Framework for assessing the capacity of a health ministry to conduct health policy processes—a case study from Tajikistan

An adequate capacity of ministries of health (MOH) to develop and implement policies is essential. However, no frameworks were found assessing MOH capacity to conduct health policy processes within developing countries. This paper presents a conceptual framework for assessing MOH capacity to conduct policy processes based on a study from Tajikistan, a former Soviet republic where independence highlighted capacity challenges. The data collection for this qualitative study included in‐depth interviews, document reviews and observations of policy events. Framework approach for analysis was used. The conceptual framework was informed by existing literature, guided the data collection and analysis, and was subsequently refined following insights from the study. The Tajik MOH capacity, while gradually improving, remains weak. There is poor recognition of wider contextual influences, ineffective leadership and governance as reflected in centralised decision‐making, limited use of evidence, inadequate actors' participation and ineffective use of resources to conduct policy processes. However, the question is whether this is a reflection of lack of MOH ability or evidence of constraining environment or both. The conceptual framework identifies five determinants of robust policy processes, each with specific capacity needs: policy context, MOH leadership and governance, involvement of policy actors, the role of evidence and effective resource use for policy processes. Three underlying considerations are important for applying the capacity to policy processes: the need for clear focus, recognition of capacity levels and elements, and both ability and enabling environment. The proposed framework can be used in assessing and strengthening of the capacity of different policy actors. Copyright © 2013 John Wiley & Sons, Ltd.     

Implementing Health Policy: Lessons from the Scottish Well Men's Policy Initiative

BackgroundLittle is known about how health professionals translate national government health policy directives into action. This paper examines that process using the so-called Well Men''s Services (WMS) policy initiative as a ‘real world’ case study. The WMS were launched by the Scottish Government to address men''s health inequalities. Our analysis aimed to develop a deeper understanding of policy implementation as it naturally occurred, used an analytical framework that was developed to reflect the ‘rational planning’ principles health professionals are commonly encouraged to use for implementation purposes.Methods and materialsA mixed-methods qualitative enquiry using a data archive generated during the WMS policy evaluation was used to critically analyze (post hoc) the perspectives of national policy makers, and local health and social care professionals about the: (a) ‘policy problem’, (b) interventions intended to address the problem, and (c) anticipated policy outcomes.Results and conclusionsThis analysis revealed four key themes: (1) ambiguity regarding the policy problem and means of intervention; (2) behavioral framing of the policy problem and intervention; (3) uncertainty about the policy evidence base and outcomes, and; (4) a focus on intervention as outcome. This study found that mechanistic planning heuristics (as a means of supporting implementation) fails to grapple with the indeterminate nature of population health problems. A new approach to planning and implementing public health interventions is required that recognises the complex and political nature of health problems; the inevitability of imperfect and contested evidence regarding intervention, and, future associated uncertainties.     

Peer Reviewed: Population Health Rankings as Policy Indicators and Performance Measures

Population health rankings can be used by various actors for different purposes. This article examines those potential uses and concludes that the chief promise of population health rankings lies in 2 areas. The first is to help set agendas — stimulating awareness, motivation, and debate over means to improved health outcomes. The second is to help establish broad responsibility for population health and the need for multisectoral collaboration to improve outcomes. A new performance regime based on rankings will require more research to establish causal pathways and relative determinants of health, as well as stronger evidence about the effects of public and private interventions to guide investment strategies. Finally, leaders who develop and promote population health rankings must further develop the technical community needed to translate the response to the rankings into constructive public debate and policy development.     

Peer Reviewed: Workplace Health Promotion in Washington State

The workplace is a powerful setting to reach large numbers of at-risk adults with effective chronic disease prevention programs. Missed preventive care is a particular problem for workers with low income and no health insurance. The costs of chronic diseases among workers — including health care costs, productivity losses, and employee turnover — have prompted employers to seek health promotion interventions that are both effective and cost-effective. The workplace offers 4 avenues for delivering preventive interventions: health insurance, workplace policies, health promotion programs, and communications. For each of the avenues, the evidence base describes a number of preventive interventions that are applicable to the workplace. On the basis of the evidence and of our work in Washington State, we present a public health approach to preventing chronic diseases via the workplace. In addition to relying on the evidence, this approach makes a compelling business case for preventive interventions to employers.     

