The International Bill of Rights enshrines a right to health, which includes a right to access essential medicines. This right frequently appears to conflict with the intellectual property regime that governs pharmaceutical patents. However, there is also a human right that protects creative works, including scientific productions. Does this right support intellectual property protections, even when they may negatively affect health? -/- This article examines the recent attempt by the Committee on Economic, Social and Cultural Rights to resolve (...) this issue and argues that it fails. This is problematic because it means defenders of the present patent regime can continue using human rights documents to support their position. I offer a new framework for resolving the problem by examining the values that underlie human rights. (shrink)

As a result of the doctoral research developed by the main author (Vargas-Chaves, 2017), it was identified the evolution and perspectives of the pharmaceutical patent in the international trade system, as well as it future legal research needs in this topic, both immediate and long-term. Furthermore, a number of problems of public health were highlighted in which the patent-term-extension mechanisms have produced a lack of access to medicines.

The moral justification of intellectual property is often called into question when placed in the context of pharmaceutical patents and global health concerns. The theoretical accounts of both John Rawls and Robert Nozick provide an excellent ethical framework from which such questions can be clarified. While Nozick upholds an individuals right to intellectual property, based upon its conformation with Lockean notions of property and Nozicks ideas of just acquisition and transfer, Rawls emphasizes the importance of basic liberties, such (...) as an individuals right to health, superceding such secondary rights as intellectual property rights. From a policy perspective, patent protection for pharmaceutical products necessarily entails the balancing of corporate intellectual property interests and public interests in healthcare. The moral dilemma that occurs when these two interests clash is not easily resolved. Aside from corporate and public interests, the state maintains an interest in creating and preserving policies that regulate the moral dilemma itself. This paper analyzes the economic and ethical factors surrounding the production and distribution of the anti-HIV medication, AZT. Potential policy implications and recommendations are also discussed. (shrink)

Most bioethicists who address questions to which global justice matters have not considered the significance of the disputes over the correct theory of global justice. Consequently, the significance of the differences between theories of global justice for bioethics has been obscured. In this paper, I consider when and how these differences are important. I argue that certain bioethical problems can be resolved without addressing disagreements about global justice. People with very different views about global justice can converge on the existence (...) of a duty to aid the very badly off — those in absolute poverty — wherever they may be. However, despite agreement on extreme cases, there should be disagreement over the extent of international obligations to those who are only relatively poor. Consequently, different theories of justice will diverge in their implications for a number of important problems in contemporary bioethics. I close by sketching in more detail two contemporary bioethical issues —concerning pharmaceutical patents and the health worker brain drain —and show how responses to them might be developed by cosmopolitan and statist liberals. (shrink)

Se hace un llamado de atención a través de este capítulo de libro a los gobiernos locales y la Academia, para proponer políticas públicas donde se incluyan bases o lineamientos para la estructuración de un derecho global de acceso a los medicamentos. Para estos efectos, se importan a manera de pilares, tres planteamientos desde la óptica de la justicia global, que consideramos pueden acoplarse a esta problemática, y que aportan elementos novedosos al abordaje de los numerosos obstáculos que se suelen (...) presentar en las discusiones, especialmente en lo que respecta a la regulación del monopolio de la patente, y al tratamiento diferenciado que se les da a los ciudadanos de países desarrollados y en desarrollo. (shrink)

Ongoing research in the fields of genetics and biotechnology hold the promise of improved diagnosis and treatment of genetic diseases, and potentially the development of individually tailored pharmaceuticals and gene therapies. Difficulty, however, arises in determining how these services are to be evaluated and integrated equitably into public health care systems such as Canada's. The current context is one of increasing fiscal restraint on the part of governments, limited financial resources being dedicated to health care, and rising costs for new (...) health care services and technologies. This has led to increasing public debate in the last few years about how to reform public health care, and whether we should prohibit, permit or perhaps even encourage private purchase of health care services. ;In Canada, some of these concerns have crystallized around the issue of gene patents and commercial genetic testing, in particular as illustrated by the case of Myriad Genetics' patented BRACAnalysis test for hereditary breast and ovarian cancer. While most Canadians who currently access genetic services do so through the public health care system, for those with the means, private purchase is becoming an option. This situation raises serious concerns---about justice in access to health care; about continued access to safe and reliable genetic testing supported by unbiased patient information; and about the broader effects of commercialization for ongoing research and the Canadian public health care system. Commercial genetic testing presents a challenge to health care professionals, policy analysts, and academics concerned with the social, ethical and policy implications of new genetic technologies. Using the Myriad case as an exemplar, tools from moral philosophy, the social sciences, and health policy and law will be brought to bear on the larger issues of how as a society we should regulate commercial research and product development, and more coherently decide which services to cover under public health insurance and which to leave to private purchase. Generally, the thesis is concerned with the question of "how best to bring capital, morality, and knowledge into a productive and ethical relationship". (shrink)

