EXPLANATORY STATEMENT
STATUTORY RULES 1986 NO 112
ISSUED BY THE AUTHORITY OF THE MINISTER FOR HEALTH
COMMONWEALTH SERUM LABORATORIES ACT 1961
COMMONWEALTH SERUM LABORATORIES REGULATIONS
(AMENDMENT)
Section 45 of the Commonwealth Serum Laboratories Act 1961 (the Act) provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters required or permitted by the Act to be prescribed, or necessary or convenient to be prescribed, for carrying out or giving effect to the Act.
The Health Legislation Amendment Act (No 2) 1985 inserted a new sub-paragraph 19(1)(b)(iiia) into the Act to provide that where the Minister so determines, the functions of the Commonwealth Serum Laboratories Commission (the Commission) include cooperation with a Government or organisation, whether Australian, or foreign, or an international organisation, in respect of research relating to production of or prescribed operations relating to the production of pharmaceutical products.
Paragraphs 20(2)(a) and 20(2)(b) of the Act provide that the Commission shall not, without the Minister’s approval, enter into any contract for the sale or purchase of pharmaceutical goods where the contract exceeds $500,000 or for any other purpose where the contract exceeds $250,000.
The regulations prescribe for the purposes of sub-paragraph 19(1)(b)(iiia) of the Act the types of operations which the Commission may be required to undertake in accordance with a request for cooperation from a Government or organisation.
The regulations also prescribe, for the purposes of paragraphs 20(2)(a) and 20(2)(b) of the Act, amounts of $2,000,000 and $1,000,000 respectively. The existing amounts were set in 1980 and since that time the value of contracts entered into by the Commission has increased rapidly and the ceilings have been increased to more realistic levels so that the Minister’s approval is not required for routine operational matters.
The regulations also effect minor drafting changes.
The regulations came into operation on the date of their notification in the Commonwealth of Australia Gazette.