China Sets Safety Regulation on Genetic Engineering in Agriculture. Genetic engineering in agriculture

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POLICIES & REGULATIONS China Sets Safety Regulation on Genetic Engineering in Agriculture Genetic engineering in agriculture is becoming increasingly important in China.

The objective of this regulation is to promote genetic engineering research and development in agriculture, strengthen safety administration, and prevent possible hazards caused by genetically

1 POLICIES & REGULATIONS China Sets Safety Regulation on Genetic Engineering in Agriculture Genetic engineering in agriculture is becoming increasingly important in China. In view of this, the Chinese Minister of Agriculture, Mr. Liu Jiang, has recently approved the Safety Administration Implementation Regulation on Agricultural Biological Genetic Engineering. The objective of this regulation is to promote genetic engineering research and development in agriculture, strengthen safety administration, and prevent possible hazards caused by genetically engineered organisms and their products to human health and the environment. The Ministry of Agriculture has established a Safety Administration Office to implement the regulation. In addition, a Safety Committee has been set up to handle the safety evaluation of research, pilot production, environmental release, and industrial production of genetically engineered agricultural organisms and their final products throughout the country. The regulation can be summarized as follows: 1. It applies to agricultural organisms (including plants and animals in agriculture, plant-related microorganisms, veterinary microorganisms, aquatic animals and plants) whose genome constitution has been changed by using genetic engineering technologies. 2. It applies to all agricultural genetic engineering work in progress including research, pilot production, environmental release or industrial production of genetically engineered organisms. The relevant principal investigator or product developer must submit an application in accordance with this regulation. 3. When any foreign companies or institutions intend to undertake the pilot production, environmental release or industrial production of genetically engineered organisms, the applicant must report to the authorities concerned in China together with the certificate and related documents which had allowed them to conduct similar research or production in their own country. They are not allowed to engage in the above-mentioned activities until their application has been approved by the Chinese Ministry of Agriculture. Companies and institutions in China must report to the authorities concerned for safety evaluation and approval before they sign any agreement with foreign partners to introduce genetically engineered organisms into China. 4. According to potential risk levels, genetic engineering work is divided into four safety classes: Safety class I: No threat to human health and the ecological environment. Safety class II: Low-level risk to human health and the ecological environment. Safety class III: Intermediate-level risk to human health and the ecological environment. Safety class IV: High-level risk to human health and the ecological environment. 5. The safety class of a genetically engineered organism is determined by the safety class of the recipient organism (organisms into which recombinant DNA molecules will be introduced) as well as the impact type and level of the genetic manipulation on the recipient organism. 6. Institutions should formulate safety control measures and emergency measures to prevent the occurrence of accidents in accordance with the safety class of the genetic engineering work. Safety control measures include 3

2 POLICIES & REGULATIONS 4 physical control, chemical control, biological control, environmental control, scale control, etc. These institutions should also work out relevant safety measures to handle waste materials according to the safety class. 7. Institutions must file applications to relevant administrative departments at different levels according to the safety class of the genetic engineering work. Legal representatives of these institutions will be in charge of setting up a safety administration group for their institution. They will also be responsible for the examination of the application materials submitted by the institutions and to provide relevant safety instructions. 8. The Ministry of Agriculture will process applications twice a year. The deadlines for submission are 31 March and 30 September each year. The applicant should fill in the relevant forms, as stipulated in the regulation, and submit them to Project Division, Scientech and Patent Development Service, Ministry of Agriculture, No. 11, Nong Zhan Quan Nanli, Beijing , China. 9. Institutions currently responsible for the production and sale of genetically engineered agricultural organisms or their products, and institutions which have entered into pilot production, environmental release or industrial production of genetically engineered agricultural organisms or their products before the release of the regulation, have to file an application to the Ministry of Agriculture before 30 September For all genetically engineered organisms and their products which have been approved for pilot production and environmental release, a report has to be submitted to the Ministry of Agriculture not later than three months after the testing. The report will have to include any unusual findings or circumstances (such as accidents, large numbers of the organisms dying or escaping, unexpected effects on non-target organisms, the performance of the organism differing from the description upon application). Under such circumstances, necessary safety measures should be taken and the Ministry of Agriculture should be notified immediately. For approved commercial production, the applicant should also report to the Ministry of Agriculture immediately of any unexpected changes. 11. Relevant administrative departments will issue warnings, or stop operations (depending on the nature of the violation) if a company or institution begins a genetic engineering project without approval; uses equipment that does not fit in with the regulations; does not comply with required safety control measures; or violates any other rule stipulated in the regulation. Source: Ministry of Agriculture, China Healthcare Sector of Singapore To Expand Abroad The healthcare sector of Singapore has been identified as a high growth area by the Trade Development Board (TDB), with great potential for expansion into the region. Given that 60% of the world s population live in Asia, amounting to 3.2 billion people, the potential market is staggering. Emerging Trend The healthcare sector in Singapore is one of the region s most advanced, both in terms of technology and medical expertise. Due to increasing affluence and a growing middle class, people from the region are more frequently seeking medical treatment in Singapore. According to TDB board member and Raffles Medical Group CEO, Loo Choon Yong, people travel to Singapore from the region for treatment and if the healthcare providers could export their services, they would capture the growing middle classes. In addition, the regional healthcare markets are increasingly opening up for foreign investment. In recent years, there are three significant trends that have emerged in the industry: An increasing number of local healthcare providers are venturing into the regional markets to set up hospitals and other healthcare facilities. Such companies include Parkway Holdings, Beng & Ooi and HMI-Balestier. The limited growth potential in the local market coupled with the increasing demand for modern private healthcare infrastructures in the region has provided the impetus for these companies to venture abroad. Increasingly, non-healthcare companies are diversifying into the healthcare business. These include property-based companies such as Pontiac Land and DBS-Land as well as other companies like Singapore Technology Precision Engineering. Healthcare companies from the US and Europe are coming to Singapore to explore possibilities of collaboration with local healthcare providers, in order to jointly venture into the regional markets. TBD s Strategy for Promoting the Healthcare Sector in the Region TDB plays the crucial role of both looking for specific investment opportunities in the regional markets for local healthcare providers, and linking them with established foreign healthcare companies in order to help them sharpen their competitive edge. In line with this purpose, TDB organizes sourcing missions to the US, Europe and Australia as well as to new and emerging markets in the region. In March 1997, a trade mission was undertaken by TDB together with 11 companies to Indonesia. Further missions to the Philippines, India and China have been planned for the next two years. Source: Trade Development Board, Singapore

