Thomas Gould
Question:684. Deputy Thomas Gould asked the Minister for Health the number of persons diverted after arrest for possession for personal use through the health diversion approach. [36225/20]
View answerDrug Treatment Programmes
Questions (684)
Written answers
The Government is implementing a public health-led approach to drug use, known as the health diversion programme. This programme will connect people who use drugs with health services and a pathway to recovery, avoiding a criminal conviction, which can have far-reaching consequences for people, particularly younger people.
There are two components to the health diversion programme whereby a person in possession of drugs, determined by An Garda Síochána to be for personal use, on the first occasion would be referred by An Garda Síochána on a mandatory basis to the Health Service Executive (HSE) for a health screening and brief intervention. On the second occasion, An Garda Síochána would have discretion to issue an Adult Caution.
An implementation, monitoring and evaluation group, chaired by the Department of Health, is implementing the health diversion programme. The Group is developing proposals to commence implementation of the programme on an administrative basis in a number of locations throughout the country in 2021.
As outlined in the Programme for Government, a review of the programme will take place following the first full year of implementation, to ensure that it is meeting all of its aims.
I am committed to a health-led approach for possession of drugs for personal use, and I look forward to the commencement of the health diversion programme in 2021.
Covid-19 Pandemic
Questions (685)
Carol Nolan
Question:685. Deputy Carol Nolan asked the Minister for Health if it is permissible under existing regulations for a shop or premises to display a "no mask, no service" sign with respect to Covid-19 restrictions; and if he will make a statement on the matter. [36235/20]
View answerWritten answers
The public health advice relating to Covid-19, including that relating to face coverings, is kept under continuing review by the National Public Health Emergency Team (NPHET).
A person, without reasonable excuse, must now wear a face covering when using public transport, in retail outlets, shops and shopping centres, in other indoor spaces such as libraries, cinemas and cinema complexes, theatres, concert halls, bingo halls, museums, businesses carrying out cosmetic nail care or nail styling, hair care or hair styling, tattoo and piercing services, travel agents and tour operators, laundries and dry cleaners and licensed bookmakers.
The Regulations relevant to retail settings are the Health Act 1947 (Section 31A – Temporary Restrictions) (Covid-19) (Face Coverings in certain premises and businesses) Regulations 2020 (S.I No. 296/2020) as amended by S.I. 511 of 2020.
These Regulations do not apply:
- to a person under 13 years,
- to the occupier, manager or person in charge or a worker where there is a screen that separates them from other persons or the person takes all reasonable steps to maintain a distance of two metres
- to a member of the Garda Síochána in the course of performing his or her duties
These Regulations provide that it is a matter for the occupier, manager or person in charge to take all reasonable steps to engage with persons entering or in a relevant premises to inform them of the requirements to wear a face covering and to promote compliance with the requirement. It is therefore a matter for the management of the retail operator concerned to decide what he/she may accept in terms of a reason for not wearing a face covering.
The Deputy may wish to note that the requirement to wear a face covering in the situations described is a penal provision for the purposes of section 31A of the Health Act 1947 (No. 28 of 1947). Enforcement is a matter for An Garda Síochána.
A reasonable excuse includes when a person cannot put on, wear or remove a face covering because of a physical or mental illness, impairment or disability or without severe distress; to communicate with a person who has difficulties communicating; to provide emergency help or care to a vulnerable person; to avoid harm or injury or to take medication. In addition, in retail outlets, it is also permitted to remove the face covering to allow for identification when the sales of goods or services have a minimum age requirement, or to assist in the provision of healthcare or healthcare advice.
The current face covering advice is available at
- https://www2.hse.ie/conditions/coronavirus/face-masks-disposable-gloves.html
- http://www.gov.ie/facecoverings/
Health Services Staff
Questions (686)
Michael Healy-Rae
Question:686. Deputy Michael Healy-Rae asked the Minister for Health the actions being taken to address a matter (details supplied); and if he will make a statement on the matter. [36250/20]
View answerWritten answers
All public health sector staff, including those working in hospitals as catering employees are paid in line with the rates set out in the Department of Health consolidated salary scales which can be viewed online here: https://www.gov.ie/en/publication/5eb5e-1-october-2020-consolidated-pay-scales/
In relation to incremental progression, each salary scale listed has either a single point, or a number of points, which an employee would progress through each year on the anniversary of their contract date, once their performance and attendance had met the necessary criteria required to achieve the increment.
