“If the scope of the waiver of TRIPS rights regarding COVID technology is extended, we will be on a ‘dangerous road’. Necessary investment incentives to pursue innovative research will be wasted and countries may claim ‘rights’ over a vast range of US patented technology.’” – Testimony of Frank Cullen, from C4IP
Screenshot from today’s ITC hearing
The International Trade Commission (ITC) today held a daylong public hearing for various stakeholders interested in the pending decision of the World Trade Organization (WTO) on the extension of what has come to be known as TRIPS. It was conducted. [Agreement on Trade-Related Aspects of Intellectual Property Rights] Exemption from strictly COVID-19 vaccine technology to COVID-19 related therapeutics and diagnostics.
The initial agreement on the waiver was made last June, leaving most of the people at the table unhappy. and are considering applying for treatment and diagnosis within 6 months from the decision date, which was December 17, 2022. It was postponed amid concerns that there was not enough information for Instead, the Office of the United States Trade Representative (USTR) sent a letter to the ITC on December 6, 2022, stating that it would “commence research into COVID-19 diagnosis and treatment, provide information on market dynamics, provide “to help inform the debate on the matter.” Demand, price range, relationship between test and treatment, manufacturing and access, etc. The USTR asked the ITC to focus on issues such as identifying specific products that the expansion would affect. manufacturing and production data; global market for COVID-19 diagnostics and treatments, including demand, unmet need, supply, and distribution; How TRIPS currently affects access, which countries have attempted to use waivers so far, and which countries have used access under the United Nations (UN) Medicines Patent Pool (MPP) Include either Today’s hearing was part of the ITC’s investigation.
Industry: Extensions Don’t Solve Problems
Industry group representatives reiterated to the ITC commissioner that the extension of the waiver would not improve existing problems related to infrastructure rather than patents. In fact, many speakers say decisions affecting vaccine technology are already clouding the investment climate and causing real damage. “Extending the TRIPS exemption will not add any more [tests or treatments] Frank Cullen testified today at the Council for Promoting Innovation (C4IP), stating: “But expanding waivers would call into question basic intellectual property support and severely hurt innovation.”
This is especially true for its “slippery slope” effect, many of the delegates said. For example, Cullen’s pre-hearing written submission states in May 2022 that United Nations Secretary-General António Guterres said that “renewable energy technologies ‘must be treated as essential and freely available global public goods.’ ” and pointed out that it would “remove barriers to knowledge sharing”. Technology transfer, including intellectual property constraints, is essential for a swift and just transition to renewable energy. If the scope of the TRIPS waiver on COVID technology is expanded, we are “on a dangerous path. is the vast scope of US patented technology,” said Cullen’s filing.
Patrick Kilbride of the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) also testified, “The discussion of the TRIPS waiver, and the waiver itself, is truly misleading in misrepresenting and unfairly stigmatizing IP’s role.” I am doing,” he said. Kilbride explained that IP’s role in the innovation process is “not an afterthought, but an afterthought.” It also continues through the lifecycle of an innovative solution, and this complex process is disrupted when intellectual property rights are disrupted. The current decision on the waiver jeopardizes US leadership on innovation and “disrupts the IP ecosystem that has enabled US industry’s highly effective response to the pandemic, undermining future US innovation.” Deaf,’ he said Mr Kilbride.
Kilbride also said the U.S. decision to support waivers came “long after its ostensible purpose was that the supply of COVID-19 vaccines had increased significantly, resulting in a surplus. It cannot be justified as a special measure in the face of a global health crisis,” he said. .
NGO: Industry warning equals threat
However, panelists representing advocacy and access organizations sharply refuted the industry’s claims. Knowledge Ecology International’s James Love emphasized that the industry argument that current supply is outstripping demand misses the point. Love explained:
“The BIO COVID-19 Therapeutic Development Tracker shows how shortsighted it is to look at only a few FDA-approved products while ignoring a much larger number of products in development.
Not only are current drugs of limited efficacy for many patients, combination therapy has often been the most effective treatment for infections. Looking at his COVID-19 meds today is somewhat like looking at HIV meds before triple therapy, or his HCV treatment before combinations involving sofosbuvir.
This decision is not about drugs on the market today, but we should try to make sure there is a way Expand access to new and innovative products entering the market in the future. ”
Love also noted that the United States has taken advantage of TRIPS flexibility during the pandemic, noting that the U.S. government “has signed at least 59 contracts, including FAR 52.227-1 grants, to use patents without the consent of the patentee.” ” was signed. According to Love, “The beneficiaries of these government licenses are well-known companies such as Corning, Eli Lilly, Merck, Moderna, Novavax, Philips, Qiagen, Sanofi and Siemens, as well as many small businesses and several It was at that university.” He added during the question. [the industry organizations’] Members were asking for a compulsory license, and today they’re here to say it’s horrible,” Love said.
Third World Network’s Sangeeta Shashikant similarly refuted the trade group’s claims, expressing disbelief that anyone could be concerned about the scope of the exemption. He said the scope would be very limited and would be difficult to extend outside of COVID-related technology. To say it’s a slope is really going too far.”
Representatives of non-governmental organizations also said the threat of compulsory licenses could be an important tool for negotiating voluntary license agreements, often more quickly and effectively/efficiently. , which may explain the low statistics on the actual use of compulsory licenses.
Commissioner question
The ITC Commissioners are concerned about the question of how to adequately limit the scope of potential extensions to diagnosis and treatment, as they do not know what kind of solutions will prove effective in the future. They also asked about the number of jobs associated with manufacturing COVID-19 diagnostic/therapeutic tests and what types of companies are involved. An industry representative explained that many of the companies doing the most innovative work are small businesses rather than large pharmaceutical companies.
The ITC study is No. 332-596 COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities. The report is expected to be submitted to the USTR by October 17, 2023. Written submissions for the record must be submitted by 5:00 p.m. on May 5, 2023 through the Commission’s electronic document information system.
To read today’s full testimony, visit the EDIS site and enter survey number 332-596.
