Team:AHUT China/HP/Human Practice/Regulation
Regulation&Safty
Regulation&Safety
1.Laws and regulations related to this project.
1.1Biological safety management regulations of pathogenic microorganism laboratory.
The biological safety management regulations of the pathogenic microorganism laboratory are the regulations adopted by the sixty-ninth executive meeting of the State Council in November 5, 2004 which was announced by the State Council Decree No. 424th in People's Republic of China in November 12, 2004.
The regulations of general principles, classification and management of pathogenic microorganisms, the establishment and management of the laboratory, laboratory of infection control, supervision and management, legal liability and supplementary provisions including 7 chapters and 72 clauses which was carried out from the date of the implementation.
1.2 Measures for the administration of biological safety environment of pathogenic microorganisms Laboratory
Measures for the administration of biological safety environment of pathogenic microorganisms Laboratorywas passed at the second executive meeting of the State Environmental Protection Administration in March 2,2006.It is hereby promulgated and shall come into force as of May 1, 2006.
The present Measures shall be applicable to the laboratory in People's Republic of China and the management of the biological safety environment for experimental activities. Pathogenic microorganisms, as mentioned in the present measures, refer to the microbes that can cause human or animal disease. The term experimental activities as mentioned in these Measures refers to the activities of laboratories engaged in research, teaching, testing and diagnosis of pathogenic bacteria (poison) species and samples.
2. Safety and ethical issues in genetic engineering
2.1The hidden trouble in the process of the recombinant DNA test.
The DNA operation of the laboratory is mainly virus, bacteria and experimental animals and plants. These experimental materials in pathogenicity, drug resistance, metastasis and its ecological effects vary widely. Once in the planning and operation of the accident, the consequences would be unbearable to contemplate. There are two potential hazards in the process of laboratory reorganization DNA test. (1)The pollution caused by the operator, especially the recombinant pathogen;(2)Pathogen or carrier and receptor with recombinant DNA escape from laboratory, causing pollution to nature and social environment.
2.2 Potential Risks of Genetic Engineering Industrialization .
The safety issues involved in the industrial production of large-scale genetic engineering are more complex than that of the recombinant DNA test. Mainly includes: (1) pathogen and its metabolites can be infected by contact to humans or animals; (2) unpredictable reactions can be caused by biological toxicity, sensitization, or by products to humans or other organisms; (3) donor, carrier, receptor and other experimental materials can be harmful to humans and other organisms and the environment in mass production which was safe in small scale test case. (4) genetic engineering drugs that are safe for use during short-term research and development are likely to produce unexpected hazards in the long term. The last two cases will be irreversible if it happens.
2.3 Safety Issues in Genetic Engineering.
Some viruses have genes that cause damage to the target tissue, such as the hepatitis virus Pro liver gene, which can never be used in the development of a recombinant live vaccine. This kind of gene can make the original harmless microorganism become extremely dangerous. In addition, the safety problem of plasmid DNA vaccines are: (1) injection of plasmid DNA in vivo may result in insertional mutagenesis, resulting in activation of cancer gene; (2)as the DNA used for inoculation of antigen expression period is not well understood, long-term expression of exogenous protein may lead to pathological immune response ( 3)the combined use of a variety of genes in order to improve the immunity may also lead to pathological immune response; (4) while inoculating the plasmid DNA, the host may lead to high levels of anti DNA antibody, immune response and induce abnormal; (5) the antigen synthesized in vivo may have biological activity which is not necessary.
2.3 Safety Issues in Genetic Engineering.
Gene therapy is different from genetic engineering drug treatment, but from the respect of the actual results of gene therapy, it is functional because of the production by the specific functional molecules into in vivo gene (such as cytokines), which is equivalent to the human body into a therapeutic drug delivery system. Therefore, the imported can be regarded as generalized gene drug. The safety problems of gene therapy are: (1) After the retroviral vector is transferred to the main cell, it may produce the insertion mutation, which makes the cell growth regulation abnormal or the occurrence of malignant transformation.(2) Introduction of the target gene does not have a general expression of the regulatory system, so the expression of the gene expression level may affect the body's physiological activities(3) It is possible to import a receptor cell with a target gene generated by a retrovirus packaging cell line, and there is a potential risk of contamination.
2.5 Genetic Engineering and Ecological Environment.
Through the technology of DNA recombinantion, people have been able to introduce the gene of animals and plants and microorganism into a variety of biological cells and even synthesize some genes that don’t exist originally in nature. However, those organisms carrying foreign genes, once escaping into the environment, will lead to the change of ecosystem structure, as a result, the balance will be broken, and thus lead to the destruction of the balance which has been formed long time ago during its lone-term revolution. For example, the escape of transferred resistant genes organisms will excessively propagate because of the increasing competitiveness. It will lead to the faster extinction of other species that compete with them, and destroy the species diversity. If the pathogens used in the recombinant DNA escape into the environment, they will directly harm the organisms in nature. Moreover, people concern about whether the genetic engineering used for treatment of diseases will do harms to the non-target organisms.
2.6.Social Ethnic problems resulted from genetic engineering.
Social Ethnic problems resulted from genetic engineering mainly includes four aspects.Firstly, it is the huge consumption or even waste of money, resources and manpower.At present,the trend of biological technology of pharmacy in the globe has been overheated. According to some research, although people are in great need of genetically engineered drugs, the required amount is very small.Thus, the social ethicists think it will bring more social benefits if putting such huge investment in the routine precautions against diseases. Secondly,the price of genetically engineered drugs has been reduced sharply, but the general public can’t be the supporter of it in the long run.The unfair distribution of medical resources and money will aggravate the inequality already existing in the society, which will make the society even more unstable. Thirdly,the general public know nothing more about genetically engineered drugs but how to take them.In a large sense, they are in a very passive position, which obviously violates the principle of “Informed Consent”in medical ethics.Fourthly,before taking genetically engineered drugs, people have to tell the doctor about their genetic secrets. So, more and more people are worrying that exposing their genetic information may lead to some bad influences on job-seeking, marriage,insurance or even on their interpersonal relationships.
