Academic literature on the topic 'Brand-name pharmaceutical company'

Brand-name pharmaceutical companies often file lawsuits against generic drug manufacturers that challenge the monopoly status of patent-protected drugs. Institutional horizontal shareholdings, measured by the generic shareholders' ownership in the brand-name company relative to their ownership in the generic manufacturer, are significantly positively associated with the likelihood that the two parties enter into a settlement agreement in which the brand pays the generic manufacturer to stay out of the market.

ObjectivesThis study investigates the information and policies that Canadian patient groups post on their publicly available websites about their relationships with pharmaceutical companies.DesignCross-sectional study.SettingCanadian national patient groups.ParticipantsNinety-seven patient groups with publicly available websites.InterventionsEach patient group was contacted by email. Information from patient groups’ websites was collected about: total annual revenue for the latest fiscal year, year revenue was reported, revenue from pharmaceutical company donors, purpose of the donation, presence of donors’ logos on the website and hyperlinks to donors’ websites, previous and current employment information about board members and staff, external audits about the group’s finances and whether the group endorses products made by donors. Analysis of publicly available policies looking at: board and/or advisory board, acceptance of donations and revenue generation, independence of decision-making, endorsements, assistance to and/or interactions between patient members from a donor or another company/person acting on behalf of a donor and audits/monitoring/compliance.Primary and secondary outcome measuresNumber of patient groups posting information on their websites about their relationships with pharmaceutical companies; the presence and contents of patient group policies covering different topics about relationships with pharmaceutical companies.ResultsFifty-three (54.6%) of 97 groups reported donations from pharmaceutical companies. Forty-one (42.3%) groups showed the logos of pharmaceutical companies on their websites and 22 (53.7%) had hyperlinks to pharmaceutical company websites. Twenty-five (25.8%) of these groups endorsed pharmaceutical products produced by brand-name companies that had donated to the groups. Twenty-six (26.8%) groups had policies that dealt with relationships with pharmaceutical companies.ConclusionsPharmaceutical industry funding of the included patient groups was common. Despite this, relatively little information was provided on patient group websites about their relationships with pharmaceutical companies. Only 26 out of 97 groups had publicly available policies that directly dealt with their relationships with pharmaceutical companies.

Regulatory exclusivity, the TRIPS-plus protection for undisclosed test data, is considered as the principal means to extend market protection for brand-name pharmaceutical companies. When China joined the World Trade Organization in 2001, it promised to enact new laws or regulations that will comply with article 39.3 of the TRIPS Agreement. China's choice of implementing the TRIPS Agreement through regulatory exclusivity resulted mainly from intrinsic demands for China's strategy of innovative-driven development, and partly from the pressure of China-US trade disputes. There are two categories of regulatory exclusivities under China's laws. One is the market exclusivity for New Drugs and Traditional Chinese Medicine. The other is the data exclusivity for Innovative Drugs, Orphan Drugs, Paediatric Drugs, Innovative Biologics; and a ‘Generic Exclusivity’ for the first generic drug company that succeeds in challenging weak patents of pharmaceutical products.

Most new drugs are protected by pharmaceutical patents, which give the patent holder exclusive control over that drug’s supply for 20 years. When the patent term expires, the drug becomes available for generic production by any company. The resulting competition typically leads to dramatic reductions in price. In Brazil, generic drugs are on average 40% cheaper than reference or brand-name drugs. In the United States, the Federal Drug Administration reports up to 85% price differences. Consumers in India have witnessed more than 100-fold price reduction for antiretroviral (ARV) drugs due to generic production. Generics thus play a key role in broadening access to health care, mostly by driving costs down, both in the developing and developed world.

Background: Promotional literature provided by the pharmaceutical companies is one of the important marketing strategies to prescribe. Many of these literatures do not follow ethical guidelines and contain biased and irrelevant information that may cause irrational prescribing. So we did this study with an aim to check the credibility, reliability and authenticity of the PDLs available with prescribers.Methods: Promotional drug literatures were analyzed based on various parameters and guidelines provided by world health organization. Statistical analysis was done using Microsoft Excel.Results: A total 395 promotional drug literatures were analyzed and very few of them fulfilled the ethical criteria for drug promotion. Most of them focused on providing information about generic name, brand name manufacture company name and claims about efficacy. Few of them focused on safety of drugs as less information provided about adverse reaction, precaution and drug-drug interaction. Many of them contain space occupying unnecessary pictures.Conclusions: It can be concluded that the majority of the promotional advertisements that were given to the prescribers do not follow ethical guidelines and were not able to improve rational prescribing but only have commercial benefits.

