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Law & Regulation

Overview

This summer, we modified the cGMP metabolism in mammalian cells using techniques of synthetic biology. This could potentially be developed into molecular medicine for the treatment of ischemic heart disease and hypertension of the lung.

In our Human Practice part, we investigated the law and regulation in China concerning gene technology, especially the gene modification and synthetic biology.

To a certain extent, it’s undeniable that gene modification is equal to gene therapy, and our project is about gene therapy to myocardial ischemia, imperceptibly we may put ourselves in the center storm of ethical and juristical issues. At the same time we want to have a deeper perspective about the ethical and juristical issues in China, so we choose to have dialogues and communications with expects in law and biology and amateur philosophers who have a greater critical thinking of moral and ethical issues, and thanks for their generous help and assistance, we finally get a complete result in the Human Practice.

A. Dialogues

Dialogues with amateur philosophers

There is an online philosophy discussion group with more than 60 people who have great interest and we have some debates whether synthetic biology based on the synthetic gene circuits makes people machine if synthetic biology is applied to human being.

The Ship of Theseus, a theory proposed by Plutarch, is one of the oldest paradoxs that we can search for help in demonstrating the question whether a man can still be defined a human being if his gene has been modified and in what degree modification can a man be ruled out of definition of human. The ship with vicarious components is definitely different from the initial one, but it’s no doubt that it was not a brand-new ship either. Well, that is a diploma that the gene modification can bypass.

Actually, the definition what human being is has perplexed people for a long time since human being come to exist. The definition of natural person has exhausted us, let alone non-natural human. But sooner or later, based on the development of gene therapy, the technique used to modified human being will come true and what should we do to distinguish natural person from non-natural human? By the proportion of gene modified or by the number of genes modified, that is a question.

We are really glad to see Merry Lin and Yaobin Ouyang who have a better understanding about jurisprudence and philosophy. And we had communication with them too. There is not doubt that without their help, there won’t be any thing about the critical thinking of law related to gene technology as we will mention below.

Dialogue with experts in biology

In order to have a more clear understanding about how China government regulate drug development, we have an interview with Doctor Huang, a teacher who has medical science background and specialize in biology. According to the conversation with Doctor Huang, we know that the review conducted by the official organization puts more emphases on the formal procedure. The review procedure is so comprehensive that it always takes a longer time than some developed countries to permit the new medicine to come to market.

And Doctor Huang also told us that only if we can make any progress in reducing drug toxicity, lowering drug price, and identifying therapeutic targets, then we succeed. However, she also mentioned that gene therapy is a technique full with dangerousness and controversy. Up until now, there are not brand safe and effective means in delivering the therapeutic gene in clinical trials because each method has its shortage. For instance, adeno-associated viruses don’t integrate DNA into the chromosome while the lentivirus do, which was spoken highly of for its efficiency and was censured for its possibility causing inserted oncogenous mutation.

Finally she encourages us just to do it and don’t worry too much about its application limited by disadvantage compared to existing chemicals, because elucidation of the molecular mechanisms of myocardial ischemic using synthetic biology alerting signal transduction pathway is something remarkable. As you find the way you alter signal transduction pathway work, you can try to alter many other pathways, most of which lead to lesion of our body like the rheumatism, based on the bio-bricks you made.

Dialogues with law experts

In order to have a better understanding about law and regulation actuality in China, we have an long talk with Shiwen Zhou, professor of South China University of Technology, who has written a book called strategic studies in the patent protection of gene and gene resources, is good at teaching and scientific research of Civil and Commercial Law and Intellectual Property Law.

She once worked in Guangdong Higher People's Court as a judge and has great experience in judicial work in Intellectual Property Law. As a visiting scholar of American Pacific University and Visiting Professor in McCain George School of Law, she provided us with a full-scale perspective of gene technology law in China.

And at the same time we have an interview with Dr. Huang, who is specialize at civil procedural law, and we introduced him some knowledge about synthetic biology and gene therapy to him, which he like it so much that he said he will communicate consult with us if he has some professional questions or he just want to learn more about life science.

Dr. Huang share some case related to reproduction lawsuit. And he told us even though judge finally coped with the problem based on the existing law system, the existing law system needs more development and progress so as to adapt to the pace of the times development.

B. Law and Regulation Actuality in China

What legal achievement has China made in gene technology?

Technical Guidelines for Gene Therapy Research and Preparation Quality Control, the first fundamental technical specification made for gene therapy, was officially promulgated and implemented in 2003 by SFDA and in 2004 its English edition was published in Biopharm International to the whole world.

The regulation of agricultural genetically modified organisms safety and Regulations on the Protection of Wild Plants of the People's Re- public of China is a relatively well-developed regulatory system in gene technology, especially in the field of transgenosis technique.

