Asia’s pharmaceutical sector has experienced remarkable growth over the last two decades, with companies in the region producing bulk of the world’s specialty generics, biologicals, and active pharmaceutical ingredients (APIs). The Asian pharma growth story has had several pillars for a strong and sustainable foundation that provided non-linear growth. This report introduces three models showing how Asian countries at different development stages — India, South Korea, and Singapore — have nurtured their own, self-sustaining pharmaceutical sectors.

This study assesses Latin America and Caribbean countries’ capacity to innovate new pharmaceuticals, defined as developing new drugs and vaccines, repurposing existing drugs, and inventing around patents to produce new drug variations. Vaccine innovation includes reengineering existing vaccines, developing new manufacturing methods, and the clinical development of unapproved vaccine candidates initiated elsewhere.

Current debates about the roles of the public and private sectors in pharmaceutical innovation have a long history. The extent to which, and ways in which, the public sector supports drug innovation has implications for assessments of the returns to public research funding, taxpayer rights in drugs, the argument the high prices are needed to support drug innovation, and the desirability of patenting publicly funded research.

Only 19 new molecular entities and 3 biologics were approved by the Food and Drug Administration in 2007, the lowest rate in 24 years. This disappointing output occurred despite steady clinical trial and regulatory review times, the FDA maintaining high approval rates, and the pharmaceutical industry consistently reporting increasing revenues. A government report suggests that fewer new drug applications have been submitted to the FDA by the pharmaceutical industry in recent years. These data have rekindled the debate as (...) to the origins of pharmaceutical innovation and the comparative importance of public and private sources in contributing to drug discovery. The pharmaceutical industry contends that its research is responsible for most new medicines, and that the primary public institution supporting U.S. biomedical research, the National Institutes of Health, supports medical innovation “distinct from the process of drug development.”. (shrink)

The prevailing model for encouraging innovation based on patents and market-oriented raises at least two economic and ethical issues: it imposes barriers on individuals and developing countries governments' access to medicines by defining prices that do not match their income, and the unavailability of new or appropriate products to address the health problems of these populations. In the last decade, this scenario has undergone some changes due to the emergence of new actors, the contribution of aid resources, the introduction (...) to the market of new products against neglected diseases, the development of new governmental healthcare policies and research programs, etc. One example of such initiatives is the Fixed-Dose Artesunate Combination Therapy (FACT) project consortium, which brought together institutions with different natures from both the North and the South, for the development of two antimalarial fixed-dose combinations recommended by the WHO – artesunate-amodiaquine (ASAQ) and artesunate-mefloquine (ASMQ). This paper proposes to describe and analyze the ASMQ consortium, which is the result of a new pharmaceutical development approach, based on a different paradigm – needs-driven instead of market-driven –, collaborative, with strategic participation of institutions from the South, funded by alternative resources (public and philanthropic). Thus, it represents an interesting object of study for bioethical debates on intellectual property and innovation, and its analysis is justified in light of the current debate on ways of stimulating needs-driven pharmaceutical innovation. (shrink)

In an earlier piece in these pages, I described the health effects of the still massive problem of global poverty: The poor worldwide face greater environmental hazards than the rest of us, from contaminated water, filth, pollution, worms, and insects. They are exposed to greater dangers from people around them, through traffic, crime, communicable diseases, sexual violence, and potential exploitation by the more affluent. They lack means to protect themselves and their families against such hazards, through clean water, nutritious food, (...) satisfactory hygiene, necessary rest, adequate clothing, and safe shelter. They lack the means to enforce their legal rights or to press for political reform. (shrink)

Though many more patents emerge from industry sources, drug-related patents generated in the non-profit setting appear to have greater importance than patents arising from the commercial sector, which helps demonstrate the value non-profit research institutions can have in driving drug development.

