Tuesday, 2 February 2016
Ceisteanna - Questions - Priority Questions
Medicinal Products Availability
61. To ask the Minister for Health why the drug Sativex is not available to persons who suffer from multiple sclerosis despite the then Minister of State for Primary Care, Deputy Alex White, signing a statutory instrument legalising its use in July 2014; when it will be available; and if he will make a statement on the matter. [4082/16]
I seek to establish the reasons why a cannabis-based medication, the drug Sativex, is not yet available to persons in this State who suffer from multiple sclerosis. This is despite the fact that a former Minister of State with responsibility for primary care, Deputy Alex White, signed a statutory instrument legalising its use as far back as July 2014. What are the obstacles to its introduction? Can we expect to see progress concerning its availability for those for whom it may make a significant difference?
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-based medicinal product Sativex to be marketed in this State. This product is indicated for the relief of symptoms of spasticity for people with multiple sclerosis where other conservative treatments have failed to provide adequate benefits.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the GMS and community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Decisions on which medicines 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. They are not political or ministerial decisions.
Following the granting of a marketing authorisation, it was open to the holder of that authorisation to make the product available for prescribing in Ireland. In September 2014, the HSE received an application for inclusion of Sativex under the community drugs scheme's high-tech arrangements. A health technology assessment report on Sativex has been completed by the National Centre for Pharmacoeconomics, 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 in relation to potential pricing arrangements for this product.
As the matter remains under consideration by the HSE, unfortunately, I am not in a position to make any further comment.
As the Minister of State knows, there are approximately 8,000 multiple sclerosis sufferers in Ireland. Two of them are very dear to me, as members of my family. Sativex is already in use in a number of EU countries for the relief of spasm symptoms in multiple sclerosis patients. The availability of this and other cannabis-based treatments has long been sought by MS Ireland, which is the representative NGO for people with multiple sclerosis.
Ongoing research into the benefits of medicinal cannabis, and cannabis-based medication extract for the symptoms of MS, has shown the efficacy of such treatments to alleviate spasticity, sleep disorders, pain and other symptoms associated with multiple sclerosis. As the Minister of State has acknowledged, in July 2014, her predecessor, Deputy Alex White, signed regulations that would allow for approved medicines containing the active ingredients of cannabis to be prescribed in Ireland. It is extremely frustrating for that cohort.
It may not make the difference to all those challenged by MS but there is unquestionably a significant cohort to whom this would bring great relief. The Minister of State concluded by saying that she could make no further comment. Even in these closing days, I ask her to reflect with the HSE on the importance of continuing engagement. I take the view that there is no substantive reason for not proceeding. We are talking about treatment of the order of €500 per month per patient over whatever number might be involved. We have approved far more expensive treatments across many other conditions through the National Centre for Pharmacoeconomics.
There is not an elected Member of this House or the other one who does not know someone who suffers from MS. We are all aware of the degrees, some mild and some far more advanced. Sativex is licensed for use throughout the UK but it is not reimbursed by the NHS. The National Institute for Health and Care Excellence has recommended that health care practitioners should not offer Sativex to treat spasticity in people with MS because it is not a cost-effective treatment. I very much take on board the Deputy's point about other treatments we have approved that cost multiples of what we are talking about here. The Deputy and I know that in the first instance, one's instinct is always to try to help people who find themselves in difficulty but on the other hand, we must always ensure that we are getting value for money in respect of the taxpayer. This is not to take from our empathy or sympathy for people who find themselves in this position. We must take the advice of those who are charged with looking at the complexities of issues, whether in terms of treatment or economics, and take that advice when it is offered.
The critical advice is the clinical assessment of the efficacy of the drugs in question. This is a proven science at this point in time. There is ample evidence across a number of EU countries as to the effectiveness of this drug.
There is a serious fault line in our insistence as a single entity - a State - on trying to engage with the drug distributor or manufacturer in this and many other cases when it is already being provided in a number of EU countries. In terms of the EU, we should be using the opportunities for collective engagement, purchase and distribution. This is not beyond the gift of this State and its representatives and would be welcomed in other EU member states. We should collectivise to our strength and in the interests of those for whom the effort will mean so much.
As a small outlier in the EU, I could not agree more with the Deputy and I think it needs to be a priority for whatever Government comes in after the election. The strength of the EU should be that we would collectively bargain. This would benefit us as much as anyone else. We cannot always be at a point where we simply say that we cannot afford this and where we are isolated and picked off one by one in terms of the types of negotiations that need to occur. It will not be about this but will be about something that could be far more unique which will treat something far rarer than that which we are experiencing here. I fully agree with the Deputy that this type of negotiation under whatever Presidency within the EU needs to be a priority for the next Government. We must insist on this happening because we would benefit more than others.