The Research on ownership of cell therapy products
The Research on ownership of cell therapy products
1. Issues concerning ownership of cell therapy products
Regarding the issue of ownership interests, American Medical Association(AMA)has pointed out in 2016 that using human tissues to develop commercially available products raises question about who holds property rights in human biological materials[1]. In United States, there have been several disputes concern the issue of the whether the donor of the cell therapy can claim ownership of the product, including Moore v. Regents of University of California(1990)[2], Greenberg v. Miami Children's Hospital Research Institute(2003)[3], and Washington University v. Catalona(2007)[4]. The courts tend to hold that since cells and tissues were donated voluntarily, the donors had already lost their property rights of their cells and tissues at the time of the donation. In Moore case, even if the researchers used Moore’s cells to obtain commercial benefits in an involuntary situation, the court still held that the property rights of removed cells were not suitable to be claimed by their donor, so as to avoid the burden for researcher to clarify whether the use of cells violates the wishes of the donors and therefore decrease the legal risk for R&D activities. United Kingdom Medical Research Council(MRC)also noted in 2019 that the donated human material is usually described as ‘gifts’, and donors of samples are not usually regarded as having ownership or property rights in these[5]. Accordingly, both USA and UK tends to believe that it is not suitable for cell donors to claim ownership.
2. The ownership of cell therapy products in the lens of Taiwan’s Civil Code
In Taiwan, Article 766 of Civil Code stipulated: “Unless otherwise provided by the Act, the component parts of a thing and the natural profits thereof, belong, even after their separation from the thing, to the owner of the thing.” Accordingly, many scholars believe that the ownership of separated body parts of the human body belong to the person whom the parts were separated from. Therefore, it should be considered that the ownership of the cells obtained from the donor still belongs to the donor. In addition, since it is stipulated in Article 406 of Civil Code that “A gift is a contract whereby the parties agree that one of the parties delivers his property gratuitously to another party and the latter agrees to accept it.”, if the act of donation can be considered as a gift relationship, then the ownership of the cells has been delivered from donor to other party who accept it accordingly.
However, in the different versions of Regenerative Medicine Biologics Regulation (draft) proposed by Taiwan legislators, some of which replace the term “donor” with “provider”. Therefore, for cell providers, instead of cell donors, after providing cells, whether they can claim ownership of cell therapy product still needs further discussion.
According to Article 69 of the Civil Code, it is stipulated that “Natural profits are products of the earth, animals, and other products which are produced from another thing without diminution of its substance.” In addition, Article 766 of the Civil Code stipulated that “Unless otherwise provided by the Act, the component parts of a thing and the natural profits thereof, belong, even after their separation from the thing, to the owner of the thing.” Thus, many scholars believe that when the product is organic, original substance and the natural profits thereof are all belong to the owner of the original substance. For example, when proteins are produced from isolated cells, the proteins can be deemed as natural profits and the ownership of proteins and isolated cells all belong to the owner of the cells[6].
Nevertheless, according to Article 814 of the Civil Code, it is stipulated that “When a person has contributed work to a personal property belonging to another, the ownership of the personal property upon which the work is done belongs to the owner of the material thereof. However, if the value of the contributing work obviously exceeds the value of the material, the ownership of the personal property upon which the work is done belongs to the contributing person.” Thus, scholar believes that since regenerative medical technology, which induces cell differentiation, involves quite complex biotechnology technology, and should be deemed as contributing work. Therefore, the ownership of cell products after contributing work should belongs to the contributing person[7]. Thus, if the provider provides the cells to the researcher, after complex biotechnology contributing work, the original ownership of the cells should be deemed to have been eliminated, and there is no basis for providers to claim ownership.
However, since the development of cell therapy products involves a series of R&D activities, it still need to be clarified that who is entitled to the ownership of the final cell therapy products. According to Taiwan’s Civil Code, the ownership of product after contributing work should belongs to the contributing person. However, when there are numerous contributing persons, which person should the ownership belong to, might be determined on a case-by-case basis.
3. Conclusion
The biggest difference between cell therapy products and all other small molecule drugs or biologics is that original cell materials are provided by donors or providers, and the whole development process involves numerous contributing persons. Hence, ownership disputes are prone to arise.
In addition to the above-discussed disputes, United Kingdom Co-ordinating Committee on Cancer Research(UKCCCR)also noted that there is a long list of people and organizations who might lay claim to the ownership of specimens and their derivatives, including the donor and relatives, the surgeon and pathologist, the hospital authority where the sample was taken, the scientists engaged in the research, the institution where the research work was carried out, the funding organization supporting the research and any collaborating commercial company. Thus, the ultimate control of subsequent ownership and patent rights will need to be negotiated[8].
Since the same issues might also occur in Taiwan, while developing cell therapy products, carefully clarifying the ownership between stakeholders is necessary for avoiding possible dispute.
[1]American Medical Association [AMA], Commercial Use of Human Biological Materials, Code of Medical Ethics Opinion 7.3.9, Nov. 14, 2016, https://www.ama-assn.org/delivering-care/ethics/commercial-use-human-biological-materials (last visited Jan. 3, 2021).
