Arthur A. Daemmrich

A Collaboratively-Derived Science-Policy Research Agenda

The need for policy makers to understand science and for scientists to understand policy processes is widely recognised. However, the science-policy relationship is sometimes difficult and occasionally dysfunctional; it is also increasingly visible, because it must deal with contentious issues, or itself becomes a matter of public controversy, or both. We suggest that identifying key unanswered questions on the relationship between science and policy will catalyse and focus research in this field. To identify these questions, a collaborative procedure was employed with 52 participants selected to cover a wide range of experience in both science and policy, including people from government, non-governmental organisations, academia and industry. These participants consulted with colleagues and submitted 239 questions. An initial round of voting was followed by a workshop in which 40 of the most important questions were identified by further discussion and voting. The resulting list includes questions about the effectiveness of science-based decision-making structures; the nature and legitimacy of expertise; the consequences of changes such as increasing transparency; choices among different sources of evidence; the implications of new means of characterising and representing uncertainties; and ways in which policy and political processes affect what counts as authoritative evidence. We expect this exercise to identify important theoretical questions and to help improve the mutual understanding and effectiveness of those working at the interface of science and policy.

RISK VERSUS RISK: Decision-making Dilemmas of Drug Regulation in the United States and Germany

The regulation of medicines is fraught with inherent dilemmas of decision-making, or `risk versus risk’ tradeoffs. Arguing that efforts to clean up the environment or improve public health often generate `countervailing risks’ , John Graham and Jonathan Wiener stress that all regulatory choicesÐ including inactionÐ can have adverse consequences (Graham and Wiener, 1995). `Risk versus risk’ is an accurate description of the predicament faced by regulatory decision-makers when reviewing new drug applications. Approving a medicinal drug too quickly can lead to countervailing risks in the form of severe side effects. Withholding or approving it too slowly can be problematic as well, most obviously when dealing with a potentially life-saving therapy. The history of pharmaceutical drugs is full of examples for both sides of this `risk versus risk’ coin. On the side of overly rapid marketing following insuf® cient testing, cases such as tainted sulfanilamide, Thalidomide, Fen ̄ uramine used in conjunction with Phentermine (phen-fen), and Rezulin have all generated extensive media attention and prompted increased regulatory oversight. Use of the solvent diethylene glycol in the antibiotic sulfanilamide caused over 100 deaths in 1937 and led to the passage of the 1938 US Food, Drug and Cosmetic Act (Jackson, 1970). In the twentieth century’ s most prominent drug disaster, widespread use of the sedative Thalidomide among pregnant women in Germany, England, and elsewhere was linked to the birth of nearly 10,000 deformed babies (Lenz, 1962; McFadyen, 1976). Three years ago, the diet pill phen-fen was linked to heart valve disease, forcing the manufacturer to withdraw it from the US market (Bachorik, 1997). More recently, in March 2000, the Food

The political economy of healthcare reform in China: negotiating public and private

China’s healthcare system is experiencing significant growth from expanded government-backed insurance, greater public-sector spending on hospitals, and the introduction of private insurance and for-profit clinics. An incremental reform process has sought to develop market incentives for medical innovation and liberalize physician compensation and hospital finance while continuing to keep basic care affordable to a large population that pays for many components of care out-of-pocket. Additional changes presently under consideration by policymakers are likely to further restructure insurance and the delivery of care and will alter competitive dynamics in major healthcare industries, notably pharmaceuticals, medical devices, and diagnostic testing. This article describes the institutional history of China’s healthcare system and identifies dilemmas emerging as the country negotiates divisions between public and private in healthcare. Building on this analysis, the article considers opportunities for public-private partnerships and greater systems integration to reconcile otherwise incommensurable approaches to rewarding innovation and improving access. The article concludes with observations on the public function of health insurance and its significance to further development of China’s healthcare system.

Healthcare reform in the United States and China: pharmaceutical market implications

ObjectivesThe United States and China are broadening health insurance coverage and increasing spending on pharmaceuticals, in contrast to other major economies that are reducing health spending and implementing a variety of drug price controls. This article analyzes the implications of health system reforms in the United States and China for national pharmaceutical markets. It follows a historical institutionalist approach that identifies path dependency in the design and operation of national health systems. On that basis, we estimate prescription sales for 2015 and 2020, analyze the sustainability of free-market pricing for drugs in the two countries, and assess future competitive dynamics in the pharmaceutical sector.MethodsThe institutional trajectories of health system reform and insurance coverage were studied for the United States and China. Next, data were collected from government, industry, and analyst reports on total healthcare spending and prescription drug expenditure by insurance status (in the United States) and by site of care (in China). Simple quantitative models were developed to estimate future drug spending based on insurance coverage, treatment locations, and health spending as a percentage of GDP.ResultsBoth countries will see rising total pharmaceutical spending and will be the two largest country markets for prescription drugs through at least 2020. In dollar terms, the U.S. pharmaceutical market will be over

Regulatory Laws and Political Culture in the United States and Germany

440 billion in 2015 and

U.S. healthcare reform and the pharmaceutical market: Projections from institutional history

700 billion in 2020; China’s prescription market will be over

Legal and Political Competitiveness for Pharmaceuticals

155 billion in 2015 and grow further to

Utopian dreams and regulatory nightmares

260 billion in 2020. In both countries, generics will increase their share of all prescriptions, but economic and structural incentives for new drug invention and brand-name prescribing by physicians will keep the share of patented drug sales high compared to countries with more direct government control over the pharmaceutical market.ConclusionsExpanding private insurance contributes to spending on branded drugs, since insurers compete for market share rather than cost savings. Health system reforms presently being enacted in the United States and China align to historical institutional trajectories in each country, but leave unresolved a core tension between incentives for new drug invention and universal access to affordable medicines.

Pharmacopolitics: Drug Regulation in the United States and Germany

By the early 1980s, requirements that new pharmaceuticals undergo pre- market testing to determine their ‘safety’ and ‘efficacy’ were common to most industrialized countries. Yet twenty years later, regulatory decisions concerning the approval or rejection of new medicines still exhibit ‘worlds of differences’ among countries with similar regulatory standards (Dukes, 1986). In order to meet different regulatory expectations, strategies followed by pharmaceutical firms in the invention, testing, and marketing of drugs often display distinctive national patterns. While it is not unusual for a new drug to come out of collaborative research between laboratories on different continents or for clinical trials to be conducted in multiple countries, different approaches to data analysis and risk assessment lead to important variation in regulatory decisions among countries around the globe. Understanding differences in cultures of testing and regulation is essential to crafting productive systems for medical innovation and will be crucial to current efforts at international harmonization across Europe, the United States, and Japan (Abraham, 1997; Kidd, 1996).

The tragedy of the commoners: biotechnology and its publics

Fiercely contested before, during, and after its passage, the 2010 Patient Protection and Affordable Care Act (ACA) is presently restructuring the U.S. healthcare market. This article describes the history of healthcare reform initiatives in the United States, analyzes the policy context in which the ACA was passed, and develops forecasts for the pharmaceutical market as insurance coverage grows. The institutional history of the U.S. healthcare system is revealing of the power of entrenched private interests, especially insurance and pharmaceutical firms, and of widespread opposition to price controls on prescription drugs or other forms of care. The ACA conforms to path dependency in the U.S. health system, continuing a unique mix of public and private insurance and private delivery of care. Building on the institutional analysis, the article develops specific projections for the U.S. prescription drug market in 2015 and 2020. The article concludes with a discussion of anticipated changes to pharmaceutical market structure under the ACA and the sustainability of free-market pricing for prescription drugs in the United States.