Adopting Flexible Mechanism to Promote Public Procurement of Innovation—the Amendment of Article 27 of the Statute for Industrial Innovation

Adopting Flexible Mechanism to Promote Public Procurement of Innovation—the Amendment of Article 27 of the Statute for Industrial Innovation

I.Introduction

  To further industrial innovation, improve industrial environment, and enhance industrial competitiveness through a systematic long-term approach, the Statute for Industrial Innovation (hereinafter referred to as the Statute) has been formulated in Taiwan. The central government authority of this Statute is the Ministry of Economic Affairs, and the Industrial Development Bureau of the Ministry of Economic Affairs (henceforth referred to as the IDB) is the administrative body for the formulation of this Statute.  Since its formulation and promulgation in 2010, the Statute has undergone four amendments. The latest amendment, passed by the Legislative Yuan on November 3, 2017, on the third reading, is a precipitate of the international industrial development trends. The government is actively encouraging the investment in industrial innovation through a combination of capital, R&D, advanced technologies and human resources to help the promotion of industrial transformation, hence this large scale amendment is conducted. The amendment, promulgated and enacted on November 22, 2017, focuses on eight key points, which include: state-owned businesses partaking in R&D (Article 9-1 of the amended provisions of the Statute), the tax concessions of the limited partnership venture capital businesses (Article 2, Article 10, Article 12-1 and Article 23-1 of the amended provisions of the Statute), the tax concessions of Angel Investors (Article 23-2 of the amended provisions of the Statute), applicable tax deferral of employees' stock compensation (Article 19-1 of the amended provisions of the Statute), tax deferral benefit of stocks given to research institution creators (Article 12-2 of the amended provisions of the Statute), the promotion of flexible mechanism for innovation procurement (Article 27 of the amended provisions of the Statute), the establishment of evaluation mechanism for intangible assets (Article 13 of the amended provisions of the Statute), and forced sale auction of idled land for industrial use (Article 46-1 of the amended provisions of the Statute).  This paper focuses on the amendment of Article 27 of the Fourth Revision of the Statute, which is also one of the major focuses of this revision—promoting flexible mechanism for innovation procurement, using the mass-market purchasing power of the government as the energetic force for the development of industrial innovation. 

II.Explanation of the Amendment of Article 27 of the Statute

1.Purposes and Descriptions of the Amendment of Article 27 of the Statute

  The original intent of Article 27 (hereinafter referred to as the Article) of the Statute, prior to the latest amendment (content of the original provisions is shown in Table 1), was to encourage government agencies and enterprises to give a priority to using green products through the "priority procurement" provisions of Paragraph 2, which allow government agencies to award contracts to green product producers using special government procurement procedures, so as to increase the opportunities for government agencies to use green products, and thereby promote the sustainable development of the industry. In view of the inherent tasks of promoting the development of industrial innovation, and considering that, using the large-scale government procurement demand to guide industrial innovation activities, has become the policy instrument accepted by most advanced countries, the IDB expects that, with the latest amendment of Article 27, the procurement mechanism policy for software, innovative products and services, in addition to the original green products, may become influential, and that "innovative products and services" may be included in the scope of "Priority Procurement" of this Article namely, make “priority procurement of innovative products and services” as one of the flexible mechanisms for promoting innovation procurement.  A comparison of the amended provisions and the original provisions is shown in Table 1, and an explanation of the amendment is described as follows:[1]

Table 1 A Comparison of Article 27 Amendment of the Statute for Industrial Innovation

Amended Provisions

Original Provisions

Article 27

  (I) Each central government authority in charge of end enterprises of a specific industry shall encourage government organizations (agencies) and enterprises to procure software, innovative and green products or services.

  (II) To enhance the procurement efficiencies, as effected by supply and demand, the central government authority shall offer assistance and services to the organizations (agencies) that handle these procurements as described in the preceding paragraph; wherein, Inter-entity Supply Contracts that are required for the aforesaid procurements, the common requirements shall be decided, in accordance with policy requirements, upon consultation between the central government authority and each central government authority in charge of end enterprises of a specific industry.   

  (III) Where the software, innovative and green products or services, as described in Paragraph 1, must be tested, audited, accredited and certified, their associated fees and charges may be reduced, exempted, or suspended.

  (IV) Government organizations (agencies) may specify in the tender document the priority procurement of innovative and green products or services that have been identified to meet the requirements of paragraph 1. However, such a specification shall not violate treaties or agreements that have been ratified by the Republic of China.

  The measures concerning specifications, categories, and identification procedures of software, innovative and green products or services as prescribed in Paragraph 1; the testing, auditing criteria, accreditation and certification as prescribed in paragraph 3; and the Priority Procurement in paragraph 4 and other relevant items, shall be established by each central government authority in charge of end-enterprises of a specific industry. 

Article 27

  (I) Each central government authority in charge of end enterprises shall encourage government agencies and enterprises to give priority to green products that are energy/resources recyclable/renewable, energy and water saving, non-toxic, less-polluting, or able to reduce the burden on the environment.

  (II) Agencies may specify in the tender documents that priority is given to green products meeting the requirement set forth in the preceding Paragraph.

  (III) The regulations governing the specifications, categories, certification procedures, review standards, and other relevant matters relating to the green products as referred to in the preceding Paragraph shall be prescribed by the central government authorities in charge of end enterprises.

Source: The Ministry of Economic Affairs

(I).Paragraph 1

  In order to compel each central government authority in charge of end enterprises of a specific industry to motivate industrial innovation activities and sustainable development on the basis of requirements, and to support the development of the software industry in Taiwan, the provision, that such an authority should encourage government organizations (agencies) and enterprises to procure software and innovative products and services, is added in paragraph 1.

(II).Paragraph 2

  This procurement, as described in paragraph 1, is different from the property or services procurement of general affairs as handled by various organizations. To enhance procurement efficiencies, as effected by supply and demand, the central government authority, i.e., the Ministry of Economic Affairs, shall provide relevant assistance and services to organizations (agencies) handling these procurements, hence the added provisions in paragraph 2. For purchases using inter-entity supply contracts, which are bound by the requirements of this Article, due to their prospective nature, and that the common demand of each organization is difficult to make an accurate estimate by using a demand survey or other method, the Ministry of Economic Affairs shall discuss the issues with each central government authority in charge of end-enterprises of a specific industry, who consult or promote policies, and are in charge of end enterprises of a specific industry, and then make decisions in accordance with the policy promotion requirements. 

(III).Paragraph 3

  The fee schedule for testing, auditing, accrediting and certifying software, innovative and green products or services is covered by Article 7, Administrative Fees of the Charges And Fees Act. The authorities in charge should determine relevant fee standards.However, considering that the test, audit, accreditation and certification may be conducted during a trial or promotional period, or circumstances dictate that it is necessary to motivate tenderer participation, the fee may be reduced, waived or suspended; hence, paragraph 3 is added.