2.7. Genetic Engineering and International Security.
Today, as terrorist activities in the globe running wild, the biggest concern of people is the proliferation of biochemical weapons. As long as there are 20 square meters space and 10 thousand dollars, the most cutting-edge biochemical arsenal can be built, pointed out by some experts. There are no more secrets in developing the technology of biochemical weapon, which will make a lot of vaccines and antibiotics useless through recombinant DNA technology. At present, brand-new, high efficient and infectious viruses have been produced. New biological toxin, blended by toxin genes and influenza viruses, has been put into mass production. If those terrorists who have already lost their minds mentally and behaviorally control the technology of producing biochemical weapons, any anti-terrorism powers would become so fragile that the international security can’t be guaranteed.
2.8 Impact of genetic engineering on biological evolution.
If the frequency of recombinant DNA technology is similar to natural evolution process, which triggered insertion mutation, it doesn’t effect on human and other creatures. However, in fact, the frequency of gene mutation,caused by the recombinant DNA technology, is more than natural mutation frequency. It maybe cause a disastrous effect on the human genetic system that has evolved over millions of years or even longer. The human body based on the long evolution can not adapt to the biological effects caused by the frequent gene recombination. In this regard, the reaction of other biological species is the same.
3. Corresponding strategies about genetic engineering safety and ethical issues
3.1 Objective and comprehensive research on the theoretical origin of bioethics.
The research of bioethics have many disputes, the main reason is that some researchers just focus on the surface problem, and seldom discuss the ethical problems. Genetic engineering drugs cause ethical problems, the fundamental reason lies in its appearance not only has a huge impact on the evolution of human nature, and also influence the biological world at the same time, meanwhile it has a great impact on the traditional ethics. The impact and influence further increases the contrast between "biological evolution" and "cultural evolution", and makes people difficult to adapt to the new problems in ethics. Therefore, it will be an important prerequisite for the public acceptance of the social public to understand the root of the problem arising from the ethics of genetic engineering drugs.
3.2 A profound understanding of the dual nature of human beings.
The evolution of human beings is composed of two parts: "biological evolution" and "cultural evolution"". Therefore, all human behaviors have the double attributes of "biological" and "cultural". With the development of human society, "cultural evolution" on human behavior often plays a leading role, but "biological evolution" to human behavior will also be eternal. From the point of view of the dual attributes of human behavior, it is possible to understand why genetic engineering will lead to ethical contradictions and conflicts of ethics, then seeking solutions on the basis of objective law.
3.3 Coordinate the relationship between short-term and long-term benefits of human development.
All human behaviors of science and technology are related to the short-term and long-term benefits of its development. The emergence of some ethical problems are often caused by the conflict of these two benefits. For example, people are worried about some genetic engineering drugs that have a therapeutic effect on some kind of genetic diseases but are likely to have a negative impact on the long-term health. Therefore, coordinating the relationship between short-term and long-term interests is the only way to keep balance.
3.4 Balance the relationship between human beings and other creatures.
The survival and multiplication of human are not isolated from other creatures and the human evolution cannot exist without the living environment. Therefore, we must stand at the height of ecological ethics to rationally deal with the relationship between humans and other creatures. Otherwise, we will lose our habitat of survival and multiplication like many endangered species.
3.5 Improve the level of biological security research and monitoring management.
Biological safety studies and bioethics research have become a pair of "twin" in the relevant research fields. Many genetic engineering ethics problems are caused by the lack of security research and the lack of effective measures of monitoring. Experts pointed out that all genetic technology research projects should contain the research of safety and ethics. In addition, the monitoring and management level of genetic engineering products also need to be improved and extra attention should be paid to the outflow products.
3.6 Enhancing the Establishment of Law and Regulations Relevant to Biological Safety.
Simply depending on restraining moral principles will not ensure the safety of genetic engineering. Many problems that appear to be concerned with social ethics are actually about those litigants who ignore the most fundamental codes of social behaviors and regulations for their own interests. Thus, it is a must to build a series of scientific and strict laws and regulations which are not only good for research and development, but also able to ensure safety. For those developers who only care about commercial interests but not public security, severe punishments should be given, even if they might be experts or scholars.
3.7 Adjusting the Speed and Scale of the Development of Genetic Engineering.
During the process of developing, everything should have its limits. At present, the development of genetic engineering is too excessive, if not controlled, the situation of supply exceeding the demand will certainly come, which will not only waste resources, but also bring about many consequences that are against social morals such as low-quality products caused by immature technology and counterfeits. To some extent, regulating the development and manufacturing of genetic engineering in a scientific way will release some burdens of those relevant problems concerning safety and morality.
3.8 Popularizing the Consciousness of Public Safety and Life Ethics.
If the public lack the knowledge of safety and ethics, the inflation of the issue dealing with the safety and morality of genetic engineering will only be more serious. For that, the public ought to know more and better about genetic engineering and its safety, ethics and so forth so that they can strengthen their awareness of self-protection and the ability to differentiate. Meanwhile, it is also necessary to make them realize the fact that the research, exploration and appliances of genetic engineering will never stop in its tracts because of the global truth of its safety and ethical issues. It is universally acknowledged that no scientific research and its development are downright safe or conform with the absolute moral principles when it is benefiting human beings. One can only seek for a dynamic balance among all kinds of conflicts which is beneficial for all. It would not be objective or rational to affirm or negate simply.
