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Quarterly Issue Dec 2009 NO.04

LATEST LEGAL NEWS

THE EXECUTIVE YUAN HAS PASSED THE NATIONAL SCIENCE AND TECHNOLOGY DEVELOPMENT PLAN 2009-2012

To promote future technology development around the island, every four years the Government has proposed the National Science and Technology Development Plan (Herein referred to as "NSTDP"), NSTDP serve as a blueprint for the nation´s technology development policies over the following four years.

As the NSTDP 2005-2008 has come to an end, the Executive Yuan has passed the Draft of "National Technology Development Plan 2009-2012" (Herein refer to as "NSTDP 2009-2012") proposed by National Science Council. As the NSTPD support the nation´s development as a whole, the planning shall take social needs and resource distributions into considerations. According to the Fundamental Science and Technology Act, the planning of NSTDP involves discussion from Academia Sinica, the academic community, the industry and other social organizations, and was deliberated by the National Science and Technology Conference to reach a final decision. The NSTPD has provided an impetus for technology research and innovations as well as in policy making.

The NSTPD 2009-2012 will influence the development of emerging industries in the coming years, including biotechnology, tourism, green technology, healthcare, innovative culture and post-modern agriculture. Overall, the NSTPD 2009-2012 develops strategies to enhance living quality and develop local industry by supporting future development of science and technology. In the long run, NSTPD 2009-2012 will increase emphasis on innovative solutions, advanced technologies and lead the nation toward a sustainable development in the future.

For instance, among all the emerging industries, recently the biotechnology industry has been highly regarded as a growth generating and future promising sector, thus NSTDP has provided the biomedical industry with following measures in various aspects:

1. Ensure safety and better living quality:
Coordinating healthcare system to create an intelligent living environment, improving health risk evaluation to secure occupational health, setting up occupational injuries surveillance systems, and establishing a database to include all the information mentioned above.
2. Strengthen academic research and emphasize technology ethics:
Biotechnology raises important questions relating to ethics, safety, security, and other fundamental rights, thus NSTPD will promote researches in agricultural biotechnology and emerging infectious disease, to support innovative research in neuroscience, biomedical engineering, and bioformatics through interdisciplinary studies. Moreover NSTDP request the research institutions pay attention to technology ethics by setting up an Institutional Review Board (IRB).
3. Provide technical assistance to support the industry:
Develop global medical service by building related business models, marketing strategies, prospective mechanisms, and other kinds of innovative service.

NSTDP offers more than supporting the biomedical industry, the purpose of NSTDP is to ensure the best possible governance of research and development of technology; therefore, in the next four years, NSTDP 2009-2012 will implement a more direct, integrated and continuous technology policy, enhance collaboration between local regions, coordinate national resources, promote innovation and competitiveness, deepen research efforts to pursue sustainable development.

IMPROVING TAIWAN ENERGY SECURITY AND REDUCING GREENHOUSE GAS EMISSION BY LAUNCHING THE NATIONAL SCIENCE AND TECHNOLOGY PROGRAM-ENERGY (NSTPE)

The National Science Council has approved the National Science and Technology Program-Energy (NSTPE) as the Government will make an investment up to 3.03 billion to support this 5-year project. NSTPE focuses on reduce carbon dioxide and pollution, improving energy self sufficiency, develop energy industry and provide social and economic benefits to the people on the island.

When most countries around the globe focus on greenhouse gas emission and tackle issues of energy policy, here in Taiwan has followed the global trend of reducing greenhouse gas emissions by setting up reduction target. In the near future, Taiwan expect to reduce emission to 2008 levels during 2016-2020, reduce emission to 2000 level by 2025, and cut down 50% from 2000 level by 2050. Aside from carbon dioxide reduction, Taiwan emphasizes the importance of ensure energy independence and energy security.

As the implementation of NSTPE took place, the Government has made the first move by adjusting the energy supply structure, enhance energy efficiency, and support local industry. Overall, the NSTPE will establish energy technology strategy, support energy technology R&D, promoting energy efficiency by reducing emission, and offering relevant education program. To establish an energy technology strategy, there will be researches conducted in studying energy policy, new energy source, clean energy, and the energy industry to promote energy efficiency by cutting down emissions. As for developing energy technology, the NSTPE has selected solar power, wind power, biofuel, marine energy, hydrogen, nuclear and geothermal, other activities including research on carbon capture and sequestration, more plantations help to reduce global warming, and offer the education programs to strengthen basic research, with an effort to improve productivity, reduce cost and get ready for the application of future green technology, and transform the nation toward a low carbon economy.

