The world’s trade ministers reached an agreement to allow a partial intellectual property (IP) waiver for Covid-19 vaccines at the 12th Ministerial Conference (MC-12) of the World Trade Organization in Geneva, Switzerland, on Friday.
Korean Covid-19 vaccine makers are paying keen attention to how the decision will affect their strategies to sell vaccines in the global market, especially in low-income countries.
The latest accord allows developing nations to use the IP rights on existing Covid-19 vaccines to produce and supply them in the country without the consent of the patent right holder.
As Korea is a developed country, Korean manufacturers of Covid-19 vaccines, including SK Bioscience, EuBiologics, Eyegene, and Quratis, will have to revise their strategies to export their vaccines, observers said.
The Ministerial Conference is the topmost decision-making body of the WTO that brings together all members of the WTO every two years. From Korea, Trade Minister Ahn Duk-geun attended the meeting.
According to the Ministry of Trade, Industry and Energy, the WTO’s IP exemption on Covid-19 vaccines aimed to address the Covid-19 pandemic that caused a global economic crisis and another pandemic.
The WTO agreed that a developing nation might limit the rights of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) by authorizing the use of a Covid-19 vaccine’s patent without the consent of the right holder.
Korea is not a developing country, so it is excluded from the WTO’s IP waiver on Covid-19 vaccines. Among the developing nations, China was excluded because it was a large exporter.
Under the WTO’s decision, an eligible member country does not have to request a patent-holding company of a Covid-19 vaccine to obtain approval to use the vaccine in the country. In addition, an eligible member may export such Covid-19 vaccines to other developing countries or provide them for international or regional vaccine supply initiatives to ensure access to Covid-19 vaccines in low-income countries.
However, eligible members should undertake all reasonable efforts to prevent the re-exportation of the imported Covid-19 vaccine and the importation of a vaccine that is not under the latest WTO agreement, the WTO said.
It added that eligible members should determine the price of the vaccine, considering that the IP waiver has a humanitarian and not-for-profit purpose.
An eligible member should report to the WTO’s Council for TRIPS all the measures related to the IP waiver decision, including the name of the company that was on the waiver, the product and the duration of the waiver, the quantity of the vaccine, and the country to which the vaccine is to be supplied.
The WTO’s decision will be effective for five years, and the General Council will review the operation annually, the WTO said.
The IP waiver for developing countries on Covid-19 vaccines is likely to significantly impact Korean vaccine developers wishing to ship their Covid-19 vaccines to other countries.
Some Korean companies seek to market the vaccine in low-income countries where any existing Covid-19 vaccine has yet to reach.
EuBiologics and Eyegene are conducting clinical trials of vaccine candidates to win marketing approval in other countries.
Quratis discussed Covid-19 vaccine studies and approval with Indonesia’s delegation headed by the deputy health minister who visited Korea last month.
SK Bioscience is conducting multinational phase 3 trials of SKYCovione (pipeline name: GBP510) to supply it to countries that have yet to import Covid-19 vaccines. The company also revealed a plan for the “SKYshield” project to establish vaccine manufacturing facilities in other countries by collaborating with each government and partner companies.
The WTO’s decision on the IP waiver applies to Covid-19 vaccines only. Members of the WTO will decide whether to extend it to cover Covid-19 diagnostics and treatments.