Generic Entry into the Regulated Spanish Pharmaceutical Market

Moreno-Torres, Iván; Puig‐Junoy, Jaume; Borrell, Joan-Ramón

doi:10.1007/s11151-009-9214-3

Cited by 34 publications

(19 citation statements)

References 37 publications

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“…and pro-generic policy changes in other countries. Moreno-Torres et al (2009) provide detailed evidence on generic entry in Spain. Ghislandi et al (2005) and Garattini and Ghislandi (2006) discuss recent changes in Italy.…”

Section: Previous Literaturementioning

confidence: 99%

Cross-National Evidence on Generic Pharmaceuticals: Pharmacy vs. Physician-Driven Markets

Danzon

Furukawa

2011

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This paper examines the role of regulation and competition in generic markets. Generics offer large potential savings to payers and consumers of pharmaceuticals. Whether the potential savings are realized depends on the extent of generic entry and uptake and the level of generic prices. In the U.S., the regulatory, legal and incentive structures encourage prompt entry, aggressive price competition and patient switching to generics. Key features are that pharmacists are authorized and incentivized to switch patients to cheap generics. By contrast, in many other high and middle income countries, generics traditionally competed on brand rather than price because physicians rather than pharmacies are the decision-makers. Physician-driven generic markets tend to have higher generic prices and may have lower generic uptake, depending on regulations and incentives.Using IMS data to analyze generic markets in the U.S., Canada, France, Germany, U.K., Italy, Spain, Japan, Australia, Mexico, Chile, Brazil over the period 1998-2009, we estimate a three-equation model for number of generic entrants, generic prices and generic volume shares. We find little effect of originator defense strategies, significant differences between unbranded and unbranded generics, variation across countries in volume response to prices. Policy changes adopted to stimulate generic uptake and reduce generic prices have been successful in some E.U. countries.

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Section: Previous Literaturementioning

confidence: 99%

Cross-National Evidence on Generic Pharmaceuticals: Pharmacy vs. Physician-Driven Markets

Danzon

Furukawa

2011

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“…20 For these drugs, patients pay a standard coinsurance, which is currently 38 percent of the price of the drug, constrained by expenditure caps per script and per year. 21 If the medical expenditures exceed these caps, patients receive 100 percent insurance coverage for any additional medical costs.…”

Section: Institutional Backgroundmentioning

confidence: 99%

“…19 The reference countries for Norway are Austria, Belgium, Denmark, Finland, Germany, Ireland, the Netherlands, Sweden, and the UK. 20 For over-the-counter drugs and prescription drugs not listed for reimbursement, which usually are pharmaceuticals aimed at treating short-term conditions, the patients have to pay out-of-pocket 100 percent of the medical costs. 21 For 2014 the expenditure caps were NOK 520 per script and NOK 2105 per year.…”

Section: Institutional Backgroundmentioning

confidence: 99%

Does Reference Pricing Drive Out Generic Competition in Pharmaceutical Markets? Evidence from a Policy Reform.

2015

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Re ef fe er re en nc ce e P Pr ri ic ci in ng g D Dr ri iv ve e O Ou ut t G Ge en ne er ri ic c C Co om mp pe et ti it ti io on n i in n P June 2015AbstractIn this paper we study the impact of reference pricing (RP) on entry of generic firms in the pharmaceutical market. For given prices, RP increases generic firms' expected profit, but since RP also stimulates price competition, the impact on generic entry is theoretically ambiguous. In order to empirically test the effects of RP, we exploit a policy reform in Norway in 2005 that exposed a subset of drugs to RP. Having detailed product-level data for a wide set of substances from 2003 to 2013, we find that RP increased the number of generic drugs. We also find that RP increased market shares of generic drugs, reduced the prices of both branded and generic drugs, and led to a (weakly significant) decrease in total drug expenditures. The reduction in total expenditures was relatively smaller than the reduction in average prices, reflecting the fact that lower prices stimulated total demand.

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“…Second, to the best of our knowledge this is the first paper to examine the role of Health Technology Assessment (HTA) into generic entry and diffusion. Price regulation has been shown to have a negative impact on generic prices and entry [11,29]. In the UK context, where there is no (direct) price regulation on pharmaceutical products, the only 1 Data Exclusivity prohibits the re-use of clinical trials data, and thus generics cannot be validated by the relevant regulator-the Food and Drugs Administration (FDA) in the US and European Medicines Agency (EMA) respectively.…”

Section: Introductionmentioning

confidence: 99%

Does NICE influence the adoption and uptake of generics in the UK?

et al. 2020

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The aim of this paper is to examine generic competition in the UK, with a special focus on the role of Health Technology Assessment (HTA) on generic market entry and diffusion. In the UK, where no direct price regulation on pharmaceuticals exists, HTA has a leading role for recommending the use of medicines providing a non-regulatory aspect that may influence the dynamics in the generic market. The paper focuses on the role of Technology Appraisals issued by the National Institute for Health and Care Excellence (NICE). We follow a two-step approach. First, we examine the probability of generic entry. Second, conditional on generic entry, we examine the determinants of generic market share. We use data from IQVIA British Pharmaceutical Index (BPI) for the primary care market for 60 products that lost patent between 2003 and 2012. Our results suggest that market size remains one of the main drivers of generic entry. After controlling for market size, intermolecular substitution and difficulty of manufacturing increase the likelihood of generic entry. After generic entry, our estimates suggest that generic market share is highly state dependent. Our findings also suggest that while NICE recommendations do influence generic uptake, there is only marginal evidence they affect generic entry.

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Generic Entry into the Regulated Spanish Pharmaceutical Market

Abstract: Generic entry, Pharmaceutical industry, Reference pricing, I11, L11, L65,

Cited by 34 publications

References 37 publications

Cross-National Evidence on Generic Pharmaceuticals: Pharmacy vs. Physician-Driven Markets

Cross-National Evidence on Generic Pharmaceuticals: Pharmacy vs. Physician-Driven Markets

Does Reference Pricing Drive Out Generic Competition in Pharmaceutical Markets? Evidence from a Policy Reform.

Does NICE influence the adoption and uptake of generics in the UK?

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