scholarly journals TRIPS to Where? A Narrative Review of the Empirical Literature on Intellectual Property Licensing Models to Promote Global Diffusion of Essential Medicines

Pharmaceutics ◽  
2021 ◽  
Vol 14 (1) ◽  
pp. 48
Author(s):  
Shiri Mermelstein ◽  
Hilde Stevens
Keyword(s):  
Intellectual Property ◽  
Access To Medicines ◽  
Essential Medicines ◽  
Empirical Literature ◽  
Future Research ◽  
Middle Income ◽  
Compulsory Licensing ◽  
Parallel Import ◽  
Policy Tool ◽  
Trade Offs

Governed through the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) since 1995, the current medical R&D system requires significant trade-offs between innovation and high monopoly prices for patented drugs that restrict patient access to medicines. Since its implementation, few amendments have been made to the original TRIPS agreement to allow low- and middle-income countries (LMICs) to facilitate access by generic manufacturers through flexible provisions, such as compulsory licensing and parallel import. Although a useful policy tool in theory, the routine use of TRIPS flexibilities in LMICs in the procurement of new essential medicines (EMs) is regarded as a ‘last resort’ due to strong political response in high-income countries (HICs) and new trade agreements’ restrictions. In this context, access-oriented biomedical Public-Private Partnerships (PPPs) have emerged. More recently, leading multilateral health organizations have recommended different types of intellectual property (IP) interventions, voluntary biomedical patent pools, as strategies to reduce prices and increase the diffusion of novel EMs in LMICs. Nevertheless, the recent Ebola and COVID-19 outbreaks highlight growing concerns regarding the use of TRIPS flexibilities and the limited success of voluntary mechanisms in promoting access to medicines in the Global South amidst health crises. This review aims at describing the state-of-the-art empirical research on IP-related options and voluntary mechanisms applied by emerging PPPs to guarantee timely and affordable access to EM in LMICs and reflect on both models as access paradigms. Some suggestions are put forward for future research paths on the basis of these analyses and in response to contemporary debates on waiving key IP rights on COVID-19 therapies, diagnostics, and vaccines.

scholarly journals Drug shops for stronger health systems: learning from initiatives in six LMICs

2021 ◽  
Vol 14 (S1) ◽  
Author(s):  
Geetanjali Lamba ◽  
Zubin Cyrus Shroff ◽  
Zaheer-Ud-Din Babar ◽  
Abdul Ghaffar
Keyword(s):  
Case Studies ◽  
Health Systems ◽  
Access To Medicines ◽  
Health System Strengthening ◽  
Essential Medicines ◽  
Middle Income ◽  
Positive Attitudes ◽  
Drug Shops ◽  
Client Pressure ◽  
High Level

Abstract Background Private sector retail pharmacies, or drug shops, play an important role in access to essential medicines and services in low-and-middle-income countries. Recognising that they have the potential to contribute to health system strengthening efforts, many recent initiatives to engage with drug shops have been launched. These include initiatives that focus on changes in policy, regulation and training. However, the specific factors that influence their success remain poorly understood. Seven country case studies supported under the Alliance’s programme of work ‘Strengthening health systems: the role of drug shops’ help to explore this issue. Methods Country case studies from the above programme of research from Bangladesh, Indonesia, Myanmar, Nigeria, Tanzania and Zambia were used as the main sources of data for this paper. A modified version of Bigdeli et al.’s Access to Medicines framework was applied within a partially grounded approach to analyze each country case study and compare themes between countries. Results Many factors may help initiatives targeting drug shops successfully achieve their intended outcomes. At the micro level, these include community demand for drug shops and a positive relationship between drug shops and their clients. At the meso level, facilitators of initiative success include training and positive attitudes from drug shops towards the initiative. Barriers include client pressure, procurement challenges and financial and administrative costs associated with initiatives. At the macro level, collaboration between stakeholders, high-level buy in and supervision, monitoring and regulation may influence initiative success. These factors are inter-dependent and interact with each other in a dynamic way. Conclusions Using a framework approach, these country case studies demonstrate common factors that influence how drug shops can strengthen health systems. These learnings can help inform the design and implementation of successful strategies to engage drug shops towards sustainable systems change.

