Medicinal Products

Ceisteanna (184)

John Brassil

Ceist:

184. Deputy John Brassil asked the Minister for Health the reason a national biosimilar policy has not been published; and if he will make a statement on the matter. [3548/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

My Department and the HSE are engaging in a number of initiatives which will endeavour to lead to better access to medicines for patients, value for the taxpayer and the cost- effective provision of medicines in Ireland. 

A public consultation on a National Biosimilar Medicines Policy was undertaken by my Department in 2017.  The responses to that consultation and other possible policy levers are being considered by my Department with a view to developing a National Biosimilar Medicines Policy which will require the involvement of stakeholders from across the health service.  I expect that my Department will make progress in this regard in 2019.

At an operational level, the HSE's Acute Hospitals Drugs Management Programme has a biosimilar strategy in place since 2017 which is making considerable progress using a collaborative approach with hospital pharmacists and clinical teams to bring about changes in prescribing practice.  In that respect, hospitals are working towards a targeted minimum prescribing rate for biosimilars of 50%.

Medicinal Products Expenditure

Ceisteanna (185)

John Brassil

Ceist:

185. Deputy John Brassil asked the Minister for Health the full spend by his Department and the HSE on biologic medicines and biosimilar medicines respectively in each of the years 2016 to 2018; and if he will make a statement on the matter. [3549/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Pharmaceutical Sector

Ceisteanna (186)

John Brassil

Ceist:

186. Deputy John Brassil asked the Minister for Health his views on the proposal by the HPRA to increase its fees to Irish pharmaceutical companies by 8% in 2019; his plans to grant this increase; the work he has undertaken to analyse the merits of the increase in view of the pressures faced by companies in meeting the challenges of Brexit and by the introduction of the falsified medicines directive in February 2019. [3550/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

The Health Products Regulatory Authority (HPRA) has increased its fees to all pharmaceutical companies by an average of 8% in 2019. It should be noted that the Authority's last significant fee increase was in 2010. In 2011 and 2012, the HPRA reduced fees, and there were no fee increases between 2013 and 2017. Fees were increased by approximately 2% in 2018.

The impact of new EU legislation continues to be felt across the HPRA. For example, the Falsified Medicines Directive will commence in February 2019, the Medical Devices Regulations will commence in May 2020, the Clinical Trials Regulation is scheduled to be implemented in 2020 and the In Vitro Diagnostic Medical Devices Regulations will commence in 2022. The regulatory model for medicines is becoming more complex, and EU pharmacovigilance legislation has led to an increase in the number of referrals and regulatory actions arising from the outcome of these referrals. Public scrutiny and the role of the regulator in relation to medical devices and medicines such as the HPV vaccine has increased, while compliance activity is also increasing.

Over the last several years, the HPRA has continued to enhance services to support the pharmaceutical industry in Ireland. The development of an innovation office and an international platform has brought greater oversight and global co-operation to the benefit of all stakeholders and of public health. The development of the agency has ensured that the HPRA is well placed to negotiate the impact of Brexit and continual changes in the regulatory environment.

It is acknowledged that Brexit and the Falsified Medicines Directive will also present significant challenges to the pharmaceutical industry. However, the HPRA plays a vital role in supporting this industry, and this fee increase is considered necessary in order to enable the Authority to continue to fulfil its public health remit.

Hospital Transfers

Ceisteanna (187)

Éamon Ó Cuív

Ceist:

187. Deputy Éamon Ó Cuív asked the Minister for Health further to Parliamentary Question No. 385 of 4 December 2018, the reason a reply to same has not issued; when a reply will issue (details supplied); and if he will make a statement on the matter. [3551/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

The Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives.  This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities. 

As the Deputy's question relates to a service issue, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.

Health Services Provision

Ceisteanna (188)

Éamon Ó Cuív

Ceist:

188. Deputy Éamon Ó Cuív asked the Minister for Health the reason there is a delay in the delivery of items to a person (details supplied); when the matter will be rectified; and if he will make a statement on the matter. [3560/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

As this is a service matter it has been referred to the HSE for direct reply to the Deputy.

General Practitioner Services

Ceisteanna (189)

Margaret Murphy O'Mahony

Ceist:

189. Deputy Margaret Murphy O'Mahony asked the Minister for Health his plans to extend the retirement age of general practitioners after 72 years of age; and if he will make a statement on the matter. [3567/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

The Government is committed to the continued development of GP capacity to ensure that patients across the country continue to have access to GP services and that general practice is sustainable in all areas into the future.

Several efforts to increase the number of practising GPs have been undertaken in recent years. These include increases in the number of GP training places, which have risen from 120 places in 2009 to 202 places available in 2019.

Changes have been made to the entry provisions to the GMS scheme to accommodate more flexible/shared GMS/GP contracts, and to the retirement provisions for GPs under the GMS scheme, allowing GPs to hold GMS contracts until their 72nd birthday, as well as the introduction of an enhanced supports package for rural GP practices.

