Impediments to Parallel Trade in Pharmaceuticals Within the European Community

Impediments to Parallel Trade in Pharmaceuticals Within the European Community PDF Author: Commission of the European Communities. Directorate General for Competition
Publisher:
ISBN:
Category : Antitrust law
Languages : en
Pages : 112

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Impediments to Parallel Trade in Pharmaceuticals Within the European Community

Impediments to Parallel Trade in Pharmaceuticals Within the European Community PDF Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 93

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Parallel Trade in Europe

Parallel Trade in Europe PDF Author: Christopher Stothers
Publisher: Hart Publishing
ISBN: 1841134376
Category : Business & Economics
Languages : en
Pages : 527

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Are parallel importers the key to unlocking the single European market, breaking down long-established national barriers for the benefit of all? Or do they instead just operate in a dubious "grey market", free-loading on the investment of innovators and brand owners to the ultimate detriment of future investment? Parallel importers are in turn lionized and demonized, both in legal commentary and in the mainstream press. Trade is economically possible whenever the price of a particular product is higher in one area than in another. However, in the real world, trade will only occur if this price differential is sufficient to cover the costs of the trader together with a sufficiently attractive margin of profit. Some costs can be viewed as barriers to trade which result in an economically imperfect allocation of resources across the world. They can also operate as a waste of resources. Various attempts have been made to reduce unnecessary barriers, encouraging trade, and reducing waste - the clearest example being the WTO, which is dedicated to eliminating barriers to trade. Regional trading areas, such as the European Community share these goals, along with certain other aims. Although many barriers have already been removed, the process is far from complete. Parallel trade occurs when goods are manufactured by one party (the manufacturer) and put onto the market in country A but are then imported into country B by a second party (the parallel importer). The manufacturer may have manufactured the goods and/or put them on the market in country A directly or through third parties, but the distinguishing feature of parallel trade is that the manufacturer did not intend the goods to end up in country B. Parallel trade normally occurs when the manufacturer sells the goods in question in both countries (thus the trade is "parallel" to the main trade organized by the manufacturer) but the price of the goods in country A is lower than the price in country B. However, it may also occur when the manufacturer does not sell in country B at all, or does not sell sufficient quantities there. The goods are typically described in country B as "parallel imports" or "grey market goods." Understanding how EC law operates to restrict parallel trade involves exploring a complex matrix of different rules derived from the different fields of competition, free movement, and intellectual property, together with their corresponding private and public enforcement regimes, as well as the relationship with other external regimes. Author Christopher Stothers' comprehensive treatment of the subject successfully casts light on this difficult topic and is set to become the definitive work of reference in the area.

Strategic Responses to Parallel Trade

Strategic Responses to Parallel Trade PDF Author: Margaret K. Kyle
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 38

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This paper examines how pharmaceutical firms have responded to changes in intellectual property rights and trade barriers that legalized "parallel imports" within the European Union. The threat of arbitrage by parallel traders reduces the ability of firms to price discriminate across countries. Due to regulations on price and antitrust law on rationing supply, pharmaceutical firms may rely on non-price responses. Such responses include differentiation of products across countries and selective "culling" of product lines to reduce arbitrage opportunities, as well as raising arbitrageurs' costs through choice of packaging. Using a dataset of drug prices and sales from 1993-2004 covering 30 countries, I find evidence that the behavior of pharmaceutical firms in the EU with respect to their product portfolios is consistent with attempts to reduce parallel trade. This may at least partially explain why parallel trade has not yet resulted in significant price convergence across EU countries. Accounting for non-price strategic responses may therefore be important in assessing the welfare effects of parallel imports.