The Scientific Basis for Law as a Public Health Tool

Systematic reviews are generating valuable scientific knowledge about the impact of public health laws, but this knowledge is not readily accessible to policy makers. We identified 65 systematic reviews of studies on the effectiveness of 52 public health laws: 27 of those laws were found effective, 23 had insufficient evidence to judge effectiveness, 1 was harmful, and 1 was found to be ineffective. This is a valuable, scientific foundation—that uses the highest relevant standard of evidence—for the role of law as a public health tool.Additional primary studies and systematic reviews are needed to address significant gaps in knowledge about the laws’ public health impact, as are energetic, sustained initiatives to make the findings available to public policy makers.Law is a traditional public health tool that has made vital contributions to the major public health achievements of the 20th century. Examples include school immunization laws that helped reduce the rates of infectious disease and tobacco control laws that helped reduce the rates of chronic disease.¹ Indeed, many, if not all, government public health endeavors rely on laws crafted to address specific health conditions or risk factors (“interventional” public health laws), laws that create and empower public health agencies and jurisdictions (“infrastructural” public health laws), or the general police powers of state governments. In addition, many laws not designed principally for public health objectives nonetheless have public health consequences (e.g., taxation and education laws). While potentially powerful legal tools for public health, these latter laws are not considered here.Policy makers weigh many factors as they consider adopting and promoting public health laws. A central question—especially in this time of emphasis on evidence-based practice and policy—is whether there is sound scientific evidence that a given public health law is effective. The number of peer-reviewed publications reporting on the impact of interventional public health laws is growing, as is the number of systematic reviews and meta-analyses of such primary studies.² However, this body of scientific knowledge, although potentially of great value, to date has not been summarized and made readily accessible to policy makers. We begin to address this gap.Systematic reviews and meta-analyses apply the most sophisticated methodologies currently available to assess the findings of multiple primary studies focused on a given intervention.³ Systematic reviews have been defined as

review[s] of a clearly formulated question that use[s] systematic and explicit methods to identify, select, and critically appraise relevant research, and to collect and analyze data from the studies that are included in the review.⁴

Often considered a subset of systematic reviews, meta-analyses are

quantitative statistical analyses … applied to separate but similar experiments of different and usually independent researchers and that involve[s] pooling the data and using the pooled data to test the effectiveness of the results.⁵

For the sake of simplicity, we use the term “systematic review” for both.We report on a survey of systematic reviews of peer-reviewed primary studies of individual interventional public health laws. It is thus a report on the highest-quality scientific evidence currently available on the effectiveness of such laws. In addition, we identified recommendations contained in those reviews for future research on interventional public health laws.     

Health as foreign policy: harnessing globalization for health

This paper explores the importance for health promotion of the rise of public health as a foreign policy issue. Although health promotion encompassed foreign policy as part of 'healthy public policy', mainstream foreign policy neglected public health and health promotion's role in it. Globalization forces health promotion, however, to address directly the relationship between public health and foreign policy. The need for 'health as foreign policy' is apparent from the prominence public health now has in all the basic governance functions served by foreign policy. The Secretary-General's United Nations (UN) reform proposals demonstrate the importance of foreign policy to health promotion as a core component of public health because the proposals embed public health in each element of the Secretary-General's vision for the UN in the 21st century. The emergence of health as foreign policy presents opportunities and risks for health promotion that can be managed by emphasizing that public health constitutes an integrated public good that benefits all governance tasks served by foreign policy. Any effort to harness globalization for public health will have to make health as foreign policy a centerpiece of its ambitions, and this task is now health promotion's burden and opportunity.     

