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The Making of Domestic and International Biotechnology Policy Robin J.R. Blatt

Abstract: Biotechnology policy will become one of the most challenging dynamics of the early 21st century. Consider that applications of biotechnology now exist in almost all areas of public health concern: health care (screening and diagnostics, therapeutics, biopharmaceutical and vaccine development, xenotransplantation, tissue regeneration, and stem cell research); veterinary medicine (cloning); food (genetically altered crops, functional foods, and nutraceuticals); agriculture (engineered seeds, crop protection herbicides and insecticides); aquaculture (transgenic fish); bioremediation (waste purification); the environment (release of genetically modified organisms); and industrial manufacturing (bioenergy). Further, scientific exploration and commercialization of the genetic frontier is creating new specialties and sectors. While these developments may bring forth many benefits, this result will not be automatic. Each of these innovations raise new challenges, along with unique ethical, legal and social policy issues that we must confront. Growth and governance of these innovations will be determined by emerging science, law, business, regulatory and technology policies. And momentum in generating biotechnology policy is mounting.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Feature Article (6 pages)

Advisory Committees and the Federal Regulation of Biomedical Research Robert P. Charrow, Esq.

Abstract: It is perhaps in the nature of government that national leaders more readily seek advice from their friends and confidants than from those who serve in official capacities. President Andrew Jackson took this practice to an extreme: during the first two years of his administration, he never held an official cabinet meeting. Instead, he relied on the advice of a small group of trusted advisors and old friends, only a few whom held official positions in the government. Jackson's critics dubbed this group of influential advisors the "Kitchen Cabinet," a term that has survived. Jackson's practice was quickly emulated and over time amplified by those in the departments and agencies. By the 1960s, the number and influence of these advisory groups - some of which were statutorily recognized - had grown to such a degree that many questioned the wisdom of permitting largely unregulated, and in some cases anonymous, groups of non-officials to formulate government policy frequently behind closed doors. Congress responded by enacting in 1972 the Federal Advisory Committee Act (FACA). The FACA sought to bring a semblance of order, openness and balance to the process of creating, staffing and operating advising committees. The FACA is particularly significant to the biomedical research community, owing to the number and influence of advisory committees that operate under the aegis of the National Institutes of Health, the National Science Foundation, and the Food and Drug Administration. This article examines the metes and bounds of the FACA, explores the relationship between the Freedom of Information Act, the Government in the Sunshine Act and the FACA, and analyzes some of the fundamental constitutional questions surrounding the operation of advisory committees with an emphasis on the biomedical and life sciences.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Feature Article  ( 8 pages)

Business, Process, and Legal Implications of Web-Based Data Collection in Clinical Trials Ann Miller, Gilbert Benghiat, and Paul Bleicher

Abstract: Advances such as combinatorial chemistry, high throughput screening, and genomics, have dramatically increased the number of compounds that are candidates to enter the clinical phase of drug development. The capacity of the pharmaceutical industry to execute clinical trials has not increased to the same degree as the compound discovery rate (Figure 1), creating a clinical trial backlog. Web-based clinical trials have the potential both to increase the number of clinical trials and to increase the quality of the clinical data. This paper explores web-based clinical trials by comparing the paper collection process to a web-based collection process, examining barriers to adoption of web-based trials, presenting techniques for migrating to a web-based data collection and cleaning process, and examining legal and regulatory issues.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Feature Article  ( 10 pages)

Employer Guidelines for Workplace E-Mail and Internet Policies Mark E. Schreiber and Emily C. Ehl

Abstract: E-mail and Internet use have become an integral part of the way in which biotechnology business is now conducted. The issues surrounding e-mail and Internet use in the workplace are complex and the law pertaining to these issues is unsettled. For biotech and high tech companies in particular, the implementation of policies governing e-mail and Internet use and monitoring present difficult questions. Such policies should be tailored to the employersí particular needs. To do this, employers need to be aware of the potential problems that may arise from e-mail and Internet misuse in the workplace, understand their workforce, clarify the scope of permitted private use, if any, and the assess realistic breadth of monitoring that the employer is willing to undertake. This article provides guidance in developing such e-mail and Internet use and monitoring policies.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Feature Article  ( 11 pages)

