2022 Special 301 Review: Docket (USTR-2021-0021)
January 31, 2022
1. The public comment process should provide the public with the opportunity to respond to industry submissions.
The Special 301 submissions are primarily from rights holders and their representatives, and contain assertions of facts and claims that the U.S. interest is served by advocating on their behalf. Since the beginning of the Special 301 process, the industry submissions have contained numerous inaccuracies and inappropriate demands that the United States promote anti-consumer and anti-public health policies. The process is designed for making specific requests to USTR about country policies and practices, and although the industry submissions have a certain amount of continuity, there are differences each year.
Until KEI or others see what the industry is actually asking of the USTR, we can only speculate on what misleading or erroneous data or bad policy proposals that may be advanced.
In the past, the public hearings have provided opportunities to respond to the initial industry subjections, and for the second year, there will be none. USTR could have easily provided the public with the formal opportunity to comment on the industry’s initial submissions. The fact that USTR has not done so illustrates how little USTR listens to consumer interests and how little value is placed on non-right holder views.
2. US trade policy is not consistent with the 2001 Doha Declaration on TRIPS and Public Health.
In 2001, the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS agreement and public health, WT/MIN(01)/DEC/2, which stated “We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.”
The pharmaceutical industry seeks measures every single year that are inconsistent with policies to achieve “access to medicines for all”. This includes efforts to curtail compulsory license, negotiate affordable prices and promote a range of sui generis regulatory exclusivities including those relating to test data.
3. The COVID crisis illustrates the importance of sharing manufacturing know-how and access to biological resources and providing global access to countermeasures.
Trade policies that promote the hoarding of intellectual property and manufacturing know-how are particularly harmful in a global public health crisis like the COVID pandemic.
4. There is no policy to address the trade related aspects of public goods.
The COVID 19 pandemic illustrates the weakness of trade policies as they relate to the importance of inducing the supply of global public goods. The U.S. is a major supplier of global public goods, and would benefit from measures to ensure greater global cooperation and sharing of the costs of supplying global public goods.
5. The United States is among the countries facing a crisis of providing timely and universal access to new biomedical inventions. Trade policies should be consistent with future efforts to delink biomedical R&D incentives from monopolies and high prices.
In order to delink R&D incentives from legal monopolies and high prices and to overcome patent thickets in new technologies, governments should have the freedom to refashion the patent system from one of strong exclusive rights to systems of liability rules, eliminating exclusive rights on products to be replaced with claims on market entry rewards and other innovation inducement incentives.
6. Transparency has trade related aspects.
The WHO resolution WHA72.8, “Improving the transparency of markets for medicines, vaccines, and other health products,” sets out global norms to make the markets for medicines, vaccines, and other health products more transparent. There are trade related aspects of such initiatives. Every country wants to have information about the pharmaceutical value chain, but often have domestic demands to provide secrecy for a wide range of topics such as clinical trial costs, licensing arrangements, patent landscapes, prices and quantities of products sold, manufacturing methods and clinical trial outcomes.
Trade policy should ensure that when transparency benefits everyone, governments cooperate to make transparency happen.
There is also a need to work towards standards for sharing information about the pharmaceutical value chain, so that disclosures are more useful.
One of the more appalling failures regarding transparency has been the COVID pandemic, where contracts, licensing terms, and prices and procurement agreements were often secret.