This chapter describes in very general terms the integration of clinical research and marketing, drawing on books by marketers and recent cases that have come to the public eye. The tools that have been used to accomplish this integration over the past half-century are various, but they all stem from a realization that in a rational world centered on health there need be no intrinsic divide between research and marketing. Most obviously, marketing drugs to physicians, who are professionals acting within (...) their own spheres, depends crucially on research. Physicians respond, and need to see themselves as responding, to fact, figures, and studies. The well-chosen images and vehicles for marketing campaigns must be subordinated to research. Yet at the same time research is a means of increasing sales. (shrink)

Globalized in 1995 through the TRIPs Agreement, humanity’s dominant mechanism for encouraging innovations involves 20-year product patents, whose monopoly features enable innovators to reap large markups or licensing fees from early users. Exclusive reliance on this reward mechanism in the pharmaceutical sector is morally problematic for two main reasons. First, it imposes a great burden on poor people who cannot afford to buy patented treatments at monopoly prices and whose specific health problems are therefore neglected by pharmacological research. Second, (...) it discourages pharmaceutical firms from fighting diseases at the population level with the aim of slashing their incidence. These problems can be alleviated by establishing a supplementary alternative reward mechanism that would enable pharmaceutical innovators to exchange their monopoly privileges on a patented product for impact rewards based on the actual health gains achieved with this product. As such, an international Health Impact Fund would create powerful new incentives to rapidly develop remedies against diseases concentrated among the poor, provide such remedies with ample care at very low prices, and deploy them strategically to contain, suppress, and ideally eradicate the target disease. By promoting innovations and their diffusion together, the HIF would greatly enlarge the benefits, and thereby also the cost-effectiveness, of the pharmaceutical sector, especially in favor of the world’s poor. (shrink)

The controversy over the prescription drug, alosetron, is examined in order to investigate what is permitted to count as ‘therapeutic advance’ and ‘therapeutic breakthrough’ within pharmaceutical innovation and regulation. It is argued that those official accounting categories can mask very modest efficacy of some drugs by reference to the official techno-scientific evidence, thus leading to questionable acceptance of risks to public health. This is explained by: the drug availability options set by the commercial interests of manufacturers; the FDA (...) management's need to demonstrate rapid approval of therapeutic advances to their budgetary masters, especially in the context of patient demands for access to new drugs; and the increasing capacity of patient groups, sometimes in collaboration with pharmaceutical manufacturers, to challenge techno-scientific expertise and evidence with experiential testimony. It is concluded that regulatory policy-makers need much more sophisticated accounting systems for differentiating between drugs defined as significant therapeutic advances, and between drugs (‘therapeutic breakthroughs’ fast-tracked to treat serious or life-threatening conditions. Contrary to some STS analyses, the desirability of an ascendancy of patients’ anecdotal evidence in regulatory decisions for public health is questioned. (shrink)

Innovation is fundamental to the pharmaceutical industry and a key to improvements in healthcare. Its effectiveness depends on huge, constant investments in research. This innovative industry directly affects the course of studies in healthcare and medicine. Its efforts translate directly into the length and quality of our lives. For several years now, the progress underway in pharmaceutical industry has produced measurable benefits. Doctors have new pharmaceuticals at their disposal, including many types of antibiotics and anti-viral drugs, vaccines (...) and a wide range of drugs which save lives or make them more comfortable. In the near future, ever more efficient cures for neoplastic, rheumatic, neurological, psychic, metabolic, circulatory or respiratory diseases can be expected. (shrink)

Neodevelopmental patent regimes aim to facilitate local actors’ access to knowledge and also encourage incremental innovations. The case of pharmaceutical patent examination in Brazil illustrates political contradictions between these objectives. Brazil’s patent law includes the Ministry of Health in the examination of pharmaceutical patent applications. Though widely celebrated as a health-oriented policy, the Brazilian experience has become fraught with tensions and subject to decreasing levels of both stability and enforcement. I show how one pillar of the neodevelopmental regime, (...) the array of initiatives to encourage incremental innovations, has fostered the acquisition of innovative capabilities in the Brazilian pharmaceutical sector, and how these new capabilities have altered actors’ policy preferences and thus contributed to the erosion of the coalition in support of the other pillar of the neodevelopmental regime, the health-oriented approach to examining pharmaceutical patents. The analysis of capability-derived preference formation points to an endogenous process of coalitional change. (shrink)

This article argues that the misalignment of private profit-maximizing objectives with public health needs causes institutional corruption in the pharmaceutical sector and systematically leads firms to act contrary to public heath. The article analyzes how financial incentives generate a business model promoting harmful practices and explores several means of realigning financial incentives in order to foster therapeutic innovation and promote the rational use of medicines.

The global market for biologics and biosimilar pharmaceutical products is experiencing rapid expansion, primarily driven by the continuous discovery of new molecules. However, information regarding Latin America’s biological market remains limited.

