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◦ This case study of generic drug markets illustrates the importance of interpersonal relationships in forming a cartel.
◦ Price fixing began in 2013 when Teva Pharmaceuticals, the world’s leading generic drugmaker, hired Nisha Patel to be the Director of Strategic Customer Marketing. Ms. Patel was tasked with “price increase implementation” and her approach to raising prices was to form an unlawful agreement with competitors to raise prices. She was well placed to engage in this activity as she had close ties to key salespeople at the major generic drugmakers due to having served as Director of Global Generic Sourcing for one of the largest US drug distributors.
◦ Cartels formed in about 90 percent of markets where she had close ties to all market participants, but only about 20 percent of markets where she lacked such relationships.
◦ The effects of collusive behavior persisted long after the cartel’s discovery. Though the conspirators discontinued direct communications after learning about the investigation, the evidence is that collusive prices persisted for many years afterwards.
◦ Collusion did induce some entry but its impact proved limited in these regulated markets. Many cartelized markets did not attract any entry, and the markets with entry saw a delay of two to four years before production started.
In addition to the current uses of algae as food and as sources of pigments and polysaccharides, there is potential for the further use of algae as sources of additional specific biomolecules. In addition to this, there is the possibility of the use of alga in a wide variety of processes such as bioenergy (production of liquid fuels and algal biophotovoltaic generation of electricity), removing pollutants from wastewater, and the production of plant growth enhancers and crop protection materials. The eventual commercialisation of these requires the processes to be scalable and economical. The targeted use of algae, other than as food sources, is less than 100 years old and our knowledge of algal biology, physiology and chemistry is still growing and only a very small number of algal species have been studied in detail. One of the main limitations is the need for more reliable, lower cost and larger-scale algae production systems and their development, in turn, requires a good understanding of basic algal biology and life histories. In addition, more work is needed on increasing the efficiency of light utilisation in photosynthesis and hence in growth.
Access to psychedelic drugs is liberalizing, yet responses are highly unpredictable. It is therefore imperative that we improve our ability to predict the nature of the acute psychedelic experience to improve safety and optimize potential therapeutic outcomes. This study sought to validate the ‘Imperial Psychedelic Predictor Scale’ (IPPS), a short, widely applicable, prospective measure intended to be predictive of salient dimensions of the psychedelic experience.
Methods
Using four independent datasets in which the IPPS was completed prospectively – two online surveys of ‘naturalistic’ use (N = 741, N = 836) and two controlled administration datasets (N = 30, N = 28) – we conducted factor analysis, regression, and correlation analyses to assess the construct, predictive, and convergent validity of the IPPS.
Results
Our approach produced a 9-item scale with good internal consistency (Cronbach's α = 0.8) containing three factors: set, rapport, and intention. The IPPS was significantly predictive of ‘mystical’, ‘challenging’, and ‘emotional breakthrough’ experiences. In a controlled administration dataset (N = 28), multiple regression found set and rapport explaining 40% of variance in mystical experience, and simple regression found set explained 16% of variance in challenging experience. In another (N = 30), rapport was related to emotional breakthrough explaining 9% of variance.
Conclusions
Together, these data suggest that the IPPS is predictive of relevant acute features of the psychedelic experience in a broad range of contexts. We hope that this brief 9-item scale will be widely adopted for improved knowledge of psychedelic preparedness in controlled settings and beyond.
