On March 21st, 2019, the Executive Yuan approved the draft Amendment of the Statute for Industrial Innovation （“Amendment”）, offering the companies an additional 10-year tax incentive. The grace period will be ended on December 12, 2029. The Amendment aims to promote the circulation and utilization of the results of innovation, and give the Venture Capitalists and Angels more incentives to invest. The details of the incentives have already stated in the original statute, which is believed to have positive influence to the innovative circumstances. Within the realm of the extension, it includes:

（1） Article 10 and Article 12-1
The eligible companies may be credited against the profit-seeking enterprise income tax payable up to fifteen percent of the R&D expenses may by it in the then current year. Up to ten percent of the R&D expenses may be credited against the profit-seeking enterprise income tax payable by it in each of the three years following the then current year. For the individual, up to 200 percent of an individual’s R&D expenditures may be deducted from the amount of an individual’s taxable income up to the amount of the above revenue in that year.

（2） Article 12-2
According to the Fundamental Science and Technology Act, a domestic academic or research institution may transfer or license the intellectual property rights from its R&D to a company, and acquire the company shares, and distributes shares to the creators of the R&D achievements. In such situation, the creators may opt to exclude the new shares acquired from his/her income taxable in the year.

（3） Article 19-1
Where a company employee acquires stock-based employee compensation, the employee may opt to exclude up to an annual total of NT$5 million worth of the acquired shares from his/her annual taxable income as calculated at the market price prevailing in the year such shares are acquired or the year of the day the acquired shares become disposable.

（4） Article 23-1
Venture capital enterprises incorporated under the Limited Partnership Act may enjoy tax benefit if the venture capital enterprises use at least 50% of the aggregate capital contributions received in that year within the territory of Taiwan or invest funds in foreign companies conducting their substantial operational activities within Taiwan.

（5） Article 23-2
Angel investors also enjoy the tax incentives. If an individual invests more than NT $1 million in cash per year in a domestic startups incorporated for less than two years, up to 50 percent of the investment may be excluded from the individual’s consolidated income for the year in which the second anniversary of such shareholding falls.

In recent years, Taiwan government is proactively building a startup friendly ecosystem. The Statute for Industrial Innovation promulgated on May 12, 2010 with a goal to pursuing furtherance of industrial innovation, improvement of the industrial environment, and enhancement of industrial competitiveness. Hopefully, Taiwan will garner more long-term investments in innovative research and development, university and research organization collaboration, or innovation business development. Moreover, the Government hopes that the Amendment will attract global talents and retain local professionals.

On 2019 May 31, the Legislative Yuan approved the Telecommunications Management Act, in consideration of rapid changes in the telecommunications industry, the bill is designed to replace the Telecommunications Act.

Telecommunications Management Act aims to improve the development of the telecommunications industry, encourage innovative services, promote fair competition in the market and telecommunications infrastructure, build a secure and trustworthy public telecommunications network, ensure the rational use and efficiency of resources, enhance technology development and interoperability, and protect consumer rights.

In the personal privacy aspect, pursuant to Article 9 of the Telecommunications Management Act, the telecommunications enterprise shall ensure that the records are correct, kept for a certain period and shall be kept confidential for the communication records and accounting records of the telecommunications services used by users.

Otherwise, under a specific circumstance, the telecommunications enterprise shall provide communication records and communications user information to the government in accordance with The Communication Security and Surveillance Act.

According to the Act, the lawmakers defines communication record as "After the user or telecommunications user uses the telecommunication service, the telecommunications number, and communication of the sender and receiver generated by the public telecommunication network, records such as time, length of use, IP address, service type, mailbox or location information. Such records shall be provided to the extent that the technology of the public telecommunications network telecommunications performance allows".

The National Communications Commission （NCC） said that communication record is including data services and various types of value-added services, to meet the usage habits of the public nowadays. Furthermore, pursuant Article 9 （3） of the Telecommunications Management Act, NCC will set the procedures for the storage of communication records and accounting records, the operating systems for users to query, the charging methods and other related matters, to facilitate the compliance of the telecommunications industry.

The focus of the Act includes decreasing the market entry threshold and revising licensing system to the registration system; the telecommunications service can built or leased network, and the frequency can be shared; Encourage large telecom operators to invest in infrastructure construction and limit procurement and use of specific telecommunications equipment for national security. NCC said that the Telecommunications Management Act would help the release and development of 5G in the future.

