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Broadly defined, biotechnology is a term for a group of technologies based on applying biological processes to solve problems and make products. Traditional examples include fermentation in beer, cheese, bread making and cosmetics, as well as plant and animal breeding techniques.
New Zealand has the ability to be world-leading in key areas of biotechnology, such as animal and human health products and plant science. As a sector, biotech can potentially add value to existing exports and create new industries in its own right. This will deliver significant economic benefits to New Zealand, including increased export sales and local employment opportunities.
Many organisations are involved in the biotech sector, including start-ups, corporations, multinationals, Crown Research Institutes, universities, and medical research teams.
Some people mistakenly think that biotechnology and genetic modification (GM) are the same. GM, based on the modification of genetic material, is only one aspect of biotechnology. While GM is an important area of biotechnology, several technologies do not involve GM at all.
Marker-assisted breeding to enhance plant and animal lines, fermentation processes to produce beer, wine and cheese, and enzymes used in detergents.
Yes. New Zealand’s Government has identified biotechnology as integral to the country’s long-term future economic growth and is one of the industries supported through the Growth and Innovation (GIF) Framework.
It has been estimated that New Zealand’s core biotechnology companies will need to double the number of employees with tertiary qualifications within the next five years. Some examples of the sorts of jobs available are scientists, molecular biologists, research associates, educational, pathologists, biochemists, investment analysts, and sales and marketing roles.
Biotechnology in medicine has enabled the development of more effective drugs and therapies for serious diseases, including diabetes and malaria. It has also been used in many countries to grow crops that require less spray and are better for the environment, such as cotton, soy and corn.
In New Zealand, there are several different authorities that biotech companies and researchers must gain approval from before they start work.
The Agricultural Compounds and Veterinary Medicines Group (ACVM) is responsible for the regulatory control of agricultural compounds, their importation, manufacture, sale and use on behalf of the New Zealand Food Safety Authority under the Agricultural Compounds and Veterinary Medicines Act 1997.
The Agricultural Compounds and Veterinary Medicines (ACVM) Act (1997) controls agricultural compounds and veterinary medicines used in association with animals and plants, and is a companion measure to the Hazardous Substances and New Organisms (HSNO) Act 1996, the Animal Products Act (1999), the Dairy Industry Act (1952), the Food Act (1981), the Animal Welfare Act (1999) and the Biosecurity Act (1993). For further information, visit: www.nzfsa.govt.nz
Medsafe is responsible for ensuring that medicines available in New Zealand are expected to have greater benefits than risks when used appropriately. This is achieved through: assessing the safety, quality and efficacy of medicines before they are marketed; auditing manufacturers, packers and wholesalers of medicines to ensure their premises and practices meet an acceptable standard; and monitoring the safety of medicines on the market.
A company wishing to market a medicine that has not previously been marketed in New Zealand must obtain the consent of the Minister of Health (or his delegate) to distribute a “new medicine”. Such medicines fall into three categories:
1. Innovator medicines that contain new active substances or are administered in a novel way. To obtain consent, the company must submit an application dossier containing detailed information about the safety, quality and efficacy of the medicine. The application is considered by the Medicines Assessment Advisory Committee, which is a committee of experts set up to advise the Minister of Health.
2. Multi-source or generic medicines that don’t have new active substances or novel dose forms, but are a different brand from the previously approved product.
3. Over-the-counter medicines that contain active ingredients with a well-established record of use. These may be new products containing active ingredients in different combinations, or new brands of previously approved over-the-counter medicines. For further information, visit: www.medsafe.govt.nz
The Environmental Risk Management Authority (ERMA New Zealand) considers and weighs the risks, costs and benefits of using any new organism, including GM organisms, on a case-by-case basis.
Under the amended Hazardous Substances and New Organisms Act (HSNO), ERMA can impose conditions on any approval it grants for the release of a new organism, including when and how the organism is used, as well as any other monitoring or special requirements. For more information, visit: www.ermanz.govt.nz
The Ministry of Agriculture and Forestry (MAF) is the agency responsible for enforcing the Hazardous Substances and New Organisms Act regarding new organisms, and it has several roles related to GM.
It is involved in monitoring compliance with controls imposed by ERMA on GM organisms approved for use within containment, for example, in laboratories and during field tests. For further information, visit: www.mpi.govt.nz
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