Michael Moynihan
Ceist:191. Deputy Michael Moynihan asked the Minister for Health the position regarding the provision of cannabis for medicinal use here; and if he will make a statement on the matter. [22212/17]
Amharc ar fhreagraMedicinal Products Licensing
Ceisteanna (191)
Freagraí scríofa
Cannabis is strictly controlled under the Misuse of Drugs Acts, 1977 to 2016 and the Regulations made thereunder.
There are two pathways for medical practitioners to prescribe cannabis-based products containing THC for medical purposes: (i) through the Medicinal Cannabis Access Programme (which is currently being established); (ii) through the Ministerial licence application route.
(i) Medicinal Cannabis Access Programme:
In February I published the Health Products Regulatory Authority’s (HPRA) report ‘Cannabis for Medical Use – A Scientific Review’. On foot of the conclusions from the HPRA’s report I announced my intention to establish an access programme for cannabis-based treatments, for patients under the care of a medical consultant, for the following medical conditions:
- spasticity associated with multiple sclerosis resistant to all standard therapies and interventions;
- intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes;
- severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications.
A critical focus of the Department’s work in setting-up the access programme has been engagement with clinicians, patients and pharmacists who will be central to the drawing up of guidelines on the safe use of cannabis for those patients who will be prescribed cannabis-based treatments through the access programme. An expert reference group has been established to develop the operational, clinical and practice guidelines for this access programme. Officials in the Department are also working on secondary legislation to underpin the access programme. This work will take a number of months to complete.
(ii) Ministerial licence application route
Under existing arrangements it is open to me, as Minister, to consider granting a licence under the Misuse of Drugs Acts, for access to medical cannabis for named patients, where the proposed course of treatment has been endorsed by the patient’s consultant who is responsible for the management of the patient, and who is prepared to monitor the effects of the treatment over time. One such licence has already been granted under this mechanism.
The main elements of an application submitted under the Misuse of Drugs legislation for a licence for cannabis for medicinal use must include:
- an outline of the treatment the patient has received to date and justification from the doctor as to why it is appropriate in their patient’s specific circumstances to prescribe a Schedule 1 drug;
- details of the cannabis-based product which it is proposed to prescribe and administer to the patient;
- the source of the cannabis-based product;
- the arrangements for the ongoing monitoring and care of the patient once the cannabis-based treatment has commenced.
Ultimately it is the decision of the clinician, in consultation with their patient, to prescribe or not prescribe a particular treatment for a patient under their care. The Minister for Health has no role in this clinical decision-making process.
Hospital Services
Ceisteanna (192)
Sean Fleming
Ceist:192. Deputy Sean Fleming asked the Minister for Health if the statutory inpatient charge in respect of a baby born prematurely who left the hospital before the date the baby was due to be born, in the amount of €800 will be cancelled (details supplied); and if he will make a statement on the matter. [22216/17]
Amharc ar fhreagraFreagraí scríofa
The HSE makes in-patient services available to specific categories of persons under Section 52 of the Health Act 1970, as amended. In accordance with Section 53 of the Act, the charge in respect of in-patient services is set out in the Health (In-Patient Charges) Regulations 1987 (S.I. No. 116/1987). Regulation 4(1) provides the list of persons exempted from any charge made in respect of in-patient services provided under Section 52 of the Health Act.
One of the exemptions for the in-patient charge is "children up to the age of 6 weeks". All children after the age of 6 weeks are liable for in-patient charges unless they hold a medical card. My officials have forwarded the details of the above case to the HSE and brought their attention to the exemptions contained in S.I. 116/87.
Hospital Procedures
Ceisteanna (193)
Bernard Durkan
Ceist:193. Deputy Bernard J. Durkan asked the Minister for Health if tonsillectomy will be facilitated in the case of a person (details supplied); and if he will make a statement on the matter. [22217/17]
Amharc ar fhreagraFreagraí scríofa
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 scheduling of appointments for patients is a matter for the hospital to which the patient has been referred. Should a patient's general practitioner consider that the patient's condition warrants an earlier appointment, he or she should take the matter up with the consultant and the hospital involved. In relation to the specific case raised, I have asked the HSE to respond to you directly.
Birth Data
Ceisteanna (194)
Kathleen Funchion
Ceist:194. Deputy Kathleen Funchion asked the Minister for Health the number of babies that were delivered prematurely in 2016; and the number of babies that have been delivered prematurely to date in 2017. [22231/17]
Amharc ar fhreagraFreagraí scríofa
I have asked the Health Service Executive to respond to the Deputy directly.
National Treatment Purchase Fund Eligibility
Ceisteanna (195)
Eamon Scanlon
Ceist:195. Deputy Eamon Scanlon asked the Minister for Health if parents can avail of psychiatric services for their children through the National Treatment Purchase Fund with a view to reducing waiting times for child and adolescent mental health services; and if he will make a statement on the matter. [22239/17]
Amharc ar fhreagraFreagraí scríofa
The Department of Health and the HSE are working hard, on a continuous basis, to improve the delivery of mental health services for children and the services have benefitted from the significant additional investment in mental health in recent years. Additional funding in Budget 2017 has resulted in an overall provision of €853m for all HSE mental health services in 2017.
