Among American adults 20 years and older, 59 percent take at least one prescription drug on a regular basis. Unlike most branded drugs, which are generally drugs that have a trade name and are protected by a patent, off‐patent generic drugs make up approximately 90 percent of prescriptions annually filled in the United States; yet in 2017, generic drugs made up only 23 percent of total drug costs in the U.S. The U.S. Food and (...) Drug Administration has taken the lead in encouraging increased competition in the nation's prescription drug marketplace, most recently with its release of the agency's Drug Competition Action Plan, but also with its regulatory guidance and enforcement efforts to eliminate “gaming” of the regulatory process by both branded and generic pharmaceutical manufacturers. Such “gaming” activities include “pay‐for‐delay” agreements involving financial compensation between branded and generic pharmaceutical manufacturers to forestall the emergence into the market of generic pharmaceuticals to compete against a formerly patent‐protected branded drug. A combination of new enabling legislation, federal judicial guidance, and agency regulatory activities show promise in encouraging increased competition in the prescription drug marketplace, with the American consumer the ultimate beneficiary of lower health care costs and improved overall personal health. (shrink)

Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs purchased, particularly through public health insurance and grant programs. Brand firm anti-competitive practices around the leading buprenorphine product Suboxone — including product hops, citizen petitions and Risk Evaluation and Mitigation Strategy abuses — helped to maintain high prices by extending (...) brand exclusivity periods and hindering generic drug entry. Remedies to address costly anti-competitive activities include adoption of the proposed CREATES Act and modernization of the Hatch-Waxman Act by the Congress, and implementation of substantive modifications to the Food and Drug Administration citizen petition filing procedures. Given the persistence of these abuses, prescriptive changes are favorable to the procedural and clarifying steps thus far favored by the federal government. Extrapolating from the 37% price declines attributable to generic entry for buprenorphine tablets in 2011, our calculations suggest that implementing these remedies to facilitate generic competition with Suboxone film would have resulted in savings of approximately $703 million overall and $203 million to Medicaid in 2017. (shrink)

Access to medicines faces a new legal threat: “border enforcement” of drug patents. Using Brazil as an example, this article shows how the right to health depends on international trade. Border seizures of generic drugs present human rights and trade institutions with a unique challenge. Can public health advocates rise to meet it?

Most new drugs are protected by pharmaceutical patents, which give the patent holder exclusive control over that drug’s supply for 20 years. When the patent term expires, the drug becomes available for generic production by any company. The resulting competition typically leads to dramatic reductions in price. In Brazil, generic drugs are on average 40% cheaper than reference or brand-name drugs. In the United States, the Federal Drug Administration reports up to 85% price differences. Consumers (...) in India have witnessed more than 100-fold price reduction for antiretroviral drugs due to generic production. Generics thus play a key role in broadening access to health care, mostly by driving costs down, both in the developing and developed world. (shrink)

The COVID-19 pandemic has revealed the vulnerability of the US generic drug supply chain to foreign production. Many policies have been proposed to mitigate this vulnerability. In this article, we argue that nonprofit drug manufacturers have the potential to make important contributions.

Antiretroviral pre-exposure prophylaxis (PrEP) is protective against HIV. Low utilization rates amongst HIV vulnerable populations are due in part to the high cost of PrEP. Generic PrEP offers the potential to improve health at significantly reduced costs. In this study, we examine early utilization patterns and prices for generic PrEP. We discuss the opportunities and challenges for generic PrEP to improve health among HIV vulnerable populations.

This article describes the shortage of generic injectable medications in Canada that affected hospitals in 2012. It traces the events leading up to the drug shortage, the causes of the shortage, and the responses by health administrators, pharmacists, and ethicists. The article argues that generic drug shortages are an ethical problem because health care organizations and governments have an obligation to avoid exposing patients to resource scarcity. The article also discusses some options governments could pursue in order to (...) secure the drug supply and thereby fulfill their ethical obligations. (shrink)

Recently I reported in this journal1 how it became necessary for a judge to settle a dispute between the pharmaceutical industry and certain Dutch pharmacists. It considered the question of whether a pharmacist is permitted, without prior consultation, to give a patient a generic drug instead of the patent drug mentioned on the prescription.Another dispute has now arisen after the pharmaceutical industry discovered that healthcare insurers were paying general practitioners a bonus if they prescribed generic drugs, such (...) as simvastatin or omeprazol (which reduces the …. (shrink)

Brand-name prescription drug manufacturers use various strategies to extend their market exclusivity periods by delaying generic or biosimilar competition. Recent Congressional legislation has targeted four such tactics. We analyze these proposals and assess their likely effect on competition in the U.S. drug market.

