National policies and practices as regards the granting of and exceptions to patents, copyrights, and other types of intellectual property are often influenced by pressure from other countries. The United States is the most important source of pressure on intellectual rights, although certainly not the only country to do so.
The USTR reports
The US pressures tend to be more transparent than most countries and include two widely read reports published annually by the United States Trade Representative (USTR).
Special 301 Report
The annual Special 301 Report, typically published at the end of April, is described as follows:
“The Special 301 Report (Report) is the result of an annual review of the state of intellectual property (IP) protection and enforcement in U.S. trading partners around the world, which the Office of the United States Trade Representative (USTR) conducts pursuant to Section 182 of the Trade Act of 1974, as amended (the Trade Act, 19 U.S.C. § 2242). Congress amended the Trade Act in 1988 specifically “to provide for the development of an overall strategy to ensure adequate and effective protection of intellectual property rights and fair and equitable market access for United States persons that rely on protection of intellectual property rights.”1 In particular, Congress expressed its concern that “the absence of adequate and effective protection of United States intellectual property rights, and the denial of equitable market access, seriously impede the ability of the United States persons that rely on protection of intellectual property rights to export and operate overseas, thereby harming the economic interests of the United States.”
Copies of the Special 301 List are available on the USTR web page here:
https://ustr.gov/issue-areas/intellectual-property/special-301
KEI has some additional documents and analysis of the Special 301 list, including a table listing every time a country has appeared on the list, here:
https://www.keionline.org/ustr/special301
KEI also has some additional information on web pages that have links to 973 U.S. Department of State cables mentioning “Special 301” based on a 2011 search of Wikileaks cables, available here:
https://www.keionline.org/book/cables-mentioning-special-301-details-of-us-trade-pressure-on-ipr
The NTE Report
Broader than intellectual property rights, but also relevant, is another USTR report titled “National Trade Estimate Report on Foreign Trade Barriers.” The 2024 version of the report is available here.
https://ustr.gov/sites/default/files/2024%20NTE%20Report_1.pdf
European Union
European Commission
The European Commission similarly publishes reports on intellectual property rights in third countries. In these reports the European Commission identifies ‘priority countries’ in which they view the state of intellectual property rights protection and enforcement to be a major source of concern.
- May 17 2023, Report on the Protection and Enforcement of Intellectual Property Rights (IPR) in third countries. List of priority countries named in the report: China, India, Türkiye, Argentina, Brazil, Ecuador, Indonesia, Malaysia, Nigeria, Saudi Arabia and Thailand.
- January 9 2020, Report on the protection and enforcement of intellectual property rights in third countries. List of priority countries named in the report: China, India, Indonesia, Russia, Türkiye, Ukraine, Argentina, Brazil, Ecuador, Malaysia, Nigeria, Saudi Arabia and Thailand.
- February 21 2018, Report on the protection and enforcement of intellectual property rights in third countries. List of priority countries named in the report: China, Argentina, India, Indonesia, Russia, Türkiye, Ukraine, Brazil, Ecuador, Malaysia, Mexico, Philippines, Thailand and the United States.
- June 1 2015, Report on the protection and enforcement of intellectual property rights in third countries. List of priority countries named in the report: China, Argentina, Russia, Turkey, Brazil, Canada, Ecuador, Indonesia, Korea, Malaysia, Mexico, Philippines, Thailand, Ukraine, USA and Vietnam.
Medicines Law & Policy published a blog outlining the pressure the European Union places on other countries on their use of TRIPS flexibilities and contextualizes it alongside the proposed ‘peace clause’ in the World Health Organization pandemic accord negotiations.
WTO Trade Review Comments by the European Union
On 2 June 2015 and 4 June 2015, the World Trade Organization (WTO) conducted a trade policy review of India. In this review, the European Union (and others) raised questions on India’s Patent Act, amongst other topics, read here:
- August 3 2015, Thiru Balasubramaniam, WTO Trade Policy Review of India – EU, Japan, Switzerland and the US question India over Section 3(d) and Compulsory Licensing
On 14 September 2011 and 16 September 2011, the World Trade Organization (WTO) undertook a trade policy review of India. In this review, the European Union (and others) raised questions related to India’s IPR regime in the context of pharmaceuticals, read here:
- August 28 2012, Thiru Balasubramaniam, September 2011: Spotlight on India at the WTO Trade Policy Review
Selected KEI blogs and reports on trade pressures
Below is a list of a few (definitely non-exhaustive) examples of KEI blogs and web pages featuring trade pressures on intellectual property and health, organised by countries subjected to trade pressures.
