Parallel trade of pharmaceuticals: The Danish market for statins

Méndez, Susan J.

doi:10.1002/hec.3551

Cited by 4 publications

(1 citation statement)

References 45 publications

(51 reference statements)

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“…In the European Union, parallel trade is allowed within the single market. A firm cannot prevent parallel imports from other European Union member states (Méndez 2018). Parallel trade is a common phenomenon, especially for pharmaceuticals, for which price differences may reach up to 300% (Kanavos and Costa-Font 2005).…”

Section: European Unionmentioning

confidence: 99%

Pharmaceutical regulation under market integration through parallel trade

Birg

2023

Canadian J of Economics

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I study the e¤ect of parallel trade (cross border resale of goods without the authorization of the manufacturer) on pharmaceutical regulation in a North-South framework. Governments in both countries may restrict prices directly via price caps or limit third-party payer reimbursement for the drug via reimbursement limits.Parallel trade may relax regulation in the source country of parallel imports (South) and intensify regulation in the destination country (North): In the source country, parallel trade may relax regulation both under a price cap and a reimbursement limit under certain conditions. In the destination country, parallel trade has no e¤ect on the level of regulation under a price cap, and it intensi…es regulation under a reimbursement limit.Parallel trade may change regulatory preferences: Under no parallel trade, both the source and destination country set price caps. Under parallel trade, the source country sets a price cap, but the destination country sets a reimbursement limit, thereby enforcing a higher price cap in the South. This implies higher drug prices under parallel trade in both source and destination country.

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Section: European Unionmentioning

confidence: 99%

Pharmaceutical regulation under market integration through parallel trade

Birg

2023

Canadian J of Economics

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The Price Effects of Competition from Parallel Imports and Therapeutic Alternatives: Using Dynamic Models to Estimate the Causal Effect on the Extensive and Intensive Margins

Granlund

2021

Rev Ind Organ

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This paper studies responses to competition with the use of dynamic models that distinguish between short- and long-term price effects. The dynamic models also allow lagged numbers of competitors to become valid and strong instruments for the current numbers, which enables studying the causal effects using flexible specifications. A first parallel trader is found to decrease prices of exchangeable products by 7% in the long term. On the other hand, prices do not respond to the first competitor that sells therapeutic alternatives; but competition from four or more competitors that sell on-patent therapeutic alternatives decreases prices by about 10% in the long term.

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What is the impact of intellectual property rules on access to medicines? A systematic review

et al. 2022

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Background It is widely accepted that intellectual property legal requirements such as patents and data exclusivity can affect access to medicines, but to date there has not been a comprehensive review of the empirical evidence on this topic. The World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires Member States to implement minimum standards of intellectual property protection including patents for pharmaceutical products, but also contains ‘flexibilities’ designed to address barriers to access to medicines. National intellectual property laws can also include TRIPS-plus rules that go beyond what is required by TRIPS. We aimed to systematically review literature that measures the impact of intellectual property rules on access to medicines, whether implemented as a result of TRIPS, TRIPS-plus provisions in other trade agreements, or unilateral policy decisions. Methods We searched Proquest, SCOPUS, Web of Science, PubMed, JSTOR, Westlaw and Lexis Nexis. Peer reviewed articles, government reports and other grey literature were included. Articles were eligible for inclusion if they were quantitative, in English, included a measure of cost, price, availability of or access to medicines, were about intellectual property or data exclusivity rules and published between January 1995 and October 2020. Ninety-one studies met our inclusion criteria. We systematically reviewed the studies’ findings and evaluated their quality using a modified quality assessment template. Results and conclusion Five broad overarching themes and 11 subthemes were identified based on the articles’ foci. They were: trade agreements (divided into EU FTAs and those that include the USA); use of TRIPS flexibilities (divided into compulsory licencing and parallel importation); patent expiry/generic entry/generic pathway (divided into comparative studies and single country studies); patent policies (also divided into comparative studies and single country studies) and TRIPS-plus rules (divided into data exclusivity, patent term extensions and secondary patenting). Most studies focused not on specific trade agreements, but on TRIPS-plus provisions, which can also be found within some trade agreements. The main finding of this review is that the stronger pharmaceutical monopolies created by TRIPs-plus intellectual property rules are generally associated with increased drug prices, delayed availability and increased costs to consumers and governments. There is evidence that TRIPS flexibilities can facilitate access to medicines although their use is limited to date. There were few studies that included resource poor settings, signalling a need for greater research in such settings where the impact on access to medicines is likely to be more damaging.

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Parallel trade of pharmaceuticals: The Danish market for statins

Cited by 4 publications

References 45 publications

Pharmaceutical regulation under market integration through parallel trade

Pharmaceutical regulation under market integration through parallel trade

The Price Effects of Competition from Parallel Imports and Therapeutic Alternatives: Using Dynamic Models to Estimate the Causal Effect on the Extensive and Intensive Margins

What is the impact of intellectual property rules on access to medicines? A systematic review

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