389. Deputy Gino Kenny asked the Minister for Health if his Department will consider replicating the FDA black box warning regarding cautionary use by persons under 18 years of age on antidepressants such as Prozac in the USA on the packaging of similar drugs here (details supplied); and if he will make a statement on the matter. (Question 17660/18 asked on 24 Apr 2018 - Medicinal Products Regulation)

Minister for Health (Deputy Simon Harris): The legal framework for provision of detailed warnings for medicines across the EU is through the product information, which specifically provides for the format and content of these documents. The summary of product characteristics (SmPC) for the healthcare professional and the package leaflet (PL) for patients are reviewed and approved as an intrinsic part of the licensing of a medicine, and continuously updated to reflect the current state of kno...

91. Deputy Gino Kenny asked the Minister for Health his plans to use a drug approval and reimbursement system for MS drugs similar to that in Germany (details supplied); and if he will make a statement on the matter. (Question 16408/18 asked on 19 Apr 2018 - Medicinal Products Reimbursement)

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 pur...

378. Deputy Gino Kenny asked the Minister for Health when the result of the assessment of the PKU treatment drug Kuvan will be made available; and if he will make a statement on the matter. (Question 13807/18 asked on 27 Mar 2018 - 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 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 reply to the Deputy.
 ...

137. Deputy Gino Kenny asked the Minister for Health if sativex is available or being prescribed by general practitioners here; and if he will make a statement on the matter. (Question 8889/18 asked on 21 Feb 2018 - 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 drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
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-b...

76. Deputy Gino Kenny asked the Minister for Health if a decision has been made by the HSE on the drug, Kuvan, for those that are living with PKU; and if he will make a statement on the matter. (Question 6094/18 asked on 08 Feb 2018 - Medicinal Products Licensing)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 76 and 186 together.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, under the Health (Pricing and Supply of Medical Goods) Act 2013.
In reaching a decision, the HSE examines all the evidence which may be relevant in its view for the decision and will take into account such expert opinions and recommendations which it may have sought, includin...

255. Deputy Gino Kenny asked the Minister for Health if a decision has been made in relation to the libre continuous glucose monitoring system being made widely available to persons with type 1 diabetes here; and if he will make a statement on the matter. (Question 52637/17 asked on 12 Dec 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.
 ...

51. Deputy Gino Kenny asked the Minister for Health the likely timescale of the conclusion of HSE negotiations with the manufacturer of the drug Kuvan; his views on the urgency of it being made available for persons with PKU here; and if he will make a statement on the matter. (Question 48174/17 asked on 15 Nov 2017 - Medicinal Products Reimbursement)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 49 and 51 together.
The HSE 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.
In reaching a decision, the HSE examines all the evidence which may be relevant in its view for the decision and will take into account such expert opinions and recommendations which may have been so...

59. Deputy Gino Kenny asked the Minister for Health the circumstances in which the drug, Vimizin, a treatment for those that suffer from the rare disease Morquio, has been refused funding by the HSE; and if he will make a statement on the matter. (Question 40922/17 asked on 28 Sep 2017 - Medicinal Products Reimbursement)

Minister for Health (Deputy Simon Harris): The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE issued a Notice of Proposal not to support reimbursement of Elosulfase alfa (Vimizim) to the manufacturer BioMarin in June 2017.
The Health (Pricing and Supply of Medical Goods) Act 2013 allows suppliers at least 28 days in wh...

101. Deputy Gino Kenny asked the Minister for Health if he will consider the motion recently adopted by an organisation (details supplied) calling for the prescription of cannabis for medicinal use not to be restricted to consultants only but to allow general practitioners to do so also; and if he will make a statement on the matter. (Question 27734/17 asked on 21 Jun 2017 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): As you know, I published the Health Products Regulatory Authority’s report ‘Cannabis for Medical Use – A Scientific Review’ in February and announced my intention to establish a Cannabis Access Programme for cannabis-based treatments to be provided for qualifying patients. The HPRA report recommended that patients accessing cannabis through the programme should be under the care of a medical consultant. 
The Chief Medical Officer’s advice reiterates tha...

390. Deputy Gino Kenny asked the Minister for Health if his Department signed a contract with the manufacturers of Orkambi; when the drug will be made available to persons with cystic fibrosis; and if he will make a statement on the matter. (Question 25284/17 asked on 30 May 2017 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
I am informed that an agreement has been confirmed, in principle, between the HSE and the manufacturer for the supply of two cystic fibrosis treatments to Irish patients. These are Orkambi (for patients aged 12 years and older) and Kalydeco (for patients aged 2-5 and certain patients...