This article aims to focus on how signatories versus nonsignatories in the U.S. pharmaceutical sector compare with respect to the internal and external stakeholders and principles of the United Nations Global Compact (UNGC). We seek to answer the question: Do signatories to the UNGC walk the talk better than nonsignatories as determined by a variety of published rankings and data? This research presents an innovative approach to the evaluation of UNGC signatories. It uses several objective and independent data sources (...) to assess a matched group of signatories versus nonsignatories in the U.S. pharmaceutical sector. Signatory organizations in the same sector as determined by SIC codes were matched with nonsignatories on variables such as size and number of employees in U.S. pharmaceutical companies. Then both types of organizations were compared on the following data sources: Coalition for Environmentally Responsible Economies ratings, ratings by external stakeholders, ratings by employees, unionization data, financial measures, and annual reports to shareholders. Using nonparametric testing the research found there are differences between signatories and nonsignatories in the U.S. pharmaceutical sector for some of the external stakeholder measures and no differences were found for the internal stakeholder measures. (shrink)

Michael Ravvin, Department of Political Science, Columbia University, 420 W. 118th Street, New York, NY 10027 Email: mer2133{at}columbia.edu ' + u + '@' + d + ' '//--> Abstract The existing intellectual property regime discourages the innovation of, and access to, essential medicines for the poor in developing countries. A successful proposal to reform the existing system must address these challenges of access and innovation. This essay will survey the problems in the existing pharmaceutical patent system and (...) offer critical analysis of some reform proposals. I will argue that existing mechanisms that are intended to mitigate the harms of the current pharmaceutical patent system, such as bulk buying, differential pricing and compulsory licenses, are inadequate and perhaps even counter-productive over the long-term. Other incentive mechanisms based on push funding, such as government research grants, are inefficient and limited in scope. Pull mechanisms, which offer some reward for successful pharmaceutical innovations, offer a more promising incentive mechanism. I will evaluate three pull mechanisms -- Priority Review Vouchers, Advance Market Commitment (AMC) and the Health Impact Fund -- on the basis of their capacity to incentivize access and innovation, as well as their efficiency and political feasibility. Though the Health Impact Fund appears to be the most promising proposal, more work must be done to overcome challenges of its implementation. CiteULike Connotea Del.icio.us What's this? (shrink)

The need to better balance the promotion of scientific and technological innovation with risk management for consumer protection has inspired several recent reforms attempting to make regulations more flexible and adaptive. The pharmaceutical sector has a long, established regulatory tradition, as well as a long history of controversies around how to balance incentives for needed therapeutic innovations and protecting patient safety. The emergence of disruptive biotechnologies has provided the occasion for regulatory innovation in this sector. This article (...) investigates the regulation of advanced biotherapeutics in the European Union and shows that it presents several defining features of an adaptive regulation regime, notably institutionalized processes of planned adaptation that allow regulators to gather, generate, and mobilize new scientific and risk evidence about innovative products. However, our in-depth case analysis highlights that more attention needs to be paid to the consequences of the introduction of adaptive regulations, especially for critical stakeholders involved in this new regulatory ecosystem, the capacity and resource requirements placed on them to adapt, and the new tradeoffs they face. In addition, our analysis highlights a deficit in how we currently evaluate the performance and public value proposition of adaptive regulations vis-à-vis their stated goals and objectives. (shrink)

BackgroundPatient skepticism concerning medical innovations can have major consequences for current public health and may threaten future progress, which greatly relies on clinical research.The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in clinical research. Specifically, we sought to evaluate if distrust in pharmaceutical companies and associated psychosocial factors could represent a recruitment bias in clinical trials and thus threaten the applicability of their results.MethodsThis prospective, multicenter survey consisted in (...) the administration of a self-questionnaire to patients during a pulmonology consultation. The 1025 questionnaires distributed collected demographics, socio-professional and basic health literacy characteristics. Patients were asked to rank their level of trust for pharmaceutical companies and indicate their willingness to participate in different categories of research.Logistic regression was used to determine factors contributing to “trust” versus “distrust” group membership and willingness to participate in each category of research.ResultsOne thousand patients completed the survey, corresponding to a response rate of 97.5%. Data from 838 patients were analyzed in this study.48.3% of respondents declared that they trusted pharmaceutical companies, while 35.5% declared distrust. Being female, inactive in the employment market, and not-knowing the name of one’s disease are factors related to declared distrust. Distrust-group membership is associated with unwillingness to participate in certain categories of trials such as pre-marketing and industry-sponsored trials.ConclusionDistrust in pharmaceutical companies is associated with a specific patient profile and with refusal to participate in certain subcategories of trials. This potential recruitment bias may explain the under-representation of certain categories of patients such as women in pre-marketing drug trials. (shrink)

