Article
Public, Environmental & Occupational Health
Rong Dai, Jayashree Watal
Summary: The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has significant impacts on global access to medicines by making it obligatory for member states to protect pharmaceutical product patents. Introducing product patents can speed up the launch of innovative medicines, but there is little evidence that this improves drug availability in low-income countries. Disease-specific global policy responses have led to more affordable prices for HIV/AIDS, malaria, and tuberculosis medicines, while brand competition in the market can effectively drive down prices of both originator and generic medicines. Multiple generic entry is crucial to achieving drug affordability.
SOCIAL SCIENCE & MEDICINE
(2021)
Article
Chemistry, Medicinal
Zhang Cao, Yichao Chen, Wenjie Jiang, Wei Li
Summary: Although China's compulsory licensing system for drug patents has been gradually improved, there are still issues that need to be addressed, such as expanding the scope of objects, removing restrictions on initiating entities, adjusting initiating rights, determining the duration and scope of licenses, and considering reasonable exploitation fees.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
Article
Business
Sunil Mani
Summary: In 2005, India's patent regime underwent significant changes to align with the TRIPS Agreement in order to strengthen protection of intellectual property and incentivize innovation, especially among domestic enterprises. This paper examines India's patenting record to assess the level of activity by domestic enterprises and institutions in creating important knowledge assets, recognizing the increasing importance of ownership of intangible assets as India moves towards enhanced technological self-reliance.
ASIAN JOURNAL OF TECHNOLOGY INNOVATION
(2021)
Review
Pharmacology & Pharmacy
Shiri Mermelstein, Hilde Stevens
Summary: The current medical R&D system governed by the TRIPS agreement has trade-offs between innovation and high monopoly prices that limit patient access to medicines. Although there are flexible provisions in TRIPS for low- and middle-income countries to access generic drugs, they are rarely used in practice. Access-oriented biomedical PPPs have emerged as an alternative. Multilateral health organizations have recommended IP interventions and voluntary mechanisms to reduce prices and increase the diffusion of medicines, but the recent Ebola and COVID-19 outbreaks have raised concerns about the effectiveness of these approaches in the Global South.
Article
Law
Ezinne Mirian Igbokwe, Andrea Tosato
Summary: The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has been criticized for limiting access to medicines for poorer nations. However, an amendment in 2001 allowed countries with limited resources to request patented medicines at affordable prices. Despite this option, the mechanism has been utilized only once.
FORDHAM LAW REVIEW
(2023)
Article
Medicine, General & Internal
Montse Gasol, Noelia Paco, Laura Guarga, Josep Angel Bosch, Caridad Pontes, Merce Obach
Summary: The study developed an early access framework using reflective multiple criteria decision analysis, which provides predictability and robustness in decision making for heterogeneous treatment requests involving sensitive and complex situations.
JOURNAL OF CLINICAL MEDICINE
(2022)
Article
Public, Environmental & Occupational Health
Marion Motari, Jean-Baptiste Nikiema, Ossy M. J. Kasilo, Stanislav Kniazkov, Andre Loua, Aissatou Sougou, Prosper Tumusiime
Summary: This study analyzes the role of intellectual property in access to medicines in the African region. It found that patenting activity is low for African countries, with only South Africa and Cameroon appearing in the top ten originator countries for ARIPO and OAPI respectively. Most countries have legislation allowing for compulsory licensing and parallel importation of medicines, while the least legislated flexibilities include explicit exemption of pharmaceutical products from patentable subject matter, new or second use of patented pharmaceutical products, imposition of limits to patent term extension and test data protection.
Article
Law
Lowri Davies
Summary: This paper examines the importance of improving access to Covid-19 vaccines for developing countries. It analyzes the request for a temporary waiver of intellectual property rights and evaluates the flexibility of compulsory licensing provisions in helping these countries obtain vaccines. The human rights perspective is explored to offer insights on enhancing access to medicines and vaccines for developing states.
