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.
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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...

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.
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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...

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...

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 ...

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...