Volume 60 Issue 3
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Table of Contents
> Promoting Public Health and Protecting Consumers in a Global Economy: An Overview of HHS/FDA's International Activities
by David P. Kelly, Associate Director for International Policy, Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Rockville, MD
and
Lawrence L. Bachorik, Senior Advisor for International Policy and Communications, HHS/FDA, Rockville, MD.
> Can the U.S. Food and Drug Administration Act Against Global Frauds? The Extraterritorial Effect of Food and Drug Administration Sanctions After Small v. United States
by James O'Reilly, Adjunct Professor of Law, University of Cincinnati College of Law, Cincinnati, OH.
> The Framework for Global Organic Food Trade Circa 2005: Accomplishments and Challenges
by William J. Friedman, former Vice-Chair of the U.S. National Organic Standards Board; currently practices law at Covington & Burling, Washington, D.C.
> The New European Community Rules on the Labeling of Allergen Ingredients in Foodstuffs
by Ignacio Carreño, Lawyer at O'Connor and Company—European Lawyers, Brussels, Belgium.
> Safe Food International: A Blueprint for Better Global Food Safety
by Caroline Smith DeWaal, J.D., Director of Safe Food International, a project of the Center for Science in the Public Interest (CSPI), Washington, D.C.
and
Gonzalo R. Guerrero Brito , Program Coordinator for Safe Food International, a project of CSPI, Washington, D.C.
> Harmonization of Regulatory Requirements for the Development of Veterinary Clinical Trials—A Drive Toward Globalization and Simplification
by Jill C. Alvarez, Member with the law firm of Epstein Becker & Green, P.C., Washington, D.C.
and
Gregory W. Fortsch, Associate with the law firm of Epstein Becker & Green, P.C., Washington, D.C.
> Globalization of Cosmetic Regulations
by Janet Winter Blaschke, Principal with the International Cosmetics & Regulatory Specialists, L.L.C., Manhattan Beach, CA.
> The Seventh Amendment Directive—An Unnecessary Measure to a Necessary End—Possible Legal Challenges to Directive 2003/15/EC of the European Parliament and of the Council Amending Council Directive 76/768/EEC Under European Union Law
by Azalea P. Rosholt, Director, International Regulatory Affairs, Cosmetic, Toiletry, and Fragrance Association, Washington, D.C.
> The International Conference on Harmonization Common Technical Document—
Global Submission Format?
by Justina A. Molzon, M.S. Pharm., J.D., Associate Director for International Programs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Rockville, MD and the CDER representative to the International Conference on Harmonization Steering Committee and Global Cooperation Group.
> Global Medicine Does Not Make for Global Courts
by Daniel J. Herling, Partner with the law firm of Duane Morris LLP, San Francisco, CA
and
Lina M. Brenner, Associate with the law firm of Duane Morris LLP, San Francisco, CA.
> Amendments to the Canadian Patent Act to Address Drug Access: Is Help on the Way?
by Mark D. Penner, Intellectual Property Attorney in the law firm of Blake, Cassels & Graydon LLP, Toronto, Canada
and
Prakash Narayanan, Student-at-Law at the law firm of Blake, Cassels & Graydon LLP, Toronto, Canada.
> Brazil's AIDS Controversy: Antiretroviral Drugs, Breaking Patents, and Compulsory Licensing
by Ubirajara Regis Quintanilha Marques, Lawyer with Vicente Nogueira Advogados, Brazil
and
Valeska Santos Guimarães, Lawyer with Vicente Nogueira Advogados, Brazil
and
Caitlin Sternberg, Summer Intern with Vicente Nogueira Advogados, Brazil and J.D. candidate at the University of San Francisco School of Law, San Francisco, CA.
Promoting Public Health and Protecting Consumers in a Global Economy:
An Overview of HHS/FDA's International Activities
Authors: David P. Kelly & Lawrence L. Bachorik
60 Food and Drug Law Journal 339-346 (2005).
Globalization has brought both increased risks to human health and greater opportunities to promote public health and to protect consumers. Government agencies that historically are primarily domestic in nature, such as the Department of Health and Human Services (HHS), are addressing global issues such as increased international trade in foods, pharmaceuticals, and medical products; bioterrorism; and, emerging infectious diseases with potential global impact. Within HHS, the U.S. Food and Drug Administration (FDA's), Office of International Programs (OIP) leads, manages, and coordinates HHS/FDA's international activities. HHS/FDA conducts this work through a mixture of interactions within multinational organizations and multilateral and bilateral arrangements with specific foreign counterpart agencies—efforts that are all supported by appropriate U.S. government interagency and interdepartmental cooperation. OIP works in close collaboration with each of HHS/FDA's programmatic centers and the Office of Regulatory Affairs to conduct international activities. Experts from all over the agency, as appropriate, are engaged in the agency's international work.
