Dáil Éireann debate -
Tuesday, 19 Feb 1991

Vol. 405 No. 3

Written Answers. - Natural and Herbal Medicines.

Richard Bruton

Question:

288 Mr. R. Bruton asked the Minister for Health whether he has reviewed the impact of the current licensing fees and procedures for natural and herbal medicines in view of (1) the claims that the heavy costs imposed are reducing the range of preparations available to Irish consumers, (2) the claim that Irish licensing and testing is being applied to products which have already been certified to be in compliance with EC standards and (3) the claim that these regulations are not within the spirit of Articles 30 to 36 of the Treaty of Rome which lay down the conditions for free trade among EC members; and if he will make a statement on the matter.

Richard Bruton

Question:

289 Mr. R. Bruton asked the Minister for Health the current licensing fees and test charges which are being levied on (a) retailers and (b) wholesalers in respect of natural and herbal medicines; and the estimated average payment by (a) retailer and (b) wholesaler in total licence fees on the typical range of natural and herbal medicines that they would carry.

Minister for Health (Dr. O'Hanlon)

I propose to answer Questions Nos. 563 and 564 together.

Ireland along with the other member states of the EC maintains its own independent licensing system for medicinal products. These take account of, and reflect, the provisions of Community directives on the licensing of medicines and I do not accept that Irish regulations are contrary to the spirit of the Treaty of Rome.

The requirements regarding the licensing of medicines are set out in the Medical Preparations (Licensing, Advertisement and Sale) Regulations 1984-1989. The procedures followed are the same for all medicines and in the interests of protecting public health, I would not wish to introduce lesser standards of scrutiny for particular categories of medicines.

I do not accept that the costs of licensing fees in respect of medicines are reducing the range of natural or herbal medicines available in this country. The licence fees are set at the level necessary to meet the costs incurred by the State in assessing and evaluating applications for licences.

The current licence fee in respect of a product authorisation is £1,605 for a period of five years. This is equivalent to an annualised fee of £321 per product authorisation.

The following is a schedule of fees currently payable in respect of the licensing of medicines. There is no distinction made between different categories of medicines, such as natural or herbal, nor are there separate scales of fees depending on whether an applicant for a product authorisation is a manufacturer, wholesaler or retailer.

Product Authorisation (Licence) — New Products (containing new chemical entity), £3,150 (five year period); New Product, £1,605 (five year period); Additional Formulations, £1,200 (five year period); Renewal of Product Authorisation, £535 (five year period); Manufacturing Licence, £965 per annum; Wholesale Licence, £480 per annum; Additional outlets, £160 per annum.

For the purposes of clarification, I would mention that a retailer engaged solely in the business of retailing would not normally be required to be a holder of product authorisations for those medicines he may be engaged in retailing. A product authorisation is normally obtained by the person responsible for placing the product on the market in Ireland, usually the manufacturer or importer of the medicine.

It is not possible to estimate the average payments in respect of licensing fees by any individual or company dealing with natural or herbal medicines because of the range of variable factors that would arise.