This paper aims to characterize the main actors in the Brazilian pharmaceutical industry — national companies, foreign companies and public laboratories — and analyze how they were affected and how they reacted to changes over the last 30 years in the institutional framework. The results show that national companies have been gaining prominence in the Brazilian pharmaceutical market with their internationalization movement and their strengthening of innovation strategies.

Data exclusivity is a temporary exclusive user right on the clinical data that need to be submitted to the regulatory authorities to prove that a new drug is safe and effective. For the pharmaceutical industry, data exclusivity is an important addition to the patent system, as data exclusivity will de facto delay the market entry of generic drugs until after the exclusive user rights on the clinical data have expired. In order to assess the normative legitimacy of the industry’s (...) demand to include minimum standards for data exclusivity in international agreements, this chapter evaluates the three justifications that have frequently been advanced, depicting data exclusivity as an essential policy tool to promote innovation, a mechanism to prevent the generic industry from ‘free-riding,’ and a legal instrument to protect the industry’s property rights in clinical data. (shrink)

Kesselheim proposes doubling the NIH’s budget to promote clinically meaningful pharmaceutical innovation. Since the effects of a previous doubling (from 1998-2003) were mixed, I argue that policymakers should couple future budget growth with investments in experimentation and evaluation.

The aim of this paper is finding an answer to a question how the current crises caused by the Covid-19 pandemic and changes in the energy sector have affected research and development and innovation? It seems likely that the COVID-19 crisis caused financial weakness for many actors, having the most significant impact on the willingness or ability of smaller firms to support R&D and innovation. However, where firms are able to sustain these investments, they will be more likely (...) to survive, grow more strongly, and have higher profitability. A big challenge that companies face is energy changes. While the post-pandemic effects were slowly brought under control by enterprises, the energy crisis poses new challenges to companies. And here the most important challenge is not just financing, but sometimes a complete change in the line of products offered, by moving away from traditional energy sources based on oil and gas. The subjects of the analysis are companies in Poland engaged in continuous research and development activities and implementing innovations. This research was conducted by the Ayming Institute in several editions, starting in 2020, and the surveyed companies belonged to seven identified sectors: Chemical and Civil Engineering, IT & Telecoms, Energy & Biotech, Automotive & Industrial, Consumer Goods & Manufacturing, Healthcare & Pharmaceuticals and Finance & Capital. (shrink)

Armed with expanded federal funding for human embryonic stem cell research and new methods for deriving pluripotent stem cells, stem cell researchers in the U.S. are poised to proceed with unprecedented speed toward the development of new clinical therapies. Staring into the new dawn of regenerative medicine, many observers may assume that the only responsible route to the clinic, both scientifically and ethically, is through FDA-approved clinical trials processes. Conventional wisdom dictates that, like pharmaceutical drugs and the use of (...) biological therapeutics, stem cell-based therapies will have to pass through a series of controlled studies — initially to assess safety and toxicity, then efficacy and comparative efficacy — before they can be justifiably administered to patients outside a clinical trials context. (shrink)

Primary stakeholder pressure has long been considered the main reason that firms engage in responsible behaviors. However, prior studies are generally silent on how industry characteristics reshape the relationships among stakeholders. By integrating information asymmetry in credence goods industries with the stakeholder power framework, we posit that the extent to which consumers can evaluate the qualities of goods alters the dynamics between a firm and its two primary stakeholders, regulators and consumers. Longitudinal data collected on 72 pharmaceutical companies indicate (...) that consumers of pharmaceutical products can only influence firms indirectly through the regulator. Further, contrary to the conventional wisdom that innovative firms are more capable of resisting stakeholder pressure, we find that R&D investment increases the dependency of pharmaceutical firms on the regulator. Lastly, we do not find that lobbying reduces dependency on the regulator except for high R&D firms. These findings provide important theoretical, ethical, and policy implications. (shrink)

