Bio-medical research in Hong Kong and the use of laboratory animals:
Outdated legislation and ethical concerns. (Paper prepared in early 2000).

Abstract.

Current legislation controlling animal experimentation in HK is outdated and cannot cope with the changes in both animal research protocols and veterinary bioethics that has taken place over the past 36 years since the legislation was first enacted. It does not satisfy the international norms on animal welfare that now form the basis of most animal research legislation enacted in advanced countries.

The HKSAR Government must address the issue of animal use in biomedical research if it is to continue to be considered an advanced and humane community. To achieve this, new legislation controlling animal-based research must be enacted. Self-regulation of animal-use protocols using an AREC must be a feature of the new legislation, control of the new legislation and the enforcement of the provisions within the legislation should be given to the Department of Agriculture and Fisheries which has the veterinary resources needed to assess animal welfare issues and the experience in enforcing animal welfare legislation and finally the legislation must ensure the use of animals in teaching is fully justified to both the students involved and the community at large.

1. Introduction.

In Hong Kong (HK), research using laboratory animals is regulated by the Animals (Control of Experiments) Ordinance'. This Ordinance is outdated, having been in force since 1963 and is based on outdated concepts of laboratory animal research, The Ordinance no longer conforms to internationally accepted norms about animal based research3,4,5. This has created a dilemma for the organisations, mainly academic institutions, which carry out research in HK. To enable these institutions to conduct internationally recognised research and to enable them to engage in international research collaborations they have had to introduce a system of self-regulation of the their animal-based research ensuring that there is recognition and resolution of the animal welfare issues that may be part of their research activities. The Research Grants Council (RGC) has recognised this international pressure for the ethical review of the use of animals in biomedical research. It mandates academic institutions must self-regulate their animal based research. The RGC-approved method of self-regulation is the formation of an animal research ethics committee (AREC) in each academic institution and enabling the institution's AREC to review the ethics of the use of animals in RGC-funded research. Since the RGC controls the bulk of money invested in bio-medical research in academic institutions, the ARECs do have the power to enforce the ethical use of animals in the majority of research protocols using animals. However, there are no RGC guidelines to ensure the uniformity of standards, composition or functioning of each academic institution's AREC. Therefore the efforts of these ARECs are largely uncoordinated and inconsistent, Furthermore, as the RGC has no control over privately-funded research there is no requirement for privately funded research to be peer reviewed or reviewed by members of the community. Therefore it is only because the academic institutions voluntarily accept their responsibilities about using animals in research that they have their internal regulations requiring privately funded research to also be reviewed by the institutions' ARECs. The HK Special Administration Region (SAR) Government is not taking the lead in this matter even though community views are changing, reflecting a wider acceptance of the need to regulate in favour of improved animal welfare7,8,9.

The real problem for HK's international reputation and for animals used in research will be the development of the biotechnology industry mooted by the HKSAR Government as one of its goals for the 21st century 10 . The biotechnology industries are not going to have their money controlled by any HKSAR Government granting agency nor are they likely to be subjected to the same internal pressures by their employees to introduce ethical standards for the review of animal based research 11. Hence the only control over animal research in private research institutions will be their compliance with the current Ordinance and this compliance with the ordinance will be touted by these institutions as adequate justification for the use and treatment of the animals in their research.

2. The Hong Kong Animals (Control of Experiments) Ordinance.

Chapter 340.

The ordinance was originally enacted in 1963 and was amended in 1964, 1989 and 1994, These amendments did not significantly alter the legislation and therefore the legislation is basically the same as it was 36 years ago. The aim of the legislation is "to provide for the control of experiments on living vertebrate animals" by ensuring researchers are licensed, that they keep records and that the researchers make available their records for inspection by an authorised medical or health officer. The legislation also provides for penalties for any one who is found guilty of an offence under this legislation however only the Secretary of Justice can institute a prosecution 1.

