The Government has proposed amendments to the Patents Ordinance to implement a protocol the World Trade Organisation adopted which gives WTO member economies greater flexibility in sourcing generic versions of patented pharmaceutical products to address public health problems.

The Patents (Amendment) Bill 2007 was gazetted today and will be introduced into the Legislative Council on April 18.

The bill will enable Hong Kong to have a wider choice of supply of medicines in extremely urgent situations caused by public health problems, the Commerce, Industry & Technology Bureau said.

Import compulsory licence

The bureau proposed in the bill that the Chief Executive-in-Council may declare a period of extreme urgency in Hong Kong by way of notice in the Gazette if it is considered necessary or appropriate in the public interest to address a public health problem.

During such a period of extreme urgency, if the Director of Health considers that Hong Kong is unable to produce a certain medicine to contain the health problem in question, he may grant an import compulsory licence to a suitable party to import the medicine - without the authorisation of the proprietor of the patent concerned. 

If a WTO member makes a request for supply of a generic medicine under the protocol, the Director of Health may issue an export compulsory licence to a local manufacturer to make and export the medicine to that member.

Appeal mechanism

The import and export compulsory licences will be subject to terms and conditions which fully comply with the protocol. In line with the protocol requirements, the bill includes provisions for the payment of adequate remuneration to the proprietor of the patent concerned.

An appeal mechanism will also be put in place for aggrieved parties to apply to the court for a review of the Director of Health's decisions in connection with the grant of a compulsory licence to import or export a pharmaceutical product under the protocol.