Engineering makes profound contributions to our health. Many of these contributions benefit whole populations, such as clean water and sewage treatment, buildings, dependable sources of energy, efficient harvesting and storage of food, and pharmaceutical manufacture. Thus, ethical assessment of these and other engineering activities has often emphasized benefits to communities. This is in contrast to medical ethics, which has tended to emphasize the individual patient affected by a doctor’s actions. However, technological innovation is leading to an entanglement of (...) the activities, and hence ethical responsibilities, of healthcare professionals and engineering professionals. The article outlines three categories of innovation: assistive technologies, telehealthcare and quasi-autonomous systems. Approaches to engineering ethics are described and applied to these innovations. Such innovations raise a number of ethical opportunities and challenges, especially as the complexity of the technology increases. In particular, the design and operation of the technologies require engineers to seek closer involvement with the persons benefiting from their work. Future innovation will require engineers to have a good knowledge of human biology and psychology. More particularly, healthcare engineers will need to prioritize each person’s wellbeing, agency, human relationships and ecological self rather than technology, in the same way that doctors prioritize the treatment of persons rather than their diseases. Content Type Journal Article Category Article Pages 204-221 DOI 10.1558/hrge.v17i2.204 Authors W. Richard Bowen, i-NewtonWales, 54 Llwyn y mor, Caswell, Swansea, SA3 4RD, UK Journal Human Reproduction & Genetic Ethics Online ISSN 2043-0469 Print ISSN 1028-7825 Journal Volume Volume 17 Journal Issue Volume 17, Number 2 / 2011. (shrink)

The discovery and development of new therapeutics has always been central to improving health worldwide. However, there is ongoing concern regarding the current state of medical innovation. Output from the pharmaceutical industry has been criticized for not being “transformative,” that is, offering substantial improvements in patient outcomes over existing therapeutics. While the cost of drug development continues to rise, breakthrough therapies remain elusive and one half of Phase 3 studies fail. Venture capital, a traditional source of funding for (...) new breakthrough biomedical innovations, has decreased investment by 30% in the biotechnology and medical device sectors from 2007 to 2013. Stakeholders question whether the new drugs approved each year by the FDA —many criticized as marginal improvements over existing therapies — justify the enormous investment. (shrink)

Health innovation is mainly envisioned in direct connection to medical research institutions or pharmaceutical and technology companies. Yet, these types of innovation often do not meet the needs and expectations of individuals affected by health conditions. With the emergence of digital health technologies and social media, we can observe a shift, which involves people living with illness modifying and improving medical and health devices outside of the formal research and development sector, figuring both as users and innovators. (...) This patient‐led innovation has been celebrated in innovation studies and economics as a “bottom‐up” type of innovation. In this article, we take a closer look at open‐source patient‐led innovation in the context of type 1 diabetes care. In our inquiry, we pay particular attention to the social and ethical dimensions of this innovation, building on empirical material. Upon exploring the notion of patient‐led innovation and its socio‐political context through the lens of intersectional and global health justice, we argue that a proactive strategy is needed to ensure that open‐source patient‐led innovation will be more globally accessible, center the health needs of the most underserved populations, as well as facilitate equitable and just health benefits. To support this aim, we provide a range of examples of different initiatives addressing the persistent inequalities that have so far inhibited patient‐led innovation from more fully materializing its innovative potential. (shrink)

From the leader of the nation's most powerful animal-protection organization comes a frontline account of how conscience and creativity are driving a revolution in American business that is changing forever how we treat animals and create wealth. Wayne Pacelle of the Humane Society of the United States reveals how entrepreneurs, Fortune 500 CEOs, world-class scientists, philanthropists, and a new class of political leaders are driving the burgeoning, unstoppable growth of the "humane economy." Every business grounded on animal exploitation, Pacelle argues, (...) is ripe for disruption. Indeed each one of us is, and will be, touched by this far-reaching transformation in food and agriculture; in the pharmaceutical, chemical, and cosmetics industries; in film, television, and live entertainment; in tourism and wildlife management; in the pet trade for dogs and cats and exotic wildlife; and in fur and leather fashions. Collectively it promises to relieve or end the suffering of billions of creatures, while allowing businesses aligned with the best instincts and values of their customers to flourish. Pacelle shows, for instance, how the cruelties of industrial chicken farming are quickly becoming obsolete with a visit to Hampton Creek, the makers of a plant-based egg substitute and the world's fastest-growing food startup ever. Pacelle also recounts the stories of how established companies are joining in this economic transformation: from Petco and PetSmart, which have turned the conventional pet store model on its head by forswearing puppy mill suppliers in favor of shelter dogs; to John Paul Mitchell Systems, the Body Shop, and Lush, which use safe ingredients instead of animal tests for their cosmetics; to major food retailers like Whole Foods, Chipotle, and even Costco and Walmart, which are embracing animal welfare standards that are one by one unwinding the horrors of the factory farm. The Humane Economy is a clarion call to business leaders and to the world's growing animal protection movement; it is equally a warning to the static thinking of animal-use industries and their apologists: "Here, in this humane economy," Pacelle argues, "human ingenuity meets human virtue, and we discover at last that we can have it both ways--a better world for us and for animals, too. (shrink)

