Introduction to Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials
2023/12/15
The development of digital tools such as the internet, apps, and wearable devices have meant major breakthroughs for clinical trials. These advances have the potential to reduce the frequency of trial subject visits, accelerate research timelines, and lower the costs of drug development. The COVID-19 pandemic has further accelerated the use of digital tools, prompting many countries to adopt decentralized measures that enable trial subjects to participate in clinical trials regardless of their physical location. In step with the transition into the post-pandemic era, the Taiwan Food and Drug Administration (TFDA) issued the Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials in June, 2023[1]. The Guidelines are intended to cover a wide array of decentralized measures; they aim to increase trial subjects’ willingness to participate in trials, reduce the need for in-person visits to clinical trial sites, enhance real-time data acquisition during trials, and enable clinic sponsors and contract research organizations to process data remotely.
I. Key Points of Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials
The Guidelines cover primarily the following matters: General considerations for implementing decentralized measures; trial subject recruitment and electronic informed consent; delivery and provision of investigational medicinal products; remote monitoring of trial subject safety; trial subject reporting of adverse events; remote data monitoring; and information systems and electronic data collection/processing/storage.
1. General Considerations for Implementing Decentralized Measures
(1) During clinical trial execution, a reduction in trial subject in-person visits may present challenges to medical observation. It is recommended that home visits for any given trial subject be conducted by the principal investigator, sub-investigator, or a single, consistent delegated study nurse.
(2) Sponsors must carefully evaluate all of the trial design’s decentralization measures to ensure data integrity.
(3) Sponsors must conduct risk assessments for each individual trial, and must confirm the rationality of choosing decentralized measures. These decentralized measures must also be incorporated into the protocol.
(4) When electronically collecting data, sponsors must ensure information system reliability and data security. Artificial intelligence may be considered for use in decentralized clinical trials; sponsors must carefully evaluate such systems, especially when they touch on determinations for critical data or strategies.
(5) As the design of decentralized clinical trials is to ensure equal access to healthcare services, it must provide patients with a variety of ways to participate in clinical trials.
(6) When implementing any decentralized measures, it is essential to ensure that the principal investigator and sponsor adhere to the Regulations for Good Clinical Practice and bear their respective responsibilities for the trial.
(7) The use of decentralized measures must be stated in the regulatory application, and the Checklist of Decentralized Elements in Medicinal Product Clinical Trials must be included in the submission.
2. Subject Recruitment and Electronic Informed Consent
(1) Trial subject recruitment through social media or established databases may only be implemented after the Institutional Review Board reviews and approves of the recruitment methods and content.
(2) Must comply with the Principles for Recruiting Clinical Trial Subjects in medicinal product trials, the Personal Data Protection Act, and other regulations.
(3) Regarding clinical trial subject informed consent done through digital software or devices, if it complies with Article 4, Paragraph 2 of the Electronic Signatures Act, that is, if the content can be displayed in its entirety and continues to be accessible for subsequent reference, then so long as the trial subject agrees to do so, the signature may be done via a tablet or other electronic device. The storage of signed electronic Informed Consent Forms (eICF) must align with the aforementioned Principles and meet the competent authority’s access requirements.
3. Delivery and Provision of Investigational Medicinal Products
(1) The method of delivering and providing investigational medicinal products and whether trial subjects can use them on their own at home depends to a high degree on the investigational medicinal product’s administration route and safety profile.
(2) When investigational medicinal products are delivered and provided through decentralized measures to trial subjects, this must be documented in the protocol. The process of delivering and providing said products must also be clearly stated in the informed consent form; only after being explained to a trial subject by the trial team, and after the trial subject’s consent is obtained, may such decentralized measures be used.
(3) Investigational products prescribed by the principal investigator/sub-investigator must be reviewed by a delegated pharmacist to confirm that the investigational products’ specific items, dosage, duration, total quantity, and labeling align with the trial design. The pharmacist must also review each trial subject’s medication history, to ensure there are no medication-related issues; only then, and only in a manner that ensures the investigational product’s quality and the subject’s privacy, may delegated and specifically-trained trial personnel provide the investigational product to the subject.
(4) Compliance with relevant regulations such as the Pharmaceutical Affairs Act, Pharmacists Act, Regulations on Good Practices for Drug Dispensation, and Regulations for Good Clinical Practice is required.
