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Pharmaceuticals supply chain management (SCM) requires special expertise to transport the medicinal products because of weird features of their demand, supply and sensitivity towards quality. The purpose of this study is to establish the linkage of pharmaceutical quality system requirements with the SCM principles. The study enables the collaborative approach of technical, transport, logistics and supply chain teams within the pharmaceutical industry.

The methodology followed for this study is literature review and survey. The study is supplemented with data obtained through the structured questionnaire.

Through this study, an exclusive perspective for pharmaceutical good transportation practice (GTP) has been propagated in alignment with seven principles of SCM by Anderson. This study offers guidance to pharmaceutical industry for transportation of products by conceptualizing basic supply chain features such as segmentation, customization of requirement, market signals, differentiation, technology orientation and channel spanning performance.

Here is limited information available about the transportation failures in the pharmaceutical industry. Application of supply chain principles to pharmaceutical transportation is sometimes affected by technical knowledge bias of the researcher.

The study has successfully expounded the practical aspects of pharmaceutical GTP for supply chain professionals.

The study facilitates the patients and pharmaceutical consumers to get quality products in a timely manner across the globe.

The application of SCM principles to the pharmaceutical GTP is the result of novel research and has not been studied earlier.

The World Health Organization estimated that in 1999 roughly one-third of the world's population lacked access to essential medicines that would have saved or improved their lives. Our analysis focuses on how pharmaceutical product patents restrict access to essential medicines in developing countries. It is well established that pharmaceutical product patents provide little incentive for pharmaceutical companies to develop new medicines designed to treat diseases prevalent in developing countries or to market in developing countries those patented medicines developed to treat diseases prevalent in developed countries. Economists have developed theoretical models showing that these incentives could be changed if (1) developing countries provided intellectual property protection for new pharmaceutical innovations and (2) an international regulatory framework were established to facilitate pharmaceutical companies setting lower prices in developing countries and higher prices in developed countries for patented medicines. We develop an index of property rights in pharmaceutical innovations covering 129 countries from 1960 to 2005. It shows that in 1960 only a handful of countries provided significant protection for pharmaceutical innovations, but by 2005 over 95 percent of countries in our sample provided significant statutory protections. However, an international framework to allow pharmaceutical companies to price discriminate has not been put in place. We conclude that international price discrimination mechanisms, compulsory patent licenses, and regional patent buyouts are not viable mechanisms for providing access to essential medicines to patients in developing countries. Global patent buyouts are more likely to achieve this goal, as they are not founded on an impractical separation of pharmaceutical markets in developing and developed countries and they provide critical incentives to develop new essential medicines.

There is much evidence of bias in research on the effectiveness and efficacy of drugs as a result of the influence of the pharmaceutical industry. The purpose of this paper is to present the views of those involved in a major evidence-based policy initiative from Canada and examine the adequacy of existing academic conflict of interest (COI) rules.

Data came from the Alzheimer’s Drug Therapy Initiative in British Columbia, a coverage with evidence development (CED) initiative, where a form of action research collected insights from the authors’ experiences, combined with qualitative interviews with members of the research team.

The majority of researchers perceive the influence of pharmaceutical manufacturers as problematic. Even when the strictest of COI rules are followed, extending well beyond disclosure, the reach of industry is so great that existing COI rules lag far behind their expanding influence.

The authors support others who call for the funding of independent research, enforcement of existing disclosure rules, and unfettered publication rights. In addition, the authors urge the education of all research team members, including clinicians, on the evidence indicating the variety of forms through which industry influence is exerted. The authors believe that this awareness-raising can help toward minimizing that influence in the analyses that are conducted.

Consideration of pharmaceutical influence on CED research is important. There may be an untrue assumption that CED is functioning at arms-length from the drug companies.

The regulatory reach of the international trade regime beyond its own boundaries is attracting increasing scholarly and political attention as the World Trade Organization (WTO) is expected to reconcile free trade with concerns related to public health, environmental and labour issues or intellectual property rights. This paper aims to investigate to what extent and why the degree of legalization of non‐trade concerns in the WTO varies across issue areas.

The paper first assesses the degree of legalization (in terms of obligation, delegation and precision) for technical (phyto) sanitary, environmental, intellectual property and labour standards. It then adopts a neoliberal institutionalist perspective to account for the uneven legalization across issue areas.

The paper shows that legalization is strong for intellectual property rights, moderate for public health and environmental matters and weak for labour issues. It is argued that legalization is uneven because of members' (divergent) preferences regarding the regulation of non‐trade concerns and because of certain institutional aspects of the WTO.

The paper shows that it cannot be assumed that the WTO is a highly legalized trade regime, implying an even legalization across issue areas. It hopes to contribute to three strands in international relations literature: standard setting, legalization and “regime complexity”, a debate which deals with the interaction between partially overlapping, not hierarchically ordered international regimes.