At last, the National Science Technology Council indicated that the NSTPE involves the work of government, industry and academia. Major government agencies will participate in the project including MOEA (Ministry of Economic Affairs), Ministry of the Interior, Ministry of Education, Ministry of Transportation and Communications, EPA (Environmental Protection Agency), Atomic Energy Council, Council of Agriculture and National Science and Technology Council in support of the implementation of NSTPE. And local industry will also join NSTPE to carry out carbon reduction researches, including CPC Corporation, China Steel Corporation (CSC), Taiwan Power Corporation (Taipower), Taiwan Sugar Corporation (Taisugar), Taiwan Fertilizer Corporation (Taifer) and Formosa Plastic Group.

THE GOVERNMENT PLANS TO PROMOTE THE BIOTECHNOLOGY AND OTHER NEWLY INDUSTRIES BY INVESTING TWO HUNDRED BILLION

To expand every industrial scale, enhance industrial value, increase the value around the main industrial field, and to encourage the industrial development by government investments for creating the civil working opportunities to reach the goal of continuous economic development, the Executive Yuan Economic Establishment commission has expressed that, the government has selected six newly industrials including "Biotechnology", "Green Energy", "Refined Agriculture", "Tourism", "Medicare", and "Culture Originality" on November 19, 2009 to promote our national economic growth. The government will invest two hundred billion NT dollars to support the industrial development aggressively and to enhance the social investments from year 2009 to 2012. According to a Chung-Hua Institution for Economic Research report, the future growth rate will reach 8.16% after the evaluation, Hence, the future of the industries seems to be quite bright.

Currently, the government plans to put money into six newly industries through the existing ways for investment. For instance, firstly, in accordance with the "Act For The Development Of Biotech And New Pharmaceuticals Industry" article 5 provision 1 ",for the purpose of promoting the Biotech and New Pharmaceuticals Industry, a Biotech and New Pharmaceuticals Company may, for a period of five years from the time it is subject to corporate income tax, enjoy a reduction in its corporate income tax payable for up to thirty-five percent (35%) of the total funds invested in research and development ("R&D") and personnel training each year; provided, however, that if the R&D expenditure of a particular year exceeds the average R&D expenditure of the previous two years or if the personnel training expenditure of a particular year exceeds the average personnel training expenditure of the previous two years, fifty percent (50%) of the amount in excess of the average may be used to credit against the amount of corporate income tax payable. Secondly, according to same act of the article 6 provision 1 ", in order to encourage the establishment or expansion of Bio tech and New Pharmaceuticals Companies, a profit-seeking enterprise that (i) subscribes for the stock issued by a Biotech and New Pharmaceuticals Company at the time of the latter's establishment or subsequent expansion; and (ii) has been a registered shareholder of the Biotech and New Pharmaceuticals Company for a period of three (3) years or more, may, for a period of five years from the time it is subject to corporate income tax, enjoy a reduction in its corporate income tax payable for up to twenty percent (20%) of the total amount of price paid for the subscription of shares in such Biotech and New Pharmaceuticals Company; provided that such Biotech and New Pharmaceuticals Company has not applied for exemption from corporate income tax or shareholders investment credit based on the subscription price under other applicable laws and regulations. Thirdly, to promote the entire biotechnological industry development, the government has drafted the "Biotechnology Takeoff Package" for subsidizing the startup´s social investment companies which can satisfy the conditions to invest in "Drug discovery", "Medical Device" or other related biotech industries up to 5 billion with the capital invest in domestic industry over 50%, , with operating experience of multinational biotech investment companies with capital over 150 million in related industrial fields, and with the working experiences of doctor accumulated up to 60 years.

Additionally, the refined agriculture industry field has not only discovered the gene selected products, but also combined the tourism with farming business for new business model creation. According to the "Guidelines for Preferential Loans for the Upgrading of Tourism Enterprises" point 4 provision 1, the expenditure for spending on machine, instruments, land or repairing can be granted a preferential loan in accordance with the rule of point 6, and government will provide a subsidy of interest for loaning Tourism Enterprises with timely payments.