In September 1998 the Dutch Ministry of Health together with the Dutch Society of General Practitioners , the Royal Dutch Society of Pharmacists , and the Dutch Patient and Consumer Federation published a pamphlet entitled: The same medicine in a different coat. Drugs without a trademark, equally effective, but cheaper. Patients could obtain a copy at the local pharmacy or in the waiting room of their general practitioner. It deals with the question whether the name of the patent drug (...) should be written on the prescription or only the active component. This is important because, according to the authors, the costs of health care can be reduced without reducing the quality of the care if the doctor prescribes the generic form. It is also mentioned that another advantage of prescribing the generic form is that, contrary to the …. (shrink)

Many people have been enraged lately by the enormous increases in certain generic prescription drugs. But free marketeers defend these prices by arguing that they simply represent what the market will bear, and in a capitalist society there is accordingly nothing wrong with charging them. This paper argues that such a defense is actually contrary to the very principles that free marketeers claim to embrace. These prices are not only unjust and exploitative, but government interference with them would (...) not render the market less free, at least if what it means for a market to be “free” is properly understood. Everyone, even free marketeers with a libertarian or neoliberal bent, should accordingly be against this kind of profiteering. (shrink)

We conducted a scoping review to map and critically examine the knowledge, perceptions and utilization of generics and biosimilars, among physicians, pharmacists, patients, the general population, and other stakeholders from LAC.

In early 1984, the AIDS epidemic was less than four years old. Chemists at the pharmaceutical company Syntex, situated in the rolling green hills near Stanford University in Palo Alto, California, had recently synthesized a new antiviral drug (Martin et al. 1983). The drug, at first given the awkward chemical abbreviation DHPG, later came to be known by the generic name ganciclovir. Ganciclovir was a potent drug for the treatment of herpes virus infection (such as genital herpes or chickenpox), (...) but the unique characteristic of ganciclovir was that it worked against cytomegalovirus (CMV), a heretofore untreatable virus infection. Although relatively harmless in healthy individuals, CMV caused .. (shrink)

Given the profound public health and economic ramifications of decisions made by the U.S. Food and Drug Administration, the degree to which FDA activities should reflect an approach founded on complete transparency versus one focused on preserving confidentiality of information deserves public discussion. On one hand, reasonable requirements for transparency are critical to stimulating effective innovation, knowledge dissemination, and good business practice. On the other, ensuring the vitality of the medical products industry requires protecting legitimately proprietary information. With current standards (...) reflecting a lengthy accumulation of legal, regulatory, and practical precedent, recent significant changes in the environment in which the FDA operates should prompt a critical examination of current practices. In this article, I comment on Sharfstein and colleagues’ “Blueprint for Transparency,” which calls for multiple specific actions to increase transparency at the agency across five key areas, including interactions between FDA and industry, public disclosure of internal FDA analyses, deliberations concerning generics and biosimilars, expanded access to raw study data, and approaches to countering misleading information in the public sphere. I evaluate these recommendations in light of my experience as a clinician, researcher, and former FDA Commissioner, and reflect on possible outcomes that could result from enacting these practices. (shrink)

Imagine a drug—let's call it Curebitt—that is safe, cheap, and very effective: take a pill once a day and you will be healthier. Curebitt's taste is so unpleasant, so bitter, however, that a significant proportion of patients cannot bring themselves to ingest the pill regularly. Now suppose that after some time, another drug, Curesweet, hits the market. This drug is clinically equivalent to Curebitt and costs the same, but it is much more palatable, so adherence rates for it are significantly (...) higher than for Curebitt. Should physicians continue prescribing Curebitt, now that Curesweet is available? No, prescribing the bitter pill puts patients at a greater risk of nonadherence and ultimately results in reduced clinical benefit for a significant proportion of patients, whereas prescribing Curesweet benefits more patients and increases the probability that any given patient's health will improve. The Curebitt versus Curesweet scenario draws our attention to how a physician can fail her patients by prescribing drugs with lower adherence rates when equivalent drugs with higher adherence rates are available. What does this fictional case tell us about the real world? A lot. We know that adherence rates vary with out‐of‐pocket costs. Name‐brand drugs carry higher out‐of‐pocket costs than their generic counterparts; as a result, when name‐brand drugs are prescribed rather than their generic counterparts, fewer patients receive health benefits. If prescribing Curebitt is unethical, then so is prescribing the name‐brand drug. (shrink)

