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Non-profit Drug Research and Development at a Crossroads.

In wealthy nations, non-profit drug R&D has been proposed to reduce the prices of medicines. We sought to review the ethical and economic issues concerning non-profit drug R&D companies, and the possible impact that their pricing strategy may have on the innovation efforts from for-profit companies targeting the same segment of the pharmaceutical market. There are two possible approaches to pricing drugs developed by non-profit R&D programs: pricing that maximises profits and Baffordable^pricing that reflects the cost of manufacturing and distribution, plus a margin that ensures sustainability of the drug supply. Overall, the non-profits face ethical challenges -due to the lack of resources, they are unable to independently commercialize their products on a large scale; however, the antitrust law does not permit them to impose prices on potential licensees. Also, reduced prices for the innovative products may result in drying the for-profit R&D in the area.

Selected Concepts on Ethics in Biopharmaceutical Innovation

MOJ Proteomics & Bioinformatics, 2017

We are at a time where diseases, epidemics and viruses spreading with unlimited rate and neither young nor elderly individuals have escaped from it. At a time when the average of chronic patients, epidemic, disabled and mortality is increasing day after day, this dilemma pushed and motivated the biopharmaceutical sectors to innovation in order to mitigate this plight. giving birth to a new bio drug need to pass through several phases, and every phase should pass through several ethical guidelines and some responsibilities, according to the rational and moral principle the pharmacists, stakeholders, the managers and the whole company crew form a team with different specialization but with one principle, is to serve the patients' health, improve the healthcare system and enhance the humanity wellbeing with a high ethical and responsibility values. This article gives a glance about some ethical standards, behavior and responsible guidelines which should the whole biopharmaceutical crew adhere to before and during and after the bio drug innovation's process.

Research Ethics and Commercial Drug Development: When Integrity Threatens Profitability

2016

This case, based on personal experiences and on those found in the literature, highlights the delicate tension faced by drug development companies having to balance research integrity and their profitability. | Ce cas, basé sur des expériences personnelles ainsi que sur celles trouvées dans la littérature, met en évidence la tension délicate à laquelle sont confrontées les entreprises vouées au développement des médicaments soit d'équilibrer l'intégrité de la recherche et leur rentabilité.

Ethical Issues in Resource Allocation, Research, and New Product Development

The ethical justification for developing and providing the means to reduce the burden of disease in developing countries is self-evident. Nevertheless, those who pursue these laudable ends encounter ethical dilemmas at every turn. The development of new interventions requires testing with human subjects, an activity fraught with controversy since the dawn of scientific medicine and especially problematic with poor and vulnerable participants in developing countries. Ethical dilemmas arising in setting priorities among interventions and among individuals in need of care are most acute when needs are great and resources few. We address some of these concerns in this chapter, identifying some of the principal ethical issues that arise in the development and allocation of effective interventions for developing countries and discussing some alternative resolutions. We omit discussion of two other aspects of these ethical decisions: ensuring that the process of decision making is fair and...

Nonprofit biomedical companies

Clinical pharmacology and therapeutics, 2008

Nonprofit biomedical firms are an integrated market-based solution to improve incentives for investment in promising scientific areas that have high social value but minimal potential for profit. We briefly review the current market with an emphasis on the financing of innovative product development and propose ideas for new nonprofit companies centered on the health concerns of developed countries. We conclude with a suggestion that opportunities exist for nonprofit firms focused on cancer diagnostics, given the limitations of current financing incentives and ripe scientific opportunity.

Strategic Corporate Social Responsibility and Orphan Drug Development: Insights from the US and the EU biopharmaceutical industry, journal of business ethics, a paraitre en 2013

Journal of Business ethics

In recent years, the biopharmaceutical industry has seen an increase in the development of so-called orphan drugs for the treatment of rare and neglected diseases. This increase has been spurred on by legislation in the United States, Europe, and elsewhere designed to promote orphan drug development. In this article, we examine the drivers of corporate social responsibility (CSR) activities in orphan drug markets and the extent to which biopharmaceutical firms engage in these activities with a strategic orientation. The unique context of orphan drugs constitutes a research opportunity to test the applicability of existing theoretical perspectives on CSR and strategic CSR. Using Schwartz and Carroll’s (Bus Ethics Q, 13(4):503–530, 2003) three-domain approach to CSR and the literature on strategic CSR as a theoretical background, we employ a combination of semi-structured interviews and a quantitative website content analysis to study practices of biopharmaceutical firms in the United...

In Defense of Pharmaceutical Industry: Ethics, Pricing, and Distributive Justice

This article explores the business dynamics of international pharmaceutical companies operating within a globalized free-trade market from an ethical standpoint. We review the consequentialist moral philosophies that shape the private drug industry. This is contrasted with a growing consumer frustration based on a social intuitionist model that argues for cheaper—even free-of-cost—drugs as a human right. Comparisons are drawn across different political and economic systems across the world where a common strain of growing resentment is observed against a perceived greedy and heartless drug industry. We examine the rationale for this case of distributive justice violations stemming from a seemingly unfair system of drug pricing and a lack of government intervention. Several mechanisms proposed to address these issues are analyzed on merits of ethical justifications and pragmatic efficacy. Case studies related to the effects of government intervention, effective implementation of intellectual property rights and an upcoming generic drug industry are looked upon. Finally, we argue in defense of pharmaceutical industry's freedom to make business decisions pertaining to drug pricing; as a means to sustain growth, innovation and achieve collective human prosperity through an ethical commitment towards protection of private enterprise.