There are several problems with the legislation in that the legislation does not recognise the realities of scientific research as it enters the 21st century. Specifically,. it has a very narrow definition of experiment, it permits experiments on the basis of advancing physiological knowledge, it licenses researchers without adequate checks and balances that they are complying with the conditions of the licenses, and it does not allow for community or peer review of animal-use protocols.

Under the ordinance, "experiment" means "any experiment performed on an animal and calculated to give pain"1. This definition is so narrow that any procedure that does not cause pain would be excluded. The definition is based on the Victorian concept of vivisection and it ignores the broader concepts of distress2,12. An animal does not need to be in pain to be distressed. The concept of distress is completely foreign to the legislation although it has been included in the other significant piece of legislation concerning animal welfare, namely the Prevention of Cruelty to Animals Ordinance, where any person causing unnecessary suffering to an animal is guilty of cruelty 13. However one needs to ask the question, is prosecution under this latter legislation likely or practical in those cases of animal suffering that involve major research institutions, especially if "public interest" becomes a justification cited by HKSAR government's senior justice officer for not prosecuting contentious cases14? Furthermore, there is no recognition of genetic manipulation which could result in a significantly malformed animal that is not necessarily in pain but which is suffering 15. Finally, what about those animals that have been manipulated so as not to feel pain (e.g. neonatal mice that have been treated with capsacin)8? Would experiments on these animals be exempt from the definition and hence the ordinance?

The legislation permits experiments provided the research advances humankind's knowledge of physiology, or it provides knowledge required for saving or prolonging life or for the combating of any disease. This pre-requisite ignores the reality of modem day research ,where knowledge advancement is incremental and often without a specific or definable endpoint16. A claim that knowledge has been advanced must surely wait until the completion a number of experiments, or the completion of a number of animal-use protocols or the completion of a comprehensive research program. Yet the researcher must seek a license for each animal-use protocol, not knowing if the experiments are going to add to humankind's wealth of knowledge. Furthermore, every animal-use protocol must be licensed, this requirement becomes administratively, quite cumbersome for both the researcher and the Licensing Authority (i.e. the Department of Health). If the researcher complies with the legislation he/she would end up with a number of licenses. Most researchers avoid the need to apply for a number of individual licences by applying for a single license using non-specific descriptions for their animal-use protocols and general explanations to justify their research project(s). This "shotgun" approach to license application ensures that the license will encompass as many research scenarios as possible17.
An example of the wording used in a recent license approval is as follows:
"Type of experiment(s): Thoracic, abdominal, limb, cranial surgery and antibody production and toxicological studies.
Place(s) where experiment(s) may be conducted: Conducted at <name of location>.
Conditions :
1. Such experiment(s) may only be conducted for the following purposes <list of purposes>.
2. This license is valid until: 31.12.99.

However, this method of license application is not in accordance with the true meaning of the legislation, and it effectively circumvents the aim of the legislation making the licensing system unreliable and keeping the Licensing Authority ill-informed about the real nature of the experiment(s) conducted in HK's academic institutions.

Another problem of using the licensing method to control research, is that it is highly labour intensive. It requires an inspectorate to be located within the Licensing Authority that will use the power specified within the legislation to check the records of researchers and to inspect their research to ensure compliance with the conditions of their licenses. The reality is that research in HK has grown significantly since the legislation was enacted, there are now 3 major institutions heavily involved in animal based research and at least 2 other tertiary institutions now moving into animal based research, yet when the legislation was first drafted there was only one such institution involved in animal based research. The labour resources of the Licensing Authority have not increased to match this growth of academic institutions that are conducting animal based research. The Licensing Authority prefers to rely on the researchers' compliance with the legislation through their "professionalism", which the Licensing Authority believes is conferred upon the researchers through their position as academics within an academic institution 18,19. In addition the Licensing Authority does not have the expertise to assess the well-being of the animals, the research ethics of the protocol, the likelihood of the research to advance knowledge nor the skills of the researchers. Furthermore, there is no opportunity under the current ordinance for seeking the expertise and experience that exists within the veterinary profession, research peers, ethicists or the community and incorporating these diverse views into the licensing system or the review of animal-use protocols. This is not desirable in a free, open and accountable society, where public money is being used to fund research that no-one knows about and that is not inspected.