There is a consensus suggesting that the theoretical underpinning associated with supply chain quality management practices remain evolutionary to current thinking. Therefore, this study aims to explore how absorptive capacity (AC) supports supply chain quality integration (SCQI) by building product and process quality within a supply chain (SC).

A comparative case study of global pharmaceutical manufacturers in a developing market was undertaken. A two-round qualitative research method was designed to collect data through 54 semi-structured interviews with pharmaceutical managers and senior managers.

The results demonstrate that AC is essential to the development of SCQI because of its ability to use valuable strategic and operational knowledge, which is important when improving consistent internal product and process quality, along with establishing a robust SC design. The authors found that AC enables companies to design their quality and continuously improve their products and processes among their SC members.

The authors acknowledge that these sets of findings are difficult to generalise to other sectors, however, the authors are confident that they can be extrapolated to other companies in the pharmaceutical industry.

The study develops a framework to support practitioners and decision makers to leverage their AC towards facilitating their SCQI practices.

This study explains the role of the AC process in relation to SCQI practices, in the context of the pharmaceutical SC. The study profiles the characteristics of dynamic capabilities to increase the companies’ competencies, processes and resources.

The purpose of the study is to review The False Claims Act (FCA) settlements and challenges facing the industry to suggest the motivation behind firms’ alleged fraudulent activity. FCA has been applied against pharmaceutical companies by the US Government to combat marketing fraud including kickbacks, improper pricing and off-label promotion. The interests of the US Government and medical professionals are also considered. Changes to the law governing pharmaceutical marketing practices are recommended.

Cases settled under the FCA between 2005 and 2012 were identified by accessing the US Department of Health and Human Services (DHHS) Corporate Integrity Agreements Web site and annual reports and the quitamhelp.com Web site. Case details were collected from US Department of Justice press releases, DHHS annual reports, and case documents in the Public Access to Court Electronic Records database.

Of the settled cases in the final sample, improper pricing practices were evident in 33 per cent of the cases; off-label promotion in 52 per cent; and both in 15 per cent of the cases. Forty-eight per cent of the alleged fraudulent marketing activity occurred within the brands’ first year and 68 per cent within the first two years on the market. Reported settlements ranged from US$4 million to US$4.3 billion.

This research simultaneously considers business issues facing the pharmaceutical industry and alleged fraudulent marketing activity to recommend changes to the law governing drug promotion. Changes have the potential to improve the balance between the respective interests of industry, medicine and government and to improve compliance and patient care in the future.

Brand-name pharmaceutical companies have engaged in a variety of business conduct that has increased price. One of these activities involves “product hopping,” or brand switches from one version of a drug to another. The antitrust analysis of product hopping implicates antitrust law, patent law, the Hatch–Waxman Act, and state drug product selection laws, as well as uniquely complicated markets characterized by buyers different from decision makers. As a result, courts have offered inconsistent approaches to product hopping.

In this chapter, we offer a framework that courts and government enforcers can employ to analyze product hopping. The framework is the first to incorporate the characteristics of the pharmaceutical industry. It defines a “product hop” to include instances in which the manufacturer (1) reformulates the product to make the generic nonsubstitutable and (2) encourages doctors to write prescriptions for the reformulated rather than the original product.

When the conduct meets both requirements, our framework offers two stages of analysis. First, we propose two safe harbors to ensure that the vast majority of reformulations will not face antitrust review. Second, the framework examines whether the hop passes the “no-economic-sense” test, determining if the behavior would make economic sense if the hop did not have the effect of impairing generic competition. Showing just how far the courts have veered from justified economic analysis, the test would recommend a different analysis than that used in each of the five product-hopping cases that have been litigated to date, and a different outcome in two of them.

The Federal Trade Commission (FTC) has initiated policies and legal challenges that have shaped the evolution of competition in healthcare. This chapter discusses not only discusses the current matters in healthcare competition, but it also gives a history of past issues faced by the FTC and the approaches used to resolve them. These FTC actions range from challenges to hospital mergers to preventing “reverse payments” from patent holders to generic entrants in pharmaceuticals. Ultimately the healthcare industry faces many unique regulatory and competitive aspects that, while challenging, do not require special rules.

Health sector is one of the most important sectors when the size of spending and the number of people and organizations involved are considered. An important characteristic of this sector is the dominance of governments as health care providers and/or financers. This fact has important procurement policy implications. This paper gives a detailed overview of the health sector in Turkey and issues surrounding public procurement in this sector. It presents a model for implementation of eprocurement in Turkey’s public health sector, a discussion about the extent to which e-procurement can solve prevailing problems and suggestions to improve procurement in this sector.

Companies in the health field supplying drugs to government hospitals and medical services need to have accurate information on the relevant regulatory standards. This article describes a regulatory affairs and quality assurance programme instituted and operated by a major multinational drug manufacturer and supplier, referring to the appropriate British standards.