[2]Moore v. Regents of University of California, 793 P.2d 479 (Cal. 1990)
[3]Greenberg v. Miami Children's Hospital Research Institute, 264 F. Suppl. 2d, 1064 (SD Fl. 2003)
[4]Washington University v. Catalona, 490 F 3d 667 (8th Cir. 2007)
[5]Medical Research Council [MRC], Human Tissue and Biological Samples for Use in Research: Operational and Ethical Guidelines, 2019, https://mrc.ukri.org/publications/browse/human-tissue-and-biological-samples-for-use-in-research/ (last visited Jan. 3, 2021).
[6]Wen-Hui Chiu, The legal entitlement of human body, tissue and derivatives in civil law, Angle Publishing, 2016, at 327.
[7]id, at 341.
[8]Okano, M., Takebayashi, S., Okumura, K., Li, E., Gaudray, P., Carle, G. F., & Bliek, J. UKCCCR guidelines for the use of cell lines in cancer research. Cytogenetic and Genome Research, 86(3-4), 1999, https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC2363383&blobtype=pdf (last visited Jan. 3, 2021).
Brief Introduction to Taiwan Social Innovation Policies 2021/09/13 1. Introduction The Millennium Development Goals (MDGs)[1] set forth by the United Nations in 2000 are carried out primarily by nations and international organizations. Subsequently, the Sustainable Development Goals (SDGs) set forth by the United Nations in 2015 started to delegate the functions to organizations of all levels. Presently, there is a global awareness of the importance of balancing “economic growth”, “social progress”, and “environmental protection” simultaneously during development. In the above context, many similar concepts have arisen worldwide, including social/solidarity economy, social entrepreneurship and social enterprise, and social innovation. Generally, social innovation aims to alter the interactions between various groups in society through innovative applications of technology or business models, and to find new ways to solve social problems through such alterations. In other words, the goal is to use innovative methods to solve social problems.The difference between social innovation and social enterprise is that social enterprise combines commercial power to achieve its social mission under a specific perspective, while social innovation creates social value through cooperation with and coordination among technology, resources, and communities under a diversified nature. 2. Overview of Taiwan Social Enterprise Policy To integrate into the global community and assist in the development of domestic social innovation, Taiwan’s Executive Yuan launched the “Social Enterprise Action Plan” in 2014, which is the first policy initiative to support social enterprises (from 2014 to 2016).Under this policy initiative, through consulting with various ministries and applying methods such as “amending regulations”, “building platforms”, and “raising funds”, the initiative set to create an environment with favorable conditions for social innovation and start-ups. At this stage, the initiative was adopted under the principle of “administrative guidance before legislation” in order to encourage private enterprise development without excessive burden, and avoid regulations restricting the development of social enterprises, such as excessive definition of social enterprises. Moreover, for preserving the original types of these enterprises, this Action Plan did not limit the types of social enterprises to companies, non-profit organizations, or other specific types of organizations. To sustain the purpose of the Social Enterprise Action Plan and to echo and reflect the 17 sustainable development goals proposed in SDGs by the United Nations, the Executive Yuan launched the “Social Innovation Action Plan” (effective from 2018 to 2022) in 2018 to establish a friendly development environment for social innovation and to develop diversified social innovation models through the concept of “openness, gathering, practicality, and sustainability”.In this Action Plan, “social innovation” referred to “social innovation organizations” that solve social problems through technology or innovative business models. The balancing of the three managerial goals of society, environment value, and profitability is the best demonstration of the concept of social innovation. 3. Government’s Relevant Social Enterprise Policy and Resources The ministries of the Taiwan Government have been promoting relevant policies in accordance with the Social Innovation Action Plan issued by the Executive Yuan in 2018, such as the “Registration System for Social Innovation Enterprises” (counseling of social enterprises), the “Buying Power - Social Innovation Products and Services Procurement”, the “Social Innovation Platform” established by the Ministry of Economic Affairs, the “Social Innovation Manager Training Courses”, the “Promoting Social Innovation and Employment Opportunities” administered by the Ministry of Labor, and the “University Social Responsibility Program” published by the Ministry of Education. Among the above policies stands out the measures adopted by the Ministry of Economic Affairs, and a brief introduction of those policies are as follows: i. Social Innovation Platform To connect all resources involved in social issues to promote social innovation development in Taiwan, the Ministry of Economic Affairs established the “Social Innovation Platform”.