Richard Bruton
Ceist:154 Mr. R. Bruton asked the Minister for Health and Children the basis upon which prices are agreed with drug companies for modified versions of a drug. [6822/98]
Written Answers. - Drug Costs.
Richard Bruton
Ceist:157 Mr. R. Bruton asked the Minister for Health and Children further to Parliamentary Question No. 182 of 17 February 1998, the itemised make-up of the approved price of the three types of aspirin on the market, specifically the fees for licensing or approval, production costs, margin to cover research costs, margin to cover recurring branding marketing and so on and retail mark-up; and the exact differences in the products that could justify the price differential. [6885/98]
I propose to take Questions Nos. 154 and 157 together.
The price to wholesalers, wholesale price, of drugs and medicines prescribable and reimbursable under the general medical services, GMS, scheme and the community drug schemes is determined in accordance with the agreements between the Department of Health and Children, the Irish Pharmaceutical Healthcare Association and the Irish Pharmaceutical Manufacturers Association. These agreements provide that the price to the wholesaler of any new item of medicine introduced to the market and covered by the agreements shall not, on the date of notification, exceed the currency adjusted United Kingdom wholesale price or the average of a basket of EU countries, whichever is the lower. This is the position in the case of new medicinal products or modified versions of existing products. Accordingly, the Department has no function in determining the component elements within the price of a product as applied by pharmaceutical companies in respect of production costs, margin to cover research costs or recurring branding marketing.
Regarding the fees for licensing, the position is that a product must be the subject of a product authorisation before it can be placed on the market. The fees for granting such an authorisation are set down under the Irish Medicines Board (Fees) Regulations, 1996. These fees can vary depending on the nature of the application concerned. In the case of an application for an established drug which would not be considered complex and consists of a single dosage form, the fee would be £3,000. In the case of an application in respect of a medicinal product containing a new drug substance and which consists of a single dosage form the fee would be £6,000. Additional fees would be applicable if further dosage forms and strengths were involved in the application.
There is no retail mark-up in respect of medicines dispensed under the general medical services scheme. Pharmacies are reimbursed the trade price of the product plus a dispensing fee of £1.69. In the case of medicines dispensed under the other community drug schemes, pharmacies are reimbursed the trade price of the medicines plus a 50 per cent mark-up, plus a standard fee of £1.53. The Department has no function in determining the retail mark-up or the dispensing fee in respect of the private dispensing of medicines, as these were established on the basis of tradition and practice. Generally, these are the same as under the community drug schemes.
There are three versions of aspirin 75mg on the Irish market. There is a non-proprietary form and two proprietary forms of the product available. The three products in question are identical in that they contain the same active ingredient and all are intended for the management of cardio-vascular disease. The price differential arose when two companies introduced proprietary versions of the product to the Irish market. The pricing of each of these products complies fully with the terms of the agreements in place with the industry.
The following table sets out the current prices for the products concerned and shows the differential in price between the various versions:—
|
Product |
Wholesale Price |
Trade Price |
GMS Reimbursement price under the GMS Scheme |
DCSS/LTI Reimbursement price |
|
Aspirin 75 mg Dispersible (1000 pack size) |
£8.50 |
£10.00 |
£11.69 |
£16.53 |
|
Lowasa 75 mg (28 Pack size) |
£2.50 |
£2.94 |
£4.63 |
£5.94 |
|
Nu-Seals 75 mg (56 Pack size) |
£3.00 |
£3.53 |
£5.22 |
£6.83 |