- Sung-Goo Han*
Senior Researcher, Korea Institute of S&T Evaluation and Planning (KISTEP), 275 Yangjae-dong, Seocho-gu, Seoul
137-130, Korea
Email: hsg@kistep.re.kr

- Young Je Yoo, Ph.D.
School of Chemical Engineering , Seoul National University, Shinlim-dong, Kwanak-gu, Seoul 151-742, Korea
Email: yjyoo@snu.ac.kr

- Wha-Joon Rho, Ph.D.
Graduate School of Public Administration, Seoul National University, Shinlim-dong, Kwanak-gu, Seoul 151-742, Korea
Email: wjrho@snu.ac.kr

Bioethics has become a political issue in promoting biotechnology around the world. Korea was the fifth country in the world to have cloned animals. Twelve attempts were made to legislate bioethics issues from 1997 to March 2003. To the present, there are no existing governmental laws that ban human cloning. All bills proposed on this subject are under consideration. We will analyze the conduct of the Korean legislative process regarding bioethics issues proposed by Korean government ministries and the National Assembly, particularly concerning cloning technologies. Experience in Korea will provide some lessons, especially for developing countries.

Because biotechnology is considered essential for national economic and social development, Korea has taken great strides to set up an efficient institutional system related to this field. Twelve attempts were made to legislate bioethics issues from 1997 to March 2003.

Although cloning technologies need to be regulated in Korea, bills are only in the review stage in the National Assembly. Presently, no binding laws exist to indict a person who wrongfully uses cloning technology in Korea. More recently, the Korean government has submitted a unified bill on bioethics issues to the National Assembly. A Bioethics law is expected to be established in the future.

In this paper, the conduct of the Korean legislation regarding bioethics issues is analyzed. In particular, focus is on the bills in the legislative process initiated by Korean government ministries and the National Assembly. We used secondary analysis in our study. To overcome the defects of this analysis, interviews and field surveys were carried out. Some Korean-specific characteristics were identified. The results of this study can be applied to conditions in developing countries trying to enhance their capabilities constructing a biotechnology policy.

Biotechnology development in Korea

Biotechnology related laws & national plan

In Korea, it was not until the 1980s that a systematic effort to develop biotechnology was launched at the national level (1). In the early 1980s, the Korean government had to face unprecedented challenges in its attempts to promote biotechnology. An important milestone in biotechnology policy was the enactment of the Genetic Engineering Promotion Law (now known as the Biotechnology Promotion Law), submitted by the members of the National Assembly in 1983. This law contributed greatly to the establishment of a solid foundation for biotechnology promotion in Korea. This law was the first to refer to the bioethics issues in Korea. From that time to the early 1990s, nothing on bioethics issues was additionally considered.

In 1993, on the basis of the R&D infrastructure built on biotechnology over the past decade, the Ministry of Science and Technology (hereinafter MOST) initiated a strategic plan called 'Biotech 2000' to promote biotechnology (2). This plan addressed a few issues in bioethics.

R&D outputs in cloning technology

The Roslin Institute in the UK announced in Feb. 1997 that it had succeeded in cloning a sheep named 'Dolly' after ten years of research. Since then, Japan and New Zealand have succeeded in cloning cows, while the United States successfully duplicated a mouse. Other animals have also been cloned in a range of countries.

As a part of a chain, in 1999, a group of Korean scientists succeeded in cloning a milk cow, making Korea the fifth country in the world to have cloned animals. The research team at Seoul National University successfully gave birth to a genetically duplicated calf by using a cloned cell of a super milk cow. The female calf dubbed 'Young-long' inherited all the superior hereditary characteristics from its mother cow. In 2002, Korean scientists succeeded in cloning a human embryo by fusing human tissue with cow eggs, a breakthrough that is expected to spark an uproar among religious and civic groups opposed to such experiments. Maria Life Engineering Research Institute extracted a nucleus from human tissue and transplanted it into cow eggs, a step that could lead to the production of embryonic stem cells.

Bioethical issues

Bioethics

International comparative overview on cloning technology

Many countries in fact have addressed cloning in a broader context (5). In the United Kingdom, the main principle for policy on these subjects has been the human embryo itself, though their approach is regulative rather than proscriptive. In Germany, for example, this broader approach has taken the form of a series of legal proscriptions and restrictions, centered on the Embryo Protection Act of 1990. The act treats all embryo research together and prohibits all interventions not undertaken for the well-being of the embryo (including the creation of embryos specifically for research). Canada is completing the process of establishing a national system, combining elements of legal proscription and governmental regulation, to govern all technological activities used to help people have children as well as the use of embryos in research. The United States to date has not; indeed, they lack any national monitoring, oversight, or regulatory system in this area. It may therefore be appropriate, in connection with thinking about specific policies for human cloning in the United States, to initiate discussions of a national policy for these related arenas.

