Written Answers. - Technology and Drugs Assessments.

Dick Spring

Question:

74 Mr. Spring asked the Minister for Health and Children the procedures and the principal criteria used by his Department in assessing new health technology and drugs; the extent to which patients or their representatives are consulted in this assessment; and if he will make a statement on the matter. [1964/99]

In an overall context the principal criteria used by my Department in assessing new technology and drugs is based on the assessment of needs and the service plans submitted by health boards and voluntary hospitals to my Department.

Health technology assessment is a process that goes beyond describing equipment specifications and it requires an assessment of the use of technology including drugs in the context of the processes and medical procedures to be carried out.

In this regard anad hoc group was set up by my Department in May 1998 to develop a health technology framework that will provide the basis for better decision making and enable benefits and cost effectiveness to be measured and evaluated in relation to health and social gain and level of service to the patient. It will also assist health service providers in optimising their economic health resources.

The members of the group are drawn from across the health sector on the basis of their knowledge and expertise in the area of health technology. They are currently focusing on technology that is emerging into practice and the development of protocols and guidelines in this regard. Other interested parties will be identified and consulted as work progresses.

In relation to medical devices there are two sets of regulations which transposed two EU directives into Irish law. They contain provisions which must be followed before medical devices can be placed on the Irish market. These are: The European Communities (Medical Devices) Regulations, 1994, Statutory Instrument No. 252 of 1994 and the European Communities (Active Implantable Medical Devices) Regulations, 1994, Statutory Instrument No. 253 of 1994.
The regulations form part of an overall drive to complete the single market in Europe by laying the groundwork for establishing harmonised standards in the manufacturing of medical devices. The regulations have a defined scope and lay down essential requirements for medical devices and the procedures for checking that all products comply with them. Devices meeting these requirements will be entitled to carry the CE marking and be placed on the Community market without further restrictions.
Before affixing the CE marking to a device, a manufacture must go through one or more conformity assessment procedures to confirm that the design and-or production ensures compliance with the essential requirements of the regulations. The stringency of these procedures depends on which regulations apply and also on the risk classification of the device concerned.
With regard to the conducting of clinical trials, the Irish Medicines Board has sole responsibility for ensuring that all clinical trials are carried out in accordance with the Control of Clinical Trials Acts, 1887 to 1990.