Without data, many people may think pharmaceutical companies' influence over mental health services is negligible. We audited the marketing activities of, and payments to, drug companies in relation to public mental health services in England. Forty-three of 53 Trusts responded to Freedom-of-Information-Act requests. Trusts' policies varied in covering seven activities: from 86% (gifts) to 37% (leaflets). In practice, industry-sponsored training events (51%) and direct talks (40%) were common (averaging 36 events or talks per Trust annually). Only 22% of Trusts produced legally required Conflicts-of-Interests registers; and 14% had none. All 22 Trusts that reported which company received the largest share of their drug expenditure named the same company. On average, Trusts spent 44% of their drugs budget on long-acting injectable antipsychotics (13% to 77%) and 32% on brand name drugs (5%–74%). Five Trusts ban the Pharma marketing activities investigated. Independent post-qualification medical education, and marketing-bans, are needed to avoid over-medicalized practice.

In response to the recent increase in FDA-approved specialty drugs and escalating specialty drug prices, drug companies now offer patient support programs (“PSPs”) for eligible patients prescribed a particular pharmaceutical drug. Such programs encompass both financial assistance for the purchase of a specialty drug and behavioral services, including nursing support and injection training, intended to improve drug adherence. Although ostensibly gratuitous, these programs have a steep and underappreciated cost: disclosure of protected health information. In effect, patient support programs compel patients to trade protected health information for drug access. This Article provides the first in- depth examination of the legal and ethical concerns associated with patient support programs. Enrollment in a drug company’s patient support program furnishes the company with linked patient- and prescriber- identifying information for each enrollee, data which may enable drug companies to target marketing to patients and healthcare providers with an otherwise unattainable degree of precision. Moreover, once a drug company acquires an enrollee’s protected health information pursuant to a valid Health Insurance Portability and Accountability Act (HIPAA) authorization, a drug company faces few limits on downstream uses of those data. This Article illuminates a possible role for patient support program-mediated data collection in two unlawful drug company practices: (1) kickback schemes in coordination with foundations that cover pharmaceutical drug copays, and (2) “product hopping” to a new brand-name drug formulation after patent expiration of an older formulation. The current regime for health data privacy in the United States lacks adequate safeguards to prevent drug companies from exploiting patient support program-derived data to the detriment of patients. The Article ends by proposing practical modifications to the HIPAA Privacy Rule to modernize HIPAA’s protections vis-à-vis health data transferred from covered entities to noncovered entities such as drug companies.

Background: Drug promotional literature (DPLs) is an integral approach of pharmaceutical marketing strategy, which can almost influence a physician to prescribe definite variety of medicine from a particular company. The objective was to evaluate the accuracy, consistency, and validity of the information in accordance with the World Health Organization (WHO) ethical criteria for medicinal drug promotion.Methods: This was an observational study, in which total 100 DPLs were sorted out to evaluate whether the information is consistent/relevant with that presented by the criteria laid down by the WHO guidelines; such as nature of claims, pictorial content presented, cited references, the indication and significance of various data such as figure, graphs, table and clinical data.Results: From all the 100 promotional literatures sorted out, all showed the INN name and brand name, amount of active ingredient, dosage form and name and address of manufacturers/distributers was shown in all; adjuvants known to cause problem were not shown. Moreover, approved therapeutic uses were clearly mentioned in 35, 48 were having pictures presented, scientific graphs and clinical data were shown in 19.Conclusions: The results reveal that, majority of DPLs satisfied only half of the WHO criteria for rational drug promotion and none of them fulfilled all the specified criteria. Incomplete or exaggerated information in DPLs may mislead and result in irrational prescription. Therefore, physicians should critically evaluate DPLs regarding updated scientific evidence required for quality patient care.

Subject area The case offers a study of change management in the pharmaceutical industry in India. Study level/applicability The case is designed for undergraduate and postgraduate students to examine strategic decisionmaking in the context of mergers and acquisitions (M&As), firm capabilities and management practices. In particular, it has important pedagogical lessons for businesses eager to start operations in emerging countries. Students learn to recognize the unique nature of the pharmaceutical market and the factors affecting the demand and supply of drugs, including the economics of generics. The case can be discussed in one class session of approximately one-and-a-half to two hours duration. Case overview In 2012, the pharmaceutical industry in India was undergoing dynamic changes. There was keen interest among MNC pharmaceutical giants to buy up Indian generic manufacturing companies since their revenues were drying up with the impending patent expirations of many blockbuster brand name drugs. Japan's Daiichi Sankyo's had taken over the largest Indian pharmaceutical company, Ranbaxy Laboratories, known for its heritage of process innovations and market leadership. However, after the acquisition, Ranbaxy slipped to third position in the domestic market and was facing multiple problems including net losses and falling share prices, cultural differences in management practices, recall of drugs from foreign markets and a US FDA ban on its manufacturing plants. Further, Ranbaxy had always been viewed as a national champion and a customer-friendly company but drug prices had increased after the merger causing problems of affordability. The new CEO of Ranbaxy was facing a dilemma: how to regain the company's position as the market leader. Students are asked to advise the CEO of Ranbaxy how to tackle the challenges arising from the integration of an Indian company with a Japanese company. More specifically, the case focuses on M&A as a strategy for growth and also touches on issues related to competition, regulation, innovation and corporate governance. Expected learning outcomes The case discusses the different motives behind the deal for Daiichi Sankyo and Ranbaxy and why it was a strategic move by both the alliance partners. The case also raises issues of corporate governance for the management of Ranbaxy and the need for a proactive corporate social responsibility (CSR) strategy. The case provides students with the opportunity to develop their analytical skills in a real-life setting and apply theoretical concepts to the consideration of the various issues raised by the acquisition deal. Supplementary materials Teaching notes are available; please consult your librarian for access.