(IV).Paragraph 4

  Paragraph 2 of the original provision is moved to paragraph 4 with the revisions made to paragraph 1, accordingly, and the provision for using Priority Procurement to handle innovative products or services is added. However, for organizations covered by The Agreement on Government Procurement (GPA), due to Taiwan's accession to the WTO, ANZTEC, and ASTEP, their procurement of items covered in the aforesaid agreements with a value reaching the legislated threshold, shall be handled in accordance with the regulations stipulated in the aforesaid agreements; hence the stipulation in the proviso that the procurement must not violate the provisions of treaties or agreements ratified by the Taiwan government.

(V).Paragraph 5

  Paragraph 3 of the original Article is moved to paragraph 5 with the revisions made to paragraph 1, accordingly, and the provision, that authorizes each central government authority in charge of end enterprises of a specific industry to determine appropriate measures concerning the methods of defining software, innovative and green products and services, as well as matters relating to test, accreditation, certification and priority procurement, is added.

2.The Focus of the Amendment of Article 27 of the Statute—Promoting a Flexible Mechanism for Innovation Procurement

  As previously stated, the amendment of this Article aims to stimulate activities of industrial innovation by taking advantage of the huge demand from government agencies. With the government agencies being the users of the innovative products or services, government's procurement market potential is tapped to support the development of industrial innovation. The original intention of amendment is to incorporate the spirit of Public Procurement of Innovation[2] into this Article, and to try to introduce EU's innovation procurement mechanism[3] into our laws. So that, a procurement procedure, that is more flexible and not subject to the limitation of procurement procedures currently stipulated by the Government Procurement Act, may be adopted to facilitate government sector action in taking the lead on adopting innovative products or services that have just entered their commercial prototype stage, or utilizing the demand for innovation in the government sector to drive industry's innovative ideas or R&D (that can not be satisfied with the existing solutions in the marketplace).  However, while it is assessing the relevant laws and regulations of our government procurement system and the practice of implementation, the use of the current government procurement mechanism by organizations in the public sector to achieve the targets of innovation procurement is still in its infancy. It is difficult to achieve the goal, in a short time, of establishing a variety of Public Procurement of Innovation Solutions (PPI Solutions) as disclosed in the EU's Directive 2014/24 / EU, enacted by the EU in 2014, in ways that are not subject to current government procurement legislation.  Hence, the next best thing: Instead of setting up an innovative procurement mechanism in such a way that it is "not subject to the restrictions of the current government procurement law", we will focus on utilizing the flexible room available under the current system of government procurement laws and regulations, and promoting the "flexible mechanism for innovation procurement” paradigm. With the provisions now provided in Article 27 of the Statute for Industrial Innovation, the government sector is authorized to adopt the "Priority Procurement" method on innovative products and services, thus increasing the public sector's access to innovative products and services.

  With this amendment, in addition to the "green products" listed in the original provisions of paragraph 1 of the Statute, "software" and "innovative products or services"[4] are now incorporated into the target procurement scope and each central government authority in charge of end enterprises of a specific industry should now encourage government organizations and enterprises to implement; however, the provisions of this paragraph do not have the specific effect of law, they are declaratory provisions.  Two priorities are the1 primary focus of the provisions of paragraph 2 and paragraph 4 of this Article for promoting flexible mechanism for innovation procurement:

(I)The procurement of software, innovative and green products or services that uses Inter-entity Supply Contracts may rely on the "policy requirement" to establish the common demand.

  According to the first half of the provisions of paragraph 2 of this Article, the Ministry of Economic Affairs, being the central government authority of the Statute, may provide assistance and services to organizations dealing with the procurement of software, innovative and green products and services.This is because the procurement subjects, as pertaining to software, products or services that are innovative and green products (or services), usually have the particularities (especially in the software) of the information professions; different qualities (especially in innovative products or services), and are highly profession-specific. They are different from the general affairs goods and services procured by most government agencies. Hence, the Ministry of Economic Affairs may provide assistance and service to these procurement agencies, along with the coordination of relevant organizations, in matters relating to the aforesaid procurement process in order to improve procurement efficiency as relates to supply and demand.

  Pursuant to the second half of Paragraph 2 of this Article, if the inter-entity supply contract method is used to process the procurement of software, innovative products and services, green products (or services) and other related subjects, there could be "Commonly Required" by two or more organizations concerning the procurement subjects, so in accordance with the stipulations of Article 93 of the Government Procurement Act, and Article 2 of the Regulations for The Implementation of Inter-entity Supply Contracts[5], an investigation of common requirements should be conducted first. However, this type of subject is prospective and profession-specific (innovative products or services in particular), and government organizations are generally not sure whether they have demand or not, which makes it difficult to reliably estimate the demand via the traditional demand survey method[6], resulting in a major obstacle for the procurement process. Therefore, the provisions are now revised to allow the Ministry of Economic Affairs to discuss procurement with each central government authority in charge of end enterprises of a specific industry, who consult or promote policies (such as the National Development Council, or central government authority in charge of end enterprises of a specific industry relevant to the procurement subjects), and then make decisions based on the quantities of goods and services of common requirements in accordance with the demand for promoting the policy. The provisions explicitly stipulate such flexibility in adopting methods other than the "traditional demand survey" method, as is required by laws for the common demand of Inter-entity Supply Contracts. Thus, agencies currently handling procurement of prospective or innovative subjects using inter-entity supply contracts, may reduce the administrative burden typically associated with conducting their own procurement. In addition, with a larger purchase quantity demand, as generated from two or more organizations, the process can more effectively inject momentum into the industry, and achieve a win-win situation for both supply and demand.

(II)Government organizations may adopt "Priority Procurement" when handling procurement of innovative and green products or services.

  Prior to the amendment, the original provision of paragraph 2 of this Article stipulates that organizations may specify in the tender document Priority Procurement of certified green products; Additionally, a provision of paragraph 3 of the original Article stipulates that each central government authority in charge of end enterprises of a specific industry is authorized to establish the specifications, categories and other relevant matters of the green products[7] (according to the interpretation of the original text, it should include "Priority Procurement" in paragraph 3 of the Article).After the amendment of the Article, paragraph 2 of the original Article is moved to paragraph 4. In addition to the original green products, "innovative products or services" are included in the scope of "Priority Procurement" that organizations are permitted to adopt (but, the "software" in paragraph 1 was not included[8]). However, for organizations covered by The Agreement on Government Procurement (GPA), due to Taiwan's accession to the WTO, ANZTEC, and ASTEP, their procurement of items covered by the aforesaid agreements with a value reaching the stated threshold, shall be handled in accordance with the regulations stipulated in the aforesaid agreements; hence the stipulation in the proviso that the procurement must not violate the provisions in treaties or agreements ratified by the Taiwan government. Additionally, paragraph 3 of the original Article is moved to paragraph 5. Each central government authority in charge of end enterprises of a specific industry is authorized to use their own judgment on matters concerning the specifications, categories, certification processes of software, innovative and green products or services and the method for Priority Procurement of paragraph 4.

