Biotechnology law is a rapidly growing, highly specialized field of law, closely associated with pharmaceutical law and stemming from the field of science and technology. Despite its specialized nature, this area of law does overlap with a few other main practice areas: intellectual property law; patent law (and specifically, patent prosecution); licensing law; litigation; business law; and venture capital law.
Biotechnology is generally defined as the manipulation of microorganisms to perform certain processes and is largely identified with genetic engineering. The procedure usually involves the transfer of genes from one living entity into another, or into a synthetic compound, using advanced recombinant DNA technology. It covers any technological application that uses biological systems, living organisms, or their derivatives, to create, manufacture, modify or adapt plants, products, goods, animals or processes for specific use.
Its applications are useful in the medical field (red biotechnology), the aquatic field (blue biotechnology), the agricultural field (green biotechnology), and the industrial field (white biotechnology). It is involved in the development of new medicines and therapies; new research tools; increasing crop yields; creating hardier crops and plants; increasing the taste, texture and nutritional value of food; decontamination; removal of manmade pollutants and waste; and much more.
With biotechnology, the development time between working theory and a tangible product is far longer than that of other companies, generally seven to ten years. And these are very costly endeavors, ranging from $250 million to $300 million to create, develop, test and prepare a drug/product for market. The nature of these types of innovations and the rapidly evolving laws and regulations regarding biotechnology make this legal practice area both difficult and challenging. Lawyers, companies and scientists must struggle with complex issues involving necessary and applicable financial backing and how best to develop and create business agreements; intellectual property rights; convoluted, drawn-out regulatory proceedings; and many other challenges and obstacles spread over a lengthy time period.
The Coordinated Framework for Regulation of Biotechnology is the U.S. government’s formal policy for dealing with biotechnology and its applications. It was enacted by the Office of Science and Technology Policy (OSTP) Agency and is implemented by the Department of Agriculture (DOA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA). The federal Biotechnology Patent Protection Act allows the patenting of biotechnological processes and/or the resulting products or materials, provided they are novel and non obvious. The FDA largely regulates how drugs and other pharmaceutical products may be brought to market.
Biotechnology Law - US
- ABA - Biotechnology Law Commitee
The Biotechnology Law Committee, part of the ABA Section of Science & Technology Law, keeps abreast of various topics relating to biotechnology including research, commercial, regulatory and patent issues. The committee also covers biotechnology issues relating to clinical medicine, such as gene therapy, forensic medicine, such as DNA fingerprinting, and other areas of biotechnology raising ethical and/or evidentiary issues. The committee follows pending legislation designed not only to control the availability of products of biotechnology, but also to protect the proprietary rights of biotechnology developments in the U.S.
- Animal and Plant Health Inspection Service (APHIS)
APHIS uses the term biotechnology to mean the use of recombinant DNA technology, or genetic engineering (GE) to modify living organisms. APHIS regulates certain GE organisms that may pose a risk to plant or animal health. In addition, APHIS participates in programs that use biotechnology to identify and control plant and animal pests. Below is a list of the regulatory requirements for genetically engineered organisms and facilities.
- Biological Product Deviations
On November 7, 2000, the Food and Drug Administration published a final rule to amend the requirements of reporting errors and accidents in manufacturing of products. The rule amended the regulation at 21 CFR 600.14 for licensed biological products, and added a requirement at 21 CFR 606.171 applicable to all manufacturers of blood and blood components.
- FDA's Biotechnology Policy
In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human foods and animal feeds derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods.
- Federal Food, Drug, and Cosmetic Act
The FDA's online reference edition of the Federal Food, Drug and Cosmetic Act is based on the publication Compilation of Selected Acts Within the Jurisdiction of the Committee on Energy and Commerce; Food, Drug, and Related Law, As Amended Through December 31, 2004, prepared for the use of the Committee on Energy and Commerce, U.S. House of Representatives, March 2005. Updates have been made in the online edition as the act was amended since that time. Notes in the text indicate when the online version was updated, rather than the date the change was enacted.
- Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
EPA and the states (usually that state's agriculture office) register or license pesticides for use in the United States. EPA receives its authority to register pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Exit EPA disclaimer States are authorized to regulate pesticides under FIFRA and under state pesticide laws. States may place more restrictive requirements on pesticides than EPA. Pesticides must be registered both by EPA and the state before distribution.
