of a number of medicines/vaccines, which is subject to additional monitoring requirements, identifiable by an inverted black triangle on the product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)) and an accompanying explanatory statement.
EU legislation introduced this concept in 2012 to support prompt identification of any new information associated with medicines/vaccines that are subject to additional monitoring, and healthcare professionals and patients/carers are particularly encouraged to report all adverse reactions associated with their use. The main goal of this monitoring activity is to facilitate the collection of additional information as early as possible to further elucidate the risk profile of products when used in clinical practice and to increase awareness about the safe and effective use of the medicines concerned. All newly authorised biological medicines including vaccines are subject to these additional monitoring requirements, usually for the first five years following authorisation and Gardasil 9 is being monitored in this way at EU and national level.
As part of the system for monitoring the safety of medicinal products, the HPRA operates a spontaneous reporting system by which patients/consumers and healthcare professionals can report suspected adverse reactions through various reporting options available through the HPRA website (www.hpra.ie). All reports of suspected adverse reactions received by the HPRA are routinely transmitted to the European Medicines Agency (EMA) EudraVigilance (EV) database for inclusion in global signal detection activities.
In December 2018 the Health Information and Quality Authority completed a health technology assessment (HTA) in relation to extending the national immunisation schedule to include the human papilloma virus (HPV) vaccination of boys.
The HTA recommended that the HPV immunisation programme be extended to include boys and the introduction of 9-valent HPV vaccine. A policy decision has been made to extend the HPV immunisation programme to include boys and introduce 9-valent HPV vaccine starting in September 2019.
The National Immunisation Office are working towards a gender-neutral HPV programme, information on which will be available for parents and healthcare professionals in advance of the start of the gender-neutral programme.
400. Deputy Clare Daly asked the Minister for Health his views on the use by HIQA of Norwegian health technology assessment local data in the absence of validated Irish data on hospitalisation rates for the associated adverse events of the HPV vaccine (details supplied); and if he will make a statement on the matter. [9583/19]
Amharc ar fhreagraThe Health Information and Quality Authority (HIQA) has advised that, in order to assess vaccine safety, they carried out a comprehensive, independent review of all available safety data. A systematic review of all relevant international literature was preformed which encompassed 70,000 trial participants and surveillance of many millions of individuals in cohort studies and had a follow up of up to 10 years. This review, which concluded that the vaccine was safe, included Ireland-specific safety data from the Health Products Regulatory Authority (HPRA).
The HIQA economic model, which assessed the cost-effectiveness of the vaccine, required an estimate of the hospitalisation rate associated with HPV vaccination. In the absence of relevant Irish data, evidence from the Norwegian Medicines Agency, which does report these data, were used.
401. Deputy Clare Daly asked the Minister for Health his views on the HIQA health technology assessment report on extending the HPV vaccine to boys (details supplied); if HIQA included studies in its review that did not conform with the EU, European Medicines Agency, EMA, Health Products Regulatory Authority, HPRA, Food and Drug Administration, FDA, and World Health Organization, WHO, definition of a serious adverse event; and if so, the definition of such an event HIQA used to select relevant international literature for the purpose of its assessment. [9584/19]
Amharc ar fhreagraThe Health Information and Quality Authority (HIQA) has advised that, in relation to their comprehensive safety assessment, included studies that reported serious and or minor adverse events associated with HPV vaccination. HIQA did not exclude studies based upon their definition of ‘serious adverse event’. Comparisons between studies were difficult as differing definitions were used. However, the within study comparisons of adverse event rates between HPV-vaccinated and non HPV-vaccinated individuals remain valid. Studies consistently show no increase in adverse event rates associated with the HPV vaccine.
402. Deputy Peter Burke asked the Minister for Health the status of a hospital appointment for a person (details supplied). [9586/19]
Amharc ar fhreagraUnder the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
The National Waiting List Management Policy, a standardised approach to managing scheduled care treatment for in-patient, day case and planned procedures, since January 2014, has been developed to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care. This policy, which has been adopted by the HSE, sets out the processes that hospitals are to implement to manage waiting lists.
In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to the Deputy directly.
404. Deputy Brendan Griffin asked the Minister for Health his views on a matter in relation to the temporary absence of legislation for pharmacists (details supplied); and if he will make a statement on the matter. [9588/19]
Amharc ar fhreagraThe Pharmacy Act 2007 established the Pharmaceutical Society of Ireland (PSI) and the functions of the Society are set out in the Act. The functions of the PSI are carried out on its behalf by the Council of the Society.
Section 30 of the Pharmacy Act 2007 provides for an exception to the general provision in the Act which requires the sale and supply of medicines at a pharmacy to be conducted under the personal supervision of a registered pharmacist, and specifies that no offence is committed where a registered pharmaceutical assistant “acts on behalf of a registered pharmacist during the temporary absence of the registered pharmacist”.
Section 30 also permits the Council to make rules as to:
1. What may or may not be done by a registered pharmaceutical assistant when acting on behalf of a registered pharmacist; and
2. What constitutes the temporary absence of a registered pharmacist.
Following a period of public consultation, the Council of the PSI considered the proposed draft Pharmaceutical Society of Ireland (Temporary Absence of Pharmacist from Pharmacy) Rules 2018 at its meeting of 20 September 2018, where the Council approved the draft rules without amendment. Following this, the PSI undertook to redraft the Rules in relation to what may or not be done by a registered pharmaceutical assistant when acting on behalf of a registered pharmacist.
On 6 December, the Council of the PSI approved a revised draft of the Pharmaceutical Society of Ireland (Temporary Absence of Pharmacist from Pharmacy) Rules 2018 for issuance for public consultation. This public consultation commenced on 13 December 2018 and ran until 11 January 2019, affording any interested party the opportunity to make representations on the matter directly to the PSI.
Following completion of the public consultation phase, the Council of the PSI considered the proposed draft Pharmaceutical Society of Ireland (Temporary Absence of Pharmacist from Pharmacy) Rules 2018 at its meeting on 14 February 2019.
My role in relation to this process is limited to the consideration of any such Rules once submitted for my consent. I must consider any Rules presented to me from a fair and impartial perspective, without prejudice or prejudgment.
I await the receipt of the Rules for my consideration from the PSI and, until that time, I am unfortunately not in a position to comment any further on the matter raised.
