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Article
Publication date: 6 June 2016

John F. Riggs, Scott Widmier and Richard E. Plank

The purpose of this research is to develop a taxonomy of the impact of sales process regulations, guidance statements and laws (henceforth, referred to as “regulations”) on sales…

Abstract

Purpose

The purpose of this research is to develop a taxonomy of the impact of sales process regulations, guidance statements and laws (henceforth, referred to as “regulations”) on sales behaviours within the pharmaceutical industry, particularly as it relates to those within the USA.

Design/methodology/approach

Given the large number of regulations, guidance statements and laws and sales behaviours that comprise the domain of this study, this research uses a “multicenter, parallel-arm clinical trial data gathering method”. This approach aggregated or “stacked” the responses from three individual questionnaires; 7,493 total observations generated by 381 respondents were analyzed.

Findings

The analysis produced a six-cluster solution of regulations, guidance statements and laws indicating distinct taxonomic structures of items that affect selling activities.

Research limitations/implications

The research was conducted with a single firm in the USA. Therefore, results may not be applicable to other geographical areas, firms and industries.

Practical Implications

The knowledge of which behaviours are perceived by the salespeople to be impacted by what regulations, guidance statements and laws provides managers with a useful tool to sort their own companies’ regulations on the basis of the classification scheme.

Originality/value

This paper provides a novel taxonomic approach to organize sales activities affected by regulations, guidance statements and laws which provides a look at the unintended consequences of the item not compliance. Additionally, it uses a research methodology relatively unknown to social science inquiry.

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 10 no. 2
Type: Research Article
ISSN: 1750-6123

Keywords

Article
Publication date: 22 November 2022

Lu Liu

This research studies the effect of deregulation of price cap in pharmaceutical market. Price regulation (either through price cap or reference price) is common practice in the…

Abstract

Purpose

This research studies the effect of deregulation of price cap in pharmaceutical market. Price regulation (either through price cap or reference price) is common practice in the pharmaceutical market but recently there are increasing voices calling for deregulation claiming that deregulation could help in lowering drug price and increase revenue of pharmaceutical firms. Upon those callings, Chinese government removed the price cap regulation in June 2015. The author uses this natural policy experiment to study this effect.

Design/methodology/approach

In this study, the author applied the interrupted time series analysis (ITSA) on the revenue data of nine categories of both generic and branded drugs in China from March 2011 to August 2016 (the time frame includes both before and after of the initialization of the deregulation) and analyzed the effect of deregulation.

Findings

The results showed that, whether the revenue of drugs will increase or decrease after the deregulation of price cap depends on the level of competition and the change of patterns of the branded and generic drugs are different. When HHI (Herfindahl–Hirschman index) is sufficiently low (competition is high), revenue does not change as a result of deregulation, when HHI is moderately low (moderate competition), revenue from generic drugs will decrease significantly and revenue from branded drugs will increase significantly, and when HHI is high (low competition), revenue from generic drugs will increase significantly and revenue from branded drugs will decrease significantly.

Originality/value

This is a unique study with a unique data set. Most previous studies focus on regulation of drug price and analyze how this may affect drug revenue; however, this is a natural policy experiment of de-regulation. Moreover, previously most studies focus on reference pricing regulation and this is price-cap, a different mechanism that is rarely studied. The originality/value is high of this article.

Details

International Journal of Health Governance, vol. 28 no. 1
Type: Research Article
ISSN: 2059-4631

Keywords

Book part
Publication date: 25 March 2010

Philip Sax and Amir Shmueli

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…

Abstract

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.

Details

Pharmaceutical Markets and Insurance Worldwide
Type: Book
ISBN: 978-1-84950-716-5

Article
Publication date: 8 May 2017

M. Monirul Azam

This paper aims to analyse the impacts of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) as adopted by the World Trade Organization (WTO…

Abstract

Purpose

This paper aims to analyse the impacts of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) as adopted by the World Trade Organization (WTO) on the pharmaceutical regulation and pricing of drugs in Bangladesh. The purpose of this paper is to explore how Bangladesh could adjust obligations for patent and pharmaceutical law reforms in the context of TRIPS Agreement while maintaining societal goals to ensure access to medicines. Another prime objective of this study is to examine viability of arguments regarding pharmaceutical patents for affordability and accessibility of pharmaceuticals in Bangladesh.