Cigarettes Become a Dangerous Product: Tobacco in the Rearview Mirror, 1952–1965

Tobacco control’s unparalleled success comes partly from advocates broadening the focus of responsibility beyond the smoker to include industry and government. To learn how this might apply to other issues, we examined how early tobacco control events were framed in news, legislative testimony, and internal tobacco industry documents. Early debate about tobacco is stunning for its absence of the personal responsibility rhetoric prominent today, focused instead on the health harms from cigarettes. The accountability of government, rather than the industry or individual smokers, is mentioned often; solutions focused not on whether government had a responsibility to act, but on how to act. Tobacco lessons can guide advocates fighting the food and beverage industry, but must be reinterpreted in current political contexts.Tobacco control shines as a beacon of success in public health, having demonstrated unequivocally that policy interventions can improve environments and reduce morbidity and mortality at a population level.1–3 Yet tobacco remains the leading cause of preventable death in the United States4 and worldwide.5Indeed, the tobacco industry continues to resist a wide variety of tobacco control initiatives by insisting that there is no need for government intervention: smoking is a choice, and if smokers want to quit, they should take personal responsibility for their own health and just quit. For example, the Centers for Disease Control and Prevention’s Communities Putting Prevention to Work program, which emphasized tobacco control interventions, came under attack from tobacco industry representatives claiming that,

All across the country, Americans are growing increasingly concerned about the role of government, and it’s believed by a substantial population in this country that the government is overreaching its bounds and getting too involved in our personal lives.6

Indeed, beginning in the 1980s the tobacco industry was instrumental in fomenting conservative activism focused on concerns about the role of government.7 Thus, it is no surprise that public health advocates working on other issues are subject to similar arguments. The food industry, for example, has responded to concerns about obesity with arguments that focus attention on personal responsibility and negate the role of government.8We were interested in better understanding how public health has weathered the drumbeat of personal responsibility rhetoric to inform ongoing tobacco control efforts and emerging public health interventions to address obesity. We know, for example, that successful tobacco control programs such as California’s9^,10 have sought to denormalize tobacco use and the tobacco industry by employing a spectrum of strategies from individually oriented cessation programs to tax policy and environmental changes to reduce exposure to secondhand smoke.11 California’s famously effective media campaign illustrated that comprehensive approach with advertising that ranged from messages reminding smokers that “quitting takes practice” to warning that “the tobacco industry is not your friend.” One set of messages placed responsibility on individuals to quit smoking; the other set placed responsibility on the tobacco industry and government regulation.12 Both discourses exist in tobacco control just as they coexist in society at large, though one or another may dominate the public discussion at any given time.Since the 1970s in the United States, personal responsibility rhetoric has increasingly dominated public policy debate.13,14 President Clinton’s 1996 landmark welfare reform legislation, the Personal Responsibility and Work Opportunity Reconciliation Act,15 and the rise of the Tea Party16 in 2010 are 2 manifestations of this perspective.“Framing” refers to how an idea or issue is defined, portrayed, and understood. Frames operate at the cognitive level, consciously or unconsciously, to construct meaning17 by promoting “a particular problem definition, causal interpretation, moral evaluation, and/or treatment recommendation for the item described.”18^(p52)One of the most enduring frames in American discourse is “rugged individualism,”19 which presents problems as a matter of personal choice or accomplishment independent of—or despite—social, historical, or environmental forces. This frame presumes that individuals or the laissez-faire market, not government or other entities, are the genesis of and appropriate agent for remedy of problems.20 Alternatively, American discourse at times includes frames suggesting collective responsibility in which government or institutions are the source of or solution to social problems.21The precursor to questions about individual responsibility or institutional accountability in tobacco control is this: does smoking harm health? Although for most people this question was definitively answered by the 1964 Surgeon General’s Report, it was doggedly contested by the tobacco industry for another 3 decades.22,23Once the cause of the health harm is established, responsibility can be framed along the continuum from individuals to the environment surrounding them, including society and its institutions. Within the individualism frame, if people experience harm from cigarettes it is because they choose to smoke; to avoid the harm individuals can avoid smoking. A public health approach demands a broader conception that includes shared responsibility between individuals and the forces that shape the environment in which those individuals act. From a public health perspective, responsibility for creating and solving health problems, including from tobacco, can be assigned to individuals and to institutions, either of which may be culpable for the problem or accountable for remedial action. How causality, culpability, and accountability are framed can determine whether society calls upon individuals, industry, or government to take action.Like other social problems, public health problems—and their solutions—are in large part defined by how they are framed and who is influencing the framing.24 Framing takes place in private communications as well as public forums that shape policy decisions, including the news media as well as judicial, regulatory, and legislative proceedings.Decades of communications research show that the news sets the agenda and frames debate for the public and policymakers.25–29 News frames can affect attributions of responsibility for both lung cancer and obesity.30 Although news stories typically contain several frames, on balance, most reinforce an individualistic point of view.17 The power of framing in judicial, regulatory, and legislative forums is less well documented, but may directly affect the policy decisions on controversial public health issues.31–33In addition, different speakers within these public forums may frame issues in conflicting ways.34,35 In the context of a public debate about a controversial topic such as tobacco policy, different actors will frame the issue to serve their own interests.36–38To learn how responsibility for causing and remedying tobacco-related problems has been characterized, we examined how the policy debate was framed during the events leading up to and including the first major national policy in tobacco control, the Federal Cigarette Labeling and Advertising Act (FCLAA) of 1965.39 We examined how arguments about responsibility were framed in tobacco industry internal documents, legislative testimony, and news coverage about tobacco. In our investigation, responsibility could be characterized in 3 ways. Causality addresses whether tobacco—in this era, almost always cigarettes—causes health harms, usually lung cancer. Culpability assumes that smoking is harmful and points to whom or what might be to blame. Accountability frames go further to name who has responsibility for taking action to remedy the problem—individual smokers, government agencies, the tobacco industry, or clinicians. By asking how responsibility for causing health harms from cigarettes was framed, who was blamed for them, and who was held accountable for rectifying them during this early era to control tobacco, we can peer back through a window in time before the tobacco industry—and before government—were both demonized.     