4. Remote Monitoring of Subject Safety
(1) Decentralized trial designs involve trial subjects performing relatively large numbers of trial-related procedures at home. The principal investigator must delegate trained, qualified personnel to perform tasks such as collecting blood samples, administering investigational products, conducting safety monitoring, doing adverse event tracking, etc.
(2) If trial subjects receive protocol-prescribed testing at nearby medical facilities or laboratories rather than at the original trial site, these locations must be authorized by the trial sponsor and must have relevant laboratory certification; only then may they collect or analyze samples. Such locations must provide detailed records to the principal investigator, to be archived in the trial master file.
(3) The trial protocol and schedule must clearly specify which visits must be conducted at the trial site; which can be conducted via phone calls, video calls, or home visits; which tests must be performed at nearby laboratories; and whether trial subjects have multiple or single options at each visit.
5. Subject Reporting of Adverse Events
(1) If the trial uses a digital platform to enhance adverse event reporting, trial subjects must be able to report adverse events through the digital platform, such as via a mobile phone app; that is, the principal investigator must be able to immediately access such adverse event information.
(2) The principal investigator must handle such reports using risk-based assessment methods. The principal investigator must validate the adverse event reporting platform’s effectiveness, and must develop procedures to identify potential duplicate reports.
6. Remote Data Monitoring
(1) If a sponsor chooses to implement remote monitoring, it must perform a reasonability assessment to confirm the appropriateness of such monitoring and establish a remote monitoring plan.
(2) The monitoring plan must include monitoring strategies, monitoring personnel responsibilities, monitoring methods, rationale for such implementation, and critical data and processes that must be monitored. It must also generate comprehensive monitoring reports for audit purposes.
(3) The sponsor is responsible for ensuring the implementation of remote monitoring, and must conduct risk assessments regarding the implementation process’ data protection and information confidentiality.
7. Information Systems and Electronic Data Collection, Processing, and Storage
(1) In accordance with the Regulations for Good Clinical Practice, data recorded in clinical trials must be trustworthy, reliable, and verifiable.
(2) It must be ensured that all organizations participating in the clinical trial have a full picture of the data flow. It is recommended that the trial protocol and trial-related documents include data flow diagrams and additional explanations.
(3) Define the types and scopes of subject personal data that will be collected, and ensure that every step in the process properly protects their data in accordance with the Personal Data Protection Act.
II. A Comparison with Decentralized Trial Regulations in Other Countries
Denmark became the first country in the world to release regulatory measures on decentralized trials, issuing the “Danish Medicines Agency’s Guidance on the Implementation of Decentralized Elements in Clinical Trials with Medicinal Products” in September 2021[2]. In December 2022, the European Union as a whole released its “Recommendation Paper on Decentralized Elements in Clinical Trials”[3]. The United States issued the draft “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” document in May 2023[4]. The comparison in Table 1 shows that Taiwan’s guidelines a relatively similar in structure to those of Denmark and the EU; the US guidelines also cover medical device clinical trials.
