Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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I am slightly disappointed that the Minister for Health, Deputy Harris, is not here to answer the questions I have been trying to raise in the Dáil for at least a year.

Two years ago the Health Products Regulatory Authority, HPRA, produced a report entitled Cannabis for Medical Use - A Scientific Review. I argue that the review was fast-tracked due to Vera Twomey's fight for access to medicinal cannabis for her daughter. In the two years since the report's publication nothing has been done. We were critical of the report because of its limitations, its conservatism and its stipulation that medicinal cannabis should only be used in the treatment of three conditions. Incredibly a major omission from the report related to chronic pain. The greatest efficacy for medicinal cannabis is for chronic pain.

The report was published two years ago and we still have no cannabis, no access and no programme. Parents and patients are forced to go abroad and forced to break the law which is completely unsustainable. Parents have run out of options. They have tried everything clinically, but they have to leave the jurisdiction to obtain this medication. The Government has failed them.

The Minister for Health has come out with the mantra that it is a supply issue, but it is not a supply issue. I do not find that a credible response. This comes from institutionalised resistance by the HSE, the Department of Health, the HPRA, the Government and some in the medical profession.

After waiting for two years, the people want meaningful progress on the issue. Just before Christmas, Thailand, which has one of the most extreme anti-drug laws, passed legislation on the legalisation of medicinal cannabis. It has also happened in Mexico and other countries. Six months ago Britain had no policy on the matter and the Tory Government has changed even though it is extremely restrictive.

In this country we have issued 13 licences to 13 individuals over two years. I have been extremely critical of that licensing system. It is extremely bureaucratic and cumbersome. Most of the time people going to their doctor or specialist have a negative experience. The specialists claim they do not have enough information about it and so forth. That licensing system is not workable.

If the patient is granted a licence, there is no guarantee that they will be reimbursed and in addition they have to go abroad to get the medication. Therefore we are sending the patient to, in particular, the Netherlands to get the medication and bring it back. The medical profession, the public and the vast majority of Deputies will say that is not sustainable. I keep going on about this issue because of the injustice of normal parents seeking the best for their children having to go abroad and break the law which is unacceptable.

Finian McGrath (Dublin Bay North, Independent)
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I thank Deputy Gino Kenny for raising this very important issue and apologise on behalf of the Minister for Health, Deputy Harris, who is unavailable. The report of the Health Products Regulatory Authority, HPRA, entitled Cannabis for Medical Use - A Scientific Review, recommended that if access to cannabis is to be permitted for medical purposes, its use should only be initiated as part of a structured process of formal, ongoing clinical evaluation for a limited number of clearly defined medical conditions which have failed to respond to all other previous treatments and where there is at least modest evidence that cannabis may be effective. Patients should be under the direct supervision of an appropriately trained and experienced medical consultant. The specified medical conditions or indications are spasticity associated with multiple sclerosis, intractable nausea and vomiting associated with chemotherapy and severe, refractory or treatment-resistant epilepsy.

The Minister for Health undertook to establish an access programme to facilitate access to cannabis based treatments in certain circumstances, in line with the HPRA’s recommendations. An expert reference group was tasked with the development of operational, clinical and practice guidelines for this access programme. The group was asked to advise on the development of operational, clinical and practice guidelines for healthcare professionals treating patients through an access programme. These guidelines have been published on the Department of Health’s website as part of a comprehensive repository of information on cannabis for medical use. The purpose of the access programme is to facilitate access to cannabis based products or preparations that are of a standardised quality and which meet an acceptable level of quality assurance during the manufacturing process. Availability of cannabis products that are of an appropriate quality standard and are affordable to patients is clearly critical in establishing the access programme. Canada and the Netherlands are the only two countries that currently permit the export of cannabis products which meet acceptable quality control standards beyond their borders. The Netherlands permits exports of cannabis dried herb but does not permit commercial export of oil-based cannabis formulations. Department officials continue to work intensively on finding solutions to the supply of appropriate quality assured cannabis products for Irish patients. Doctors continue to utilise the ministerial licence route to prescribe medical cannabis for their patients. Until suitable medical cannabis products are made available in Ireland, prescribers and their patients are sourcing the prescribed product from a pharmacy in the Netherlands, on foot of their medical prescription. It is intended that the ministerial licence application scheme will continue to operate in parallel with the cannabis for medical use access programme after the programme becomes operational, for exceptional cases only and where there is an un-met clinical need.

Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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I do not know who writes this rubbish but this answer is exactly the same as all previous answers I have received. The HPRA report was published two years ago but there is still no access programme. People are having to go abroad, break the law or use the ministerial licence system. The Minister of State made reference to the clinical guidelines which hold that the access programme will not recommend cannabis based products with THC for refractory epilepsy. There are 13 licencees at the moment, nine of whom have epilepsy. These patients are being prescribed cannabis with THC by specialist doctors. What will happen to them when and if the access programme is up and running? Will they stay in the ministerial licence system? Will they still have to go abroad and will they continue to have fears around reimbursement? This is an absolute mess. There are hundreds, if not thousands of people who could benefit from medical cannabis but this Government is denying them access because of bureaucracy. This is a question of institutionalised resistance from top to bottom.

I do not find it credible that the Department cannot find a supplier of medical cannabis for Irish patients. That is just not credible. Why was this issue not flagged a year and a half ago by the HPRA, the Department or the Minister? There is serious institutional resistance to this. The Government may have time on its hands but thousands of patients do not. They are suffering because of bureaucracy. I do not know how members of the Government can live with themselves.

If it is not possible to get the access programme up and running, the Government should revert to the Bill that I put before the House over two years ago and which garnered the support of the majority of Members of this Dáil. The Government has stalled the progress of that legislation.

Finian McGrath (Dublin Bay North, Independent)
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I disagree with the Deputy's argument because the answer is not the same-----

Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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It is the same.

Finian McGrath (Dublin Bay North, Independent)
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There is no issue of institutionalised resistance. Considerable progress is being made on the cannabis for medical use access programme. An expert group has drawn up clinical guidelines for healthcare professionals treating patients through the access programme. These guidelines are available on the Department's website. While medical cannabis products are not medicines, ensuring that such products meet appropriate quality standards when they are made available to the Irish market is a critical aspect of facilitating safe access to medical cannabis for Irish based patients.

Officials from the Department of Health are working intensively on this issue to ensure a supply of appropriate medical cannabis products to meet the needs of Irish patients. They recently visited Denmark and held meetings with a number of government bodies and other stakeholders in the medical cannabis supply chain. The aim of these meetings was to ascertain whether aspects of the Danish programme can be replicated in Ireland, including the importation of medical cannabis products. This represents real progress.

I assure the Deputy that I will bring the other issues he raised to the attention of the Minister.