Human genetic resources management interim measures, a regulation serves as the criterion for the management of human genetic resources, went into effect in 1998. And there are many other regulations that have some statements related to gene technology indirectly.

And some other laws concerning to genetic engineering directly or indirectly like the Seed law, Forest law, Grassland law, Fisheries law and the Agriculture law made by Ministry of Science and Technology, Ministry of Agriculture, or Ministry of Health play a significant role in protecting the development of gene technology in China nowadays.

legislative shortcomings：

Although China has made a great progress in the gene technology legislation, there still are some legislative shortcomings we need to face. And only if we have a clear understanding about the current situation can conquer these shortcomings.

Firstly, there is not a statute book for gene technology and the regulations are so miscellaneous that it’s not easy to regulate gene technology development systematically and effectively. Secondly, because most regulations like the The regulation of agricultural genetically modified organisms safety and Regulations on the Protection of Wild Plants of the People's Re- public of China are made by the State Council and/or its departments working under it and these regulations are classified into administrative laws and regulations and/or Departmental rules, it’s not so possible for the regulations to work as powerfully and compulsively as law made by People's Congress.

Limited by the development of government department, these regulations were put more emphases in principle of legality instead of practical operating. For example, as stated in Human genetic resources management interim measures, research and development institutions in our country shall enjoy the exclusive ownership of human genetic resources information within the territory of China, including important genetic genealogy and genetic resources like data, materials and samples from specific areas and without permission, no one should transfer the possession of this information to others. Actually, where we should come for permission is still puzzlement.

Meanwhile, shortage of compound talents with gene science background and legal professional knowledge and ability is another obstruction that impedes the development of gene technology legislation research. During the conversation with Prof. Zhou, she mentioned several times that she has not enough talents to carry out more researches in gene legislation, for life science itself is difficult for professional students to understand and it’s easy to picture a law school student without life science background is pressed up against the wall unsurprisingly when he/she try goes deep into research.

The Chinese law concerning gene is permissive.

It’s more common to regulate gene therapy by administrative laws and regulations in China, such as technical guidelines for Gene therapy research and preparation quality control, which is not powerful enough to regulate gene therapy systematically, a rapidly developing and changing subject, for its temporality and contingent character.

Legal remedy problem is another theme that China must face in the field of bioscience. Technical guideline is just rules or instructions that are given by the official organization telling you how to do something, especially something difficult, and it is not equal to law that has the power to compulsively urge people to abbey. When the infringement happens, it’s the law, not the guideline to cope with the problem during the lawsuits.

To summarize, laws in our country China is permissive and patchy and we need to learn from counties with thorough law system and to do research to seek out the compatible pattern in biology to avoid potential accidents and disasters buried under gene editing and therapy.

C. Suggestion for Legislation in China

What should the Chinese government do?

Government can choose to compile a specialized legislation for gene technology including the gene therapy and gene editing so as to systematically regulate and promote academic research and market practice. And at the same time, there should be a specialized department with specialized talents in charge of gene technology for professional supervision.

National Health and Family Planning Commission of Republic of China should bring the gene editing technology into the management of the third class medical technology. Think about how to regulate gene editing and therapy research by setting a threshold. For example, setting a specialized government department in investigating, registering, and supervising the total procedure of making research in gene editing and therapy is obligatory.

Actually there are many discussions about gene legislation in China and we can learn a lot from them. For example, for the lawmaker, general principle and reasonable exception rule should be kept in the lawmaking process preventing gene discrimination. Based on the general principle, employer should not require gene information from employee to prevent unfair treatment. And when it comes to the exception concerning the public safety, the employer can obtain gene information from employee but should make sure to keep the gene privacy.

[Reference：The Discussion on the Gene Discrimination from the perspective of the first gene discrimination case in China]

What can we do in advocating for political legal change?

Have a deeper investigation into gene technology legislation and prepare a comprehensive proposal for the Deputy to the People's Congress. In China, People's Congress is the lawmaker in a real sense, and if we want to emphasize the importance of starting the legislation process, we should draw the deputy’s attention with reasonable and sufficient preparation. But it’s really difficult to achieve so because of the deficiency our scholarly attainments and influence.

The other way to promote the lawmaking is to influence the government. In our country China, the government plays a role as the lawmaker to some extent even though government is administrative body. If we can make great achievement in our research about myocardial ischemia disease, we may have dialogue with the government to share our views of point in policy making. And the government may keep a watchful eye on the gene development to promote gene therapy, gene editing and synthetic biology, a subject booming since the beginning of 21th century by government subsidies, government procurement and financial allocation.