Clay is unique especially from the perspective of medical geology, that is, the impacts of geologic materials and geologic processes on animal and human health. Clay is the only natural material that can impact human health through all routes of exposure: ingestion, inhalation, and dermal contact. Moreover, these impacts can be harmful as well as beneficial. Ingestion of clay, a form of geophagy, has been practiced for millennia and is still widely practiced today. Humanoids have been ingesting clay for at least two million years to ease indigestion and counteract poisons. Some additional benefits may accrue from eating clays such as providing some nutrients but these benefits are far outweighed by the likely negative consequences such as tissue abrasion, intestinal blockage, anemia, exposure to pathogens and toxic trace elements, and potassium overdose. Inhalation of airborne minerals including clays has impacted the heath of millions. In the 1930s thousands of people living in the Dust Bowl in the U.S. southwest inhaled copious amounts of clay contributing to deadly ‘dust pneumonia.’ Using clay as a poultice to stem bleeding and cure certain skin ailments is an age-old practice that still has many adherents. A classic recent example of the antibacterial properties of clay is the use of certain clays to cure Buruli ulcer, a flesh eating disease. However, walking barefoot on clays in certain volcanic soils can result in non-filarial podoconiosis or elephantiasis. The absence of clays in soils can have serious health consequences. In South Africa, clay-poor soils yield crops lacking in essential nutrients and may be the principal cause of Msileni joint disease. Clearly, a detailed knowledge of the clays in the environment can have significant benefits to human health and wellbeing.
The increased detection of pharmaceuticals in finished drinking water has become a growing cause of concern in recent years. The removal of atenolol, ranitidine, and carbamazepine by sepiolite, following functionalization of its surface by organosilane grafting, constituted the subject of this investigation. Silylated surfaces include octyl, γ-aminopropyl, 3-chloropropyl, and triphenyl moieties. The sorption of atenolol and ranitidine was higher on sepiolite functionalized with 3-chloropropyl, while carbamazepine showed a higher sorption on sepiolite with triphenyl groups. Filtration experiments of both ranitidine and carbamazepine on octyl- and triphenyl-sepiolite, respectively, showed a higher retention of ranitidine in comparison to carbamazepine, in spite of the fact that the number of sorption sites was lower due to its higher binding rate.
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.
This chapter discusses the pharmaceutical industry, with specific attention given to the role of intellectual property and R&D. The chapter also explains (broadly) the process by which a new drug is approved by the Food and Drug Administration. The key concept in the chapter is the tradeoff inherent in intellectual property protections: stronger protections spur more innovation but at the cost of higher prices for a longer period of time. On the other hand, weaker protections allow for more affordable products more quickly, but at the cost of reduced innovation. The end of chapter supplement explores the role of international trade agreements in solving research and development coordination problems.
In contrast to the well-known stories of the embryotoxic drug, thalidomide, in countries where it was responsible for large numbers of birth defects, there is limited information on its history in India. Its presence before 2002, when the country issued the first marketing licence for a thalidomide-containing preparation, is assumed to be negligible. This article challenges this view by showing that the drug entered the Indian subcontinent through the former Portuguese territory of Goa around 1960. We examine the subsequent development of its distribution, use and regulation in India from the mid-1960s up to the present situation. Colonial legacies are a crucial explanation for the early appearance of thalidomide on the Indian subcontinent. They also influenced its re-emergence as drug for treating leprosy reactions in India after 1965. We identify key actors in this process: the original German producer that delivered thalidomide free of charge, European doctors who worked for international non-governmental organizations, the World Health Organization (WHO), which supported clinical trials and later discouraged the use of the drug, and finally the Indian state institutions that limited its distribution and later quickly opened the way for the private sector to produce and market thalidomide and its analogues. Finally, we discuss the risk of thalidomide-induced birth defects by casting a critical look on the present state of regulatory provisions and the monitoring of birth defects in India.
A free world is one in which human beings can live free, self-directed lives. A great obstacle to such a world is severe poverty, still blighting the lives of half of humankind. We have the resources, technologies, and administrative capacities to eradicate severe poverty, but doing so requires some restructuring of existing social arrangements. We might begin with the current regime governing innovation, which has monopoly markups as its key funding source. Such monopoly rents encourage the quest for innovations, but also greatly impede their diffusion. This headwind harms the poor, who cannot afford monopoly prices and whose specific needs innovators thus tend to ignore. It also works against potential innovations whose benefits would mostly go to third parties whom buyers care little about. Both problems can be much alleviated through a supplementary alternative reward mechanism that would enable innovators to exchange their monopoly privileges on any patentable technology for impact rewards based on the social benefits achieved with it. By promoting innovations and their diffusion together, international impact funds would bring substantial gains in justice and cost-effectiveness, especially in the pharmaceutical and green-technology sectors.