Opinions on cloning technology in Korea

In Korea, the policy issue of bioethics started with the birth of the cloned animal 'Dolly'. Recent heated debates over bioethics have demanded social consensus among government ministries, scientific experts, NGOs, and the general public.

Industries and research institutes agreed that research aimed at gaining knowledge in basic developmental biology or developing new cloning-based technologies should be allowed to proceed freely. They viewed that the benefits of these types of research far outweighed the risks, and the many possible contributions to science and medicine warranted this type of research. In contrast, public opposition to cloning technology was shaped under the movement of NGOs and religious groups. In addition to the social-ethical problems of cloning technology, opponents noted and pointed out that new technology still had an extremely low feasibility rating. They cited that Dolly was the first success after 297 failures. Most embryos would die in formation and those that survive the stage are still born with birth defects. Surrogate mothers would die, too, of miscarriages.

Agenda setting

The government began to formulate a policy agenda. In response to the news of the cloning of Dolly, the Korean government set up a Bioethics Advisory Commission (hereinafter KBAC) under MOST in Nov. 2000, mediated by the Office for Government Policy Coordination (hereinafter OPC) under the Prime Minister.

Other international factors, such as the news of human cloning by Clonaid in 2002, are also in the background.

The legislative process on bioethics issues in Korea

The general legislation process

The enactment process of laws in Korea take the following course (6). (1) introduction: legislative bills may be introduced either by at least twenty members of the National Assembly ('National Assembly bill') or by the executive branch ('Government Bill'); (2) passage: bills shall be passed by the affirmative vote from a majority of the members present with the attendance of at least half of the membership; (3) procedures: when a bill is proposed and submitted, it is referred to the competent Standing Committee for examination and to the Legislation and Judiciary Committee thereafter for review of its legality and wording. The bill is then sent to the plenary for deliberation and passage, and finally sent to the executive for promulgation. The duration of the process varies according to the topic.

In the USA, a bill can be proposed by either the House or Senate (7, 8, 9). By contrast, the committee holds the main strength in Japan's legislative process. However, actual actors in this process are Japanese government officials and the government party. In Korea, a bill can be divided into two types: Government bill and the National Assembly bill.

The legislation on bioethics issues

Examples of legislation on bioethical issues exist around the world. For instance, Japan prepared its ethics guidelines in March 2001. "The Ethics Guidelines for Human Genome/Gene Analysis Research" was issued as jointly prepared ethics guidelines by three ministries (the Ministry of Education, Sports, Science and Technology, the Ministry of Health, Labor and Welfare, and the Ministry of Economy, Trade and Industry). This was followed, in June 2002, by the issuance of "Ethics Guidelines for Epidemiological Studies" jointly presented by the Ministry of Education, Sports, Science and Technology, and the Ministry of Health, Labor and Welfare (10). Becker and Doering have discussed a call for legislation in China (11, 12). Bonnicksen has introduced the attempts to the legislation of U. S. Congress in 1997 (13). Diniz analyzed the legislative process on reproductive technologies in Brazil (14).

In the legislative process of bioethics issues in Korea, the participants have come from such organizations as the National Assembly, MOST, and scientists by 1998 (15). They shared two basic values: (1) the improvement of biotechnology is more important than bioethics; and (2) more scientists have to participate in the policy agenda setting process. The NGOs were consciously excluded from the policy community.

Twelve attempts to legislate for bioethics issues were made by the National Assembly and Korean government from 1997 to March 2003. Nine staff members of the National Assembly during seven years, and MOST and the Ministry of Health and Welfare (hereinafter MOHW) were the major actors in the legislative process for bioethics issues from 2000 to 2003. Each attempt involved close-linked coordination among the actors regarding legislation timing and the bill's main contents. Nine of twelve attempts were presented by the National Assembly. In Korea, the first bill was proposed in 1997 by the National Assembly. However all the attempts have failed in legislation so far. Also, near the end of 1999, the National Assembly discussed revising the Biotechnology Promotion Act to add regulations concerning bioethics, but the legislation program did not pass. Three of twelve attempts were presented by the government. In the first step, MOST formed the KBAC to legislate the national regulations on cloning technology in Nov. 2000. The panel proposed legislation on domestic cloning practices and monitors bioethics laws. This was the first government bill.

