IPR laws in Pharmaceutical Industry

Intellectual Property Rights (IPR) Laws in Pharmaceutical Industry are in the Continuous State of Evolution in Emerging Markets
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Executive Summary
Intellectual property rights are the legal rights granted to the creator or inventor to protect his invention for a given time, usually 20 years, in the pharmaceutical industry (Zafar, 2020). Intellectual property rights (IPR) in the pharmaceutical industry have for many years remained controversial. The controversy is the perceived monopoly associated with IPR laws which made the cost of treatment high and access to drugs difficult, especially for people in emerging and low-income nations. However, a historical review of IPR laws in the pharmaceutical sector indicates that there has been a significant but deliberate erosion of IPR rights majorly in two key areas: (1) increased access to exclusive use of patented inventions by third parties; and (2) an overall increase on IPR laws that allow consumers to use patented inventions (Prud'homme et al., 2021).
Notably, patent laws are used to safeguard public interests. So far, in developed and emerging markets, nations continue to make exceptions to patent rights and laws to meet set policy goals. IPR laws have constantly been advancing, and, notably, developed nations advanced their IPR laws as early as the 1970s and 1980s. This event led to the culmination of TRIPS which made it a requirement for all WTO members to apply minimum standards on Intellectual property (IP) in 1995 and the following years (Imasuen, 2021).
TRIPS has significantly impacted the balance of interests between pharmaceutical companies, the public, and the states. For emerging markets, TRIPS has not only continued to restrict their abilities but also granted developed nations more power. Over the years, calls for revisions to the TRIPS agreement have been made to allow emerging markets to exercise their rights under the TRIPS agreement. Unlike developed nations, the health crisis in emerging markets is always high. IPR laws continue to evolve in emerging markets to enhance access and equity to pharmaceutical products. This paper examines the evolution of IPR laws in the pharmaceutical sector regarding emerging markets.
Table of Contents TOC \o "1-3" \h \z \u Introduction PAGEREF _Toc106913635 \h 4Aims of Study PAGEREF _Toc106913636 \h 5Research Questions PAGEREF _Toc106913637 \h 6Methodology PAGEREF _Toc106913638 \h 7The Rationale of the Population Selection PAGEREF _Toc106913639 \h 7Data Collection PAGEREF _Toc106913640 \h 8Data process PAGEREF _Toc106913641 \h 8Steps used in Preparing Data Set for Analysis PAGEREF _Toc106913642 \h 9Challenges during Data Analysis PAGEREF _Toc106913643 \h 10Ethicals Biases and Challenges PAGEREF _Toc106913644 \h 10Evaluating the Data PAGEREF _Toc106913645 \h 12Major Findings PAGEREF _Toc106913646 \h 12Research Limitations and Future Research PAGEREF _Toc106913647 \h 13Conclusion PAGEREF _Toc106913648 \h 14References PAGEREF _Toc106913649 \h 14
Introduction
The pharmaceutical industry has dominated the IPRs laws debate for many decades because the sector is significant to human existence and complex, thus requiring massive regulations (Cockburn, 2012, p.150). Ideally, the factors that influence and complicate laws in the pharmaceutical sector are intertwined and include but are not limited to the involvement of states in price controls and purchasing, restrictions on marketing, the involvement of learned experts such as pharmacists and physicians, and the public and private insurance schemes (Watal, 2018).
Regulatory oversight bodies exist on drug manufacturing, product safety review bodies, and legal complications surrounding technology transfer between public-funded biomedical research institutions and commercial entities (Sideri, 2020). Amid all these complications, IPRs are understood to have two significant impacts on the pharmaceutical sector: (1) pricing and access to the medical product; and (2) the issue of research and development (R&D) (Goldberg, 2010).
On the one hand, the pharmaceutical industry continually feels excessive pressure due to the rising R&D costs and the decreasing effects of patent laws (Chandran et al., 2005). On the other, high prices of patents continue to raise major political questions on drug and medicine access and equity issues, especially for disadvantaged groups, often located outside developed countries that have for many years controlled most IPRs.
Notably, the IPR laws in the pharmaceutical industry are complex, and the continuous improvements made by all stakeholders, especially in emerging markets, have reshaped the sector significantly (Miller, 2017). The establishment of the World Trade Organization (WTO) in 1995 gave rise to a new intellectual property rights (IPR) regime that significantly impacted medicine access (Lanoszka, 2003). With the emergence of WTO and TRIPS, developed countries saw the need to negotiate mandatory protection of their pharmaceuticals under the TRIP agreement because such mandatory protection would guarantee protection and continuity of the pharmaceutical industry.