At last, Council for Economic Planning and Development also points out because most of technology industry has been impacted seriously by fluctuation of international prosperity due to conducting the export trade oriented strategy. Furthermore, the aspects of our export trade of technology industry have been impacted by the U.S. financial crisis and the economic decay in EU and US; and the industrial development seems to face the problem caused by over centralization in Taiwan. Hence, the current framework of domestic industry should be rearranged and to make it better by promoting the developmental project of six newly industries.

THE GOVERNMENT PLANS TO SPEED UP THE VACCINE DEVELOPMENT AND ESTABLISH PROMOTION SYSTEM TO RESPOND THE H1N1 EPIDEMIC SITUATION

H1N1 has caused death of one thousand people, hospitalization of twenty thousand people, and an estimation of over millions of infected cases. To control the H1N1 epidemic situation, US government has announced an emergency announcement that hospitals can set up the alternative Medicare facilities outside the building for speed up curing the H1N1 infected patients. The White House has pointed out that such announcement is a kind of precaution measures, not to respond to the current progressing of the H1N1 epidemic situation. Even though, the US government has tried to pacify people through such announcement, however, such action has causes people crowned in every vaccine injection station and also made the problem of slow vaccine manufacture to appear. In Taiwan, the H1N1 infection cases have accumulated up to 149, meanwhile, the death caused by H1N1 was up to 10. Hence, our nation has also showed highly concern about the vaccine supplement problem.

To overcome the increasing of H1N1 epidemic situation, one of famous biotech companies which is responsible for vaccine manufacture in Taiwan has announced that the homemade H1N1 vaccine named "An-Tin-Fu", has already been accomplished and the Clinical test will be initiated after the pass through the examination process by Bureau of Food and Drug Analysis. According to the "Guidelines for Drug Review and Approval" article 22, the clinical test will be implemented when applicant complies with the following rules, (1) has to comply with the Good Clinical Practice rules, and follows the central administration announced "Guidelines for Clinical test application" and the "Standard of Connection test", (2) should submit the Drug Clinical test plan with detail descriptions about the list of clinical test items and the application for central administration reviewing, (3) the planed clinical test will be implemented, after the central administration have reviewed the applicant´s examination plan and grants a permission, and should send all experimental data back for central administration checking. Moreover, the responsible biotech company has also expressed that the clinical test will be executed in September and if without any side effect, will be placed on the domestic market for remission of the H1N1 supplement problem.

Moreover, to assisted our nation to purchase the products to prevent the H1N1 virus infection, the Center for Disease Control has particularly authorized the Institute for Biotechnology industry to build up a "Rapid reviewing mechanism for epidemic prevention product" to ensure people health. Hence, the Center for Disease Control expresses that those products can be fast reviewed beforehand for confirming the associated fields, related administrations, and regulations. If such confirmation is required, the CDC will provide suggestions to file for reviewing or certification, firstly; if not required, the CDC will invite experts from the public health, epidemic disease, and clinical epidemic prevention fields to compose the reviewing team for product inspection from the technology, effectiveness, safety, and quality control of epidemic prevention aspects to ensure the safety, technicality, scientifically of product to fit in with the submitted data. Recently, the Institute for Biotechnology industry has initiated reviewing of the cases which were passed from CDC. The final reviewing results will be provided to consumer for epidemic prevention product selection.

However, to prevent the global H1N1 epidemic situation, the Government has tried to prevent it from multiple measures. And according to the "Communicable Disease Control Act" article 7 "Competent authorities shall conduct various investigations and implement effective preventive measures to control the occurrence of communicable diseases; when there are outbreaks or epidemics of communicable diseases, control them promptly to prevent further transmission"; and article 20, provision 1, "Competent authorities and medical care institutions shall stock sufficient quantity of various pharmaceuticals, devices and protective equipments for communicable disease control." Also, according to the article 26, "The central competent authority shall formulate procedures for reporting communicable diseases, methods of epidemiological investigations, and establish systems for surveillance, warning and disease control resources for epidemic conditions of communicable diseases. The implementation regulations shall be decided by the central competent authority". Therefore, it is important that not only to speed up vaccine developmental rate, and to cooperate with the people, but also have to establish the epidemic prevention mechanism and product surveillance system for controlling the domestic H1N1 epidemic situation.