[2] With visibility through the Social Innovation Platform, it has become more efficient to search for targets in a public and transparent way and to assist with the input of resources originally belonging to different fields in order to expand social influence. As a digital platform gathering “social innovation issues in Taiwan,” the Social Innovation Platform covers multiple and complete social innovation resources, which include the “SDGs Map” constructed on the Social Innovation Platform, by which we can better understand how county and city governments in Taiwan implement SDGs and Voluntary Local Review Reports, and which allow us to search the Social Innovation Database[3] and the registered organizations, by which citizens, enterprises, organizations, and even local governments concerned with local development can find their partners expediently as possible, establish service lines to proactively assist public or private entities with their needs/resources, and continue to enable the regional revitalization organizations, ministries, and enterprises to identify and put forward their needs for social innovation through the function of “Social Innovation Proposals”, which assist social innovation organizations with visibility while advancing cooperation and expanding social influence. In addition, the “Event Page” was established on the Social Innovation Platform and offers functions, such as the publishing, searching, and sorting of events in four major dimensions with respect to social innovation organization, governments, enterprises, and citizens; and encourages citizens, social innovation organizations, enterprises, and governments to devote themselves via open participation to continuously expande the influence of the (Civic Technology) Social Innovation Platform. The “Corporate Social Responsibility Report” collects the corporate social responsibility reports, observes the distribution of resources for sustainable development by corporations in Taiwan, offers filtering functions by regions, keyword, popular rankings, and or SDGs types, and provides contact information and a download function for previous years’ reports, in order to effectively assist social innovation organizations to obtain a more precise understanding of the status quo, needs, and trends with respect to their development of respective products and services. Figure 1: SDGs Map Reference: Social Innovation Platform (https://si.taiwan.gov.tw/) Figure 2: Social Innovation Database Reference: Social Innovation Platform (https://si.taiwan.gov.tw/) Figure 3: Social Innovation Proposals Reference: Social Innovation Platform (https://si.taiwan.gov.tw/) Figure 4: Event Page Reference: Social Innovation Platform (https://si.taiwan.gov.tw/) Figure 5: Corporate Social Responsibility Report Reference: Social Innovation Platform (https://si.taiwan.gov.tw/) ii. Social Innovation Database To encourage social innovation organizations to disclose their social missions, products and services, and to guide society to understand the content of social innovation, and to assist the administrative ministries to be able to utilize such information, the Ministry of Economic Affairs issued the “Principles of Registration of Social Innovation Organizations” to establish the “Social Innovation Database”. Once a social innovation organization discloses the items, such as its social missions, business model, or social influence, it may obtain the relevant promotional assistance resources, including becoming a trade partner with Buying Power (Social Innovation Products and Services Procurement), receiving exclusive consultation and assistance from professionals for social innovation organizations, and becoming qualified to apply to entering into the Social Innovation Lab.Moreover, the Ministry of Economic Affairs is simultaneously consolidating, identifying, and designating the awards and grants offered by the various ministries, policies and measures in respect of investment, and financing and assistance, as resources made available to registered entities. As of 25 May 2021, there were 658 registered social innovation organizations and 96 Social Innovation Partners (enterprises with CSR or ESG resources that recognize the cooperation with social innovation under the social innovation thinking model may be registered as a “Social Innovation Partner”).The public and enterprises can search for organizations registered in the Social Innovation Database through the above-said Social Innovation Platform, the search ability of which advances the exposure of and the opportunities for cooperation with social innovation organizations. Figure 6: Numbers of registered social innovation organizations and accumulated value of purchases under Buying Power Reference: Social Innovation Platform(https://si.taiwan.gov.tw/) iii. Buying Power - Social Innovation Products and Services Procurement In order to continue increasing the awareness on social innovation organizations and related issues and promote responsible consumption and production in Taiwan, as well as to raise the attention of the commercial sector to the sustainability-driven procurement models, the Ministry of Economic Affairs held the first “Buying Power - Social Innovation Products and Services Procurement” event in 2017. Through the award system under the Buying Power, it continues to encourage the governments, state-owned enterprises, private enterprises, and organizations to take the lead in purchasing products or services from social innovation organizations, to provide the relevant resources so as to assist social innovation organizations to obtain resources and to explore business opportunities in the markets, to practice responsible consumption and production, and to promote innovative cooperation between all industries and commerce and social innovation organizations. The aim of the implementation of the Buying Power is to encourage the central and local governments, state-owned enterprises, private enterprises, and non-governmental organizations to purchase products or services from organizations registered in the Social Innovation Database, while prizes will be awarded based on the purchase amounts accumulated during the calculation period. The winners can obtain priority in applying for membership in the Social Innovation Partner Group, with corresponding member services, in the future. Under the Social Innovation Platform, both the amount of purchase awards and the number of applicants for special awards continue to increase.So far, purchases have accumulated