Glossary, References and Appendices

Glossary

COVAX (Covid-19 Vaccines Global Access): Co-led by Gavi, the Vaccine Alliance, the WHO, and the Coalition for Epidemic Preparedness Innovations (CEPI), COVAX aims to provide equitable access to Covid-19 vaccines.

CSR (Corporate Social Responsibility): A concept where companies, including pharmaceutical firms, take responsibility for their impact on society and contribute to public health, particularly in underserved regions.

Doha Declaration (2001): A declaration by the WTO emphasizing the right of countries to safeguard public health and use flexibilities within the TRIPS Agreement to improve access to essential medicines during health emergencies

FDA (Food and Drug Administration): A U.S. federal agency responsible for regulating and approving drugs, including vaccines, for public use.

GAVI, the Vaccine Alliance: An international organization focused on improving access to immunization in low-income countries, notably through the COVAX initiative.

HIV/AIDS: A viral disease that targets the immune system, often treated with antiretroviral therapies. The issue of access to these treatments is central in discussions about global health and intellectual property.

IP (Intellectual Property): Legal rights granted to the creators of original works, inventions, or innovations, enabling them to control the use and distribution of their creations.

LMICs (Low- and Middle-Income Countries): Nations with a gross national income (GNI) per capita between low and middle-income thresholds, often facing challenges in accessing affordable healthcare.

Medicines Patent Pool (MPP): An initiative by UNITAID to license essential medicines to generic manufacturers to improve access to affordable treatments, particularly for HIV, hepatitis C, and tuberculosis.

Pharmaceutical Industry: Large multinational companies responsible for the research, development, and distribution of medicines, and central to the ongoing debate around pricing and access to medicines.

Patent Thickets: A strategy used by pharmaceutical companies to create dense webs of overlapping patents, extending market exclusivity and preventing competition from generics and biosimilars.

Public-Private Partnerships (PPP): Collaborative arrangements between government bodies and private enterprises, typically used to fund research and development, such as in the field of translational medicine.

TRIPS (Trade-Related Aspects of Intellectual Property Rights): An international legal framework that governs intellectual property rights and their impact on global trade, including access to medicines.

WTO (World Trade Organization): An international body overseeing the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and global IP policy, particularly in relation to medicines.

WHO (World Health Organization): The global public health agency responsible for international health coordination, setting health standards, and advising governments on health policies.

References

1. World Trade Organization (WTO) (1994), Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Available at: https://www.wto.org/.

2. World Health Organization (WHO) (2001), Doha Declaration on the TRIPS Agreement and Public Health. Available at: https://www.who.int/.

3. Medicines Patent Pool (MPP) (2021), Annual Report on Licensing and Access to Medicines. Available at: https://medicinespatentpool.org/.

4. Loua A. (2020), The Role of Intellectual Property Rights on Access to Medicines in the WHO African Region: 25 Years After the TRIPS Agreement, Academia.edu. Available at: https://www.academia.edu/104273818/The_Role_of_Intellectual_Property_Rights_on_Access_to_Medicines_in_the_WHO_African_Region_25_Years_After_the_TRIPS_Agreement.

5. Smith J., Turner C. (2007), Innovative Financing for Global Health: Tools for Analyzing the Financial Impact of Health Interventions, SSRN. Available at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1325363.

6. GAVI, the Vaccine Alliance (2020), COVAX: Ensuring Global Equitable Access to Covid-19 Vaccines. Available at: https://www.gavi.org/covax-facility.

7. Adigwe O.P., & Oturu D. (2022), The Role of Patent Waivers and Compulsory Licensing in Facilitating Access to Covid-19 Vaccines: Findings from a Survey Among Healthcare Practitioners in Nigeria, PLOS Global Public Health. Available at: https://doi.org/10.1371/journal.pgph.0000683.

8. Chaudhary T., & Chaudhary A. (2021), TRIPS waiver of Covid-19 vaccines: Impact on pharmaceutical industry and what it means to developing countries, «Journal of World Intellectual Property», 24(5-6), pp. 202-210. Available at: https://doi.org/10.1111/jwip.12198.

9. Antons C. (Ed.) (2021), Access to Medicines and Vaccines: Implementing Flexibilities Under the TRIPS Agreement, Springer. Available at: https://doi.org/10.1007/978-3-030-83114-1.

10. Matthews D. (2009), Intellectual Property Rights, Human Rights, and the Right to Health, SSRN. Available at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1414900.

11. de Menezes H.Z. (2021), The TRIPS Waiver Proposal: An Urgent Measure to Expand Access to the Covid-19 Vaccines, EconStor. Available at: https://www.econstor.eu/bitstream/10419/248628/1/RP-129.pdf.