- Federal Issuance of Experimental Use Permits
An experimental use permit (EUP) is generally required for testing of any unregistered pesticide or any registered pesticide being tested for an unregistered use. However, as described in paragraph (b) of this section, certain of such tests are presumed not to involve unreasonable adverse effects and, therefore, do not require an EUP.
- Food Biotechnology in the United States - Science, Regulation, and Issues
This report provides basic information on the science of food biotechnology. It discusses regulatory policies and issues of concern about the use of biotechnology to modify foods through genetic engineering. It describes the scientific processes used and current products available. It explains how all three major federal agencies - the Food and Drug Administration, the U.S. Department of Agriculture, and the Environmental Protection Agency - regulate these foods.
- Microbial Products of Biotechnology: Final Rule (62 FR 17910)
The regulation under which the TSCA Biotechnology Program functions is titled "Microbial Products of Biotechnology; Final Regulation Under the Toxic Substances Control Act", promulgated in the Federal Register on April 11, 1997. This rule was developed under TSCA Section 5, which authorizes the Agency to, among other things, review new chemicals before they are introduced into commerce. Under a 1986 intergovernmental policy statement, intergeneric microorganisms (microorganisms created to contain genetic material from organisms in more than one taxonomic genera) are considered new chemicals under TSCA Section 5. The Biotechnology rule sets forth the manner in which the Agency will review and regulate the use of intergeneric microorganisms in commerce, or commercial research.
- Microbial Products of Biotechnology; Final Regulation Under the Toxic Substances Control Act
EPA is promulgating this final rule under section 5 of the Toxic Substances Control Act (TSCA), 15 U.S.C 2604, to establish notification procedures for review of certain new microorganisms before they are introduced into commerce. &&New'' microorganisms are those formed by deliberate combinations of genetic material from organisms classified in different taxonomic genera. This review process is designed to prevent unreasonable risk of injury to human health and the environment without imposing unnecessary regulatory burdens on the biotechnology industry. This final rule describes notification procedures and the microorganisms that would be exempt from notification.
- Office of Science and Technology Policy
The mission of the Office of Science and Technology Policy is threefold; first, to provide the President and his senior staff with accurate, relevant, and timely scientific and technical advice on all matters of consequence; second, to ensure that the policies of the Executive Branch are informed by sound science; and third, to ensure that the scientific and technical work of the Executive Branch is properly coordinated so as to provide the greatest benefit to society.
- Office of Science Coordination and Policy Biotechnology Team
The Biotechnology Team located in EPA's Office of Science Coordination and Policy (OSCP) coordinates scientific, technical, and policy development activities within the Office of Chemical Safety and Pollution Prevention (OCSPP). The OSCP Biotechnology Team is also a focal point for coordination with other Federal agencies on any issues involving biotechnology, including international activities.
- Regulations of Genetically Engineered Organisms and Products - Biotechnology Information Series
The United States Department of Agriculture (USDA), the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and most state governments closely monitor the development and testing of a genetically engineered product and can provide pages of test results concerning its safety. However, in the end, only consumers themselves can decide if using a product, whether it is developed by genetic engineering or traditional methods, is right for them.
- Stem Cell Therapeutic and Research Act of 2005
On May 23, 2005, Representative Christopher Smith (R-NJ) introduced H.R. 2574, the Stem Cell Therapeutic and Research Act of 2005. The bill to provide for the collection and maintenance of human cord blood stem cells for the treatment of patients and research, and to amend the Public Health Service Act to authorize the C.W. Bill Young Cell Transplantation Program.
- The Plant Protection Act (PPA)
The Plant Protection Act (PPA) became law in June 2000 as part of the Agricultural Risk Protection Act. The PPA consolidates all or part of 10 existing USDA plant health laws into one comprehensive law, including the authority to regulate plants, plant products, certain biological control organisms, noxious weeds, and plant pests. The Plant Quarantine Act, the Federal Pest Act, and the Federal Noxious Weed Act are among the 10 statutes the new Act replaces.