to a value of more than NT$1.1 billion (see Figure 6), and more than 300 organizations have proactively participated. iv. Social Innovation Mark In order to promote public awareness of social innovation, the Ministry of Economic Affairs has been charged with the commissioned task of promoting the Social Innovation Mark, and issued “ The Small and Medium Enterprise Administration of the Ministry of Economic Affairs Directions for Authorization of the Social Innovation Mark” as the standard for the authorization of the Social Innovation Mark. Social innovation organizations can use the Mark, through obtaining authorization, to hold Social Innovation Summits or other social innovation activities for promoting social innovation concepts. In order to build the Mark as a conceptual symbol of social innovation, the Ministry of Economic Affairs has been using the Social Innovation Mark in connection with various social innovation activities, such as the Social Innovation Platform, the Buying Power, and the annual Social Innovation Summit. Taking the selection of sponsors of the Social Innovation Summit in 2022 as an example[4], only organizations that have obtained authorization of the Social Innovation Mark can use the Mark to hold the Social Innovation Summit. Figure 7: The Social Innovation Mark of the Small and Medium Enterprise Administration, Ministry of Economic Affairs IV. Conclusion The “Organization for Economic Cooperation and Development” (OECD) regards social innovation as a new strategy for solving future social problems and as an important method for youth entrepreneurship and social enterprise development.Taiwan’s social innovation energy has entered a stage of expansion and development. Through the promotion of the “Social Innovation Action Plan,” the resources from the central and local governments are integrated to establish the Social Innovation Platform, the Social Innovation Database, the Social Innovation Lab, and the Social Innovation Mark. In addition, incentives such as the Buying Power have been created, manifesting the positive influence of Taiwan’s social innovation. [1] MDGs are put forward by the United Nations in 2000, and are also the goals requiring all the 191 member states and at least 22 international organizations of the United Nations to be committed to on their best endeavors, including: 1. eradicating extreme poverty and hunger, 2. applying universal primary education, 3. promoting gender equality and empowering women, 4. reducing child mortality rates, 5. improving maternal health, 6. combatting HIV/AIDS, malaria, and other diseases, 7. ensuring environmental sustainability, and 8. establishing a global partnership for development. [2] Please refer to the Social Innovation Platform: https://si.taiwan.gov.tw/. [3] Please refer to the Social Innovation Database: https://si.taiwan.gov.tw/Home/Org_list. [4] Please refer to the guidelines for the selection of sponsors of the 2022 Social Innovation Summit: https://www.moeasmea.gov.tw/files/6221/4753E497-B422-4303-A8D4-35AE0B4043A9
Observing Recent Foreign Developments upon Bio-medicine、 Marketing Medical Devices、Technology Development Project and the Newest Litigation Trend Concerning the Joint Infringement of Method/Process Patents1、Chinese REACH has put into shape, how about Taiwan REACH? - A Perspective of Chinese Measures on Environmental Management of New Chemical Substances Taiwan food industry has been struck by the government agency's disclosure that certain unfaithful manufacturers have mixed toxic chemicals into the food additives for the past 30 years, and the chemicals may seriously threaten public health. This event has not only shocked the confidence of the customers to the industry, but also drew public attention on the well-management and the safe use of chemicals. In order to manage the fast advancing and widely applicable chemical substance appropriately, the laws and regulations among the international jurisprudences in recent years tend to regulate unfamiliar chemicals as “new chemical substances” and leverage registration systems to follow their use and import. REACH is one the most successful models which has been implemented by European Union since 2006. China, one of our most important business partners, has also learned from the EU experience and implemented its amended " Measures on Environmental Management of New Chemical Substances" (also known as "Chinese REACH") last year. It is not only a necessity for our industry which has invested or is running a business in China to realize how this new regulation may influence their business as differently , but also for our authority concerned to observe how can our domestic law and regulation may connect to this international trend. Therefore, except for briefing the content of Chinese REACH, this article may also review those existing law and regulations in Taiwan and observe the law making movement taken by our authority. We expect that the comparison and observation in this article may be a reference for our authorities concerned to map out a better environment for new chemical management. 