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Explainer: What is the patent exemption for COVID vaccine? | Coronavirus pandemic news

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Since the United States last month supported the temporary suspension of intellectual property protection for the COVID-19 vaccine, the campaign to promote vaccine supply and production has gained momentum.

The United Nations warned that vaccine inequalities between countries have allowed COVID-19 to continue to spread and increase the chances of escaping the emergence of mutations in current vaccination.

World leaders have adopted different approaches to meet the challenge of vaccinating people who lack vaccine doses.

In October last year, India and South Africa made an initiative in the World Trade Organization (WTO) to temporarily suspend the intellectual property rules for COVID-19 vaccines and other coronavirus-related medical equipment, believing that abandoning patents will enable more countries to manufacture the much-needed COVID -19 dose.

Large pharmaceutical companies and countries, including the United Kingdom, Canada, and Germany, opposed the plan, citing the potential harm to innovation and the lack of a viable manufacturing base needed to promote production.

More than 3 billion doses of COVID-19 vaccine have been vaccinated worldwide Our data world. But the vast majority of doses are done in richer countries. Less than 2% of the dose administered in Africa.

“The situation is so chaotic,” said Hu Yuanqiong, the legal counsel of the MSF Access Movement.

“We see huge inequalities around the world. People are highly concerned about who owns this technology and who produces it,” she added.

As negotiations on exemptions will resume at an informal WTO meeting on Wednesday, let’s take a look at the heated debate surrounding exemptions.

What is intellectual property?

Intellectual Property (IP) rights Varies from country to country. WTO definition They serve as the right to give people the so-called “creation”.

Creators can use intellectual property rights to prevent others from using their creations or negotiate payment in exchange for licenses. Creation may include inventions, artistic expressions, ideas or formulas, etc.

They are protected by patents, trademarks, and copyrights, which give creators a temporary monopoly on their ideas, while others cannot copy them.The biotech company argues that these protective measures provide impetus for development and production COVID vaccine record time.

The WTO Agreement on Trade-Related Intellectual Property Rights (TRIPS) “is the most comprehensive multilateral agreement on intellectual property rights” and has been in force since 1995.

What is the effect of intellectual property exemption?

The exemption temporarily “cancelled” the intellectual property protection provided by the WTO.

This Requests made by India and South Africa The proposal allows countries to choose not to implement patents and other intellectual property rights related to health products and technologies, including diagnosis, treatment, vaccines, equipment, and other materials or components, as well as “their methods and means to prevent, treat or contain COVID-19” .

This can provide countries with room to strengthen R&D cooperation and avoid the risk of WTO members being sued by others for failing to implement the TRIPS agreement during the pandemic.

This is an option that each country decides to implement. The proposal requires the exemption to be valid for at least three years from the date of the decision.

“The intellectual property exemption will not automatically cancel all intellectual property related to vaccines, personal protective equipment, ventilators and anything else,” said Duncan Matthews, director of the Queen Mary Intellectual Property Institute in London. “It gives specific countries the discretion to do so.”

“For example, we don’t want to see exemptions for intellectual property rights in Europe, the United States, or other developed regions of the world. This will only create opportunities for middle and low-income countries to shelve these rights if they believe it is necessary to increase supply and expand production. ,” he added.

Who opposes this initiative? why?

Organizations including the World Bank and the European Union, as well as countries including Japan, the United Kingdom, Switzerland, Brazil, and Australia, oppose the initiative.

Some leaders believe that this will pose a threat to innovation.

“I don’t think that giving up patents is a solution to provide vaccines to more people,” German Chancellor Angela Merkel told reporters in early May.

Activists held a rally with Angela Merkel’s puppet outside the EU delegation in Washington, DC, calling on the EU to end its opposition to COVID-19 exemption from WTO intellectual property barriers [File: Evelyn Hockstein/Reuters]

“I think we need the creativity and innovation of the company-for this we need patent protection,” she added.

Others believe that countries lack the facilities, technology and know-how to produce vaccines. As an alternative, the European Union called on the United States and the United Kingdom to increase exports of vaccines and finished ingredients.

“The European Union is the only continent or democratic region in the world that has large-scale exports,” European Commission President Ursula von der Lein said at a press conference in May.

“We invite all those involved in the intellectual property exemption debate to join us and promise to export most of the products produced in the region,” she added.

Others say that even if the exemption is cancelled, the production capacity Will not automatically increase In the short and medium term.

Pharmaceutical companies argue that they are negotiating contracts and License transaction Work with producers on a case-by-case basis to protect intellectual property rights and ensure safety.

Will the exemption promote production?

Manufacturers in Bangladesh, Canada, Denmark, and India have all stated that they have the ability to produce vaccines, but they cannot do so due to lack of licenses.

An example is Biolyse in Canada. The company produces anti-cancer drugs and considers it to be one of the few companies in the country capable of producing COVID-19 vaccines. But patent restrictions prevent It moves forward.

Activists call on the EU to end its opposition to COVID-19 exemption from WTO intellectual property barriers in order to produce more vaccines [File: Evelyn Hockstein/Reuters]

However, in addition to the so-called vaccine “formula”, potential manufacturers also need to obtain the trade secrets or knowledge and technology needed to produce the vaccine.

Professor Matthews said that this type of knowledge “usually is what really exists in people’s minds. It’s about how to run the manufacturing process in a factory and know what to do if something goes wrong.”

“So how do you get this confidential information? The typical approach is to send experts to train locals, so one of the things discussed now is that instead of letting a country do it on its own, it is better to make regional manufacturing more efficient. The center,” he added .

The WTO has no right to force companies such as Pfizer and Moderna to share this technology with other companies that use new messenger RNA (mRNA) technology in their vaccines.

South Africa has Recently said They will host the first COVID-19 mRNA vaccine technology transfer center on the African continent supported by WHO.Goal is Scale up Produce and obtain a COVID vaccine.

What’s the next step?

On June 30, the WTO TRIPS Council will hold the first in a series of meetings next month to negotiate the scope and coverage of TRIPS exemptions. The group has not yet begun text-based negotiations, which is a crucial step towards any exemption agreement.

Brooke Baker, a professor at Northeastern University School of Law, said: “They will propose texts that solve some problems and advance the agenda, and the initial meeting will discuss which products should be covered.”

“They have tried to explain the drugs, medical technologies and products, vaccines, drugs, diagnostic tests, personal protective equipment that prevent, treat or control the spread of COVID-19… So my question is which of these products is not included in Germany. Inside?

“Which have not been used? All South Africa and India are asking for are the same products provided by rich countries,” he added.

Negotiation is Expected to continue, And reached an agreement in time at the next WTO Ministerial Council meeting scheduled to be held from November 30 to December 3.

“This process, even at the fastest speed, even if everything goes smoothly, will not be realized until early December,” Matthews said.

Baker said there are concerns that protracted negotiations will make the proposal unrealistic, and that involving pharmaceutical companies in the negotiations may speed up the negotiation process.

“Just giving up the threat of immunity is enough to bring large pharmaceutical companies to the negotiating table in a different way,” Baker explained.

“Wealthy countries can basically tell their pharmaceutical companies that we have to expand production capacity… We can do this the hard way. It will take a long time. We will make exemptions… Or why don’t you negotiate now, we It will compensate you, but you need to transfer your technology so that we can have more production, lower prices and fair distribution worldwide,” he said.



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