I propose to take Questions Nos. 176 and 177 together.
Recommendation 30 of the National Rare Disease Plan recommends that the HSE develop a Working Group to bring forward appropriate decision criteria for the reimbursement of orphan medicines and technologies.
The HSE has advised my Department that the terms of reference for the proposed Rare Diseases Technology Review Group are at final draft stage. A chairperson has been provisionally identified subject to provision of expert pharmacologic support to advise the candidate. The rare disease drugs to be considered by the Rare Diseases Technology Review Group have not been determined yet.
The membership of the group will include:
1. A minimum of three members who are Consultants in Rare or highly specialised diseases, recommended by the relevant professional society, faculty or college, who have content experience in the specific discipline and are approved by the Clinical Lead for the National Clinical Programme for Rare Diseases. In addition the Clinical Lead for the National Clinical Programme for Rare Diseases will be a member;
2. Chief Pharmacist – to be advised;
3. A minimum of one member with Health Economical, Pharmacoeconomics or statistics and epidemiology expertise;
4. A minimum of one invited participant from a related designated centre of expertise, recommended by the Clinical Advisory Group for the National Clinical Programme for Rare Diseases, as required, according to the speciality area;
4. One representative appointed by HIQA;
5. Patient Group representative;
6. Primary Care Reimbursement Services representative;
7. Up to three additional members may be appointed.
The group will report to the HSE Committee for Optimising Pharmaceutical Value. Patient interest groups recently met with the National Director for Acute Hospitals and were asked for their comments on the final draft document.