“There is always a better way”: Managing uncertainty in decision making about new cancer drugs in Canada

Policy decisions about the approval and funding of new cancer drugs must often be made in an environment of complex uncertainty about clinical and cost‐effectiveness data. The focus of this article is on the results from qualitative interviews with senior officials (n = 16) who make decisions about or influence cancer drug policy in various organizations in the Canadian cancer control system. Most participants identified the use of a limited number of informal approaches to address uncertainty, such as grounding decisions in evidence and advice from expert groups. People tended to focus on evidence informed decisions including price negotiations, the ability to implement policy changes, and stakeholder values. Lessons from the Canadian context related to continuing efforts to build a public culture of understanding into how policy decisions like cancer drug funding are made may result in greater acceptance and increased confidence in health policy decision‐making processes across multiple sectors internationally.     

The Bureaucratic Destruction of Patients' Faith in Their Doctors: Public Psychiatry's Negative Lessons for General Medicine

The doctor-patient relationship, so important in all of medical practice, has been destroyed in much of American public psychiatry. That destruction should serve as an important negative lesson for a medical care system facing reorganization. The desirability of having the same psychiatrist caring for a patient both in the mental hospital and after discharge—continuity of care—should have been obvious, but its significance was not defined explicitly, to this author''s knowledge, until about 1979. White''s demonstration that the therapeutic relationship''s positive impact seems to “account for about half of the benefits” associated with medical and similar ministrations underlines its importance. Continuity of competent public psychiatric care, and its therapeutic effectiveness, have been impeded by the harmful attitudes and actions of American psychiatry and the care-fragmenting acts of public officials. Soon after the continuity concept was informally presented in 1979, official American psychiatry, increasingly influenced by drug companies, began denying the importance of a physician''s continuing care by redefining “continuity” as though public mental health care had to be fragmented. Specific policy decisions by officials are also largely responsible for the destruction of good public psychiatric care. This in turn has produced gross overuse of medications and the near disappearance of competent public psychiatric leadership and effective therapeutic relationships. An example from the federal Health Care Finance Administration shows how comparably harmful bureaucratic decisions concerning health care can also be made on the federal level. If similar decisions are made under the proposed reorganization of general medical care, that care, like American public psychiatry, may become harmful to its patients.     

