...1. Do pharmaceutical companies have a responsibility to distribute drugs for free or at low cost in developing countries? What are the main arguments for and against such an approach? -I don’t necessarily think that they have the “responsibility” to do so but I think that they should want to as there are millions dying and suffering tremendously from this epidemic. Pharmaceutical companies make billions and billions of dollars a year, I feel that they should want to help people who can’t help themselves. It is not fair for them to suffer and die because they don’t have the money to treat themselves. -Arguments for: Devastating amounts of people are dying and suffering from this disease and are not able to afford proper treatments. Activists and organization believe that there shouldn’t be a price on life and that treatment should be available to these less fortunate people. -Arguments Against: It argues that they will not make enough profit. The price of research and development is outrageous and they worry that the decrease of profits will not be able to recover from the other expenses. -Giving the drug away for free could potentially hurt the supplier and it could also start corruption. If it is given for free there is no telling who will be getting the drug, there is no control of distribution. Someone who is in extremely bad shape and really needs the drug could be losing their opportunity to the drug to someone who is fine and just wants it to try to sell and make...
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...| Pharmaceutical companies | Research Paper | | Daren Smith | 5/21/2012 | | Abstract There is a lot of discussion about pharmaceutical companies, intellectual property, and the global AIDS epidemic. Do pharmaceutical companies have a responsibility to distribute drugs for free or low cost in developing countries? Why is intellectual property such a big deal? What impact would South Africa’s decision to levy duties on drugs in the country have on the international distribution of drugs? Was the change that provided patent protection for pharmaceutical companies an appropriate change or a dangerous precedent? Was it necessary to relax intellectual property rules in order to ensure that adequate supplies of AIDs medications would be available for distribution in the developing world? What role to multi-national corporations have in providing funding or other assistance to international organizations such as the Global Fund? All these questions have many arguments for and against but the right answers probably lie somewhere in between. Having and providing access to affordable medication is one of the greatest challenges we face in today’s world. Many people see that pharmaceutical companies are irresponsible. The evidence is in the high prices individuals have to pay for medications. Although I don’t care for higher priced medications I do believe in the right for a business, or individual, to make money. To come up with medications it takes...
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...Delicate Balance Of Intellectual Property And Access Economics Essay Health is a human right and intellectual property must not become overemphasized at the expense of human life. There is a delicate balance between the human rights of HIV/AIDS sufferers and the economic, political, and human rights of corporate citizens to protect intellectual property within the pharmaceutical industry. This essay intends to answer the six questions related to the In-Depth Integrative Case 1.2 and highlight the global rights conflict of between a developing country’s fight to confront the AIDS epidemic and intellectual property protection. Delicate Balance Of Intellectual Property And Access To Medication Introduction When the South African Medicines Act was introduced it quickly resulted in battle lines being drawn between patent rights and public health. While all parties acknowledged the scope of the AIDS crisis, how to go about solving the problem became the subject of significant moral and legal debate (Halbert, 2012). Case Study Review In the case study Pharmaceutical companies, intellectual property, and the global AIDS epidemic, there are a number of questions to review. First, do pharmaceutical companies have responsibility to distribute drugs for free or at low cost in developing countries? What are the arguments for and against such an approach? There are socio-economic responsibilities of businesses and pharmaceutical companies have responsibility to distribute drugs for free...
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...Intellectual capital can be defined as a set of knowledge and skills that company has developed about making goods or services. Such a knowledge can be used for obtaining money or any other purpose. Meaning combines idea of intellect and know-how with the idea of capital. Any benefits gained from this kind of knowledge can be invested in producing more goods and services. One of the strongest and most competitive industry in the world and in U.S is Pharmaceutical industry . Supreme pledge to research and development is main reasons for its success. Intellectual property protection has a goal to insure return on investment and future profits. Discovering and testing a new drug is a process that requires approval from regulatory agencies in the United States and Europe. This process might cost millions of dollars per new product. After such a large investment has been made, next step is to obtain approvals in other nations. This approval is necessary so that new product can be sell as widely as possible. The main risk that pharmaceutical industry is facing is imitation. Once a product have been developed to be safe and effective risk is that another firm might enter the market with same or similar products. It is much cheaper and faster to invest in manufacturing process and developing existing and start competing with the pioneering firm with lower prices. If such imitation were widespread and rapid, pioneer company might...
