Animal Research in a Global Environment Meeting the Challenges: Proceedings of the November 2008 International Workshop (2011) / Chapter Skim
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GLOBAL ISSUES: WORKING ACROSS DIFFERENT STANDARDS
GLOBAL ISSUES: WORKING ACROSS DIFFERENT STANDARDS
Pages 41-66
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From page 41... ...
The last word we often hear is "guidance." Whether it's the Guide for the Care and Use of Laboratory Animals, guidance, as you might suspect, deals with influencing, trying to influence a certain way, trying to achieve a particular outcome. I will give you a perspective from my responsibility at GlaxoSmithKline (GSK)
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From page 42... ...
For the last point, I would like to describe the main influences that drive differences in European versus American culture when it comes to animal research. In Europe, as opposed to the US, many things are uniform, because things are the equivalent of federally driven, whether it's a speed limit that goes across the country, whether it's VAT or sales tax across the country.
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From page 43... ...
We have also established seven core principles of animal care and welfare. These principles are used no matter where we are in the world -- whether we do research in China, North Carolina, or Croatia.
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From page 44... ...
However, it does not necessarily affect animal welfare proportionately as some would think. The other option is to use performance standards, such as the standards upon which our core principles are based, and to use international standards such as AAALAC.
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From page 45... ...
we don't have. It is much more important to talk and disagree than not speaking and believing that "never the twain shall meet." Standards, particularly engineering standards, should be based on science and show a clear benefit.
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From page 46... ...
I have been in Singapore for four years having left an academic environment at the Oregon National Primate Research Center to help with a startup contract research organization (CRO) .1 I am going to use some of my experiences to illustrate some of the challenges, operationally, that we face as a CRO in working across different standards.
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From page 47... ...
There may be different government agencies that affect permits related to a CRO's activities without specific laboratory animal welfare regulations. I will give an example.
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From page 48... ...
They recruited people from other countries, too, because there was not a base of study directors or technical staff with experience in laboratory animal care in Singapore.
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From page 49... ...
Malaysia is now working on setting up some national animal welfare standards for laboratory animals. As mentioned earlier, while Maccine has a facility in Indonesia where there are no laboratory animal welfare standards and therefore no government inspections, the company applies the same standards as in Singapore.
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From page 50... ...
For example, some people may be under the misconception that Singapore is in China and, if they have heard horror stories about melamine in baby formula or colleagues have revealed their bad experiences in China, they may think that Singapore has the same negative issues. From my own experience, when we have been audited by pharmaceutical companies and biotech companies, the auditors are greatly relieved when they see our AAALAC accreditation.
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From page 51... ...
For CROs doing toxicology, GLP certification is also necessary. There have been some frustrations in not being able to work with architects, engineers, and contractors that have experience in building animal research facilities.
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From page 52... ...
Buprenorphine is an analgesic that is commonly used in laboratory animals, but has been overprescribed by physicians in Singapore, resulting in human abuse. The Ministry of Health abruptly removed it from the market and it was suddenly unavailable in Singapore.
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From page 53... ...
It is important to continue to look beneath the surface to determine if what is seen is "show" rather than actual improvement in the quality of animal care and use. I want to thank my company for allowing me to take part in this; Gary Morrow for his help, based on experience he has had in other CRO inspections; and articles by Stacy Pritt and Jayne Mackta.
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From page 54... ...
In other words, I was asked to describe how US scientists in academia grapple with the variety of national laws, regulations, standards, practices, customs (or lack thereof for any of these) when laboratory animals are involved in multiple countries, and how things may evolve over the foreseeable future.
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From page 55... ...
This avoids having to distinguish between national differences for animal husbandry and veterinary support versus differences involving actual animal experimentation. And from the public's perception and certainly from the animal's experience, animal care and animal use represent a continuum.
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From page 56... ...
By contrast, addressing the differences only between wealthy countries with respect to laboratory animals and academic research is less compelling because those differences are minor in comparison with poorer nations. Furthermore, investment in animal-based biomedical research in China and other developing countries will likely accelerate.
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From page 57... ...
Consider that for the first nine months of 2004, 53% of the research papers published in Science and Nature from Chinese laboratories included American scientists as coauthors.8 When laboratory animals are involved, the cost differential may be even more striking when one appreciates the much greater investment made in each animal in biomedical research today. For example, genetically engineered mice have proven to be a critical tool in dissecting the influences of various genes in diseases and other biological phenomena.
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From page 58... ...
American scientists have become accustomed to established standards of laboratory animal oversight, and their respective institutions have administrative and physical infrastructures for compliance with regulations that have been in effect for many years. In fact, the biggest academic concerns to transnational collaborative research involving lab animals involve just the opposite situation, i.e., the lack of those same quality standards and safeguards that protect the health and welfare of today's expensive animal models in developed countries.
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From page 59... ...
OLAW encourages foreign institutions to use the standards in the Guide, which is available in a number of foreign transla tions.13 Currently, institutions in 79 countries have an animal welfare assurance approved by OLAW.14 OLAW cannot impose US laws and regulations on foreign entities, and regulatory site visits to those entities to ensure compliance with the Guide and other standards are impractical and unaffordable. Thus, the 13 PHS Policy on Humane Care and Use of Laboratory Animals, "Frequently Asked Questions" (http://grants.nih.gov/grants/olaw/faqs.htm, last revised February 26, 2008)
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From page 60... ...
In the meantime, there remains a need to upgrade global lab animal welfare standards not only to establish a more fair and consistent playing field between scientists in developed and developing countries but also to ensure that lab animals used anywhere are provided protection consistent with evolving values. The often referenced International Guiding Principles for Biomedical Research Involving Animals was issued by the Council for International Organizations of Medical Sciences "as a result of extensive international and interdisciplinary consultations spanning the three-year period 1982-1984."15 It continues to be used as an acceptable foundation to guide lab animal welfare around the world, but has not been upgraded or otherwise revised for the past 23 years.
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From page 61... ...
It is imperative that lab animal welfare standards be adjusted and universally adopted to ensure that good science and good animal care continue to go hand in hand everywhere lab animals are used. 17 "Optimal Laboratory Animal Care and Use: The Road to International Guidelines," AAAS Annual Meeting, Boston, February 17, 2008.
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From page 62... ...
Therefore, we are interested in developing alternative test models to decrease animal use and use lower, more relevant doses at lower cost. The idea was to make animal models that are more sensitive to carcinogens and in that way use fewer animals.
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From page 63... ...
As noted already, in the European Union animal experiments are performed based on engineering standards according to local and EU rules and regulations. Animal welfare is a critical issue and, at least in the Netherlands, we are required to prepare an animal welfare book.
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From page 64... ...
One, designed by the European Union, is the Council Directive 86/609, which is quite old, from 1986; it is currently being revised. This document was mainly based on economic and political considerations, and not animal welfare; however, in the revision there will be attention paid to animal welfare issues.
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From page 65... ...
Finally, we have the Article 14 officer, who is an animal welfare officer with an academic education in a biological discipline and postdoctoral training in laboratory animal sciences. This person is not, per se, a veterinarian in our country, but is involved in all ethical and animal welfare issues.
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From page 66... ...
We are intensifying our collaboration with the National Institute of Environmental Health Services, to develop alternative tests for the National Toxicology Program (NTP) for carcinogenicity testing.
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