Raising the Barriers to Access to Medicines in the Developing World – The Relentless Push for Data Exclusivity

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.     

Synthetic biology, patenting, health and global justice

The legal and moral issues that synthetic biology (SB) and its medical applications are likely to raise with regard to intellectual property (IP) and patenting are best approached through the lens of a theoretical framework highlighting the “co-construction” or “co-evolution” of patent law and technology. The current situation is characterized by a major contest between the so-called IP frame and the access-to-knowledge frame. In SB this contest is found in the contrasting approaches of Craig Venter’s chassis school and the BioBricks school. The stakes in this contest are high as issues of global health and global justice are implied. Patents are not simply to be seen as neutral incentives, but must also be judged on their effects for access to essential medicines, a more balanced pattern of innovation and the widest possible social participation in innovative activity. We need moral imagination to design new institutional systems and new ways of practising SB that meet the new demands of global justice.     

Social value,clinical equipoise,and research in a public health emergency

The 2016 CIOMS International ethical guidelines for health‐related research involving humans states that ‘health‐related research should form an integral part of disaster response’ and that, ‘widespread emergency use [of unproven interventions] with inadequate data collection about patient outcomes must therefore be avoided’ (Guideline 20). This position is defended against two lines of criticism that emerged during the 2014 Ebola outbreak. One holds that desperately ill patients have a moral right to try unvalidated medical interventions (UMIs) and that it is therefore unethical to restrict access to UMIs to the clinical trial context. The second holds that clinical trials in contexts of high‐mortality diseases are morally suspect because equipoise does not exist between a standard of care that offers little prospect of clinical benefit and a UMI that might offer some clinical advantage.     

Genes, diet and public health

Common chronic diseases such as coronary heart disease (CHD), diabetes, cancer, hypertension and obesity are significantly influenced by dietary and other behavioural habits. There is increasing scientific evidence that genetic factors (SNPs), conferring either protection or risk, also contribute importantly to the incidence of these diseases. SNPs are of particular interest because they influence disease in a complex but largely unknown manner by interacting with environmental and lifestyle factors. Because genetic factors also affect a person's response to dietary habits, SNPs likely will be useful in helping to determine and understand why individuals differ in their response to diets. Therefore, the discovery of SNPs will likely revolutionize not only the diagnosis of disease but also the practice of preventative medicine. Other developments, like new biomarkers and noninvasive imaging techniques, might turn out to be highly sensitive and specific in order to identify patients at risk, especially in cases with asymptomatic coronary heart disease. Thus, further knowledge of such new risk factors and their interaction with nutrition, has the potential to provide a more precise and personalized approach to prevent and treat chronic diseases like coronary artery disease, myocardial infarction and stroke.     

Focus: Bioethics: Scaling Up the Global COVID-19 Vaccination Program: Production, Allocation,and Distribution with an Emphasis on Equity

After just over 2 years, the COVID-19 pandemic continues to contribute to extensive morbidity and mortality worldwide. In addition to the burden and loss caused by the virus itself, collateral consequences of the pandemic wreak havoc on the global economy, disrupt essential health care services and childhood education, and weaken existing mechanisms of preventing other infectious diseases such as HIV and tuberculosis (TB). These impacts are unequally felt in low- and middle-income countries due to an insufficient supply of COVID-19 vaccines and an unfair allocation process of distributing vaccines worldwide. An emphasis on equity throughout the continued scaling up of the global COVID-19 vaccination program with production, allocation, and distribution of COVID-19 vaccines could begin to mitigate the disparities in vaccinations seen across the world. Current policy solutions including COVAX, intellectual property waivers, technology transfer in South Africa, and dose donations are examined to evaluate efficacy in increasing equitable access to COVID-19 vaccines.     

A historical analysis of public health, the law, and stigmatized social groups: the need for both obesity and weight bias legislation

History teaches that discrimination against socially undesirable groups leads to societal and governmental neglect of the stigmatized group's health problem. By placing weight discrimination in a historical context, this article demonstrates that legislation specifically aimed at rectifying obesity is less likely while weight bias is socially acceptable. Beyond obesity legislation, public health professionals may consider advocating for legislation directly targeting discrimination based on weight. This article reviews the history of discrimination against distinct groups and provides statutory solutions for discrimination based on weight. In addition to revising current statutes and regulatory rules, a unique statute targeting weight bias in the employment context is considered.     

Medicine, public health, and the ethics of rationing.

Physicians, like all citizens, have communal and private identities, each attending various associated roles and fulfilling diverse obligations. In light of these dual personae, we seek a moral philosophy which encompasses the responsibility for providing care to the patient and at the same time acknowledges the physician's role of arbiter of distributed care. In the traditional doctor/patient relationship, rationing, the admission that health resources are limited and must be distributed equitably by universally accepted criteria, is essentially ignored. When the physician assumes a population-based system of ethics to optimize care for all patients within a group, rationing is embraced as the realistic admission that any social action resides within boundaries--in this case health care resources--and that such restraints have economic consequences that present ethical choices. A common ground to accommodate these dual allegiances is offered by communitarian philosophy, whose outline and applicability is presented here as an alternative to the apparent moral opposition of optimized individual care and the requirement of community-wide distribution of limited health resources.     

Covert moral bioenhancement,public health,and autonomy

In a recent article in this journal, Parker Crutchfield argues that if moral bioenhancement ought to be compulsory, as some authors claim, then it ought to be covert, i.e., performed without the knowledge of the population that is being morally enhanced. Crutchfield argues that since the aim of compulsory moral bioenhancement is to prevent ultimate harm to the population, compulsory moral bioenhancement is best categorized as a public health issue, and should therefore be governed by the norms and values that apply in public health settings. In this article, I argue for two related claims. First, I question the extent to which compulsory moral enhancement should be considered a public health issue that ought to be governed by the norms and values that apply in public health settings. Second, I argue that Crutchfield's argument that covert moral bioenhancement would better respect people's autonomy than an overt program overlooks two important autonomy‐based reasons that, in fact, favor an overt moral enhancement program over a covert one.     

Climate change and local public health in the United States: preparedness, programs and perceptions of local public health department directors

While climate change is inherently a global problem, its public health impacts will be experienced most acutely at the local and regional level, with some jurisdictions likely to be more burdened than others. The public health infrastructure in the U.S. is organized largely as an interlocking set of public agencies at the federal, state and local level, with lead responsibility for each city or county often residing at the local level. To understand how directors of local public health departments view and are responding to climate change as a public health issue, we conducted a telephone survey with 133 randomly selected local health department directors, representing a 61% response rate. A majority of respondents perceived climate change to be a problem in their jurisdiction, a problem they viewed as likely to become more common or severe over the next 20 years. Only a small minority of respondents, however, had yet made climate change adaptation or prevention a top priority for their health department. This discrepancy between problem recognition and programmatic responses may be due, in part, to several factors: most respondents felt personnel in their health department--and other key stakeholders in their community--had a lack of knowledge about climate change; relatively few respondents felt their own health department, their state health department, or the Centers for Disease Control and Prevention had the necessary expertise to help them create an effective mitigation or adaptation plan for their jurisdiction; and most respondents felt that their health department needed additional funding, staff and staff training to respond effectively to climate change. These data make clear that climate change adaptation and prevention are not currently major activities at most health departments, and that most, if not all, local health departments will require assistance in making this transition. We conclude by making the case that, through their words and actions, local health departments and their staff can and should play a role in alerting members of their community about the prospect of public health impacts from climate change in their jurisdiction.