Adjustments to rates of pay across the public sector are generally agreed during a series of pay talks between trade unions and their representative bodies and the civil and public sector employer representatives during negotiations in advance of each Public Service Stability Agreement (PSSA).
Adjustments to rates of pay agreed between the parties generally apply to the full public health sector cohort of grades, including catering staff, in return for a set of agreed productivity and efficiency measures.
Since 2016, a number of increases to annualised salaries have been applied via public service agreements and the Public Service Pay and Pension Act 2017. These adjustments have been applied across all public health sector grades, including catering staff as appropriate.
1.1.2016 - 1% increase to annualised salaries between €24,001 and €31,000.
1.4.2017 - €1,000 increase to annualised salaries up to €65,000
1.1.2018 - 1% increase to annualised salaries.
1.10.2018 - 1% increase to annualised salaries.
1.9.2019 - 1.75% increase to annualised salaries.
1.10.2020 - 2% increase to annualised salaries.
I trust this information will be of assistance to the Deputy.
Speech and Language Therapy
Questions (687, 688)
Kathleen Funchion
Question:687. Deputy Kathleen Funchion asked the Minister for Health the number of children nationally who are waiting for an assessment for speech and language therapy in tabular form. [36397/20]
View answerKathleen Funchion
Question:688. Deputy Kathleen Funchion asked the Minister for Health the length of time children nationally are waiting to see a therapist for speech and language in tabular form. [36398/20]
View answerWritten answers
I propose to take Questions Nos. 687 and 688 together.
The Programme for Government, Our Shared Future, recognises the need to improve services for both children and adults with disabilities through better implementation and by working together across Government in a better way.
The Government commits to prioritising early diagnosis and access to services for children and ensuring that the most effective interventions are provided for each child, to guarantee the best outcomes.
As these questions relate to service matters, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
Health Promotion
Questions (689)
Brendan Griffin
Question:689. Deputy Brendan Griffin asked the Minister for Health if public health messaging advertising will be extended to local print media in view of the fact that these advertisers are currently not being utilised despite having widespread circulation. [36893/20]
View answerWritten answers
As this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
Budget 2021
Questions (690, 732)
Gerald Nash
Question:690. Deputy Ged Nash asked the Minister for Health the amount of additional ring-fenced funding to be provided to domestic violence services under budget 2021 in order that services can respond adequately to increased incidence of domestic violence through Covid-19 and beyond; and if he will make a statement on the matter. [37131/20]
View answer
Fergus O'Dowd
Question:732. Deputy Fergus O'Dowd asked the Minister for Health the additional ring-fenced funding to be provided by his Department to domestic violence services in budget 2021 in order that services can respond adequately to the shadow pandemic of domestic violence through Covid-19 and beyond; and if he will make a statement on the matter. [36345/20]
View answerWritten answers
I propose to take Questions Nos. 690 and 732 together.
Budget 2021 provides an allocation of €175,000 for initiatives for victims of domestic violence and the LGBTI community. From this allocation, €50,000 will be provided for on-line training programmes for health care professionals responding to victims of domestic violence.
The HSE Social Inclusion Division provide support and training to health and community service providers to ensure that all families experiencing, or at risk of experiencing domestic violence, sexual violence, or both, will receive supports when they access a health service.
This training programme will help create a consistent, appropriate and culturally competent response to persons presenting to health services as a result of domestic and gender-based violence. The training will ensure staff respond appropriately and are able to make referrals, as required, to a specialist service, where victims are supported to make changes in their lives at a pace that suits their situation.
As minister for public health, I am happy to support health and community service providers to respond to domestic violence, especially given the increased risk during Covid-19.
General Medical Services Scheme
Questions (691)
Seán Canney
Question:691. Deputy Seán Canney asked the Minister for Health the options open to medical card holders who are being charged for blood tests by their general practitioners; if his attention has been drawn to the difficulty and additional costs being placed on many medical card holders; his plans to change the current regime; and if he will make a statement on the matter. [36142/20]
View answerWritten answers
Persons who are eligible for GP care without charge under the Health Act 1970 are not subject to any co-payments or other charges in respect of such services. There is no provision under the GMS GP contract for persons who hold a medical card or GP visit card to be charged for routine phlebotomy services provided by their GP which are required to either assist in the diagnosis of illness or the treatment of a condition and the HSE has advised GPs accordingly.