Good Gene Hunting: Commercializing Safety and Efficacy of Home Genetic Test Kits Commercializing Safety and Efficacy of Home Genetic Test Kits Marcus Stevenson

Abstract: The rapid advancement of genetic identification as a means of diagnosing illness or identifying the existence of a genetic trait for preventative and reproductive concerns should compel legal experts to determine whether there is sufficient safety and efficacy in genetic tests. Genetic testing has been used by physicians for a number of years to enhance their allopathic practice. Specifically, genetic tests are now being considered as aids in understanding the development and proliferation of certain diseases in society as a whole, and in specific ethnic and familial groups. The purposes of this paper are to: (1) articulate what genetic testing offers, by way of definition and scope; (2) identify statutory and regulatory limitations on the development, distribution, and use of genetic tests; and (3) consider whether the potential availability of home genetic tests should be made accessible to the American public. This paper will further provide a proposed regulation to encourage the development and distribution of home genetic tests.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: On March 22, 1999, Carl B. Feldbaum, President of the Biotechnology Industry Organization (BIO), submitted comments to the National Bioethics Advisory Committee (NBAC) in response to their request for comments on stem cell research. In the statement submitted to Harold Shapiro, PhD (Chair, NBAC), Mr. Feldbaum made clear that BIO members want to ensure that the promise of new therapies and cures from research using stem cells is realized in a responsible and ethical way. In addition, all BIO members are committed to ensuring that every avenue of promising research can be responsibly explored to improve the health of individuals living with currently intractable diseases.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: A new line of insurance products are now available to handle intellectual property, and more specifically patent infringement issues. ìEnforcementî products are designed to help defray the costs of initiating and maintaining an infringement action against an infringer of the insuredís patents. ìDefenseî products are intended to cover the legal costs incurred in defending against allegations of infringement and can provide limited coverage for damage awards. These insurance products are most useful for the small and mid-sized biotechnology company or early phase company for whom the financial costs of a patent suit may be otherwise prohibitive. This article describes insurance for the current patent environment and discusses the application of new insurance products as an Intellectual Property (IP) enhancement tool.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: A recent article in the Journal of BioLaw & Business describes the types of corporate partnering deals that platform technology companies are striking. A key feature of these agreements is the connection between use by a pharmaceutical company of the biotechnology companyís technology and the pharmaceutical companyís obligation to make clinical milestone payments and pay royalties on product sales resulting from the collaboration. This article provides a template of defined contractual terms that make such a connection. The author discusses the issues involved from the perspectives of both biotechnology and pharmaceutical company representatives and reduces these perspectives to potential clauses in a contract. Through suggested template definitions, the author suggests contract wording that in most cases meets the concerns of pharmaceutical company representatives, while providing fair compensation to the biotechnology company.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Technology convergence, mergers & acquisitions, and leapfrogging technologies pressure todayís high tech companies to take a closer look at exploiting and protecting their intellectual capital. Before these companies can acquire, sell, or license the technology, they are faced with the difficult tasks of identifying and valuing their intellectual property. Many companies are completely unaware of the true value and potential competitive advantage of their intellectual property. Since determining the value of intellectual property is very different from determining the value of real property. How does one quantify an idea or its expression? In fact, intellectual property by itself has no value. It is the application of the idea to generate increased profits, in conjunction with the business and financial strategies of the organization, that determines its value. This article discusses how intellectual property creates value and ways in which its value can be maximized.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Mounting non-governmental organization (NGO) and consumer concerns relating to food has lead to overwhelming skepticism against modern food processing technology, including food produced with biotechnology. Such concern has been heightened subsequent to the European mad cow crisis. The current European political situation has direct ramifications for the United States (US) biotech and food industry trading with Europe. This article summarizes the regulatory procedures to be completed and related administrative practice prior to importing/marketing biotech food in the European Union (EU).

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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