Written Answers Nos. 994-1021
994. Deputy Gino Kenny asked the Minister for Health the timeframe for the commencement of the medicinal cannabis access programme in 2021; the funding that has been allocated for the programme; if those who are in receipt of a ministerial licence will be included in the programme; and if he will make a statement on the matter. [12078/21]
View answerThe Medical Cannabis Access Programme (MCAP) has been included in the HSE National Service Plan 2021.
The HSE will be responsible for the operation of the programme. The HSE will establish and maintain a Register to facilitate the enrolment and recording of certain data including patient identifiers (in anonymised format), prescribers enrolled in the Programme, as well as prescribed / supplied medical cannabis products.
The HSE has indicated that it is looking at commencement in June 2021.
Ministerial licences under Section 14 of the Misuse of Drugs Act are issued to clinicians whose applications to treat their patients with cannabis-based products have been approved.
The Medical Cannabis Access Programme is for the treatment of three specified conditions:
- spasticity associated with multiple sclerosis resistant to all standard therapies and interventions whilst under expert medical supervision
- intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes whilst under expert medical supervision
- severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications whilst under expert medical supervision
A Consultant currently in possession of a Ministerial licence under the Misuse of Drugs Acts to treat their patient suffering from one of the three specified conditions in the Medical Cannabis Programme can apply to that Programme in order to treat their patient.
995. Deputy Sorca Clarke asked the Minister for Health if he will introduce an initiative under which taxi drivers could provide a door-to-door transport service on a flat rate cost per kilometre for those who have no other method of transport given the distances required to travel to vaccination centres in rural areas in counties Longford and Westmeath. [12084/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
996. Deputy Pearse Doherty asked the Minister for Health when a person (details supplied) in County Donegal will receive an appointment at Holles Street hospital; if the referral is urgent or routine; and if he will make a statement on the matter. [12087/21]
View answerIt is recognised that waiting times for scheduled appointments and procedures have been impacted in the last year as a direct result of the COVID-19 pandemic.
The HSE is currently recommending that only critical time dependent elective procedures are undertaken at this time due to the on-going and significant increased demand for bed capacity related to Covid-19.
This decision was made arising from the rapid increase in Covid-19 admissions and to ensure patient safety and that all appropriate resources were made available for Covid-19 related activity and time-critical essential work.
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.
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.
997. Deputy Pearse Doherty asked the Minister for Health when a person (details supplied) in County Donegal will receive a Covid-19 vaccination; and if he will make a statement on the matter. [12088/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
998. Deputy Catherine Connolly asked the Minister for Health if private study centres offering supervised study time in the evenings for leaving certificate students are considered to be organised indoor gatherings under the national framework for living with COVID-19; if not, if they are included in either the retail and services or the schools and higher and adult education categories; and if he will make a statement on the matter. [12103/21]
View answerAs you will be aware, the public health restrictions at level 5 of the Government's Framework Resilience and Recovery 2020-2021: Plan for Living with COVID-19 will remain in place until 5th April 2021, when a further review will be conducted. The Framework continues to provide an appropriate mechanism to guide decision-making, and it will continue to be supplemented by more detailed sectoral guidance in relation to measures that apply at each level of the Framework.
On 23 February, 2021, the Government published COVID-19 Resilience & Recovery 2021: The Path Ahead which sets out how in-school education and childcare services will be reinstated in a phased manner from 1 March, with staggered return throughout March to be concluded after the Easter break on 12 April. Information on the revised plan is available here –
https://www.gov.ie/en/publication/c4876-covid-19-resilience-and-recovery-2021-the-path-ahead/?referrer=http://www.gov.ie/ThePathAhead/
As I'm sure you can appreciate, COVID-19 spreads when individuals and groups come into close contact with one another, enabling the virus to move from one person to another. COVID-19 is infectious in a person with no symptoms, or for the period of time before they develop symptoms. The number of people allowed to gather in different scenarios in the Government's Framework are based on a review of international practice and the judgment of public health experts. It seeks to balance the risks of different types of gatherings against the desire to allow normal activities to proceed in so far as possible.