THE EXECUTIVE YUAN APPROVED THE AMENDMENT OF THE CHILDREN AND JUVENILE WELFARE LAW

The Executive Yuan approved the amendment of the Children and Juvenile Welfare Law on December 24, 2009. The amendment would require the National Communication Commission to implement several mechanisms to protect children and juveniles from contents considered illegal under the proposed act.

The Children and Juvenile Welfare Law was promulgated on May 28, 2003. This law was enacted with the goal of protecting children´s and teenagers´ physical and mental health , safeguarding their rights and benefits as well as enhancing their welfare.

For the purpose of prohibiting the dissemination of inappropriate information via the Internet, based on Article 27 of the Children and Juvenile Welfare Law, the Government Information Office enacted Internet Content Rating Regulation in 2004. The Regulation classifies Internet content into restricted and non-restricted categories. The former category is inaccessible to people under 18, and the latter is accessible to the general public.

In order to keep minors away from accessing to unsuitable materials, Internet Content Providers (ICP) publishing restricted contents were obligated to post a label showing the rating on homepages or specific webpages on their website. However, the former Article 27 of the Children and Juvenile Welfare Law and the Internet Content Rating Regulation had been receiving strong criticisms about violating the right to freedom of expression. This amendment, therefore, is to make changes to the rating system under the Article 27 and input new ideas to protect children from unsuitable internet content.

It is hard to find a point of balance between the freedom of expression and the best benefit for children and juveniles. Although the "internet content" item would be deleted from Article 27 of the Children and Juvenile Welfare Law, the amendment would require Internet platform provider (IPP) to perform self-regulations and to adopt practical mechanisms to protect children and juvenile from the potential risks of using internet. IPPs that fail to follow the new requirements could be fined between NT $ 60,000 and NT $ 300,000 in the future.

TAIWAN MOBILE´S INTENTION TO MERGE WITH KBRO IS APPROVED BY FTC

With respect to the case where Taiwan Mobile Co., Ltd., Taiwan´s second largest telecom service carrier, filed for the merger with Kbro Co., Ltd., the Fair Trade Commission (hereinafter "the FTC") of Taiwan has decided on December 2, 2009 that the merger is not prohibited pursuant to Article 12 of the Fair Trade Act. However, the FTC has also decided to attach some certain conditions to the merger.

The FTC stated that the merger would have little impact on mobile and fixed communication sectors but may limit competition in the markets of cable TV and satellite TV broadcasting. Meanwhile, the merger is likely to facilitate the competition in the internet sector. After careful review, FTC found that the merger will make a breakthrough on the market of fixed network, improving the competition in the broadband internet sector. The merger will also promote the development of cable TV digitalization, providing more options to consumers and facilitating the development of video media. In addition, the merger will integrate all the resources in mobile, broadband and cable TV sectors, providing innovative digital convergence services while promoting the development of digital convergence industry as well.

In the markets of cable TV and satellite TV broadcasting, Taiwan Mobile and its subsidiaries have been raised concerns about being engaged in abusing their market power, leading to difficulty of access to these particular markets. However, as the FTC has considered the advance of communication technology, the digitalization of cable TV, the participation of multimedia content distribution service by fixed network providers, and the regulations regarding the digital convergence, the concerns will be eased off to a certain extent. Moreover, while reviewing the merger case, the FTC also refers to opinions from relevant authorities, experts and industries, and most of them hold positive views towards the merger.

The FTC holds the opinion that, as the digital convergence keeps developing, the borders among several communication broadcasting related industries are becoming vague. The part of the merger which raises concerns of competition restraint is the markets of cable TV and satellite TV broadcasting. Since the concentration ratio of these two markets is relatively low compared to that of the fixed network and internet sector, the predominant company of the fixed network industry will be able to get involved in the video media related industry, which will largely influence the market structure of communication broadcasting industry after convergence. Based on the current market structure and the future development trend, the only way to ensure the competition after digital convergence is to encourage relevant industries to change the competition pattern from competition in certain sectors to competition in the platform of communications infrastructure.