407. Deputy Gino Kenny asked the Minister for Health if his attention has been drawn to the fact that the Health Products Regulatory Authority supports on its website an information leaflet on the medicine fluoxetine (details supplied); if this explanation of thoughts of self-harm or suicide when starting an antidepressant as being due to a delay in onset of action is an evidence based one; if it is contradicted by placebo controlled randomised clinical trials; and if he will make a statement on the matter. (Question 22948/17 asked on 16 May 2017 - Medicinal Products)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 407 and 408 together.
The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines in Ireland. The HPRA highlights the fact that all medicines have some risks and a small number of people may develop side effects (also known as adverse reactions). The clinician treating the patient balances the risks associated with a medicine in the context of the overall benefit of the me...

408. Deputy Gino Kenny asked the Minister for Health if his attention has been drawn to the fact that the Health Products Regulatory Authority supports on its website an information leaflet on the medicine fluoxetine which includes with regard to the way fluoxetine works the statement that (details supplied); if this is evidence based information supported by expert mental health professionals; and if he will make a statement on the matter. (Question 22949/17 asked on 16 May 2017 - Medicinal Products)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 407 and 408 together.
The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines in Ireland. The HPRA highlights the fact that all medicines have some risks and a small number of people may develop side effects (also known as adverse reactions). The clinician treating the patient balances the risks associated with a medicine in the context of the overall benefit of the me...

508. Deputy Gino Kenny asked the Minister for Health his views on the monitoring of trends in the prescription of psychoactive psychotropic drugs here, especially to children, over the past 20 years; if his attention has been drawn to concerns regarding the rise in problems associated with prescribed medications, especially opioid painkillers, in terms of drug dependency and overdose, including fatal overdose; the measures being taken to address the rise in prescription rates and associated problems regarding prescription medications; and if he will make a statement on the matter. (Question 17648/17 asked on 11 Apr 2017 - Medicinal Products Data)

Minister of State at the Department of Health (Deputy Catherine Byrne): I propose to take Questions Nos. 508 and 509 together. 
I think it is very important to monitor trends in the prescription of psychotropic drugs in Ireland including to children and young adults. It is also important to ensure that prescribing policies are evidence based thereby ensuring safe use of these medicines. 
The Deputy will be aware that all medicines have side effects. However before being made available to the...

509. Deputy Gino Kenny asked the Minister for Health his views on the monitoring of trends in the prescription of psychoactive psychotropic drugs here, especially to children, over the past 20 years; if his attention has been drawn to concerns regarding the rise in problems associated with prescribed medications, especially stimulants, anti-depressants and anti-psychotic drugs, in terms of tolerance and withdrawal and the lack of support from systematic reviews of their use in children; the measures being taken to address the rise in prescription rates and associated problems regarding prescription medications; and if he will make a statement on the matter. (Question 17651/17 asked on 11 Apr 2017 - Medicinal Products Data)

Minister of State at the Department of Health (Deputy Catherine Byrne): I propose to take Questions Nos. 508 and 509 together. 
I think it is very important to monitor trends in the prescription of psychotropic drugs in Ireland including to children and young adults. It is also important to ensure that prescribing policies are evidence based thereby ensuring safe use of these medicines. 
The Deputy will be aware that all medicines have side effects. However before being made available to the...

115. Deputy Gino Kenny asked the Minister for Health the changes since the Minister of State, Deputy Finian McGrath, confirmed to Dáil Éireann on 15 November 2016 that compassionate access to cannabis-based medicine should be prescribed by an Irish-registered doctor and recent comments by himself and the Taoiseach on 28 February 2017 and 1 March 2017 that this medicine now needs to be prescribed by a consultant neurologist; and if he will make a statement on the matter. (Question 12070/17 asked on 08 Mar 2017 - Medicinal Products Licensing)

Minister for Health (Deputy Simon Harris): The granting of an individual licence under the Misuse of Drugs Act for the use of cannabis for medical purposes sets aside the usual regulatory processes which are in place to protect the public and which ensure that only those medications which have been found to be both effective and safe are made available to the public. 
Applications for controlled drugs licences are considered on a case by case basis. The Chief Medical Officer has advised me that ...

654. Deputy Gino Kenny asked the Minister for Health the advice he has received from the Chief Medical Officer, as referred to in Dáil Éireann on 28 February 2017, with regard to compassionate access to cannabis based medicine; if he will publish this advice; and if he will make a statement on the matter. (Question 12071/17 asked on 07 Mar 2017 - Medicinal Products)

Minister for Health (Deputy Simon Harris): Under the Misuse of Drugs Acts and the Regulations made thereunder, the manufacture, production, preparation, sale, supply, distribution and possession of cannabis is currently unlawful except under licence. 
Following the recent publication of the Health Products Regulatory Authority’s report Cannabis for Medical Use – A Scientific Review a process is currently underway to establish an access programme for cannabis-based treatments in Ireland.
For the...

414. Deputy Gino Kenny asked the Minister for Health the assistance he has provided to a person (details supplied); and if he will make a statement on the matter. (Question 8192/17 asked on 21 Feb 2017 - Medicinal Products)

Minister for Health (Deputy Simon Harris): 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. In relation to the query raised by the Deputy, as this is a service issue, I ha...