3 Shanghai s Biomedical Industry: Strategy for Growth The biomedical industry in Shanghai has achieved rapid growth over the last five years and has now been identified by the Shanghai government as the preferred new high technology industry. It is targetted to become the pillar industry of Shanghai by the turn of the century. To achieve this goal, development of the biomedical industry has now been placed under the office of the mayor of Shanghai. Over the last three years, Shanghai has initiated a series of national level pioneer projects involving a group of top academicians and scientists. At the same time, research institutes and higher institutions have successfully commercialized selected biomedical projects through joint ventures such as those between the Institute of Biochemistry and the Dongya Group and the Institute of Cell Biology and a Philippine company. Under a golden triangle plan, the area surrounding the Jing River Canal, River Jiang and the Pudong New Area (named the Zhangjiang High-tech Park and the Jianqioa Export Process Park ) has been designated as the triangular growth region of the city s biomedical research and industry. The aim is to integrate all development processes as well as to provide research and development services to all parts of China. In 1995, six Shanghai-based medical enterprises ranked among the top 50 medical enterprises in China. In particular, the joint venture company between Shanghai s Sanwei Pharmaceutical Company and the Swiss Roger Company was listed on the Hong Kong Stock Exchange. Sanwei is now the largest pharmaceutical enterprises in Shanghai with more than ten subsidiaries. Other significant projects include the research into streptosepticemia by the Shanghai University of Medicine, the human growth factor by the Institute of Cell Biology, and the epidermal growth factor and GM-CSF by the Institute of Biochemistry. Together with other projects undertaken by the Institute of Medicine and the Second University of Military Medicine, these have generated billions of yuan which were ploughed back for developments along the Pudong and River Song area. During the last three years, efforts have also been directed at improving the technological design, as well as to the remaking of biomedical products. In 1995, there were 23 products worth 50 million yuan (US$6 million) and three products worth more than a billion yuan (US$120 million). In 1996, the number of products with sales potential of 50 million yuan rose to 30. Over the last three years, a total of 90 products have been developed involving an investment of 2.98 billion yuan (US$360 million). When complete, these will be worth a sum of 9.38 billion yuan (US$1.1 billion). 5

POLICIES & REGULATIONS Biotechnology in Singapore Developing a Regional Hub for Biotechnology R & D and Manufacturing Singapore accords a high priority to the development of the biotechnology

