155. Deputy Clare Daly asked the Minister for Health his views on the delays for persons with multiple sclerosis to access life-changing medication; and if he will engage with an organisation (details supplied) to discuss the matter. (Question 19481/18 asked on 03 May 2018 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): 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 sets out criteria for decisions on reimbursement. As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines. 
In line with the 2013 Act, if a company would like a medicine to be reimbursed through the community drug schemes, i...

72. Deputy Clare Daly asked the Minister for Health the progress made towards securing consistent access to a drug (details supplied) for persons suffering with alpha-1 antitrypsin deficiency via its approval for reimbursement by the HSE. (Question 17008/18 asked on 19 Apr 2018 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 28 and 72 together.
The HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE carefully considered the pricing and reimbursement of human alpha1-proteinase inhibitor (Respreeza). The manufacturer, CSL Behring, was notified in August 2017 that the HSE was unable...

256. Deputy Clare Daly asked the Minister for Health if he will engage with an organisation (details supplied) and the pharmaceutical industry to ensure new medicines are available to persons with MS; and if he will make a statement on the matter. (Question 17338/18 asked on 19 Apr 2018 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.   As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines. The Act specifies the criteria for decisions on the reimbursement of medicines.
In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE pu...

206. Deputy Clare Daly asked the Minister for Health the reason for the decision to discontinue supplying of Versatis medicated plasters with lidocaine to medical card holders; the alternative that will be made available to persons that rely on these items; and if he will make a statement on the matter. (Question 2577/18 asked on 18 Jan 2018 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): Medicines play a vital role in improving the health of Irish patients. Securing access to existing and new and innovative medicines is a key objective of the health service. However, the challenge is to do this in an affordable and sustainable manner. The medicines bill for the community drugs schemes – primarily the GMS, Long Term Illness and Drugs Payment schemes and the High Tech Arrangement – is forecast at just over €1.7 billion in 2017.
To ensu...

165. Deputy Clare Daly asked the Minister for Health if he will meet with a person and a group (details supplied). (Question 44435/17 asked on 19 Oct 2017 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): 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. The Act does not give the Minister for Health any powers in this regard. 
In relation to the access scheme for Respreeza, the operation of such schemes is at the discretion of manufacturers. As Minister for Health I have no role in the operation of th...

978. Deputy Clare Daly asked the Minister for Health if he has had discussions with the HSE regarding the decision to withdraw funding for Duchenne muscular dystrophy medication Translarna; if he has satisfied himself that every effort has been made to provide adequate alternative access to this medication to the small numbers of persons that are currently reliant on this medication; if he will detail the alternatives; and if he will make a statement on the matter. (Question 37473/17 asked on 11 Sep 2017 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 890, 891, 978, 995 and 1075 together.
The Health Service Executive has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE informed my Department of its decision not to reimburse Ataluren (Translarna) in July 2017. The HSE informed the manufacturer of this decision, in keep...

965. Deputy Clare Daly asked the Minister for Health the steps he will take to review all the evidence relating to the drug Respreeza objectively and enter into meaningful discussions with a company (details supplied) in order to find a solution that will make Respreeza available for persons with alpha-1 anti-trypsin deficiency as soon as possible. (Question 19852/17 asked on 02 May 2017 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): 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.
 ...

638. Deputy Clare Daly asked the Minister for Health if persons who need access to the life changing drug Respreeza have the option of accessing it abroad via the cross-Border directive health care scheme. (Question 10298/17 asked on 28 Feb 2017 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): The EU Directive 2011/24/EU on Patients’ Rights in Cross Border Healthcare aims to ensure EU citizens may access safe and good quality healthcare services across EU borders. The Directive establishes a framework for cross border healthcare between EU/EEA states to facilitate patients to access care in another Member State in accordance with their entitlements in their own country. Under the Directive, known as the Cross Border Healthcare Directive (CB...

362. Deputy Clare Daly asked the Minister for Health the steps he will take to ensure that a drug (details supplied) continues to be available to treat individuals with alpha-1 antitrypsin deficiency. (Question 40627/16 asked on 16 Dec 2016 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 362 and 363 together.
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 reaching its decision, the HSE examines all the evidence which may be relevant in its view for the decision (including the information /dossier submitted by the Company) and will take into acc...