3. The Academic Institutions.

The implementation of ARECs was imposed on the academic institutions through necessity and not just because the RGC linked the ethical review of animal based research to funding. As the academic institutes of HK attempt to collaborate with other universities around the world but particularly those of Australia, New Zealand, Western Europe (including the UK) Canada and the USA the need for the research carried out in HK academic institutions to be scrutinised by an AREC has become almost mandatory, as the collaborating overseas academic institutions invariably require confirmation that the HK collaborators have had the research protocol approved by an AREC20. Added to this has been the policy of most prestigious scientific journals not to accept papers for publication unless the research has been reviewed and approved by an AREC. However, as the RGC, collaborating academic institutions and journals do not stipulate how such committees are to be constituted, the end result is that there is a variability between the ARECs of the academic institutions of HK in their diligence, designation, composition and functioning resulting in no uniformity and no common or even minimum standard for the ethical assessment of animal-use protocols.
Further pressure on academic institutions to introduce self-regulation of animal based research has come from their employees. The academic institutions have employed professionals from many endeavours and many different cultures and they bring to the academic institutions a variety of experiences and expectations about the humane treatment of animals in research and as such many of the researchers have advocated for the implementation of a peer review system of the ethics of animal-use protocols21. The implementation of an institutional AREC has been the common and adopted by academic institutionsl7, preferred option but even so, the lack of legislative guidelines has meant that the resulting ARECs are not fulfilling their potential. So what should be done?

4. Control of Animal Research Ethics in HK: A Proposal for Discussion.

4.1 . Update the Legislation.

4.1.1. The Problem.

There has been no major revision of the Animals (Control of Experiments) Ordinance since it was first introduced in 1963.

4.1.2. A Suggested Solution.

The Ordinance should be completely rewritten to recognise the realities of research in the next century. It needs to expand its definition of experimentation to include "any test or trial for a scientific purpose, including any activity to test an hypothesis or demonstrate a known fact"20

Furthermore, the new legislation must not confine itself to determining if an animal is or is not experiencing pain but it must instead ensure an animal is not experiencing distress. Distress in this case would be defined as an "acute or chronic response of an animal caused by stimuli that produce biological stress which produces observable, abnormal physiological or behavioural responses."20

Finally the new legislation must tackle the animal welfare issues created by genetic manipulation.

4.2. Abolish Individual Researcher/Individual Project Licensing

4.2.1. The Problem.

Individual licensing of the researcher and/or the research project is impractical. The license is for one year but most projects especially RGC funded projects run for up to three years. The Licensing Authority has no administrative system to send reminders for license renewal and there is no administrative system for checking on researcher compliance with the requirement to submit annual returns or license renewal because such a system is labour intensive and requires a modem and efficient computer system to maintain records and adequate human resources to administer the scheme19. None of the resources of the Licensing Authority are solely committed to supervising animal experimentation in HK.

4.2.2. A Suggested Solution.

Although licensing and inspectorate systems exist in several countries of the EU (UK, Germany, Netherlands and Denmark)22, in many other countries such as Australia, NZ, Sweden and USA a self-regulatory system based on local ethics committees which review experimental protocols has been operating4,20,22,23,24. HK in many ways reflects the voluntary system of self-regulation already operational in countries such as France, Spain and Italy where there is either few or no regulations concerning the use of animals in research22, however this similarity between HK and the countries named in no way justifies inaction on improving the system of checks and balances in the HK system. In fact, all countries of the EU (including those described in the above paragraph) are being directed to work towards the harmonization of legislative, regulatory and administrative provisions of Member States 22.25.
As HK already has voluntary self-regulation through its existing ARECs, the appropriate pathway for HK to follow would be the development of the self-regulatory system. This system should be enshrined in legislation, thereby creating a legal framework for the better designation, composition and functioning of animal research ethics committees. The legislation covering the formation and function of the ARECs could be designed to allow the involvement of veterinary surgeons, ethicists and community members in the reviewing and approving of animal-use protocols20.