Public participation in regional health policy: a theoretical framework

How best to involve the public in local health policy development and decision-making is an ongoing challenge for health systems. In the current literature on this topic, there is discussion of the lack of rigorous evaluations upon which to draw generalizable conclusions about what public participation methods work best and for what kinds of outcomes. We believe that for evaluation research on public participation to build generalizable claims, some consistency in theoretical framework is needed. A major objective of the research reported on here was to develop such a theoretical framework for understanding public participation in the context of regionalized health governance. The overall research design followed the grounded theory tradition, and included five case studies of public participation initiatives in an urban regional health authority in Canada, as well as a postal survey of community organizations. This particular article describes the theoretical framework developed, with an emphasis on explaining the following major components of the framework: public participation initiatives as a process; policy making processes with a health region; social context as symbolic and political institutions; policy communities; and health of the population as the ultimate outcome of public participation. We believe that this framework is a good beginning to making more explicit the factors that may be considered when evaluating both the processes and outcomes of public participation in health policy development.     

Beyond Reproduction: The “First 1,000 Days” Approach to Nutrition through a Gendered Rights-Based Lens

The First 1,000 Days approach highlights the importance of adequate nutrition in early life—from conception to a child’s second birthday—for good development and growth throughout the child’s life and potentially onto their own offspring. The approach has been highly influential in mobilizing policy attention and resources to improve maternal and infant nutrition in global health and development. This paper undertakes a critical review of this approach from a gendered human rights lens, finding that the theoretical underpinnings implicitly reflect and reproduce gender biases by conceptualizing women within a limited scope of reproduction and child care. We explore the processes of systemic neglect through Pierre Bourdieu’s theories on how social structures are reproduced. Understanding theory is important to the governance of global health, how we frame priorities, and how we act on them. Revisiting influential theories is a means of accountability to ensure inclusiveness and to reduce gender and health inequities in research. We argue that a greater focus on women could increase the potential impact of nutrition interventions.     

Bridging the gap: Translating research into policy and practice

Effective physical activity interventions do not achieve their full potential if they are not applied beyond their original testing in research studies. Potentially effective interventions can be adopted in community settings through the efforts of numerous agencies, organizations, and individuals. This paper highlights the important roles of public health practitioners and policy makers, who differ in their decision-making processes. To enhance the uptake of evidence-based interventions, several steps are needed to: build the science by moving upstream, increase the understanding of practice-based evidence, move beyond the “what” to the “how,” re-frame the dissemination challenges, place greater emphasis on workforce development, and make research more accessible for policy audiences. The most effective strategies to bridge the gap between research and practice, will have at their heart, effective academic-practice-policy maker partnerships.     

Putting knowledge to trial: ‘ADHD parents’ and the evaluation of alternative therapeutic regimes

The role of patients' organisations in shaping (medical) knowledge about particular health conditions and illnesses sheds light on notions of informed patienthood and the dynamics of lay-expert knowledge in the context of medicalisation. This paper considers dynamics of knowledge production in relation to a specific condition area, Attention Deficit Hyperactivity Disorder (ADHD), by investigating how parents of children with ADHD are intervening in knowledge creation about the effectiveness of different treatments for the disorder. It draws on qualitative research carried out between 2009 and 2011 with organisations representing parents of children with ADHD in Ireland, to explore how parents have commissioned evaluations of alternative interventions to medication. Drawing on analysis of 12 semi-structured interviews with both parents and professionals active in the arena of ADHD, documentary evidence, and observation at parent organisations' events, the study demonstrates how parents' interventions have sought to expand the therapeutic domain of ADHD beyond the exclusive realm of biopsychiatry, and the dilemmas they face in making their experiences count in a context where the need for evidence has become paramount in the governance of health.     

