Paddy Burke (Fine Gael)
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I welcome the Minister of State, Deputy Damien English. I call Senator Colm Burke who has four minutes.

Colm Burke (Fine Gael)
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I welcome the Minister of State.

Sativex is a new add-on treatment option indicated for multiple sclerosis, MS, patients with moderate to severe resistant spasticity symptoms, that is muscle rigidity spasms. Sativex contains the active substances THC and CVD, extracted from herbal cannabis cloned plants at a 1:1 ratio. Sativex was issued a licence by the Health Products Regulatory Authority in Ireland on 18 July 2014, shortly after new regulations were signed to enable authorised cannabis based medicinal products to be legally prescribed by physicians. The Irish health technology assessment was evaluated by the National Centre for Pharmaeconomics and the company which provides the product was surprised and disappointed at the subsequent decision not to recommend Sativex for reimbursement at the price submitted. There is plenty evidence to show this drug assists people with MS. Many people are looking to use it to assist them. As the Minister of State is aware, once a person has MS there is no going back. One thing we can do is try to make sure they enjoy a normal way of living by providing pharmaceuticals and medications that can assist them. Those who have MS and who would benefit from this drug are disappointed it is not included in the drugs refund scheme. It is in that context I raise the matter.

Damien English (Meath West, Fine Gael)
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I thank the Senator for raising the issue. I am taking this Commencement matter on behalf of the Minister for Health, who regrets that he is unavailable to address the issue today. The Minister is aware that access to potentially beneficial drug treatments is an important issue for people with MS and that MS sufferers and their families face enormous day-to-day challenges in dealing with this progressive and debilitating condition.

Decisions on which medicines are licensed for use in Ireland, and which are reimbursed by the taxpayer, are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics, NCPE. The NCPE is a team of clinicians, pharmacists, pharmacologists and statisticians who evaluate the benefits and costs of medical technologies and provide advice to the HSE.The NCPE conducts health technology assessments of pharmaceutical products for the HSE and can make recommendations on reimbursement to assist the HSE in its decision-making process. The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. It is appropriate that these should not be political or ministerial decisions and that a scientific and evidence-based approach is taken to determine the extent to which patients would benefit from treatment with expensive new drugs and whether this represents cost-effectiveness for the health service and the taxpayer.

Sativex is indicated for the relief of symptoms of spasticity for people with MS where other conservative treatments have failed to provide adequate benefits. In July 2014, the Health Products Regulatory Authority granted a marketing authorisation for the cannabis-based medicinal product Sativex to be marketed in Ireland. In early September 2014, the HSE received an application for inclusion of Sativex under the community drugs schemes high-tech arrangements. A health technology assessment on Sativex has been completed by the NCPE, which did not recommend reimbursement of Sativex at the submitted price. The report by the NCPE is an important input to assist the HSE in its decision-making process and informed further engagement between the HSE and the supplier relating to potential pricing arrangements for this product.

The matter remains under consideration by the HSE and therefore it would not be appropriate to comment further on the matter at present. The Minister appreciates that some may take the view that the taxpayer should reimburse every licensed medicine for whatever price a drug company demands, the interests of the health service as a whole require that we only reimburse the most effective medicines and only at a fair price.

Colm Burke (Fine Gael)
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I thank the Minister of State for his response and I fully accept his comments, as pricing is an issue that must be dealt with carefully. I am one of the people who highlighted how the cost of drugs increased from €570 million in 2000 to €2 billion in 2008 or 2009. Nevertheless, this medication may assist people with MS. The Minister of State knows that a person must live with MS for the rest of his or her life, so it is important that we try to make their lives as comfortable as possible. This drug helps that.

The end of the Minister of State's response was vague. Is he indicating that if a further submission was made, it would be given serious consideration or did he say that a further submission has been made and considered?

Damien English (Meath West, Fine Gael)
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My understanding is the matter remains under consideration by the HSE and the report from the NCPE has helped in the decision-making process and helping to inform further engagement between the HSE and the supplier on the pricing of the product. It is down to price and effectiveness, as people recognise the benefits. My reading is that this is ongoing so the issue is up for discussion. I will get clarification from the HSE.