In this process, scientists, industries, MOST, and the Committee of Science, Technology and Information and Telecommunication of the National Assembly form one policy community on bioethics issues. They shared the same basic value that is, that the improvement of biotechnology is more important than bioethics, and more scientists have to participate in the policy agenda setting process. By contrast, bioethicsts, NGOs, MOHW and the Committee of Health, Welfare of the National Assembly shared the reverse values. These differences of each policy community tended to lead to conflicts in legislation.

The contents of proposed bills

National Assembly bills

The first National Assembly bill on bioethics issues in Korea was proposed in 1997. It was one of the revised bills on the Genetic Engineering Promotion Law. The National Assembly proposed nine bills in total. The revised bill was debated four times; whereas, the new one was debated five times.

According to the first bill by the National Assembly, a National Bioethics Advisory Commission (NBAC) would be organized to deal with the ethics of biotechnology. Also, the bill disallowed any financial support of human cloning, directing the heads of national agencies not to allocate national funds and impose penalties for illegal actions. Through a detailed guideline, the second bill in 1998 would establish and organize a National Advisory Commission under the MOST to deal with the ethics and safety of biotechnology. Also, the bill disallowed any financial support of human cloning. Genetic or cancer researches should be allowed by the commission's review.

The third bill in 1999 was actually a new bill. The bill stated that government set up a Bioethics Commission under the Prime Minister, which would decide permitted research. At the end of the 15^th National Assembly session, three proposed bills were automatically abrogated because the term's of the assemblymen expired. Since then, there have been three attempts to legislate bioethics issues by the National Assembly to Nov. 2002. All were revised bills of the Biotechnology Promotion Act.

1^st Government bill by MOST (16)

MOST's bill was based on the KBAC recommendations. The major activities of the KBAC were as follows: (1) constitution: the commission is comprised of 20 experts from areas in the humanities and social sciences, science, biotechnology and medical recommended by academia, social and religious groups and MOHW; (2) mission: case study of systems in developed countries on securing ethics of biotechnology, design a protocol by collecting every opinion on the safety and ethics of biotechnology, and form a basic framework to make legislation for acquiring the ethics on biotechnology; (3) administration: 18 committee-meetings have been held, including an open forum and public hearing, and 16 subcommittee-meetings also have been opened. The web site (www.kbac.or.kr) has been opened to collect third party opinions and to arrange the open and on-line forum.

The KBAC's study dealt with (1) organizing a National Bioethics Advisory Commission (hereinafter referred to as NBAC) to deal with the ethics and safety of biotechnology; (2) planning for a counter plan applied to the domestic situation, a substantial guide and data to make relative legislations framed as being focused on this case; (3) examining thoroughly bioethics issues such as cloning of humans and animals; (4) also openly collecting the opinions of industry, academia, research institutions, social and religious groups, and academic fields of humanities and social sciences.

2^nd Government bill by MOHW (17)

The results of the Korea Institute of Health and Social Affairs (KIHASA) suggested the enactment of the Law on Biosafety and Ethics. The basic principle was that the Law on Biosafety and Ethics would require that the researcher and administrator follow clear and legal procedures and were responsible for regulating the development of biotechnology so as not to violate human dignity and not to infringe upon the safety of the human body. On the issue of human cloning, it suggested the following: first, a strict ban on human cloning; second, restriction of usage on a fourteen-day embryo for medical applications; third, restriction of embryo research to only the spare embryo; fourth, a strict ban on fertilization, fusion, or transplantation between human and animal; and fifth, in the case of embryo utilization, the granting of the right to make an informed decision.

Current legal status

To the present, all bills proposed on the subject are still under consideration.

MOST and MOHW agreed to submit a single bill ('initial draft') on bioethics issues to the National Assembly, in July 2002. In a meeting presided by OPC and attended by MOST and MOHW, the two ministries decided to draft a bioethics bill that stated the following: (1) responsibility of MOHW for legislation on bioethics with support of MOST; (2) ban of human cloning and sales of eggs and sperms, but permit research using adult stem cells and frozen embryos left over from infertility treatments; and (3) set up a Bioethics Commission, which will decide what research will be allowed case by case. This is the political compromise bill; that is, OPC took over both ministries' demands. This is one of the Korean-specific characteristics in policy-making process. The consensus on working out a unified bill on bioethics was expected to expedite its legislation at the National Assembly.