Article
Public, Environmental & Occupational Health
Matthew B. Flynn, Eric O. Silva
Summary: The COVID-19 pandemic has led to questioning of the institutional structure of the pharmaceutical industry, with public and companies having different views on drug pricing. Analysis of online comments on Gilead Science's drug pricing highlights discourse on innovation, pricing, saving lives, and healthcare cost savings.
GLOBAL PUBLIC HEALTH
(2021)
Review
Public, Environmental & Occupational Health
Brigitte Tenni, Hazel V. J. Moir, Belinda Townsend, Burcu Kilic, Anne-Maree Farrell, Tessa Keegel, Deborah Gleeson
Summary: This article systematically reviews the literature on the impact of intellectual property rules on access to medicines. The findings show that TRIPS-plus intellectual property rules are generally associated with increased drug prices, delayed availability, and increased costs. There is evidence that TRIPS flexibilities can facilitate access to medicines, but their use is limited. This research is important for understanding the effect of intellectual property rules on access to medicines.
GLOBALIZATION AND HEALTH
(2022)
Article
Law
Ma Mercedes Curto Polo
Summary: The article discusses the World Health Organization's strategy update on global response to the COVID-19 challenge, as well as the increase in patent applications related to COVID-19 announced by patent offices around the world. Patent protection increases the cost of accessing medicines, leading to a conflict between patents and public health, highlighting the need to explore alternative mechanisms to meet global demand for health products.
RED-REVISTA ELECTRONICA DE DIREITO
(2021)
Article
Health Policy & Services
Qian Yin
Summary: The recurrence of public health emergencies has made access to drugs a significant problem for developing countries. The compulsory license system, embodied in international intellectual property norms, provides flexibility to member states in the face of public health crises. However, the different interpretations of this flexibility and the lack of clear procedural provisions in China hinder the effective use of compulsory licenses for pharmaceutical patents. This article assesses China's compulsory license system and suggests reforms to enhance its utilization in public health emergencies and better integrate the TRIPS flexibility.
ASIAN JOURNAL OF WTO & INTERNATIONAL HEALTH LAW AND POLICY
(2023)
Article
Public, Environmental & Occupational Health
Anna S. Y. Wong, Clarke B. Cole, Jillian C. Kohler
Summary: This study evaluates the transparency and accountability of the United States' public consultation process during the negotiation of the USMCA, specifically regarding public comments about the pharmaceutical sector and access to medicines. The results show that while the public at-large prioritized access to medicines and affordability, members of the pharmaceutical industry advocated for strengthened intellectual property rights. The study reveals mixed outcomes in terms of transparency and highlights the need for clearer rationales for negotiation positions to maintain public trust in the process and outcomes.
GLOBALIZATION AND HEALTH
(2021)
Article
Area Studies
Jagjit Kaur Plahe, Don McArthur
Summary: India has played a crucial role in supplying low-cost pharmaceuticals to developing countries, but changes to its intellectual property regime under the TRIPS agreement have affected its ability to provide affordable medicines. The future of Indian generic pharmaceutical companies as suppliers of affordable medicines in the post-TRIPS environment is uncertain, with challenges stemming from ownership rights awarded to multinational corporations and market systems favoring these corporations. The Indian government faces challenges in creating an environment that ensures access to life-saving medicines.
SOUTH ASIA-JOURNAL OF SOUTH ASIAN STUDIES
(2021)
Article
Health Care Sciences & Services
Diederik Lohman, James Cleary, Stephen Connor, Liliana De Lima, Julia Downing, Joan Marston, Claire Morris, Sara Pardy, Katherine Pettus
Summary: Significant progress has been made in global palliative care development, including the integration of palliative care into health systems, improved availability of controlled medicines, and the expansion of pediatric palliative care. However, challenges remain due to limited funding, issues with opioid availability, and the impact of the COVID-19 pandemic on universal health coverage.
JOURNAL OF PAIN AND SYMPTOM MANAGEMENT
(2022)