In contrast to discussions of BiDil, this paper explores racial meaning-making processes around an old generic hypertension drug. By unpacking a vignette about race and thiazide outside marketing or medicine, it shows that racialization of drugs exceeds those spheres and moves in unpredictable ways.

If we want to understand the allure of pharmaceuticals, we need to look beyond both medical efficacy and profit motives. The success of a drug depends not only on these, but also on how it mobilizes prior conceptions of identity. The extent to which a drug is taken — or talked about — is related to commodity properties that exceed the physiological and the economic. In implicit contrast to the discussions of BiDil elsewhere in this collection, I explore how the (...) links between race and pharmaceuticals can be both unstable and generative even when the drug in question is old and generic. By attending closely to an encounter around generic thiazide outside of a medical or marketing context, I show that although pharmaceuticals can seem to rely on scientific data and marketing for their power, they are, in fact, also subject to claims on many more registers that cannot quite subsume or refute each other. (shrink)

In May 2011, the Brazilian Ministry of Health announced the distribution of the first batch of locally produced generic tenofovir disoproxil fumarate (TDF) to support its program of universal and free access for the treatment of HIV/AIDS. The inclusion of TDF in the public health program illustrates what has been considered the ‘Brazilian model’ of HIV/AIDS response, as it illustrates the current phase of the Brazilian pharmaceutical economy. Brazil is known for having managed to control the expansion of HIV/AIDS (...) through a unique initiative combining the public health and the industrial production of generics. But, if at first local manufacturers could freely copy ARVs and produce cheaper generic versions that were delivered to the Ministry of Health, since the country started to grant patents on drugs in 1996, the sustainability of this policy has been challenged by the high cost of patented second-line HIV/AIDS treatments. In order to assure continuity of the local production of ARVs, and keep the program of public health alive, Brazilians are now forced to deal with conflicts of drugs' intellectual property rights in order to open the path to generic production. This article aims to describe the experiences surrounding TDF in Brazil and the unprecedented conflicts and challenges it has brought for our different interviewees. Blurring the frontier between the public and the private, the TDF case was driven at the same time by an ethic of drug access and regulation of drug quality, which has inspired Brazilians to intervene and transform the world they live in. (shrink)

In The Ethics of Food, Gregory E. Pence brings together a collection of voices who share the view that the ethics of genetically modified food is among the most pressing societal questions of our time. This comprehensive collection addresses a broad range of subjects, including the meaning of food, moral analyses of vegetarianism and starvation, the safety and environmental risks of genetically modified food, issues of global food politics and the food industry, and the relationships among food, evolution, and human (...) history. (shrink)

Children who experience well-being are engaging more confidently and positively with their caregiver and peers, which helps them to profit more from available learning opportunities and support current and later life outcomes. The goodness-of-fit theory suggests that children’s well-being might be a result of the interplay between their temperament and the environment. However, there is a lack of studies that examined the association between children’s temperament and well-being in early childhood education and care, and whether this association is affected by (...) ECEC process quality. Using a multilevel random coefficient approach, this study examines the association between toddlers’ temperament and well-being in Norwegian ECEC and investigates whether process quality moderates this association. Results reveal an association between temperament and well-being. Staff-child conflict moderates the association between shyness and well-being, and between activity and well-being. Moreover, high emotional behavioral support moderates the association between activity and well-being. Extra attention should be paid by the staff to these children’s needs. (shrink)

