More than a year after South Africa and India initially proposed waiving provisions of the Trade-Related Intellectual Property Rights (TRIPS) Agreement in October 2020, the World Trade Organization (WTO) on Friday granted developing countries the right to produce Covid vaccines. -19. .
This means that developing countries can now produce their own vaccines without the permission of the patent holders.
With their initial proposal, South Africa and India formed a coalition of support from over 100 countries and a number of organizations.
Among them were trade union and business representatives in Nedlak, who met virtually with the South African government during 12th WTO Ministerial Conference and declared their full support for South Africa’s efforts to reach an agreement.
The 12th WTO Ministerial Conference began on Sunday 12 June and ended on Thursday 16 June.
Intellectual property rights are governed by the WTO-administered treaty known as the Treaty on Trade-Related Intellectual Property Rights (TRIPS) and the WTO Ministerial Conference Agreement, which recently identified waivers and flexibilities with respect to the rights of intellectual property (IP) owners, which then led to the latest developments.
“After several months of stalemate, engagement between South Africa and India with the European Union (EU) and the United States (USA) in recent months has led to textual negotiations at the WTO that have given further impetus to the waiver request and led to the decision to waive TRIPS” explained the Department of Trade, Industry and Competition (DTIC) in a statement welcoming the agreement.
Manufacturers from developing countries are now allowed to export vaccines produced under the terms of the exemption to other developing countries without restrictions, which apply under the current TRIPS agreement.
In addition, it allows the use of certain information available in regulatory dossiers to speed up the production of generics.
“The scope of the agreement extends to vaccines and requires countries to decide to expand it to therapeutic and diagnostic agents used in the fight against Covid-19 within six months,” explained the DTIC.
Speaking during a media briefing on Saturday, welcoming the developments, the South African government, represented by South African ministers Ebrahim Patel and Toko Didiz, explained that the agreement allows governments to allow local manufacturers to produce and use vaccines or their ingredients, substances or elements. patent-protected processes without the permission of the patent holders during the pandemic.
“We welcome the agreement as a solid and useful basis for strengthening our joint efforts to build strong African vaccine manufacturing capacity. Expanding production on the continent will require further partnerships, including access to know-how and technology. The unanimous support of the waiver agreement by all WTO countries should lay the foundation for such a partnership and give countries more flexibility,” DTIC said.
Didisa and Patel also called it “a step in the government’s efforts to spur Africa’s industrialization” and said it had “the potential to unlock production beyond filling and finishing”.
“Rejection is one element of a broader set of actions to build both innovation and manufacturing capacity in South Africa and other parts of the continent. South Africa has four vaccine initiatives. We are now focusing on meeting demand by convincing global vaccine suppliers to source from African manufacturers.
“This waiver and other commitments made at the WTO are also about pandemic preparedness to allow developing countries to have the legal tools to address Covid-19 options in the future and indeed to prepare for future pandemics,” Patel said. .
Other organizations that welcomed the agreement were local vaccine manufacturers Biovac, Afrigen and Aspen PharmaCare, as well as the country’s largest trade union federation, Cosatu.
“The WTO has reached an important milestone by relinquishing intellectual property rights applicable to the production of vaccines. We applaud South Africa’s leading role in this breakthrough agreement. This will open up production facilities on the continent,” said Prof. Petro Terblanche, MD of Afrigen, a local company that designed and developed South Africa’s first mRNA vaccine, which is currently being tested.
Dr. Stavros Nicolaou, senior executive director of strategic trading for Africa’s largest pharmaceutical manufacturer Aspen Pharmacare, called the development “a positive step for the diversification of global pharmaceutical supply chains and manufacturing on the African continent.”
“This strikes a balance between providing access to Covid vaccines in developing countries within a framework that continues to reward the much-needed innovation of the original patent holders,” added Dr. Nicolaou.