Design/methodology/approach

This paper used doctrinal research and case study using surveys and interviews in Bangladesh to understand the perceptions of different stakeholders regarding TRIPS and possible impacts on the local pharmaceutical industry and also consequences as to access to pharmaceuticals in terms of pricing, availability and affordability.

Findings

This study suggests that in the case of Bangladesh, the main health bottleneck is not patents or any drugs, but the lack of proper healthcare service, health infrastructure and lack of efficient healthcare personnel. Again, most of the necessary drugs for the local market are off patent, but patented drugs, issues of price, availability and affordability could become a concern for Bangladesh in situation of multi-drug resistance and for diseases like HIV AIDS, cancer and cardio-vascular problems.

Research limitations/implications

This study was based on randomly selected interview and surveys. To get a broader picture of the impacts of TRIPS compliant patent law and pharmaceutical patents in a country like Bangladesh, more in-depth socio-legal studies need to be conducted. Due to shortage of time and resources, it was not possible to conduct broader socio-legal studies; therefore, this study may not reflect views of all related stakeholders.

Practical/implications

This paper will guide how countries like Bangladesh could adopt intellectual property policies for pharmaceuticals in a way not only adjusting societal goals for accessibility and affordability of pharmaceuticals but also promoting innovation and capability of local industries.

Social/implications

Countries like Bangladesh should adopt intellectual property policies balancing not only investment and innovation side but also societal goals to ensure access to medicines for the vast majority of poor populations.

Originality/value

This study is an original study based on primary sources as collected during field studies in Bangladesh. It also used doctrinal research, and related materials are duly referred.

Details

International Journal of Law and Management, vol. 59 no. 3
Type: Research Article
ISSN: 1754-243X

Keywords

Article
Publication date: 1 March 2015

Lobna Abdellatif and Mohamed Zaky

The current paper explores the effect of private market characteristics on the access of small and medium enterprises (SMEs) to public markets in some sectors. Using survey data…

Abstract

The current paper explores the effect of private market characteristics on the access of small and medium enterprises (SMEs) to public markets in some sectors. Using survey data of small and medium enterprises in the pharmaceutical sector in Egypt, we confirmed this effect. We found that regulations of drugs pricing and registration in the private market constrained the capacity of those firms to compete in the public markets. However, some other factors play it the other way. The policy implications of these findings indicate that governments need to account for private markets characteristics when designing support packages for smaller enterprises in public procurement markets.

Details

Journal of Public Procurement, vol. 15 no. 4
Type: Research Article
ISSN: 1535-0118

Book part
Publication date: 25 March 2010

Pedro Pita Barros

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…

Abstract

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).

Details

Pharmaceutical Markets and Insurance Worldwide
Type: Book
ISBN: 978-1-84950-716-5

Article
Publication date: 29 June 2012

Shufang Huang

This paper aims at discovering the opportunities and challenges for China's pharmaceutical industry (pharma) in technological, management and products innovation and thinking of…

1318

Abstract

Purpose

This paper aims at discovering the opportunities and challenges for China's pharmaceutical industry (pharma) in technological, management and products innovation and thinking of the strategies for the industrial development based on thinking for high‐tech to create the future.

Design/methodology/approach

The study is primarily based on the literature review, data collection and interviews in varied research institutions, colleges as well as corporations. The literature review pays close attention to pharmaceutical industry and management. And the interviews took place in person, by telephone and via face‐to‐face conversations. By means of studying on the resulting data, this archive develops somewhat policy implications which can probably contribute to renew the competitiveness of China's pharmaceutical industry in innovation.

Findings

The critical shortages and the difficulties of China's pharmaceutical industry for development have been deeply discussed in this study, such as outdated healthcare system, controversial intellectual property regulation, and unconfident data system, which can handicap China's innovation.

Originality/value

This paper presents a systematic analysis of China's pharma, through addressing most key aspects, which is committed to driving incentives towards genuine innovation, and to sharing the potential competitive market. The findings of the dynamic health innovation system and the policy implications should be an original comprehensive understanding, all of which might be of interests to China's scholars, government officials and company practicing managers.