- Toxic Substances Control Act
The objective of the Toxics Substances Control Act (TSCA) is to allow EPA to regulate new commercial chemicals before they enter the market, to regulate existing chemicals (1976) when they pose an unreasonable risk to health or to the environment, and to regulate their distribution and use.
- United States Regulatory Oversight in Biotechnology Responsible Agencies - Overview
The Agencies primarily responsible for regulating biotechnology in the United States are the US Department of Agriculture (USDA), Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). Products are regulated according to their intended use, with some products being regulated under more than one agency.
- US Regulatory Agencies - Unified Biotechnology
The Federal Government of the United States of America has a coordinated, risk-based system to ensure new biotechnology products are safe for the environment and human and animal health. Established as a formal policy in 1986, the Coordinated Framework for Regulation of Biotechnology describes the Federal system for evaluating products developed using modern biotechnology. The Coordinated Framework is based upon health and safety laws developed to address specific product classes. The U.S. Government has written new regulations, policies and guidance to implement these laws for biotechnology as products developed. This framework has allowed the United States to build upon agency experience with organisms and products developed using conventional techniques.
Biotechnology Law - Europe
- European Biosafety Association (EBSA)
European Biosafety Association (EBSA) was founded in June 1996. It is a not for profit organisation which aims to provide a forum for its members to discuss and debate issues of concern and to represent those working in the field of biosafety and associated activities. The Association has individual members, representing over 15 countries in Europe, as well as other regions.
- European Food Information Council (EUFIC) - Modern Biotechnology in Food
Modern biotechnology - will touch the lives of most European by the close of the 20th century, whether in food, medicine or environmental protection - is the subject of lively and sometimes controversial debate throughout society. In common with many other major scientific and industrial advances, biotechnology raises a range of issues, such as safety, ethics and possible environmental impact.
- Food Safety and Biotechnology Policy
In order to ensure that the development of modern biotechnology, and more specifically of GMOs, takes place in complete safety, the European Union has established a legal framework regulating genetically modified (GM) food and feed in the EU. This framework pursues the global objective of ensuring a high level of protection of human life and health and welfare, environment and consumer interests, whilst ensuring that the internal market works effectively.
- Life Sciences and Biotech Strategy
The EU's Life Sciences and Biotech Strategy aims to make the European biotech sector more competitive and to foster research in the areas of health care, agriculture, manufacturing and the environment.
- Task Group on Public Perceptions of Biotechnology
The Task Group on Public Perceptions of Biotechnology is one of the six Task Groups of the European Federation of Biotechnology. It was established in 1991, to increase public awareness and understanding of biotechnology and the life sciences throughout Europe. The objectives are to advance the public debate on biotechnology and to facilitate dialogue between interested parties.
Biotechnology Law - International
- Convention on Biological Diversity
The Convention on Biological Diversity (CBD) entered into force on 29 December 1993. It has 3 main objectives: 1. To conserve biological diversity 2. The use biological diversity in a sustainable fashion 3. To share the benefits of biological diversity fairly and equitably.
- UN Department of Economic and Social Affairs - Biotechnology
Environmentally-sound management of biotechnology is the subject of Chapter 16 of Agenda 21. Biotechnology is not directly addressed in the Johannesburg Plan of Implementation. Biotechnology is the integration of the new techniques emerging from modern biotechnology with the well-established approaches of traditional biotechnology. It is a set of enabling techniques for bringing about specific human-made changes in DNA, or genetic material, in plants, animals and microbial systems, leading to useful products and technologies.
- UN Food and Agricultural Organization (FAO) - Biotechnology
Biotechnology provides powerful tools for the sustainable development of agriculture, fisheries and forestry, as well as the food industry. When appropriately integrated with other technologies for the production of food, agricultural products and services, biotechnology can be of significant assistance in meeting the needs of an expanding and increasingly urbanized population in the next millennium.
- United Nations Environment Programme - Environmentally Sound Management of Biotechnology
Biotechnology is the integration of the new techniques emerging from modern biotechnology with the well-established approaches of traditional biotechnology. Biotechnology, an emerging knowledge-intensive field, is a set of enabling techniques for bringing about specific man-made changes in deoxyribonucleic acid (DNA), or genetic material, in plants, animals and microbial systems, leading to useful products and technologies.
