Wednesday, 11 Jul 2018

Written Answers Nos. 394-410

Hospitals Data

Ceisteanna (394)

Pat Buckley

Ceist:

394. Deputy Pat Buckley asked the Minister for Health the number of patients who have been treated in Our Lady's Hospital, Cashel, in 2016, 2017 and to date in 2018, respectively. [31409/18]

Freagraí scríofa

Minister of State at the Department of Health

As this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.

Hospital Beds Data

Ceisteanna (395)

Pat Buckley

Ceist:

395. Deputy Pat Buckley asked the Minister for Health the number of beds operational in Our Lady's Hospital, Cashel; the maximum capacity; and the plans for expansion of current levels. [31410/18]

Freagraí scríofa

Minister of State at the Department of Health

As this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.

Hospital Staff Data

Ceisteanna (396)

Pat Buckley

Ceist:

396. Deputy Pat Buckley asked the Minister for Health the number of staff in place at Our Lady's Hospital, Cashel; the roles they are in; and the cost of salaries for positions operating at the facility. [31411/18]

Freagraí scríofa

Minister of State at the Department of Health

As this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.

Medicinal Products Reimbursement

Ceisteanna (397, 398, 399, 400, 401, 403)

Michael Harty

Ceist:

397. Deputy Michael Harty asked the Minister for Health if the evaluation process for orphan drugs has changed since the Oireachtas Joint Committee on Health published its report on evaluating orphan drugs in February 2018; and if he will make a statement on the matter. [31424/18]

Michael Harty

Ceist:

398. Deputy Michael Harty asked the Minister for Health if a review of the Health (Pricing and Supply of Medical Goods) Act 2013 Act has been carried out to identify potential legislative barriers to the reimbursement of orphan drugs and recommended legislative amendments as appropriate; and if he will make a statement on the matter. [31425/18]

Michael Harty

Ceist:

399. Deputy Michael Harty asked the Minister for Health his plans to appoint an independent academic with knowledge of pricing and reimbursement systems for orphan drugs to conduct a review of the current process of evaluation and its role in orphan drug availability here; and if he will make a statement on the matter. [31426/18]

Michael Harty

Ceist:

400. Deputy Michael Harty asked the Minister for Health if a specific budget for orphan drugs has been established; and if he will make a statement on the matter. [31427/18]

Michael Harty

Ceist:

401. Deputy Michael Harty asked the Minister for Health if the QALY process for assessing orphan drugs has been revised; and if he will make a statement on the matter. [31428/18]

Michael Harty

Ceist:

403. Deputy Michael Harty asked the Minister for Health if arrangements have been made with other EU states to align the assessment processes for orphan drugs; and if he will make a statement on the matter. [31430/18]

Freagraí scríofa

Minister for Health

I propose to take Questions Nos. 397 to 401, inclusive, and 403 together.

The Oireachtas has put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. 

The 2013 Act requires the HSE to have regard to both the clinical benefits and cost effectiveness  but it does not include provision for a different rule set when assessing orphan drugs.  However, both the National Centre of Pharmacoeconomics (NCPE) and HSE are mindful of the differences and challenges in terms of patient numbers when assessing this type of medicine.

This rigorous assessment process ensures that treatments that are clinical and cost effective are reimbursed. In circumstances where a company has failed to demonstrate the clinical benefit to support the price that they are seeking for the drug, the HSE reaches a decision not to reimburse the medicine.

In February I received the Report on Evaluating Orphan Drugs from the Joint Committee on Health.  Currently my Department is examining the Committee's Report and its recommendations. The report raises some significant policy issues which require careful consideration by my Department, the HSE and the National Centre for Pharmacoeconomics.  This process is underway and once completed I will be in a position to report back to the Joint Committee.

HSE Reviews

Ceisteanna (402)

Michael Harty

Ceist:

402. Deputy Michael Harty asked the Minister for Health if the rare disease technology review committee of the NCPE has commenced assessing orphan drugs; and if he will make a statement on the matter. [31429/18]

Freagraí scríofa

Minister for Health

As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.

Question No. 403 answered with Question No. 397.