2、The study on Taiwanese businessmen Join the Bid Invitation and Bidding of Science and Technology Project China government invests great funds in their Science and Technology Project management system, containing most of innovated technology. It also creates the great business opportunity for domestic industry. China government builds up a Bid Invitation and Bidding Procedure in the original Science and Technology Project Regime recent years, in order to make the regime become more open and full of transparency. It also improves Regime to become more fairness and efficiency. Taiwan industry may try to apply for those Science and Technology Project, due to this attractive opportunity, but they should understand china's legal system before they really do that. This Article will introduce the "Bid Invitation and Bidding Law of the Peoples Republic of China", and the "Provisional Regulation on Bid Invitation and Bidding of Science and Technology Project", then clarify applied relationship between the "Bid Invitation and Bidding Law of the Peoples Republic of China", and "Government Procurement Law of the Peoples Republic of China". It also analyzes "Bid Invitation and Bidding Procedure", "Administration of Contract Performance Procedure", "Inspection and Acceptance Procedure", and "Protest and Complaint Procedure, providing complete legal observation and opinion for Taiwan industry finally. Keyword Bid Invitation and Bidding Law of the Peoples Republic of China; Government Procurement Law of the Peoples Republic of China; Provisional Regulation on Bid Invitation and Bidding of Science and Technology Project; Applying for Science and Technology Project Regime; Bid Invitation and Bidding Procedure; Administration of Contract Performance Procedure; Inspection and Acceptance Procedure; Protest and Complaint Procedure. 3、Comparing the Decisions of the United States Supreme Court regarding Preempting Marketing Medical Devices and Drugs from State Tort Litigations with the Decision of a Hypothetical Case in Taiwan The investment costs of complying with pertinent laws and regulations for manufacturing, marketing, and profiting from drugs and medical devices (abbreviated as MD) are far higher than the costs necessary for securing a market permit. The usage of MD products contains the risk of harming their users or the patients, who might sue the manufacturer for damages in the court based on tort law. To help reduce the risk of such litigation, the industry should be aware of the laws governing the state tort litigations and the preemption doctrine of the federal laws of the United States. This article collected four critical decisions by the United States Supreme Court to analyze the requirements of federal preemption from the state tort litigations in these cases. The article also analyzed the issues of preemption in our law system in a hypothetical case. These issues include the competing regulatory requirements of the laws and regulations on the drugs and MDs and the Drug Injury Relief Act versus the Civil Code and the Consumer Protection Law. The article concluded: 1. The pre-market-approval of MD in the United States is exempted from the state tort litigations; 2. Brand-name-drug manufacturers must proactively update the drug label regarding severe risks evidenced by the latest findings; 3. Generic-drug manufacturers are exempted from the product liability litigations and not required to comply with the aforementioned brand-name-drug manufacturers' obligation; 4. No preemption issues are involved in these kinds of product liability litigations in our country; 5. The judge of general court is not bound by the approval of marketing of drug and MD; 6. The judge of general court is not bound by the determination and verdict of the Drug Injury Relief Act. 4、Through Computer-Aided Detection Software, Comparing by Discussing and Analyzing the Regulatory Requirements for Marketing Medical Devices in the United States and in Taiwan Computer-Aided Detection (CADe) software systematically assists medical doctors to detect suspicious diseased site(s) inside patients' bodies, and it would help patients receive proper medical treatments as soon as possible. Only few of this type of medical device (MD) have been legally marketed either in the United States of America (USA) or in Taiwan. This is a novel MD, and the rules regulating it are still under development. Thus, it is valuable to investigate and discuss its regulations. To clarify the requirements of legally marketing the MD, this article not only collects and summarizes the latest draft guidance announced by the USA, but also compares and analyzes the similarities and differences between USA and Taiwan, and further explains the logics that USA applies to clarify and qualify CADe for marketing, so that the Department of Health (DOH) in Taiwan could use them as references. Meanwhile, the article collects the related requirements by the Administrative Procedure Act and by the Freedom of Government Information Law of our nation, and makes the following suggestions on MD regulations to the DOH: creating product code in the system of categorization, providing clearer definition of classification, and actively announcing the (abbreviated) marketing route that secures legal permission for each individual product. 5、A Discussion on the Recent Cases Concerning the Joint Infringement of Method/Process Patents in the U.S. and Japan In the era of internet and mobile communication, practices of a method patent concerning innovative service might often involve several entities, and sometimes the method patent can only be infringed jointly. Joint infringement of method/process patents is an issue needed to be addressed by patent law, since it is assumed that a method patent can only be directly infringed by one entity to perform all the steps disclosed in the patent. In the U.S., CAFC has established the "control or direction" standard to address the issue, but the standard has been criticized and it is under revision now. In Japan, there is no clearly-established standard to address the issue of joint infringement, but it seems that the entity that controls and benefits from the joint infringement might be held liable. Based on its discussion about the recent development in the U.S. and Japan, this article attempts to provide some suggestions for inventors of innovative service models to use patents to protect their inventions properly: they should try to avoid describing their inventions in the way of being practiced by multi-entities, they should try to claim both method and system/apparatus inventions, and they should try to predict the potential infringement of their patents in order to address the problem of how to prove the infringement.