Table 1: Summary of Decentralized Clinical Trial Guidelines in Taiwan, Denmark, the European Union as a whole, and the United States
|
Taiwan |
Denmark |
European Union as a whole |
United States |
What do the guidelines apply to? |
Medicinal products |
Medicinal products |
Medicinal products |
Medicinal products and medical devices |
Trial subject recruitment and electronic informed consent |
Covers informed consent process; informed consent interview; digital information sheet; trial subject consent form signing; etc. |
Covers informed consent process; informed consent interview; trial subject consent form signing; etc. |
Covers informed consent process; informed consent interview; digital information sheet; trial subject consent form signing; etc. |
Covers informed consent process; informed consent interview; etc. |
Delivery and provision of investigational medicinal products |
Delegated, specifically-trained trial personnel deliver and provide investigational medicinal products. |
The investigator or delegated personnel deliver and provide investigational medicinal products. |
The investigator, delegated personnel, or a third-party, Good Distribution Practice-compliant logistics provider deliver and provide investigational medicinal products. |
The principal investigator, delegated personnel, or a distributor deliver and provide investigational products. |
Remote monitoring of trial subject safety |
Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits, and may undergo testing at nearby laboratories. |
Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits, and may undergo testing at nearby laboratories. |
Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits. |
Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits, and may undergo testing at nearby laboratories. |
Trial subject reporting of adverse events |
Trial subjects may self-report adverse events through a digital platform. |
Trial subjects may self-report adverse events through a digital platform. |
Trial subjects may self-report adverse events through a digital platform. |
Trial subjects may self-report adverse events through a digital platform. |
Remote data monitoring |
The sponsor may conduct remote data monitoring. |
The sponsor may conduct remote data monitoring. |
The sponsor may conduct remote data monitoring (not permitted in some countries). |
The sponsor may conduct remote data monitoring. |
Information systems and electronic data collection, processing, and storage |
The recorded data must be credible, reliable, and verifiable. |
Requires an information system that is validated, secure, and user-friendly. |
The recorded data must be credible, reliable, and verifiable. |
Must ensure data reliability, security, privacy, and confidentiality. |
III. Conclusion
The implementation of decentralized clinical trials must be approached with careful assessment of risks and rationality, with trial subject safety, rights, and well-being as top priorities. Since Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials were just announced in June of this year, the status of decentralized clinical trial implementation is still pending industry feedback to confirm feasibility. The overall goal is to enhance and optimize the clinical trial environment in Taiwan.
Reference:
[1] 衛生福利部食品藥物管理署,〈藥品臨床試驗執行分散式措施指引〉,2023/6/12,https://www.fda.gov.tw/TC/siteListContent.aspx?sid=9354&id=43548(最後瀏覽日:2023/11/2)。
[2] [DMA] DANISH MEDICINES AGENCY, The Danish Medicines Agency’s guidance on the Implementation of decentralised elements in clinical trials with medicinal products (2021), https://laegemiddelstyrelsen.dk/en/news/2021/guidance-on-the-implementation-of-decentralised-elements-in-clinical-trials-with-medicinal-products-is-now-available/ (last visited Nov. 2, 2023).
[3] [HMA] HEADS OF MEDICINES AGENCIES, [EC] EUROPEAN COMMISSION & [EMA] EUROPEAN MEDICINES AGENCY, Recommendation paper on decentralised elements in clinical trials (2022), https://health.ec.europa.eu/latest-updates/recommendation-paper-decentralised-elements-clinical-trials-2022-12-14_en (last visited Nov. 2, 2023).
[4] [US FDA] US FOOD AND DRUG ADMINISTRATION, Decentralized Clinical Trials for Drugs, Biological Products, and Devices (draft, 2023), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/decentralized-clinical-trials-drugs-biological-products-and-devices (last visited Nov. 2, 2023).
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.
New Version of Personal Information Protection Act and Personal Information Protection & Administration SystemI.Summary In 1995, the Computer-Processed Personal Data Protection Law was implemented in the Republic of China. With the constant development of information technology and the limitations in the application of the legislation, the design of the original legal system is no longer consistent with practical requirements. Considering the increasing number of incidents of personal data leaks, discussions were carried out over a long period of time and the new version of the Personal Information Protection Act was passed after three readings in April, 2010. The title of the law was changed to Personal Information Protection Act. The new system has been officially implemented since 1 October, 2012. The new Act not only revised the provisions of the law in a comprehensive way, but also significantly increased the obligations and responsibilities of enterprises. In terms of civil liability, the maximum amount of compensation for a single incident is 200 Million NTD. For domestic industries, how to effectively respond to the requirements under the Personal Information Protection Act and adopt proper corresponding measures to lower the risk has become a key task for enterprise operation. II. Main Points 1. Implementation of the Enforcement Rules of the Personal Information Protection Act Personal information protection can be said the most concerned issue in Taiwan recently. As a matter