Rare Diseases Strategy Implementation

Ceisteanna (404)

Michael Harty

Ceist:

404. Deputy Michael Harty asked the Minister for Health if recommendations 30 to 39 of the Report of the Consultation for a National Rare Disease Plan for Ireland have been fully implemented; and if he will make a statement on the matter. [31431/18]

Freagraí scríofa

Minister for Health

As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.

General Practitioner Services Provision

Ceisteanna (405)

Aindrias Moynihan

Ceist:

405. Deputy Aindrias Moynihan asked the Minister for Health the procedure available to persons in cases in which a general practitioner refuses to take them in as part of their practice; the number of persons who have had to obtain access to a general practitioner in that way, in each county for each of the past three years; and if he will make a statement on the matter. [31435/18]

Freagraí scríofa

Minister for Health

As this question relates to service matters, I have arranged for the question to be referred to the Health Service Executive for direct reply to the Deputy.

Medicinal Products Availability

Ceisteanna (406)

Gerry Adams

Ceist:

406. Deputy Gerry Adams asked the Minister for Health if he met an organisation (details supplied) in June 2018; if a report of the meeting will be provided; and if new medications in the treatment of multiple sclerosis will now be made available to patients. [31457/18]

Freagraí scríofa

Minister for Health

The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.   As Minister for Health, I do not have any statutory power or function in relation to reimbursement of medicines.

Under the 2013 Act, if a company wishes to have a medicine reimbursed through the community drugs schemes, it must submit an application to the HSE to have the medicine added to the Reimbursement List.

As outlined in the 2016 Framework Agreement on the Supply and Pricing of Medicines, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to add the medicine to the reimbursement list, agree to reimburse it as a hospital medicine or refuse to reimburse it.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments for the HSE, and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an ongoing basis. This can lead to a protracted deliberation process.

I am keen to explore ways in which new medicines might be more easily available for public patients in Ireland, but innovative approaches must be compatible with the statutory provisions in place and must also recognise fundamental pricing and funding issues, in the context of finite Exchequer resources. 

Owing to scheduling difficulties, it was not possible for me to meet with MS Ireland in June. However, I am willing to meet with MS Ireland on a mutually convenient date.

Hospital Procedures

Ceisteanna (407)

Róisín Shortall

Ceist:

407. Deputy Róisín Shortall asked the Minister for Health the number of full and partial lower limb amputations that were carried out in each of the years 2015 to 2017; the number of these patients who had diabetes by county; and if he will make a statement on the matter. [31459/18]

Freagraí scríofa

Minister for Health

This is a HSE matter I have referred this to the HSE.

General Data Protection Regulation

Ceisteanna (408, 409, 410)

Catherine Murphy

Ceist:

408. Deputy Catherine Murphy asked the Minister for Health the changes he has made to allow access by persons to their own data held by his Department and bodies under its aegis following the introduction of GDPR; and if he will make a statement on the matter. [31473/18]

Catherine Murphy

Ceist:

409. Deputy Catherine Murphy asked the Minister for Health the staffing complement and resources of his Department's data protection officer; and if he will make a statement on the matter. [31497/18]

Catherine Murphy

Ceist:

410. Deputy Catherine Murphy asked the Minister for Health the data protection impact assessments his Department has commenced since 15 May 2018; and if he will make a statement on the matter. [31514/18]

Freagraí scríofa

Minister for Health

I propose to take Questions Nos. 408 to 410, inclusive, together.

My Department has not commenced any Data Protection Impact Assessments (DPIAs) since the General Data Protection Regulation (GDPR) came into effect on 25 May 2018.

Since 25 May 2018, there is a Privacy Statement on my Department's website setting out information on individuals' rights under Data Protection legislation and rights to access personal data.  The Privacy Statement also contains information on how to contact the Department's Data Protection Officer and the Data Protection Commissioner.  A Subject Access Request Form is also available on the Department's website.

Information relating to access to personal data held by agencies under the aegis of my Department is an operational matter for the agencies concerned.  I have forwarded your question to the Health Service Executive (HSE) for direct reply.  For information relating to other bodies the Deputy should contact the relevant Director/CEO/Registrar directly.

My Department's Data Protection Officer is assisted by one part-time head of staff.  In addition, my Department is engaged in a tendering process for consultancy services to assist the Data Protection Officer in the roll-out of a programme of implementation to ensure my Department's full compliance with the GDPR.  The closing date for receipt of tenders is 13 July 2018.