The Minister for Health has no responsibility for private study groups or organisations. You may wish to note that under the current public health measures, no indoor gatherings are permitted - further information is available here - https://www.gov.ie/en/publication/2dc71-level-5/#organised-indoor-gatherings
For your further assistance, the Health Act 1947 (Section 31A - Temporary Restrictions) (COVID-19) (NO. 10) Regulations 2020 Regulation (S.I. 701 of 2020), sets out the relevant businesses or services which are permitted to operate under the current public health measures. Statutory Instruments related to the Covid-19 pandemic are available here:
https://www.gov.ie/en/collection/1f150-view-statutory-instruments-related-to-the-covid-19-pandemic/
999. Deputy Robert Troy asked the Minister for Health his plans to transport persons to vaccination centres in areas in which no public transport is available (details supplied). [12104/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
1000. Deputy Sean Sherlock asked the Minister for Health the number of vacant posts across all grades in each hospital and healthcare setting under HSE operation in tabular form including the post grade; and if recruitment is under way. [12110/21]
View answerAs this is a service matter, I have asked the HSE to respond directly to the Deputy on this matter, as soon as possible.
1001. Deputy Sean Sherlock asked the Minister for Health if he has engaged with National Broadband Ireland on any aspect of broadband provision in the past six months; and the outcome of any engagement. [12122/21]
View answerI wish to advise the Deputy that I have not had any engagement with National Broadband Ireland on any aspect of broadband provision in the past 6 months.
1002. Deputy Catherine Murphy asked the Minister for Health the number of patient files on the Covid-19 tracker application, that is, the number of individual entries who have been contact-traced. [12136/21]
View answerI assume when the Deputy refers to the Covid-19 tracker application she is referring to Covid Tracker App (the app that is used on peoples smartphones).
On that basis, the app does not store patient files on the app. It only records anonymous keys that indicate a close contact with another individual, also carrying the app. These keys can be uploaded by any person carrying the app who is subsequently confirmed as Covid positive and used to alert others that are also carrying the app. The app is designed with privacy at its core which means the contact tracing service can only see how many people were alerted - not who they are - which means they are still reliant on those people contacting the health service to facilitate contact tracing and further intervention. Fortunately the majority of app users choose to store their mobile phone number in the app and permit contact tracers can contact them directly if necessary. The mobile number is stored on the phone and only released to contact tracers if and when they receive a close contact notification.
Statistics on the number or people choosing to upload their keys and those notified by the app are reported in the app itself.
1003. Deputy Catherine Murphy asked the Minister for Health if he is satisfied with the standard of data protection compliance in respect of the Covid-19 tracker application; the number of complaints notified to him that have been made to the Data Protection Commissioner in respect of the application; the way in which personal details are being processed by the application; and the way in which contact tracing information and-or data are processed and stored. [12137/21]
View answerI assume when the Deputy refers to the Covid-19 tracker application she is referring to Covid Tracker App (the app that is used on peoples smartphones).
The Covid Tracker App was designed with privacy at its core with minimum data stored within the app itself. This data is stored within the phone and only released to the HSE if (a) the user received a close contact alert and (b) the user consents to share that data - which ordinarily relates to making a contact number available for a call back from contact tracing operations.
A full Data Privacy Impact Assessment (DPIA) was developed as part of the app and shared with the Data Protection Commission before go live. The app also contains a Data Privacy Information Notice, which together with the DPIA describe the way in which information is processed and stored. The DPIA is published on the internet and the source code is open sourced so anyone can inspect it. All this was done to ensure transparency and enhance trust.
The department have not received and complaints in relation to the apps compliance with data protection that could not be addressed or required onward notification to the Data Protection Commissioner.
1004. Deputy Catherine Murphy asked the Minister for Health the number of doses of a vaccine (details supplied) that have been delivered to Ireland to date; the number of those doses that have been delivered to administering locations; and if he will provide a full and complete schedule of locations in which the vaccines will be delivered. [12138/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1005. Deputy Catherine Murphy asked the Minister for Health the number of medical professionals working in the health system who have expressed a preference for a vaccine other than a vaccine (details supplied) and have declined to receive the vaccine, respectively, when offered it to date. [12139/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
1006. Deputy Verona Murphy asked the Minister for Health if a Covid-19 quarantine hotel will be established to service Rosslare Europort; if so, if a site has been identified for this purpose; and if he will make a statement on the matter. [12143/21]
View answerThe Health Amendment Bill, which gives effect to the Government Decision on mandatory quarantine at designated facilities, has been prioritised.