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Can the U.S. Food and Drug Administration Act Against Global Frauds?
The Extraterritorial Effect of Food and Drug Administration Sanctions After Small v. United States
Author: James T. O'Reilly
60 Food and Drug Law Journal 347-360 (2005).
As the U.S. Food and Drug Administration (FDA) becomes part of a globalized world enforcement process, Americans need to consider whether regulatory prosecutions and violations that occur outside U.S. borders can be counted in making U.S. prosecution choices about drug marketers. This article examines the effect of a recent U.S. Supreme Court decision, and predicts that Department of Justice and FDA lawyers will need to be creative and thoughtful in handling overseas offenses. Gaps in current law are explored and suggestions for the future are offered.
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The Framework for Global Organic Food Trade Circa 2005: Accomplishments and Challenges
Author: William J. Friedman
60 Food and Drug Law Journal 361-374 (2005).
Before 1990, food products bearing organic labels transacted in largely unregulated markets; since 1990, many countries have established labeling standards and domestic and international trade in these products has flourished. Because the emergence of this market has been recent, it has had global aspects from the beginning. The complete harmonization of standards has proved elusive, however, because the market is based on the accommodation of ecological principles and farming practices that are geographically and culturally distinct. This article reviews the major legal provisions that facilitate international trade in organic food products.
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The New European Community Rules on the Labeling of Allergen Ingredients in Foodstuffs
Author: Ignacio Carreño
60 Food and Drug Law Journal 375-392 (2005).
This article describes recent changes in European Community (EC) legislation on the labeling of ingredients in foodstuffs that may trigger allergic reactions. It analyzes whether there are still gaps in the law and identifies problems concerning foods sold loose, in small packages and indelible marked bottles, fancy confectionary, and food supplied by mass caterers. The article then examines how new EC rules on the hygiene of foodstuffs might cover some of these gaps. The article also looks at the issues of accidental traces of allergens in foodstuffs and liability for failure to comply with the new legislation. Finally, recent developments in U.S. law and the Codex Alimentarius rules on the labeling of allergen ingredients are described.
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Safe Food International: A Blueprint for Better Global Food Safety
Authors: Caroline Smith DeWaal & Gonzalo R. Guerrero Brito
60 Food and Drug Law Journal 393-406 (2005).
Effective food safety programs are vital in all parts of the world in order to reduce the burden of illness and to promote the trade of safe food products. The World Health Organization (WHO) and the Food and Agriculture Organization (FAO) created Codex as the central mechanism for harmonizing food standards. Strong standards are not sufficient, however, if national governments lack the tools to enforce them. To address this problem, these two international bodies convened two Global Forums for Food Safety Regulators to promote dialogue with national governments on how to improve their systems. As an outgrowth of these efforts, WHO and FAO are starting to support efforts to empower nongovernmental organizations through dialogue and the development of guidance to promote stronger food safety systems.
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Harmonization of Regulatory Requirements for the Development of Veterinary Clinical Trials—
A Drive Toward Globalization and Simplification
Authors: Jill C. Alvarez & Gregory W. Fortsch
60 Food and Drug Law Journal 407-412 (2005).
Since 1996, the United States has been an active member of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), along with the European Union and Japan. The growth and development of VICH has paralleled the efforts toward globalization of clinical trial standards conducted under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), of which the United States also is a member. Through VICH, the member countries have been working to develop and encourage the use of harmonized good clinical practices and other standards and procedures for the development of veterinary medical products for use in both companion animals and farm animals. This article examines the good clinical practices that have been developed and implemented through VICH, and compares these efforts to standards developed under the ICH and the U.S. Food and Drug Administration.
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Globalization of Cosmetic Regulations
Author: Janet Winter Blaschke
60 Food and Drug Law Journal 413-420 (2005).
Cosmetic regulations, as with all regulations, are in a state of constant change. All of the primary world markets have undergone major changes in their regulatory systems within the last fifteen years. The concept of globalization, or harmonization, is an admirable goal, however, because having the same sets of standards worldwide clearly would benefit not only the cosmetic industry, but also the regulators and the consumers. This article focuses only on three of the major trading partners—the United States, the European Union, and Japan—and reviews the current state of cosmetic harmonization. The article takes into account the definition of a cosmetic as compared to related categories; regulatory schemes for the ingredients used in cosmetic products; product labeling, including language requirements; and company responsibility for registration or notification.