Conflicts of interest are rampant in the American medical community. Today it is not uncommon for doctors to refer patients to clinics or labs in which they have a financial interest (40% of physicians in Florida invest in medical centers); for hospitals to offer incentives to physicians who refer patients (a practice that can lead to unnecessary hospitalization); or for drug companies to provide lucrative give-aways to entice doctors to use their "brand name" drugs (which are much more expensive (...) than generic drugs). In Medicine, Money and Morals, Marc A. Rodwin draws on his own experience as a health lawyer--and his research in health ethics, law, and policy--to reveal how financial conflicts of interest can and do negatively affect the quality of patient care. He shows that the problem has become worse over the last century and provides many actual examples of how doctors' decisions are influenced by financial considerations. We learn how two California physicians, for example, resumed referrals to Pasadena General Hospital only after the hospital started paying $70 per patient (their referrals grew from 14 in one month to 82 in the next). As Rodwin writes, incentives such as this can inhibit a doctor from taking action when a hospital fails to provide proper service, and may also lead to the unnecessary hospitalization of patients. We also learn of a Wyeth-Ayerst Labs promotion in which physicians who started patients on INDERAL (a drug for high blood pressure, angina, and migraines) received 1000 mileage points on American Airlines for each patient (studies show that promotions such as this have a direct effect on a doctor's choice of drug). Rodwin reveals why the medical community has failed to regulate conflicts of interest: peer review has little authority, state licensing boards are usually ignorant of abuses, and the AMA code of ethics has historically been recommended rather than required. He examines what can be learned from the way society has coped with the conflicts of interest of other professionals --lawyers, government officials, and businessmen--all of which are held to higher standards of accountability than doctors. And he recommends that efforts be made to prohibit and regulate certain kinds of activity (such as kickbacks and self-referrals), to monitor and regulate conduct, and to provide penalties for improper conduct. Our failure to face physicians' conflicts of interest has distorted the way medicine is practiced, compromised the loyalty of doctors to patients, and harmed society, the integrity of the medical profession, and patients. For those concerned with the quality of health care or medical ethics, Medicine, Money and Morals is a provocative look into the current health care crisis and a powerful prescription for change. (shrink)

The use of single-use items is now ubiquitous in medical practice. Because of the high costs of these items, the practice of reusing them after sterilisation is also widespread especially in resource-poor economies. However, the ethics of reusing disposable items remain unclear. There are several analogous conditions, which could shed light on the ethics of reuse of disposables. These include the use of restored kidney transplantation and the use of generic drugs etc. The ethical issues include the question (...) of patient safety and the possibility of infection. It is also important to understand the role of informed consent before reuse of disposables. The widespread practice of reuse may bring down high healthcare costs and also reduce the huge amount of hospital waste that is generated. The reuse of disposables can be justified on various grounds including the safety and the cost effectiveness of this practice. (shrink)

Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional ‘regulatory’ protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted to the (...) regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free-riding’ encounters some important problems: Neither legitimize excluding all others. (shrink)

This paper interrogates the routine and unproblematic use of terms such as in biomedical and anthropological discourse. A typical depiction of the social factors that explain the practice of in India is to put together the supply side factors (such as protection offered by the government for the production of generic drugs, especially in the small scale sector, and expansion of the number of drug store outlets), with the increasing demand for allopathic drugs. The paper provides an (...) ethnographic account of the intricate connections between households and biomedical practitioners in urban neighbourhoods in Delhi. It breaks away from the conventional opposition drawn between the practices of physicians and the beliefs of their patients, and suggests that what constitutes the medical environments of these neighbourhoods is the product of medical practices, household economies and concepts of disease. Thus pharmaceutical use is determined as much by practices of dispensation and by how practitioners understand what constitutes therapy as by household understanding of the normal and the pathological. This paper uses both quantitative data and narrative interviews to provide an in-depth understanding of the circulation of pharmaceuticals within the life worlds of the urban poor. (shrink)

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)

It is a common charge that treaties, perhaps especially recent treaties relating to economic activity, provide unreasonable restrictions on the sovereignty of the state parties. While this charge has been made most forcefully by smaller states, it is sometimes raised with justification by larger states or state-like bodies such as the E.U. as well. When a tribunal judging a dispute on an economic treaty tells a state that it may no longer make decisions such as to accept or reject genetically (...) modified foods, allow internet gambling, or produce generic drugs for domestic consumption, the citizens of the state may rightfully think they have lost important aspects of sovereignty to bodies that do not have legitimate authority to govern. This, in turn, makes negotiating treaties, despite their obvious value, much harder than it otherwise would be, leading to decreased cooperation and the forgoing of potentially significant gain. In this paper, I argue that by importing certain ideas from contract theory to the interpretation of treaties, these worries may be significantly reduced. Contracts have the seemingly paradoxical ability to increase the autonomy of the signers by allowing them to bind themselves to perform certain future actions. But, the ability of contracts to perform this function would be greatly reduced if the only possible remedy for breach were specific performance. Yet, an analogous approach to treaties is common among many important theorists of international law, who demand the equivalence of specific performance in the case of treaties. I will show how importing ideas from contract law can help ensure that treaties, especially economic treaties, are sovereignty-enhancing for states in a way that is similar to the way that contracts may be autonomy-enhancing for individuals, and will show that importing these elements from contract law will strengthen, not undermine, the legitimacy and fairness of international law. (Please download the full paper from SSRN at the link on this page). (shrink)