The operationalisation of designated quarantine facilities, including location of same, is a complex issue which is currently being advanced on a cross-departmental basis as a matter of priority. The Government is presently focused on the practical implementation measures which are required in order to give effect to the provisions of the Bill.
1007. Deputy Gary Gannon asked the Minister for Health if his attention has been drawn to women suffering from hyperemesis gravidarum repeatedly presenting at accident and emergency departments as they are unable to afford to pay for their prescriptions to alleviate the symptoms of same; and if he will make a statement on the matter. [12146/21]
View answer1008. Deputy Gary Gannon asked the Minister for Health his views on whether the HSE-recommended first-line treatments for medical conditions should be available on the drugs payment scheme, including Cariban, Xonvea and Navalem which are used to treat hyperemesis gravidarum; and if he will make a statement on the matter. [12147/21]
View answer1009. Deputy Gary Gannon asked the Minister for Health if unlicensed prescription medications are available on the drugs payment scheme in circumstances in which licensed versions are not currently available or marketed in Ireland; and if licensed medications for hyperemesis gravidarum are currently available and marketed in Ireland. [12148/21]
View answer1010. Deputy Gary Gannon asked the Minister for Health if his attention has been drawn to the fact that an application for Xonvea was rejected for inclusion on the drugs payment scheme by the HSE on the advice of the National Centre for Pharmacoeconomics, NCPE, which determined that the medicine is not good value for money and that comes at a higher cost than other ways to manage this condition (details supplied); and the other ways of managing hyperemesis gravidarum that were assessed by the HSE and NCPE. [12153/21]
View answerI propose to take Questions Nos. 1007 to 1010, inclusive, together.
As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1011. Deputy Gary Gannon asked the Minister for Health the number of vaccinators and vaccine staff Ireland requires to meet vaccination goals; if applicants who meet the correct criteria for vaccinators' roles and applied for the Be on Call for Ireland initiative will be contacted for the HSE Covid-19 vaccinator recruitment initiative; and if he will make a statement on the matter. [12156/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
1012. Deputy Róisín Shortall asked the Minister for Health if he conducted patient and public engagement prior to enacting SI No. 18/2021 Data Protection Act 2018 (section 36(2)) (Health Research) (Amendment) Regulations 2021; and if he will make a statement on the matter. [12160/21]
View answerSince the Data Protection Act 2018 (section 36(2)) (Health Research) Regulations (SI 314 of 2018) were made in August 2018, my Department has engaged widely and publicly on the amendments that have now been set out in SI 18 of 2021. It had due regard to all the views put forward which came from a range of groups and individuals, including groups like the Medical Research Charities Group which plays an important role in highlighting patient perspectives on research and in ensuring that the patient voice is central to decisions made about health research. That engagement is reflected in the balanced nature of the amendments.
Giving an ongoing tangible voice to patients and the public is ensured in the amendments where it is expressly provided that the consultations to be undertaken by a researcher making an application for a consent declaration are not just with data subjects but now extend to patients and the public too.
Further, the appeals mechanism in the Health Research Regulations has been strengthened to allow the appeal panel to invite submissions from any person that it considers appropriate and consult with any person who it believes could assist in the consideration of an appeal. This will allow patients and the public to be heard in the appeals process.
1013. Deputy Róisín Shortall asked the Minister for Health if section 3B(1) of the Data Protection Act 2018 (section 36(2)) (Health Research) (Amendment) Regulations 2021 applies to genomic research in circumstances in which there are implications for relatives of the data subject (details supplied); and if he will make a statement on the matter. [12161/21]
View answer1014. Deputy Róisín Shortall asked the Minister for Health the position in respect of deferred consent of personal data in circumstances in which an individual dies without capacity to give explicit consent for research purposes; and if there is an ethical framework or policy to deal with this matter. [12162/21]
View answer1015. Deputy Róisín Shortall asked the Minister for Health if a deceased person’s personal data may be used in genomic research if consent was not obtained while the data subject was alive in view of the implications for relatives of the deceased. [12163/21]
View answer1016. Deputy Róisín Shortall asked the Minister for Health if a controller may use a patient’s data for research purposes in circumstances in which the patient lacks the capacity to consent and his or her next of kin and or power of attorney objects; and if he will make a statement on the matter. [12164/21]
View answerI propose to take Questions Nos. 1013 to 1016, inclusive, together.
