Written answers

Thursday, 11 February 2010

Department of Health and Children

Medicinal Products

5:00 pm

Photo of Darragh O'BrienDarragh O'Brien (Dublin North, Fianna Fail)
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Question 113: To ask the Minister for Health and Children the progress that has been made to date in the Programme for Government commitment to promote and ensure coexistence of complementary and conventional medicine; and if she will make a statement on the matter. [7344/10]

Photo of Mary HarneyMary Harney (Dublin Mid West, Independent)
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The Irish Medicines Board (IMB) is responsible for the regulation of medicinal products in Ireland; this includes herbal homeopathic medicinal products which could be seen as complementary medicines. The IMB authorises and registers these medicinal products in accordance with Irish and EU legislation. This ensures that they meet the necessary standards of quality, safety and where appropriate efficacy.

The IMB has established a Simplified Registration Scheme for homeopathic medicinal products. This covers homeopathic products for oral and external use without medicinal claims. In addition the IMB is currently putting in place a National Rules Scheme for homeopathic medicinal products with medical indications which do not qualify for registration under the Simplified Registration Scheme. This new scheme will provide for homeopathic medicines with claims for mild self limiting conditions. It is anticipated that the introduction of this National Rules Scheme will, in addition to the Simplified Scheme already established, facilitate licensing of homeopathic medicinal products on the Irish market, thus ensuring their standards and their continued availability to the public.

Herbal medicinal products can be licensed in two ways. They can either obtain a marketing authorisation using the same procedures as for conventional medicines or a Certificate of Traditional-use Registration as per Directive 2001/83/EC, as amended. The Traditional-use Registration Scheme has been established in recognition of the significant number of medicinal products which do not fulfil the requirements for a marketing authorisation despite their long tradition of use, recognised efficacy and acceptable levels of safety. It is anticipated that the introduction of this Traditional-use Registration Scheme will facilitate licensing of herbal medicinal products on the Irish market, thus ensuring their safety and continued availability to the public.

In relation to the role of complementary therapists in the provision of health services, the Report of the National Working Group in the Regulation of Complementary Therapists outlined guidance for professional associations and provided examples of codes of ethics and good practice, including grievance and disciplinary procedures. In addition, the Department of Health and Children has facilitated the provision of work days. The purpose of these days is for different therapies to come together to undertake a process of harmonisation and development with regard to common basic standards of practice, education and training. In addition, these facilitated work days provide a forum for greater cohesion within each therapy. Work days were organised in 2007 for a number of the higher risk therapies as categorised in the Report of the National Working Group on the Regulation of Complementary Therapists i.e. acupuncture, traditional Chinese medicine, herbal medicine, aromatherapy and homeopathy.

Among the recommendations contained in the Report of the National Working Group on the Regulation of Complementary Therapists was that the Higher Education and Training Awards Council (HETAC) take a role in the accreditation of programmes of higher education and training for complementary therapists. HETAC has now determined and published a set of standards for complementary therapies to be used in the accreditation of any programmes submitted by providers of education and training in complementary therapies. These standards will be a valuable tool in the accreditation of relevant education and training programmes. In adopting these standards, HETAC has identified a requirement that each programme within a therapy should only be validated when there is federation into one representative organisation for that therapy.

Federation of individual professional therapy associations into one representative organisation for that therapy is a key component required for the development of common standards of education and training for complementary therapies. This approach is essential to ensure harmonisation of standards and to eliminate variations in standards of education and training or codes of practice within each complementary therapy discipline. The complementary therapy sector is currently engaged in forming the solid frameworks and federations with which to link and to govern the sector.

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