  In accordance with the authorization in paragraph 5 of the amended provision of this Article, each central government authority in charge of end enterprises of a specific industry may, depending on the specific policy requirement that promotes innovation development of its supervised industry, establish methods of identification and the processes of Priority Procurement for “Specific categories of innovative products or services", especially on products or services fitting the requirements of the method of using the demands of government organizations to stimulate industrial innovation. The established "Regolations for priority procurement of Specific categories of innovative products or services" is essentially a special regulation of the government procurement legislation, which belongs to the level of regulations, that is, it allows the organizations to apply measures other than the government procurement regulations and its related measures to the procurement process, and adopt "Preferential Contract Awarding" for qualified innovative products or services.  Any government agency that has the need to procure a particular category of innovative product or service may, in accordance with the provisions of paragraph 4 of this Article, specify the use of Priority Procurement in the tender document, and administer the procurement, in accordance with the process of this particular category of innovative products, or priority procurement. The agency is now enabled to follow a more flexible procurement process than that of the government procurement regulations to more smoothly award contracts for qualified innovative products or services. 

  Citing two examples of this applied scenario: Example one, "innovative information services": The central government authority in charge of information services is IDB. Thus, IDB may, according to the authorization provided for in paragraph 5 of the Article, establish the identification methods for innovative information services (the purpose of which is to define the categories and specifications of innovative services covered in the scope of priority procurement) and priority procurement processes, pertaining to emerging information services that are more applicable to the requirements of government agencies, such as: cloud computing services, IoT services, and Big Data analysis services.Example two, "Innovative construction or engineering methods": The central government authority in charge of construction affairs is the Construction and Planning Agency of the Ministry of the Interior. Since the agency has already established the "Guidelines for Approval of Applications for New Construction Techniques, Methods, Equipment and Materials", the agency may establish a priority procurement process for new construction techniques, methods or equipment, in accordance with the stipulations in paragraph 5 of the Article. Government agencies may conduct procurement following any of these priority procurement practices, if there is a requirement for innovative information services, or new construction techniques, methods or equipment.

  In addition to the two aforementioned flexible mechanisms for innovation procurement, where government agencies are granted flexible procedures to handle the procurement of innovative products or services via the use of the flexible procurement mechanism, paragraph 3, concerning the incentive measures of concessionary deductions, is added to the Article to reduce the bidding costs for tenderers participating in the tender.  For the Procurement of software, innovative and green products or services encouraged by each central government authority in charge of end-enterprises of a specific industry (not limited to those handled by the authorities themselves, using inter-entity supply contracts or priority procurement methods), if the procurement subjects are still required to be tested, audited, accredited and certified by the government agencies, such a process falls under the scope of administrative fees collection, pursuant to paragraph 1 Article 7 of the Charges And Fees Act. However, considering that the item subject to test, audit, accreditation and certification may be in a trial or promotional period, or that it may be necessary to motivate tenderer participation, the provisions of paragraph 3 are thusly added to the Article to reduce, waive, or suspend the collection of aforementioned fees. Executive authorities in charge of collecting administrative fees shall proceed to reduce, waive, or suspend the collection pursuant to the stipulations of paragraph 3 of the Article and Article 12 subparagraph 7 of the Charges And Fees Act.[9]

III.The direction of devising supporting measures of flexible mechanism for innovation procurement

  The latest amendment of the Statute for Industrial Innovation was promulgated and enacted on November 22, 2017, it is imperative that supporting measures pertaining to Article 27 of the Statute be formulated. As previously stated, the flexible mechanism for innovation procurement, as promoted in this Article, is designed specifically for the products or services that are pertinent to the government procurement requirements and are capable of stimulating industrial innovation, and providing a more flexible government procurement procedure for central authorities in charge of a specific industry as a policy approach in supporting industry innovation. Thus, the premise of devising relevant supporting measures is dependent on whether the specific industry, as overseen by the particular central authority, has a policy in place for promoting the development of industrial innovation, and on whether it is suitable in promoting the flexible mechanism for innovation procurement as described in this Article.

  The purpose of this Article is to promote the flexible mechanism for innovation procurement. Supporting measures pertaining to this Article will focus on the promotion of devising an "Innovation Identification Method", and of the "Priority Procurement Process" of the innovative products or services of each industry that central government authorities oversee. The former will rely on each central government authority in charge of a specific industry to charter an industry-appropriate and profession-specific planning scheme; while, for the latter, the designing of a priority procurement process, in accordance with the nature of the various types of innovative products or services, does not have to be applicable to all.  However, regardless what type of innovative products or services the priority procurement process is designed for, the general direction of consideration should be given to - taking the different qualities of innovative products or services as the core consideration. Additionally, the attribute of the priority procurement procedures focusing specifically on the different qualities of the innovative subjects relates to the special regulation relevant to the government procurement regulations. Thus, the procurement procedures should follow the principle that if no applicable stipulation is found in the special regulation, the provisions of the principal regulation shall apply.

  The so-called "Priority Procurement" process refers to the "Preferential Contract Awarding" on tenders that meet certain criteria in a government procurement procedure.  The existing Government Procurement Act (GPA, for short) and its related laws that have specific stipulations on "Priority Procurement" can be found in the "Regulations for Priority Procurement of Eco-Products" (Regulations for Eco-Products Procurement, for short), and the "Regulations for Obliged Purchasing Units / Institutions to Purchase the Products and Services Provided by Disabled Welfare Institutions, Organizations or Sheltered Workshops" (Regulations for Priority Procurement of Products or Services for Disabled or Shelters, for short). After studying these two measures, the priority procurement procedures applicable to criteria-conformed subjects can be summarized into the following two types:

1.The first type: Giving preferential contract awarding to the tenderer who qualifies with "the lowest tender price”, as proposed in the tender document, and who meets a certain criteria (for example, tenderers of environmental products, disabled welfare institutions, or sheltered workshops).  There are two scenarios: When a general tenderer and the criteria-conformed tenderer both submit the lowest tender price, the criteria-conformed tenderer shall obtain the right to be the "preferential winning tender" without having to go through the Price Comparison and Reduction Procedures. Additionally, if the lowest tender price is submitted by a general tenderer, then the criteria-conformed tenderers have the right to a "preferential price reduction” option, that is, the criteria-conformed tenderers can be contacted, in ascending order of the tender submitted, with a one time option to reduce their bidding prices. The first tenderer who reduces their price to the lowest amount shall win the tender. Both the Regulations for Eco-Products Procurement[10] and Regulations for Priority Procurement of Products or Services for Disabilities or Shelters[11] have such relevant stipulations. 

