The Government has allowed the Industry and Commerce Ministry to ratify a World Trade Organisation linked agreement that allows for the local production of generic drugs in special circumstances.
Industry and Commerce Minister Rishad Bathiudeen will ratify the relevant amended agreement after receiving Cabinet approval this week. The move will allow Sri Lanka to access a global movement to allow generic drug production to poorer countries.
Agreements of Trade Related Aspects of Intellectual Property Rights (TRIPS) administered by the World Trade Organisation (WTO) requires all WTO Members to implement appropriate legislation which protects intellectual property rights including copy rights and related rights, trade marks, geographical indications, industrial designs, patents, layout designs and integrated circuits and undisclosed information.
“Notwithstanding the obligations imposed on members to provide substantial intellectual property rights protection for patented medicinal drugs in the context of the TRIPS, the agreement provides some flexibilities for members to permit the local manufacture or produce generic versions of patented medicines without the authorisation of patent holders, when their population face any eminent health crises situations such as malaria, tuberculosis and HIV/AIDS and other circumstances of extreme urgency,” the Cabinet paper noted.
The TRIPS agreement introduced intellectual property law into the international trading system for the first time and remains the most comprehensive international agreement on intellectual property to date.
In 2001, developing countries, concerned that developed countries were insisting on an overly narrow reading of TRIPS, initiated a round of talks that resulted in the Doha Declaration. The Doha Declaration is a WTO statement that clarifies the scope of TRIPS, stating for example that TRIPS can and should be interpreted in light of the goal “to promote access to medicines for all”.
The most visible conflict has been over AIDS drugs in Africa. Despite the role that patents have played in maintaining higher drug costs for public health programs across Africa, this controversy has not led to a revision of TRIPs. Instead, an interpretive statement, the Doha Declaration, was issued in November 2001, which indicated that TRIPs should not prevent states from dealing with public health crises. After Doha, PhRMA, the United States and to a lesser extent other developed nations began working to minimize the effect of the declaration.