Explanatory: What are the patent exemptions for COVID vaccines? | Coronavirus pandemic news


Since the United States last month supported the temporary suspension of intellectual property protections for COVID-19 vaccines, the move to increase supply and production of shots has gained momentum.

The United Nations has warned that the inequality of vaccines between nations has allowed COVID-19 to continue to spread and has increased the chances of the emergence of variants that could circumvent the current vaccine culture.

World leaders have taken different approaches to the challenge of inoculating populations that do not have vaccine doses.

Last October, India and South Africa presented an initiative to the World Trade Organization (WTO) to temporarily suspend intellectual property rights rules for COVID-19 vaccines and other equipment. coronavirus-related physicians, arguing that renouncing patents would allow more countries to be manufactured. much needed doses of COVID-19.

Major pharmaceutical companies and countries, including the United Kingdom, Canada and Germany, have opposed the plan and cited possible damage to innovation and the lack of viable manufacturing sites needed to boost production.

Second, more than 3 billion doses of COVID-19 vaccine have been administered worldwide Our world in data. But the vast majority of doses have been administered in richer countries. Less than two percent of doses have been administered in Africa.

“It’s such a chaotic situation,” said Yuanqiong Hu, legal adviser to the Access Campaign for Doctors Without Borders.

“We see a huge inequality worldwide. There is a high level of concentration on who owns the technology and who produces it, ”he added.

With negotiations on waivers set to resume on Wednesday at an informal WTO meeting, let’s take a look at the intensification of the debate around waivers.

What are intellectual property rights?

Intellectual property rights (IP) they vary from country to country. The WTO defines as rights granted to people by what are called “creations”.

Creators may use IP rights to prevent others from using their creations or negotiating payment in exchange for permission to use them. Creations can include inventions, artistic expressions, ideas or formulas, among others.

They are covered by patents, trademarks and copyrights, which give creators a brief monopoly on their idea, when others cannot copy it. Biotechnology companies argue that these protections have provided the motivation to develop and produce COVID vaccines in record time.

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

What does an IP exemption do?

A waiver temporarily “eliminates” the intellectual protections provided by the WTO.

He petition filed by India and South Africa proposes to allow countries to choose not to implement patents and other intellectual properties related to health products and technologies, including diagnostics, therapeutics, vaccines, equipment and other materials or components, as well as “their methods and means for prevention, treatment or the containment of COVID -19 ”.

This could provide countries with the space to increase R&D collaboration, exempting WTO members from the risk of being sued by others for not implementing the TRIPS agreement during the pandemic.

It is an option that countries can implement at their discretion. The proposal requires that the waiver remain valid for at least three years from the date of the decision.

“An intellectual property exemption does not automatically remove all intellectual property rights related to vaccines, PPE, fans, and anything else,” said Duncan Matthews, director of the Intellectual Property Research Institute. Queen Mary in London. “It gives discretion to certain countries to do so.”

“For example, we would not expect to see a renunciation of intellectual property in Europe, the United States or other developed parts of the world. It would simply create an opportunity for middle- and low-income countries to set aside those rights when they see the need to increase supply and increase production, ”he added.

Who opposes the initiative and why?

Organizations such as the World Bank and the European Union, and countries such as Japan, the United Kingdom, Switzerland, Brazil and Australia have opposed the initiative.

Some leaders have argued that it would pose a threat to innovation.

“I don’t think giving up patents is the solution to supplying the vaccine to more people,” German Chancellor Angela Merkel told reporters in early May.

Activists hold a rally with a puppet of Angela Merkel in front of the EU delegation in Washington, DC, calling on the EU to end opposition to a waiver of COVID-19 on intellectual property barriers. the WTO [File: Evelyn Hockstein/Reuters]

“I think we need the creativity and innovation of companies, and for that we need patent protection,” he added.

Others have argued that countries do not have the facilities, technology and know-how to produce vaccines. Alternatively, the EU has called on the US and the UK to increase exports of vaccines and ingredients in finished products.

“The European Union is the only continental or democratic region in the world that exports on a large scale,” Commission Head Ursula von der Leyen told a news conference in May.

“We invite all those involved in the debate on a waiver of intellectual property rights to also join us in committing to be willing to export a large part of what is produced in this region,” he added.

Others say that even if the waiver is suppressed, the capacity for production it would not increase automatically in the short and medium term.

Pharmaceutical companies argue that they are negotiating contract and license offers with producers on a case-by-case basis with the aim of protecting intellectual property and ensuring security.

Would resignations increase production?

Manufacturers in Bangladesh, Canada, Denmark and India have said they have the capacity to produce vaccines, but they cannot do so due to lack of licenses.

An example is Biolysis in Canada. The company produces drugs against cancer and believes that it is one of the few companies in the country with the capacity to produce COVID-19 vaccines. but patent restrictions have been prevented that does not advance.

Activists have called on the EU to end opposition to a COVID-19 waiver of WTO intellectual property barriers so that more vaccines can be produced [File: Evelyn Hockstein/Reuters]

However, in addition to the so-called “recipe” for vaccines, potential manufacturers would also require access to trade secrets or the knowledge and technology needed to produce vaccines.

Professor Matthews said that this kind of knowledge “is often something that is literally in people’s minds. It’s the skill on how to run the manufacturing process in the factory and know what to do if something goes wrong. ”

“So how can you access this confidential information? The typical way to get it is that you have to send an expert to train local people, so one of the things that is being discussed now is more than having a country. to do it alone, it would be more efficient to have regional manufacturing centers, ”he added.

The WTO does not have the power to force companies like Pfizer and Moderna, whose vaccines use the new messenger RNA (mRNA) technology, to share this knowledge with other companies.

South Africa has done it he said recently will host the first COVID-19 mRNA vaccine technology transfer center, with WHO support. The goal is to climb production and access to COVID vaccines.

What’s next?

On June 30, the WTO TRIPS Council will hold the first of a series of meetings scheduled for next month, for talks on the scope and coverage of the TRIPS waiver. The group has not yet begun text-based negotiations, a critical step toward any waiver agreement.

“They will propose the text that addresses some of the concerns and advance the agenda, the initial meeting will be on what products should be covered,” said Brook Baker, a professor at Northeastern University School of Law.

“They have tried to specify that it is already drugs that prevent, treat or control the spread of COVID-19, medical technologies and products, vaccines, drugs, diagnostic tests, PPE … so my question would be which of these products does not Don’t want to include Germany?

“Which ones have they not used? Everything South Africa and India demand are the same products available in rich countries, ”he added.

Negotiations are it is expected to continue, with a potential agreement in time for the next meeting of the WTO Ministerial Council scheduled for 30 November to 3 December.

“This process, even at its fastest pace, even if all goes well, will not be possible until early December,” Matthews said.

Baker said there was concern that protracted negotiations would make the proposal less practical and that convening businesses at pharmaceutical companies could speed things up.

“The mere threat of a waiver should be enough to bring a large pharmacy to the table in a different way,” Baker explained.

“Rich countries could basically tell their pharmaceutical companies that we need to expand capacity … we can do it in the hardest way, it will take a long time, we will adopt a waiver … Or why don’t you come to the table now , we will do it? compensate you, but you have to transfer your technology so that we can have more production, lower prices and equitable distribution worldwide, ”he said.

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