I am aware that, nonetheless, some GPs are charging GMS patients for phlebotomy services in some circumstances. The GP chronic disease management programme which is being phased in from this year will involve the ongoing monitoring of patients’ condition and any blood tests required in this context will be covered by the fees payable for this care.
However, it remains a matter of concern to me that a GMS and GP visit card patient might be charged for blood tests which are clinically necessary and I have asked my officials to discuss with the HSE what further solutions to this issue may be possible. If a patient who holds a medical card or GP visit card believes he or she has been incorrectly charged for routine phlebotomy services by his or her GP, then that patient should report the matter to their HSE Local Health Office. The local management, upon being notified of potential inappropriate charging of GMS patients, carry out an investigation into each complaint and will, where appropriate, arrange for a refund of charges incorrectly applied by the GP.
Health Services
Questions (692)
Michael McNamara
Question:692. Deputy Michael McNamara asked the Minister for Health if an association (details supplied) is classified as an essential service following the implementation of level 5 restrictions; and if he will make a statement on the matter. [36146/20]
View answerWritten answers
As the Deputy is aware, the situation regarding COVID-19 has been, and continues to be, an evolving situation. COVID-19 is still having a major impact both here in Ireland and elsewhere.
On Tuesday 15 September the Government published ‘Resilience and Recovery 2020-2021: Plan for Living with COVID-19’. This Plan outlines our medium-term strategy for COVID-19 and sets out a Framework of 5 Levels which outline the broad measures which will apply depending on the level of the virus at any given time. It will be possible for different regions and counties to be at different levels, depending on the prevailing epidemiological situation. The Plan is designed to help everyone – individuals, organisations and sectors – to better understand, anticipate and prepare for the measures that might be introduced to contain transmission of the virus. The intention is that Departments and sectors will provide guidance for specific sectors and activities in line with the 5 level framework.
At Level 5 of the Plan, only essential retail outlets and essential services are allowed to open to the public. The list of essential services that can remain open during Level 5 includes therapy services provided by a member of a designated profession within the meaning of section 3 of the Health and Social Care Professionals Act 2005 (No. 27 of 2005). There are seventeen professions designated under the 2005 Act, which are encompassed in the list of essential services. These are: Dietitians, Dispensing Opticians, Medical Scientists, Occupational Therapists, Optometrists, Physiotherapists (which includes Physical Therapists), Radiographers, Radiation Therapists, Social Workers, Speech and Language Therapists, Clinical Biochemists, Counsellors, Orthoptists, Podiatrists, Psychologists, Psychotherapists and Social Care Workers.
The public health advice relating to Covid-19 is kept under continuing review by the National Public Health Emergency Team (NPHET), and it provides advice to Government in line with the current epidemiological position. The latest public health advice on these matters is available at the links below and is updated on a regular basis:
https://www.gov.ie/en/organisation/department-of-health/
https://www2.hse.ie/coronavirus/
https://www.gov.ie/en/
Health Services
Questions (693)
Michael Fitzmaurice
Question:693. Deputy Michael Fitzmaurice asked the Minister for Health the reason senior HSE management have refused to meet with a company (details supplied) to discuss the benefits of single UV light emitter technology and its potential use in nursing homes or hospitals; and if he will make a statement on the matter. [36149/20]
View answerWritten answers
As this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
Hospital Waiting Lists
Questions (694)
David Cullinane
Question:694. Deputy David Cullinane asked the Minister for Health the services offered by the HSE for which there is a waiting list; the median and mean wait time on each list; and if he will make a statement on the matter. [36163/20]
View answerWritten answers
As a result of the significant impact of COVID 19 on routine health services and the impending Winter period which brings its own pressures, the health service is facing unprecedented challenges for the delivery of services in a COVID environment.
Resuming health and social care services and building the health sector capacity and capability for the pressures of Winter 2020 and into 2021 is a priority for the Government.