12. AbbVie Inc. (2020), Annual Financial Report: Humira Patents and Sales. Available at: https://investors.abbvie.com/.

13. UN Committee on Economic, Social and Cultural Rights (CESCR) (2000), General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art. 12 of the Covenant). Available at: https://www.refworld.org/pdfid/4538838d0.pdf,

14. Thrasher, R. (2024), Reigniting the Spirit of the Doha Declaration: Why a TRIPS Waiver Extension is Key to the Legitimacy of the World Trade Organization, Global Development Policy Center. Available at: https://www.bu.edu/gdp/2024/02/05/reigniting-the-spirit-of-the-doha-declaration-why-a-trips-waiver-extension-is-key-to-the-legitimacy-of-the-world-trade-organization/.

15. Global Commission on HIV and the Law (2012), HIV and the Law: Risks, Rights & Health, United Nations Development Programme (UNDP). Available at: https://hivlawcommission.org/.

16. Waning B., Diedrichsen E., & Moon S. (2010), A lifeline to treatment: The role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries, «Journal of the International AIDS Society», 13(1), pp. 33-35. Available at: https://doi.org/10.1186/1758-2652-13-35.

17. International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) (2022), The Role of Intellectual Property in the Biopharmaceutical Sector. Available at: https://www.ifpma.org/publications/the-role-of-intellectual-property-in-the-biopharmaceutical-sector/.

18. Stolpe M. (2022), How the G7 can use patent buyouts to help the world win the race against coronavirus mutations, Global Solutions Initiative. Available at: https://www.global-solutions-initiative.org/wp-content/uploads/think7-uploads/2022/03/Health_How-the-G7-can-use-the-patent-buyputs-to-help-the-world-win-the-race-against-Coronavirus-mutations_Michael_Stolpe_v2.pdf.

19. Love J., & Hubbard T. (2007), Prizes for Innovation of New Medicines and Vaccines, «Annals of Health Law», 16, pp. 155-182. Available at: https://keionline.org/sites/default/files/prizes_new_medicines_annals_healthlaw.pdf.

20. Open Source Malaria Consortium (2015), Open Source Drug Discovery for Malaria Project Overview. Available at: http://opensourcemalaria.org/.

21. U.S. Food and Drug Administration (FDA) (2020), Biologics Price Competition and Innovation Act (BPCIA). Available at: https://www.fda.gov/.

22. Knowledge Ecology International (KEI) (2023), Comments on Paragraph 8 of the Ministerial Decision on the TRIPS Agreement: TRIPS Waiver and Access to Medicines, Knowledge Ecology International. Available at: https://www.keionline.org/39143.

23. Sampath P.G. (2019), A Proposal for New Pricing Approaches to Enhance Access to Medicines, SSRN. Available at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3656916.

24. Health Market Innovations (2021), Improving Access to Essential Medicines: Public-Private Partnerships, Compulsory Licensing, and Patent Pools. Available at: https://healthmarketlinks.org/sites/default/files/resources/Improving_Access_to_Essential_Medicines.pdf.

25. United Nations Development Programme (UNDP) (2015), The Doha Declaration 10 Years On and Its Impact on Access to Medicines and the Right to Health, United Nations Development Programme. Available at: https://www.undp.org/publications/doha-declaration-10-years-and-its-impact-access-medicines-and-right-health.

26. Abbott F.M., & Reichman J.H. (2007), The Doha Round’s Public Health Legacy: Strategies for the Production and Diffusion of Patented Medicines Under the Amended TRIPS Provisions, «Journal of International Economic Law», 10(4), pp. 921-987. Available at: https://doi.org/10.1093/jiel/jgm040.

Appendices

Appendix A: Key Provisions of the TRIPS Agreement Related to Pharmaceuticals

The TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights) is the most comprehensive multilateral agreement on intellectual property (IP). Several provisions of the TRIPS Agreement have particular relevance to the pharmaceutical industry:

• Article 27: Defines patentable subject matter. TRIPS requires WTO member states to make patents available for any invention, including pharmaceutical products and processes, provided they are new, involve an inventive step, and are capable of industrial application. It prohibits discrimination as to the field of technology, meaning pharmaceuticals must be treated like any other invention
• Article 31: Addresses compulsory licensing, allowing governments to grant licenses to use a patented product without the consent of the patent holder under certain conditions, such as in cases of national emergency or for public, non-commercial use.
• Article 33: Sets the term of patent protection at a minimum of 20 years from the filing date, ensuring that patent holders have a guaranteed period of market exclusivity.
• Article 39: Requires protection of undisclosed information, such as data submitted for regulatory approval of pharmaceuticals, which prevents competitors from using this data to market generics for a specified period (data exclusivity).
• Article 8: Allows member states to take necessary steps to protect public health and nutrition, providing flexibility to bypass certain IP protections in public interest scenarios.

Appendix B: Doha Declaration on the TRIPS Agreement and Public Health (2001)

The Doha Declaration on the TRIPS Agreement and Public Health was adopted by the WTO Ministerial Conference in 2001 in response to growing concerns about the impact of patent protections on access to medicines, particularly in LMICs during the HIV/AIDS crisis.