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...selling diabetes drug. A few years ago PharmaCARE’s study showed the AD23 would also slow the advancement of Alzheimer’s disease. This led John and the other pharmacologists that he led to reformulate the drug to capitalize on its outcome. To evade the Food and Drug Administration’s (FDA) inspection, PharmaCARE founded an exclusively held company, CompCARE, to function as a compounding pharmacy. This company would retail the new invention to people by prescription only. CompCARE profited from PharmaCARE’s standing, records, systems, and trades and marketing skill, and within several months the health community was talking about AD23. Response was good, mainly amongst Medicare, Medicaid, and Veterans Affairs patients. Realizing the chance to get additional income, CompCARE started marketing AD23 straight to customers and promoting AD23 right to clinics, hospitals, and physician offices, although compounding pharmacies are not allowed to market medicines in large qualities for common use. To dodge this provision, CompCARE pushed doctors to give them fabricated patient names. As time passed, PharmaCARE sold CompCARE to WellCo, a big pharmacy company, a little while before AD23 was connected to over 200 heart attack deaths. CompCARE and its new establishment revel in best ever earnings and PharmaCARE’s stock price came close to 300 dollars per share. Individuals who used AD23 appeared to be having cardiac arrest at a...
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...impact of pharmaceutical patent laws on Anti-AIDS drug, substantial controversy which has been generated around the globe on ethical grounds. Pharmaceutical patents on Anti-AIDS drug availability in the third world countries, focusing on an ethics of the Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement. It highlights the value of essential drugs and generic production in developing countries, using India, Cipla as a case study. It also explores global ways to deal with unethical grounds to TRIPs. History of Cipla, Indian Pharmaceutical Company Cipla is one of the world's largest producers of generic medicines.Cipla is one of India's top five pharmaceutical manufacturers. Although Cipla's primary market is India, the company sells its products worldwide. Cipla's lines of more than 400 drugs include anti-asthmatic, anti-cancer, anti-inflammatory, anti-depressant and anti-AIDS medications. Over the years, the company has developed strong research and marketing capabilities. In recent times, Cipla has attracted considerable media attention because of its efforts to offer AIDS drugs globally at very low prices. But in its quest to capture this market, Cipla faces the might of global multinational corporations, who are doing all they can to protect and enforce their patent rights. The case deals with all these issues in detail. World Trade Organization’s (WTO) The World Trade Organization’s (WTO) Trade Related Aspects of Intellectual Property Rights (TRIPS)...
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...When analyzing the issue of the intellectual property of pharmaceutical and biomedical companies we must consider how to balance the right to our intellectual property with our right to health and in some cases, our right to life. These rights conflict in this case which illustrates the tension that can exist between the creator of a product and the consumer. For instance, the creators want to benefit from the value of their intellectual property while the consumer wants to benefit from the creation (Kubasek, Browne, Herron, Dhooge, & Barkacs, 2016). If we were to imply that medical companies are obligated to make their product available and affordable to the public or other companies to produce, that would infringe on the property rights...
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...and Intellectual Property Amanda Terry Professor: Dr. Michael Hanners LEG 500- Law, Ethics, and Corporate Governance March 12, 2015 Introduction John, a former research employee at PharmaCare pharmaceuticals, asked my law firm to represent him as a client. He expressed his concerns about his involvement with PharmaCare’s top-selling drug AD23. John and his team of pharmacists discovered that the drug could slow down the progression of Alzheimer’s. Therefore, his team reformulating the drug to maximize the effect of the drug without the approval from Federal and Drug Administration. In this paper, I will evaluate three ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety, as well as, analyze whether PharmaCare violated any of the issues in questions. I will argue the pros and cons of Direct-to-Consumer (DTC) Marketing by drug companies. I will determine which parties were responsible for regulating compounding pharmacies under the current regulatory scheme. Also, the actions that either party, or the FDA could/ should have taken in this scenario; whether PharmaCare could face legal exposure surrounding its practices. I will analyze whether or not the PharmaCare used U.S. Law to protect its own intellectual property, and if John (the client) has any claim of being the true “inventor” of AD23. I will present at least three ways the company could compensate John for the use of his intellectual property if...