NCC expects to complete the first wave of 5G license release in the first half of 2020. At present, after the list of announcements issued by the Executive Yuan, the 5G management rules will be revised as soon as possible, which is expected to take 6 to 8 months.

It is noteworthy that revision will be a significant change about telecommunication in the foreseeable future.

Precision medicine, also known as personalized medicine, sets out appropriate and accurate disease prevention, diagnosis, and treatment plans for the patients. Typically, the physician will analyze a patient’s genetic composition, background environment, lifestyle, or even take the ethnic into consideration. In recent years, the development of molecular detection application technology leads to the rapid development of precision medical molecular detection and services. Most precision medical molecular detection technics and services used by the laboratory are self-established, so it is called Laboratory Developed Tests and Services, LDTS.

Taiwan Food and Drug Administration （TFDA） published Directions for Registration and Monitoring of Laboratory Developed Test and Service for Precision Medicine Molecular Testing （“The Direction”）, which came into force on 31st, May 2019. The Direction aims to improve the quality of the service and testing of Taiwan's precision medical molecular testing laboratory. Through the laboratory certification system, the laboratory is encouraged to be self-discipline and the government can ensure clients receive reliable test results, and the related industries can be more compatible.

The laboratories who wish to apply for registration shall prepare the application form and relevant documents in accordance with the relevant application requirements and apply to TFDA with official documents. The laboratories that have been registered through the list must accept irregular inspections and reapply the extension of the registration period every three years in order to maintain the registration qualification.

The other main contents are as follows:

After the applicant submits an application, the TFDA shall conduct written reviews and field inspections. If the application is approved, it will be registered, listed and published on the TFDA website.

TFDA may inspect the laboratory's instruments, equipment, personnel, quality management, operating procedures, testing capabilities and testing records, and may request reports on the testing business of the listed registration scope.

If the laboratory violates the regulations that may not be circumvented, obstructed or refused to be inspected, or the registration application documents, test data, test results or other report materials are false, TFDA may suspend or cancel all or part of the registrations, and disclose such affairs on TFDA’s website.

RECENT DEVELOPMENTS

Abstract

According to the Precision Medicine Initiative, precision medicine is "an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person." U.S. Food and Drug Administration （FDA） believes that advances in genetic testing, such as NGS, can enable rapid, broad, and deep sequencing of a portion of a gene, an entire exome（s）, or a whole genome and may be used clinically for a variety of diagnostic purposes, including risk prediction, diagnosis, and treatment selection for a disease or condition. This article focuses upon the latest trends and developments of the U.S. policies on precision medicine and FDA's non-binding regulatory guidance, including Discussion Paper on Laboratory Developed Tests （LDTs）, and three copies of （draft） guidance: Infectious Disease Next Generation Sequencing-Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers, Considerations for Design, Development, and Analytical Validation of NGS-Based In Vitro Diagnostics （IVDs） Intended to Aid in the Diagnosis of Suspected Germline Diseases, and Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based IVDs. As to privacy protection and data security, this article introduces the White House's Precision Medicine Initiative: Privacy and Trust Principles, and Precision Medicine Initiative: Data Security Policy Principles and Framework and its Implementation Guide. Through the lens of these regulatory practice, this article generalizes some conclusions and shows possible direction for the Government of Taiwan and the industry.

Keyword: Precision Medicine, Next Generation Sequencing （NGS）, Molecular Diagnostics, Personalized Medicine

< Source: Tzu-Hsiung Wang, Policies and Legal Aspects of Precision Medicine: Focusing on the U.S. Regulation, Science and Technology Law Review Vol. 30 No. 12 p.24~47 >

Abstract

The automation, networking and digitalization of the transportation sector drive the development of autonomous driving and intelligent transportation system. Many countries have allowed autopilot road testing, and Germany cleared the way for its giant automotive industry to develop and test self-driving cars, when the upper house of its parliament approved a law setting out the conditions under which they could take to German roads. In addition to bringing more convenience and economic growth, the use of autonomous driving is accompanied by many legal issues. This article will introduce the development of German-related Autonomous driving policies, and further focus on ethical issues and Preventive measures, issues of personal protection and data utilization, and issues of civil liability attribution, and from foreign experience as a reference for R.O.C's legal development.

Keyword: Autonomous driving、Vehicle-to-everything （V2X）、Intelligent Transportation System

< Source: Chun-Liang Pan, Policies and Legal Aspects of Precision Medicine: Focusing on the U.S. Regulation, Science and Technology Law Review Vol. 30 No. 12 p.48~72　>