Federal intervention of police under section 14141 – a state-of-the-art literature review

2020 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Jason W. Ostrowe
Keyword(s):  
Scoping Review ◽  
State Of The Art ◽  
Empirical Studies ◽  
Empirical Literature ◽  
Future Research ◽  
Content Type ◽  
Gray Literature ◽  
Federal Intervention ◽  
Trade Offs ◽  
National Police

PurposeThe purpose of this state-of-the-art review is to explore the empirical literature on federal intervention of police under 42 USC Section 14141.Design/methodology/approachA five-stage scoping review of the empirical literature related to 14141 was conducted through searches of scholarly databases and gray literature.FindingsThis scoping review revealed 21 empirical studies of 14141 published between 2002 and 2020 in criminal justice, criminology, legal and gray literature. Researchers employed various methodologies and designs to study 14141 reflecting the complexity of evaluating a multistage and multi-outcome federal intervention of police. The success of 14141 to reform police agencies is mixed. The empirical evidence suggests that application of this law is fraught with trade-offs and uncertainties including de-policing, increased crime and organizational difficulties in sustaining reform. Overall, more research would assist in understanding the efficacy of this federal mechanism of police accountability and reform.Originality/valueThis review is the first synthesis of the empirical literature on 14141. In consideration of the current national police crisis, findings help illuminate both what is known about federal intervention and areas for future research.

Compulsory Licensing in Canada and Thailand: Comparing Regimes to Ensure Legitimate Use of the WTO Rules

2009 ◽  
Vol 37 (2) ◽  
pp. 222-239 ◽  
Author(s):  
Kristina M. Lybecker ◽  
Elisabeth Fowler
Keyword(s):  
Developing Countries ◽  
Intellectual Property ◽  
Intellectual Property Rights ◽  
World Trade ◽  
Trips Agreement ◽  
Essential Medicines ◽  
Compulsory Licensing ◽  
The World ◽  
Aids Crisis ◽  
Doha Declaration

The tension between economic policy and health policy is a longstanding dilemma, but one that was brought to the fore with the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 1994. The pharmaceutical industry has long argued that intellectual property protection (IPP) is vital for innovation. At the same time, there are those who counter that strong IPP negatively impacts the affordability and availability of essential medicines in developing countries. However, actors on both sides of the debate were in agreement that something needed to be done to address the HIV/AIDS crisis, especially in developing countries. In response to sustained and significant pressure from civil society groups, members of the World Trade Organization agreed to the Declaration on the TRIPS Agreement and Public Health (the Doha Declaration) in 2001. The Declaration clarified that countries unable to manufacture the needed pharmaceuticals could obtain more affordable generics elsewhere if necessary.

Debt Covenants and Corporate Governance

2019 ◽  
Vol 11 (1) ◽  
pp. 197-219 ◽  
Author(s):  
Sudheer Chava ◽  
Shunlan Fang ◽  
Praveen Kumar ◽  
Saumya Prabhat
Keyword(s):  
Empirical Studies ◽  
Empirical Literature ◽  
Future Research ◽  
Debt Covenants ◽  
Corporate Policies ◽  
Ex Post ◽  
Trade Offs ◽  
Ex Ante ◽  
The Impact ◽  
Covenant Violations

We review the recent theoretical and empirical literature on debt covenants with a particular focus on how creditor governance after covenant violations can influence the borrower's corporate policies. From the theoretical literature, we identify the key trade-offs that help explain the observed heterogeneity in covenant types, inclusion, likelihood of violation, and postviolation renegotiation flexibility. Empirically, we first review the literature that deals with ex ante evidence on covenant design and the various factors that influence covenant design; we next review the ex post evidence on the impact of technical covenant violations on the borrower. We then discuss limitations of the existing theoretical and empirical studies and conclude with some directions for future research in this burgeoning area.

