On 13 December 2021, the Office of United States Trade Representative (USTR) posted the following request for public comment in relation to its 2022 Special 301 Review: Identification of Countries Under Section 182 of the Trade Act of 1974 noting the following:
Each year, the Office of the United States Trade Representative (USTR) conducts a review to identify countries that deny adequate and effective protection of intellectual property (IP) rights or deny fair and equitable market access to U.S. persons who rely on IP protection. Based on this review, the U.S. Trade Representative determines which, if any, of these countries to identify as Priority Foreign Countries. USTR requests written comments that identify acts, policies, or practices that may form the basis of a country’s identification as a Priority Foreign Country or placement on the Priority Watch List or Watch List.
By the deadline of 31 January 2022, USTR received 43 submissions from groups including the International Intellectual Property Alliance (IIPA), Knowledge Ecology International (KEI), the US Chamber of Commerce, Union des Associations Européennes de Football (UEFA), The Football Association Premier League Limited, and PhRMA.
Typically, trade associations use these submissions to name and shame countries in efforts to persuade USTR to designate countries as “Priority Watch List” countries or “Watch List” countries. However, this process is more than just a naughty list. The Special 301 process can be linked to the iron fist of preferential market access through the Generalized System of Preferences (GSP) program.For example between 2019 and 2020, the Intellectual property Alliance (IIPA) whose members include the Motion Picture Association (MPA) and the Recording Industry Association of America (RIAA) beseeched the US government to “impose higher tariffs (revoke GSP benefits) on South Africa and Indonesia over copyright issues.” (Source: KEI Request to appear at the January 30, 2020 public hearing on GSP benefits for South Africa and Indonesia). Based on the IIPA’s petition USTR convened a hearing on 30 January 2020 to focus on “whether Indonesia and South Africa are meeting the GSP eligibility criterion requiring adequate and effective protection of intellectual property rights”. (Source: Public Hearing: Generalized System of Preferences: Country Practice Reviews of Azerbaijan, Ecuador, Georgia, Indonesia, Kazakhstan, Thailand, South Africa, and Uzbekistan, and for the Country Designation Review of Laos).
Since 2017, PhRMA has targeted multilateral agencies including the World Health Organization (WHO), the United Nations Development Program (UNDP), the United Nations Conference on Trade and Development (UNCTAD). In 2017, PhRMA asserted: “While UNDP does not appear to have specialized expertise on intellectual property matters, it issued patent examination guidelines in 2016 that, if followed, would prevent innovators from securing patents on many kinds of biopharmaceutical inventions.”
In its 2022 Special 301 submission to USTR, PhRMA set its sights on agencies including the United Nations Development Programme (UNDP), the United Nations Conference on Trade and Development (UNCTAD), Unitaid, the World Health Organization (WHO), the World Intellectual Property Organization (WIPO), and the World Trade Organization (WTO).
Multilateral organizations that once served as custodians of the international rules-based system increasingly are seeking to undermine and even eliminate intellectual property protections that drive and sustain biopharmaceutical innovation in the United States and around the world. By reinterpreting international agreements and through meetings, reports,guidelines and training programs, the WHO, the United Nations Development Program (UNDP), the United Nations Conference on Trade and Development (UNCTAD), Unitaid and other organizations are promoting acts, policies and practices globally and in specific countries that prevent biopharmaceutical innovators from securing and maintaining patents, protecting regulatory test data and from enjoying fair and equitable market access. (Source: PhRMA Special 301 Submission 2022)
In 2022, PhRMA accused WIPO and WTO for inappropriately focusing on limitations and exceptions to intellectual property rights. Perhaps PhRMA chafed at the fact that exceptions and limitations to patent rights and patents and health are standing items in WIPO’s Standing Committee on the Law of Patents (SCP). WHO’s Roadmap on Access to Medicines drew PhRMA’s ire because it raised the specter of WHO providing technical advice to countries seeking to engage in compulsory licensing (something WHO has done for over two decades). PhRMA took umbrage at the WHO Director-General’s public support of the TRIPS waiver. Given that the recipient of PhRMA’s submission is USTR, one wonders how this particular complaint will be received considering that on 5 May 2021, United States Trade Representative Katherine Tai “released a statement announcing the Biden-Harris Administration’s support for waiving intellectual property protections for COVID-19 vaccines.” (Source: Statement from Ambassador Katherine Tai on the Covid-19 Trips Waiver)
Organizations such as the WHO, the World Intellectual Property Organization (WIPO), the WTO, UNDP and UNCTAD often focus their work inappropriately on limitations and exceptions to intellectual property rights, as well as promote a range of harmful policies that would undermine vital incentives for innovation.vFor example, WHO’s Roadmap on Access to Medicines envisions providing “technical support” to countries that intend to engage in compulsory licensing, with one regional WHO office openly asserting that compulsory licensing is “important and to be encouraged.” The WHO Director-General even publicly supported an extreme and unnecessary proposal at the WTO TRIPS Council to waive entirely certain international obligations with respect to COVID-19 technologies, even as Member States were still debating this proposal in a separate multilateral forum. Unitaid has directed millions of dollars to programs that seek to weaken intellectual property laws and lobby governments to reject provisions in international trade agreements that would strengthen innovation incentives. U.S. leadership is essential to preventing such organizations from weakening or even eliminating the intellectual property protections that drive America’s innovation economy. (Source: PhRMA Special 301 Submission 2022)
In addition, multilateral organizations such as UNDP and Unitaid advocate actively for patentability restrictions and additional patentability requirements that are inconsistent with international practice. For example, although UNDP does not appear to have specialized expertise on intellectual property matters, it issued patent examination guidelines in 2016 that, if followed, would prevent innovators from securing patents on many kinds of biopharmaceutical inventions.84 Similarly, Unitaid partnered with various non-governmental organizations in 2018 to launch a campaign to erode intellectual property policies and laws globally. (Source: Ibid)
Finally, PhRMA requested the United States to “strengthen interagency coordination and ensure that officials with intellectual property expertise are part of U.S. delegations to relevant global meetings.”