John Lyons (Dublin North West, Labour)
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986. To ask the Minister for Health if there is a list of agreed treatments available to Irish citizens as part of the treatment abroad scheme; if novel therapies and new cancer drugs trials, particularly in the National Health Service are included as part of this scheme; and his plans to extend the scheme in the future [33801/14]

Leo Varadkar (Dublin West, Fine Gael)
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The HSE operates a Treatment Abroad Scheme (TAS) for persons entitled to treatment in another EU/EEA member state or Switzerland under EU Regulation 1408/71, as per the procedures set out in EU Regulation 574/72, and in accordance with Department of Health Guidelines. Under this framework the TAS provides for the cost of approved treatments in another EU/EEA member state or Switzerland through the issue of form E112 (IE).

The TAS allows for an Irish based Consultant to refer a patient that is normally resident in Ireland for treatment in another EU member state or Switzerland, where the treatment in question meets the following criteria:

(a) The application to refer a patient abroad has been assessed and a determination given before that patient goes abroad.

(b) Following clinical assessment, the referring Consultant certifies the following:

- They recommend the patient be treated in another EU/EEA country or Switzerland;

- The treatment is medically necessary and will meet the patient’s needs;

- The treatment is a proven form of medical treatment and is not experimental or test treatment;

- The treatment is in a recognised hospital or other institution and is under the control of a registered medical practitioner;

- The hospital outside the state will accept EU/EEA form E112 (IE)

Patients in conjunction with their Irish based public referring hospital consultant have the ability to apply to the HSE TAS seeking access to a specific identified treatment in the public healthcare outside the state through model form E112. Applications to the TAS are processed and a determination given in accordance with the statutory framework prior to a patient travelling to avail of treatment. Approved applicants/patients’ hospital treatment costs are covered through the issue of form E112 (IE) for specific identified episode of care. Each individual application is reviewed on its own merits and a decision is given specific to each case and therefore there is no list of treatments that qualify/do not qualify under the scheme.

However, in relation to participation in clinical trials, the criteria for qualifying for funding under TAS is specifically for proven forms of treatment and do not provide for funding of patients participating in clinical trials. It is normal practise that the hospitals or pharmaceutical companies conducting the trial fund the participating patients in full. It is recommended that any patient seeking to participate in a trial discuss the matter of funding with the hospital/pharmaceutical company conducting the trial. The HSE cannot accept liability for any patient participating in a clinical trial abroad.

John Lyons (Dublin North West, Labour)
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987. To ask the Minister for Health if the Health Service Executive's treatment abroad scheme provides funding to citizens here to take part on new cancer drug trials in other jurisdictions; if the treatment of chronic lymphocytic leukaemia is currently covered as part of the treatment abroad scheme; and if he will make a statement on the matter. [33802/14]

Leo Varadkar (Dublin West, Fine Gael)
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The HSE funds treatment for patients in Ireland under the statutory framework and in the EU/EEA under the governing EU legislation (EU Regulations 1408/71 and 574/72) and in accordance with Department of Health Guidelines. These statutory frameworks do not provide for the HSE Treatment Abroad Scheme (TAS) to fund patients participating in clinical trials. A requirement of the TAS is that the referring Consultant certifies the treatment is a proven form of medical treatment and is not experimental or test treatment.

Applications to TAS are based on the specific identified treatment to be provided outside the State that is not available in Ireland. No decision is given on an application prior to its submission and processing. It is therefore not possible for the HSE to confirm, prior to the submission of an application and appropriate documentation, whether the unidentified treatment for chronic lymphocytic leukaemia will be authorised. Each individual application is reviewed on its own merits and a decision is given specific to each case.