Peter Fitzpatrick (Louth, Independent)
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523. To ask the Minister for Health to outline the reason a person (details supplied) is being refused versatis patches; and if he will make a statement on the matter. [44741/18]

Simon Harris (Wicklow, Fine Gael)
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Medicines play a vital role in improving the health of Irish patients. Securing access to existing and new and innovative medicines is a key health service objective. However, the challenge is to do this in a safe and sustainable manner. Treatment must be appropriate and proportionate and clinical decision-making, such as prescribing, should be based on both patient needs and sound medical evidence.

Lidocaine 5% medicated plasters are licensed for localised relief of post-shingles pain in adults. This is the patch's only licensed use in Ireland. It has been reimbursed in the community drug schemes since 2010.

Clinical concern arose when, from 2012 on, usage increased significantly, to the point where more plasters were being used in Ireland than in the entire UK National Health Service. In such situations, it is important and appropriate for clinicians to review usage and, in 2016, the HSE Medicines Management Programme (MMP) reviewed the use of the plasters. The review estimated that only 5-10% of prescribing was for the licensed indication.

From September 2017, following the clinical review, the HSE introduced a new reimbursement approval system for the patches, to support appropriate use and patient care. Under these arrangements, the patient's GP or consultant applies to the MMP for reimbursement approval on behalf of the patient. If an application is refused, the clinician may submit an appeal to the MMP, making a clear clinical case for the patient. Information for patients and practitioners is on the HSE MMP website at: hse.ie/yourmedicines.

The outcome of an application or an appeal for reimbursement of lidocaine patches is a matter between the MMP and the treating clinician. The Deputy will appreciate that, as Minister for Health, I cannot intervene in individual cases.

The decision to introduce a new reimbursement approval process is a matter for the HSE. However, I fully support the objectives of the HSE Medicines Management Programme.

Clare Daly (Dublin Fingal, Independent)
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524. To ask the Minister for Health to outline his plans to allow the sale of 5-hydroxytryptophan here; and the reason it has not been permitted for sale over the counter or on prescription to date. [44746/18]

Simon Harris (Wicklow, Fine Gael)
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Products containing 5-hydroxytryptophan (5-HTP) are considered to be medicines in Ireland. 5-HTP is reported to have actions in the body that could potentially be used to treat some medical conditions such as depression. Under national and European legislation, products for which medicinal claims are made, or which contain substances that could have medicinal effects on the body, are considered to be medicines.

All medicines must have a marketing authorisation prior to being placed on the Irish market. At present no medicine containing 5-HTP is authorised for use in Ireland. An application for a marketing authorisation for a medicine containing 5-HTP could be submitted by any company that has compiled data demonstrating the quality, safety and efficacy of the product and any such application would be reviewed in line with the standard requirements for medicines.

Where a medicine is not authorised in Ireland, a licensed wholesaler may import it if it has been prescribed by a doctor for a patient under his/her care, on his/her direct responsibility and to meet the special needs of a patient. The process for this is described in the ‘Guide to the Notification System for Exempt Medicinal Products’ which is available on the website of the Health Products Regulatory Authority.

The decision to prescribe or not prescribe any treatment, including 5-HTP, for an individual patient is a decision for the treating clinician, in consultation with their patient.