118. Deputy Clare Daly asked the Minister for Health the reason a drug (details supplied) is not available to multiple sclerosis sufferers here, despite clinical trials showing its effectiveness in reducing symptoms and improving quality of life for persons with MS. (Question 32157/16 asked on 26 Oct 2016 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): On 11 July 2014, the Misuse of Drugs Regulations 1988 were amended to allow for certain cannabis-based medicinal products to be used in Ireland. The Health Products Regulatory Authority subsequently granted a marketing authorisation for the cannabis-based medicinal product Sativex to be marketed in this State. It was then open to the holder of that authorisation to make the product available for prescribing in Ireland.
The HSE has statutory responsibili...

146. Deputy Clare Daly asked the Minister for Health if negotiations with the manufacturer of the drug, Orkambi, have been completed; and the outcome regarding its likely availability for cystic fibrosis patients. (Question 31164/16 asked on 19 Oct 2016 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 144 and 146 together.
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. Prior to deciding whether to reimburse a medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness and the resources available. 
The decisions on which...

425. Deputy Clare Daly asked the Minister for Health the factors in his decision not to recommend the Orkambi drug for cystic fibrosis patients. (Question 15543/16 asked on 14 Jun 2016 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 425 and 429 together.
I understand that this is a matter of great concern for many Cystic Fibrosis patients and their families and would like to clarify that the process of assessing Orkambi is not yet complete. I would also like to clarify the process, as the premise of your question is incorrect, and have set out the factual position below for your information.
The HSE has statutory responsibility for decisions on pric...

429. Deputy Clare Daly asked the Minister for Health if he recommends the use of Orkambi drug for cystic fibrosis patients. (Question 15585/16 asked on 14 Jun 2016 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 425 and 429 together.
I understand that this is a matter of great concern for many Cystic Fibrosis patients and their families and would like to clarify that the process of assessing Orkambi is not yet complete. I would also like to clarify the process, as the premise of your question is incorrect, and have set out the factual position below for your information.
The HSE has statutory responsibility for decisions on pric...

470. Deputy Clare Daly asked the Minister for Health if he is aware of the unregulated sale of false treatments for autism spectrum disorder and cancer over the Internet; and if he will make a statement on the matter. (Question 15966/16 asked on 14 Jun 2016 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): Under the Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended, a medicine cannot be placed on the market in Ireland unless it has a marketing authorisation from the Health Products Regulatory Authority (HPRA) or a community marketing authorisation from the European Medicines Agency (EMA). Any product which makes a medicinal claim to treat medical conditions such as autism is considered to be a medicine and requires an aut...

300. Deputy Clare Daly asked the Minister for Health if he has had consultations with the Health Service Executive regarding the possible funding of a drug, eculizumab, for a person (details supplied); the outcome of those consultations, if they have taken place. (Question 7428/16 asked on 20 Apr 2016 - Medicinal Products Availability)

Minister of State at the Department of Health (Deputy Kathleen Lynch): I propose to take Questions Nos. 300 and 335 together.
Eculizumab is an ultra-orphan medicine licensed for the treatment of paroxysmal nocturnal haemaglobinurea (PNH) and atypical haemolytic uraemic syndrome (aHUS). Eculizumab is reimbursable for the treatment of these two conditions, for which the European Medicines Agency has completed assessments in relation to safety and efficacy.
The drug is not licensed for the treatme...

280. Deputy Clare Daly asked the Minister for Health the date on which the Health Products Regulatory Authority was first informed by a company (details supplied) that Lariam was being withdrawn. (Question 37033/15 asked on 22 Oct 2015 - Medicinal Products Availability)

Minister of State at the Department of Health (Deputy Kathleen Lynch): On the 13 July 2015 the Health Products Regulatory Authority (HPRA) was informed of the potential discontinuation.
The official letter of withdrawal was received by HPRA on 5 August 2015.
 ...

745. Deputy Clare Daly asked the Minister for Health if the Health Service Executive has agreed to make a drug (details supplied) available to sufferers of phenylketonuria. (Question 30518/15 asked on 22 Sep 2015 - Medicinal Products Availability)

Minister of State at the Department of Health (Deputy Kathleen Lynch): I propose to take Questions Nos. 745, 749, 815, 820, 994 and 1088 together.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Prior to reimbursing any medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiv...

815. Deputy Clare Daly asked the Minister for Health if the Health Service Executive will make available the drug sapropterin or Kuvan, for the treatment of those effected by the condition phenylketonturia, PKU, here; and when patients may avail of this treatment. (Question 30784/15 asked on 22 Sep 2015 - Medicinal Products Availability)

Minister of State at the Department of Health (Deputy Kathleen Lynch): I propose to take Questions Nos. 745, 749, 815, 820, 994 and 1088 together.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Prior to reimbursing any medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiv...