On the contrary, emerging markets and least developed nations argued that having patent laws that strictly comply with TRIPS would likely restrict the production and sale of low-cost generic medicines by local pharmaceutical industries, thus increasing costs of pharmaceuticals to the point where pharmaceuticals become highly inaccessible by the local populations (Otten, 2015). Arguably, the incentive structure underpinning TRIPS failed to drive R&D investment, especially in emerging markets leading to alternative strategies such as product development partnerships (PDP), including the Drug and Neglected Disease Initiatives, and promotion of equitable public health interests through revisions to the TRIPS agreements (Moran et al., 2010). Access to medicine in emerging markets has been a significant challenge. This problem is complicated by other problems, including insufficient scientific, manufacturing, and technological capabilities; and poor medicine regulatory frameworks compared to developed nations.
Aims of the Study
The establishment of the TRIPS agreement 27 years ago offers a solid framework to explore the status of IPRs and overall trends made by emerging nations to exploit TRIPS flexibilities to increase access to medication. This study reviews IPR regulation and governance landscape in emerging markets, namely China, India, and Russia. The research further assesses the abilities of these emerging nations to respond to health emergencies such as Covid-19. The implications of IPR laws assessment and study in emerging markets are enormous. Any emerging market can easily leverage the benefits of IPR by recreating new and competitive policies and practices and increasing its overall ability to utilize its IPRs.
Overall, the research makes a contribution to the body of knowledge in the following ways: (1) by analyzing contemporary literature, including TRIPS and its effects on the access to medicine in emerging nations over the past two decades; (2) set up a case study using interviews to evaluate the status of IPR laws in the pharmaceutical sector in emerging markets; (3) offer recommendations that could improve IPR laws for increased access and equity in emerging markets; (4) identify in detail the state of IPR laws in the post TRIPS patent regime, especially in emerging nations.
Research Questions
The research aims to identify how emerging markets are improving their policy space to preserve their pharmaceutical industries and enhance innovation and increase the domestic availability of pharmaceutical products. IPR has complex institutional and infrastructural limitations, but the goal is to explore ways of attaining optimal pharmaceutical innovation while still offering affordable pharmaceuticals. The research examines three key questions:
1 How are intellectual property rights (IPR) laws evolving in emerging markets?
2 What policy options are used by emerging markets to preserve their pharmaceutical sector?
3 What have infrastructural and institutional issues been introduced to resolve IPR issues in emerging markets over the past 20 years?
4 How have emerging markets used policy options to promote the local pharmaceutical industry and its access to medicine?
Methodology
My research method is qualitative, and I will do a case study to collect data. On top of case study research, I will utilize both primary and secondary data sources extensively. Using both primary and secondary data will lay the foundation and background of my research and allow me to answer my research questions conclusively. They are appropriate for my research question because it allows me to target businesses that are likely to be impacted by changes in IPR laws. This is important because I want to ensure that the results of my study are relevant to the population of interest. The purposive sampling method is also less time-consuming and expensive than other methods, such as random sampling. This is important because I have limited time and resources to conduct my study (Ford, 2016).
Considering that the research explores the overall evolution of IPR laws in emerging markets, a combined doctrinal analytical approach is adopted. The research study uses a comparative review and a field research case study to explore the research questions in detail. More so, the doctrinal analysis adopts interpretive methods to explore relevant sources of patent law and trends and the initiatives taken by emerging markets to protect pharmaceutical industries since 1995. It is necessary to review and analyze patents granted in the past 25 years and cluster them in broad disease categories. The doctrinal analysis will help assess IPR options adopted in some emerging countries. The legal research analysis relies on primary and secondary sources such as regulations, patent laws, academic literature, judicial decision, and state reports. Overall, the research question cuts through a broader spectrum of laws, so the number of primary sources explored is broad.
The Rationale of the Population Selection
Our research data will be obtained from patents and case studies; as such, our sole goal is to collect as many patents are possible during the last 20 years in emerging markets. Patent and IPR offices exist in most emerging markets, and through defined parameters, it is possible to collect relevant health-related patents stored on websites since 1995 (Motari et al., 2021). World Intellectual Property Organization (WIPO) records over 4000 patents in the past 20 years. We aim to identify and analyze patents issued in the past 27 years. Some critical categories of patents that will be considered cover diseases such as malaria, HIV/AIDS, viral infections, cardiovascular diseases, tumors, cancers, TB, and lung diseases.
Our study also explores the patent and policy framework of the selected emerging markets with the sole goal of determining whether there has been significant leverage on TRIPS flexibilities by emerging markets. Patents associated with the selected diseases were chosen, while those that did not mention diseases (malaria, HIV/AIDS, viral infections, cardiovascular diseases, tumors, cancers, TB, and lung diseases) were left. Choice of patents was ideal in this research as it was the most cost-efficient and less cumbersome research option. Through patents, it is possible to understand the IPR laws trends and framework and answer our key research questions on whether IPR laws have become more flexible and beneficial to emerging nations in the past 27 years.
Data Collection
Data process
Case studies and questionnaires will advance understanding of IPR laws in emerging markets and pharmaceutical industries. Case studies create room for collecting data necessary t...