One of the most attractive, but nevertheless highly controversial proposals to alleviate the negative effects of today’s international patent regime is the Health Impact Fund (HIF). Although the HIF has been drafted to facilitate access to medicines and boost pharmaceutical research, we have analysed the burdens for the global poor a similar proposal designed to promote the use and development of climate-friendly technologies would have. Drawing parallels from the access to medicines debate, we suspect that an analogous “Climate Impact (...) Fund” will increase the already very high scientific and technological supremacy of the developed world over the Global South. We advocate countering this dominance on the ground that countries with scarce research and development capacities will be in a difficult position to reject technologies and will not have a say on how such technologies should look like. Further, addressing global hazards should be an inclusive endeavour and not only a privilege reserved for the developed world. Incentivizing grassroots innovation would be a major step to promote scientific and technological inclusion. (shrink)

Nanomedicine applications are an extension of traditional pharmaceutical drug development that are targeting the most pressing health concerns through improvements to diagnostics, drug delivery systems, therapeutics, equipment, surgery and prosthetics. The benefits and risks to the individual have been extrapolated to include broader societal impacts of nanomedicine with concerns extending to inequitable distribution of benefits accruing to developed, or North countries, rather than developing, or South countries. Analysis reveals a great deal of overlap between the North and South's most (...) serious health priorities which kill millions each year. A significant amount of nanomedicine research activity is also underway for the most pressing South country-specific health concerns. Nanomedicine development promises profound breakthroughs for both North and South countries; however, the existing inequities in pharmaceutical drug development, patenting, access and delivery remain significant barriers for South countries. (shrink)

How heavily should ethical considerations weigh in allowing or disallowing genetic patents? The concept of 'ordre public' can be useful in offsetting a simple utilitarian view.

Risk communication has been generally categorized as a warning act, which is performed in order to prevent or minimize risk. On the other side, risk analysis has also underscored the role played by information in reducing uncertainty about risk. In both approaches the safety aspects related to the protection of the right to health are on focus. However, it seems that there are cases where a risk cannot possibly be avoided or uncertainty reduced, this is for instance valid for the (...) declaration of side effects associated with pharmaceutical products or when a decision about drug approval or retirement must be delivered on the available evidence. In these cases, risk communication seems to accomplish other tasks than preventing risk or reducing uncertainty. The present paper analyzes the legal instruments which have been developed in order to control and manage the risks related to drugs – such as the notion of “development risk” or “residual risk” – and relates them to different kinds of uncertainty. These are conceptualized as epistemic, ecological, metric, ethical, and stochastic, depending on their nature. By referring to this taxonomy, different functions of pharmaceutical risk communication are identified and connected with the legal tools of uncertainty management. The purpose is to distinguish the different functions of risk communication and make explicit their different legal nature and implications. (shrink)

Pharmaceutical paternalism is the normative stance upheld by pharmaceutical regulatory agencies like the US Food and Drug Administration. These agencies prevent patients from accessing treatments declared safe and ineffective for the patient’s good without their consent. Libertarian critics of the FDA have shown a number of significant flaws in regulatory paternalism. Against these objections, I will argue that, in order to make an informed decision about treatments, a libertarian patient should request full disclosure of the uncertainty about an (...) experimental treatment. But pharmaceutical markets, on their own, are not a reliable source of information about such uncertainty. And companies have the power to capture any independent expert who may assess it. Therefore, the libertarian is better off deferring on an independent regulatory body the assessment of the pharmaceutical risks, constraining access to treatments until tested. (shrink)

This paper examines the claims that moral objections to the patenting of human genes are misplaced and rest on confusions about what a patent is, or what is patented by a human gene patent. It shows that theese objections rest on too simple a conception of property rights, and the connections betwteen familiar moral objections to private property and moral objections to the patenting of human genes. Above all, the paper claims, objections to HGPs often reflect worries about the lack (...) of democratic oversight, accountability and participation involved in grants of intellectual property. The paper claims that we should take these worries seriously, whether or not we think HGPs immoral. (shrink)