974. Deputy Clare Daly asked the Minister for Health the steps taken to ensure that multiple sclerosis sufferers are provided with access to the drug Fampyra; the reason the issue has not been resolved; and if he will make a statement on the matter. (Question 31333/15 asked on 22 Sep 2015 - Medicinal Products Availability)

Minister of State at the Department of Health (Deputy Kathleen Lynch): I propose to take Questions Nos. 725, 968 and 974 together.
The Health Service Executive (HSE) has confirmed that it is in the final stages of putting in place the governance arrangements and processes around a responder-based reimbursement programme for the multiple sclerosis drug Fampridine (brand name Fampyra®).
It is expected that reimbursement will be extended where a demonstration of clinical response (based on objectiv...

471. Deputy Clare Daly asked the Minister for Health further to Parliamentary Question No. 199 of 12 March 2015, if he will request the Health Service Executive to answer the question asked, which was the reason the person (details supplied) in Dublin 5 is not receiving access to the drug Lemtrada, rather than an explanation of the overall policy of Beaumont Hospital in that regard. (Question 15432/15 asked on 21 Apr 2015 - Medicinal Products Availability)

Minister for Health (Deputy Leo Varadkar): The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013, therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
If the Deputy has not received a reply from the HSE within 15 working days will she please contact my Private Office and they wil...

199. Deputy Clare Daly asked the Minister for Health the reason a person (details supplied) in Dublin 5 is being denied access to the multiple sclerosis drug treatment, Lemtrada. (Question 10852/15 asked on 12 Mar 2015 - Medicinal Products Availability)

Minister of State at the Department of Health (Deputy Kathleen Lynch): The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013, therefore, the matter has been referred to the HSE for attention and direct reply to you. 
If you have not received a reply from the HSE within 15 working days please contact my Private Office and t...

417. Deputy Clare Daly asked the Minister for Health the progress in ensuring that MS sufferers who require the Fampyra drug are able to avail of it under the drug treatment scheme. (Question 46188/14 asked on 02 Dec 2014 - Medicinal Products Availability)

Minister of State at the Department of Health (Deputy Kathleen Lynch): I propose to take Questions Nos. 417 and 433 together.
The decisions on which medicines are reimbursed by the taxpayer, are not political or ministerial decisions. These are made on objective, scientific and economic grounds by the Health Service Executive (HSE) on the advice of the National Centre for Pharmacoeconomics (NCPE). 
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal prod...

713. Deputy Clare Daly asked the Minister for Health further to Parliamentary Question No. 367 of 21 October 2014, if he will address the problem of MMS and CD being available via open information sharing by doctors and other doctors, parents, schools, counsellors, therapists and so on, as to the nature of chlorine dioxide, its effects on the human body and co-operating with a company (details supplied) and other online suppliers in order to shut them down and ensure that Customs and Excise can seize products on entry into the country. (Question 41604/14 asked on 04 Nov 2014 - Medicinal Products Availability)

Minister of State at the Department of Health (Deputy Kathleen Lynch) (Deputy Kathleen Lynch): As previously advised, under the Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended, a medicinal product cannot be placed on the market in Ireland unless it has a marketing authorisation from the Health Products Regulatory Authority (HPRA) or a community marketing authorisation from the European Medicines Agency (EMA). Any product which makes a medicinal claim requires ...

207. Deputy Clare Daly asked the Minister for Health the position regarding Fampyra being made available to multiple sclerosis sufferers who have benefitted from same and could not afford the cost; and if he will make a statement on the matter. (Question 30542/14 asked on 10 Jul 2014 - Medicinal Products Availability)

Minister of State at the Department of Health (Deputy Alex White): The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. 
The HSE received an application for the inclusion of fampridine (Fampyra®) in the GMS and community drugs schemes. The application was considered in line with the procedures...

516. Deputy Clare Daly asked the Minister for Health if he will increase custom and exercise supervision of commercial packaging operators, in order to deal with the explosion of prescription drugs being ordered on-line and delivered within a 24 hour period. (Question 14779/13 asked on 26 Mar 2013 - Medicinal Products Availability)

Minister of State at the Department of Health (Deputy Alex White): The Revenue Commissioner’s Customs Service and the Irish Medicines Board (IMB) have shared competency in relation to the prevention and detection at importation of illicit medicines. In addition the IMB and the Customs Service have a Memorandum of Understanding (MOU) and under this MOU both organisations work closely to detain and prohibit prescription medicines purchased online from being imported.
IMB and the Customs Service d...