It is important to recognise that many vital services have continued throughout the pandemic, ensuring that priority care needs were addressed and the most vulnerable protected even at the height of this crisis
The HSE published its Strategic Framework for Delivery of Service Continuity in a COVID Environment (June 2020). This ensures that services are restored in a prioritised manner with investments targeted at rebuilding services guided by Sláintecare - shifting service provision from Hospital to community-based care. This ensures a safer environment for patients and service users.
Over the summer period we have seen a gradual resumption of many of those services that were curtailed, although unfortunately there are still areas where the level of service falls below that which was being delivered up to mid-March.
To ensure the continued and appropriate delivery of Health Services in a COVID Environment, The HSE have developed the ‘Delivering Health Services in a COVID-19 Pandemic’ Plan. This plan includes the normal winter plan that would incorporate enhancement to services to cope with winter pressures, but also takes a more strategic approach by considering actions necessary to resume services and building capacity such that the system can deal with expected demand and pressures to the end of 2020/21.
The Plan was considered as part of the estimates process which concluded with the Government announcing an additional €4 billion in Budget 2021 for health services which is the largest health budget increase in the history of the State.
The HSE are in process of developing it’s 2021 National Service Plan which will set out the type and volume of services that the HSE will provide for its financial allocation including the additional €4 billion announced in Budget 2021.
I have asked the Health Service Executive to examine the issues raised by the deputy and to respond to him directly and to provide the data sought, as soon as possible.
Hospital Waiting Lists
Questions (695)
Pa Daly
Question:695. Deputy Pa Daly asked the Minister for Health the duration of waiting lists at a hospital (details supplied) by the number of patients waiting in three-month increments - for example, the number waiting for three months, six months, nine months and so on; and if he will make a statement on the matter. [36175/20]
View answerWritten answers
Reducing waiting time for patients for hospital operations and procedures is a key priority for Government. In recent years, my Department has worked with the HSE and the National Treatment Purchase Fund (NTPF) and made considerable improvements to access for patients waiting for high volume procedures, including cataracts.
It is recognised that waiting times for scheduled appointments and procedures have been impacted as a direct result of the COVID-19 pandemic.
In response to the Covid-19 pandemic the HSE had to take measures to defer most scheduled care activity in March, April, and May of this year. This was to ensure patient safety and that all appropriate resources were made available for Covid-19 related activity and time-critical essential work. This decision was in line with the advice issued by the National Public Health Emergency Team (NPHET) in accordance with the advice of the World Health Organisation.
Patient safety remains at the centre of all hospital activity and elective care scheduling. To ensure services are provided in a safe, clinically-aligned and prioritised way, hospitals are following HSE clinical guidelines and protocols.
The HSE continues to optimise productivity through alternative work practices such the use of alternative settings including private hospitals, community facilities and alternative outpatient settings.
The data requested by the Deputy concerning Cataract surgery waiting lists in Cork University Hospital is not available as this Hospital provides a regional tertiary referral ophthalmic service for the South-South West region and access to inpatient services for Ophthalmology is via the South Infirmary Victoria University Hospital (SIVUH).
The waiting lists for patients awaiting cataract surgery at the South Infirmary Victoria University Hospital, as well as the number originating from County Kerry is outlined in the document below.
Hospice Services
Questions (696)
Dara Calleary
Question:696. Deputy Dara Calleary asked the Minister for Health the criteria under which funding was awarded via the recent announcement of funding for hospices; the reason some hospice organisations providing homecare supports were excluded; if additional funding will be made available to those excluded given that they have the same funding pressures in 2020 as the others; and if he will make a statement on the matter. [36182/20]
View answerWritten answers
On 8 November 2020, I announced the provision of €10 million in once-off funding in 2020 to support the voluntary palliative care sector to maintain critical and ongoing care services for adults and children in the context of the challenges posed by the COVID-19 pandemic. Voluntary organisations in the palliative care sector, funded by the HSE under a Section 38 or Section 39 Service Level Arrangement, were deemed to be eligible for inclusion in the fund.
On the basis of these criteria:
- 85% of the funding is being allocated to the six voluntary hospices which provide around 90% of the country's adult inpatient hospice beds and deliver palliative homecare and other community supports;
- 7.5% of the funding is being allocated to LauraLynn children's hospice which provides respite, end of life care and other services for children with life limiting conditions and their families;
- 4% of the funding is being divided equally between the Irish Hospice Foundation, the All Ireland Institute of Hospice and Palliative Care, the Jack and Jill Children's Foundation and the Irish Cancer Society Night Nursing Service;
- The remaining 3.5% of the funding is being divided equally between four voluntary palliative care homecare providers in the south east of the country, all of which have a Service Level Arrangement with the HSE.
