Margaret Kyle

Investments in Pharmaceuticals Before and after Trips

The TRIPS Agreement, which specifies minimum levels of intellectual property protection for countries in the WTO, has increased levels of patent protection around the world. Using variation across countries in the timing of patent laws and the severity of disease, we test the hypothesis that increased patent protection results in greater drug development effort. We find that patent protection in wealthy countries is associated with increases in R&D effort. However, the introduction of patents in developing countries has not been followed by greater R&D investment in the diseases that are most prevalent there.

Deregulating Direct-to-Consumer Marketing of Prescription Drugs: Effects on Prescription and Over-the-Counter Product Sales

This paper examines the impact and interrelationships between direct‐to‐consumer (DTC) and physician‐oriented marketing on the sales composition of the prescription (Rx) and over‐the‐counter (OTC) versions of antiulcer and heartburn medications. To understand better the implications for competition of the 1997 Food and Drug Administration’s policies regarding DTC marketing, as well as recent Rx‐to‐OTC switch approvals, we also examine the relationship between order‐of‐entry effects and marketing intensities. We find spillover effects of marketing for Rx drugs on same‐brand OTC versions of the drugs. We also find that the ratio of cumulative marketing intensity (cumulative marketing efforts divided by cumulative sales) in the OTC segment increases monotonically with order of entry. Our regression results show that various marketing demand elasticities depend on order of entry. Our findings document the importance of nonprice competition in the OTC drug market and suggest that the recent deregulation of Rx DTC marketing enhances rivalry and facilitates competition.

Intervening in global markets to improve access to HIV/AIDS treatment: an analysis of international policies and the dynamics of global antiretroviral medicines markets

BackgroundUniversal access to antiretroviral therapy (ART) in low- and middle-income countries faces numerous challenges: increasing numbers of people needing ART, new guidelines recommending more expensive antiretroviral (ARV) medicines, limited financing, and few fixed-dose combination (FDC) products. Global initiatives aim to promote efficient global ARV markets, yet little is known about market dynamics and the impact of global policy interventions.MethodsWe utilize several data sources, including 12,958 donor-funded, adult first-line ARV purchase transactions, to describe the market from 2002-2008. We examine relationships between market trends and: World Health Organization (WHO) HIV/AIDS treatment guidelines; WHO Prequalification Programme (WHO Prequal) and United States (US) Food and Drug Administration (FDA) approvals; and procurement policies of the Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM), US Presidents Emergency Plan for AIDS Relief (PEPFAR) and UNITAID.ResultsWHO recommended 7, 4, 24, and 6 first-line regimens in 2002, 2003, 2006 and 2009 guidelines, respectively. 2009 guidelines replaced a stavudine-based regimen (

Markets for Pharmaceutical Products

88/person/year) with more expensive zidovudine- (

Objective and self‐report work performance measures: a comparative analysis

154-260/person/year) or tenofovir-based (

Intellectual Property Protection and the Geography of Trade

244-465/person/year) regimens. Purchase volumes for ARVs newly-recommended in 2006 (emtricitabine, tenofovir) increased >15-fold from 2006 to 2008. Twenty-four generic FDCs were quality-approved for older regimens but only four for newer regimens. Generic FDCs were available to GFATM recipients in 2004 but to PEPFAR recipients only after FDA approval in 2006. Price trends for single-component generic medicines mirrored generic FDC prices. Two large-scale purchasers, PEPFAR and UNITAID, together accounted for 53%, 84%, and 77% of market volume for abacavir, emtricitabine, and tenofovir, respectively, in 2008. PEPFAR and UNITAID purchases were often split across two manufacturers.ConclusionsGlobal initiatives facilitated the creation of fairly efficient markets for older ARVs, but markets for newer ARVs are less competitive and slower to evolve. WHO guidelines shape demand, and their complexity may help or hinder achievement of economies of scale in pharmaceutical manufacturing. Certification programs assure ARV quality but can delay uptake of new formulations. Large-scale procurement policies may decrease the numbers of buyers and sellers, rendering the market less competitive in the longer-term. Global policies must be developed with consideration for their short- and long-term impact on market dynamics.

Does Reimportation Reduce Price Differences for Prescription Drugs? Lessons from the European Union

This chapter describes the market for pharmaceuticals, which exceeded

Mergers and Alliances in Pharmaceuticals: Effects on Innovation and R&D Productivity

500 million in sales in 2010. The industry is also characterized by extensive regulation of almost every activity, from product development through manufacturing and marketing, which we summarize. We next describe the industrys market structure. Large, fully integrated, multinational firms that develop and market new drugs have historically dominated the industry, but the emergence of smaller firms focused on the application of biotechnology to drug development as well as firms that specialize in low-cost production of off-patent “generic†drugs has had an important impact on the market structure of the industry. The last two decades have seen a shift towards vertical specialization as well as many horizontal mergers. We discuss trends in the productivity of pharmaceutical research and incentives for innovation. We then summarize the pricing and marketing of drugs in the US and several other countries.

Competition and the Efficiency of Markets for Technology

Purpose – The purpose of this paper is to assess the feasibility and comparability of daily self‐report and objective measures of work performance in complex office tasks, and factors affecting the correlation between these measures.Design/methodology/approach – Medical bill auditors provided daily information for 12 weeks through interactive voice response (IVR) on their speed, concentration and accuracy at work, compared to their best job performance.Findings – The paper found that 124 of 142 recruited subjects (87 percent) completed > 50 percent of daily IVR reports. Concentration, speed and accuracy were highly inter‐correlated (R=0.75), and right‐skewed (mean speed=7.7, SD=1.5). Mean adjusted daily productivity rate (MAP) was 34 bills/hour (range 4.7 to 111, SD12.6, 61 percent within‐person variation). Subject‐specific speed – MAP correlation varied from R=−0.20 to +0.75 (mean, 0.28). Health status, years on job, age, IVR completion rate, site, month of study, or total hours worked were not associate...

Assessing the population health impact of market interventions to improve access to antiretroviral treatment

This paper investigates how the implementation of intellectual property rights in developing countries under the 1995 TRIPS agreement affected trade in knowledge‐intensive goods. We compare trade in knowledge‐intensive goods with trade in other types of goods for 158 members and observers of the World Trade Organization from 1993–2009. Trade in knowledge‐intensive goods increased relative to a control group after TRIPS implementation. The increase in imports by developing countries was driven by exchange with high‐income countries and was concentrated in the information and communications technology sector. Our findings suggest that the effect of TRIPS on promoting knowledge diffusion from high‐income to developing countries varies by sector.