Social contract is one of the most common schemes for justifying patents. According to this theory, inventors obtain a commercial exclusivity in exchange for the disclosure of the invention, with the final aim of allowing others to use that knowledge in future innovations. Under the rationale of this social contract theory of patents, if a patent system is not guided by impartiality in its decisions, the relation between disclosure of inventions and future innovation becomes an issue, because non-merit (...) factors in patent examination influence the quality of the knowledge disclosed. The aim of this article is to analyse impartiality in patent systems and, by doing so, defend that there is an epistemic side on both impartiality and social contract theory. (shrink)

Software patents are commonly criticised for being fuzzy, context-sensitive, and often granted for trivial inventions. More often than not, these shortcomings are said to be caused by the abstract nature of software - with little further analysis offered. Drawing on Plato’s Parmenides, this paper will argue (1) that the reason why software patents seem to be elusive is that patent law suggests to think about algorithms as paradigmatic examples and (2) that Plato’s distinction between two modes of predication (...) and the role of competence in his account of knowledge are helpful not only for conceptualising knowledge of algorithms, but also for understanding the limits of software patent regimes. (shrink)

The objective of the paper is to analyze whether that the pharmaceutical companies producing HIV drugs have moral obligation(s) towards the HIV victims in developing countries who don‟t have access to get drug to reduce their risks. The primary assessment is that the pharmaceutical companies have minimum moral obligation(s) to the HIV patients especially in developing countries. It is because they are human beings and hence they are the subject of moral considerations. The paper argues that from the (...) sense of benevolence, there may be an obligation that will tend pharmaceutical companies to make an opportunity of the concerned HIV patients of developing countries to get drugs. The discussion will be made from the utilitarian point of view. Though it is assumed that, utilitarianism is too demanding, I will show that the too demanding ness of utilitarianism can be minimized and it will not be contradictory with the main theme of utilitarian morality. In this respect the counter examples and arguments will also be analyzed to make the claim stronger. The paper also argues that though the primary aim of the pharmaceutical companies is to make money, the actions that might be taken by the pharmaceutical companies for the welfare of HIV victims will not hamper them in making money for which they are deployed. (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)

Purpose. The main objective of this article is to discuss the suitability of moral and ordre public clauses, and to advance the view that ethical reflection within patent systems is valuable. Methodology. This is a conceptual paper that draws upon the present situation in Europe to illuminate a discussion of the different views about the morality patents, with particular emphasis on criticism of authors who have espoused a narrow interpretation of moral clauses, such as that adopted by the EPO. (...) Findings. This research found that the claim that patent systems are not appropriate places in which to evaluate moral matters and, therefore, they cannot inform us about morality, is false. This is because inventors do not need to wait for authorizing legislation prior to making use of their technology. Hence, moral implications can be evaluated. Practical implications. It is shown how the bioethicist community can be incorporated into patent offices. The responsibilities of examiners and businesses in the process are also discussed. Research limitations/implications. These ideas also lead to important theoretical consequences, especially regarding the debate on value-laden science and technology. However, further efforts are needed to address other patent regimes, such as the non-European. Originality. There have been a limited number of studies that examine the value of ethical considerations within the patent system. This article provides a thought-provoking discussion of moral clauses in Europe. I also suggest new ways of incorporating ethical scrutiny into patent systems. (shrink)

A number of concerns have been raised about the possible future use of pharmaceuticals designed to enhance cognitive, affective, and motivational processes, particularly where the aim is to produce morally better decisions or behavior. In this article, we draw attention to what is arguably a more worrying possibility: that pharmaceuticals currently in widespread therapeutic use are already having unintended effects on these processes, and thus on moral decision making and morally significant behavior. We review current evidence on the moral effects (...) of three widely used drugs or drug types: propranolol, selective serotonin reuptake inhibitors, and drugs that effect oxytocin physiology. This evidence suggests that the alterations to moral decision making and behavior caused by these agents may have important and difficult-to-evaluate consequences, at least at the population level. We argue that the moral effects of these and other widely used pharmaceuticals warrant further empirical research and ethical analysis. (shrink)

