Written answers

Tuesday, 4 November 2014

Department of Health

Medicinal Products Availability

Photo of Clare DalyClare Daly (Dublin North, United Left)
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713. To ask the Minister for Health further to Parliamentary Question No. 367 of 21 October 2014, if he will address the problem of MMS and CD being available via open information sharing by doctors and other doctors, parents, schools, counsellors, therapists and so on, as to the nature of chlorine dioxide, its effects on the human body and co-operating with a company (details supplied) and other online suppliers in order to shut them down and ensure that Customs and Excise can seize products on entry into the country. [41604/14]

Photo of Kathleen LynchKathleen Lynch (Cork North Central, Labour)
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As previously advised, under the Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended, a medicinal product cannot be placed on the market in Ireland unless it has a marketing authorisation from the Health Products Regulatory Authority (HPRA) or a community marketing authorisation from the European Medicines Agency (EMA). Any product which makes a medicinal claim requires an authorisation under this legislation. Master Mineral Solution (MMS) or CD is not authorised as a medicine for sale or supply in Ireland and it is therefore an offence to place this product on the market in Ireland without a marketing authorisation.

The HPRA advises consumers not to take Master Minister Solution (MMS) or CD. The Food Safety Authority and the National Poisons Information Centre of Ireland have also issued a public safety warning regarding the use of MMS.

The professions cited in the Deputies question may, at their discretion, choose to circulate, through the appropriate fora, publicly available material regarding the product.

The HPRA has confirmed that it is actively following up on this issue as a matter of urgency. The HPRA is satisfied that it has sufficient powers under existing legislation to investigate attempts to supply this product in Ireland.

The power to 'shut down' online internet suppliers of unauthorised medicinal products is beyond the remit of my Department.

Photo of Andrew DoyleAndrew Doyle (Wicklow, Fine Gael)
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714. To ask the Minister for Health if he will reinstate the drug Fampridine for Health Service Executive drug funded schemes to patients who qualify for its use; and if he will make a statement on the matter. [41609/14]

Photo of John O'MahonyJohn O'Mahony (Mayo, Fine Gael)
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755. To ask the Minister for Health his plans to make Fampyra available to multiple sclerosis suffers; and if he will make a statement on the matter. [41856/14]

Photo of Kathleen LynchKathleen Lynch (Cork North Central, Labour)
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I propose to take Questions Nos. 714 and 755 together.

Firstly I would like to clarify that Fampridine (Fampyra®) was never available to multiple sclerosis patients under the GMS and community drugs schemes. However, I understand that the manufacturer of Fampridine supplied the drug free of charge to some patients who were prescribed the drug by their clinician. The manufacturer has decided to stop supplying the drug free of charge and, as a consequence, these patients are now faced with financing the drug themselves if they wish to continue with this drug treatment.

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.

The HSE received an application for the inclusion of Fampridine in the GMS and community drugs schemes. The application was considered in line with the procedures and timescales agreed by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association for the assessment of new medicines.

In accordance with these procedures, the NCPE conducted a pharmacoeconomic evaluation of Fampridine and concluded that, as the manufacturer was unable to demonstrate sufficient effectiveness and a fair price for Fampridine in the Irish health care setting, it was unable to recommend the reimbursement of the product. The report is available on the NCPE's website ().

On foot of this, the HSE decided that it was not in a position to add the drug to the List of Reimbursable Items supplied under the GMS and other community drug schemes.

It is open to the supplier, at any time, to submit a new application to the HSE for the inclusion of Fampridine on the community drugs schemes incorporating new evidence which demonstrates the cost-effectiveness of the drug, by offering a reduced price or both. A revised application was received by the HSE on 25th July 2014 and is currently being considered in line with the agreed procedures and timescales. No further comment is possible at this time as the HSE decision making process is ongoing.

I would like to assure the Deputy that the Department, and the HSE, fully understand the concerns of patients regarding the availability of this drug. While I appreciate that some may take the view that the taxpayer should reimburse every licensed medicine for whatever the price the drug company demands, I hope the Deputy will appreciate that the better interests of the health service require that we reimburse only the most effective medicines and only at a fair price.

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