Focusing on firm-level behavior in the US pharmaceutical and agrochemical industries, Chapter 4 provides evidence that companies do indeed seek stricter standards on their own, out-of-patent products in order to boost sales of newer, patented substitutes, even providing negative information about their own products in pursuit of this goal. In order to show this, the chapter leverages petitions submitted by pharmaceutical and agrochemical companies to the US FDA and EPA, respectively, requesting that the agencies place stricter standards or all out bans on products that these companies themselves developed. In the case of the pharmaceutical petitions, the chapter provides evidence that all but one of the requests for a product ban has targeted a drug that is about to lose or has already lost patent protection and for which the company had a more recently patented substitute. This suggests that such requests are not publicly minded attempts to ensure dangerous products remain off the market but, instead, are strategic gambits to boost profits of exclusively produced alternatives. In addition, the chapter provides a statistical analysis of petitions submitted by agrochemical companies and farm groups to show that, whereas farmers are no more likely to seek stricter standards on out-of-patent pesticides, agrochemical companies systematically request stricter standards on these products while requesting more lenient standards on products still enjoying patent protection.
The paper surveys the intellectual property (IP) laws of seven Southern African Development Community countries to better understand the nature, scope, and depth of their patent laws with particular focus on their utilisation of TRIPS flexibilities to facilitate pharmaceutical access. The selected countries – Botswana, Malawi, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe – represent a mix of both major and modest economies. While the current literature contains widespread assertions on the impact and effect of TRIPS on access to medicines in these countries and less-developed countries in general, this paper finds that the countries lack explicit and workable provisions implementing key TRIPS flexibilities. Hence, available TRIPS flexibilities have not been well utilised and it is often the complicated and unworkable domestic framework – rather than TRIPS – which becomes the stumbling block to pharmaceutical access. Another major finding is that patents may not be a major impediment in the region given that few patents and even fewer pharmaceutical patents are filed. The paper argues that since the surveyed countries are mainly net IP importers with similar developmental contexts and aspirations, the best approach would be to fully take advantage of existing flexibilities and more aggressively leverage policy space to engender access to cheaper medicines.
Equitable access to health products is a key condition and an indicator for countries’ progress towards Universal Health Coverage (UHC). Access to healthcare, including essential medicines, is a fundamental human right. Realization of this right involves various combinations of public and private financing and service provision arrangements. The pharmaceutical system is an integral subset of the health system which requires mature regulatory structures and robust supply systems to ensure that health goals are achieved and support country efforts to effectively advance UHC. The landscape of pharmaceutical systems is rapidly changing with increasingly complex technologies, often without clear regulatory approaches or mechanisms to achieve equitable access, especially in low and middle-income countries (L&MICs). Medicines are life-enhancing and lifesaving commodities. For a health system to achieve public health goals, medicines should be available in sufficient quantities and be affordable to the population. Health products must also be safe, quality assured, efficacious and used appropriately to achieve desired health outcomes.
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.
Scanning electron microscopes (SEMs) are a popular analytical tool due to their high spatial resolution, large depth of field, and analytical capabilities. However, in many cases, the large-scale installation and cost of SEMs can be a barrier to entry for smaller laboratories or facilities. The introduction of a more compact benchtop SEM has changed the landscape, enabling scientists in many fields to adopt the technology and revolutionize research. Benchtop SEMs can be used in a variety of industries including materials science, pharmaceutical research, energy exploration, science education, and academia. These industries require analysis at the nanoscale for quality control, failure analysis, and R&D, for all of which the benchtop SEM is perfectly positioned to provide necessary detail. These advantages and new developments in the technology have made the benchtop SEM a widely available and well-accepted tool.