of fact, the Computer-Processed Personal Data Protection Law was established in Taiwan as early as August 1995. After more than 10 years of development, computer and information technology has evolved significantly, and many emerging business models such as E-commerce are extensively collecting personal data. It has become increasingly important to properly protect personal privacy. However, the previous Computer-Processed Personal Data Protection Law was only applicable to certain industries, i.e. the following 8 specific industries: the credit investigation business, hospital, school, telecommunication business, financial business, securities business, insurance business, and mass media. And other business was designated by the Ministry of Justice and the central government authorities in charge of concerned enterprises. In addition, the law only protected personal information that was processed by “computer or automatic equipment”. Personal information that was not computer processed was not included. There were clearly no sufficient regulations for the protection of personal data privacy and interest. There were numerous incidents of personal data leaks. Among the top 10 consumer news issued by the Consumer Protection Committee of the Executive Yuan in 2007, “incidents of personal data leaks through E-commerce and TV shopping” was on the top of the list. This provoked the Ministry of Justice and the Ministry of Economic Affairs to “jointly designate” the retail industry without physical boutique (including 3 transaction models: online shopping, catalogue shopping and TV shopping) to be governed by the Computer-Processed Personal Data Protection Law since 1 July 2010. To allow the provisions of the personal information protection legal system to meet the environment of rapid change, the Executive Yuan proposed a Draft Amendment to the Computer-Processed Personal Data Protection Law very early and changed the title to the Personal Information Protection Act. The draft was discussed many times in the Legislative Yuan. Personal Information Protection Act was finally passed after three readings in April 2010, which was officially published by the Office of the President on 26 May. Although the new law was passed in April 2010, to allow sufficient time for enterprises and the public to understand and comply the new law, the new version of the personal information protection law was not implemented on the date of publication. In accordance with Article 56 of the Act, the date of implementation was to be further established by the Executive Yuan. After discussions over a long period of time, the Executive Yuan decided for the Personal Information Protection Act to be officially implemented on 1 October 2012. However, the implementation of two articles is withheld: Article 6 of the Act about the principal prohibition against the collection, processing and use of special personal information and Article 54 about the obligation to notice the Party within one year for personal information indirectly acquired before the implementation of the new law. In terms of the personal data protection legal system, other than the most important Personal Data Protection Act, the enforcement rules established in accordance with the main law also play a key role. The previous Enforcement Rules of the Computer-Processed Personal Data Protection Law were published and implemented on 1 May, 1996. Considering that the Computer-Processed Personal Data Protection Law was amended in 2010 and that its title has been changed to the Personal Data Protection Act, the Ministry of Justice also followed the amended provisions under the new law and actively studied the Draft Amendment to the Enforcement Rules of the Computer-Processed Personal Data Protection Act. After it was confirmed that the new version of the Personal Data Protection Act would be officially launched on 1 October 2012, the Ministry of Justice announced officially the amended enforcement rules on 26 September, 2012. The title of the enforcement rules was also amended to the Enforcement Rules of the Personal Data Protection Act. The new version of personal data protection law and enforcement rules was thus officially launched, creating a brand new era for the promotion of personal data protection in Taiwan. II. Personal Data Administration System and Information Privacy Protection Charter Before the amendment to the Personal Data Protection Act was passed, the Legislative Yuan made a proposal to the government in June 2008 to promote a privacy administration and protection certification system in Taiwan, in reference to foreign practices. In August of the following year, the Strategic Review Board of the Executive Yuan passed a resolution to promote the E-Commerce Personal Data Administration and Information Security Action Plan. In December of the same year, approval was granted for the plan to be included in the key government promotion plans from 2010 to 2013. Based on this action plan, since October 2010, the Ministry of Economic Affairs has asked the Institution for Information Industry to execute an E-Commerce Personal Data Administration System Setup Plan. Since 2012, the E-Commerce Personal Data Administration System Promotion Plan and the Taiwan Personal Information Protection and Administration System (TPIPAS) have been established and promoted, with the objective of procuring enterprises to, while complying with the personal data protection legal system, properly protect consumers’ personal information through the establishment of an internal administration mechanism and ensuring that the introducing enterprises meet the requirements of the system. The issuance of the Data Privacy Protection Mark (dp.mark) was also used as an objective benchmark for consumers to judge the enterprise’s ability to maintain privacy. Regarding the introduction of the personal data administration system, enterprises should