Bio-policy in China

Synthetic biology is one the most dynamic field in Life Sciences not only all over the world, but also in China. Except the teams participated in iGEM, other scientific organization mostly are supported by the governments. It is also among the 22 key strategic technologies in Innovation 2050: Technology revolution and the future of China. (CAS roadmap, 2007) It brings us opportunity to solve environment and health problems, but also brings us potential risks to us. In bio-policy part, we investigated the existing effective regulations in China, interviewed law expert Mr. Wang and gave our suggestions.

1. Review of Biosafety Regulations

Regulation is a complex concept in China, which includes laws, administrative laws and regulations, judicial explanations, industry regulations. This part will give deep discussion on how they regulate researchers ‘actions in China and the insufficient of them.

Biosafety is an old topic for America and a young one for China. It originated between 1950s and 1960s in America. (Qi, 2006) People pay attention to it because they want to reduce the accidents among labs. In 1984, Centers for Disease Control (CDC) and National Institutes of Health (NIH) published Biosafety in Microbiological and Biomedical Laboratories and it became guidance document in America soon. It even became popular around the world.

However, Chinese realized the importance of biosafety later than that. In December, 1993, State Science and Technology Commission promulgated genetic engineering safety regulation, but the second article restricted the scope of genetic engineering within "directly inducing heterology DNA".

Legislation process is slow, but the Severe Acute Respiratory Syndromes (SARS) triggered people and administrators’ attention in 2013 and speed up the legislation process, because some of the researchers were affected with it. (Yang, 2006).

In January, 2004, Regulation on the Bio-safety Management of Pathogenic Microbe Labs was published soon. This is a milestone and since then, many other detailed regulations were published, either. The regulations includes highly pathogenic microbes transportation regulation (《可感染人类的高致病性病原微生物菌（毒）种或样本运输管理规定》) in 2005 by Ministry of Health, interpersonal infectious catalogue (《人间传染的病原微生物名录》) in 2006 by Ministry of Health，Regulations on Administration of Agricultural Genetically Modified Organisms Safety(《农业转基因生物安全管理条例》) in 2001 by State Council, highly pathogenic microbes laboratory creature management rules(《人间传染的高致病性病原微生物实验室和实验活动生物安全审批管理办法》) in 2006 by Ministry of Health. These regulations are all restricted to the microorganism that is capable of causing human or animal diseases.

However, until now, there is not a specific regulation for synthetic biology. This phenomenon may be the result that the previous regulations for genetic engineering have covered the synthetic biology. Some people, such as Furger and Schweiz (2007) held similar view that synthetic biology will not have significant difference between genetic engineering in the future 25 years. However, synthetic biology has its own special features. The traditional regulations care less about homologous DNA transition. However, no one can guarantee that transfer several homologous DNA at a time is also safe.

Some institutions in China are trying their best to contribute to biosafety. In January, 2010, Chinese Academy of Sciences Institute of Botany held the first discussion about biosafety and held a second one in November, 2011. Synthetic biology regulation, management, related legislative suggestion (Guan, 2012).

2. Interview Vice Professor Wang

BNU-China:

An illegal pathogen smuggling last year both in China and Canada, Weiling Yu, a researcher at Ottawa Laboratory, Animal Diseases Research Institute, Canadian Food Inspection Agency, was suspected to have conspired with Klaus Nielsen to smuggle Brucella, pathogen of Brucellosis into China. Yu is now wanted by Canada, and Nielsen, a now retired former senior expert in CFIA, was arrested last October. Their trial started this 17th April.

Brucella is a notorious human-bird virus. What laws has this smuggle broken?

Vice Professor Wang:

I’ve learnt about the news on Xinhua.com. Smuggling pathogens illegally, is violating the Canada “Export and Import Permits Act”, “Transportation of Dangerous Goods Act”, and “Human Pathogens and Toxins Act” and so on.

BNU-China:

Do we have similar laws and regulations in China to prevent cases alike?

Vice Professor Wang:

Domestically, we have Health Law, in which such cases are stated illegal, but no corresponding penalty is clarified. Just like smuggling pathogens, many other conducts violating scientific ethics currently don’t have relevant rules and regulations specified in China. We can only make the sentences with Criminal Law, in respect to the harm already done on people.

BNU-China:

Do such cases involve in academic ethics issues, or smuggling property right?

