Written Answers Nos. 644-661
647. Deputy Paul Murphy asked the Minister for Health in view of the NCPE's recent negative recommendation in relation to Evusheld, the action he will take on behalf of immunosuppressed people; if he will direct the HSE to make Evusheld available to all who need it; and if he will make a statement on the matter. [6729/23]
Amharc ar fhreagraThe National Centre for Pharmacoeconomics (NCPE) has responsibility for assessing evidence for comparative effectiveness and cost-effectiveness of technologies for use by patients in Ireland. This is done through assessment of evidence submitted by manufacturers and independent systematic review.
The NCPE has conducted a Health Technology Assessment (HTA) on Evusheld. This is a standard approval process for all new therapeutics, including those indicated for COVID-19. Following assessment of the submission made by AstraZeneca in respect of Evusheld, the NCPE has recommended that Evusheld not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.
In addition, available scientific evidence raises concerns in terms of the efficacy of Evusheld in light of emerging/increasing variants, and for that reason there is also significant risk around utilising the product as a potential contingency given the uncertainty around new variants, and the current evolutionary pattern towards sub-lineages of Omicron strains. The European Medicines Agency’s Emergency Task Force and the U.S. Food and Drug Administration have outlined concerns around the declining efficacy of these treatments and have cautioned that monoclonal antibodies currently authorised for COVID-19, including Evusheld, are unlikely to be effective against emerging strains of SARS-CoV-2.
The status of Evusheld and other existing and emerging COVID-19 therapeutics will continue to be monitored and assessed in order to ensure both the public interest and the capacity of the health system and service delivery is protected. Any individual who has concerns about an underlying condition or their level of risk in relation to COVID-19 should continue to seek advice from their GP or treating clinician.
648. Deputy Paul Murphy asked the Minister for Health if he will support the inclusion of the future of the medically vulnerable to Covid-19 on the agenda of the next Cabinet committee on health on 13 February 2023; and the plans of his Department and the HSE in relation to enabling the immunocompromised and immunosuppressed to fully participate in society. [6730/23]
Amharc ar fhreagraI wish to inform the Deputy that "future of the medically vulnerable to Covid-19" was not an agenda item at the Cabinet Committee for Health, and that I am committed to supporting those who are immunocompromised and immunosuppressed to fully participate in society as we emerge from the pandemic.
As the Deputy will be aware, from the outset, our response to the pandemic has been supported by a strong cross-Government COVID-19 oversight structure to ensure a public health-led, whole-of-society approach to the COVID-19 response.
Our approach to decision making in the pandemic has been underpinned by the core national priorities of protecting the most vulnerable in society from the severe impacts of COVID-19, minimising the burden on the healthcare system, and continuing to keep schools and childcare facilities open. The approach has also been guided by a number of core ethical principles: a duty to provide care, equity, solidarity, fairness, minimising harm, proportionality, reciprocity, and privacy.
Our national response has now transitioned from a focus on regulation and population-wide restrictions to public health advice, personal judgement, and personal protective behaviours.
It is important to note that current public health advice states that it is safe for the public to go about their daily lives and socialise, while being mindful of the current public health advice. For those with continued concerns, or patients who are immunocompromised, it is important that they speak with their treating clinician or clinical team to understand what their personal risk factors are and what protective measures they can take to protect themselves from COVID-19, including by availing of the vaccine offered to them and the potential use of therapeutics should they test positive for COVID-19.
The HSE has dedicated webpages with advice on how those who are at higher risk can protect themselves from COVID-19, advice for those with a weak immune system, and advice on treatments available for people at the highest risk from COVID-19. See the following links: www2.hse.ie/conditions/covid19/people-at-higher-risk/overview/
www2.hse.ie/conditions/covid19/people-at-higher-risk/weak-immune-system/
www2.hse.ie/conditions/covid19/symptoms/treatments-for-covid-19/
There is also a specific strand of communication (see: youtu.be/dLUwaA4YCkU) acknowledging that as we interact with people in our daily lives, we do not know who amongst them may be at risk from COVID-19, but we do know how to protect them: vaccination, staying home if sick, washing hands, wearing masks, and opening windows.
Finally, I wish to strongly emphasise the importance of vaccination in our continued efforts to mitigate the worst effects of COVID-19. Ireland's COVID-19 vaccination programme is based on the principles of safety, effectiveness and fairness, with the objective of prevention of sickness and mortality, and to preserve the health of people, by prioritising those at highest risk.
The NIAC has recommended a third mRNA booster for people aged 65 years and older, and those aged 12-64 years who are immunocompromised. The NIAC will continue to examine emerging evidence regarding booster vaccines for others in the population where there is evidence of waning immunity and reduced effectiveness and will make further recommendations if required. My Department continues to monitor COVID-19 and will continue to issue public health advice as required.