Limitless is a movie (released in 2011) as well as a novel (published in 2001) about a tormented author who (plagued by a writer’s block) becomes an early user of an experimental designer drug. The wonder drug makes him highly productive overnight and even allows him to make a fortune on the stock market. At the height of his career, however, the detrimental side-effects become increasingly noticeable. In this article, Limitless is analysed from two perspectives. First of all, building on (...) the views of the French novelist Emile Zola, the novel is seen as the report of a closely monitored experiment. Subsequently, building on the phenomenology of Ludwig Binswanger, I will show how the cognitive enhancement drug not only boosts the protagonist’s information processing capacities, but also modifies his experience of space and time, his sense of spatiality, his way of being-in-the-world. On the basis of these (complementary) analyses I will indicate how genres of the imagination (such as movies and novels) may play a significant role in assessing the societal implications of emerging technological developments such as neuro-enhancement, especially during the preparatory or anticipatory stage. (shrink)

Genetically engineered (GE) insects, such as the GE OX513A Aedes aegypti mosquitoes, have been designed to suppress their wild-type populations so as to reduce the transmission of vector-borne diseases in humans. Apart from the ecological and epidemiological uncertainties associated with this approach, such biotechnological approaches may be used by individual governments or the global community of nations to avoid addressing the underlying structural, systemic causes of those infections... We discuss here key ethical questions raised by the use of GE mosquitoes, (...) with the aim of fostering discussion between the public, researchers, policy makers, healthcare organizations, and regulatory agencies at the local, national, and international levels. We affect that goal by outlining a procedural approach to decision-making about the use of the “biotechnology” that goes beyond “community engagement.” The protocol we advocate for entails informed deliberations and decision-making at the community level. It is designed to ensure that the voices of the marginalized and vulnerable groups that would be disproportionately affected by the decision are heard during the community-wide discussions. Moreover, we make the case that the values embedded in the risk assessment should be identified so that the community can make an informed decision about the use of GE insects. In addition, we advocate for the involvement of a variety of actors whose responsibility would be to ensure that the community has the opportunity to make an informed decision based on deliberations about the use of the “biotechnology.”. (shrink)

All parties involved in researching, developing, manufacturing, and distributing COVID-19 vaccines need guidance on their ethical obligations. We focus on pharmaceutical companies' obligations because their capacities to research, develop, manufacture, and distribute vaccines make them uniquely placed for stemming the pandemic. We argue that an ethical approach to COVID-19 vaccine production and distribution should satisfy four uncontroversial principles: optimising vaccine production, including development, testing, and manufacturing; fair distribution; sustainability; and accountability. All parties' obligations should be coordinated and mutually consistent. (...) For instance, companies should not be obligated to provide host countries with additional booster shots at the expense of fulfilling bilateral contracts with countries in which there are surges. Finally, any satisfactory approach should include mechanisms for assurance that all parties are honouring their obligations. This assurance enables countries, pharmaceutical companies, global organisations, and others to verify compliance with the chosen approach and protect ethically compliant stakeholders from being unfairly exploited by unethical behaviour of others. (shrink)

Abstract: To improve the countries’ pharmaceutical situation and to monitor the progress, the World Health Organization (WHO) and member states developed a system of indicators to measure the respective important aspects as a prerequisite step. Level I indicators to assess the country’s pharmaceutical situation include the national drug policy; legislation and regulations; drug accessibility and affordability; essential drug list; quality control; pharmacovigilance; storage and distribution; information and rational use. This study is aimed to document the professional opinion of (...) 20 pharmacy practice professionals on Libya’s current pharmaceutical situation, utilizing WHO indicator-based approach. The core indicators measure the most important information needed to understand the pharmaceutical situation in a country. A closed-end questionnaire was distributed to ten practicing pharmacists and ten pharmacy teaching staff members who practice pharmacy. The questionnaires were handed over personally and collected on the same day. The responses were analyzed using simple statistics. The results were argued in the light of the first author’s observation and view, being expert in this field, with reference to the other experts’ views, relevant publications’ findings and WHO reports’ conclusions on these indicators. Suggestions and recommendations for a proper situation assessment, planning and action taking are presented. Primarily, government’s commitment towards appropriate restructuring, management and monitoring of the pharmaceutical sector is crucial. That is to enhance the country’s pharmaceutical situation, to provide and sustain efficient pharmaceutical services and to improve the overall health care system’s performance. (shrink)