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...A “Calibrated Approach”: Pharmaceutical FDI and the Evolution of Indian Patent Law Web version: August 2007 Authors: Katherine Connor Linton and Nicholas Corrado1 Abstract India has charted its own intellectual property (IP) path over the last 35 years, attempting to foster the growth of a domestic pharmaceutical industry and access to medicine while, more recently, also addressing the requirements of the international IP regime. Multinational companies (MNCs) have responded to India’s movement towards compliance with the W TO intellectual property agreement, TRIPS, by increasing the quantity and quality of foreign direct investment (FDI) in the areas of pharmaceutical research and development (R&D) and manufacturing. By contrast, MNCs have adopted a more cautious attitude toward the patenting and commercialization of new pharmaceutical products in India, waiting to see how Indian courts and patent offices interpret the new laws, and awaiting the enactment of longdebated data protection legislation. The ultimate success of the Indian “calibrated approach” to fostering the domestic industry and access to medicine while also addressing international IP requirements remains to be seen. 1 Katherine Connor Linton (katherine.linton@usitc.gov) is the International Trade Analyst for Intellectual Property and Nicholas Corrado was a law student intern in the Office of Industries of the U.S. International Trade Commission (USITC). The views expressed are those of Ms. Linton and...
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...A Landmark Judgement on Indian Patent Law & Pharmaceutical Industry: A Report The Supreme Court judement on the Novartis v. Union of India & Others is a landmark decision on the issue of pharmaceutical patent in India. The decision taken after a seven year long litigation fought by pharmaceutical major Novartis is based on a case pertaining to grant of Indian patent on a compound called Imatinib Mesylate in Beta Crystalline Form (referred as Imatinib hereinafter as convenience of brevity). The Supreme Court decided that Imatinib, the substance for which Novartis sought patent does not qualify the test of invention as laid down in section 2(1)(j), section 2(1)(ja) and the test of efficacy under section 3(d) of the Indian Patent Act, 1970. The decision generated widespread discussion and debate on affordability of life saving drugs in India for public good and impact on R&D for further innovation in pharmaceutical industry. The report covers following contents. 1. Background of the Novartis Case ❖ Fact of the case ❖ Underlying legal provisions 2. Overview of patent law in India with special focus on pharmaceutical industry 3. Supreme Court Decision in Novartis Case 4. Impact of the Supreme Court Judgement ❖ On affordability of life saving drugs ❖ On innovation for future improvement and development ❖ Overall impact on pharmaceutical industry both global & Indian. 5...
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...Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property Wanda T. Diggs Professor William Stone Law, Ethics and Corporate Governance – LEG-500 March 18, 2014 Abstract The PharmaCARE scenario is a case study based on a real life tragedy. Corporate corruption is alive and well and, as this case proves, unethical corporations will break the law for extra profit. Utilitarian ethics should be considered when in the business of providing consumable products to the public. Unfortunately, there are pharmaceutical corporations operating in the U.S. who are not abiding by the law and who are endangering public safety. Introduction This case study involves a pharmaceutical company that violated the intellectual property rights of a foreign nation; violated state compounding regulations, and violated product safety laws. The company established a compounding pharmacy to mass-produce a new drug formulation that executives believed would earn huge profits. The most disturbing aspect of this case is that there was a tremendous loss of life as a result of the company’s decisions. The federal government has granted authority to the Food and Drug Administration (FDA) to ensure drugs are safe for human consumption. Today, the FDA faces obstacles relating to lack of oversight control, funding, and human resources needed to provide adequate oversight over compounding pharmacies. This paper covers a broad-brush of ethical and legal issues relating...