4 POLICIES & REGULATIONS Biotechnology in Singapore Developing a Regional Hub for Biotechnology R & D and Manufacturing Singapore accords a high priority to the development of the biotechnology cluster, which comprises the key sectors of pharmaceuticals, healthcare, agriculture and food. R & D INFRASTRUCTURE In the mid-1980s, Singapore began the transformation of its low-cost, manufacturing-based economy to one which is high value-added, high technology based. In keeping with this progression, the National Biotechnology Program, which details the strategic action plans for the development of the biotechnology industry, was launched by the Economic Development Board (EDB) in Biotechnology in Singapore Under the National Biotechnology Program, the key sectors in the biotechnology cluster identified for priority development are pharmaceuticals, healthcare, agriculture and food. The Biotechnology Program is complemented by the National Science and Technology Plan, launched in 1991 by the National Science and Technology Board (NSTB). This scheme provides a strategic framework for the development of high tech industries in the country, of which biotechnology is one. The objective is to develop Singapore into one of the world's leading biotechnology hubs. Total Business Support The linchpin of the National Biotechnology Program is the total business plan, which comprises four elements - research and development infrastructure; TOTAL BUSINESS SUPPORT MANUFACTURING INFRASTRUCTURE INDUSTRIAL LAND AND FACILITIES FINANCIAL OPPORTUNITIES manufacturing infrastructure; enhanced business infrastructure; and financial incentives. Research and Development Infrastructure The Singapore government recognizes the need to develop world-class capabilities in research and development in order to stay ahead of the competition in the high technology arena. It invests heavily in new national research institutes, in order to build up a core competence in biotechnology and to provide skilled manpower for the industry. Under the 1991 National Science and Technology Plan ( ), it invested a total of S$2 billion (US$1.4 billion) in R & D and is doubling its commitment to science and technology to S$4 billion (US$2.8 billion) over the next five years. National Research Institutions and Centres During the period 1984 to 1995, the following national research institutes and centres were set up (the year in which they were established is shown within brackets): Institute of Molecular and Cell Biology (1984) Bioprocessing Technology Centre (1990) Food Biotechnology Centre (1991) Bioscience Centre (1992) National University Medical Institutes (1994) Institute of Molecular Agrobiology (1995) Bioinformatics Centre (1996) Centre for Information Enhanced Medicine (1997) Together with the two universities, the National University of Singapore and the Nanyang Technological University, these centres of competence form the national resource of technology from which the industry can draw support. The research institutes and centres support technology development within the industry through transfer of 'know-how', and through co-developing of technology with the industry as well as training of R & D manpower. 6

Photograph: Courtesy of the Singapore Tourist Promotion Board The research institutions are encouraged to pursue international links with market-driven technology development.

Within a year of its establishment, the IMA has secured a fiveyear research contract with Delta & Pine Land, a major US cotton seed company, to work on cotton biotechnology.

5 Photograph: Courtesy of the Singapore Tourist Promotion Board The research institutions are encouraged to pursue international links with market-driven technology development. For example, the IMCB has entered into various partnerships with R & D companies including Boehringer Mannheim and Glaxo Wellcome. Within a year of its establishment, the IMA has secured a fiveyear research contract with Delta & Pine Land, a major US cotton seed company, to work on cotton biotechnology. It has also forged strategic alliances with CIRAD, a French research organization and more recently with the Chinese Academy of Sciences and Chinese Ministry of Culture to co-develop and commercialize research in agrobiotechnology. Skilled Manpower Singapore has one of the best workforces in the world, a key reason being that it has an excellent, bilingual education system to train its workforce. The National University of Singapore, the Nanyang Technological University and the various research institutes provide training from undergraduate to postdoctoral level. Project-based training in strategic fields is available at the various research centres, while the polytechnics conduct four-year courses in biotechnology and other related areas to train technical personnel for employment in the industry. Various other schemes are also in place to ensure a steady flow of trained personnel to the industry To continue to build up a local pool of researchers, science and engineering students are encouraged to pursue postgraduate studies in relevant research areas, and to undertake research projects at the university and at research centres The EDB operates an International Manpower Program to help companies attract people with critical skill sets from abroad to work in Singapore The NSTB offers scholarships to foreign students to undertake postgraduate studies in the local universities with a view of taking up a R & D career in Singapore The NSTB also initiates and administers a series of other programs to facilitate the training and recruitment of R & D manpower. Manufacturing Infrastructure Singapore has a well established infrastructure to support product development. The Singapore Productivity and Standards Board, an accredited standards authority, issues ISO 9000 certification to diagnostics companies operating here. Leading pharmaceutical companies are already operating at facilities in Singapore that meet global GMP (Good Manufacturing Practice) requirements for the manufacture of bulk active ingredients and healthcare products. Singapore is now a signatory to the World Intellectual Property Organization, the Paris Convention, the Budapest Treaty and the Patent Cooperation Treaty. A National Patent Information Centre has been set up as a one-stop resource centre. Recently, the World Competitiveness Yearbook 1996 has ranked Singapore as number five in intellectual property protection, ahead of many other developed countries. The Ministry of Health is in the process of setting up a new Drug Unit. This is a significant step in the development of Singapore's drug approval capabilities to support R & D into pharmaceuticals in Singapore. Singapore is also host to the newly formed APEC Coordinating Centre for Good Clinical Practice, launched in April This regional centre brings APEC countries together to address good 7

