Statement by the Research-based Pharmaceutical Industry on the Consultation on Exemptions from Intellectual Property Protection Obligations Scheduled for the Twelfth WTO Ministerial Conference

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June 10, 2022

Japan Pharmaceutical Manufacturers Association The Japan Pharmaceutical Manufacturers Association (Chairman: Yasushi Okada, hereinafter referred to as "JPMA") is pleased to announce the release of the "Statement by the Research-based Pharmaceutical Industry on the Consultation on the TRIPS Weber (Intellectual Property Protection Obligation Exemption) Scheduled at the 12th WTO Ministerial Conference".

The Japanese translation of this joint statement is as follows. The official language of this statement is English, and English shall prevail with respect to its content and interpretation.

Japanese Translation

Statement by the Research-based Pharmaceutical Industry on the upcoming discussions at the 12th WTO Ministerial Conference on the TRIPS Weber

Several organizations representing the global research-based pharmaceutical industry reaffirm that weakening the intellectual property (IP) framework proposed in the Quad Compromise is unnecessary and will have a negative impact on innovation. and jeopardize global health security. It will also undermine the pharmaceutical industry's ability to collaborate, take risks, invest, and respond quickly to possible future pandemics, as well as its ability to innovate.

The pharmaceutical industry must adopt unusual approaches to tackle the COVID-19 pandemic, breaking new ground in science, building viable solutions, and focusing critical resources to ensure the ability to scale up manufacturing once a solution is found, while at the same time ensuring that patients continue to have access to existing We have worked tirelessly to ensure that patients continue to have access to their existing medicines. As a result, we achieved vaccine development and approval in the fastest time ever (only 326 days).

Despite this progress in science and manufacturing, over the past 18 months there have been discussions among World Trade Organization (WTO) members on various methods aimed at weakening the IP framework. To date, however, there is no evidence that IP has been a barrier to the production of or access to COVID-19 vaccines, nor is there recognition of the important role IP has played in the research, development, and production of vaccines and treatments that are safer and more effective than ever before.

From the outbreak of the pandemic, the pharmaceutical industry has felt the need to scale up manufacturing quickly, sought to expand manufacturing facilities before approvals were available, partnered wherever possible in all geographic regions, and always remained uncompromising about quality, safety, and efficacy in the ^process1. To date, the pharmaceutical industry has entered into 381 partnerships for COVID-19 vaccines and 150 for its therapeutics, with over 88% and 79% involving technology transfer, respectively. with IP protection, years of research and risk-taking and investment have paid off, Today, 11 vaccines are on the WHO's emergency use list and 36 treatments are approved globally. ² The pharmaceutical industry continues to research and invest. In addition, industry and academia combined have 659 vaccine candidates (192 in the clinical stage) and 1,706 therapeutic candidates (885 in the clinical stage) in the ^pipeline3 .
By May 2021, less than six months after the first vaccine was approved, monthly production was close to one billion ^doses4. This is enough to vaccinate everyone in the world if countries were willing and able to distribute the vaccine. At the time, the pharmaceutical industry was urging governments to remove trade restrictions, distribute vaccines, and develop health care systems in order to initiate vaccination ( "COVID-19 Five Steps to Urgently Improve Vaccine Equity" ). This demand was reiterated in March 2022, when it was becoming increasingly clear that critical bottlenecks in the supply and management of vaccines were often associated with weak health care systems ( "Three Priorities for Urgently Increasing Access to COVID-19 Vaccine" ). Today, it is generally accepted that the supply status of COVID-19 vaccine is not a barrier to access to the vaccine, as the global vaccine manufacturing capacity significantly exceeds the demand and the amount needed to vaccinate/booster people worldwide.
Many lessons were learned during this pandemic that will help promote equitable access to be made during possible future pandemics. ⁵ We need to strengthen our collective efforts to achieve health equity and ensure that our health care systems and health care delivery infrastructure are reinforced.COVID- 19 vaccines and therapeutics were made possible by decades of research investment as well as an IP framework that encourages rapid and voluntary partnerships across the private, public, and academic sectors.

The consultations on the TRIPS Weber were not evidence-based and the IP framework was used for political gamesmanship. As the 12th WTO Ministerial Meeting convenes this week, its leaders must be mindful that weakening the IP framework could threaten global health security. A far better approach would be to target substantive issues related to access to COVID-19 vaccines, such as eliminating trade barriers, addressing distribution challenges, strengthening health systems, and partnering to drive innovation and improve access.

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The original text of this joint statement can be found here.
RESEARCH-BASED BIOPHARMACEUTICAL INDUSTRY ON THE TRIPS WAIVER DISCUSSIONS AT WTO MINISTERIAL CONFERENCE 12

Appendix

Statement by the R&D-Based Pharmaceutical Industry on the upcoming discussions at the 12th WTO Ministerial Conference on the TRIPS Weber (Intellectual Property Protection Obligation Exemption)

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