The Health Research Regulations, which are derived from GDPR and are made under the Data Protection Act 2018, apply where there is processing of personal data for health research purposes. Where the health research does not involve, give rise to or become associated with personal data the Regulations, the Act and GDPR do not apply. In that same context, the Health Research Regulations do not change the law on, for example, taking or using bio-samples for research purposes. That is very important to bear in mind.
As with all aspects of data protection law and across all sectors, it is for the data controller to determine whether personal data is involved and, if so, whose personal data. The definition of personal data is set out in Article 4 of the GDPR as is the definition of genetic data. Those definitions are binding on the Health Research Regulations and those involved in genetic and genomic research should make sure that they are fully conversant with those definitions, compliant with the law in this area and also adhere to international best ethical practice.
I will deal now with the specifics of Regulation 3B of the Health Research Regulations. Emergency care and treatment is a real-life reality that saves lives. It is also an internationally recognised reality that the only way to develop new emergency care treatments and procedures is through research studies that are carried out side by side with the care being provided to the patient. That is what Regulation 3B of the Health Research Regulations is designed to help facilitate to the extent that it can do so as secondary legislation that deals only with information processing.
The amendment is a tightly drawn provision that allows for deferred consent of the data subject for the processing of his or her personal data in health research in limited and specified circumstances subject to safeguards.
In fact, it is expressly provided in Regulation 3B that the circumstances must be exceptional and that the principal purpose of the processing or further processing of the personal data concerned by the data controller is necessary for the provision of health care to an individual and necessary to protect the vital interests of the individual. It is further expressly provided that the research must be “related health research” which means research that is related to the care and treatment being provided to the individual. It is difficult to see how genomic research, given its nature, would fall under this provision.
On the question of the processing of personal data of a deceased individual, the provisions of data protection law apply only to the personal data of living individuals. That rule is applicable equally in the limited cases covered by Regulation 3B. Ethical matters associated with health research are considered by RECs and Regulation 3B requires REC approval.
Where an individual is alive, the GDPR does not give consent rights to other individuals to act on behalf of an adult data subject where the data subject lacks capacity to consent so the question of next of kin is moot and enduring powers of attorney are not generally viewed as extending into the health-related realm.
However, the duty of confidentiality survives death so health professionals holding the medical records of deceased individuals should exercise considerable care in releasing that information to a third party. In that regard, the Medical Council’s advice to doctors is “if it is unclear whether the patient consented to the disclosure of information after their death, you should consider how the disclosure might benefit or cause distress to the deceased’s family or carers. You should also consider the effect of the disclosure on the reputation of the deceased and the purpose of the disclosure.”
Given that the thrust of these questions relates to protecting the privacy of individuals in the complex area of genomic research, I want to take the opportunity afforded by the Deputy’s questions to provide some contextual elaboration. Genomics is applied to health, especially within rare disease and cancer, to provide diagnosis, prognosis and uncover links between genetic variation and disease. Genomics can bring significant benefits to healthcare systems, by accelerating clinical research and drug development, personalizing treatment regimens, improving patient outcomes, and reducing the cost of care.
While genomic research opens up exciting possibilities such research also poses particular societal, ethical and regulatory challenges. From a privacy perspective, one of the ways that genomic data are special is in their potential to yield information that relates to more than one individual. This means that genome sequence data should be handled carefully even if, for example, it is derived from a deceased individual, and otherwise out of scope of the GDPR. It could be argued that aspects of the genome that are highly likely to be shared with living family members will constitute ‘personal data’ if they can be connected with those data. For example, if a tissue block or sample from a deceased relative is analysed to inform the treatment of a living individual, the data should be treated as ‘personal data’ relating to the living individual because the GDPR does not regulate based on the source of the information but focuses on its content.