Recommendation of the Regulations on the Legal and Effective Access to Taiwan’s Biological ResourcesPreface Considering that, 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. Can Taiwan's regulations comply with the purposes and objects of CBD? Is there a need for Taiwan to set up specific regulations for the management of these access activities? This article plans to present Taiwan's regulations and review the effectiveness of the existing regulations from the aspect of enabling the legal and effective access to biological resources. A recommendation will be made on whether Taiwan should reinforce the management of the bio-resources access activities. Review and Recommendation of the Regulations on the Legal and Effective Access to Taiwan's Biological Rersearch Resources （1）Evaluate the Needs and Benefits before Establishing the Regulation of Access Rights When taking a look at the current development of the regulations on the access of biological resources internationally, we discover that some countries aggressively develop designated law for access, while some countries still adopt existing regulations to explain the access rights. Whether to choose a designated law or to adopt the existing law should depend on the needs of establishing access and benefit sharing system. Can the access and benefit sharing system benefit the functioning of bio-technological research and development activities that link closely to the biological resources? Can the system protect the interests of Taiwan's bio-research results? In Taiwan, in the bio-technology industry, Agri-biotech, Medical, or Chinese Herb Research & Development are the key fields of development. However, the biological resources they use for the researches are mainly supplied from abroad. Hence, the likelihood of violating international bio-piracy is higher. On the contrary, the incidence of international research houses searching for the biological resources from Taiwan is comparatively lower, so the possibility for them to violate Taiwan's bio-piracy is very low. To look at this issue from a different angle, if Taiwan establishes a separate management system for the access of biological resources, it is likely to add more restrictions to Taiwan's bio-tech R&D activities and impact the development of bio-industry. Also, under the new management system, international R&D teams will also be confined, if they wish to explore the biological resources, or conduct R&D and seek for co-operation activities in Taiwan. Not to mention that it is not a usual practice for international R&D teams to look for Taiwan's biological resources. A new management system will further reduce their level of interest in doing so. In the end, the international teams will then shift their focus of obtaining resources from other countries where the regulation on access is relatively less strict. Before Taiwan establishes the regulations on the legal and effective access to bio-research resources, the government should consider not only the practical elements of the principal on the fair and impartial sharing of the derived interests from bio-research resources, but also take account of its positive and negative impacts on the development of related bio-technological industries. Even if a country's regulation on the access and benefit sharing is thorough and comprehensive enough to protect the interests of bio-resource provider, it will, on the contrary, reduce the industry's interest in accessing the bio-resources. As a result, the development of bio-tech industry will be impacted and the resource provider will then be unable to receive any benefits. By then, the goal of establishing the regulation to benefit both the industry and resource provider will not be realized. To sum up, it is suggested to evaluate the suitability of establishing the management system for the access to biological resources through the cost-effect analysis first. And, further consider the necessity of setting up regulations by the access the economic benefits derived from the regulation for both resource provider and bio-tech industry. （2）The Feasibility of Managing the access to Bio-research Resources from existing Regulations As analysed in the previous paragraphs, the original intention of setting up the Wildlife Conservation Act, National Park Law, Forestry Act, Cultural Heritage Preservation Act, and Aboriginal Basic Act is to protect the environment and to conserve the ecology. However, if we utilize these traditional regulations properly, it can also partially help to manage the access to biological resources. When Taiwan's citizens wish to enter specific area, or to collect the biological resources within the area, they need to receive the permit from management authority, according to current regulations. Since these national parks, protection areas, preserved areas, or other controlled areas usually have the most comprehensive collections of valuable biological resources in a wide range of varieties, it is suggested to include the agreements of access and benefit sharing as the mandatory conditions when applying for the entrance permit. Therefore, the principal of benefit sharing from the access to biological resources can be assured. Furthermore, the current regulations already favour activities of accessing biological resources for academic research purpose. This practice also ties in with the international trend of separating the access application into two categories - academic and business. Australia's practice of access management can be a very good example of utilizing the existing regulations to control the access of resources. The management authority defines the guidelines of managing the entrance of control areas, research of resources, and the collection and access of resources. The authority also adds related agreements, such as PIC (Prior Informed Consent), MTA (Material Transfer Agreement), and benefit sharing into the existing guidelines of research permission. In terms of scope of management, the existing regulation does not cover all of Taiwan's bio-research resources. Luckily, the current environmental protection law regulates areas with the most resourceful resources or with the most distinctive and rare species. These are often the areas where the access management system is required. Therefore, to add new regulation for access management on top of the existing regulation is efficient method that utilizes the least administrative resources. This could be a feasible way for Taiwan to manage the access to biological resources. （3）Establish Specific Regulations to Cover the Details of the Scope of Derived Interests and the Items and Percentage of Funding Allocation In addition to the utilization of current regulations to control the access to biological resources, many countries establish specific regulations to manage the biological resources. If, after the robust economic analysis had been done, the country has come to an conclusion that it is only by establishing new regulations of access management the resources and derived interests of biological resources can be impartially shared, the CBD (Convention of Bio Diversity), the Bonn Guidelines, or the real implementation experiences of many countries can be an important guidance when establishing regulations. Taiwan has come up with the preliminary draft of Genetic Resources Act that covers the important aspects of international access guidelines. The draft indicates the definition and the scope