This paper argues that regulatory agencies have a responsibility to further the public interest when they determine the conditions under which new technological products may be commercialized. As a case study, this paper analyzes the US 9th Circuit Court’s ruling on the efforts of the US Environmental Protection Agency to regulate an herbicide meant for use with seed that are genetically modified to be tolerant of the chemical. Using that case, it is argued that when regulatory agencies evaluate new technological (...) products, they have an obligation to draw on data, analyses, and evaluations from a variety of credible epistemic sources, and not rely solely or even primarily on the technology developer. Otherwise, they create conditions for their own domination and that of the polity by the technology developer. Moreover, in the interest of advancing the public interest, regulatory agencies must evaluate new technologies in a substantively and procedurally unbiased manner. (shrink)

Many people believe that the research-based pharmaceutical industry has a ‘special’ moral obligation to provide lifesaving medications to the needy, either free-ofcharge or at a reduced rate relative to the cost of manufacture. In this essay, I argue that we can explain the ubiquitous notion of a special moral obligation as an expression of emotionally charged intuitions involving sacred or protected values and an aversive response to betrayal in an asymmetric trust relationship. I then review the most common arguments (...) used to justify the claim that the pharmaceutical industry has a special moral obligation and show why these justifications fail. Taken together, these conclusions call into question the conventional ideologies that have traditionally animated the debate on whether the pharmaceutical industry has special duties of beneficence and distributive justice with respect to the impoverished in dire need of their products. (shrink)

This study presented the policy of functional integration of the product planning team as a strategy for the development of the pharmaceutical industry in Palestine. The study population consists of all the workers in companies operating in the field of medicine in Palestine, which are (5) companies producing in the West Bank only for pharmaceuticals used by these companies, which are (296) employees, and was used a simple random sample to choose the sample and size (87) employees of the (...) study population, and to achieve the objectives of the study (87) questionnaires were distributed. The descriptive analytical method was used, and SPSS was used to answer and discuss the study's questions. The results showed that there is a significant relationship between the effectiveness of the policy of product development and the competitiveness of pharmaceutical companies in Palestine (West Bank), where the policy of product development efficiency accounts for 56.6% of the total change in the competitiveness of companies. The product quality component was most influential at all levels of product development effectiveness policy, followed by product identification, product cost reduction, packaging and product deletion. The weakest areas of strategic direction in pharmaceutical companies in Palestine (West Bank) are 67%. The weakest aspects of job integration are: non-regular meetings of representatives of different positions to participate in any project related to product development, to achieve spatial convergence of members of the product planning policy team in offices, laboratories and workplaces. (shrink)

With the passage and implementation of the “first-to-file” provisions of the America Invents Act of 2011, the U.S. patent system must rely more than ever before on patent documents for its own ontological commitments concerning the existence of claimed kinds of useful objects and processes. This Article provides a comprehensive description of the previously unrecognized function of the patent document in incurring and securing warrants to these ontological commitments, and the respective roles of legal doctrines and practices in the patent (...) system’s ontological project. Among other contributions, the resulting metaphysical account serves to reconcile competing interpretations of the written description requirement that have emerged from the Federal Circuit’s recent jurisprudence, and to explain why the patent system is willing and able to examine, grant and enforce claims reciting theoretical entities. While this Article is entirely descriptive, it concludes by identifying promising normative and prescriptive implications of this work, including the formulation of an appropriate test for the patent-eligibility of software-implemented inventions in the post-Bilski era. (shrink)

The aim of this paper is to retrace the history of genetic patents, analyzing the metaphors used in the public debate, in patent offices, and in courtrooms. I have identified three frames with corresponding metaphor clusters: the first is the industrial frame, built around the idea that DNA is a chemical; the second is the informational frame, assembled around the concept of genetic information; last is the soul frame, based on the idea that DNA is or contains the essence (...) of the individual. (shrink)

After raising some minor philosophical points about Kevin Elliott’s A Tapestry of Values (2017), I argue that we should expand on the themes raised in the book and that philosophers of science need to pay as much attention to the loom of science (i.e., the institutional structures which guide the pursuit of science) as the tapestry of science. The loom of science includes such institutional aspects as patents, funding sources, and evaluation regimes that shape how science gets pursued, and (...) that attending to these aspects will enable us to provide more robust guidance on the values that infuse the tapestry of science. (shrink)