Right Idea, Wrong Result—Canada's Access to Medicines Regime

2008 ◽  
Vol 34 (4) ◽  
pp. 567-584 ◽  
Author(s):  
Paige E. Goodwin
Keyword(s):  
Low Income ◽  
Essential Medicine ◽  
Developed Countries ◽  
Access To Medicines ◽  
Production Costs ◽  
Essential Medicines ◽  
World Health ◽  
Low Income Countries ◽  
Brand Name ◽  
Middle Income

In 2007, an estimated 33.2 million people were living with HIV, 2.5 million had become infected, and 2.1 million died from the virus. The majority of infected individuals reside in Africa, where in some countries as many as 33.4% of adults have HIV. In developed countries, effective drug therapies have reduced AIDS-related deaths by over seventy percent each year. These drugs have been so effective that over the last two years the global number of individuals dying from AIDS-related illness has actually declined. These therapies, however, are currently sold for $10,000 USD a year, a purchase price that is not feasible for low income countries where the annual health expenditure may be only $29 per person. A lack of essential medicine is not only a problem for those suffering from AIDS. Low and middle-income countries are disproportionately burdened by many additional chronic and infectious illnesses. The World Health Organization (“WHO”) estimates that one third of the world's population cannot regularly access essential medicines. The WHO cites the high cost of drugs as one of the major hurdles countries face in obtaining access to medication. However, the high cost of these brand-name medications does not reflect their minimal production costs. Drug manufacturers can produce generic versions of these drugs for as little as 1/30th of the cost of their brand-name counterparts.

scholarly journals Patents and Innovation: Evidence from Economic History

2013 ◽  
Vol 27 (1) ◽  
pp. 23-44 ◽  
Author(s):  
Petra Moser
Keyword(s):  
Intellectual Property ◽  
Empirical Evidence ◽  
Intellectual Property Rights ◽  
Economic History ◽  
Future Research ◽  
Compulsory Licensing ◽  
Patent Pools ◽  
Diffusion Of Knowledge ◽  
Patent Laws ◽  
Over Time

What is the optimal system of intellectual property rights to encourage innovation? Empirical evidence from economic history can help to inform important policy questions that have been difficult to answer with modern data: For example, does the existence of strong patent laws encourage innovation? What proportion of innovations is patented? Is this share constant across industries and over time? How does patenting affect the diffusion of knowledge? How effective are prominent mechanisms, such as patent pools and compulsory licensing, that have been proposed to address problems with the patent system? This essay summarizes results of existing research and highlights promising areas for future research.

scholarly journals Defending access to medicines in regional trade agreements: lessons from the Regional Comprehensive Economic Partnership – a qualitative study of policy actors’ views

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Belinda Townsend
Keyword(s):  
Public Health ◽  
Civil Society ◽  
Intellectual Property ◽  
Trade Agreement ◽  
Access To Medicines ◽  
Health Issues ◽  
Regional Trade ◽  
Middle Income ◽  
Health Concerns ◽  
Economic Partnership

Abstract Background The Regional Economic Partnership Agreement (RCEP) is a mega regional trade agreement signed by fifteen countries on 15 November 2020 after 8 years of negotiation. Signatories include the ten members of the Association of South East Asian Nations (ASEAN) plus China, New Zealand, Japan, South Korea and Australia. India was a negotiating party until it withdrew from the negotiations in November 2019. The RCEP negotiations were initially framed as focused on the needs of low income countries. Public health concerns emerged however when draft negotiating chapters were leaked online, revealing pressures on countries to agree to intellectual property and investment measures that could exacerbate issues of access to medicines and seeds, and protecting regulatory space for public health. A concerted Asia Pacific civil society campaign emerged in response to these concerns, and in 2019, media and government reporting suggested that several of these measures had been taken off the table, which was subsequently confirmed in the release of the signed text in November 2020. Results This paper examines civil society and health actors’ views of the conditions that successfully contributed to the removal of these measures in RCEP, with a focus on intellectual property and access to medicines. Drawing on twenty semi-structured qualitative interviews with civil society, government and legal and health experts from nine countries participating in the RCEP negotiations, the paper reports a matrix of ten conditions related to actor power, ideas, political context and specific health issues that appeared to support prioritisation of some public health concerns in the RCEP negotiations. Conclusions Conditions identified included strong low and middle income country leadership; strong civil society mobilisation, increased technical capacity of civil society and low and middle income negotiators; supportive public health norms; processes that somewhat opened up the negotiations to hear public health views; the use of evidence; domestic support for health issues; and supportive international public health legislation. Lessons from the RCEP can inform prioritisation of public health in future trade agreement negotiations.