4.3. Remove the Control of the Animal Experimentation Legislation from the Department of Health.

4.3.1 The Problem.

Currently, doctors within the HK Department of Health are used to assess research protocols and to approve research licenses but they are not solely employed to oversee or control animal experimentation. They are also responsible for the implementation of HKSAR Government's health policy, which is given greater priority than animal welfare in academic and other research institutions. Furthermore, the doctors are not trained in matters of animal health, animal welfare and have little or no comparative knowledge of physiology, anatomy or pharmacology. An informed judgement about the nature of an experimental protocol or a licensee's skills seems unlikely.

4.3.2. A Suggested Solution.

In many countries (for example Australia, Canada, Czech Republic and the USA) the responsibility for the supervision of the relevant animal experimentation legislation is vested in the Government Veterinary Services (for example in an Animal Welfare Bureau within the Government Veterinary Services)4,20,22,23. The reasoning behind this is that the enforcement of the Countries' respective prevention of cruelty to animals legislation and consequential animal welfare issues are frequently managed, investigated, and prosecuted by government veterinary surgeons. Veterinary surgeons are among the few professionals with the appropriate training and expertise to oversee such animal welfare issues23. It therefore seems appropriate that they should also be responsible for the enforcement of the animal experimentation legislation23,26.

The HK Agriculture and Fisheries Department is no exception to the above generalisation. it is already responsible for the register and professional standards of veterinary surgeons in HK (via the HK Veterinary Surgeons Board), animal health legislation, prevention of cruelty to animals legislation and it receives advice from the Animal Welfare Advisory Group on all manner of animal welfare issues. It is also the largest employer of veterinary surgeons in HK and hence has significant animal science resources at its disposal. Therefore it would seem appropriate that the responsibility for the overseeing of animal experimentation should be a function of this department.

4.4. The Control of Animal Use in Teaching.

4.4.1. The Problem.

The legislation permits the use of animals in teaching in academic institutions if specific permission by the researcher is sought from the Licensing Authority. The application is required to describe why the experimentation is necessary for the academic syllabus, but the requirements for assessing the necessity of the animal-use protocol are quite vague.
Furthermore the legislation says nothing about the use of animals in primary and secondary schools, assuming they are not performing animal experimentation (as defined by the Ordinance).

4 4.2. A Suggested Solution.

Any new legislation needs to address the important ethical issue of using animals in teaching, especially now that there are a range of alternatives that can provide the same information (for example interactive software)27.
The value of using animals in teaching whether at the primary, secondary or tertiary level must be comprehensively investigated and fully justified28 and this would require an independent method of review and arbitration. A suggested format would be to use a subcommittee of the Animal Welfare Advisory Group to assess the need to use animals in primary and secondary schools, while the academic institutions' ARECs would assess the need for animal use for tertiary education. Guidelines on animals in teaching and school programs do exist in other countries29,30,31. Generally, they do not permit any type of animal-use research nor live animal dissection in primary or secondary schools but do permit the use of animals in programs that encourage students to develop positive attitudes about animal welfare, to teach animal care and to respect animal life and to encourage an understanding of animals and their environment. HKSAR Government needs to identify the extent of animal usage within schools and academic institutions and to legislate against unwarranted animal usage.

5. Conclusion.

Only when the HKSAR Government recognises the growth and development of animal-based bio-medical research in HK and tackles the ethical issues raised by the growth and diversification of this type of research can the outdated Animals (Control of Experiments) Ordinance be rewritten, and only when the legislation is rewritten will the welfare of animals used in research in HK be properly addressed.

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