1012. Deputy Gino Kenny asked the Minister for Health if he will ensure that the result of the health technology assessment by the NCPE of the human alpha1 proteinase inhibitor drug Respreeza is processed in a timely way, so that it can be promptly reimbursed by the HSE as it is reimbursed in other countries (details supplied); if he will ensure that those persons currently on the drug with beneficial results are guaranteed continued reimbursed use; and if he will make a statement on the matter. (Question 41569/16 asked on 17 Jan 2017 - Medicinal Products Availability)

Minister for Health Deputy Simon Harris: I propose to take Questions Nos. 1006, 1012, 1053 and 1118 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 t...

180. Deputy Gino Kenny asked the Minister for Health if his attention has been drawn to the fact that prescribed low protein foods are required to prevent neurological damage and to supplement the diet of adults and children with phenylketonuria, PKU; if his attention has further been drawn to the fact that no new low protein products have been added to the long-term illness card list in more than six years; if he will ensure a full and appropriate updated list of foods prescribed for PKU is added to the reimbursement list; and if he will make a statement on the matter. (Question 36618/16 asked on 24 Nov 2016 - Medicinal Products Reimbursement)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 177 and 180 together.
The HSE has statutory responsibility for decisions on pricing and reimbursement of products under the community drug schemes, including the LTI Scheme, 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 reply to the Deputy. 
 ...

599. Deputy Gino Kenny asked the Minister for Health the arrangements he has made to enable compassionate access to cannabis based medicines for a person (details supplied) and other persons with medical conditions; and if he will make a statement on the matter. (Question 35010/16 asked on 15 Nov 2016 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): I am aware that many patients believe that cannabis should be a treatment option for their medical condition. However, with the exception of Sativex, cannabis-based preparations are not currently authorised as medicines in Ireland. Cannabis has not gone through the normal regulatory procedures for medicines which are designed to protect patients and ensure treatments are supported by good evidence of their safety and efficacy. 
I am however committed ...

33. Deputy Gino Kenny asked the Taoiseach and Minister for Defence if he will consider launching a full investigation into possible negative health effects of drugs used on members of the Defence Forces; and if he will make a statement on the matter. (Question 33817/16 asked on 09 Nov 2016 - Defence Forces Medicinal Products)

Minister of State at the Department of Defence (Deputy Paul Kehoe) (Deputy Paul Kehoe): At the outset, I want to assure the deputy that the military authorities and I place high priority on the health and welfare of the men and women of the Defence Forces.
The provision of medicines is an integral part of the medical service provided to members of the Defence Forces. I am informed that the range of medications used by the Defence Forces, and the effects of those medications, is kept under revie...

486. Deputy Gino Kenny asked the Minister for Health the estimated saving to the health budget and to the out-of-pocket expenses of the public, were drug prices here equivalent to each of the five EU countries with the lowest drug prices, in addition to Portugal and Denmark if they are not included in the lowest five; and if he will make a statement on the matter. (Question 32003/16 asked on 25 Oct 2016 - Medicinal Products Prices)

Minister for Health (Deputy Simon Harris): It is not feasible to provide a robust estimate of savings from a reduction in the price of branded medicines to the lowest European Union level, as the price of each dosage form and strength would need to be assessed and compared with pricing data from all of the other member states. In addition, the HSE must consider continuity and security of supply in setting prices. Accordingly, the lowest EU price of an individual product may not always represen...

53. Deputy Gino Kenny asked the Minister for Health the efforts he is making to secure cost-effective prescribing, pricing and payment systems; the reason the cost of drugs here is greater than in comparable countries; and if he will make a statement on the matter. (Question 30692/16 asked on 18 Oct 2016 - Medicinal Products Prices)

Minister for Health (Deputy Simon Harris): The State has introduced a series of reforms in recent years to reduce pharmaceutical prices and expenditure.
A new four-year Framework Agreement on the Supply and Pricing of Medicines was signed in July 2016 with the Irish Pharmaceutical Healthcare Association (IPHA) which is expected to deliver approximately €600 million in savings over the lifetime of the Agreement. The principles captured in the Agreement will also be extended to non-IPHA suppliers ...

421. Deputy Gino Kenny asked the Minister for Health to clarify the availability of the anti-epilepsy drug Epidiolex here; the arrangements for facilitating access by children with Dravet syndrome and Lennox-Gastaut syndrome; and if he will intervene to improve access. (Question 17166/16 asked on 21 Jun 2016 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): Epidiolex is an investigational medicinal product currently undergoing clinical trials in a number of EU Member States. I have no authority to compel pharmaceutical companies to conduct such trials in Ireland. 
Under European and Irish legislation, before a medicine can be placed on the market the manufacturer must seek an authorisation from the Health Products Regulatory Authority (HPRA), or in the case of certain medicines, the European Medicines Age...