Colombia
- August 30 2018, Thiru Balasubramaniam, WTO Trade Policy Review: China, Japan, Switzerland, and the United States question Colombia about compulsory licensing
- March 15 2018, Andrew Goldman, 13 NGOs Call on USTR To Support Colombia in Special 301 Following Pressure Over Legal Access to Meds Efforts
- December 13 2017, Thiru Balasubramaniam, SCP27: KEI statement on pressures faced by Brazil and Colombia in using TRIPS flexibilities
- June 8 2017, Andrew Goldman, FOIA documents: In 2015 Novartis asked U.S. Dept of Commerce to Pressure Colombia Against Compulsory License on Glivec
- June 9 2016, CM& Emisión Central Segment on Glivec Compulsory License
- May 27 2016, Andrew Goldman, Sens. Sherrod Brown and Bernie Sanders send letter to USTR condemning pressure on Colombia compulsory license for cancer drug
- May 25 2016, Andrew Goldman, Senator Hatch Defends Pressure on Colombia in Interview Regarding Imatinib
- May 12 2016, KEI Staff, April 28, 2016 letter regarding US Senate Finance threats over compulsory license on Novartis cancer drug patents
- May 11 2016, KEI Staff, April 27, 2016 Letter from Colombian Embassy regarding Senate Finance, USTR pressure on Novartis compulsory license
- August 17 2015, KEI Staff, Switzerland pressures Colombia to deny compulsory license on imatinib
Brazil
- December 13 2017, Thiru Balasubramaniam, SCP27: KEI statement on pressures faced by Brazil and Colombia in using TRIPS flexibilities
- August 12 2010, KEI Staff, U.S. Department of State cables regarding Brazil and pharmaceutical patents and prices – 1986-1987
India
- June 30 2017, James Love, Groups, individuals write to Senator Wyden, appalled at pressure on India over drug patents
- June 8 2017, Andrew Goldman, FOIA documents: In 2015 Novartis asked U.S. Dept of Commerce to Pressure Colombia Against Compulsory License on Glivec
- March 26 2013, James Love, India pressured by U.S. Congressional committee, Pfizer, over drug patents
European Union
- August 30 2011, James Love, Wikileaks cables shows Obama Administration role in lobbying EU to approve Oracle acquisition of MySQL and other Sun assets
Italy
- September 10 2011, Manon Ress, “Ipr In Italy – American Voices Among Italian Elite,” cooperation and how to make them change their mind (cables)
Taiwan
- March 6 2010, James Love, USTR pressures Taiwan on pricing and reimbursement of pharmaceuticals and medical devices
Thailand
- July 23 2001, Susannah Markandya, Timeline of Trade Disputes involving Thailand and access to medicines from 1979 to 2001
Malaysia
- November 28 2018, James Love, Communications between Gilead and USTR regarding Malaysia compulsory license on HCV patents, 2017 to May 2018
Dominican Republic
- July 23 2001, Susannah Markandya, Timeline of disputes over pharmaceutical patent protection in the Dominican Republic from 1991 to 2001
South Africa
- October 16 2020, Thiru Balasubramaniam WTO TRIPS Council (October 2020): South Africa issues clarion call urging support for TRIPS waiver proposal
- August 5 1999, Time-line of Disputes over Compulsory Licensing and Parallel Importation in South Africa, 1994 to 1999
Argentina
- April 20 2005, Jennifer Ellen Mattson, Timeline of US-Argentina Dispute on Pharmaceutical Patents from 1989 to 2000
Philippines
- September 3 2011, James Love, Wikileaks cables on the US opposition to Philippines legislation on affordable medicines
- February 9 2005, Jennifer Ellen Mattson, 1999 Collaboration between the US government and pharmaceutical industry to oppose Philippine government effort to promote expanded use of generics for off-patented drugs
Guatemala
- August 29 2011, James Love, From Wikileaks, a US government cable on its involvement to shape Guatemala legislation on pharmaceutical IPR
Finland