Details

Journal of Knowledge-based Innovation in China, vol. 4 no. 2
Type: Research Article
ISSN: 1756-1418

Keywords

Article
Publication date: 7 June 2011

Shin‐Yun Wang and Chih‐Chiang Hwang

The purpose of this paper is to apply options to the pharmaceutical markets to solute the corruption and counterfeit drugs in emerging markets.

1043

Abstract

Purpose

The purpose of this paper is to apply options to the pharmaceutical markets to solute the corruption and counterfeit drugs in emerging markets.

Design/methodology/approach

This article proposes a framework for using pharmaceutical options. The application of options to pharmaceuticals will enable a freer and more competitive pharmaceutical market, and assist medicine producers and hospitals using pharmaceutical options market to hedge price risk.

Findings

The paper finds that it is possible, for example, to apply the theoretical framework to case studies in pharmaceutical markets.

Research limitations/implications

The present study provides a starting‐point for further research in the pharmaceutical markets sector. The environment of the existing pharmaceutical markets, the implementation of pharmaceutical options, and the potential benefit of such implementation are discussed in details.

Originality/value

This framework has proven to be useful in improving the pharmaceutical markets of the medical industry.

Details

International Journal of Accounting & Information Management, vol. 19 no. 2
Type: Research Article
ISSN: 1834-7649

Keywords

Article
Publication date: 29 March 2013

Sudhir Yadav

The internationalization of pharmaceutical firms faces major barriers in terms of managing regulatory requirements in various international markets. This paper aims to identify…

Abstract

Purpose

The internationalization of pharmaceutical firms faces major barriers in terms of managing regulatory requirements in various international markets. This paper aims to identify the requirements related to regulations in various markets of the world. It further seeks to identify how the firms develop such capabilities i.e. processes undertaken by the firms to develop regulatory capabilities.

Design/methodology/approach

The research is exploratory in nature. Case study method is adopted to study the requirements related to regulations in international markets and processes to build regulatory capabilities.

Findings

To manage regulatory requirements firms need knowledge related to plant approval and product registration. Firms have to submit dossiers to the respective country's regulatory authority to get plant approval and product registration. They can simultaneously apply for both to save time to enter the target market. The requirements for each market are unique in terms of format and contents for dossier preparation. Dossier preparation needs data from various departments which calls for good coordination among various functional areas, i.e. production, QA and QC, R&D, purchasing, etc. If the firm has operations in multiple markets and offers multiple products in a single market the regulatory function is separately organized for less regulated, semi‐regulated and regulated markets.

Practical implications

Pharmaceutical firms targeting international markets can get insight into the regulatory requirements and the process to be adopted to build regulatory requirements.

Originality/value

The paper shows that firms use a systematic process to build capabilities for managing regulations. The paper also offers a process model for firms to build regulatory capabilities for internationalization.

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 7 no. 1
Type: Research Article
ISSN: 1750-6123

Keywords

Article
Publication date: 1 February 1996

Charles Pahud de Mortanges, Jan‐Willem Rietbroek and Cort MacLean Johns

States that although Japan's pharmaceutical industry has succeeded in steadily advancing its total sales revenues in recent years, its market share of worldwide volume has…

Abstract

States that although Japan's pharmaceutical industry has succeeded in steadily advancing its total sales revenues in recent years, its market share of worldwide volume has actually retreated slightly. Its major competitor continues to be the USA, while its three top European rivals: Germany, France and Italy ‐ in combination ‐ have consistently outperformed Japan. Significantly, Japan remains the single largest recipient of US pharmaceutical exports with a surplus over imports of more than $500 billion. Discusses various findings based on survey results within Japan's market structure. Posits that the US experience shows that successfully operating on the Japanese market requires considerable preparation, especially in the areas of distribution and promotion. Owing to the technical segmentation and endemic distribution system of the Japanese pharmaceutical industry, concludes that it is unlikely that the pharmaceutical industry in Japan will rise to dominate this industrial sector on a global basis as they have prevailed in others.

Details

Asia Pacific Journal of Marketing and Logistics, vol. 8 no. 2
Type: Research Article
ISSN: 1355-5855

Keywords

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