Most recently, the government (MOHW with MOST) has relaxed the rules proposed for cloning. The Ministry has eased restrictions on cloning research in the 'second draft' of proposed legislation sent to the National Assembly in Feb. 2003. The ministry's initial draft provided that proposed cloning experimentation would have to be approved by the NBAC and then be approved by the President. The new rules would allow the scientists to produce manmade organs and to develop methods of treating diseases by use of the cloning technologies. The ban on experimentation using a mixture of human and other animal cell tissue will stand.

The results of this research can serve as good example of legislation on bioethics issues. They can identify Korean-specific characteristics and serve as data for developing guidelines on bioethics issues in developing countries.

First, the importance of bioethics issues in Korea is increasing. The NBAC's jurisdiction was first designated to MOST, then the Prime Minister, and finally the President. Second, there were two types of bill initiators in Korea, the National Assembly and Government. There have been twelve attempts to legislate on bioethics issues from 1997 to March 2003. Each attempt has involved close-linked coordination among actors regarding legislation timing and the bill's main contents. Third, Korea has been very sensitive to international factors, such as political issues or R&D outputs, (for example, 'Dolly') in legislating bioethics issues. Fourth, in Korea, the Biotechnology Promotion Law was revised in the early stage, but the revision was slowly abandoned in favor of making a new law. Fifth, the bill involved a mixture of bioethics and bio-safety concerns. All contents of the twelve bills regarding bioethics issues were nearly the same. However, the implementation systems of these bills were different.

The implicit and explicit efforts by the Korean government have played an important role in the legislation process for bioethics issues. Active intervention by the Korean government will be interestingly viewed by other countries, because strong support and coordination by the government will be needed to effectively develop key technologies, especially in countries where these technologies are at an initial stage.

In future research, we would like to the use coordination concepts (18, 19, 20), resource dependence theory (21), and transaction cost model (22), as analytical frameworks in analyzing bioethics issues in Korea.

1 Choi, Kwan Yong, Kyung-Soo Hahm, Sang-Ki Rhee, and Moon Hi Han, "An Overview of Biotechnology in Korea", TIBTECH 17(1999), 95-100.

2 Ministry of Science and Technology, National Biotechnology Development Program -Biotech 2000- (Seoul: MOST, 1993).

3 http://www.cid.harvard.edu/cidbiotech/projects/ethical_consid.htm.

4 O'Neill Onora, "Stem Cells: Ethics, Legislation and Regulation", C. R. Biologies 326(2003), 673-676.

5 The President's Council on Bioethics, "Human Cloning and Human Dignity: An Ethical Inquiry" (Washington D.C., 2002).

6 http://www.moleg.go.kr.

7 Keefe, W. J., M. S. Ogul, The American Legislative Process (1993).

8 http://www.house.gov/.

9. http://www.senate.gov/.

11 Becker, Gerhold K., "Cloning Humans? The Chinese Debate and Why It Matters" , EJAIB 7(1997), 175-178.

13 Bonnicksen, Andrea L., Crafting a Cloning Policy: From Dolly to Stem Cell (Washington D.C.: Georgetown University Press, 2002), 30-53.

14 Debora Diniz, "New Reproductive Technologies, Ethics and Gender: The Legislative Process in Brazil", Developing World Bioethics 2(2002), 144-158.

15 Kim, Hoon-ki, A Study on the Policy Agenda Setting of Bioethics in Korea, Doctoral Dissertation, (Seoul: Korea University, 2001) (in Korean).

16 Ministry of Science and Technology, Study on Securing the Ethics of Biotechnology (Seoul: MOST, 2001) (in Korean).

17 Ministry of Health and Welfare, Development of the Infrastructure and Policies for Bio-safety and an Ethics Ensuring System (Seoul: MOHW, 2001) (in Korean).

18 Peters, B. Guy, "Managing Horizontal Government: the Politics of Co-ordination" Public Administration 76(1998), 295-311.

19 Challis, L. et al., Joint Approaches to Social Policy: Rationality and Practice, (Cambridge: Cambridge University Press, 1988), 106.

20 Jennings, E. T. and D. Crane, "Coordination and Welfare Reform: the Quest for the Philosopher's Stone" Public Administration Review 54(1994), 341-348.

21 Pfeffer, J., and G. R. Salancik, The External Control of Organization: A Resource Dependence Perspective (New York: Harper & Row, 1978).

22 Jones, Gareth R., Organizational Theory: Text and Cases (New York: Prentice Hall International, 2001).