Purpose Many people in developing countries are suffering from serious diseases, such as HIV and tuberculosis. On the other hand, drug patents impact the availability of the drug for patients. Pharmaceutical technology transfer is widely used by domestic and foreign pharmaceutical enterprises because it promotes the availability of the drug for patients. The purpose of this paper, which is on drug technology transfer, is mainly to discuss how to solve the conflict between drug patent protection and public health from the perspective of the law, but not from the perspective of economics. To fill this gap, the authors introduce a model in the prescription drug market and analyze how a foreign manufacturer that produces brand name drugs authorizes a domestic enterprise that produces common drugs. Design/methodology/approach In this paper, the authors consider a situation that if the patent holders are provided a certain amount of compensation, then whether compulsory licensing would be an effective tool to promote competition and improve the availability of drugs. Furthermore, they also consider three different cooperation mechanisms, namely, fixed-fee contract, royalty contract and two-part tariff contract, under the case of technology transfer and give the condition of which contract would be better under different scenarios. Findings It is found that the product differentiation and the agent behavior of doctor in the domestic market have a deep impact on the foreign enterprise’s decision on technology transfer. If both fixed-fee contract and royalty contract are permitted, foreign enterprise will choose different transfer contracts under different conditions. Under two-part tariff contract, it is equivalent to a fixed-fee or royalty contract under certain conditions. Furthermore, all contracts can improve patients’ benefits, while the royalty contract and the two-part tariff contract would reduce importer’s social welfare under certain conditions. Originality/value Prescription drugs can treat many acute diseases and improve people’s quality of life. On the other hand, it requires investment in pharmaceutical research and development and is hard to afford the drug for the people living in poverty. This paper tries to solve the problem by introducing three cooperation contracts. The authors consider an innovative drug company and a regular drug company. The regular drug company can improve the quality of its drug by signing a technology transfer agreement with the innovative company. Three contracts are discussed in this paper; they are fixed-fee contract, royalty contract and two-part tariff contract. The authors examine the impact of different contracts on the companies’ profit, patients’ benefit and social welfare. It is found that quality differentiation of drugs and doctor behaviors can have large impacts on the company’s decision about technology adoption as well as contract choice strategies. In all of the three contracts, patients’ benefit improves, while the profit of the two companies and social welfare can increase or decrease under different contracts.

This chapter begins with a description of the various reasons for the accelerating costs of prescription drugs in the United States. It then discusses benefits and burdens of drug therapy within public and private insurance programs. Insurance risk pooling is examined in light of the requirement in the Affordable Care Act to buy health insurance and the consequences when people decide not to buy insurance. Disagreements between the personal beliefs of the owners of a privately held company and the Affordable Care Act’s requirement to cover contraceptives through employee insurance plans are discussed. The chapter also addresses co-pay coupons that encourage patients to ask for expensive, brand-name drugs and the increasing costs of specialty or biotechnology pharmaceuticals, highlighting the problems insurers face in their efforts to manage costs. Finally, the common problems of high-cost drugs that have marginal impact and off-label uses of drugs are examined.

We propose a model to improve estimation accuracy of the future sales volume, focusing on pharmaceutical products, from their patents. Our approach is based on an analysis of patents obtained in the early development stages of the products. The development of pharmaceuticals often takes a long time (up to several decades in some cases), and the costs are huge, even exceeding one billion USD for just one product. Therefore, it is strongly desirable to estimate future sales volume at an early stage. One piece of information potentially useful for the estimation is the brand, i.e., the name of the developing company. Our model learns the sales volume and words used in multiple patent specifications and also focuses on the extent to which “seasonal” words are used. Experiments showed that our model much improved the accurately of the sales volume estimation compared with the case of just estimating from its brand name.