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Medicinal Products.

Dáil Éireann Debate, Wednesday - 29 September 2004

Wednesday, 29 September 2004

Questions (754)

Caoimhghín Ó Caoláin

Question:

932 Caoimhghín Ó Caoláin asked the Minister for Health and Children if his Department has examined the results of studies in Canada and France which have shown that new drugs classified as medical breakthroughs represent only between 5% and 10% of all new drugs brought to the market; if his Department has examined these studies or similar studies on the questionable value of much of the volume of drugs coming on the market that have little or no therapeutic gain as compared to existing drugs; if his Department will examine the policy implications of this issue for health services here, including general practice and the general medical services scheme and their prescribing policies; and if he will make a statement on the matter. [22501/04]

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Written answers

As the competent authority for the regulation of medicinal products in Ireland, the Irish Medicines Board assesses the quality, safety and efficacy of medicinal products. A product authorisation is only issued where the appropriate criteria are met in all three areas. The IMB also has responsibility for ensuring the ongoing quality and safety of medicinal products on the Irish market. These activities are carried out in conjunction with the European Medicines Evaluation Agency and international regulatory authorities.

If the Deputy wishes to send me further information in regard to the studies to which he refers I will arrange to have them examined but I am advised that it is generally the case that a significant number of new drugs coming on the market are developments of existing products. While not all new drugs provide breakthrough treatments, benefits might be expected in terms of reduced dosage frequencies or reduced side effect profiles. Where similar products are available on the market, the introduction of an alternative new product may also have price competitive benefits. Currently, the choice between related or similar treatments for individuals is a matter for clinical judgment.

Initiatives have been taken at EU level to develop products for rare conditions where the number of breakthrough medicines developed has been small due to the significant costs involved in bringing a new product to the market. It is hoped that these initiatives will stimulate research and development in this area, leading in turn to the development of genuine "breakthrough" products for rare conditions.

With regard to the supply of medicinal products on the Irish market, an agreement is in place between the Department of Health and Children, the Irish Pharmaceutical Healthcare Association, IPHA, and the Association of Pharmaceutical Manufacturers of Ireland, APMI, which sets out the supply terms and prices of medicines supplied to the health services. The agreement covers all reimbursable prescription medicines in the general medical services and community drug schemes and all medicines supplied to hospitals and health boards.

The current agreement expires in mid-2005 and the Department will shortly be entering into negotiation with IPHA-APMI. Any new agreement entered into must: be sensitive to the needs of stakeholders; ensure security of supply of medicines; meet the needs of patients; and achieve value for money for the taxpayer. In so far as the issues referred to by the Deputy relate to the supply of medicinal products to the Irish market, these matters will be considered in the context of the negotiations on the new agreement.

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