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The Indian pharmaceutical industry currently faces multiple challenges, including rising costs and slowing export growth, which in turn have limited its ability to expand presence in global canvas. Given the nature of sectoral dynamics, a pharmaceutical firm must undertake huge investments in R&D to introduce product innovation, in turn enhancing market share and sustaining profit streams. The development of novel medicines, confirmed by the granting of patent rights, provides a pharma company edge over its competitors. In addition, presence of innovator firms within the industry invigorates the sectoral value chain and raises efficiency. Hence, it is important to analyze whether granting patent rights enhances the exports of pharmaceutical products in the Indian context.

The current study explored this question using a simultaneous-equation framework. Specifically, the authors use the methods developed by Davidson and MacKinnon (1993) and Greene (2003) to obtain heteroscedasticity-consistent estimates. The time-series properties of the data were further probed, and robust estimates were used to test the theory. Methods developed by Baltagi (1981) have been used further to refine the authors’ estimations.

After controlling for relevant variables, it is observed that granting of patents caused a significantly positive impact on pharmaceutical exports. Furthermore, the change in the patent administration regime had a significant impact on patent fillings, which further impacted their exportability. Compared to patents granted patents filed had a higher impact on pharmaceutical exports.

This study attempts to apply the framework developed by Goldstein and Khan (1978) with necessary modifications to suit the context of a developing country. The application of the 3SLS method to estimate the export supply equation for pharmaceutical products is a novel approach to the research question in general and to the Indian context in particular. System autocorrelation and heteroscedasticity tests were performed to refine the results further.

The imperative to conserve resources and minimize operational expenses has spurred a notable increase in the adoption of lean manufacturing within the context of the circular economy across diverse industries in recent years. However, a notable gap exists in the research landscape, particularly concerning the implementation of lean practices within the pharmaceutical industry to enhance circular economy performance. Addressing this void, this study endeavors to identify and prioritize the pivotal drivers influencing lean manufacturing within the pharmaceutical sector.

The outcome of this rigorous examination highlights that “Continuous Monitoring Process for Sustainable Lean Implementation,” “Management Involvement for Sustainable Implementation” and “Training and Education” emerge as the most consequential drivers. These factors are deemed crucial for augmenting circular economy performance, underscoring the significance of management engagement, training initiatives and a continuous monitoring process in fostering a closed-loop practice within the pharmaceutical industry.

The findings contribute valuable insights for decision-makers aiming to adopt lean practices within a circular economy framework. Specifically, by streamlining the process of developing a robust action plan tailored to the unique needs of the pharmaceutical sector, our study provides actionable guidance for enhancing overall sustainability in the manufacturing processes.

This study represents one of the initial efforts to systematically identify and assess the drivers to LM implementation within the pharmaceutical industry, contributing to the emerging body of knowledge in this area.

Purpose – Pharmaceutical expenditures have an important role in Europe. The attempts to control expenditure have used a wide range of policy measures. We reviewed the main measures adopted by the European Union countries, especially in countries where governments are the largest third-party payers.

Methodology – To complement a literature review on the topic, data was gathered from national reviews of health systems and direct inquiries to several government bodies.

Findings – Almost all countries regulate prices of pharmaceutical products. Popular policy measures include international referencing to set prices (using as benchmark countries that have set lower prices), internal reference pricing systems to promote price competition in domestic markets, and positive lists for reimbursement to promote consumption of generics (including in some cases substitution by pharmacists of drugs prescribed by physicians). Despite the wide range of policy measures, it is not possible to identify a “silver bullet” to control pharmaceutical expenditures. We also identified two main policy challenges: policy coordination among countries within the European Union to maintain incentives for R&D at the global level, and the development of new relationships with the pharmaceutical industry; namely, the so-called risk-sharing agreements between the pharmaceutical industry and governments/regulators (or large third-party payers).

Using the pharmaceutical sector as a microcosm of the health sector, we highlight the most prevalent structural and policy issues that make this sector susceptible to corruption and ways in which these vulnerabilities can be addressed. We conducted a literature review of publications from 2004 to 2015 that included books, peer-reviewed literature, as well as gray literature such as working papers, reports published by international organizations and donor agencies, and newspaper articles discussing this topic. We found that vulnerabilities to corruption in the pharmaceutical sector occur due to a lack of good governance, accountability, transparency, and proper oversight in each of the decision points of the pharmaceutical supply chain. What works best to limit corruption is context specific and linked to the complexity of the sector. At a global level, tackling corruption involves hard and soft international laws and the creation of international standards and guidelines for national governments and the pharmaceutical industry. At a national level, including civil society in decision-making and monitoring is also often cited as a positive mechanism against corruption. Anticorruption measures tend to be specific to the particular “site” of the pharmaceutical system and include improving institutional checks and balances like stronger and better implemented regulations and better oversight and protection for “whistle blowers,” financial incentives to refrain from engaging in corrupt behavior, and increasing the use of technology in processes to minimize human discretion. This chapter was adapted from a discussion piece published by Transparency International UK entitled Corruption in the Pharmaceutical Sector: Diagnosing the Challenges.