649. Deputy James Lawless asked the Minister for Health the status of a hospital appointment for a person (details supplied); and if he will make a statement on the matter. [6732/23]
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.
In relation to the particular query raised, as this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
650. Deputy Carol Nolan asked the Minister for Health if he will outline the age of consent to medical treatment, as well as the policy basis for the current law on the matter; and if he will make a statement on the matter. [6741/23]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
651. Deputy Michael Ring asked the Minister for Health when staff in a section 39 organisation (details supplied) will receive the Covid-19 pandemic recognition payment; and if he will make a statement on the matter. [6746/23]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly.
652. Deputy Niamh Smyth asked the Minister for Health the options a person (details supplied) has to get dental works carried out; and if he will make a statement on the matter. [6754/23]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
656. Deputy Duncan Smith asked the Minister for Health if he has plans to introduce a national lung cancer screening service; if he has received any proposals for such a service; the projected annual cost for such a programme; the annual cost for each individual cancer screening service currently in place; the projected number of people each will screen in 2022 and 2023, respectively, in tabular form; and if he will make a statement on the matter. [6779/23]
Amharc ar fhreagraI am fully committed to supporting our population screening programmes which are a valuable part of our health service, enabling early treatment and care for many people, and improving the overall health of our population.
Any decisions about screening will be made on the advice of the National Screening Advisory Committee (NSAC).
This independent expert group considers and assesses evidence in a robust and transparent manner, and against internationally accepted criteria. It is important we have rigorous processes in place to ensure our screening programmes are effective, quality assured and operating to safe standards, and that the benefits of screening outweigh the harms.
An exact costing cannot be provided for the introduction of a new population-based screening programme as financial cost is but one factor that is considered in the decision-making process. Due to the complex nature of the evaluation process and the criteria against which a decision is made, it would be impossible to accurately quantify the cost of a new screening programme until a full evidential assessment was completed.
The Committee's first Annual Call (2021) for proposals for new screening programmes or changes to our existing programmes, received a significant response with over 50 submissions, including proposals for Lung Cancer. Submissions were received from various sources, including members of the public and patient advocates, and underwent consideration by the committee at its scheduled meetings during 2022. The Committee recently published its Work Programme on its website and launched a second Annual Call.
Under Europe’s Beating Cancer Plan, a Proposal for an updated European Council Recommendation on cancer screening was formally approved on 9 December 2022 and published thereafter. The NSAC will consider this recommendation and advise me and the Department of Health on the evidence as it applies to Ireland.
Please note the additional queries raised are a service matter they have been referred to the Health Service Executive for attention and direct reply to you.
657. Deputy Duncan Smith asked the Minister for Health the level of expenditure on new medicines in 2022; and if he will make a statement on the matter. [6780/23]
Amharc ar fhreagraUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for pricing and reimbursement of new medicines.
The HSE in its decision making considers the 5-year budget impact of each new medicine notwithstanding that the budget of the HSE is set on an annual basis. The year 1 costs of most medicines represent a fraction of the overall costs of those medicines when fully introduced.
In 2021, 29 new medicines and 21 new uses of existing medicines and 2 expansions of reimbursement were approved at a year one cost of €34.39 million, with an additional cost of €477m over the first 5 years of those decisions.
In 2022, 30 new medicines and 30 new uses of existing medicines were approved at a year one cost of €15.5 million, with an additional cost of €178m over the first 5 years of those decisions.
658. Deputy Mairéad Farrell asked the Minister for Health his views on the use of the private sector to deliver the new Galway city west primary care centre at Seamus Quirke Road; his views on whether this will offer the best value for money to the State; the reasoning behind the decision to lease a privately owned building for this project; how it offers savings to the State when compared with purchasing a property for this purpose, given the briefing document for the project which that the project claims the procurement has been competitively sourced and, based on the proposed lease terms to be agreed, provides the HSE value for money; and if he will make a statement on the matter. [6781/23]
Amharc ar fhreagraA central objective of the Programme for Government is to deliver increased levels of integrated health care with service delivery reoriented towards general practice, primary care and community-based services to enable a “home first” approach.
Primary Care Centres play an essential role in the delivery of that objective and significant progress has been made in the delivery of these centres nationally. These centres support the delivery of integrated care by facilitating closer coordination and cooperation between health professionals from across different disciplines. They also provide a single point of access to services for the individual and can serve as a resource more broadly for the community.
The operational lease model is often the preferred model for developing primary care centres as it has the potential to offer better value for money and enable streamlined delivery of projects. Under the model, the Health Service Executive (HSE) enters into fixed term leases with developers for locations selected for the provision of primary care centres. The HSE identifies the locations requiring Primary Care Centre and invites interested parties to express their interest in providing suitable accommodation by way of public notice in national and/or local press. The developer provides the completed facility and has responsibility for maintaining it. The HSE pays annual rent and service charges and operates the facility. The lease term is often 15-20 years and after the expiration of this period, the facility reverts to ownership by the landlord.