2.The second type: It is permitted to give Preferential Contract Awarding to a criteria-conformed tenderer, when the submitted tender is within the rate of price preference.  When the lowest tenderer is a general tenderer, and the tender submitted by the criteria-conformed tenderer is higher than the lowest tender price, the law permits that if the tender submitted is "within the rate of price preference ", as set by the procuring entity, the procuring entity may award the contract preferentially to "the tender submitted by the criteria-conformed tenderer." The premise for allowing this method is that the tender submitted by the criteria-conformed tenderer must be within the preferential price ratio. If the submitted tender is higher than the preferential price ratio, then the criteria-conformed tenderer does not have the right to preferential contract awarding. The contract will be awarded to theother criteria-conformed tenderer, or to a general tenderer.  This method is covered in the provisions of the Regulations for Eco-Products Procurement[12].

  However, the important premise for the above two priority procurement methods is that the nature of the subject matter of the tender is suitable for adopting the awarding principle of the lowest tender (Article 52, Paragraph 1, Subparagraphs 1 and 2 of the Procurement Act), that is, it is difficult to apply these methods to the subjects if they are different qualities. Pursuant to the provisions of Article 66 of the Enforcement Rules of the Government Procurement Act, the so-called "different qualities" refers to the construction work, property or services provided by different suppliers that are different in technology, quality, function, performance, characteristics, commercial terms, etc. Subjects of different qualities are essentially difficult to compare when based on the same specifications. If just looking at pricing alone it is difficult to identify the advantages and disadvantages of the subjects, hence, the awarding principle of the lowest tender is not appropriate. The innovative subjects are essentially subjects of different qualities, and under the same consideration, they are not suitable for applying the awarding principle of the lowest tender. Therefore, it is difficult to adopt the lowest-tender-based priority procurement method for the procurement of innovative subjects.

  In the case of innovative subjects with different qualities, the principle of the most advantageous tender should be adopted (Article 52 Paragraph 1 Subparagraph 3 of the Procurement Act) to identify the most qualified vender of the subjects through open selection. Therefore, the procedure for the priority procurement of innovative subjects with different qualities should be based on the most advantageous tender principle with focus on the "innovativeness" of the subjects, and consideration on how to give priority to tenderers, who qualify with the criteria of innovation. Pursuant to the provisions of Article 56 Paragraph 4 of the Procurement Act, the Procurement and Public Construction Commission has established the "Regulations for Evaluation of the Most Advantageous Tender". The tendering authorities adopting the most advantageous tender principle should abide by the evaluation method and procedures delineated in the method, and conduct an open selection of a winning tender. According to the Regulations for Evaluation of the Most Advantageous Tender, in addition to pricing, the tenderers' technology, quality, function, management, commercial terms, past performance of contract fulfillment, financial planning, and other matters pertaining to procurement functions or effectiveness, maybe chosen as evaluation criteria and sub-criteria. According to the three evaluation methods delineated in the provisions of Article 11 of the Regulations for Evaluation of the Most Advantageous Tender (overall evaluation score method, price per score point method, and ranking method), pricing could not been included in the scoring. That is, "the prices of the subjects" is not the absolute criterion of evaluation of the most advantageous tender process.

  The priority procurement procedures designed specifically for innovative subjects with different qualities may adopt an evaluation method that excludes "pricing" as part of the scoring criterion so as to give innovative subject tenderers the opportunity to be more competitive in the bidding evaluation process, and due to the extent of their innovativeness, obtain the right to preferential tenders. If it must be included in the scoring, the percentage of the total score for pricing should be reduced from its usual ratio[13], while stipulating explicitly that "innovation" must be included as part of the evaluation criteria. In addition, its weight distribution should not be less than a ratio that highlights the importance of innovation in the evaluation criteria.  Furthermore, when determining how to give preference to tenderers who meet certain innovation criteria in the contract awarding procedures, care should be taken to stay on focus with the degree of innovation of the subject (the higher the degree of innovation, the higher the priority), rather than giving priority to arbitrary standards. In summary, with consideration of priority procurement procedures designed specifically for innovative subjects with different qualities, this paper proposes the following preliminary regulatory directions:

1.Adopt the awarding principle of the most advantageous tender.

2.Explicitly stipulate the inclusion of "innovation" in the evaluation criteria and sub-criteria, and its ratio, one that indicates its importance, should not be less than a certain percentage of the total score (for example 20%).

3.Reduce the distributed ratio of "price" in the scoring criteria in the open selection.

4.After the members of the evaluation committee have concluded the scoring, if more than two tenderers have attained the same highest overall evaluated score or lowest quotient of price divided by overall evaluated score, or more than two tenderers have attained the first ranking, the contract is awarded preferentially to the tenderer who scores the highest in the "innovation" criterion.

5.When multiple awards (according to Article 52 Paragraph 1 Subparagraph 4 of the Procurement Act) are adopted, that is, there is more than one final winning tender, the procuring entity may select the tenderers with higher innovation scores as the price negotiation targets for contract awarding, when there are more than two tenderers with the same ranking.

  Using the above method to highlight the value of innovative subjects will make these suppliers more competitive, because of their innovativeness ratings in the procurement procedures, and not confine them to the limitation of price-determination.  So that, subject suppliers with a high degree of innovation, may attain the right to the preferential contract awarding that they deserve due to their innovativeness, and the procuring entity can purchase suitable innovative products in a more efficient and easy process. It also lowers the threshold for tenderers with innovation energy to enter the government procurement market, thus achieving the goal of supporting industrial innovation and creating a win-win scenario for supply and demand.


[1] Cross-reference Table of Amended Provisions of the Statute for Industrial Innovation, The Ministry of Economic Affairs, https://www.moea.gov.tw/MNS/populace/news/wHandNews_File.ashx?file_id=59099 (Last viewed date: 12/08/2017).

[2] According to the Guidance for public authorities on Public Procurement of Innovation issued by the Procurement of Innovation Platform in 2015, the so-called innovation procurement in essence refers to that the public sector can obtain innovative products, services, or work  by using the government procurement processes, or that the public sector can administer government procurement with a new-and-better process. Either way, the implementation of innovation procurement philosophy is an important link between government procurement, R & D and innovation, which shortens the distance between the foresighted emerging technologies/processes and the public sector/users.