Rational drug design is a method for developing new pharmaceuticals that typically involves the elucidation of fundamental physiological mechanisms. It thus combines the quest for a scientific understanding of natural phenomena with the design of useful technology and hence integrates epistemic and practical aims of research and development. Case studies of the rational design of the cardiovascular drugs propranolol, captopril and losartan provide insights into characteristics and conditions of this integration. Rational drug design became possible in the 1950s when theoretical (...) knowledge of drug-target interaction and experimental drug testing could interlock in cycles of mutual advancement. The integration does not, however, diminish the importance of basic research for pharmaceutical development. Rather, it can be shown that still in the 1990s, linear processes of innovation and the close combination of practical and epistemic work were interdependent. (shrink)

Rational drug design is a method for developing new pharmaceuticals that typically involves the elucidation of fundamental physiological mechanisms. It thus combines the quest for a scientific understanding of natural phenomena with the design of useful technology and hence integrates epistemic and practical aims of research and development. Case studies of the rational design of the cardiovascular drugs propranolol, captopril and losartan provide insights into characteristics and conditions of this integration. Rational drug design became possible in the 1950s when theoretical (...) knowledge of drug-target interaction and experimental drug testing could interlock in cycles of mutual advancement. The integration does not, however, diminish the importance of basic research for pharmaceutical development. Rather, it can be shown that still in the 1990s, linear processes of innovation and the close combination of practical and epistemic work were interdependent. (shrink)

In this paper, we provide an overview of how the outcomes of the Uruguay Round affected the application of pharmaceutical intellectual property rights globally. Second, we explain how specific pharmaceutical policy tools can help developing states mitigate the worst effects of the TRIPS Agreement. Third, we put forward solutions that could be implemented by the World Bank to help overcome the divide between creating private incentives for research and development of innovative medicines and ensuring access of the poor (...) to medicine. Fourth, we evaluate these solutions on the basis of utilitarian considerations and urge that equitable pricing is morally preferable to the other solutions. (shrink)

Purpose: The research explored empirical evidence to assess the impact of cyber security and supply chain risk on digital operations in the UAE pharmaceutical industry. Methodology/Design/Approach: Based on responses from 243 personnel working at 14 pharmaceutical manufacturing companies in Dubai, data were examined for normality, instrument validity and regression analysis. Cyber security and SC risk on digital operations were explored by applying convenient sampling and descriptive and analytical research design. Findings: The findings validated the significant positive association between (...) cyber security and supply chain risk with digital operations. Research implications and Limitations: The research model was developed with three variables evaluated only on the pharmaceutical industry in Dubai. Future research should focus on multiple manufacturing industries by covering a larger geographic area. Practical implications: When suppliers are highly concentrated, customer-focused organisations with uncertain levels of digital transformation could improve their ability to manage supply chain risk by diversifying their clients. Pharmaceutical firms may require a greater focus on technology-based manufacturing firms to build and maintain customer trust. Originality Value: To illustrate how the pharmaceutical industry has explored the relationship between cyber security, supply chain risk and digital operations, the research highlights the significant and convoluted consequences of the relationship model that have not been previously considered. (shrink)

In this paper, we provide an overview of how the outcomes of the Uruguay Round affected the application of pharmaceutical intellectual property rights globally. Second, we explain how specific pharmaceutical policy tools can help developing states mitigate the worst effects of the TRIPS Agreement. Third, we put forward solutions that could be implemented by the World Bank to help overcome the divide between creating private incentives for research and development of innovative medicines and ensuring access of the poor (...) to medicine. Fourth, we evaluate these solutions on the basis of utilitarian considerations and urge that equitable pricing is morally preferable to the other solutions. (shrink)

This special JLME symposium addresses ways that federal policy can incentivize innovation in medical therapeutics and make pharmaceuticals more financially accessible.