scholarly journals THE IMPACT OF TRIPS AGREEMENT ON ACCESS TO MEDICINES IN DEVELOPING COUNTRIES: LEGAL CHALLENGES FACED BY THE PHARMACEUTICAL INDUSTRY PARTICULARLY IN INDIA

2012 ◽  
Author(s):  
Kamini Shanmugaiah
Keyword(s):  
Public Health ◽  
Developing Countries ◽  
Intellectual Property ◽  
Pharmaceutical Industry ◽  
Intellectual Property Rights ◽  
Access To Medicines ◽  
Trips Agreement ◽  
Compulsory Licensing ◽  
Legal Challenges ◽  
The Impact

The impact of intellectual property rights in particular patent relating to public health has posed numerous challenges faced by developing countries who are members of World Trade Organisation (WTO). This paper examines the impact of TRIPS Agreement (Trade Related Intellectual Property Rights) in relation to developing countries in general with specification made to India. Significant changes brought about by the TRIPS flexibilities in particular usage of compulsory licensing and Bolar provision have to a certain extent benefited the developing countries in the field of public health during national emergency. The TRIPS flexibilities by way of amendment have helped countries that (do not possess manufacturing capacities) to import medicines. Some developing countries even utilised TRIPS flexibilities in an aggressive manner to enforce their right to have access to medicines from other countries for the benefit of their citizens. Further, TRIPs flexibilities have helped developing countries to manufacture generic products to make it affordable to the people. This paper specifically examines the impact of the TRIPS Agreement on Indian generic pharmaceutical industry and the legal challenges faced by Indian pharmaceutical industry after the implementation of product patent regime effective from 1 January 2005. The Patent Amendment Act 2005(India) will be looked into especially on the controversy in respect of Section 3(d) of the Patent Amendment Act 2005(India) on the requirement of patentability. The new Section 92A of the Patent Amendment Act 2005(India) on the grounds to invoke compulsory licensing will be analysed to see whether Indian government has applied restrictive or broad approach, as compulsory licensing is certainly an important legal

scholarly journals THEORIES OF INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES IN THE SOUTHERN AFRICAN DEVELOPMENT COMMUNITY (SADC)

Obiter ◽  
2016 ◽  
Vol 37 (3) ◽  
Author(s):  
Lonias Ndlovu ◽  
Amos Saurombe
Keyword(s):  
Intellectual Property ◽  
Developed Countries ◽  
Access To Medicines ◽  
Southern African Development Community ◽  
Essential Medicines ◽  
Least Developed Countries ◽  
African Development ◽  
Research And Innovation ◽  
Parallel Importation ◽  
Doha Declaration

Despite the adoption of the World Trade Organization (WTO) Doha Declaration on the Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS) and Public Health in 2001, which unequivocally affirmed WTO members’ rights to use compulsory licences and other TRIPS flexibilities to access essential medicines, thirteen years on, developing countries and least developed countries are still grappling with access to medicines issues and a high disease burden. Despite some well-researched and eloquent arguments to the contrary, it is a trite fact that patents remain an impediment to access to medicines by encouraging monopolistic prices. In the Southern African Development Community (SADC), a number of possible solutions to the access to medicines problem, such as local manufacturing of pharmaceuticals, using compulsory licences, using parallel importation and investing in research and innovation, have been raised. This paper looks at the possibility of solving the SADC access-to-medicines problem through rewarding innovation and investment into diseases of the poor, by applying the rewards theory of patents. After an initial exposition of theories of intellectual property in general, the paper specifically looks at the rewards theory and contextualizes it to the SADC situation, and comes to the conclusion that the theory may point to one of the viable solutions to the access-to-medicines problem in the region.

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