While those matters are for the Data Protection Commission to determine and are likely to feature in the European Data Protection Board Guidelines on processing personal data for scientific research purposes (currently in preparation and due sometime this year) I will conclude by repeating a point I made at the beginning of this answer: namely, that those involved in genetic and genomic research should make sure that they look very carefully at the relevant definitions in Article 4 of GDPR, comply fully with the law in this area and meet international best ethical practice in the conduct of their research. Such an approach will be critical to achieving the necessary public support for such research.
1017. Deputy Róisín Shortall asked the Minister for Health the reason explicit consent or ethical approval is not required when a controller obtains personal data to establish if a person may be suitable or eligible for inclusion in research; the criteria used to ascertain if research is preliminary or substantive (details supplied); and if he will make a statement on the matter. [12165/21]
View answerThe Health Research Regulations include explicit consent as a safeguard when an individual’s personal data is being processed for health research. However, before health research can be carried out it is invariably critical to establish whether there would be enough potential suitable or eligible research participants for the study to proceed. It seems reasonable to allow that process to be undertaken without explicit consent and that is what the pre-screening amendment to the Health Research Regulations allows subject to very clear rules and safeguards. Moreover, the requirement for explicit consent is still applicable for the substantive research if the pre-screening process indicates a sufficient number of potential participants for the study to commence.
The same logic applies to the research ethics committee (REC) condition for the pre-screening process and REC approval is still required should the research proceed following the pre-screening.
The Guidelines prepared by my Department, in collaboration with the HSE, Health Research Board and Health Research Consent Declaration Committee, in consultation with the Data Protection Commission set out the actions that are to be regarded as pre-screening actions. They are:
(a) reviewing the personal data of a data subject in order to assess whether he or she might be suitable or eligible for inclusion in a health research study.
(b) analysing the pre-screening data and documenting the findings,
(c) sharing the findings (in a non-identifiable way) with others involved in the research team.
(d) approaching an individual found to be eligible or suitable to determine their interest in participation in the study and it is considered best practice that the approach to the prospective research subject to establish their interest should always be done only by a health practitioner.
(e) sharing the identity of the individual with the research team on a confidential basis where the individual has consented to be contacted by the research team.
1018. Deputy Róisín Shortall asked the Minister for Health if he will provide a composite version of regulations (details supplied) as amended. [12166/21]
View answerThe Health Research Regulations 2018 and the amendments thereto were drafted in the Office of the Attorney General and are publicly available on the electronic Irish Statute Book (eISB) at www.irishstatutebook.ie. I have no plans, at the present time, to prepare a composite version.
1019. Deputy Róisín Shortall asked the Minister for Health the number of persons who have arrived into Ireland based on their original country of departure for each category 2 designated state in each week from 1 January 2021 to date in tabular form [12167/21]
View answerMy Department does not hold the information requested. The COVID-19 Passenger Locator form is used for public health engagement with arriving passengers for the purposes of contact tracing and to issue targeted public health messages via SMS, rather than a record of passenger arrivals into the country.
1020. Deputy Róisín Shortall asked the Minister for Health the steps he is taking to ensure that school aged children do not miss their routine vaccinations as a result of school closures due to Covid-19; and if he will make a statement on the matter. [12170/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1021. Deputy Holly Cairns asked the Minister for Health the status of the safe access to termination of pregnancy services Bill; the publication date towards which his officials are working; and if he will make a statement on the matter. [12173/21]
View answerIt was originally intended to provide for safe access to termination of pregnancy services in the Health (Regulation of Termination of Pregnancy) Act 2018. However, a number of legal issues were identified which necessitated further consideration. Since services under the Health (Regulation of Termination of Pregnancy) Act 2018 commenced in January 2019, there has been a limited number of reports of protests or other actions relating to termination of pregnancy. This is an extremely positive development, suggesting that termination of pregnancy services have bedded in relatively smoothly to date and are becoming a normal part of the Irish healthcare system, in line with Government policy.
However, where problems do arise with protests outside health care services, there is existing public order legislation in place to protect people accessing services, employees working in the service and local residents.
The Department of Health has previously liaised with An Garda Síochána around safe access to termination of pregnancy services, and the Garda National Protective Services Bureau issued a notice to all Garda Stations raising awareness about the issue. The notice directed that any protests be monitored, and breaches of existing law dealt with.
The Department has provided information on existing public order and other relevant legislation to the HSE for appropriate distribution.