Questioning the Consensus: Managing Carrier Status Results Generated by Newborn Screening

An apparent consensus governs the management of carrier status information generated incidentally through newborn screening: results cannot be withheld from parents. This normative stance encodes the focus on autonomy and distaste for paternalism that characterize the principles of clinical bioethics.However, newborn screening is a classic public health intervention in which paternalism may trump autonomy and through which parents are—in effect—required to receive carrier information. In truth, the disposition of carrier results generates competing moral infringements: to withhold information or require its possession.Resolving this dilemma demands consideration of a distinctive body of public health ethics to highlight the moral imperatives associated with the exercise of collective authority in the pursuit of public health benefits.NEWBORN SCREENING programs identify serious conditions for which early detection reduces mortality or morbidity.¹ Yet, in the pursuit of information about targeted disorders, screening may incidentally generate information about carrier status that is irrelevant to the infant''s health. The consensus to date is that this information should be disclosed to parents—indeed, that to withhold such information would be unethical.In our view, the current practice of automatic disclosure of incidental carrier results reflects a bad marriage between clinical bioethics and public health praxis. It combines clinical bioethics'' emphasis on autonomy and distaste for paternalism with the determination of public health to exercise collective authority and entertain justifiable compulsion. We seek to shed new light on this enduring dilemma. We considered the moral significance of reproductive risk information as well as the interests of the child to explore why automatic disclosure to parents might be morally troubling. We then considered how the application of distinctive ethical principles of public health could guide the development of sound policy on this issue.     

Developing Data Governance Agreements with Indigenous Communities in Canada: Toward Equitable Tuberculosis Programming,Research, and Reconciliation

Indigenous rights to self-determination and data sovereignty support Indigenous-led data governance, which, when adequately resourced, can act as a catalyst for Indigenous-led strategic planning and decision-making in public health research and programming. Respecting Indigenous data sovereignty and governance requires time, resources, education, and planning. Here we share our experiences and lessons learned when developing and implementing data governance agreements with select First Nations and Métis partnering communities in Canada in the context of tuberculosis prevention and care. We define the process undertaken to create a decision space, supported by data governance agreements, where researchers, program (government) stakeholders, and Indigenous community partners are equally and equitably informed to co-develop public health interventions. The decision space has implications for tackling all manner of public health concerns and can inform policy for nation-to-nation public health relationships to advance public health goals.     

Peer Reviewed: Healthy Maine Partnerships: Policy and Environmental Changes

Background

Tobacco settlement funds were used to establish the Healthy Maine Partnerships (HMPs) to reduce tobacco use, increase physical activity, and improve nutrition through local policy and environmental change.

Context

The HMP model is a progressive approach to public health. It provides for coordinated efforts between state and local partners for health promotion and disease prevention. Community coalitions, supported with funding and guidance by the state, are the basis for policy and environmental change.

Methods

The state awarded contracts and provided program guidance to foster policy and environmental change at the local level. The partnerships'' efforts were assessed with a retrospective evaluation that consisted of 2 data collection periods conducted using the same tool. A survey booklet containing lists of possible environmental and policy changes was developed and mailed — once in 2005 and once in 2006 — to all 31 local partnership directors and school health coordinators who completed it. Additional data were collected from the local partnerships in the form of narrative reports required by their funder (Maine Center for Disease Control and Prevention).

Consequences

All local partnerships implemented policy or environmental interventions to address tobacco use, physical activity, and nutrition during the period covered by the surveys (July 2002-June 2005 [fiscal years 2003-2005]). Cumulatively, more than 4,600 policy or environmental changes were reported; tobacco use policies represent most changes implemented. A second round of HMP funding has since been secured.