Ten years after the enactment of the Biologics Price Competition and Innovation Act, competition in biologics markets remains scant and far from sufficient for lowering prices of biologics to the level of 80-90% price drops seen in generic drug markets. This reality is not a result of one or two cardinal reasons, but many. If lowering the price of biologics is the goal and competition is the means by which we seek to achieve that goal, then there does not (...) seem to be a quick fix to address all of the many impediments to competition that plague biologics markets. Yet, certain changes to how the Food and Drug Administration evaluates and approves biologics may go a long way toward the creation of meaningful competition in biologics markets. One such change would be making original biologics' manufacturing information available to follow-on manufacturers.As recognized by several commentators, access to biologics manufacturing information is key to increasing competition in biologics markets. Without access to such information, making follow-on biologics is difficult and expensive, if not outright impossible. This is expected to be especially true for the highly anticipated class of interchangeable biologics, none of which has been approved by the FDA to date. Yet, it has long been the position of the brand-name pharmaceutical industry that biologics manufacturing information is proprietary and, thus, may not be shared. Congress has subscribed to the Industry's position, prohibiting the FDA from disclosing regulatory filings submitted by developers of original biologics, including manufacturing information, to third parties. That prohibition not only undermines competition in biologics markets, but is also wasteful, potentially unethical, and poses unnecessary risks to the health and safety of patients.This article makes the case for FDA sharing of original biologics manufacturing information with follow-on biologics developers. It is informed by the similar legal and commercial circumstances in the area of pesticides and the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act, which is administered by the Environmental Protection Agency. The article reviews the FIFRA regime, including its upholding as constitutional by the United States Supreme Court, and then examines its applicability to the area of biologics. The article concludes with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets. (shrink)

The need for rationing of clinical services and medical resources is a crucial issue facing healthcare systems. On most accounts, the demand for medical services vastly exceeds what can be provided on limited budgets, requiring difficult decisions about which services should and should not be provided to patients, whether patients might have to bear some of the cost of the services they use, and on what basis rationing decisions should be made. At the same time, we know that healthcare systems (...) are far from perfectly efficient; some of the expenditures of healthcare systems are wasteful and bring no benefits at all to patients. In light of the evidence of such inefficiencies within healthcare systems, it may seem problematic to insist on the importance of rationing: can it really be appropriate to deny patients beneficial services while inefficiencies remain within the system?1This is the question Strech and Danis take on in their paper, ‘How can bedside rationing be justified despite coexisting inefficiency? The need for “benchmarks of efficiency”’. As they highlight, the evidence about inefficiencies within the healthcare system is sometimes taken to undermine the legitimacy of rationing. Their response focuses on the implications of particular clinicians’ involvement in both inefficient decisions and bedside rationing: if clinicians cause or contribute to inefficiencies in the system—for example by prescribing more expensive ‘brand name’ medication instead of equally effective but cheaper generic drugs—is it legitimate for them also to make, or be involved in, rationing decisions? Strech and Danis argue that even though no healthcare system can be fully efficient, clinicians must make ‘sufficient’ efforts to reduce inefficiencies within their own realm of decision-making if their engagement in rationing decisions is to be legitimate. They offer a set of ‘benchmarks’ against which we can judge whether or not such efforts should …. (shrink)