establish a content administration mechanism step by step in accordance with the Regulations for Taiwan Personal Information Protection and Administration System. Such system also serves as the review benchmark to decide whether domestic enterprises can acquire the Data Privacy Protection Mark (dp.mark). Since domestic enterprises did not have experience in establishing internal personal data administration system in the past, starting 2011, under the Taiwan Personal Information Protection and Administration System, enterprises received assistance in the training of system professionals such as Personal Data Administrators and Personal Data Internal Appraisers. Quality personal data administrators can help enterprises establish complete internal systems. Internal appraisers play the role of confirming whether the systems established by the enterprises are consistent with the system requirements. As of 2012, there are almost 100 enterprises in Taiwan that participate in the training of system staff and a total of 426 administrators and 131 internal appraisers. In terms of the introduction of TPIPAS, in additional to the establishment and introduction of administration systems by qualified administrators, enterprises can also seek assistance from external professional consulting institutions. Under the Taiwan Personal Information Protection and Administration System, applications for registration of consulting institutions became available in 2012. Qualified system consulting institutions are published on the system website. Today 9 qualified consulting institutions have completed their registrations, providing enterprises with personal data consulting services. After an enterprise completes the establishment of its internal administration system, it may file an application for certification under the Taiwan Personal Information Protection and Administration System. The certification process includes two steps: “written review” and “site review”. After the enterprise passing certification, it is qualified to use the Data Privacy Protection Mark (dp.mark). Today 7 domestic companies have passed TPIPAS certification and acquired the dp.mark: 7net, FamiPort, books.com.tw, LOTTE, GOHAPPY, PAYEASY and Sinya Digital, reinforcing the maintenance of consumer privacy information through the introduction of personal data administration system. III. Event Analysis The Taiwan Personal Information Protection and Administration System (TPIPAS) is a professional personal data administration system established based on the provisions of the latest version of the domestic Personal Data Protection Act, in reference to the latest requirements of personal data protection by international organizations and the experience of main countries in promoting personal data administration system. In accordance with the practical requirements to protect personal data by industries, TPIPAS converted professional legal conditions into an internal personal data administration procedure to effectively assist industries to establish a complete and proper personal data administration system and to comply with the requirements of personal data legislations. With the launch of the new version of the Personal Data Protection Act, introducing TPIPAS and acquiring dp.mark are the best strategies for enterprises to lower the risk from the personal data protection law and to upgrade internal personal data administration capability.
Taiwan Recent Regulatory Development- Promoting Biotech and New Pharmaceuticals IndustryOver the past twenty years, the Government has sought to cultivate the biopharmaceutical industry as one of the future major industry in Taiwan. Back in 1982, the Government has begun to regard biotechnology as a key technology in Technology Development Program, demonstrated that biotechnology is a vital technology in pursuit of future economic growth. Subsequently, the Government initiated national programs that incorporated biotechnology as a blueprint for future industrial development. In order to enhance our competitiveness and building an initial framework for the industry, The Executive Yuan has passed the Biotechnology Industry Promotion Plan. As the Government seeks to create future engines of growth by building an environment conducive for enterprise development, the Plan has been amended four times, and implemented measures focused on the following six areas: related law and regulations, R&D and applications, technology transfer and commercialization, personnel training, investment promotion and coordination, marketing information and marketing service. In 2002, the Executive Yuan approved the Challenge 2008, a six-year national development plan, pointing out biotechnology industry as one of the Two Trillion, Twin Stars industries. The Government planned for future economic growth by benefiting through the attributes of the biotechnology: high-tech, high-reward and less pollution. Thus, since 1997 the Strategic Review Board (SRB) under the Executive Yuan Science and Technology Advisory Panel has taken action in coordinating government policies with industry comments to form a sound policy for the biotechnology industry. Additionally, a well-established legal system for sufficient protection of intellectual property rights is the perquisite for building the industry, as the Government recognized the significance through amending and executing related laws and regulations. By stipulating data exclusivity and experimental use exception in the Pharmaceutical Affair Act, tax benefits provided in Statute for Upgrading Industries , Incentives for Production and R&D of Rare Disease Medicine, Incentives for Medical Technology Research and Development, provide funding measures in the Guidance of Reviewing Programs for Promoting Biotechnology Investment. Clearly, the government has great expectation for the industry through establishing a favorable environment by carrying out these