of access activities, the process of access applications (for both business and academic purpose), the establishment of standardized or model MTA, the obligation of disclosing the sources of property rights (patents), and the establishment of bio-diversity fund. However, if we observe the regulation or drafts to the access management of the international agreements or each specific country, we can find that the degree of strictness varies and depends on the needs and situations. Generally speaking, these regulations usually do not cover some detailed but important aspects such as the scope of derived interests from biological resources, or the items and percentage of the allocation of bio-diversity fund. Under the regulation to the access to biological resources, in addition to the access fee charge, the impartial sharing of the derived interests is also an important issue. Therefore, to define the scope of interests is extremely important. Any interest that is out of the defined scope cannot be shared. The interest stated in the existing regulation generally refers to the biological resources or the derived business interests from genetic resources. Apart from describing the forms of interest such as money, non-money, or intellectual property rights, the description of actual contents or scope of the interests is minimal in the regulations. However, after realizing the importance of bio-diversity and the huge business potential, many countries have started to investigate the national and international bio-resources and develop a database system to systematically collect related bio-research information. The database comprised of bio-resources is extremely useful to the activities related to bio-tech developments. If the international bio-tech companies can access Taiwan's bio-resource database, it will save their travelling time to Taiwan. Also, the database might as well become a product that generates revenues. The only issue that needs further clarification is whether the revenue generated from the access of database should be classified as business interests, as defined in the regulations. As far as the bio-diversity fund is concerned, many countries only describe the need of setting up bio-diversity funds in a general manner in the regulations. But the definition of which kind of interests should be put into funds, the percentage of the funds, and the related details are not described. As a result, the applicants to the access of bio-resources or the owner of bio-resources cannot predict the amount of interests to be put into bio-diversity fund before they actually use the resources. This issue will definitely affect the development of access activities. To sum up, if Taiwan's government wishes to develop the specific regulations for the access of biological resources, it is advised to take the above mentioned issues into considerations for a more thoroughly described, and more effective regulations and related framework. Conclusion In recent years, it has been a global trend to establish the regulations of the access to and benefit sharing of bio-resources. The concept of benefit sharing is especially treated as a useful weapon for the developing countries to protect the interests of their abundant bio-research resources. However, as we are in the transition period of changing from free access to biological resources to controlled access, we are facing different regulations within one country as well as internationally. It will be a little bit disappointing for the academic research institution and the industry who relies on the biological resources to conduct bio-tech development if they do not see a clear principal direction to follow. The worse case is the violation of the regulation of the country who owns the bio-resources when the research institutions try to access, exchange, or prospect the biological resources without thorough understanding of related regulations. For some of Taiwan's leading fields in the bio-tech industry, such as Chinese and herbal medicine related products, agricultural products, horticultural products, and bio-tech products, since many resources are obtained from abroad, the incidence of violation of international regulation will increase, and the costs from complying the regulations will also increase. Therefore, not only the researcher but also the government have the responsibility to understand and educate the related people in Taiwan's bio-tech fields the status of international access management regulations and the methods of legally access the international bio-research resources. Currently in Taiwan, we did not establish specific law to manage the access to and benefit sharing of bio-resources. Comparing with the international standard, there is still room of improvement for Taiwan's regulatory protection to the provider of biological resources. However, we have to consider the necessity of doing so, and how to do the improvement. And Taiwan's government should resolve this issue. When we consider whether we should follow international trend to establish a specific law for access management, we should always go back to check the potential state interests we will receive and take this point into consideration. To define the interests, we should always cover the protection of biological resources, the development of bio-tech industry, and the administrative costs of government. Also the conservation of biological resources and the encouragement of bio-tech development should be also taken into consideration when the government is making decisions. In terms of establishing regulations for the access to biological resources and the benefit sharing, there are two possible solutions. The first solution is to utilize the existing regulations and add the key elements of access management into the scope of administrative management. The work is planned through the revision of related current procedures such as entrance control of controlled areas and the access of specific resources. The second solution is to establish new regulations for the access to biological resources. The first solution is relatively easier and quicker; while the second solution is considered to have a more comprehensive control of the issue. The government has the final judgement on which solution to take to generate a more effective management of Taiwan's biological resources.
