This Research Paper addresses the growing problem of access to essential medicines, focusing on the role of intellectual property rights, particularly patent rights, in restricting access by enabling pharmaceutical market monopolies that keep drug prices high. The paper explores the Bolar...

This Research Paper addresses the growing problem of access to essential medicines, focusing on the role of intellectual property rights, particularly patent rights, in restricting access by enabling pharmaceutical market monopolies that keep drug prices high. The paper explores the Bolar...

As a part of the European Commission support to the EU Member States in protecting public spaces against terrorist attacks by vehicle ramming, the JRC is developing guidance material and tools supporting informed decision-making by urban authorities and other local stakeholders, within the...

Background Introducing more generics has been a successful strategy for lowering pharmaceutical prices and expenditure. However, the effect of the strategy depends on the pricing schemes for generics. We aimed to update the South Korean generic markets in terms of effective competition, and to...

Markets require informed participants to function efficiently. This paper examines the impact of providing targeted information directly to patients on their purchasing-decisions regarding pharmaceutical drugs. We analyze the effect of informational letters sent by a Swiss health insurer to...

The literature on the Indian pharmaceutical industry has examined the importance of product patents and the attempts policy has made to regulate them. However, it has not done the same for the question of brands. Our study addresses this gap. The Tariff Commission Report of 1968, a turning point...

This paper analyzes the debate over the international dissemination of data exclusivity as a form of protection for clinical trial data. This is a critical demand for pharmaceutical companies seeking larger market shares and longer periods of monopoly in order to recover investments in research...

To explain heterogeneous diffusion of generics in OECD countries, we have analyzed genericsdemand as affected by information disparities and quality misperception. A sequential pricecompetition model, with perceived vertical differentiation, allows to re-consider the GenericsCompetition Paradox...

On the initiative of the JRC, SVS FEM s.r.o. prepared a generic vehicle model corresponding to the category N2A and N3D (IWA 14). This numerical model is released as Generic Vehicle N2AN3D R1.0. Key properties of the model are parametrized in order to allow convenient model modifications, which...

We study the effect of the degree of exclusivity for the lowest bidder on the average price of generic pharmaceuticals in the short and long terms. Our results indicate that a 1-percentage-point gain in market share of the lowest bidder reduces average costs by 0.2% in the short term and 0.8% in...

The impact of a reform that increased consumer information on brand name and generic pharmaceutical prices is analyzed both theoretically and empirically. The theoretical results show that an increase in information likely reduces the price of brand name pharmaceuticals, while the results...

During the 1980s the share of prescriptions sold by retail pharmacies that was accounted for by generic products roughly doubled. The price response to generic entry of brand-name products has been a source of controversy. In this paper we estimate models of price responses to generic entry in...

Policy makers use reference pricing to curb pharmaceutical expenditures by reducing coverage of expensive branded drugs. In a theoretical analysis we show that the net effect of reference pricing is generally ambiguous when accounting for entry by generic producers. Reference pricing shifts...

The use of “pay-for-delay” settlements in patent litigation – in which a branded manufacturer and generic entrant settle a Paragraph IV patent challenge and agree to forestall entry – has come under considerable scrutiny in recent years. Critics argue that these settlements are collusive...

More than 90 percent of prescriptions dispensed in the United States each year are for off-patent drugs. Yet the bulk of scholarship on prescription drug policy focuses on patented drugs. Discussions of prescription drugs are typically oriented around the “innovation-access dilemma”—the...

Close to 90% of drugs consumed in the US are generics, representing around 30% of the overall drug expenditure. Generic drugs have saved the healthcare system over 2.4 trillion dollars over the past decade. Such cost-saving benefit, however, can only be realized when the drug's effectiveness is...

Background: The aim was: i) to quantify the direct and indirect savings from parallel imports in Sweden during a period when sellers were forbidden from giving discounts to pharmacies, and ii) to study if the efects of competition from parallel imports on list prices became smaller in absolute...

The generic drug market has experienced extensive growth in the United States in the last few decades. This has meant a more prominent role for generic prescriptions in medical treatment and in the debate on health care expenditures. The interest has translated to extensive research on the...

Background: Well-functioning competitive markets are key to controlling generic drug prices. This is important since over 90% of all drugs sold in the US are generics. Recently, there have been examples of large price increases in the generic market. Methods: This paper examines price...

Policy makers use reference pricing to curb pharmaceutical expenditures by reducing coverage of expensive branded drugs. In a theoretical analysis we show that the net effect of reference pricing is generally ambiguous when accounting for entry by generic producers. Reference pricing shifts...

I use variation in approval time for generic drugs to shed light on the objectives of the federal agency in charge of granting entry permission for these drugs (FDA). Applications belonging to firms later found to have engaged in fraud or corruption were approved nine months faster on average,...

The purpose of this study is to identify elements that influence the sale of generic pharmaceutical products during their life cycle in order to achieve more comprehensive planning and to prevent a decline stage of the product life cycle (PLC). We used a system dynamic model to identify the...

Settlements of drug patent disputes that involve a potential payment from the brand to the generic signal a possible collusive profit split with a threat to competition, and have undergone intensive scrutiny in the literature on law and economics. A common feature of these brand-generic...

We explore how the Patent Office may improve the quality of issued patents on “secondary” drug features by giving examiners more time to review drug-patent applications. Our findings suggest that current time allocations are causing examiners to issue low quality secondary patents on the...

We analyze changes in the willingness to substitute from prescribed pharmaceuticals to more affordable generic equivalents in response to the first experience with a substitution. Using Swedish individual-level data of prescribed and dispensed pharmaceuticals, we employ a dynamic event study and...

Entry represents a fundamental threat to cartels engaged in price fixing. We study the extent and effect of this behavior in the largest price fixing case in US history, which involves generic drugmakers. To do so, we link information on the cartel’s internal operations to regulatory filings...

One approach that antitrust enforcement authorities use to address potentially anticompetitive mergers is to seek divestitures in specific, competitively problematic overlap markets while allowing the rest of the merger to consummate. We evaluate the efficacy of this approach by studying...

Efforts to reduce inefficient healthcare spending are prevalent across the developed world. Among available policy options, the substitution of brand name for generic drugs is of particular interest because it can deliver large savings without objective quality sacrifices. These policies are...

The introduction of generic drugs has been strongly contended, especially in France where Sanofi and BMS-UPSA lobbied and obtained a concession from the French government excluding paracetamol from the list of generic drugs. Governments have developed various strategies to promote the...

We study the patent strategy of pharmaceutical firms in reaction to the threat of generic entry. Estimating difference-in-differences saturated with a host of fixed effects, we show that while these firms continue to produce patents after a drug is approved by the US Food and Drug Administration...