Australian Firms To Finance TGA Fully By 1998-99

25 May 1997

As part of its new health budget (see page 15) the Australian governmenthas announced plans for drug firms to finance fully the running costs of the Therapeutic Goods Administration, which regulates drug products, by 1998-99. The saving to the government, and cost to the industry, is put at A$32 million ($24.7 million) over four years.

Operational cost recovery for drug regulation will be 75% industry-financed in 1997-98, rather than by 1998-99 as outlined in 1996's budget, rising to 100% in 1998-99. The reason for this, says the government, is recent boosts to the industry's viability and international competitiveness, including the extension of the Factor F scheme and 20-year patent terms (Marketletter April 21) and the new data exclusivity regime, plus a review of labeling requirements recommended by the Small Business Deregulation Task Force. With industry turnover now put at over A$4 billion a year, "the proposed industry contribution represents a very small percentage of this amount,"it says.

The TGA will also implement a range of reforms to assist the industry, including: - increased use of medicinal evaluation reports and decisions from comparable overseas regulatory bodies; - examination of export arrangements to remove unnecessary regulatory obstacles for Australian manufacturers and exporters; and - maximizing opportunities for mutual recognition or harmonization of Australia's regulatory requirements with those of countries with comparable standards.

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