As the HSE holds responsibility for the provision, along with the maintenance and operation of Primary Care Centres, I have asked the HSE to provide the Deputy with further information regarding the specific Primary Care Centre mentioned.
659. Deputy Fergus O'Dowd asked the Minister for Health if he will provide an update on the refurbishment, refitting and extension of the Castlebellingham health centre to a new primary care centre; the total expected cost of the project; the list of services that will be provided in the new premises; the expected completion date; and if he will make a statement on the matter. [6782/23]
Amharc ar fhreagraAs the Health Service Executive is responsible for the delivery of public healthcare infrastructure projects, I have asked the HSE to respond to you directly in relation to this matter.
660. Deputy Thomas Gould asked the Minister for Health if consideration has been given to the removal of the prescription requirement for naloxone. [6792/23]
Amharc ar fhreagraThe Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended sets out the system of control which applies to medicinal products, and identifies those products which may only be supplied on medical prescription.
Naloxone is an active substance contained in a number of medicinal products authorised for use, in both single and combination active substance products (see www.hpra.ie/homepage/medicines/medicines-information/find-a-medicine/results?query=Naloxone&field=ACTIVESUBSTANCES), which are subject to prescription control and may only, in normal circumstances, be supplied on foot of the presentation of a prescription by a patient for whom it is prescribed, and dispensed under the supervision of a pharmacist from a pharmacy. Once so supplied to an individual patient the product can be administered by any person.
In 2015 however the Medicinal Products Regulations were amended with the purpose of this being to allow for the supply and administration of specified prescription-only medicinal products, including Naloxone hydrochloride dihydrate 1 mg/ml pre-filled injection and Naloxone hydrochloride dihydrate 1.8 mg Nasal Spray Solution, without a prescription to a person by:
- a pharmacist, or
- by an individual appointed by a listed organisation,
for the purpose of saving life or reducing severe distress in emergency situations, where that pharmacist or individual has completed an approved course of training regarding the administration of such products and the management of any adverse reaction.
The training to be completed in the case of pharmacists must be delivered by a body recognised by the Council of the Pharmaceutical Society of Ireland (PSI) and approved by the Registrar of that organisation. In the case of the person appointed by a listed organisation, the training to be completed must approved by the Pre-Hospital Emergency Care Council (PHECC) or another body nominated by the Minister for Health for that purpose.
These Regulations provide for the creation of a list of organisations that may procure the specified medicinal products for supply and administration in an emergency, by trained persons in the organisation. This list is maintained by the Health Products Regulatory Authority (HPRA) and is available at www.hpra.ie/homepage/medicines/emergency-medicines/emergency-medicines-search .
The PSI has published an Explanatory Note for Pharmacists on the Supply of ‘Emergency’ Prescription-Only Medicines to a Listed Organisation. The HPRA also have guidance on their website in relation to their role on this matter (see www.hpra.ie/homepage/medicines/emergency-medicines).
In order to procure any of the permitted listed products (Products listed in the Tenth Schedule of the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended) as a listed organisation, a number of criteria must be satisfied (Regulation 4D), including the appointment of an accountable person(s) for that organisation. The legislation also sets out a list of responsibilities that the accountable person must meet on behalf of the listed organisation. These relate to:
- overseeing the storage requirements for the product,
- ensuring that the product is sourced appropriately,
- ensuring that the product is only supplied to a person to supply and administer in an emergency,
- maintaining confidential records,
- ensuring that person(s) with responsibility for supplying and administering the product in an emergency is trained in accordance with the framework specified in the regulations,
- assisting in any necessary investigation in the event of an adverse event.
The Regulations set out the records to be kept by pharmacists, pharmacy owners, persons who supply and administer medicinal products in emergencies, listed organisations and accountable persons in such organisations, in respect of each supply and administration of a specified prescription-only medicinal product without a prescription in accordance with these Regulations.
In relation to training for persons employed by a listed organisation, the Pre-Hospital Emergency Care Council have information on their website about training providers and courses available (see www.phecit.ie/PHECC/Publications_and_Resources/Newsletters/Newsletter_Itmes/2016_Summer/Emergency_life-saving_medicines.aspx).
The relevant legislation is S.I. No. 449/2015 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2015, (available at: www.irishstatutebook.ie/eli/2015/si/449/made/en/print?q=medicinal+&years=2015.
661. Deputy Thomas Gould asked the Minister for Health the number of naloxone prescriptions issued in each of the past five years, in tabular form. [6793/23]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