policies and revising outdated regulations. Thus, the Legislative Yuan has passed the “Act for The Development of Biotechnology and New Pharmaceuticals Industry” in June, 2007, and immediately took effect in July. The relevant laws and regulations became effective as well, driving the industry in conducting researches on new drugs and manufacturing new products, increasing sales and expanding the industry to meet an international level. For a biopharmaceutical industry that requires long-term investment and costly R&D, incentive measures is vital to the industry’s survival before the product launches the market. Accordingly, this article will be introducing the recent important regulation that supports the biopharmaceutical industry in Taiwan, and analyzing the government’s policies. Biotechnology is increasingly gaining global attention for its potential in building future economic growth and generating significant profits. In an effort to support the biotechnology industry in Taiwan, the Government has made a step forward by enacting the “Act for the Development of Biotech and New Pharmaceutical Industry”. The biopharmaceutical industry is characterized as high-risk and high-reward, strong government support and a well-developed legal system plays a vital role from its establishment throughout the long term development. Therefore, the Act was enacted tailor to the Biotech and New Pharmaceutical Industry, primarily focuses on tax benefits, R&D activities, personnel recruitment and investment funding, in support of start-up companies and attracting a strong flow of funding worldwide. To pave the way for promoting the biopharmaceutical industry and the Biotech and New Pharmaceutical Company, here the article will be introducing the incentive measures provided in the Act, and supporting development of the industry, demonstrating the efforts made by the Government to build a “Bio-tech Island”. Reference “Act for Development of Biotech and New Pharmaceutical Industry”, webpage of Law and Regulations Database of the Republic of China. 4 July, 2007. Ministry of Justice, Taiwan. 5 Nov. 2008 http://law.moj.gov.tw/Eng/Fnews/FnewsContent.asp?msgid=3180&msgType=en&keyword=undefined
The Status of Taiwan's Regulations Concerning with Access to Biological ResourcesPreface In actual practice, the research and development of biotech medicine, food, and environmental products cannot be done by in-lab researches. This is a unique character of the biotechnology industry. To get the research going, the researchers need to search for and exploit new biological materials and, samples outside the lab. Therefore, the access to and management of biological resources have significant impact on the stimulation and development of national biotech industry. Ever since the enforcement of Convention on Biological Diversity (CBD) in 1992 by 172 countries, a general principal about conserving biological diversity and using biological resources has been set. According to CBD, States have sovereign rights over their own biological resources. CBD also encourages each State to access to and manage the biological resources conformed with the principals of conservation, sustainability, NOEL environment friendly, and adequate sharing of benefit arising from biological resources. Therefore, issues such as environmental protection and sustainability have become political issues internationally. If the ABS system for the access to biological resources is designed too strictly, the establishment of the system will make the research and development staffs and related institutions hang back with hesitation both domestically and internationally. Their intention of bioprospecting in the designated country will then be reduced. On the other hand, if the system is designed too loosely, it will not be able to protect the rights of the owner of the resources. As a result, currently, every country holds a cautious attitude in setting up the regulations of managing the access to biological resources. Currently, many countries and regional international organizations already set up ABS system, such as Andean Community, African Union, Association of Southeast Asia Nations (ASEAN), Australia, South Africa, and India, all are enthusiastic with the establishment of the regulations regarding the access management of biological resources and genetic resources. On the other hand, there are still many countries only use traditional and existing conservation-related regulations to manage the access of biological resources. Since it has been more than 10 years that the regulation of access to biological resources and benefit sharing has been developed in some countries, how is Taiwan's current situation regarding this issue? Taiwan's Existing Regulations on the Access to Bioloical Resources In terms of regulations, Taiwan's existing management style of the access to biological resources is similar to that of the US and the EU. It refers to the existing regulations on environmental protection and conservation, and evaluates from the perspective of environmental protection to control and manage the exploitation and application of the related biological resources. These regulations include the Wildlife Conservation Act, theNational Park Law, the Forestry Act, the Cultural Heritage Preservation Act, and the Aboriginal Basic Act. The paragraphs below describe the contents of the acts mentioned that are related to the access to biological resources. 