[3] The EU's innovative procurement mechanism comprises the "Public Procurement of Innovation Solutions" (PPI Solutions) and "Pre-Commercial Procurement" (PCP). The former is one of the government procurement procedures, explicitly regulated in the new EU Public Procurement Directive (Directive 2014/24 / EU), for procuring solutions that are innovative, near or in preliminary commercial prototype; The latter is a procurement process designed to assist the public sector in obtaining technological innovative solutions that are not yet in commercial prototype, must undergo research and development process, and are not within the scope of EU Public Procurement Directive.

[4] The "software, innovative and green products or services", as described in paragraph 1 of Article 27 of the amended Statute for Industrial Innovation, refers to, respectively, "software", "innovative products or services", and "green products or services" in general. There is no co-ordination or subordination relationship between the three; the same applies to "innovative and green products or services" in paragraph 4.

[5] Article 93 of the Government Procurement Act stipulates: "An entity may execute an inter-entity supply contract with a supplier for the supply of property or services that are commonly needed by entities." Additionally, Article 2 of the Regulations for The Implementation of Inter-entity Supply Contracts stipulates: "The term 'property or services that are commonly needed by entities' referred to in Article 93 of the Act means property or services which are commonly required by two or more entities. The term 'inter-entity supply contract (hereinafter referred to as the “Contract”)' referred to in Article 93 of the Act means that an entity, on behalf of two or more entities, signs a contract with a supplier for property or services that are commonly needed by entities, so that the entity and other entities to which the Contract applies can utilize the Contract to conduct procurements." Therefore, according to the interpretation made by the Public Construction Commission, the Executive Yuan (PCC, for short), organizations handling inter-entity supply contracts should first conduct a demand investigation.

[6] In general, organizations in charge of handling the inter-entity supply contracts will disseminate official documents to applicable organizations with an invitation to furnish information online about their interests and estimated requirement (for budget estimation) at government's e-procurement website. However, in the case of more prospective subjects (such as cloud services of the emerging industry), it may be difficult for an organization to accurately estimate the demand when filling out the survey, resulting in a mismatch of data between the demand survey and actual needs.

[7] In accordance with the authorization of paragraph 3 of the Article, the IDB has established "Regulations Governing Examination and Identification of Advanced Recycled Products by Ministry of Economic Affairs" (including an appendix: Identification Specification for Resource Regenerating Green Products), except that the priority procurement process was not stipulated, because the Resource Regenerating Green Products, that meet the requirements of the Ministry of Economic Affairs, are covered by the "Category III Products" in the provisions of Article 6 of the existing "Regulations for Priority Procurement of Eco-Products", set forth by the PPC and The Environmental Protection Administration of the Executive Yuan. Hence, organizations that have the requirement to procure green products, may proceed with priority procurement by following the regulations in the "Regulations for Priority Procurement of Eco-Products".     

[8] After the amendment of the Article, the "software" in the provisions of paragraph 1 was excluded in paragraph 4, because the objective of paragraph 4 is to promote industry innovation and sustainable development with the use of a more flexible government procurement procedure. Thus, the subjects of the priority procurement mechanism are focused on "innovative" and "green" products or services, which exclude popular "software" that has a common standard in the market. However, if it is an "innovative software", it may be included in the "innovative products or services" in the provisions of paragraph 4.

[9] According to the provisions of Article 12 of the Charges And Fees Act: "In any of the following cases, the executive authority in charge of the concerned matters may waive or reduce the amount of the charges and fees, or suspend the collection of the charges and fees: 7. Waiver, reduction, or suspension made under other applicable laws."

[10] Refer to Article 12, Paragraph 1, Subparagraphs 1 and Article 13, Paragraph 1 and 2 of Regulations for Priority Procurement of Eco-Products.

[11] Refer to Article 4 of Regulations for Obliged Purchasing Units / Institutions to Purchase the Products and Services Provided by Disabled Welfare Institutions, Organizations or Sheltered Workshops.

[12] Refer to Article 12, Paragraph 1, Subparagraphs 2 and Article 13, Paragraph 3 of Regulations for Priority Procurement of Eco-Products.

[13] The provisions of paragraph 3 Article 16 of the Regulations for Evaluation of the Most Advantageous Tender stipulates: Where price is included in scoring, its proportion of the overall score shall be not less than 20% and not more than 50%.

※Adopting Flexible Mechanism to Promote Public Procurement of Innovation—the Amendment of Article 27 of the Statute for Industrial Innovation,STLI, https://stli.iii.org.tw/en/article-detail.aspx?no=86&tp=2&i=168&d=7969 (Date:2024/04/20)
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The Study of Estonian Human Genes Database

