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Medicinal Products Licensing

Dáil Éireann Debate, Tuesday - 21 February 2017

Tuesday, 21 February 2017

Questions (468)

Michael Healy-Rae

Question:

468. Deputy Michael Healy-Rae asked the Minister for Health if he will address concerns with regard to the use of medical marijuana (details supplied); and if he will make a statement on the matter. [8506/17]

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Written answers

The HPRA Report did not recommend the inclusion of chronic pain in the access programme. However, this position will be kept under review, and if better clinical evidence becomes available in future, the inclusion of chronic pain can be reconsidered.

Until such time as the necessary legislative amendments have been made to facilitate the implementation of the access programme, it remains open for an Irish registered doctor to apply for a licence for such preparations for an individual, named-patient under their care.

As Minister for Health I have a responsibility to patients to make decisions around healthcare based on the best scientific and clinical evidence available. When I initiated the review of policy on the use of cannabis and cannabis-based products for medicinal purposes I requested that the Health Products Regulatory Authority (HPRA) provide expert advice on the issue. The HPRA’s statutory role is to protect and enhance human health by regulating medicines and other health products and it has the necessary clinical and scientific expertise to provide advice on this issue.

I requested that the HPRA provide advice on recent developments in the use of cannabis for medical purposes including an overview of products that have been authorised in other countries and an overview of the wider on-going and emerging clinical research in new indications and evidence of efficacy. The HPRA convened an expert working group as part of their review which comprised experts from various medical fields, including a Consultant Anaesthetist/Pain Specialist, a Consultant in Palliative Medicine and a Palliative Care Pharmacist.

On 10th February I published the HPRA’s Report “Cannabis for Medicinal Use – A Scientific Review” and announced my decision to establish an access programme for cannabis-based treatments for the following conditions, spasticity associated with multiple sclerosis resistant to all standard therapies and interventions, intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes and severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications. Patients accessing cannabis through the programme will be under the care of a medical consultant.

The HPRA Report did not recommend the inclusion of chronic pain in the access programme. However, this position will be kept under review, and if better clinical evidence becomes available in future, the inclusion of chronic pain can be reconsidered.

Until such time as the necessary legislative amendments have been made to facilitate the implementation of the access programme, it remains open for an Irish registered doctor to apply for a licence for such preparations for an individual, named-patient under their care.

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