Key highlights of the Doha Declaration:

• Public Health Emphasis: The declaration explicitly recognizes the importance of public health and affirms that the TRIPS Agreement should not prevent member states from taking measures to protect public health.
• Use of TRIPS Flexibilities: It affirms the right of WTO members to use TRIPS flexibilities, such as compulsory licensing and parallel importation, to ensure access to essential medicines.
• Clarification of Rights: It clarifies that each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, including public health crises like HIV/AIDS, tuberculosis, and malaria.
• Waiver for Exporting Medicines: The declaration led to the creation of a mechanism (the 2003 waiver under Article 31bis) that allows countries with insufficient manufacturing capacity to import medicines produced under compulsory licensing from other countries.

Appendix C: Covid-19 TRIPS Waiver Proposal (2020)

In October 2020, India and South Africa proposed a temporary waiver of certain provisions of the TRIPS Agreement to facilitate global access to Covid-19 vaccines, treatments, and diagnostics. This proposal was designed to address the inequities in vaccine distribution and production, particularly in LMICs.

Key elements of the proposed waiver:

• Scope: The waiver would suspend IP protections under TRIPS for all Covid-19-related medical products, including vaccines, treatments, and diagnostics, for the duration of the pandemic.
• Objective: The aim was to remove legal barriers that prevent LMICs from producing or importing generic versions of Covid-19 vaccines and treatments, particularly in cases where high-income countries had monopolized early vaccine supplies.
• Opposition and Debate: The waiver faced opposition from several high-income countries, including the European Union and initially the United States. Opponents argued that the main bottleneck to vaccine production was not IP, but manufacturing capacity and supply chain constraints.
• Current Status: As of early 2024, negotiations on the TRIPS waiver proposal continue, reflecting the broader debate on the role of IP in global health emergencies.

Appendix D: Medicines Patent Pool (MPP) – Expanding Access to Essential Medicines

The Medicines Patent Pool (MPP), established in 2010 by UNITAID, is a public health organization that negotiates with patent holders to license essential medicines, particularly for HIV, hepatitis C, and tuberculosis, to generic manufacturers. This allows for the production and distribution of low-cost versions of these drugs in LMICs.

Key features of the MPP:

• Voluntary Licensing: MPP negotiates voluntary licenses with pharmaceutical companies, allowing generic manufacturers to produce patented medicines at reduced prices for distribution in LMICs.
• Therapeutic Areas: Initially focused on HIV medicines, the MPP expanded its mandate in 2015 to include treatments for hepatitis C and tuberculosis. In 2021, the MPP was further expanded to include Covid-19 treatments and technologies.
• Success Stories: The MPP has successfully negotiated licenses for major HIV drugs, including dolutegravir, which has dramatically increased access to affordable treatment in LMICs.
• Expanding Impact: By promoting public health through voluntary licensing, the MPP has demonstrated how collaboration between the public and private sectors can improve global access to medicines.

Appendix E: Biologics and the Patent Thicket Phenomenon

Biologic drugs, which are derived from living organisms, represent some of the most cutting-edge treatments for diseases such as cancer, autoimmune conditions, and genetic disorders. However, biologic drugs have also become notorious for their patent thickets, a practice where pharmaceutical companies file multiple overlapping patents on various aspects of a drug to extend its market exclusivity.

Understanding Patent Thickets:

• Definition: A patent thicket refers to a dense web of overlapping patents that protect different aspects of a single product, making it difficult for generic or biosimilar manufacturers to enter the market.
• Example – Humira (adalimumab): One of the most famous examples of a patent thicket is Humira, a biologic used to treat autoimmune diseases. AbbVie, the manufacturer of Humira, has filed over 100 patents related to the drug, allowing the company to extend market exclusivity well beyond the original patent’s expiration date.
• Impact on Biosimilars: Patent thickets create significant legal and financial hurdles for biosimilar manufacturers, delaying the entry of more affordable versions of biologic drugs and driving up healthcare costs.
• Policy Implications: Addressing the issue of patent thickets will require reforming patent systems to prevent excessive evergreening and ensuring that competition in the biologic drug market is not unduly delayed.

Appendix F: Global Health Governance – Key Actors and Their Roles

Global health governance involves the coordination of various international organizations, governments, and non-state actors in promoting public health. The most influential actors in global health governance include:

• World Health Organization (WHO): The primary international public health agency, responsible for coordinating responses to global health crises, setting global health standards, and advising governments on health policies.
• World Trade Organization (WTO): Oversees the TRIPS Agreement and plays a key role in shaping global IP policy, particularly in relation to access to medicines.
• United Nations Development Programme (UNDP): Focuses on broader development goals, including access to healthcare and medicines in the context of sustainable development.
• UNITAID: A global health initiative that works to expand access to treatments for diseases such as HIV/AIDS, tuberculosis, and malaria, often through market-shaping strategies like the MPP.