I. Introduction The human genes database or human genome project, the product under the policy of biotechnology no matter in a developed or developing country, has been paid more attention by a government and an ordinary people gradually. The construction of human genes database or human genome project, which is not only related to a country’s innovation on biotechnology, but also concerns the promotion of a country’s medical quality, the construction of medical care system, and the advantages brought by the usage of bio-information stored in human genes database or from human genome project. However, even though every country has a high interest in setting up human genes database or performing human genome project, the issues concerning the purposes of related biotechnology policies, the distribution of advantages and risks and the management of bio-information, since each country has different recognition upon human genes database or human genome project and has varied standards of protecting human basic rights, there would be a totally difference upon planning biotechnology policies or forming the related systems. Right now, the countries that vigorously discuss human genes database or practice human genome project include England, Iceland, Norway, Sweden, Latvia and Estonia. Estonia, which is the country around the Baltic Sea, has planned to set up its own human genes database in order to draw attention from other advanced countries, to attract intelligent international researchers or research groups, and to be in the lead in the area of biotechnology. To sum up, the purpose of constructing Estonian human genes database was to collect the genes and health information of nearly 70% Estonia’s population and to encourage bio-research and promote medical quality. II. The Origin of Estonian Human Genes Database The construction of Estonian human genes database started from Estonian Genome Project (EGP). This project was advocated by the professor of biotechnology Andres Metspalu at Tartu University in Estonia, and he proposed the idea of setting up Estonian human genes database in 1999. The purposes of EGP not only tried to make the economy of Estonia shift from low-cost manufacturing and heavy industry to an advanced technological economy, but also attempted to draw other countries’ attention and to increase the opportunity of making international bio-researches, and then promoted the development of biotechnology and assisted in building the system of medical care in Estonia. EGP started from the agreement made between Estonian government and Eesti Geenikeskus (Estonian Genome Foundation) in March, 1999. Estonian Genome Foundation was a non-profit organization formed by Estonian scientists, doctors and politicians, and its original purposes were to support genes researches, assist in proceeding any project of biotechnology and to set up EGP. The original goals of constructing EGP were “(a) reaching a new level in health care, reduction of costs, and more effective health care, (b) improving knowledge of individuals, genotype-based risk assessment and preventive medicine, and helping the next generation, (c) increasing competitiveness of Estonia – developing infrastructure, investments into high-technology, well-paid jobs, and science intensive products and services, (d) [constructing] better management of health databases (phenotype/genotype database), (e) … [supporting]… economic development through improving gene technology that opens cooperation possibilities and creates synergy between different fields (e.g., gene technology, IT, agriculture, health care)”1. III. The Way of Constructing Estonian Human Genes Database In order to ensure that Estonian human genes database could be operated properly and reasonably in the perspectives of law, ethics and society in Estonia, the Estonian parliament followed the step of Iceland to enact “Human Genes Research Act” (HGRA) via a special legislative process to regulate its human genes database in 2000. HGRA not only authorizes the chief processor to manage Estonian human genes database, but also regulates the issues with regard to the procedure of donation, the maintenance and building of human genes database, the organization of making researches, the confidential identity of donator or patient, the discrimination of genes, and so on. Since the construction of Estonian human genes database might bring the conflicts of different points of view upon the database in Estonia, in order to “avoid fragmentation of societal solidarity and ensure public acceptability and respectability”2 , HGRA adopted international standards regulating a genes research to be a norm of maintaining and building the database. Those standards include UNESCO Universal Declaration on the Human Genome and Human Rights (1997) and the Council of Europe’s Convention on Human Rights and Biomedicine (1997). The purpose of enacting HGRA is mainly to encourage and promote genes researches in Estonia via building Estonian human genes database. By means of utilizing the bio-information stored in the database, it can generate “more exact and efficient drug development, new diagnostic tests, improved individualized treatment and determination of risks of the development of a disease in the future”3 . In order to achieve the above objectives, HGRA primarily puts emphasis on several aspects. Those aspects include providing stronger protection on confidential identity of donators or patients, caring for their privacy, ensuring their autonomy to make donations, and avoiding any possibility that discrimination may happen because of the disclosure of donators’ or patients’ genes information. 1.HERBERT GOTTWEIS & ALAN PETERSEN, BIOBANKS – GOVERNANCE IN COMPARATIVE PERSPECTIVE 59 (2008). 2.Andres Rannamae, Populations and Genetics – Legal and Socio-Ethical Perspectives, in Estonian Genome Porject – Large Scale Health Status Description and DNA Collection 18, 21 (Bartha Maria Knoppers et al. eds., 2003. 3.REMIGIUS N. NWABUEZE, BIOTECHNOLOGY AND THE CHALLENGE OF PROPERTY – PROPERTY RIGHTS IN DEAD BODIES, BODY PARTS, AND GENETIC INFORMATION, 163 (2007).

Experiences about opening data in private sector

Experiences about opening data in private sector Ⅰ. Introduction   Open data is the idea that data should be available freely for everyone to use and republish without restrictions from copyright, patents or other mechanisms of control. The concept of open data is not new; but a formalized definition is relatively new, and The Open Definition gives full details on the requirements for open data and content as follows:   Availability and access: the data must be available as a whole with no more than a reasonable reproduction cost, preferably by downloading over the internet. The data must also be available in a convenient and modifiable form.   Reuse and redistribution: the data must be provided under terms that permit reuse and redistribution including the intermixing with other datasets. The data shall be machine-readable.   Universal participation: everyone must be able to use, reuse and redistribute the data— which by means there should be no discrimination against fields of endeavor or against persons or groups. For example, “non-commercial” restrictions that would prevent “commercial” use, or restrictions of use for certain purposes are not allowed.   In order to be in tune with international developmental trends, Taiwan passed an executive resolution in favor of promoting Open Government Data in November 2012. Through the release of government data, open data has grown significantly in Taiwan and Taiwan has come out on top among 122 countries and areas in the 2015 and 2016 Global Open Data Index[1].   The result represented a major leap for Taiwan, however, progress is still to be made as most of the data are from the Government, and data from other territories, especially from private sector can rarely be seen. It is a pity that data from private sector has not being properly utilized and true value of such data still need to be revealed. The following research will place emphasis to enhance the value of private data and the strategies of boosting private sector to open their own data. Ⅱ. Why open private data   With the trend of Open Government Data recent years, countries are now starting to realize that Open Government Data is improving transparency, creating opportunities for social and commercial innovation, and opening the door to better engagement with citizens. But open data is not limited to Open Government Data. In fact, the private sector not only interacts with government data, but also produces a massive amount of data, much of which in need of utilized.   According to the G20 open data policy agenda made in 2014, the potential economic value of open data for Australia is up to AUD 64 billion per annum, and the potential value of open data from private sector is around AUD 34 billion per annum. Figure 1 Value of open data for Australia (AUD billion per annum) Source: McKinsey Global Institute   The purpose for opening data held by private entities and corporations is rooted in a broad recognition that private data has the potential to foster much public good. Openness of data for companies can translate into more efficient internal governance frameworks, enhanced feedback from workers and employees, improved traceability of supply chains, accountability to end consumers, and with better service and product delivery. Open Private Data is thus a true win-win for all with benefiting not only the governance but environmental and social gains.   At the same time, a variety of constraints, notably privacy and security, but also proprietary interests and data protectionism on the part of some companies—hold back this potential. Ⅲ. The cases of Open Private Data   Syngenta AG, a global Swiss agribusiness that produces agrochemicals and seeds, has established a solid foundation for reporting on progress that relies on independent data collection and validation, assurance by 3rd party assurance providers, and endorsement from its implementing partners. Through the website, Syngenta AG has shared their datasets for agricultural with efficiency indicators for 3600 farms for selected agro-ecological zones and market segments in 42 countries in Europe, Africa, Latin America, North America and Asia. Such datasets are precious but Syngenta AG share them for free only with a Non-Commercial license which means users may copy and redistribute the material in any medium or format freely but may not use the material for commercial purposes. Figure 2 Description and License for Open data of Syngenta AG Source: http://www.syngenta.com   Tokyo Metro is a rapid transit system in Tokyo, Japan has released information such as train location and delay times for all lines as open data. The company held an Open Data Utilization Competition from 12 September to 17 November, 2014 to promote development of an app using this data and continues to provide the data even after the competition ended. However, many restrictions such as non-commercial use, or app can only be used for Tokyo Metro lines has weakened the efficiency of open data, it is still valued as an initial step of open private data. Figure 3 DM of Tokyo Metro Open data Contest Source: https://developer.tokyometroapp.jp/ Ⅳ. How to enhance Open Private Data   Open Private Data is totally different from Open Government Data since “motivation” is vital for private institutions to release their own data. Unlike the government data can be disclosed and free to use via administrative order or legislation, all of the data controlled by private institutions can only be opened under their own will. The initiative for open data therefore shall focus on how to motivate private sectors releasing their own data-by ensuring profit and minimizing risks.   Originally, open data shall be available freely for everyone to use without any restrictions, and data owners may profit indirectly as users utilizing their data creating apps, etc. but not profit from open data itself. The income is unsteady and data owners therefore lose their interest to open data. As a countermeasure, it is suggested to make data chargeable though this may contradict to the definition of open data. When data owners can charge by usage or by time, the motivation of open data would arise when open data is directly profitable.   Data owners may also worry about many legal issues when releasing their own data. They may not care about whether profitable or not but afraid of being involved into litigation disputes such as intellectual property infringement, unfair competition, etc. It is very important for data owners to have a well protected authorization agreement when releasing data, but not all of them is able to afford the cost of making agreement for each data sharing. Therefore, a standard sample of contract that can be widely adopted plays a very important role for open private data.   A data sharing platform would be a solution to help data owners sharing their own data. It can not only provide a convenient way to collect profit from data sharing but help data owners avoiding legal risks with the platform’s standard agreement. All the data owners have to do is just to transfer their own data to the platform without concern since the platform would handle other affairs. Ⅴ. Conclusion   Actively engaging the private sector in the open data value-chain is considered an innovation imperative as it is highly related to the development of information economy. Although many works still need to be done such as identifying mechanisms for catalyzing private sector engagement, these works can be done by organizations such as the World Bank and the Centre for Open Data Enterprise. Private-public collaboration is also important when it comes to strengthening the global data infrastructure, and the benefits of open data are diverse and range from improved efficiency of public administrations to economic growth in the private sector. However, open private data is not the goal but merely a start for open data revolution. It is to add variation for other organizations and individuals to analyze to create innovations while individuals, private sectors, or government will benefit from that innovation and being encouraged to release much more data to strengthen this data circulation. [1] Global Open Data Index, https://index.okfn.org/place/(Last visited: May 15, 2017)