Covid-19 Pandemic
Questions (697)
Thomas Gould
Question:697. Deputy Thomas Gould asked the Minister for Health the number of Covid-19 cases that have arisen from attendance at religious sermons. [36195/20]
View answerWritten answers
As this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
Hospital Appointments Status
Questions (698)
Duncan Smith
Question:698. Deputy Duncan Smith asked the Minister for Health the status of an appointment for surgery for a person (details supplied) in County Kildare; and if he will make a statement on the matter. [36208/20]
View answerWritten answers
It is recognised that waiting times for scheduled appointments and procedures have been impacted as a direct result of the COVID-19 pandemic.
In response to the Covid-19 pandemic the HSE had to take measures to defer most scheduled care activity in March, April, and May of this year. This was to ensure patient safety and that all appropriate resources were made available for Covid-19 related activity and time-critical essential work. This decision was in line with the advice issued by the National Public Health Emergency Team (NPHET) in accordance with the advice of the World Health Organisation.
Patient safety remains at the centre of all hospital activity and elective care scheduling. To ensure services are provided in a safe, clinically-aligned and prioritised way, hospitals are following HSE clinical guidelines and protocols.
The HSE continues to optimise productivity through alternative work practices such the use of alternative settings including private hospitals, community facilities and alternative outpatient settings.
Under 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 is a standardised approach used by the HSE to manage scheduled care treatment for in-patient, day case and planned procedures. It sets out the processes that hospitals are to implement to manage waiting lists and was developed in 2014 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.
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.
Hospital Services
Questions (699)
Aengus Ó Snodaigh
Question:699. Deputy Aengus Ó Snodaigh asked the Minister for Health the average waiting time for gynaecological services for a woman in need of an ultrasound scan in St. James’s Hospital and Tallaght Hospital. [36211/20]
View answerWritten answers
It is recognised that waiting times for scheduled appointments and procedures have been impacted as a direct result of the COVID-19 pandemic.
In response to the Covid-19 pandemic the HSE had to take measures to defer most scheduled care activity in March, April, and May of this year. This was to ensure patient safety and that all appropriate resources were made available for Covid-19 related activity and urgent time-critical work. This decision was in line with the advice issued by the National Public Health Emergency Team (NPHET) in accordance with the advice of the World Health Organisation.
Patient safety remains at the centre of all hospital activity and elective care scheduling. To ensure services are provided in a safe, clinically-aligned and prioritised way, hospitals are following HSE clinical guidelines and protocols.
In terms of the current provision of treatment to patients, the HSE has advised the Department that hospitals continue to offer appointments and treatments to patients. The HSE website provides details of services currently available and operational in each hospital. This is frequently updated by the HSE.
The HSE continues to optimise productivity through alternative work practices such as the use of alternative settings including private hospitals, community facilities and alternative outpatient settings.
The National Treatment Purchase Fund (NTPF) is currently reviewing strategies to maximise activity and benefit for patients, to include, increased use of private hospitals, funding weekend and evening work in public hospitals, funding “see and treat” services where minor procedures are provided at the same time as outpatient consultations, funding hybrid services where public and private hospitals contribute to the treatment of patients, virtual clinics and clinical validation.
The NTPF have advised that they cannot provide average wait times for diagnostics and have provided waiting times by time band instead. The data requested by the Deputy for gynaecological services/ultrasound scan in St. James’s Hospital and Tallaght Hospital is outlined in the document below by time band.
Medicinal Products
Questions (700)
David Cullinane
Question:700. Deputy David Cullinane asked the Minister for Health when the current round of discussions on the new supply and pricing of medicines agreement will conclude; when he expects to have a replacement agreement in operation; and if he will make a statement on the matter. [36213/20]
View answerWritten answers
Since the 1970’s, pricing mechanisms and supply arrangements for medicines in Ireland have been determined by the terms of agreements between the State and the respective representative bodies of the pharmaceutical industry in Ireland. The most recent agreement was the Framework Agreement on the Supply of Medicines to the Health Services 2016-2020. This was due to end in July 2020, however due to COVID-19 it was necessary to seek an extension.
