New agreement allows developing countries to manufacture Covid vaccines



More than a year after South Africa and India originally proposed waiving provisions of the TRIPS (Trade-related Intellectual Property Rights) agreement in October 2020, the World Trade Organization (WTO) on Friday granted developing countries the right to manufacture Covid-19 vaccines.

That means developing countries can now make their own vaccines without permission from patent holders.

After making their first proposal, South Africa and India formed a coalition of support from more than 100 countries and a range of organizations.

Among them were representatives of organized labor and business in Nedlac, who met virtually with the South African government during the 12th WTO Ministerial and pledged their full support for South Africa’s efforts to reach an agreement.

The 12th WTO Ministerial Conference started on Sunday 12th June and ended on Thursday 16th June.

Intellectual property rights are governed by a WTO-administered treaty known as the TRIPS (Trade-related Intellectual Property Rights Treaty) and a WTO Ministerial Agreement that recently provided waivers and flexibilities for intellectual property (IP ) identified, which then led to the latest developments.

“After months of stalemate, talks between South Africa and India with the European Union (EU) and the United States (US) in recent months have resulted in text-based negotiations at the WTO, giving further impetus to the waiver request and resulting in the Adoption of the TRIPS waiver decision,” the Department of Trade, Industry and Competition (DTIC) said in a statement welcoming the agreement.

Manufacturers from developing countries are now allowed to export vaccines manufactured under the terms of the exemption to other developing countries without the restrictions imposed under the current TRIPS agreement.

In addition, it allows certain information available in regulatory dossiers to be used to speed up the manufacture of generic drugs.

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“The scope of the agreement includes vaccines and requires countries to make a decision within six months on extending it to include therapeutics and diagnostics used in the fight against Covid-19,” the DTIC said.

During a media briefing on Saturday welcoming the development, the South African government – represented by South African ministers Ebrahim Patel and Thoko Didiza – said the agreement would allow governments to authorize local manufacturers to manufacture and use vaccines or their ingredients, substances or elements Procedures covered by patents without the consent of patent holders during the pandemic.

“We welcome the agreement as a solid and helpful basis to strengthen our joint efforts to build a strong African vaccine manufacturing capacity. Further partnerships are needed to expand production on the continent, including access to know-how and technologies. The unanimous endorsement of the Waiver Agreement by all WTO countries should lay the basis for such partnerships and give countries more flexibility,” the DTIC said.

Didiza and Patel also called this “a step forward in the government’s efforts to boost African industrialization” and said it had the “potential to unlock production beyond stuffing and finishing.”

“The waiver is one element of a broader set of measures to build innovation and manufacturing capacity in South Africa and elsewhere on the continent. South Africa has four vaccination initiatives underway. Our focus now is to ensure we meet demand by persuading global vaccine procurers to source vaccines from African manufacturers.

“This waiver and the other commitments agreed at the WTO are also about pandemic preparedness, so that developing countries have the legal tools to address variants of Covid-19 in the future and actually prepare for future pandemics,” he said patel

Other organizations welcoming the agreement included local vaccine makers Biovac, Afrigen and Aspen PharmaCare, and the country’s largest union federation, Cosatu.

“The WTO has achieved a significant milestone by renouncing intellectual property rights that apply to the manufacture of vaccines. South Africa’s leadership in this landmark agreement is welcomed. This will free up manufacturing capacity on the continent,” said Professor Petro Terblanche, MD of Afrigen, the local company that pioneered and developed South Africa’s first mRNA vaccine, which is currently undergoing testing.

dr Stavros Nicolaou, Group Senior Executive for Strategic Trade at Africa’s largest pharmaceutical manufacturer, Aspen Pharmacare, called the development “a positive move for the diversification of global pharmaceutical supply chains and for manufacturing on the African continent”.

“A balance will be struck between providing access to Covid vaccines in developing countries within a framework that still rewards much-needed innovation from the original patent holders,” added Dr. Added Nicolaou.

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