Post Brexit – An Update on the United Kingdom Privacy Regime

Post Brexit – An Update on the United Kingdom Privacy Regime 2021/9/10   After lengthy talks, on 31 January 2020, the United Kingdom (‘UK’) finally exited the European Union (‘EU’). Then, the UK shifted into a transition period. The UK government was bombarded with questions from all stakeholders. In particular, the data and privacy industry yelled out the loudest – what am I going to do with data flowing from the EU to the UK? Privacy professionals queried – would the UK have a new privacy regime that significantly departs from the General Data Protection Regulation (‘GDPR’)? Eventually, the UK made a compromise with all stakeholders – the British, the Europeans and the rest of the world – by bridging its privacy laws with the GDPR. On 28 June 2021, the UK obtained an adequacy decision from the EU.[1] This was widely anticipated but also widely known to be delayed, as it was heavily impacted by the aftermaths of the invalidation of the US- EU Privacy Shield.[2]   While the rest of the world seems to silently observe the transition undertaken by the UK, post-Brexit changes to the UK’s privacy regime is not only a domestic or regional matter, it is an international matter. Global supply chains and cross border data flows will be affected, shuffling the global economy into a new order. Therefore, it is crucial as citizens of a digital economy to unpack and understand the current UK privacy regime. This paper intends to give the reader a brief introduction to the current privacy regime of the UK. The author proposes to set out the structure of the UK privacy legislation, and to discuss important privacy topics. This paper only focuses on the general processing regime, which is the regime that is most relevant to general stakeholders. UK Privacy Legislation   There are two main privacy legislation in the UK – the Data Protection Act 2018 (‘DPA’) and the United Kingdom General Data Protection Act (‘UK GDPR’). These two acts must be read together in order to form a coherent understanding of the current UK privacy regime.   The UK GDPR is the creature of Brexit. The UK government wanted a smooth transition out of the EU and acknowledged that they needed to preserve the GDPR in their domestic privacy regime to an extent that would allow them to secure an adequacy decision. The UK government also wanted to create less impact on private companies. Thus, the UK GDPR was born. Largely it aligns closely with the GDPR, supplemented by the DPA. ICO   The Information Commissioner’s Office (‘ICO’) is the independent authority supervising the compliance of privacy laws in the UK. Prior to Brexit, the ICO was the UK’s supervisory authority under the GDPR. A unique feature of the ICO’s powers and functions is that it adopts a notice system. The ICO has power to issue four types of notices: information notices, assessment notices, enforcement notices and penalty notices.[3] The information notice requires controllers or processors to provide information. The ICO must issue an assessment notice before conducting data protection audits. Enforcement is only exercisable by giving an enforcement notice. Administrative fines are only exercisable by giving a penalty notice. Territorial Application   Section 207(1A) of the DPA states that the DPA applies to any controller or processor established in the UK, regardless where the processing of personal data takes place. Like the GDPR, the DPA and the UK GDPR have an extraterritorial reach to overseas controllers or processors. The DPA and the UK GDPR apply to overseas controllers or processors who process personal data relating to data subjects in the UK, and the processing activities are related to the offering of goods or services, or the monitoring of data subjects’ behavior.[4] Transfers of Personal Data to Third Countries   On 28 June 2021, the UK received an adequacy decision from the EU.[5] This means that until 27 June 2025, data can continue to flow freely between the UK and the European Economic Area (‘EEA’).   As for transferring personal data to third countries other than the EU, the UK has similar laws to the GDPR. Both the DPA and the UK GDPR restrict controllers or processors from transferring personal data to third countries. A transfer of personal data to a third country is permitted if it is based on adequacy regulations.[6] An EU adequacy decision is known as ‘adequacy regulations’ under the UK regime.   If there is no adequacy regulations, then a transfer of personal data to a third country will only be permitted if it is covered by appropriate safeguards, including standard data protection clauses, binding corporate rules, codes of conduct, and certifications.[7] The ICO intends to publish UK standard data protection clauses in 2021.[8] In the meantime, the EU has published a new set of standard data protection clauses (‘SCCs’).[9] However, it must be noted that the EU SCCs are not accepted to be valid in the UK, and may only be used for reference purposes. It is also worth noting that the UK has approved three certification schemes to assist organizations in demonstrating compliance to data protection laws.[10] Lawful Bases for Processing   Basically, the lawful bases for processing in the UK regime are the same as the GDPR. Six lawful bases are set out in article 6 of the UK GDPR. To process personal data, at least one of the following lawful bases must be satisfied:[11] The data subject has given consent to the processing; The processing is necessary for the performance of a contract; The processing is necessary for compliance with a legal obligation; The processing is necessary to protect vital interests of an individual – that is, protecting an individual’s life; The processing is necessary for the performance of a public task; The processing is necessary for the purpose of legitimate interests, unless other interests or fundamental rights and freedoms override those legitimate interests. Rights & Exemptions   The UK privacy regime, like the GDPR, gives data subjects certain rights. Most of the rights granted under the UK privacy regime is akin to the GDPR and can be found under the UK GDPR. Individual rights under the UK privacy regime is closely linked with its exemptions, this may be said to be a unique feature of the UK privacy regime which sets it apart from the GDPR. Under the DPA and the UK GDPR, there are certain exemptions, meaning organizations are exempted from certain obligations, most of them are associated with individual rights. For example, if data is processed for scientific or historical research purposes, or statistical purposes, organizations are exempted from provisions on the right of access, the right to rectification, the right to restrict processing and the right to object in certain circumstances.[12] Penalties   The penalty for infringement of the UK GDPR is the amount specified in article 83 of the UK GDPR.[13] If an amount is not specified, the penalty is the standard maximum amount.[14] The standard maximum amount, at the time of writing, is £8,700,000 (around 10 million Euros) or 2% of the undertaking’s total annual worldwide turnover in the preceding financial year.[15] In any other case, the standard maximum amount is £8,700,000 (around 10 million Euros).[16] Conclusion   The UK privacy regime closely aligns with the GDPR. However it would be too simple of a statement to say that the UK privacy regime is almost identical to the GDPR. The ICO’s unique enforcement powers exercised through a notice system is a distinct feature of the UK privacy regime. Recent legal trends show that the UK while trying to preserve its ties with the EU is gradually developing an independent privacy persona. The best example is that in regards to transfers to third countries, the UK has developed its first certification scheme and is attempting to develop its own standard data protection clauses. The UK’s transition out of the EU has certainly been interesting; however, the UK’s transformation from the EU is certainly awaited with awe. [1] Commission Implementing Decision of 28.6.2021, pursuant to Regulation (EU) 2016/679 of the European Parliament and of the Council on the adequate protection of personal data by the United Kingdom, C(2021) 4800 final,https://ec.europa.eu/info/sites/default/files/decision_on_the_adequate_protection_of_personal_data_by_the_united_kingdom_-_general_data_protection_regulation_en.pdf.. [2] Judgment of 16 July 2020, Data Protection Commissioner v. Facebook Ireland Limited, Maximillian Schrems, C-311/18, EU:C:2020:559, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:62018CJ0311. [3] Data Protection Act 2018, §115. [4] Data Protection Act 2018, §207(1A); REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), art 3. [5] supra note 1. [6] Data Protection Act 2018, §17A-18; REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), art 44-50. [7] Data Protection Act 2018, §17A-18; REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), art 46-47. [8]International transfers after the UK exit from the EU Implementation Period, ICO, https://ico.org.uk/for-organisations/guide-to-data-protection/guide-to-the-general-data-protection-regulation-gdpr/international-transfers-after-uk-exit/ (last visited Sep. 10, 2021). [9] Standard contractual clauses for international transfers, European Commission, https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/standard-contractual-clauses-scc/standard-contractual-clauses-international-transfers_en (last visited Sep. 10, 2021). [10] ICO, New certification schemes will “raise the bar” of data protection in children’s privacy, age assurance and asset disposal, ICO, Aug. 19, 2021, https://ico.org.uk/about-the-ico/news-and-events/news-and-blogs/2021/08/ico-approves-the-first-uk-gdpr-certification-scheme-criteria/ (last visited Sep. 10, 2021). [11] REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), art 6(1)-(2); Lawful basis for processing, ICO, https://ico.org.uk/for-organisations/guide-to-data-protection/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/ (last visited Sep. 10, 2021). [12] Data Protection Act 2018, sch 2, part 6, para 27. [13] id. at §157. [14] id. [15] id. [16] id.