BiDil, a heart failure drug for African Americans, emerged five years ago as the first FDA approved drug targeted at a specific racial group. While critical scholarship and the popular media have meticulously detailed the history of BiDil from its inauspicious beginnings as a generic combination drug for the general population to its dramatic resuscitation as a racial medicine, the enthusiastic support shown by some African American interest groups has been too little understood, as has their argument that BiDil (...) was an important response to race-based health disparities. In this essay, we show how the drugmaker, NitroMed, used the support it had solicited from black advocacy groups and community members to market BiDil as a unique “grassroots” pharmaceutical to the African American community. We go on to situate BiDil, which relied on a domestic, U.S.-centered conception of race, within the context of the global nature of both race and health disparities. Ironically, the grassroots angle of the BiDil case ultimately obscured the global crisis in health disparities. Furthermore, we argue that the grassroots model initiated by NitroMed should be taken note of, as it marks a potential avenue for the marketing of other drugs in the future. (shrink)

Point-of-care evidence-based medicine websites allow physicians to answer clinical queries using recent evidence at the bedside. Despite significant research into the function, usability and effectiveness of these programmes, little attention has been paid to their ethical issues. As many of these sites summarise the literature and provide recommendations, we sought to assess the role of conflicts of interest in two widely used websites: UpToDate and Dynamed. We recorded all conflicts of interest for six articles detailing treatment for the following conditions: (...) erectile dysfunction, fibromyalgia, hypogonadism, psoriasis, rheumatoid arthritis and Crohn's disease. These diseases were chosen as their medical management is either controversial, or they are treated using biological drugs which are mostly available by brand name only. Thus, we hypothesised that the role of conflict of interest would be more significant in these conditions than in an illness treated with generic medications or by strict guidelines. All articles from the UpToDate articles demonstrated a conflict of interest. At times, the editor and author would have a financial relationship with a company whose drug was mentioned within the article. This is in contrast with articles on the Dynamed website, in which no author or editor had a documented conflict. We offer recommendations regarding the role of conflict of interest disclosure in these point-of-care evidence-based medicine websites. (shrink)

Remaining important tasks in finding and developing new drugs and vaccines for HIV/AIDS, malaria, cancer and other diseases require continued industry research and development. Industry’s research and development pipeline has produced drugs that have saved AIDS victims previously facing certain death, but still no cure nor vaccine is yet available. Experience with the process of research and development indicates that it requires more than a decade of development to produce a new drug with costs in the hundreds of (...) millions of dollars. Intellectual property protection is critically important in assuring that drug development continues. Partnerships between industry and the public sector have increased access to new therapies in developing countries and promise to enhance access to both patented and generic medicines in the future. (shrink)

Remaining important tasks in finding and developing new drugs and vaccines for HIV/AIDS, malaria, cancer and other diseases require continued industry research and development. Industry’s research and development pipeline has produced drugs that have saved AIDS victims previously facing certain death, but still no cure nor vaccine is yet available. Experience with the process of research and development indicates that it requires more than a decade of development to produce a new drug with costs in the hundreds of (...) millions of dollars. Intellectual property protection is critically important in assuring that drug development continues. Partnerships between industry and the public sector have increased access to new therapies in developing countries and promise to enhance access to both patented and generic medicines in the future. (shrink)

Matthew Rimmer, ACIPA, The Australian National University, College of Law, Canberra, ACT, 0200, Australia. Tel.: (02) 61254164; Email: matthew.rimmer{at}anu.edu.au ' + u + '@' + d + ' '//--> Abstract This article considers the significance of the first export of essential medicines under the WTO General Council Decision 2003. In July 2007, Rwanda became the first country to provide a notification under the WTO General Council Decision 2003 of its intent to import a fixed-dose, triple combination HIV/AIDS drug manufactured by (...) the Canadian generic pharmaceutical manufacturer Apotex, Inc. In September 2007, Apotex was granted the first compulsory licence application under Canada's Access to Medicines Regime. This article considers the convoluted and protracted negotiations between the Government of Rwanda, Apotex and three patent holders, GlaxoSmithKline, Boehringer Ingleheim Canada and Shire BioChemical, Inc. It questions the efficiency of this process. This article considers the review of the Jean Chrétien Pledge to Africa Act 2004 (Canada). It is critical of the refusal of the Conservative Government of Canada to make any amendments to the legislation to improve the cost-effective delivery of essential medicines. This article queries the proposed Hong Kong Amendment to the TRIPS Agreement 1994, given the concerns of the Africa Group. It is submitted that it is undesirable to codify the WTO General Council Decision 2003, given its failure to provide a speedy, efficient and cost-effective delivery of essential medicines. CiteULike Connotea Del.icio.us What's this? (shrink)

