Statement by the Research-Based Pharmaceutical Industry on the Discussions Scheduled for the 12th WTO Ministerial Conference Regarding Exemptions from Intellectual Property Protection Obligations

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June 10, 2022
Japan Pharmaceutical Manufacturers Association

The Japan Pharmaceutical Manufacturers Association (Chairman: Yasushi Okada,hereinafter “JPMA”) has issued the “Statement by the R&D-Based Pharmaceutical Industry Regarding the Discussions on Exemptions from Intellectual Property Protection Obligations (TRIPS Waivers) Scheduled for the 12th WTO Ministerial Conference.”

The Japanese translation of this joint statement is as follows. Please note that the official language of this statement is English, and the English text shall take precedence regarding its content and interpretation.

Japanese Translation

Statement by the Research-Based Pharmaceutical Industry on the Discussions Regarding the Waiver of Intellectual Property Protection Obligations (TRIPS Waiver) Scheduled for the 12th WTO Ministerial Conference

Several organizations representing the global research-based pharmaceutical industry have reaffirmed that weakening the intellectual property (IP) framework proposed in the “Quad compromise” is unnecessary and would have a negative impact on innovation.Waiving IP rights would not only fail to address the inequities in access to COVID-19 vaccines but could also jeopardize global health security.It would also strip the pharmaceutical industry of its capacity for innovation, collaboration, risk-taking investment, and rapid response to future pandemics.

To tackle the COVID-19 pandemic, the pharmaceutical industry adopted approaches not typically used, broke new scientific ground, developed viable solutions, and focused critical resources on ensuring the capacity to scale up production once solutions were found—all while working tirelessly to ensure patients continued access to existing medicines.As a result, vaccine development and approval were achieved in the fastest time in history (just 326 days).

Despite these advances in science and manufacturing, over the past 18 months, discussions have been taking place among World Trade Organization (WTO) member states regarding various methods aimed at weakening the intellectual property (IP) framework.However, to date, there is no evidence that intellectual property (IP) has been a barrier to the manufacture of or access to COVID-19 vaccines, nor is there any recognition of the critical role IP has played in the research, development, and manufacture of unprecedented safe and effective vaccines and treatments.

From the outset of the pandemic, the pharmaceutical industry has recognized the need to rapidly scale up production; it has strived to expand manufacturing capacity even before approvals were granted, formed partnerships wherever possible across all regions, and throughout this process ^has consistently responded without compromising on quality, safety, or efficacy ^.1 To date, the pharmaceutical industry has formed 381 partnerships for COVID-19 vaccines and 150 for treatments, with over 88% and over 79% of these, respectively, involving technology transfer.Thanks to IP protection, years of research and risky investments have borne fruit: 11 vaccines are now listed on the WHO’s Emergency Use Listing, and 36 treatments have been approved worldwide ^.² The pharmaceutical industry continues to conduct research and make investments. Furthermore, the combined industry and academic pipelines include 659 vaccine candidates (192 in clinical trials) and 1,706 therapeutic candidates (885 in clinical trials) ^³.
By May 2021—less than six months after the first vaccine was approved—monthly ^{production had reached nearly 1 billion doses.⁴} This is enough to vaccinate people worldwide, provided that countries are willing and able to distribute the vaccines.At the time, the pharmaceutical industry was calling on governments to lift trade restrictions, distribute vaccines, and strengthen healthcare systems in order to begin vaccination efforts ( “Five Steps to Urgently Improve Equity in COVID-19 Vaccines” ).This call was reiterated in March 2022, as it was gradually becoming clear that major bottlenecks in vaccine supply and management were often linked to fragile healthcare systems ( “Three Priorities for Urgently Increasing Access to COVID-19 Vaccines” ).Today, it is widely recognized that the global supply of COVID-19 vaccines does not pose a barrier to access, as global vaccine production capacity significantly exceeds both demand and the quantities needed to vaccinate and administer booster shots to people worldwide.
During this pandemic, ^{we have learned} many lessons that will help promote equitable access during future pandemics. ^⁵ We must strengthen our collective efforts to achieve health equity while ensuring that health systems and healthcare infrastructure are reinforced.COVID-19 vaccines and treatments were made possible by decades of investment in research, as well as an intellectual property (IP) framework that fostered rapid and voluntary collaboration across the private, public, and academic sectors.

Discussions regarding the TRIPS waiver lacked evidence, and the intellectual property framework was exploited for political maneuvering. As the 12th WTO Ministerial Conference convenes this week, leading nations must bear in mind that weakening the intellectual property framework risks threatening global health security.It would be a far better approach to focus on substantive challenges related to access to COVID-19 vaccines, such as removing trade barriers, addressing distribution challenges, strengthening healthcare systems, and forming partnerships to drive innovation and improve access.

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Please click here to view the original text (in English) of this joint statement

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RESEARCH-BASED BIOPHARMACEUTICAL INDUSTRY ON THE TRIPS WAIVER DISCUSSIONS AT THE WTO MINISTERIAL CONFERENCE 12

Attached Documents

Statement by the Research-Based Pharmaceutical Industry on Discussions Regarding the Exemption from Intellectual Property Protection Obligations (TRIPS Waiver) Scheduled for the 12th WTO Ministerial Conference (Japanese Translation)

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