Business ethics of innovation strives to give orientation in settings where new products, new markets, new environments are predominant. The provision of new products and solutions is inseparably intertwined with the consequences of their use. These can be manifold and in some cases an (unwanted) consequence might even preclude them from being used. A case in point is illustrated by an example from the pharmaceutical industry.

The inclusion of antimicrobial resistance (AMR) and increased research and development (R&D) capabilities in the most recent outline of the World Health Organization’s (WHO’s) international pandemic instrument signals an opportunity to reshape pharmaceutical R&D system in favour of antimicrobial product development. This article explains why the current innovation ecosystem has disadvantaged the creation of antimicrobial products for human use. It also highlights how the COVID-19 pandemic experience can inform and stimulate international cooperation to implement innovative R&D incentives to (...) bring new, life-saving antimicrobial products to the market. (shrink)

The US government supports drug innovation. It is therefore crucial that it distinguish between high-value and low-value innovation in purchasing expensive prescription drugs and medical devices and ensure the continued discovery of transformative drugs and that patient and taxpayer funds are not wasted.

The purpose of the study is to analyze the changes in the pharmaceutical industry in Russia in 2020. Recently, Russia has been facing an acute threat to the economic security of the pharmaceutical industry, due to the likelihood of increasing influence on the Russian industry by world players. Therefore, the analysis of the possibilities of innovative import substitution of foreign supplies to increase the level of security of the country in the field of drug supply has now become (...) particularly relevant. The scientific novelty lies in the justification of the availability of opportunities for the development of innovative import substitution of medicines in Russia. As a result, the latest trends confirm the prospects for further effective development of the domestic pharmaceutical industry. (shrink)

The negotiations of the intergovernmental group known as the ‘IGWG’, undertaken by the Member States of the WHO, were the result of a deadlock in the World Health Assembly held in 2006 where the Member States of the WHO were unable to reach an agreement on what to do with the 60 recommendations in the report on ‘Public Health, Innovation and Intellectual Property Rights submitted to the Assembly in the same year by a group of experts designated by the (...) Director General of the WHO. The result of these negotiations was the ‘Global strategy and plan of action on public health, innovation and intellectual property’ which was approved by the World Health Assembly in 2008. The intention of the Global Strategy and Plan of Action (GSPOA) which was produced by the IGWG was to substantially reform the pharmaceuticals' research and development system in view of the findings that this system, whose purpose is to produce medicines for diseases which affect the greater part of the world population which lives in developing countries, had failed. The intellectual property rights imposed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the recent trade agreements could become one of the main obstacles to access to medicines. The GSPOA makes a critical analysis of this reality, and opens the door to searching for new solutions to this problem. (shrink)

Worries about safety of approved drugs have pushed post registration research to become the fastest growing drug research phase. Until recently, phase IV studies were mainly conducted for marketing purposes and run much like a phase III trial—at institutions with experienced investigators and a list of inclusion and exclusion criteria. Innovative phase IV studies involve ordinary physicians in research naïve communities. This brings ethical issues familiar to medical research into clinical practice. As a consequence, individual physicians are challenged to protect (...) scientific integrity and to secure the ethical conduct of research. Several ethical issues need to be addressed in the process of developing a scientifically sound and ethically high principled practice of phase IV research.PHASE IVEssential to phase IV research is the focus on how drugs work in the real world. The research goal may be to explore a specific pharmacological effect, to establish the incidence of adverse reactions, or to determine the effects of long-term administration of a drug. They may also be designed to establish a new clinical indication for a drug.1 Subjects may or may not be randomised, and the studies typically involve large numbers of patient-subjects and physicians.Doubts concerning the scientific rigor and clinical value have put postmarketing research in a poor light. However, high quality phase IV research is badly needed to further pharmaceutical science. First, because it can provide reliable data on the effectiveness, safety and optimal use of a drug in treated populations.2 3 In pre-registration clinical trials , a pharmaceutical product is studied under unrealistic circumstances. Under-representation of women and elderly are common and the concomitant use of medicines is usually extremely restrictive in these trials.4 Second, phase IV can provide much needed data for evidence-based …. (shrink)