Every year, over 250,000 public authorities in the European Union (EU) spend about 14% of GDP on the purchase of services, works and supplies. Many are in the health sector, a sector in which public authorities are the main buyers in many countries. When these purchases exceed threshold values, EU public procurement rules apply. Public procurement is increasingly being promoted as a tool for improving efficiency and contributing to better health outcomes, and as a policy lever for achieving other government goals, such as innovation, the development of small and medium-sized enterprises, sustainable green growth and social objectives like public health and greater inclusiveness. In this paper, we describe the challenges that arise within health care systems with public procurement and identify potential solutions to them. We examined the tendering of pharmaceuticals, health technology, and e-health. In each case we identify a series of challenges relating to the complexity of the procurement process, imbalances in power on either side of transactions and the role of procurement in promoting broader public policy objectives. Finally, we recommend several actions that could stimulate better procurement, and suggest a few areas where further EU cooperation can be pursued.
The complexity and inefficiency of the U.S. health care system complicates the distribution of life-saving medical technologies. When the public health is at stake, however, there are alternatives. The proposal for a national PrEP program published in this issue of the Journal applies some of the lessons of the national COVID vaccine campaign to HIV prevention. In doing so, it draws on other examples of public health approaches to the financing of medical technology, from vaccines for children to hepatitis C treatment.
This chapter focuses on the scope and content of the Intellectual Property Chapter of the TPP, to examine how strict the new IP international protection and enforcement standard is, and to determine how far it goes beyond the existing FTAs and TRIPS. TPP provisions are compared with the “Pre-TPP relevant standards” (both intra-TPP and extra-TPP), and, of course, the WTO TRIPS Agreement. We looked at the NAFTA (the US, Canada, and Mexico) and the US agreements with Singapore, Chile, Australia, the CAFTA countries, Peru, and Korea (KORUS FTA). Some references were made to agreements signed by the European Union with Korea (EU--KOREA FTA) and the one with Canada, the Comprehensive Economic and Trade Agreement (CETA), as well as to the TPP predecessor -- the P4 Agreement -- signed between Brunei Darussalam, Chile, New Zealand, and Singapore. While reviewing the enforcement provisions, comparisons were made to the Anti-Counterfeiting Trade Agreement (ACTA).
The relationship between business activity and human rights in the context of intellectual property (IP) is unique. First, it is an example of how national efforts to control the human rights impact of business activities can be frustrated by international agreements. Thus, the obligation under the Guiding Principles for states to maintain sufficient national policy space to address human rights impacts is particularly important in this area. Corporations also have a responsibility not to push for changes in domestic and international law that would enable them to maximize profits at the expense of human rights. Second, the case of human rights and IP provides an example of corporations taking advantage of legal rules that allow them to extract profits at the expense of human rights. These legal rules are directed toward a legitimate purpose, but they can also be abused in ways that harm human rights. Thus, the relationship between IP and human rights demonstrates that corporations may have a responsibility not to take maximal advantage of opportunities to make a profit where doing so would violate human rights. It also indicates that human rights law may constrain states in the choices they make about how to incentivize innovation.
The concept of a public option – a good or service that is government-provided, quality-assured and universally available at a reasonable and fixed price, which coexists with products from the private sector – is receiving increasing interest as a public policy tool (Sitaraman and Alstott 2019). The idea can be applied to a range of social and public services, such as health care, retirement, higher education, banking, and childcare. It can also be applied to innovation and manufacturing, especially in the pharmaceutical industry and with regard to issues that matter to citizens (access to health, clean energy, and the benefits of big data and AI). Indeed, the use of public options for sectors driven by fast innovation is developing into an exciting new area of policy.
A substantial portion of biomedical R&D is publicly funded. But resulting medicines are typically covered by patents held by private firms, and priced without regard to the public’s investment. The Bayh-Dole Act provides a possible remedy, but its scope is limited.