1 、 Wildlife Conservation Act According to the Wildlife Conservation Act, the Protected Species and the products made of cannot be hunted, traded, owned, imported, exported, raised, bred, and processed unless the number of protected wildlife has exceeded the amount the environment permits, or carry the objectives of academic research and education with the permits of central or regional authorities. As for the hunting of General Wildlife, pre-application and approval is needed with the exception of projects based on the objectives of academic research or education. In addition, the import and export of the living wildlife and the products of Protected Wildlife are restricted to the condition of being permitted by management authority. With respect to the import and export of living Protected Wildlife, Academic research institutions and colleagues are the only person who can seek for the approval of management authority before they proceed. 2 、 National Park Law The design and management of Taiwan's national parks are based on the regulations listed in the National Park Law with the purpose of protecting our country's exclusive natural scenery, wildlife and historical spots. Based on the properties and the nature of resources, the national park management structures the preserved area into general control area, playground and resting area, spot of historical interest, special landmark area, and ecological protection area. Ecological protection area refers to the areas where the natural surroundings, creatures, the society they live and propagate are strictly protected only for the research of ecology. According to the regulation of National Park Law, inside the national park area, it is prohibited to hunt animals, fish, take off flowers or trees, not to mention the behaviours that are prohibited by the management authority. Exceptions are made based on the conditions of preserved areas and for the research purposes. In the general control area or resting area, the national park authority allows fishing or other activities agreed by the authority. However, these activities are prohibited in the preserved area of historical interest, special landmark area, and ecological protection area. To suit special purposes, in the special landmark area or ecological protection area, collection of specimens is allowed subject to the approval of authority. Under the purpose of academic research, better management of public safety, and special management of national park, the Ministry of the Interior will permit the collection of specimen. However, to enter the ecological protection area, one must obtain the permission of authority. 3 、 Forestry Act To protect the forest resources and to maximize the public welfare and economic effectiveness, some of the properties are classified as forestry land and being managed by authority. Based on the Forestry Act, management authority has to restrict the area of cutting timber and to identify the area or period of restricted digging of greensward, tree roots, and grass roots, based on the condition of the forest. In addition, to maintain the current ecological environment in the forest, and to preserve the diversity of species, identification of natural preserved area is needed inside the forestland. The entrance and exit of human and vehicles are controlled based on the nature of the resources inside the preserve area. Unless obtaining the approval from the management authority, not a single activity of damaging, logging or digging soil, stones, greensward and roots is allowed. Furthermore, any unauthorized activity of collecting specimen inside the forest recreation area and natural reserve will be fined. Collecting flowers and plants in these areas, or trespassing the natural reserve will also be fined. Only the activities taken by the aborigines to sustain their living or accommodate their customs are not restricted. 4 、 Cultural Heritage Preservation Act The objectives of setting up the Cultural Heritage Preservation Act are to preserve and apply the cultural resources, to enrich the spiritual lives of citizens, and to add glory to the existing diverse cultures. The Cultural Heritage Preservation Act classifies the natural landscape and scenery as cultural assets. Vistas of Natural Culture refer to the natural areas, landforms, plants and mineral which contain the values of preservation. It can be further grouped into natural preserved area and natural monuments. Since the natural monuments include the unusual plants and mineral, it is connected to the management of biological resources. According to the Cultural Heritage Preservation Act, unless approved by the management authority, it is prohibited to collect, log, destroy the plants or bio resources classified as natural monuments or trespass into the area of natural preserve. For the purposes of academic research, or for the memorial ceremony of aboriginal custom, research institute and the aborigines can collect the natural monuments without the approval of authority. 5 、 Aboriginal Basic Act To protect the basic rights of the aborigines, and to sustain and develop the aboriginal society, the Aboriginal Basic Act was designed and enacted. The government not only admits the aborigine's rights in lands and natural resources, but also permits the non-profit behaviour such as hunting of wildlife, colleting of wild plants and fungi for the objective of complying with traditional culture, ceremony or private uses. In addition, the Aboriginal Basic Act provides the requirement of Prior Informed Consent (PIC) to require government or private individual to inform the aborigines before they proceed with land development, resource exploitation, ecological preservation, and academic research in the land where the aborigines live. They need to consult and obtain the aborigines' agreement or participation, and to share the related interests derived from this project. In the case of restricting the aborigine's right of the use of land or natural resources by law, the government,shall consult with the aborigines or the tribe and reach the agreement. When the government wish to design and establish national park, national scenic area, forestry area, ecological protection area, recreational area, or other resource management authorities, the government should obtain the agreement from the local aborigines and to build up the co-management mechanism.