Pat Buckley (Cork East, Sinn Fein)
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919. To ask the Minister for Health his plans to facilitate or support discussions between neurologists regarding the use of Epidiolex; and if he will make a statement on the matter. [35758/17]

Pat Buckley (Cork East, Sinn Fein)
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920. To ask the Minister for Health his plans to facilitate or support discussions between neurologists regarding an alternative to prescribing Epidiolex. [35759/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 919 and 920 together.

Epidiolex is a proprietary oral solution of plant-derived cannabidiol, or CBD, currently in phase III clinical trials. According to the manufacturer’s website “Epidiolex development is initially concentrating on severe, orphan, early-onset, treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS)”.

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 Agency (EMA). To my knowledge, no application for a marketing authorisation for Epidiolex has yet been submitted by the product manufacturer GW Pharmaceuticals to either the HPRA or the EMA.

In February I published the HPRA report ‘Cannabis for Medical Use - A Scientific Review’, on foot of which I committed to the implementation of a Cannabis for Medical Use Access Programme, in line with the HPRA’s recommendations. In March I established the Cannabis for Medical Use Expert Reference Group to advise on the development of the Access Programme. The Expert Group is chaired by Dr Mairín Ryan, Director of Health Technology Assessment at the Health Information and Quality Authority (HIQA), and comprises representation from the areas of oncology, palliative care, anaesthesiology, general practice, adult neurology, paediatric neurology, multiple sclerosis, psychiatry, pharmacy, patients, and ethics as well as representatives from HIQA’s Health Technology Assessment Directorate, the HPRA, the National Medicines Information Centre and the Department of Health.

The Expert Group is tasked with the development of operational guidance for healthcare professionals treating patients through the Access Programme. A critical requirement for the successful establishment of a Cannabis for Medical Use Access Programme is meaningful engagement with representative bodies, clinicians, patients, and pharmacists so that these groups are integral to the drafting of operational clinical guidance.

The draft Clinical Guidance on the Medical Use of Cannabis developed by the Expert Group is out for consultation. The clinical guidance will include the forms of medicinal cannabis that will be permitted for use under the access programme and will outline the requirements for education of healthcare professionals and patients, as well as ethical implications of such a scheme. The systematic process employed to develop this guidance is based on the National Standards for Clinical Practice Guidance Development. This work will take a number of months to complete.

It is important to draw the Deputy’s attention to the Royal College of Physicians in Ireland (RCPI) statement, released in March 2017, on the use of cannabis products in the treatment of severe epilepsy in children and adults. In this statement the consultants involved in the treatment of epilepsy state that "currently the main barrier to the prescribing of cannabis derivatives for epilepsy is the lack of clinical evidence of its long-term efficacy, as well as lack of data on long-term side effects.”The position of the RCPI further demonstrates the importance of any discussions relating to a patient’s care being conducted in the clinical setting in consultation with the expert clinicians, the patient and their family.

It is the professional decision of the clinician, in consultation with their patient, to prescribe or not prescribe any particular treatment for a patient under their care. The independence of the doctor-patient relationship is a fundamental principle upon which medical practice is based. As Minister for Health I have no role in the professional clinical decision-making process.

Alan Farrell (Dublin Fingal, Fine Gael)
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921. To ask the Minister for Health the status of the provision of Respreeza; if he will respond to an organisation (details supplied) within the four weeks committed to at the Oireachtas health committee on 12 July 2017; and if he will make a statement on the matter. [35760/17]

Simon Harris (Wicklow, Fine Gael)
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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.