The purpose of this investigation is to add to the body of knowledge regarding consumer skepticism toward advertising in general, and toward pharmaceutical advertising in particular. The study was conducted in the U.S. and in Germany. Skepticism toward advertising for both prescription and non-prescription pharmaceuticals was analyzed. Additional variables explored include: health consciousness, product involvement with pharmaceuticals, satisfaction with information in pharmaceutical advertising, and the importance of pharmaceutical advertising as a source of information. Furthermore, differences in the cultural value of uncertainty avoidance between U.S. and German consumers were examined and related to skepticism toward pharmaceutical advertising. Three hundred and forty-one Americans and 447 Germans were surveyed. A significant finding of this research revealed that skepticism toward pharmaceutical advertising is lower than skepticism toward advertising in general. Results also indicated that consumers showed no difference in their level of skepticism toward advertising for prescription versus non-prescription drugs. This is a particularly relevant finding as it relates directly to the ongoing discussion in Europe regarding whether or not to lift the ban on advertising for prescription drugs. Skepticism toward pharmaceutical advertising was found to be significantly negatively related to involvement with pharmaceuticals, to satisfaction with the informational content of the advertisements, to satisfaction with the comprehensibility of the advertisements, and to the importance placed on advertising as a source of health information. Regarding cultural differences, U.S. consumers appear to be less skeptical toward advertising in general, and toward advertising for prescription and non-prescription drugs in particular, than German consumers. This may be due to the lower degree of uncertainty avoidance in the U.S. Differences between the two countries related to the additional variables examined in the study are addressed as well. Implications for consumer protection policies are discussed, and recommendations for advertisers of pharmaceutical products are provided. The authors provide a cultural explanation for differences in the degree of skepticism between U.S. and German audiences.

There is sufficient evidence to prove that the improved health status of a nation’s citizens results in economic growth and development via improved functionality and productivity of labor. It is also commonly accepted that healthcare expenditure significantly influences health status through, for instance, improving life expectancy at birth and reducing morbidity, death, and infant mortality rates. Within healthcare, medicines account for a considerable share of health-related expenditure in both developed and developing countries. Therefore, it seems reasonable to assume that improved access to medicines is likely to contribute not only to the well-being of families and individuals but also to the economic growth and development in all societies. It has been widely advocated that pharmaceutical multinational enterprises (MNEs) can play an important role to address this problem, as they develop and supply a significant proportion of the drugs imported by low- and middle-income countries. This chapter is dedicated to a systematic review of literature in order to identify the strategies implemented by pharmaceutical MNEs to improve access to medicines in the low- and middle-income countries. A total of 76 research articles have been identified, and we have found that the main strategies of pharmaceutical MNEs are related to improving health outcomes through R&D, establishing partnerships for product development, pricing strategies to improve access to medicines, technology transfer, licensing agreements, and nonmarket efforts to improve access to medicines, among other strategies to overcome barriers imposed by intellectual property rights. We have also found that pharmaceutical MNEs’ strategies take place within a complex system and often involve interactions with a wide range of actors, such as international organizations, governments, private not-for-profit sector, universities and research institutes, and generic manufacturers. However, there is still a need for major progress in the field of access to medicines, and pharmaceutical MNEs should be more active in this field in order to avoid potential negative consequences, such as loss of legitimacy and compulsory licensing of their patented medicines.

To investigate the impact of knowledge-intensive FDI in the Chinese pharmaceutical industry, this study analyzes the activity of foreign MNEs operating in this context by exploring their innovative background, the organizational arrangements they use for local knowledge creation and the performance of their local innovative processes. Based on the analysis of the universe of USPTO pharmaceutical patents applied for between 1975 and 2010 and granted to foreign assignees utilizing the work of Chinese inventors, our results show that, while the presence of foreign MNEs in the Chinese pharmaceutical industry entails a strong potential for positive externalities that could enhance the performance of the local innovation system, such externalities do not completely materialize yet, likely because of local actors’ limited absorptive capacity.

Purpose – There is a particular need for health policy evaluations in terms of achievement of goals, which may help inform policy-making not only locally but for the wider international policy community. In this chapter, we review the impact of pharmaceutical regulation and policies in Israel on a range of health system performance goals that, in the pharmaceutical context, are mainly related to ensuring the availability, accessibility and affordability of medicines.

Approach – We assess pharmaceutical policies and their impact, within the Israeli National Health Insurance (NHI) system enacted in 1995, on the degree to which the following main policy goals are being achieved: containment of drug expenditures; sustainability and equity of financing for pharmaceuticals; efficiency of expenditure in the pharmaceutical sector; and availability and accessibility of pharmaceuticals.

Findings – The findings point to a number of accomplishments as well as outstanding challenges. The main accomplishment is successful cost containment of (public) expenditure on medicines. Government price regulation operates as a mechanism responsible for sickness funds’ (SFs) savings, over which the state has no information or monitoring. Although the package of publicly financed drugs is comprehensive, delays in reimbursement decisions and high level of cost sharing mean that medicines have become increasingly unaffordable for many patients, especially for low-income persons with chronic diseases.

Implications – Regulation of the pharmaceutical sector should focus on two aspects: decreasing the information gap between the SFs and the regulator and reforming the cost-sharing policy to increase affordability and equity.

This paper aims to examine the impact of announcements related to 77 interventions by 46 listed Indian pharmaceutical firms during COVID-19 on the abnormal returns of the firms. The study also finds the variables which explain cumulative abnormal returns (CARs).

This study uses standard event methodology to compute the abnormal returns of firms announcing pharmaceutical interventions in 2020 and 2021. Besides this, the multilayer perceptron technique is applied to identify the variables that influence the CARs of the sample firms.

The results show the presence of abnormal returns of 0.64% one day before the announcement, indicating information leakage. The multilayer perceptron approach identifies five variables that explain the CARs of the sample companies, which are licensing_age, licensing_size, size, commercialization_age and approval_age.

The study contributes to the efficient market literature by revealing how firm-specific nonfinancial disclosures affect stock prices, especially in times of crisis like pandemics. Prior research focused on determining the effect of COVID-19 variables on abnormal returns. This is the first research to use artificial neural networks to determine which firm-specific variables and pharmaceutical interventions can influence CARs.

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.