The year 2020 is facing one of the worst public health situations in decades. The world is experiencing a pandemic that has triggered significant challenges to healthcare systems in both high and low‐middle income countries (LMICs). Government policymakers and healthcare personnel are experiencing real‐life ethical dilemmas and are pressed to respond to these situations. Many possible treatments are being investigated, one of which is the use of hydroxychloroquine or chloroquine. These drugs are approved for use by patients with systemic (...) lupus erythematosus (SLE), rheumatoid arthritis, and malaria. The demand for these products has increased, and the stocks are depleting for the patient population for whom the drugs are intended initially. Although both innovator and generic pharmaceutical manufacturers are making plans for increased production, there are challenges with global supply chains disruption and the retention of supplies for local markets. This may cause countries that rely on the importation of pharmaceuticals to be out of stock of supplies for an extended period. There are allegations of off‐label prescribing and hoarding. Pharmacists are the custodians and dispensers of medications and are faced with the task of assessing prescriptions and making decisions about the allocation of these products. This paper seeks to 1) highlight some of the ethical challenges of dispensing hydroxychloroquine by pharmacists during the COVID‐19 pandemic, 2) identify some of the responses to these issues from various regulatory authorities in the USA, and 3) recommend approaches to assist pharmacists in their decision‐making process, especially in LMICs. (shrink)

The year 2020 is facing one of the worst public health situations in decades. The world is experiencing a pandemic that has triggered significant challenges to healthcare systems in both high and low‐middle income countries (LMICs). Government policymakers and healthcare personnel are experiencing real‐life ethical dilemmas and are pressed to respond to these situations. Many possible treatments are being investigated, one of which is the use of hydroxychloroquine or chloroquine. These drugs are approved for use by patients with systemic (...) lupus erythematosus (SLE), rheumatoid arthritis, and malaria. The demand for these products has increased, and the stocks are depleting for the patient population for whom the drugs are intended initially. Although both innovator and generic pharmaceutical manufacturers are making plans for increased production, there are challenges with global supply chains disruption and the retention of supplies for local markets. This may cause countries that rely on the importation of pharmaceuticals to be out of stock of supplies for an extended period. There are allegations of off‐label prescribing and hoarding. Pharmacists are the custodians and dispensers of medications and are faced with the task of assessing prescriptions and making decisions about the allocation of these products. This paper seeks to 1) highlight some of the ethical challenges of dispensing hydroxychloroquine by pharmacists during the COVID‐19 pandemic, 2) identify some of the responses to these issues from various regulatory authorities in the USA, and 3) recommend approaches to assist pharmacists in their decision‐making process, especially in LMICs. (shrink)

In coming decades, fetal medicine may become a routine part of reproductive care. The measures pregnant women now take to protect fetal health are largely generic, like restricting their diets and using supplements. Relatively few interventions are based on specific conditions revealed by ultrasound or genetic testing. A recent finding, though, may herald a dramatic rise in “personalized” fetal medicine: certain drugs already approved by the Food and Drug Administration can apparently boost neural growth in fetuses with Down (...) syndrome, improving cognitive functioning in the future child. Many more condition‐specific findings are likely in the near future. But as commentators have frequently observed about prenatal testing, technologies that appear to increase reproductive options also complicate and constrain them. (shrink)

Advancements in the field of biotechnology have accelerated the development of drugs that are manufactured from cultures of living cells, commonly referred to as “biologics.” Due to the complexity of the production process, generic biologics are unlikely to be chemically identical to the reference product, and accordingly are referred to as “biosimilars.”Encouraging the development of biosimilars has been presented as the key solution to decrease prices and increase access to biologics, but the development and use of biosimilars continues (...) to raise problems, none of which can easily be addressed. Developing a biosimilar requires considerable time and financial resources, and legitimate safety concerns necessitate elaborate clinical testing of biosimilars. As a consequence, the introduction of biosimilars onto the market has not resulted in significant price reductions, and concerns regarding the substitution and interchangeability of original biologics with biosimilars persist.This article will explain how the biologics production process distorts the trade-offs that traditionally guided both patent protection and regulatory exclusivities: disclosure as a key condition for benefiting from the corresponding monopoly position. Hence, we propose establishing a mechanism of mandatory deposit of the original biologic's cell line at the stage of the regulatory approval as the most effective remedy. (shrink)