The Parallel Importation of Trade-marked Pharmaceuticals Within the European Union

The Parallel Importation of Trade-marked Pharmaceuticals Within the European Union PDF Author: Despina Samara
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 700

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The aim of this thesis is to shed light into pharmaceutical regulation and trade-mark jurisprudence concerning parallel imports of pharmaceuticals. What is different about the present discussion on trade-marked goods is that it deals with "special goods", that is, pharmaceutical products. The special characteristics of the products under consideration are emphasised throughout this thesis with an extensive analysis of pharmaceutical regulation relating to pricing and reimbursement, marketing, packaging, labelling and naming requirements for medicines in the EU. Owing to pharmaceutical regulation's only partially harmonised nature, there is no common market for Pharmaceuticals in the EU as yet. -- The present analysis focuses on both pharmaceutical regulation and trade-mark jurisprudence on parallel-imported pharmaceuticals in order to examine how the two regimes have developed through the years in relation to pharmaceutical parallel imports. In a sense, this thesis is an examination of the legal responses to five strategies used by pharmaceutical companies to prevent parallel importation: (i) reliance on national trade-mark rights; (ii) reliance on the guarantee function of trade marks to prevent repackaging; (iii) use of different names for the same medicine; (iv) use of contractual terms in the distribution system; and (v) refusal to supply. -- The analysis shows that even if pharmaceutical regulation and trademark jurisprudence operate under different mandates-the first, to protect public health (public law concerns) and the second, to safeguard the interests of trademark owners (private law considerations)-they have developed in parallel and have been influenced by each other. In effect, the recent reform of pharmaceutical regulation means that repackaging, relabelling and rebranding practices will become less and less necessary, and hence likely, in the future.

Parallel Imports of Pharmaceutical Products in the European Union

Parallel Imports of Pharmaceutical Products in the European Union PDF Author: Mattias Ganslandt
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 32

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Parallel imports are legitimately produced goods imported legally into a country without the authorization of a trademark, copyright, or patent holder. In the European Union, so long as a pharmaceutical manufacturer has placed a good on the market voluntarily, the principle of free movement of goods allows individuals or firms within the EU to trade goods across borders without the consent of the producer. What is the effect of these parallel imports?

EU Law of Competition and Trade in the Pharmaceutical Sector

EU Law of Competition and Trade in the Pharmaceutical Sector PDF Author: Pablo Figueroa
Publisher: Edward Elgar Publishing
ISBN: 1785362615
Category : Business & Economics
Languages : en
Pages : 758

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Book Description
This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.

Pharmaceutical Parallel Trade in the UK

Pharmaceutical Parallel Trade in the UK PDF Author: Panos Kanavos
Publisher: Basic Civitas Books
ISBN: 9781903386392
Category : Medical
Languages : en
Pages : 86

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Parallel Trade in Pharmaceuticals Within the European Union - is Restriction Possibile?

Parallel Trade in Pharmaceuticals Within the European Union - is Restriction Possibile? PDF Author: Bodrogi Tímea
Publisher:
ISBN:
Category :
Languages : en
Pages :

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Parallel Trade in Pharmaceuticals - - By Jacob Arfwedson

Parallel Trade in Pharmaceuticals - - By Jacob Arfwedson PDF Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 0

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16 One of the underlying objectives of TRIPS is that it "should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations" (Art. [...] public safety The discussion on the price of new medicines frequently overlooks the regulatory impact, however, a large part of the final cost may be attributed to the number and length of compulsory clinical tests, as well as to the relative efficiency of the authorities in charge of approving new drugs. [...] The European Union In the EU, the legal foundation of parallel trade (or parallel distribution) is found in Articles 30 and 36 of the Treaty of Rome, which authorise the free movement of goods and confer the right to control the import of goods by national governments, provided the products are not harmful or pose a threat to the public. [...] Indeed, in the case of certain products the original manufacturer has lost almost all of its domestic sales due to parallel imports.69 This may have far-reaching consequences for the employees in the concerned company, as pointed out in the IHE survey: when most of the sales are represented by re-imports, employees lose the incentive to market and provide information about the product as the benef. [...] The report identifies four major problems that confirm the importance of the issues already discussed above: 1 - in view of the illnesses involved, the threats of re-imports will be greater for the products not covered by the EU regulation; therefore, the provisions may aggravate the problems it aims at solving; 2 - the countries in the draft regulation, e.g.