There are currently 67 Child and Adolescent Mental Health Service teams, and 3 Paediatric Liaison Teams, supported by 66 operational CAMHS beds nationally. Further CAMHS beds are planned to come on-stream in the near future. Approximately 18,500 children will attend the CAMHS service this year.
There are difficulties in recruiting and retaining specialist CAMHS staff, particularly Consultant Psychiatrists. Intensive recruitment efforts are on-going but there is currently a serious shortage of suitably qualified CAMHS Consultants both at national and European level. It should be noted however that despite increasing CAMHS demands overall and the staffing difficulties, 68% of children referred to CAMHS are seen within twelve weeks. Over the past two years, the waiting list for over 12 months reduced by 50% (from 455 cases to 255).
It is important to remember that despite increasing demands overall on CAMHS, individual cases professionally assessed as requiring urgent access to services do receive priority.
The HSE Service Plan 2017, as a priority, will further develop CAMHS, including better out-of-hours liaison and seven-day response services.
It is not envisaged that the Waiting List initiatives due to be implemented by the NTPF and the HSE under its Waiting List Action Plans will include mental health services.
Medicinal Products Regulation
Ceisteanna (196)
Clare Daly
Ceist:196. Deputy Clare Daly asked the Minister for Health further to Parliamentary Question No. 1060 of 2 May 2017, if he will clarify a matter (details supplied). [22243/17]
Amharc ar fhreagraFreagraí scríofa
As I stated in my previous response, there is no scientific evidence that the HPV vaccine causes any long-term illness. The safety of all medicines, including vaccines, is not a trivial matter and there are robust regulatory and monitoring systems in place at both EU and national level to ensure that the medicines we use are safe and effective.
The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines that are licensed in Ireland. The HPRA and the European Medicines Agency (EMA) in Europe continually monitor adverse events to vaccination.
As part of its monitoring of the safety of medicines, the HPRA operates an adverse reaction reporting system, with healthcare professionals and patients encouraged to report adverse reactions they consider may be associated with their treatment, through the range of options in place for reporting. All reports received are evaluated and considered in the context of the safety profile of the product concerned, with reports followed up as necessary for further information, that may assist in the assessment of the case.
In addition, pharmaceutical companies are obliged, as a condition of the authorisation to market a medicine, to submit reports of adverse reactions received directly, to the HPRA. In accordance with its reporting obligations, the HPRA provides anonymised details of reports received to the EMA, the WHO and to the relevant pharmaceutical companies. The fact that a suspected adverse reaction has been reported does not necessarily mean that the medicine has caused the observed effect, which may have also been caused by the disease being treated, a new disease the patient developed, or by another medicine that the patient is taking. Further data are usually needed to complete the picture.
In the context of monitoring the safety of medicines, new information on a possible risk is called a signal. Signals may arise from various data sources, including spontaneous reports, clinical trials and epidemiological studies. Once a signal has been identified, investigations are undertaken to consider the likelihood that a medicine may have caused or contributed to the effect, try to identify risk factors and estimate the frequency of occurrence. Following the assessment, a decision on the most appropriate regulatory action is taken by the competent authorities. The regulatory action is communicated to healthcare professionals, patients and the general public through established channels, and timelines reflect the degree of urgency.
The majority of reports received by the HPRA have been consistent with the expected pattern of adverse effects for the vaccines, as described in the product information (Summary of Product Characteristics and Package Leaflet). Vaccination related events, occurring at the time of vaccine administration, such as syncope (faints) has been among the most commonly reported effects. Other commonly reported symptoms include gastrointestinal symptoms, malaise, headache, dizziness and injection site reactions.
There is no indication or signal of a causal link between the symptoms suffered by the young women and administration of the HPV vaccine. However, this does not mean that their symptoms do not have a physical basis and it is important that any conditions they may have are properly diagnosed and receive appropriate treatment. The families of any girls suffering symptoms following HPV vaccination are advised to seek medical advice from their family doctor in the normal manner and be referred to consultants familiar with these syndromes for diagnosis and management.
More than 80 million girls and women worldwide have now received these vaccines, and in some European countries they have been given to 90% of the age group recommended for vaccination. Use of these vaccines is expected to prevent many cases of cervical cancer (cancer of the neck of the womb, which is responsible for over 20,000 deaths in Europe each year) and various other cancers and conditions caused by HPV.
Unfortunately, the false claims have led to a significant drop in uptake rates of the HPV vaccine from 87% in 2014/15 to 72% in 2015/16. This means that a large cohort of girls is now at risk of developing cervical cancer later in their lives.
Health Services Access
Ceisteanna (197)
Mattie McGrath
Ceist:197. Deputy Mattie McGrath asked the Minister for Health the healthcare facilities that are providing access to diagnostic services for GMS patients in Munster; the reason some facilities have been approved to provide diagnostic services while other general practices that have the facilities to do so have not been approved to offer such services; and if he will make a statement on the matter. [22254/17]
Amharc ar fhreagraFreagraí scríofa
As this question relates to service matters, I have arranged for the question to be referred to the Health Service Executive for direct reply.