This article contends that the environmental release of genetically engineered (GE) animals with heritable traits that are patented will present a challenge to the efforts of nations and indigenous peoples to engage in self‐determination. The environmental release of such animals has been proposed on the grounds that they could function as public health tools or as solutions to the problem of agricultural insect pests. This article brings into focus two political‐economic‐legal problems that would arise with the environmental release of such (...) organisms. To address those challenges, it is proposed that nations considering the environmental release of GE animals must take into account the underlying circumstances and policy failures that motivate arguments for the use of the modified animals. Moreover, countries must recognize that the UN International Covenant on Civil and Political Rights and the UN International Covenant on Economic, Social and Cultural Rights place on them an obligation to ensure that GE animals with patented heritable traits are not released without the substantive consent of the nations or indigenous peoples that could be affected. (shrink)

The controversy over the old ideal of “value-free science” has cooled significantly over the past decade. Many philosophers of science now agree that even ethical and political values may play a substantial role in all aspects of scientific inquiry. Consequently, in the last few years, work in science and values has become more specific: Which values may influence science, and in which ways? Or, how do we distinguish illegitimate from illegitimate kinds of influence? In this paper, I argue that this (...) problem requires philosophers of science to take a new direction. I present two case studies in the influence of values on scientific inquiry: feminist values in archaeology and commercial values in pharmaceutical research. I offer a preliminary assessment of these cases, that the influence of values was legitimate in the feminist case, but not in the pharmaceutical case. I then turn to three major approaches to distinguish legitimate from illegitimate influences of values, including the distinction between epistemic and non-epistemic values and Heather Douglas’ distinction between direct and indirect roles for values. I argue that none of these three approaches gives an adequate analysis of the two cases. In the concluding section, I briefly sketch my own approach, which draws more heavily on ethics than the others, and is more promising as a solution to the current problem. This is the new direction in which I think science and values should move. (shrink)

DNA possesses a double nature: it is both an analog chemical compound and a digital carrier of information. By distinguishing these two aspects, this paper aims to reevaluate the legally and politically influential idea that the human genome forms part of the common heritage of mankind, an idea which is thought to conflict with the practice of patenting DNA. The paper explores the lines of reasoning that lead to the common heritage idea, articulates and motivates what emerges as the most (...) viable version of it, and assesses the extent to which this version conflicts with gene-patenting practices as exemplified by the U.S. regime. It concludes that the genome is best thought of as a repository of information to which humanity has a fiduciary relationship, and that on this view, the perceived conflict with gene-patenting largely dissolves. (shrink)

In a gradually more interlinked world, the formation of collaborations with partners is increasingly regarded as an important driver for generating innovation. Although multidimensional proximities are important factors influencing interorganizational coinnovation performance, relevant empirical studies have not reached consistent conclusions. By focusing on organizational dyad and including intraorganizational collaboration network inefficiency as a moderating variable, we explore the effects of multidimensional proximities on interorganizational coinnovation performance. By reference to 5G patent data collected in China between 2011 and 2020, the research (...) results based on the quadratic assignment procedure (QAP) model show that geographical proximity, cognitive proximity, and institutional proximity all improve interorganizational coinnovation performance. (shrink)

Medical ghostwriting is the practice in which pharmaceutical companies engage an outside writer to draft a manuscript submitted for publication in the names of “honorary authors,” typically academic key opinion leaders. Using newly-posted documents from paroxetine litigation, we show how the use of ghostwriters and key opinion leaders contributed to the publication of a medical journal article containing manipulated outcome data to favor the proprietary medication. The article was ghostwritten and managed by SmithKline Beecham, now GlaxoSmithKline (GSK) and Scientific (...) Therapeutics Information, Inc. without acknowledging their contribution in the published article. The named authors with financial ties to GSK, had little or no direct involvement in the paroxetine 352 bipolar trial results and most had not reviewed any of the manuscript drafts. The manuscript was originally rejected by peer review; however, its ultimate acceptance to the American Journal of Psychiatry was facilitated by the journal editor who also had financial ties to GSK. Thus, GSK was able to take an under-powered and non-informative trial with negative results and present it as a positive marketing vehicle for off-label promotion of paroxetine for bipolar depression. In addition to the commercial spin of paroxetine efficacy, important protocol-designated safety data were unreported that may have shown paroxetine to produce potentially harmful adverse events. (shrink)