How corporations surveil and influence consumers using big data tools is a major area of research and public debate. However, few studies explore it in relation to physicians in the USA, even though they have been surveilled and targeted by the pharmaceutical industry since at least the 1950s. Indeed, in 2010, concerns about the pharmaceutical industry's undue influence led to the passing of the Physician Sunshine Act, a unique piece of transparency legislation that requires companies to report their (...) financial ties to physicians and teaching hospitals in a public database. This article argues that while the Sunshine Act has clearly helped expose important commercial influences on both prescribing and the scale of industry involvement with physicians, it has also, paradoxically, fuelled further commercial surveillance and marketing. The article casts new light on innovative pharmaceutical marketing approaches and the key role of data brokers and analytics companies in the identification, targeting, managing, and surveillance of physicians. We place this analysis within the political economies of the pharmaceutical industry, surveillance-based marketing, and transparency, and argue that policies to promote increased transparency must be tightly tied to policies that impede the commodification and use of transparency data for surveillance and marketing purposes. (shrink)

Cross-sectorial, dynamic, and innovative partnerships are essential to resolve the challenges of humankind in the 21st century. At the same time, trust in each other’s integrity and good will is a precondition for the solution of any complex problem, and certainly for the success of the United Nations Sustainable Development Agenda. Experience shows that a nation’s economic and social success is at its greatest if, and when, there is cooperation and even cocreation involving a fair division of labor and responsibility (...) among the different societal stakeholders. This paper uses Ralf Dahrendorf’s seminal work on obligations, as well as the European Commission’s Science with and for Society unit’s definition of responsible research and innovation (RRI), to motivate industry responsibilities to make the world a healthier place. (shrink)

Centre for Applied Philosophy and Public Ethics (CAPPE), Menzies Centre for Health Policy, The Australian National University, LPO Box 8260, ANU Canberra ACT 2601, Australia. Tel.: +61 (0)2 6125 4355; Mobile: +61 (0)431 124 286; Fax: +61 (0)2 6125 6579; Email: michael.selgelid{at}anu.edu.au ' + u + '@' + d + ' '//--> Abstract Thomas Pogge has proposed a supplement to the standard patent regime whereby innovating companies would be rewarded in proportion to the extent to which their innovations lead to (...) reduction of the global burden of disease (GBD). This paper argues that an expansion of this proposal—whereby provision of already existing medicines are incentivised in a similar way—would provide a more comprehensive solution to the healthcare situation in developing countries. It then considers the practical challenges that the implementation of such a proposal (expanded or otherwise) would entail. Though these include difficulties associated with disease burden metric, I argue that the most serious difficulties are associated with the problem of causal attribution. A basic idea underlying Pogge's proposal is that the disease burden reduction attributable to particular interventions can be determined. Theoretically speaking, in cases involving multiple interacting causal factors, there may be no fact of the matter regarding the extent to which disease burden reduction should be attributed to one intervention as opposed to another; and (even if workable practical solutions to this theoretical challenge can be met) the data requirements for implementation would be daunting. CiteULike Connotea Del.icio.us What's this? (shrink)

Great individuals are assumed to cause the success of radical innovations--thus Henry Ford is depicted as the one who established the automobile industry in America. Hayagreeva Rao tells a different story, one that will change the way you think about markets forever. He explains how "market rebels"--activists who defy authority and convention--are the real force behind the success or failure of radical innovations. Rao shows how automobile enthusiasts were the ones who established the new automobile industry by staging highly publicized (...) reliability races and lobbying governments to enact licensing laws. Ford exploited the popularity of the car by using new mass-production technologies. Rao argues that market rebels also establish new niches and new cultural styles. If it were not for craft brewers who crusaded against "industrial beer" and proliferated brewpubs, there would be no specialty beers in America. But for nouvelle cuisine activists who broke the stranglehold of Escoffier's classical cuisine in France, there would have been little hybridization and experimentation in modern cooking. Market rebels also thwart radical innovation. Rao demonstrates how consumer activists have faced down chain stores and big box retailers, and how anti-biotechnology activists in Germany penetrated pharmaceutical firms and delayed the commercialization of patents. Read Market Rebels to learn how activists succeed when they construct "hot causes" that arouse intense emotions, and exploit "cool mobilization"--unconventional techniques that engage audiences in collective action. You will realize how the hands that move markets are the joined hands of market rebels. (shrink)