Organizations Related to Biotechnology Law
- Biotechnology Industry Organization (BIO)
BIO is the world's largest biotechnology organization, providing advocacy, business development and communications services for more than 1,200 members worldwide. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.
- National Agricultural Law Center
The National Agricultural Law Center is the only agricultural law research and information facility that is independent, national in scope, and directly connected to the national agricultural information network. The Center has expanded the scope of its coverage to include food law as it recognizes the expanding scope of agricultural law and its convergence with food law topics. The Center is staffed by a team of law and research professors, lawyers, other specialists, and graduate assistants from the University of Arkansas School of Law Graduate Program in Agricultural Law.
- World Intellectual Property Organization (WIPO) - IP Services
The relationship between intellectual property and life science innovations is a particular issue of immediate interest and significance to WIPO Member States. WIPO contributes to the practical understanding of the appropriate role and impact of intellectual property rights on life science technologies, including their ethical, development and health policy implications. WIPO supports international policy discussions and promotes the capacity of policymakers to explore and assess the full range of policy options.
Publications Related to Biotechnology Law
- All Biotechnology Law Cases and Briefs
In addition to core biotechnology cases on liability and regulation, these pages include cases and regulations related to medical research, academic institutions, and general regulatory law issues that are critical to lawyers and scientists working in research and industry. Cases are added on a regular basis, and new additions can be found in the new cases section.
- Bioethics Forum
Bioethics Forum, hosted by the Hastings Center Report, publishes thoughtful commentary from a range of perspectives on timely issues in bioethics. The opinions expressed in it are those of the authors and not The Hastings Center.
- de Gruyter Journal of International Biotechnology Law
Walter de Gruyter is among the first academic publishers in the world to provide electronic access to its journals, books, and databases on a single platform. From now on, you will find all of our online journals and eBooks on this platform. Stay informed about newly added content via email or RSS feed.
- Mary Ann Liebert, Inc. - Biotechnology
Founded in 1980, Mary Ann Liebert, Inc. is universally acknowledged for publishing authoritative peer-reviewed journals, books, and trade magazines in the most promising areas of biotechnology, biomedical research/life sciences, clinical medicine and surgery, alternative and complementary medicine, law, philanthropy, environmental science and sustainability.
Articles on HG.org Related to Biotechnology Law
- How to Draft Clinical Trial AgreementsClinical Trial Agreements (“CTAs”) can be surprisingly complex documents with numerous legal issues, particularly in the setting of a multi-center trial for a new drug product candidate. This outline highlights the principal issues typically arising in a CTA and some of the considerations for companies sponsoring pharmaceutical trials (“Sponsors”) in addressing these issues.
- SEC Rules Affecting Shell CompaniesWhat is a Shell Company? Securities Act Rule 405 and Exchange Act Rule 12b-2 define a Shell Company as a company, other than an asset-backed issuer, with no or nominal operations; and either: • no or nominal assets; • assets consisting of cash and cash equivalents; or • assets consisting of any amount of cash and cash equivalents and nominal other assets. By: Brenda Lee Hamilton, Attorney Hamilton & Associates Law Group
- Can Law Keep up with Technology?Science and technology is advancing at a breakneck pace. With each passing day, new technologies and advancements make our world easier, safer and point toward a brighter future. But with each advancement and innovation, legal issues arise.
- The New Country of Origin Labeling Law (COOL) and How it Will be AppliedThis article discusses and explains the new Country of Origin Labeling Law (COOL) and describes the impact COOL will have on shoppers, food producers and retailers. The author also unwraps what foods the law covers and what foods and retailers are not regulated by this new law.
- An Inside Look At What Biotechnology Can Do For MankindThis article examines what biotechnology is and how it relates to the medical field, agriculture, bio processes, industry and the aquatic field. The author notes that as the planet becomes more polluted and more in need of clean water and food, the field of biotechnology will become even more important.
- All Science and Technology Law Articles
Articles written by attorneys and experts worldwide discussing legal aspects related to Science and Technology including: biotechnology, chemical law, computer and software, data protection, information technology, internet law, research and development, telecommunications law.