The Department of Health and the HSE entered into negotiations with the Irish Pharmaceutical Healthcare Association (IPHA) in July 2020, agreeing an extension on the terms of the existing 2016-2020 agreement for a period of 6 months, to 31st January 2021.
The Department and the HSE are considering the approach to discussions on a successor agreement.
Covid-19 Pandemic
Questions (701)
Neale Richmond
Question:701. Deputy Neale Richmond asked the Minister for Health the measures he has taken to protect Ireland from the new strain of Covid-19 that has emerged in Denmark; and if he will make a statement on the matter. [36219/20]
View answerWritten answers
Once my Department became aware of the cluster of human cases of the SARS-CoV-2 variant in Denmark associated with mink farms on 5 November last, the National Public Health Emergency Team (NPHET) took a number of precautionary and appropriate measures.
The NPHET held a initial risk assessment meeting with further meetings held over the course of the following days to identify what measures, on a precautionary basis, that should be put in place in this country in response to this issue. These precautionary measures included actions to be taken by a number of State organisations and other Government Departments such as the HSE and the Department of Agriculture, Food and the Marine.
Frontline clinicians were also immediately alerted to the importance of travel history in relation to people presenting for testing and the specific self-isolation recommendations for those who had travelled from Denmark. This information was also communicated by way of announcements on planes and made available at other points of entry onto the island. In addition, any testing that might need to be done in respect of anyone who had travelled from Denmark would be sent to the National Virus Reference Laboratory to undertake the kind of genome sequencing that was done in Denmark that allowed this strain to be identified in the first instance.
The World Health Organisation (WHO) has now made available guidance based on some of its preliminary assessments of the emergence of this strain, available at: https://www.who.int/csr/don/06-november-2020-mink-associated-sars-cov2-denmark/en/ and the European Centre for Disease Control (ECDC) have published a Rapid Risk Assessment in relation to the overall level of risk to human health posed by the SARS-CoV-2 mink-related variants, available at: https://www.ecdc.europa.eu/sites/default/files/documents/RRA-SARS-CoV-2-in-mink-12-nov-2020.pdf
You may wish to note that the precautionary prevention measures identified by the Government and that are already in place here are in line with the recommendations of the WHO and the ECDC.
The HSE has advised that they have now completed the first phase of testing of mink farm workers and their household contacts across all three mink farm sites in Ireland. They have further advised that it is planned to carry out these tests on a weekly basis to review and assess any outcomes.
I can assure the Deputy that my Department and the HSE are working very closely with the Department of Agriculture, Food and the Marine on this matter, and will continue to do so.
Medicinal Products
Questions (702)
Bernard Durkan
Question:702. Deputy Bernard J. Durkan asked the Minister for Health the position regarding approval of new or orphan drugs; the number of such drugs awaiting approval in the system; if Covid-19-related drugs are under consideration at present; if access to or reimbursement of Covid-19-related drugs is being expedited at a European or national level, in light of the ongoing pandemic; and if he will make a statement on the matter. [36220/20]
View answerWritten answers
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.
Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).
In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact.
While the 2013 Health Act does not include provision for a different ruleset when assessing orphan drugs, the HSE seeks as far as possible to take into account issues such as the small patient numbers and the nature of the condition to be treated when evaluating these medicines. The criteria that apply to the evaluation process allow sufficient scope for the HSE to take on board the particular circumstances that pertain to orphan drugs.
The HSE has advised that, as of 30 October 2020, there were 81 applications for reimbursement (including new medicines and new uses of existing medicines) undergoing assessment. Of these, 25 had orphan designation.
As of 16 November 2020, the HSE has confirmed that no pricing and reimbursement applications have been received for drugs indicated for either the management or prevention of COVID-19.
The Department of Health is participating in the European Commission Joint Procurement Agreement (JPA) for medicines for the treatment of COVID-19 including Remdesivir (Veklury®). This JPA provides for a voluntary mechanism enabling participating EU countries and the EU institutions to jointly purchase medical countermeasures for different categories of cross-border health threats including vaccines, antivirals and other treatments. The JPA falls outside current pricing and reimbursement application processes.