Mexico recognizes US position regarding patent provisions

By Dumont

Mexico, as the pro tempore president of the Community of Latin American and Caribbean States (CELAC), recognized the position of the Government of the United States to waiver certain provisions of the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for the COVID-19 pandemic.

The discussion regarding patent protection on COVID-19 vaccines was started at the WTO by India and South Africa and recently received the support from US Trade Representative Katherine Tai.

Tai met with Dr. Tedros Adhanom Ghebreyesus, Director General of the World Health Organization (WHO) to discuss the proposed waiver. She then met with India’s Minister of Commerce and Industry Piyush Goyal and with Ebrahim Patel, the South African Minister of Trade, Industry, and Competition, welcoming an update from the two countries efforts to revise and resubmit their waiver proposal.

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures. The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines. We will actively participate in text-based negotiations at the WTO needed to make that happen. Those negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved”, Tai said in a press release.

European Commission President Ursula von der Leyen also expressed willingness to explore a waiver after United States promoted the plan.

According to Dr. Tedros Adhanom Ghebreyesus, countries “must ensure vaccines are available to everyone, everywhere” boosting manufacturing by removing barriers. “Waving patents temporarily won’t mean innovators miss out. Like during the HIV crisis or in a war, companies will be paid royalties for the products they manufacture,” Adhanom Ghebreyesus stated in a letter.

India and South Africa request that the WTO's Council for TRIPS recommends, as early as possible, to the General Council a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19. The waiver should continue until widespread vaccination is in place globally, and the majority of the world's population has developed immunity.

“There are several reports about intellectual property rights hindering or potentially hindering timely provisioning of affordable medical products to the patients. It is also reported that some WTO Members have carried out urgent legal amendments to their national patent laws to expedite the process of issuing compulsory/government use licenses. Beyond patents, other intellectual property rights may also pose a barrier, with limited options to overcome those barriers. In addition, many countries especially developing countries may face institutional and legal difficulties when using flexibilities available in the TRIPS Agreement,” the proposal says.

However it is opposed by several countries and the pharmaceutical industry, worried about legal, technical and economic implications regarding the waiver, which argue that patent protection is not the biggest problem for vaccines distribution.

"Patents are not the limiting factor for the production or supply of our vaccine. They would not increase the global production and supply of vaccine doses in the short and middle term," German company BioNTech told AFP in a statement. "If any of many requirements is not met, the quality, safety and efficacy of the vaccine cannot be ensured by the manufacturer nor the innovator. This could put the health of the vaccinees at risk," warned the company.

The International Federation of Pharmaceutical Manufacturers & Associations also rejected the waiver possibility. “The decision of the US administration to support a patent waiver for COVID-19 vaccines is disappointing. We are fully aligned with the goal to ensure COVID-19 vaccines are quickly and equitably shared around the world. But, as we have consistently stated, a waiver is the simple but the wrong answer to what is a complex problem. Waiving patents of COVID-19 vaccines will not increase production nor provide practical solutions needed to battle this global health crisis. On the contrary, it is likely to lead to disruption; while distracting from addressing the real challenges in scaling up production and distribution of COVID-19 vaccines globally: namely elimination of trade barriers, addressing bottlenecks in supply chains and scarcity of raw materials and ingredients in the supply chain, and a willingness by rich countries to start sharing doses with poor countries.

While the decision of the US administration does not address the real challenges in vaccinating the world, industry will not waver in its commitment to provide safe, effective and quality vaccines and therapeutics,” the institution said in a press release.