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The Seventh Amendment Directive—An Unnecessary Measure to a Necessary End—
Possible Legal Challenges to Directive 2003/15/EC of the European Parliament and of the Council
Amending Council Directive 76/768/EEC Under European Union Law
Author: Azalea P. Rosholt
60 Food and Drug Law Journal 421-446 (2005).
This article analyzes the legal flaws and the possible challenges of the Seventh Amendment Directive under European Union (EU) law. It begins with a background of existing legislation including the Experimental Animals Protection Directive, the Cosmetics Directive, and the Seventh Amendment of the Cosmetics Directive. A discussion of the lack of Community competence to enact the Seventh Amendment under the EC Treaty is followed by a review of other conflicts with the EC Treaty and fundamental principles of EU law. Finally, the article concludes that the Seventh Amendment not only is inconsistent with the EC Treaty and secondary EU law, but also is unnecessary because its ultimate objective—to protect the welfare of animals—can be better achieved by amending existing Community legislation.
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The International Conference on Harmonization Common Technical Document—
Global Submission Format?
Author: Justina A. Molzon
60 Food and Drug Law Journal 447-452 (2005).
Drug approval is the goal of the long process of drug development. Once preclinical, clinical, and chemistry manufacturing and control data have been collected, a new drug application must be submitted to the regulatory authority for approval. Although the requirements for this submission have similarities around the world, the applications have been quite different. The Common Technical Document (CTD) developed by the International Conference on Harmonisation (ICH) has helped to harmonize the application procedure. Further, ICH's efforts in its Global Cooperation Group will promote the CTD to other regional harmonization efforts encouraging its use globally.
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Global Medicine Does Not Make for Global Courts
Authors: Daniel J. Herling & Lina M. Brenner
60 Food and Drug Law Journal 453-458 (2005).
In June 2005, the California Court of Appeals for the Sixth Appellate District, comprising the county of Santa Clara in the Silicon Valley, held that a trial court cannot exercise personal jurisdiction over a defendant pharmaceutical company based "solely on the global exchange and management of medical and scientific information relative to drug safety and regulatory compliance." As a result of this holding, the foreign pharmaceutical companies in this case were dismissed as defendants from this action and could not be held liable to the plaintiffs, in the event of any verdict or settlement. This article discusses this decision's crucial and significant implications for international pharmaceutical companies with affiliates or related entities in California, and potentially other states that have yet to embrace this standard.
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Amendments to the Canadian Patent Act to Address Drug Access: Is Help on the Way?
Authors: Mark D. Penner & Prakash Narayanan
60 Food and Drug Law Journal 459-470 (2005).
The aim of the provisions of An Act To Amend The Patent Act and the Food And Drugs Act (The Jean Chrétien Pledge To Africa), which contain significant amendments to the Canadian Patent Act, is to facilitate access of "developing" and "least-developed" countries to patented drugs by addressing the perceived difficulties of the compulsory licensing provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The TRIPS provisions dealing with compulsory licensing may present one barrier for such countries with no or insufficient manufacturing capacities in the pharmaceutical sector to obtain patented drugs. By doing so, Canada has effectively re-introduced a very limited form of the previously abolished pharmaceutical compulsory licensing regime back into its Patent Act. In this article, the authors examine the amendments to the Patent Act, their origins, and whether they provide a useful solution that could address the problems the amendments seek to remedy.
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Brazil's AIDS Controversy: Antiretroviral Drugs, Breaking Patents, and Compulsory Licensing
Authors: Ubirajara Regis Quintanilha Marques, Valeska Santos Guimarães & Caitlin Sternberg
60 Food and Drug Law Journal 471-478 (2005).
Brazil's AIDS program is world renown for its success in halting the spread of AIDS. While forecasts expected 1.2 million Brazilians to be living with HIV by the year 2000, 600,000 currently are infected. Government discussion of granting compulsory licenses, previously used to force pharmaceutical manufacturers to lower prices, has escalated to new levels. Meanwhile, Brazil's lower house passed Bill 22/03 that will, if passed by the Senate, make AIDS drugs nonpatentable. These actions leave pharmaceutical giants and intellectual property (IP) experts concerned over future IP rights in Brazil and leave the question of compliance with the Agreement on Trade-Related Aspects of Intellectual Property Rights open.
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