Taiwan Planed Major Promoting Program for Biotechnology and Pharmaceutical Industry

Taiwan Government Lauched the “Biotechnology Action Plan” The Taiwan Government has planned to boost the support and develop local industries across the following six major sectors: biotechnology, tourism, health care, green energy, innovative culture and post-modern agriculture. As the biotechnology industry has reached its maturity by the promulgation of "Biotech and New Pharmaceutical Development Act" in July, 2007, it will be the first to take the lead among the above sectors. Thus, the Executive Yuan has launched the Biotechnology Action Plan as the first project in building the leading industry sectors, to upgrade local industries and stimulate future economic growth. Taiwan Government Planed 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. Taiwan Government Had Modifies Rules to Accelerate NDA Process and Facilitate Development of Clinical Studies in Taiwan In July 2007, the "Biotech and New Pharmaceutical Development Act" modified many regulations related to pharmaceutical administration, taxes, and professionals in Taiwan. In addition, in order to facilitate the development of the biotechnology and pharmaceutical industries, the government has attempted to create a friendly environment for research and development by setting up appropriate regulations and application systems. These measures show that the Taiwanese government is keenly aware that these industries have huge potential value. To operate in coordination with the above Act and to better deal with the increasing productivity of pharmaceutical R&D programs in Taiwan, the Executive Yuan simplified the New Drug Application (NDA) process to facilitate the submission that required Certificate of Pharmaceutical Product (CPP) for drugs with new ingredients. The current NDA process requires sponsors to submit documentation as specified by one of the following four options: (1) three CPPs from three of "ten medically-advanced countries," including Germany, the U.S., England, France, Japan, Switzerland, Canada, Australia, Belgium, and Sweden; (2) one CPP from the U.S., Japan, Canada, Australia, or England and one CPP from Germany, France, Switzerland, Sweden, or Belgium; (3) a Free Sale Certificate (FSC) from one of ten medically-advanced countries where the pharmaceuticals are originally produced and one CPP from one of the other nine countries; or (4) a CPP from the European Medicines Agency. Thus, the current NDA process requires sponsors to spend inordinate amounts of time and incur significant costs to acquire two or three FSCs or CPPs from ten medically-advanced countries in order to submit an NDA in Taiwan. According to the new rules, sponsors will not have to submit above CPPs if (1) Phase I clinical studies have been conducted in Taiwan, and Phase III Pivotal Trial clinical studies have been simultaneously conducted both in Taiwan and in another country or (2) Phase II and Phase III Pivotal Trial clinical studies have been simultaneously conducted both in Taiwan and in another country. Besides, the required minimum numbers of patients were evaluated during each above phase. Therefore, sponsors who conduct clinical studies in Taiwan and in another country simultaneously could reduce their costs and shorten the NDA process in Taiwan. The new rules aim to encourage international pharmaceutical companies to conduct clinical studies in Taiwan or to conduct such studies cooperatively with Taiwanese pharmaceutical companies. Such interactions will allow Taiwanese pharmaceutical companies to participate in development and implementation of international clinical studies in addition to benefiting from the shortened NDA process. Therefore, the R&D abilities and the internationalization of the Taiwanese pharmaceutical industry will be improved.

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