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...Assignment 4: Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property Submitted by: Professor: LEG 500 Date of Submission: Research three to five (3-5) ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety and examine whether PharmaCARE violated any of the issues in question. The ethical issues are based on the social code and daily morality. Since the discussion is based on customer loyalty, stem cell research and abortion. Yet this invokes some serious arguments which proves that there are ethical issues which are yet of considerable concerns and need to be addressed. The ethical issues that are faced by the company mostly revolve around the morals and principles of the right and the wrongful actions. Here the focus is also on the moral approvals in terms of the what is viewed correct by individuals in certain professions. The main ethical issues however arise from advertising, personal selling, suppliers, contracts and pricing. Some of the main ethical issues that relate to the business are based mainly in terms of market research, audiences and pricing. The market researches can invade the privacy of the customers. In addition, in terms of the research, there is a high chance that these can be conducted based on stereotypes, which can be unethical. It is important for companies to use the market research as a means of marketing and a means to attain feedback for...
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...WESTERN DRUG COMPANIES AND THE AIDS EPIDEMIC IN SOUTH AFRICA | | | | | | | | INTRODUCTION The AIDS epidemic in South Africa is at an extreme where 4.2 million of the country’s 43 million citizens are afflicted. This translates into one in every ten citizens being infected with the virus. Additionally 34 million Sub Saharan African citizens have been afflicted and 11.5 million have died and that total accounts for 83% of the world’s AIDS related deaths. Treatment is available in the form of an anti-retroviral, but it is very costly and as such unaffordable for the already impoverished nations in Africa. The AIDS crisis and the expensive treatment have caused the government of South Africa to pass laws authorising the practice of parallel importing and compulsory licensing. Parallel importing allows importers to purchase the medication from the cheapest source whether or not the patent holders gave approval and compulsory licensing allows the government to license local companies to produce cheaper versions of the drug patented by foreign companies with or without their consent. The passing of the law by the South African government caused a legal dispute with the US drug companies regarding intellectual property rights, compulsory licensing and parallel importing. The dispute caused a debate among public health officials, activists, law makers and the drug companies over the importance of public health versus corporate profits and the bad public relations...
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...Legal and Ethical Consideration in Marketing, Product Safety, and Intellectual Property Terra Bradley LEG500, Law, Ethics, and Corporate Governance Professor Lateefah A. Muhammad 17 March 2014 Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property In this paper I will identify three ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety. I will argue against Direct-to-Consumer (DTC) marketing by drug companies. Next I will determine who regulates compounding pharmacies under the current regulatory scheme, what the Food and Drug Administration (FDA) could or should have done, and whether the FDA should be granted more power over compounding pharmacies. I will decide whether PharmaCARE’s use of Colberian intellectual property would be ethical in accordance with Utilitarianism; Deontology; Virtue Ethics; my own moral and ethical compass. Afterwards, I will analyze the way PharmaCARE uses U.S. law to protect its own intellectual property while co-opting intellectual property in Colberia. Then I will suggest at least three ways the company could compensate the people and nation of Colberia for the use of its intellectual property and the damage to its environment. I will compare PharmaCARE’s actions with those of at least one real-world company whose creativity in skirting legal technicalities led to ethical lapses and financial loss. I will also determine the...
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... Yet, an inevitable tension exists between the need for pharmaceutical companies to profit from their patented inventions and the desire to provide access for impoverished persons. Developing nations have attempted to resolve this tension through the issuance of patent compulsory licensesFauthorizations for government-approved generic copies1Fso that those in need of the n Assistant Professor of Business Law, School of Business, University of Connecticut. This article received the Holmes-Cardozo Award for Outstanding Submitted Conference Paper as well as the Ralph J. Bunche Best Paper Award at the Academy of Legal Studies in Business Annual Meeting, Indianapolis, IN, August 2007. Our thanks for comments and support go to Jayashree Watal, Peter Yu, Douglas Lippoldt, and the other participants at the University of Connecticut’s Center for International Business Education and Research Conference, ‘‘The Impact of Intellectual Property Rights on Innovation, Knowledge Diffusion, and Foreign Direct Investment in the Global Economy,’’ Storrs, CT, May 2007. Additional thanks to Anthony Kwasnica and Larry Cata-Backer for helpful comments. nn Associate Professor of Business Law, Smeal College of Business, The Pennsylvania State University. My research was supported by funding from the 2007 Smeal Competitive Research Grants Program. 1 The term ‘‘compulsory license’’ can refer to any compelled relaxation of an intellectual property owner’s right to exclude in exchange for a licensee’s...
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