MEDICINES (AMENDMENT) BILL

Order for Second Reading read. 2.18 pm

The Minister for Law (Prof. Jayakumar): Mr Speaker, Sir, I beg to move, "That the Bill be now read a Second time."

Sir, this Bill seeks to amend the Medicines Act to enable Singapore to comply with our obligations under Article 39 of the WTO Agreement on Trade-Related Aspects of Intellectual Property or the TRIPS Agreement which I have set out in greater detail earlier. Article 39 requires, among other things, countries to protect the test data of a pharmaceutical product against disclosure and unfair commercial use.

I have already set out the background concerning the implementation of the TRIPS Agreement and its significance for Singapore in the debate on the earlier Bill. I therefore will confine myself to the changes to be made in this Bill.

Sir, the Bill introduces new sections 19A and 19B which place upon the licensing authority for medicinal products, in our case either the Director of Medical Services or the Director of Primary Production, a duty to protect confidential information received in relation to an application for a product licence for a medicinal product which utilises a new ingredient. This confidential information can be in relation to the medicinal product itself or its applications.

The duty to protect the confidential information is for a period of five years from the date of receipt by the licensing authority.

There are some circumstances in which disclosure of the information is permitted which include disclosure to a Government department or statutory body for the purposes of that department or body and disclosure to the World Health Organisation, the Food and Agriculture Organisation and any regulatory agency of a WTO member state.

Sir, this Bill, as I said, is to implement a specific obligation under the TRIPS Agreement.

Sir, I beg to move.

Question put, and agreed to.

Bill accordingly read a Second time and committed to a Committee of the whole House.

The House immediately resolved itself into a Committee on the Bill. - [Prof. S. Jayakumar].

Bill considered in Committee; reported without amendment; read a Third time and passed.