To our surprise, during the conversation with Dr. Huang, an expert in legal filed, he suggested us to have more communication with the law professors in our university, South China University of Technology, because law professors in our school are always invited to draft a law with the legislative institution. The more specialized knowledge about gene we exchange with our professors, the more information about biology like the synthetic biology and gene therapy will be shared with them. And they will have a clear understanding about the importance of gene legislation. Perhaps one day our team can serve as technical consultants to give them advisors about the frontier technology.

And at the end of the talking with Professor Zhou, she jokingly invited us to join her research team about gene technology legislation after we finish our competition in MIT, and actually she really need some people to help her in biology knowledge. May be one day will do something real in advocating legal change in gene technology with support from Mrs Zhou for her outstanding experiment in Guangdong Higher People's Court being a judge.

D. Critical Thinking about Law Related to Gene Technology

Huang Jun, professor of Sun Yat-sen University, led a project team to modify Human embryonic genes to treat β thalassanemia disease by Crispr-Cas9 Technology, which maybe be used to eliminate genetic diseases in the future vastly. In theory, it can also be used to change the color of eyes or intellect etc, and ensure these changes can be passed on to further generations.

What was beyond expectation is that this paper caused enormous ethical issues on a global scale. Many China’s biologists give strong support for it, while it also strongly criticized by many foreign biologists who call for banning the research of editing the human embryonic genes especially in those countries had lax regulation in law.

Prof. Rao Yi, a former dean of the Life Sciences School at Peking University, said that Chinese scientific research needs a more effective ethical regulation urgently. He said that “The more you have in technology, the more we are exposed in danger.” The idea of Chinese researchers is “We correct the mistake after doing the wrong things. But it maybe ignores the process of conceptual discussion.”

Human rights of unborn baby

Image there is a couple doomed to give birth to a baby with a genetic defect due to their genotype and after having gene detecting they decide to edit their embryo so as to have their own healthy baby.

And now here comes the question, should we ignore the embryo’s rights and interests if we fail to edit its gene? Well in many counties embryo is not recognized as people and it’s legal to perform abortion operation so you may be thinking that we can make it legal to perform gene editing in embryo. There is not standard answer for this question since you may come from different countries and have different culture background. But currently we regard it inhuman to do experiment in normal embryo and that is why Doctor Huang in Sun yat-set University choose the embryo with 21-trisomy.

Let’s think about another condition and question. Image the couple find that their baby dooms to have small eyes after gene detecting and they regard small eyes ugly. So they choose to modify the embryo’s gene to ensure their baby with big beautiful eyes. When the baby grows up to be a male adult and he thinks his eyes are ugly and starts to complain about his parents editing his gene without his “permission”. And finally, the male adult chooses to prosecute his parents. Well, if you are the judge, what would you do?

In this hypothesis, you may have the same question as me whether what the parents do is to protect or to infringe the unborn baby’s human right if we can edit human gene? Although it seems senseless to discuss such an unrealistic issue now, but sooner or later, with the development of synthetic biology and gene therapy, we must think about how to manage such a controversial issue and help to advance technology instead of being too strict to prevent the research that will make breakthrough in solving the underlying problem of unsolvable human disease such as cancer and genetic disease.

It’s the social development that decide the answer to these question whether its moral or fair to use gene editing and therapy, but not different hypotheses that decide the development of technology. We should remember that technique itself is innocent, whether it is an evil or a virtue depends on the users. [Quote from：Gene therapy: Regulations, ethics and its practicalities in liver disease]

Gene Discrimination and law making

In 2009 Foshan, Guangdong, three examinees were rejected to be admitted as civil servant for the reason that they are the carrier of thalassemia gene, which is a fairly common gene in south China provinces like Guangdong, Guangxi and Hainan where the carriers can reach ten percent and above. After that, the three examinees prosecute Foshan human resources and social security bureau, and a verdict from Foshan Chancheng People’s Court declared the three people lose. And during the appeal, Foshan Intermediate People’s Court affirmed the orignal judgment. This case was regarded as the first gene discrimination case in China and raised some questions about genetic privacy and legislative gaps in gene.

According to this case, we can easily find something related to each of us ranging from employment to commerial insurance and from marriage to dignity. For example, if the insurance company get your gene information without your permission and detect that you may suffer from severe breast cancer in the future, and they choose to reject your insurance purchasing, and after hearing this news, no insurance company will agree to insure you, what law can protect you from infringement for the divulgence of your gene information?

E. To Summarize

Two teammates’ double degree in our SCUT-China team is law, perhaps one day we would be lawmaker in the future in China. And when that day comes, the development in gene editing and therapy techniques may have a great breakthrough, and what we are not dare to image has all happened and we begin to influence the law world in China. We are looking forward to make progress in law and biotechnology in the future and we believe we will.

Team:SCUT-China/criticalThinking