Recently, dramatic price increases by several pharmaceutical companies have provoked public outrage. These scandals raise questions both about how pharmaceutical firms should be regulated and about how pharmaceutical executives ethically ought to make pricing decisions when drug prices are largely unregulated. Though there is an extensive literature on the regulatory question, the ethical question has been largely unexplored. This article defends a Kantian approach to the ethics of pharmaceutical pricing in an unregulated market. To the extent (...) possible, pharmaceutical companies must price drugs so that those who genuinely need them can get them without financial ruin. This requirement is an ethical side constraint, like the moral prohibitions on deception and theft, that takes precedence over a business’s interest in maximizing profit. That said, the requirement’s application is sensitive to the need to recoup the costs of research and to produce a return that financially justifies the original investment. It may not be either feasible or desirable for government to attempt to enforce the ethical requirements concerning just pharmaceutical pricing. Either price regulation or subsidy could fulfill government’s obligation to protect patients from being objectionably vulnerable to pricing decisions by private companies. (shrink)

According to a common assumption, truthfulness cannot have an intrinsic value in business. Instead, it is considered only instrumentally valuable for business, because it contributes to successful trust-building. Some authors deny truthfulness even this limited role by claiming that truth-telling is not an essential part of business, which is a sui generis practice like poker. In this article, I argue that truthfulness has indeed an intrinsic value in business and identify the conceptual confusions underlying the opposite view. My account of (...) truthfulness as a virtue shows that truthfulness is both valuable for its own sake and instrumental to further valuable goals. It helps pinpoint the implicit contradiction in claiming that truthfulness has an instrumental value only. I then challenge the reasons for considering business exempt from the constraints of truthfulness and elaborate on the analogy between game and business, which in fact supports instead of undermining my claim that business is a truthful practice. Finally, I illustrate my argument with a case study of the current crisis of trust faced by the pharmaceutical industry. (shrink)

'An alarming and illuminating book. The story of how we have allowed private corporations to patent genes, to stockpile human tissue, and in short to make profits out of what many people feel ought to be common goods is a shocking one. No one with any interest at all in medicine and society and how they interact should miss this book, and it should be required reading for every medical student,'--Philip Pullman.

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)

This paper provides a critique of the contemporary notion of intellectual property based on the consequences of Wittgenstein's “private language argument”. The reticence commonly felt toward recent applications of patent law, e.g., sports moves, is held to expose erroneous metaphysical assumptions inherent in the spirit of current IP legislation. It is argued that the modern conception of intellectual property as a kind of natural right, stems from the mistaken internalist or Augustinian picture of language that Wittgenstein attempted to diffuse. This (...) view becomes persuasive once it is shown that a complete understanding of the argument against private language must include Wittgenstein's investigation of the role of the will in the creative process. It is argued that original thought is not born by decree of the will, but engendered by a public context of meaning and value. What marks a person as a genius is, therefore, according to Wittgenstein, not some sovereign capacity of conceptual world-making, but merely a propitious dose of intellectual courage. (shrink)

During the two last decades, speeded up by the development of the Internet, several types of commons have been opened up for intellectual resources. In this article their variety is being explored as to the kind of resources and the type of regulation involved. The open source software movement initiated the phenomenon, by creating a copyright-based commons of source code that can be labelled `dynamic': allowing both use and modification of resources. Additionally, such a commons may be either protected from (...) appropriation (by `copyleft' licensing), or unprotected. Around the year 2000, this approach was generalized by the Creative Commons initiative. In the process they added a `static' commons, in which only use of resources is allowed. This mould was applied to the sciences and the humanities in particular, and various Open Access initiatives unfolded. A final aspect of copyright-based commons is the distinction between active and passive commons: while the latter is only a site for obtaining resources, the former is also a site for production of new resources by communities of volunteers (`peer production'). Finally, several patent commons are discussed, which mainly aim at preventing patents blocking the further development of science. Throughout, attention is drawn to interrelationships between the various commons. (shrink)