Having taken the legal framework, relevant market structure and competition, future development trend and competition after digital convergence into consideration, the FTC has made the final decision that the overall economic benefit of the merger outweighs the disadvantages resulted from competition restraint and therefore approved the deal. However, according to Article 12, Paragraph 2, the FTC has also imposed structural and behavioral restraints in order to reduce the possibility of competition restraint resulted from the merger.

RECENT DEVELOPMENTS

A STUDY ON THE CONCEPT OF SIGNIFICANT MARKET POWER IN EU ELECTRONIC COMMUNICATIONS LAW

This article examines several issues of significant market power (SMP) in EU electronic communications law. Firstly, it defines the relevant product and service markets within the electronic communications sector and analyzes ex ante regulation on specific markets by three-criteria test. Secondly, it discusses how to determine SMP in specific markets. By examining cases and theories related to SMP in competition law under the EU regulatory framework for electronic communications networks and services, it tries to clarify the concept of SMP in its three categories of dominance position, joint dominance, and monopoly leveraging respectively. By view of share competence and principle of subsidiary in EU law, it points out how member states and EU cooperate by applying the Article 7 procedure. Finally, it argues that the introduction of asymmetric regulation on "Dominant Market Player" in the Telecommunication Act of Taiwan is controversial and problematic. Accordingly, the draft of "Communications Regulator Act" proposed by the National Communications Commission has adopted several provisions in order to cope with the significant market position problems. As conclusion, it suggests lessons that may be learned from the EU electronic communications legislation and its experience.

Keyword: European Union, EU Electronic Communications Law, Significant Market Power, Significant Market Position, Telecommunications Law.

<Source: Irving Hao-Chun Tai, "A Study on the Concept of Significant Market Power in EU Electronic Communications Law", Science & technology Law Review Vol. 21 No. 12, December 2009, p.p. 9-32>

KEY ISSUES OF JOINT R&D - TALK ABOUT SHARING & EXPLOITATION OF R&D RESULTS FROM EU FP7 EXPERIENCE

In recent years the rise of nanotechnology research and development to make use of the progress of many revolutionary innovations in many industries. While the nanotechnology industry for innovation and business opportunities brought about, but also for the relative health of human society and the environment of health system hazards, lead to many doubts about the potential risks. Order to lay the industrial operation and maintenance of the people's welfare level, must be planning to develop the national system of legal norms. However, many emerging technologies and industries just sprouting, and industrial developments in order to be are not clear, if the start to be a peremptory norm of limitations may restrict the future development. But it should take into account the well-being of the people, so many "industry self-regulation" appears timely, appropriate to this stage has become the solution. U.S. nanotechnology industry, has invested many resources to promote. In this paper, in particular the United States of the entire collection of practical development and selection mechanism into nano-liability insurance , and the promotion of Voluntary Reporting Program , related research and analysis, , and make summarized the views of a comprehensive proposal.

Keyword: Joint R & D¡FOwnership of R & D Results¡FJoint Ownership of Intellectual Property¡FBackground¡FUtilization of R & D Results

<Source: Ding-Yu Yeh, "Key Issues of Joint R&D - Talk About Sharing & Exploitation of R&D Results from EU FP7 Experience", Science & technology Law Review Vol. 21 No. 12, December 2009, p.p. 33-45>

LEARNING FROM THE EXPERIENCE IN OTHER COUNTRIES TO DISCUSS THE ADJUSTMENT OF MEDICAL REGULATIONS FOR DEVELOPING TELEHEALTH IN TAIWAN

In Taiwan, the administrative interpretations on Article 11 of the Physician Act define the physician's duty of diagnosing in person that a physician must diagnose patients at presence (face to face). This may bar the implementation of telehealth from involving practice of medicine, prescribing medicine online as well. And the substantial function of telehealth for providing medical services would be restricted.In view of this, this article primarily introduce the experience of the United States and Japan on promulgation of new regulations, revision of existing laws, and administrative interpretation to adapt legal environment to the development of telehealth. Then, it also compare the unsolved problems about related medical regulations in Taiwan to other countries mentioned above. Finally, several suggestions are tried to propose to promote further application of telehealth in Taiwan.