Interpretation

Although the survey methodology had limitations, results suggest that much work has been accomplished by the local partnerships. Plans are to share success stories among partnerships, provide training, and continue to improve the public health infrastructure in Maine.     

Academic Patents and Access to Medicines in Developing Countries

There is a widespread and growing concern that patents hinder access to life-saving drugs in developing countries.Recent student movements and legislative initiatives emphasize the potential role that research universities in developed countries could have in ameliorating this “access gap.” These efforts are based on the assumption that universities own patents on a substantial number of drugs and that patents on these drugs are currently filed in developing countries.I provide empirical evidence regarding these issues and explore the feasibility and desirability of proposals to change university patenting and licensing practices to promote access to medicines in the developing world.THE PHARMACEUTICAL REVOlution contributed to dramatic reductions in morbidity and mortality from disease in developed countries during the last century. Today, however, as many as 2 billion people in the world—most of them in developing countries—lack access to life-saving drugs.¹ Righting this imbalance is among the most important challenges in global public health in this century. One source of the access gap in developing countries is a lack of research on specific diseases within developing countries. Both the public and private sectors devote relatively little research to diseases without markets in developed countries. As a result, relatively few new drugs target diseases specific to developing countries.² Analysts have also argued that poor health infrastructure, cumbersome drug regulatory procedures, and high tariffs and taxes in developing countries are important obstacles to access.³ A third potential obstacle—my focus—is pharmaceutical patenting in developing countries, which (by restricting generic competition) can raise the prices of drugs and thus hinder access to medicines.One proposed solution to this last problem targets a perhaps surprising set of actors: research universities and public sector research institutes in developed countries. One of the main advocates of this approach, Universities Allied for Essential Medicines, a student group with over 40 campus chapters (with the slogan “Our Labs, Our Drugs, Our Responsibility”) argues on its Web site:

Many of the world''s most important medicines and public health devices are wholly or partly developed in academic laboratories. Their accessibility to those living in poor nations is profoundly affected by the research, licensing and patenting decisions made by universities… . As members of these institutions of higher learning, we believe that universities have an opportunity and a responsibility to improve global access to public health goods—particularly those they have helped develop.⁴