When you type the word “serendipity” in a word-processor application such as Microsoft Word, the autocorrection engine suggests you choose other words like “luck” or “fate”. This correcting act turns out to be incorrect. However, it points to the reality that serendipity is not a familiar English word and can be misunderstood easily. Serendipity is a very much scientific concept as it has been found useful in numerous scientific discoveries, pharmaceutical innovations, and numerous humankind’s technical and technological advances. Therefore, (...) there have been many books written around the concept. So why do we need this additional book? This is not just another book about serendipity. It has evolved from the Editor’s question lingering for a decade after finishing his widely cited article (coauthored with Prof. Nancy K. Napier of Boise State University, ID, USA) “Serendipity as a strategic advantage?” in T. Wilkinson’s edited volume Strategic Management in the 21st Century, published by Praeger. The Editor and contributing authors have tried to achieve the following in this title. Demystifying the Serendipity Myth The phenomenon of serendipity has always been thought of as a “miracle”. It is the mystery of human innovation and one of the ultimate secrets of our society. But serendipity is not just a lucky coincidence nor any hidden conspiracy. This book explores the science of the information process behind this seemingly miraculous phenomenon. It connects human society with nature, going back to the root of our existence and looking at the flame of survival to discover the harmony in making creativity. Presenting the nuts and bolts of being an adventurer of science The authors present their conceptual investigations into serendipity’s nature and its mechanism by examining interesting real events and stories. The content is thought-provoking, and readers are led to question and explore their own life stories and problems along the journey of reading this book. Catching an elusive high-value target requires great strategies and efforts. But there are no dark secrets here because this is the “way of nature” – how we humans have always strived for innovation without realizing the blueprints behind such processes. Unlike other books on serendipity, this book will show you that a powerful “secret” is closer than you think. Delivering practical uses for different audiences By understanding the conditionality and survival drivers of serendipity, individuals or organizations can make better decisions on creating the right environment to facilitate the encounter and attainment of this valuable phenomenon. For scientists: With clear explanations of the information processes underlying serendipity, flexible theoretical frameworks of mindsponge and the 3D principle of creativity, researchers are provided with the tools they need to dig deeper into their own fields of study and find practical applications, be it psychology, economics, sociology, or anything that involves innovation (which is, in fact, every scientific discipline). For curious casual readers: Everybody needs innovation to make breakthroughs or spice up one’s life. If you think great ideas come to people randomly from an unknown fairy place, this book will convince you otherwise without taking away that awe and wonder. But above all, you will know how to become more creative, scientifically and straightforwardly, with no snake oil and no weird tricks. For ambitious business people: The flame that brought about great successes throughout human history is within you. But you can only use it if you understand it. While others wait for serendipity to come, you will be able to actively hunt for those precious moments. As it has always been: the best hunters triumph, not the passive wanderers. And in this age of information chaos, finding the golden fruits is not easy. Those from information technology know this problem well, and this book is the treasure map that they have been seeking to navigate that stormy ocean looking for jewels. Like a kingfisher tracking its prey through the water, waiting to gracefully strike, with serendipity, a person seizes the prize of creativity amid the chaos of life. ¤ ¤ ¤ Official introduction: The book explores the nature, underlying causes, and the information processing mechanism of serendipity. It proposes that natural or social survival demands drive serendipity, and serendipity is conditional on the environment and the mindset, on both individual and collective levels. From Darwin's evolution theory to Sun Tzu's war tactics, major innovations throughout human history are unified by this key concept. In the rapidly changing world, information is abundant but rather chaotic. The adaptive power of serendipity allows people to notice treasures within this wild sea, but only for those who understand how it works. To increase the probability of encountering and attaining serendipity, one should employ the mindsponge mechanism and the 3D process of creativity, for without these frameworks, serendipity is truly an elusive target. The book also discusses methods to build environments and cultures rich in navigational and useful information to maximize the chance of finding and capitalizing on serendipity. As a skill, serendipity has a resemblance to how kingfishers observe and hunt their prey. (shrink)

Pharmaceuticals or other emerging technologies could be used to enhance (or diminish) feelings of lust, attraction, and attachment in adult romantic partnerships. While such interventions could conceivably be used to promote individual (and couple) well-being, their widespread development and/or adoption might lead to “medicalization” of human love and heartache—for some, a source of serious concern. In this essay, we argue that the “medicalization of love” need not necessarily be problematic, on balance, but could plausibly be expected to have either good (...) or bad consequences depending upon how it unfolds. By anticipating some of the specific ways in which these technologies could yield unwanted outcomes, bioethicists and others can help direct the course of love’s “medicalization”—should it happen to occur—more toward the “good” side than the “bad.”. (shrink)