Keywords: telehealth¡Btelemedicine¡Bpractice of medicine¡Bphysician's duty of diagnosing in person¡Bface to face

<Source: Naiwen Chang, "Learning From The Experience In Other Countries To Discuss The Adjustment Of Medical Regulations For Developing Telehealth In Taiwan", Science & technology Law Review Vol. 21 No. 12, December 2009, p.p. 46-59>

THE ANALYSIS OF LEGAL ISSUES IN TELEHEALTH

Taiwan has one of the fastest aging populations worldwide, which has formed a great challenge for health and social providers. Telehealth seems the best solution of this issue. Lately, worldwide professional reports have proved that telehealth can increase medical quality by efficiently monitoring the patients' situation and decrease costs by cutting off unnecessary clinic visits. Thus, Taiwan's government proceeds the "Telehealth" project in 2006. However, the legal environment of telehealth in Taiwan is not comprehensive. Incumbent medical laws and regulations limit the development of telehealth industry. Therefore, this article will analyze the legal issues of telehealth, and propose an appropriate legal structure for telehealth.

Keywords: telemedicine¡Btelehealth¡Bhealth reimbursement¡Bhealth information privacy¡Btelehealth lice

<Source: Pei-Shan Sung, "The analysis of legal issues in Telehealth", Science & technology Law Review Vol. 21 No. 11, November 2009, p.p. 19-33>

EXPLORING PROACTIVE APPROACH FOR NANOTECHNOLOGY-THE DEVELOPMENT OF GREEN NANOTECHNOLOGY IN THE US

The risk of nanotechnology has confound the industry for a long period of time, these risks may change along the product life cycle and exist in every phase of the life cycle as it movers from research, manufacture, and enters the market. So how to handle such issue properly has become the key to success for the industry. The article herein introduces "Green Nano" proposed by Woodrow Wilson International Center Scholars in April, 2007. "Green Nano" demonstrates green nanotechnology by taking a life cycle approach, as it influences the design of nanomaterial and nanoproduct to minimize negative impact on the environment during the manufacture process. Green Nanotechnology has the potential to minimize and eliminate risk proactively to prevent waste, pollutions and further injuries.

Meanwhile, the academia has begun conducting green nanotechnology research, as it works on implementing the life cycle approach by incorporating nanotechnology with green chemistry or green engineering to reduce waste and pollution. Furthermore, the Congress has also take action to support the development of green nanotechnology, by passing the National Nanotechnology Initiative Amendments Act of 2008 and the National Nanotechnology Initiative Amendments Act of 2009. Both amendments support the development of clean, benign and environmental-friendly nanomaufacturing technology and commercialization. Besides the support from the academia and the Congress, green nanotechnology has also gain support from the industry, including international corporations and small-and-medium enterprises from the US. Therefore, the article will be discussing the development of the green nanotechnology in the US, with the recent legislation of the National Nanotechnology Initiative Amendments Act of 2008 and the National Nanotechnology Initiative Amendments Act of 2009, in order to provide suggestions for future planning and policy-making on nanotechnology development in Taiwan.

Keywords: Environment, Green Nano, Green Nanotechnology, Nanomanufacturing and Commercialization, National Nanotechnology Initiative Amendments Act of 2008, National Nanotechnology Initiative Amendments Act of 2009

<Source: Hsiao-Lan Hsu, "Exploring Proactive Approach for Nanotechnology-The Development of Green Nanotechnology in the US", Science & technology Law Review Vol. 21 No. 11, November 2009, p.p. 34-50>

THE PLANNING OF INTEGRATED ORGANIZATION FOR VALUE-ADDED DISTRIBUTION OF INTELLECTUAL PROPERTY

According to the resolution in 8th National Congress on Science & Technology, the government will build an organization of technology transfer for enhancement of the international competitiveness. The article discusses how to achieve this goal base on similar international examples and address some practical suggestions, including collecting the results of government-funding R&D projects, establishing a National Technology Transfer Center, several Regional Technology Transfer Centers and strengthening our operational mechanism of technology transaction.

Keywords: R&D results, intellectual property rights, intellectual property management, technology transfer, technology transfer organizations

<Source: Chun-Chieh Lai, "The planning of integrated organization for value-added distribution of intellectual property", Science & technology Law Review Vol. 21 No. 11, November2009, p.p. 51-62>

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