I explore the feasibility and desirability of proposals to use the power of universities—conferred by ownership of key patents—to help reduce drug prices and promote access in developing countries. I provide and discuss new data, university ownership of key patents, and their propensity to file these patents in developing countries. However, before doing so, it is useful to reflect on the broader institutional and historical context for the current proposals. Drug patents allow their owners to exclude others from using or producing the drug until patent expiration (typically 20 years from the date the patent is filed). By excluding generic competition, patents keep prices high. The typical justification for patent protection is that these temporary high prices are needed to create incentives for firms to invest in research and development. In other words, patents involve tradeoffs: although they create incentives to innovate, they can raise prices and reduce access.Until the mid-1990s, many developing countries did not allow product patents in pharmaceuticals.⁵ This generally reflected a conscious policy decision that the benefits from low-cost access to drugs were greater than any potential negative impact that lack of domestic patents would have on the research and development decisions of multinational companies. However, following the World Trade Organization''s 1995 Trade-Related Intellectual Property Rights (TRIPs) agreement, all countries were compelled to allow product patents in pharmaceuticals. In the post-TRIPs era, there is widespread concern that, by raising prices, drug patents will reduce access to medicines in developing countries.⁶University patenting, too, is a relatively recent development. Throughout much of the 20th century, research universities did not file patents in the biomedical arena, reflecting an ambivalence about limiting access to health research and discoveries.⁷ This ambivalence faded during the 1970s, and the Bayh–Dole Act of 1980 both removed bureaucratic obstacles to patenting publicly funded research and gave congressional endorsement to the notion that academic patenting and licensing facilitated commercialization of university discoveries. The logic of the Bayh–Dole Act was that, without patents on academic discoveries—often “embryonic” in form and requiring additional development, including clinical trials—firms would lack incentives to develop them to the point where they were commercially useful. Under this theory, patents on academic research—which are then licensed to firms that develop and market the academic technologies—would promote “technology transfer.”⁸ In the decades following Bayh–Dole, academic patenting and licensing grew dramatically, with the bulk of this growth concentrated in the biomedical arena.⁹ Academic institutions collect income on licensed patents, including sales-based royalties on products commercialized based on their patents. In the most recent year for which data are available, academic licensing income exceeded 1 billion US dollars.¹⁰These activities have been surrounded by controversies, including debate about whether academic patents in fact are necessary for new product development; whether the presence of patent incentives distorts academic research agendas away from “basic” and toward “applied” research; whether they create conflict of interest in clinical research; and whether academic patents on “research tools” can hinder the progress of scientific research.^11,12The proposals just noted attempt to harness an unintended benefit from academic patenting of biomedical discoveries. By giving universities ownership rights over upstream discoveries, academic patents can give universities the power to compel licensees to not enforce these patents, or any follow-on patents, in developing countries, thus helping to promote access. This movement began in 2001, when, in response to demands from student and health activists, Yale University, the owner of the key patent on an important HIV treatment (stavudine), pressured Bristol-Myers Squibb, the licensee of this patent, to agree not to enforce the patent in South Africa.¹³ This intervention reportedly led to a 30-fold reduction in the drug''s price and a dramatic expansion of HIV treatment programs in South Africa.¹⁴These developments were catalysts for the formation of Universities Allied for Essential Medicines, the campus chapters of which aim to persuade their parent universities to develop patent licensing policies that limit the ability of licensees to enforce academic patents (or related patents held by firms) in developing countries. These proposed licensing terms are generally modeled on the equitable access license developed by legal scholars.¹⁵ The movement also led to the introduction of legislation in the US Senate: S. 4040, The Public Research in the Public Interest Act, sponsored by Senator Patrick Leahy (D, VT), which requires that, as a condition for receipt of federal funds, universities include in their licensing agreements clauses limiting the licensees'' abilities to enforce academic patents—and the licensees'' own patents on drugs with academic patents—against developing-country generic producers. Similar proposals have been endorsed by a range of international bodies, including the Association of American Medical Colleges, the World Health Organization, and the American Association of Arts and Sciences.¹⁶Although this movement is intensifying, there is little empirical information on how large an impact such a strategy would have. Is the Yale case unique, or do academic institutions have ownership rights in a large number of drugs, making this strategy more generally feasible? In addition to citing specific cases in which universities owned key patents, the proposals discussed above are motivated by research showing that academic institutions play an important role in pharmaceutical innovation, drawing on bibliometric data,¹⁷ case studies,^18,19 and survey evidence.²⁰ However, this previous research on the academic role in pharmaceutical innovation does not explicitly examine the extent to which academic institutions hold patents on the drugs, which is the relevant consideration for proposals to use university ownership of patents to attempt to affect prices and access. Academic research can affect industrial innovation through a range of channels: firms benefit from knowledge obtained through published academic articles and conference presentations, through collaborations with academic scientists, and through hiring trained graduate students. These channels of knowledge and technology transfer are generally not accompanied by patents held by universities. Accordingly, even if universities did significantly contribute to pharmaceutical innovation through these channels, because there are no patents, academic institutions can have little control over the pricing or dissemination of resulting drugs. That is, the broad research on the academic influence on drug development is not directly relevant for considerations of whether universities can help affect access; the salient consideration is whether universities hold patents on their contributions.For proposals to use university ownership of drug patents to affect drug prices (and access) in developing countries to be feasible, two things would need to be true for such proposals to be reasonable. First, universities would have to own patents on a substantial number of drugs, and second, universities or firms licensing university technologies would have to currently be filing patents in developing countries. If the first statement were false, the proposed interventions would have little effect. If the second were false, the interventions would not be needed. I provide data on these issues.