Globalization in the Pharmaceutical Industry, Part I

Tarabusi, Claudio Casadio; Vickery, Graham

doi:10.2190/7jdr-2tfn-2b3x-tyf5

Cited by 46 publications

(13 citation statements)

References 1 publication

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“…Indeed in recent years, they have become even more supportive of regulatory harmonization due to both the increasing costs of research and development and the decline in the effective patent life of drugs. "Research-based firms realized that, for innovation to be profitable, new drugs must reach markets all over the world in as short as time as possible" (Tarabusi and Vickery 1993).…”

Section: National Responsesmentioning

confidence: 99%

The Globalization of Pharmaceutical Regulation

Vogel

1998

Governance

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Drugs have long been among the most extensively regulated of all consumer products. Not only do all governments closely supervise virtually every aspect of their development, testing, production and marketing, but many also regulate their pricing and distribution. The pharmaceutical industry is highly globalized, with over half the sales of the fifty largest drug companies made outside their home country (Tarabusi and Vivkery 1993). However, until recently, drug regulation was virtually synonymous with national sovereignty. Firms were required to conduct separate tests, submit separate applications, and meet distinctive criteria to enter each national market. Because drugs are so extensively regulated and have such significant health and safety impacts, drug policy coordination has proven extremely difficult. Nonetheless over the last decade, national regulatory agencies have begun to cooperate more closely with one another. The European Union has established a centralized drug approval system, the United States Food and Drug Administration has become more willing to cooperate with its foreign counterparts, and the United States, the EU and Japan have made substantial progress in harmonizing drug approval requirements under the auspices of a new international body, the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Products (ICH). This article describes and assesses the implications of the increase in international coordination of national drug approval policies. It argues that the undermining of national regulatory sovereignty has improved both the effectiveness and efficiency of government regulation.

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Section: National Responsesmentioning

confidence: 99%

The Globalization of Pharmaceutical Regulation

Vogel

1998

Governance

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“…Starting with the R&D process, basic research, which is also the riskiest, is largely underwritten by public funds and conducted in university laboratories, with PPCs becoming involved mainly when promising results become visible. Further, as we have seen, on the supply side, the market structure is not exactly competitive; indeed, it is highly concentrated and in individual therapeutical classes it is clearly oligopolistic (Tarabusi and Vickery 1998). The demand side can also be described as an oligopsony; each medicine is purchased by a limited group of patients with a specific disease and patients are not like customers in other markets as they do not choose which medicine to purchase.…”

Section: The Modern Pharmaceutical Industry: Trends and Characteristicsmentioning

confidence: 99%

Shaping Global Rules: Proprietary Pharmaceutical Companies as Global Political Actors

Muzaka

2009

New Political Economy

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“…Ensuring that the trade of essential drugs-those that a country deems a priority based on diseases in that country and cost-effectiveness of the treatment (24)-within and to the South is not inhibited by the WTO is an important goal. In 1989, the 60 largest pharmaceutical firms of a total of 184 had 85 percent of combined sales (27). The top 20 owned just over 50 percent, and the top ten owned just under one-third of the combined sales, a share that changed slightly following mergers such that by 1995 the top ten owned almost 36 percent (27).…”

Section: Pharmaceuticalsmentioning

confidence: 99%

Globalization and International Trade in the Twenty-First Century: Opportunities for and Threats to the Health Sector in the South

Barış¹,

McLeod²

2000

Int J Health Serv

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Globalization and international trade are important forces at the turn of the century. This article explores how freer international trade will affect developing countries that are net importers of health care goods and services. Four commodities are used as special cases for discussion: pharmaceuticals, health care technologies, pesticides, and tobacco and its related products. The authors discuss the role of international specialized agencies, such as the World Trade Organization, World Health Organization, and World Bank, that are concerned with international trade and its health and health care consequences, and argue that closer collaboration is required among these agencies if the negative effects of trade liberalization on developing countries are to be mitigated. The authors pose a number of research questions that could help in developing proactive policies for the South on the trade of goods and services with harmful effects on health as well as those with potential health and economic benefits.

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Globalization in the Pharmaceutical Industry, Part I

Cited by 46 publications

References 1 publication

The Globalization of Pharmaceutical Regulation

The Globalization of Pharmaceutical Regulation

Shaping Global Rules: Proprietary Pharmaceutical Companies as Global Political Actors

Globalization and International Trade in the Twenty-First Century: Opportunities for and Threats to the Health Sector in the South

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