- September 6 2011, James Love, Cable: US Government collaboration with drug companies to lobby the Finnish Parliament on drug pricing legislation
Portugal
- September 2 2011, KEI Staff, Diplomats advise drug company executives on best way to lobby Portugal government
Chile
- September 15 2011, James Love, Cables from Chile illustrate ongoing pressure by US trade officials on behalf of drug companies
Multiple Countries
- January 1 2020, Thiru Balasubramaniam, January 2020: European Commission publishes its Report on the protection and enforcement of intellectual property rights in third countries
- September 22 2018, Zack Struver, KEI urges investigation of trade pressures on Least Developed Countries (LDCs) in light of Executive Order 13155
- May 17 2018, Thiru Balasubramaniam, Commissioner Malmström’s response to Civil Society concerns over the Third Country Report on the Protection of IPRs
- March 16 2018, Thiru Balasubramaniam, Thirty-three civil society groups write to Commissioner Malmström expressing concerns over the European Commission’s plans to create an EU Watch List
- March 14 2018, Thiru Balasubramaniam, EC publishes report on protection and enforcement of intellectual property rights in “third countries”
- December 9 2017, Thiru Balasubramaniam, KEI comments to WIPO SCP on constraints faced by countries in making full use of TRIPS flexibilities
- July 21 2016, Zack Struver, Letter from 56 non-profits and experts to Secretary of State John Kerry on pressure on global access to medicines initiatives
Third-Party Content on Trade Pressure
Brazil
- June 2021, Vitor Henrique Pinto Ido, The Role of Courts in Implementing TRIPS Flexibilities: Brazilian Supreme Court Rules Automatic Patent Term Extensions Unconstitutional
Colombia
- May 18 2016, Carolyn Johnson and Karen DeYoung, Dispute with Swiss drugmaker has Colombian officials worried about U.S. peace funding
- August 18 2015, Public Eye, Compulsory licensing in Colombia: Leaked documents show aggressive lobbying by Novartis
- 82 News reports on Senator Hatch pressure over Colombia compulsory license on Novartis drug
India
- March 15 2017, India-EFTA TEPA: Chapter on the protection of intellectual property – Note by Switzerland
- March 23 2012, Rohit Malpani and Mohga M Kamal-Yanni, One important step forward for access to medicines in india, but are tw0 giant steps backwards just around the corner?
Ecuador
- May 13, 2011, Public Citizen, Wikileaks docs cite our work and shed light on Big Pharma & U.S. government team-up in other countries
- May 10 2011, Public Citizen, Leaked Cables Show U.S. Tried, Failed to Organize Against Ecuador Compulsory Licensing
Thailand
- February 25 2008, Switzerland, Compulsory licenses in Thailand on pharmaceuticals under patent protection (Aide Mémoire)
- August 9 2007, Andrew Bounds, Thais warned on drug pricing pressure
Indonesia
- December 2012, Indonesia for Global Justice, Indonesia AIDS Coalition & Third World Network, Open Letter to EU Commission “Drop TRIPS Plus Provision on Indonesia-EU CEPA”
Multiple Countries
- May 8 2024, Medicines Law & Policy, Pressure from European countries related to the use of TRIPS Flexibilities
- July 28 2023, Ban Ki-Moon and Winnie Byanyima, EU trade deals risk affordability of generic medicines for Global South
- February 20 2018, Brook Baker, Mentions of Patent-Related Compulsory Licenses in Special 301 Reports 1998-2017
- November 20 2017, Secretariat Standing Committee on the Law of Patents, Constraints faced by developing countries and least developed countries (LDCs) in making full use of patent flexibilities and their impacts on access to affordable especially essential medicines for public health purposes in those countries: supplement to document SCP/26/5
- February 12 2013, William New, Letter Shows US Pressure On Global Fund For Compulsory Licensing, Generics