There are no plans at present to extend the retirement age for GPs beyond 72 years.

Driver Licence Renewals

Ceisteanna (190)

Eoin Ó Broin

Ceist:

190. Deputy Eoin Ó Broin asked the Minister for Health his plans to review the issue of medical certificates for persons over 70 years of age renewing driver licences not being covered by the medical card in order to reduce the significant cost that now applies to this group of drivers following changes to the rules governing driver licence renewals for persons over 70 years of age. [3575/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

The GMS contract stipulates that fees for medical and GP visit card holders are not paid to GPs in respect of certain medical certificates which may be required, for example, "under the Social Welfare Acts or for the purposes of insurance or assurance policies or for the issue of driving licences".

Any fees charged by GPs for services provided outside the terms of the GMS contract are a matter of private contract between the GP and their patients.

There are no plans at present to include the completion of forms required for driving licence applications as a service to be provided to GMS patients under the GMS or GP Visit Card scheme.

Abortion Legislation

Ceisteanna (191)

Bríd Smith

Ceist:

191. Deputy Bríd Smith asked the Minister for Health his plans to review the Health (Regulation of Termination of Pregnancy) Act 2018 as a matter of urgency in view of the recent case in which a woman was denied a termination at 14 weeks despite presenting with a foetus suffering from a severe abnormality; and if he will make a statement on the matter. [3577/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

It is not appropriate for either me, as Minister for Health, or the Department of Health to comment on any individual case.

As the Deputy is aware, the Health (Regulation of Termination of Pregnancy) Act 2018 was signed into law by the President on 20 December 2018, and services for termination of pregnancy commenced just over three weeks ago, on 1 January 2019.

Section 11 of the Act sets out the law on access to termination of pregnancy in cases where there is a condition present affecting the foetus that is likely to lead to the death of the foetus before or within 28 days of birth.  This provision is in line with the report of the Joint Committee on the Eighth Amendment of the Constitution, which recommended that “the law should not provide for the termination of pregnancy on the ground that the unborn child has a significant foetal abnormality where such abnormality is not likely to result in death before or shortly after birth.”

The operation of the legislation is entirely a matter for attending clinicians.  Neither the Minister nor the Department of Health has any role in the medical management of cases. Where a patient requires care not available in a particular location, the patient should be transferred to a hospital/service where the necessary care is available.

The Health (Regulation of Termination of Pregnancy) Act 2018 makes provision for women in cases where a medical practitioner has not given an opinion or has given an opinion that would not lead to certification for termination of pregnancy to be carried out.  Section 13 of the Act provides that the woman, or a person acting on her behalf, may make an application to the HSE for a review of the relevant decision. Within 3 days of receiving such an application, the HSE must convene a committee of medical practitioners to review the relevant decision.  The committee must complete its review not later than 7 days from the date on which it was established.

Under section 7 of the Health (Regulation of Termination of Pregnancy) Act 2018, I am committed to carrying out a review of the operation of the Act not later than three years after it was commenced.

Maternity Services

Ceisteanna (192)

Bríd Smith

Ceist:

192. Deputy Bríd Smith asked the Minister for Health if he will review the operations at maternity hospitals to ensure hospitals afford the same service to pregnant women suffering from severe foetal abnormalities; if clinical decisions are made only by the two relevant medical practitioners and not other bodies or hospital personnel; and if he will make a statement on the matter. [3578/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

As this question relates to a service issue, it has been referred to the HSE for answer.

National Children's Hospital Expenditure

Ceisteanna (193)

Mattie McGrath

Ceist:

193. Deputy Mattie McGrath asked the Minister for Health the measures he is taking to hold members of the National Paediatric Hospital Development Board accountable for the significant cost increases associated with the national children’s hospital; the number of occasions he has met with the board since April 2017; if the escalating costs were discussed; his views on same; and if he will make a statement on the matter. [3580/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

Governance structures, approved by Government in April 2017, are in place to oversee and monitor progress on the Children’s Hospital Project and Programme. These include the Children’s Hospital Project and Programme Board,  chaired by the Secretary General of the Department of Health, and the Children’s Hospital Project and Programme Steering Group, chaired by the Deputy Director General of the Health Service Executive. The Steering Group directs the overall programme of work within agreed parameters, and reports to the Children’s Hospital Project and Programme Board.

An independent review of the escalation in cost in determining the adjusted contract sum, the contributory factors and associated responsibilities so that any potential weaknesses are identified and comprehensively and speedily resolved in the interests of the successful completion of the project and the effective management of public funds commenced this week. The review is expected to take place over an 8-week period with the report to be completed in March.  

In addition, a review of the existing oversight arrangements between the Department of Health, HSE and the NPHDB will also be undertaken to assess the adequacy of existing management and governance in place to ensure the completion of this project.  It is expected that the findings from the independent review will inform the work required on the broader governance review.

The Department, the HSE and the National Paediatric Hospital Development Board are fully committed to collaborating with these reviews and to implementing any recommendations arising.