Vice Professor Wang:

Of course, such deeds undoubtedly violate the academic ethics, but considering China currently doesn’t have clarified regulation, we can’t define it as property right smuggling. Only after related regulations are stated and enacted can we call it illegal. In case of these violations, it is also controversial regarding which clauses to refer to, as well as which penalties to sentence.

BNU-China:

As Professor Zhirong Sun in Tsinghua University pointed out, development in synthetic biology could bolster the innovation and progress in energy, environment, and many other fields. Synthetic biology would even emerge as the fourth biggest industry following auto-manufacture, real estate, and tourism. Then, are there any related legislations?

Vice Professor Wang:

There’s indeed a bright outlook for synthetic biology. But we currently don’t have many related clauses; the only few counted are in “Law of the PRC on Science and Technology Progress”. However, this law was enacted back in 1992; it’s a question to think how much of it can we adopt onto the newly-emerged synthetic biology.

As with legislation, I propose to start making beforehand. For instance, the outbreak of SARS in 2003 had highlighted the urgent need of infectious diseases regulations; “Law of the Peoples Republic of China on the Prevention and Treatment of Infections Diseases” was thus born in 2004 as a response. We currently have “General Rules for Biosafety in Microbiological and Biomedical Laboratories” enacted in 2002, and “Standards for Biosafety in Veterinary Laboratories” enacted in 2003, to regulate related studies in synthetic biology on potentially pathogenic microbes.

I also suggest to establish a national committee to administrate products from synthetic biology. The committee should encompass experts from various field (including public health, environmental science, food hygiene, and food industry, etc), and would ensure the biosafety in research, mass-production, and marketing.

Besides, it’s also necessary to establish standards in safety assessment and risk evaluation. Concerning our experience in legislating and regulating GMO safety, the basis to enact risk evaluation for products form synthetic biology is the categorization with regard to the underlying principles.

BNU-China:

Thank you very much for this interview.

3. Advice on policy making

To improve biosafety, there are many different ideas. Some people, such as Kelle (2009), called for self-regulation and they think that subjective motivation is more important than regulation. However, in the view of economics, rational person are driven by profits, tragedy of the commons occasionally happens. Government regulation plays an important way in control it. Hence, clear and reasonable regulations are the most powerful weapon to gain biosafety.

The following aspects in China can be improved to make a better environment for the development of biology, especially synthetic biology.

First, we should make comprehensive regulation collections of biosafety. Regulations are the most powerful tools to lead scientific researches. If the regulations are too strict, they may inhibit the development of science. If they are too loose, biosafety will become a big problem. Good regulations are clear, comprehensive, easy to access for researchers.

Second, it would be much better if the Congress or State Council makes regulations for biosafety supervisory institutions. Besides Ministry of Science and Technology, Department of Agriculture and State Environmental Protection Administration, some other industry associations are also the supervisory institutions. Sometimes, it is hard to tell who should in charge of a certain case. No one to administrate or all to administrate makes it obscure and even finally cause corruptions or selective law enforcements.

Third, clear accountability is an essential issue. The 32 article of Regulation on the Bio-safety Management of Pathogenic Microbe Labs points out that Lab manager is the first person liable. However, it does not point out who is the second. As some labs are too big for the Lab manager to manage, the regulation does not point out whether the lab manager can appoint the second person liable and what the second liable person’s responsibility.

References

CAS roadmap. (2007) Innovation 2050: Technology revolution and the future of China.

Kelle, A. (2009) Security issues related to synthetic biology between threat perceptions and governance options. In: Synthetic Biology: The Technoscience and Its Societal Consequences (eds Schmidt M, Kelle A, Ganguli A, de Vriend H), Springer Academic Publishing: 101–119.

Furger, F. & Schweiz, F. (2007) From Genetically Modified Organisms to synthetic biology: Legislation in the European Union, in six member countries and in Switzerland. Working papers for synthetic genomics: Risks and benefits for science and society. Guan, Z. J., Pei, L., Schmidt, M., Wei, W. (2012) Assessment and management of biosafety in synthetic biology. Biodiversity Science, 2012, 20 (2): 138–150.

Zhao, Z. H. (2009) Study of biosafety in pathogenic microorganism lab [病原微生物实验室生物安全管理对策浅探]. Disease Suveillance, 2009, 24(6):468.

Qi, G. M. (2006) Pathogenic microorganism Lab Biosafety [病原微生物实验室生物安全]. Beijing: People's Medical Publishing House.

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