Continuous Evolution of IPR Laws in the Pharmaceutical Industry
ATTACHED ARE "Case assignment instructions", "week 1-4 discussions (Please use these in writing the paper)', and "paper writing guidelines by the professor". -----------------------------------------------------------------------------------------------
write a 5 - 8 page paper that integrates concepts and terms in the research process from week 1- week 4 discussions. Do not merely respond to the statements below as if you are step-by-step checking the box. Develop, synthesize, and integrate concepts in a comprehensive clear manner to the reader. You are the expert. You have the knowledge from the research. It is time to contribute to the body of knowledge you already identified. Hint: Review your previous discussion threads (week 1 - week 4) to recap what you have succinctly written.
1. Explain your general topic of interest and identify a specific problem to be addressed. What are the implications of your selected area of interest (intellectual property rights (IPR) laws in emerging markets?
2. Steps taken in the preliminary exploratory research phase of your topic, e.g., types of studies used, secondary or pilot, etc.
3. Construct your research question(s). Share how your research question addresses the identified project problem or opportunity statement.
4. Describe the rationale of the population you selected, which includes but not limited to the following:
5. What population is selected
6. Various factors to consider in population selection (data availability cost of collecting data, etc.).
7. Importance of using this population for your research question.
8. Explain limitations you anticipate based upon the planning phase of the research process.
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Writing Guidelines: - Running head and pagination. • The length of this paper should be between 5-8 pages (not including the title page, table of contents, reference page and Appendices page). • APA style formatting (7th edition), double spaced, with 1-inch margins and 12 point Times New Roman font. • The paper must have an EXECUTIVE SUMMARY (including THESIS statement), INTRODUCTION and CONCLUSION paragraphs. • Please include TITLE PAGE, TABLE OF CONTENTS PAGE, REFERENCE PAGE, and any APPENDICES. • Please submit in a word document and NOT pdf version. • Please use HEADINGS AND SUBHEADINGS to organize your paper. • Use at least 10 academic, peer-reviewed, library trade publications, scholarly or professional practitioner sources, and minimum 36 in-text CITATIONS are required. • You must cite and reference all texts used, including page numbers as applicable to avoid plagiarism. • Please provide verifiable links/web address for each academic reference used. • Paper should be proofread for spelling and grammar mistakes. • Write your paper in an integrated fashion, weaving theory and application. In other words, do not merely respond to each bullet above as a checklist.
------------------------------------------------------------------------------------------------- Professor’s Additional instructions – Please: - Use third person in writing. - Do not use quotes. - Use APA formatting (7TH Edition) of references and in text citations is required. - the following resources are NOT ACCEPTABLE as citations for this paper: • Wikipedia.com • Ehow.com • Dictionary.com • About.com • Smallbusiness.chron.com • Diffen.com • Yourbusiness.azcentral.com • Tjmarino.com • Investopedia.com • Boundless.com and Lumen • CourseHero.com • Chegg.com • Difference between • Answers.com • Any student essay website ----------------------------------------------------------------------------------------------------------------------------------------- .
Intellectual Property Rights (IPR) Laws in Pharmaceutical Industry Are in the Continuous State of Evolution in Emerging Markets
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Table of Contents TOC \o "1-3" \h \z \u Executive Summary PAGEREF _Toc104481981 \h 1Background PAGEREF _Toc104481982 \h 1Aims of Study PAGEREF _Toc104481983 \h 2Research Question and Methodology PAGEREF _Toc104481984 \h 3Research Questions PAGEREF _Toc104481985 \h 3Methodology PAGEREF _Toc104481986 \h 3The rationale for Population PAGEREF _Toc104481987 \h 3Conclusion and Limitations PAGEREF _Toc104481988 \h 3Bibliography PAGEREF _Toc104481989 \h 4
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, nations, both developed and emerging markets, 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 years that followed (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 in access to pharmaceutical products. This paper examines the evolution of IPR laws in the pharmaceutical sector regarding emerging markets.
Background
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 is continually feeling excessive pressure due to the rising R&D costs and the decreasing effects of patent laws (Chandran, Roy, and Jain, 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&Ds 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 me...