6 POLICIES & REGULATIONS clinical practice needs. These efforts will fulfill a critical role by bridging the gap between research and commercial development of therapeutic drugs. The centre will also support pharmaceutical, biotechnology and healthcare companies in their clinical development efforts in Singapore and the region. Medical researchers in Singapore are being trained to conduct clinical practice trials that meet global standards through a Good Clinical Practice (GCP) program initiated by the NSTB and NUS. The program involves a transfer of technology from Quintiles Transnational Corporation, a leading contract organization. The ability to conduct good clinical trials would make Singapore more attractive as a centre to develop new drugs for commerce. Under a joint venture agreement signed between Eli-Lilly, NSTB and NUS in May 1996, the first Clinical Pharmacology Centre in the Asia-Pacific region was established in Singapore. This centre will provide the critical infrastructure to support clinical research and drug development to address diseases endemic in the region. Industrial Land and Facilities The ability to start up rapidly is one of the many reasons that companies choose to locate themselves in Singapore. Prepared industrial lands, ready-built factories, research and development facilities and business parks in Singapore count among the world's best. The Singapore Science Park, as a major industrial park, has fully equipped sites and ready-built units for companies to undertake R & D activities. Being located in close proximity to the university and to research institutes, industry and government agencies, this park provides a conducive environment for R & D activities. Enhanced Business Infrastructure The Agri-Bio Park (APB), a new tenhectare industrial park located at the Lim Chu Kang site, will be operational by the end of September Managed by the Primary Production Department, the APB will be a centre for high-tech agriculture companies undertaking research and product development, and the setting up of demonstration farms. Apart from the necessary utilities and a sound telecommunications infrastructure, the park will also have central facilities for laboratory services and waste disposal. Another 50 hectares of industrial park, called the Pharma Zone, is being developed at Tuas to serve as a centre for pharmaceutical, biotechnology and healthcare manufacturing projects. Companies located in this zone will benefit from the synergies and cost-sharing opportunities in areas such as common utilities and waste treatment facilities. Financial Opportunities There are substantial financial schemes provided by the Singapore Government to companies prepared to site biotechnologyoriented R & D and manufacturing activities in the country. Financial incentives are available to encourage the development of R & D capabilities as well as to support specific R & D projects. Among others, the NSTB administers the Research and Development Assistance Scheme (RDAS) and the Research Incentive Scheme for Companies (RISC), while the EDB administers the Innovation Development Scheme (IDS). In addition, the EDB administers various tax incentives which can be offered to viable projects, allowing them to maximize their profits and returns on investment. Examples of these incentives are Pioneer Status, Development and Expansion Incentive, Investment Allowance and Double Deduction on R & D. Conclusion Singapore, which is home to 5000 international companies and regional base to 1800 MNCs (over 200 of which are Fortune 500 companies), is an ideal business hub. It is strategically located in Asia, with easy access by air and sea. Changi International Airport has been voted the best airport for the ninth consecutive year, while the sea port ranks as one of the busiest ports in the world. It has excellent telecommunications facilities and is served by over 450 banks and financial institutions. For the second year running, Singapore has been ranked as the world's most competitive country by the Swiss-based World Economic Forum in their 1997 Global Competitiveness Report. Under the 1991 National Science and Technology Plan, the government invested a total of S$2 billion in R & D and doubling its commitment to S$4 billion over the next five years. There are now 80 companies in the pharmaceutical, biotechnology and healthcare cluster in Singapore. The major ones with manufacturing and R & D operations in the pharmaceutical sector include Glaxo- Wellcome, SmithKline Beecham, Rhone- Poulenc Rorer, Kaneka and more recently, Schering Plough; in the biotechnology sector, the major companies include Rhone Merieux, Genelabs Diagnostics, Saliva Diagnostic System and Specialty Laboratories Asia; and in the healthcare sector, the major companies include Baxter, Becton Dickinson, Siemens, Perkin Elmer, Dornier MedTech, Ohmeda and the West Company. With its excellent business infrastructure, long term commitment to developing world-class R & D capabilities, hardworking and highly educated workforce and stable government, Singapore is well positioned to become the regional hub for biotechnology R & D and manufacturing. Lim Sook Cheng 8

THE IMPACT OF ADR REPORTING ON SAFE USE OF MEDICINES IN SINGAPORE THE 10-YR EXPERIENCE

THE IMPACT OF ADR REPORTING ON SAFE USE OF MEDICINES IN SINGAPORE THE 10-YR EXPERIENCE Dr John Lim Dr John Lim Chief Executive Officer Health Sciences Authority Singapore 13 October 2006 Ms Chan Cheng