The Key Elements for Data Intermediaries to Deliver Their PromiseThe Key Elements for Data Intermediaries to Deliver Their Promise 2022/12/13 As human history enters the era of data economy, data has become the new oil. It feeds artificial intelligence algorithms that are disrupting how advertising, healthcare, transportation, insurance, and many other industries work. The excitement of having data as a key production input lies in the fact that it is a non-rivalrous good that does not diminish by consumption.[1] However, the fact that people are reluctant in sharing data due to privacy and trade secrets considerations has been preventing countries to realize the full value of data. [2] To release more data, policymakers and researchers have been exploring ways to overcome the trust dilemma. Of all the discussions, data intermediaries have become a major solution that governments are turning to. This article gives an overview of relevant policy developments concerning data intermediaries and a preliminary analysis of the key elements that policymakers should consider for data intermediaries to function well. I. Policy and Legal developments concerning data intermediaries In order to unlock data’s full value, many countries have started to focus on data intermediaries. For example, in 2021, the UK’s Department for Digital, Culture, Media and Sport (DCMS) commissioned the Centre for Data Ethics and Innovation (CDEI) to publish a report on data intermediaries[3] , in response to the 2020 National Data Strategy.[4] In 2020, the European Commission published its draft Data Governance Act (DGA)[5] , which aims to build up trust in data intermediaries and data altruism organizations, in response to the 2020 European Strategy for Data.[6] The act was adopted and approved in mid-2022 by the Parliament and Council; and will apply from 24 September 2023.[7] The Japanese government has also promoted the establishment of data intermediaries since 2019, publishing guidance to establish regulations on data trust and data banks.[8] II. Key considerations for designing effective data intermediary policy 1.Evaluate which type of data intermediary works best in the targeted country From CDEI’s report on data intermediaries and the confusion in DGA’s various versions of data intermediary’s definition, one could tell that there are many forms of data intermediaries. In fact, there are at least eight types of data intermediaries, including personal information management systems (PIMS), data custodians, data exchanges, industrial data platforms, data collaboratives, trusted third parties, data cooperatives, and data trusts.[9] Each type of data intermediary was designed to combat data-sharing issues in specific countries, cultures, and scenarios. Hence, policymakers need to evaluate which type of data intermediary is more suitable for their society and market culture, before investing more resources to promote them. For example, data trust came from the concept of trust—a trustee managing a trustor’s property rights on behalf of his interest. This practice emerged in the middle ages in England and has since developed into case law.[10] Thus, the idea of data trust is easily understood and trusted by the British people and companies. As a result, British people are more willing to believe that data trusts will manage their data on their behalf in their best interest and share their valuable data, compared to countries without a strong legal history of trusts. With more people sharing their data, trusts would have more bargaining power to negotiate contract terms that are more beneficial to data subjects than what individual data owners could have achieved. However, this model would not necessarily work for other countries without a strong foundation of trust law. 2.Quality signals required to build trust: A government certificate system can help overcome the lemon market problem The basis of trust in data intermediaries depends largely on whether the service provider is really neutral in its actions and does not reuse or sell off other parties’ data in secret. However, without a suitable way to signal their service quality, the market would end up with less high-quality service, as consumers would be reluctant to pay for higher-priced service that is more secure and trustworthy when they have no means to verify the exact quality.[11] This lemon market problem could only be solved by a certificate system established by actors that consumers trust, which in most cases is the government. The EU government clearly grasped this issue as a major obstacle to the encouragement of trust in data intermediaries and thus tackles it with a government register and verification system. According to the Data Government Act, data intermediation services providers who intend to provide services are required to notify the competent authority with information on their legal status, form, ownership structure, relevant subsidiaries, address, public website, contact details, the type of service they intend to provide, the estimated start date of activities…etc. This information would be provided on a website for consumers to review. In addition, they can request the competent authority to confirm their legal compliance status, which would in turn verify them as reliable entities that can use the ‘data intermediation services provider recognised in the Union’ label. 3.Overcoming trust issues with technology that self-enforces privacy: privacy-enhancing technologies (PETs) Even if there are verified data intermediation services available, businesses and consumers might still be reluctant to trust human organizations. A way to boost trust is to adopt technologies that self-enforces privacy. A real-world example is OpenSAFELY, a data intermediary implementing privacy-enhancing technologies (PETs) to provide health data sharing in a secure environment. Through a federated analytics system, researchers are able to conduct research with large volumes of healthcare data, without the ability to observe any data directly. Under such protection, UK NHS is willing to share its data for research purposes. The accuracy and timeliness of such research have provided key insights to inform the UK government in decision-making during the COVID-19 pandemic. With the benefits it can bring, unsurprisingly, PETs-related policies have become quite popular around the globe. In June 2022, Singapore launched its Digital Trust Centre (DTC) for accelerating PETs development and also signed a Memorandum of Understanding with the International Centre of Expertise of Montreal for the Advancement of Artificial Intelligence (CEIMIA) to collaborate on PETs.[12] On September 7th, 2022, the UK Information Commissioners’ Office (ICO) published draft guidance on PETs.[13] Moreover, the U.K. and U.S. governments are collaborating on PETs prize challenges, announcing the first phase winners on November 10th, 2022.[14] We could reasonably predict that more PETs-related policies would emerge in the coming year. [1] Yan Carrière-Swallow and Vikram Haksar, The Economics of Data, IMFBlog (Sept. 23, 2019), https://blogs.imf.org/2019/09/23/the-economics-of-data/#:~:text=Data%20has%20become%20a%20key,including%20oil%2C%20in%20important%20ways (last visited July 22, 2022). [2] Frontier Economics, Increasing access to data across the economy: Report prepared for the Department for Digital, Culture, Media, and Sport (2021), https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/974532/Frontier-access_to_data_report-26-03-2021.pdf (last visited July 22, 2022). [3] The Centre for Data Ethics and Innovation (CDEI), Unlocking the value of data: Exploring the role of data intermediaries (2021), https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1004925/Data_intermediaries_-_accessible_version.pdf (last visited June 17, 2022). [4] Please refer to the guidelines for the selection of sponsors of the 2022 Social Innovation Summit: https://www.gov.uk/government/publications/uk-national-data-strategy/national-data-strategy(last visited June 17, 2022). [5] Regulation of the European Parliament and of the Council on European data governance and amending Regulation (EU) 2018/1724 (Data Governance Act), 2020/0340 (COD) final (May 4, 2022). [6] Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and The Committee of the Regions— A European strategy for data, COM/2020/66 final (Feb 19, 2020). [7] Proposal for a Regulation on European Data Governance, European Parliament Legislative Train Schedule, https://www.europarl.europa.eu/legislative-train/theme-a-europe-fit-for-the-digital-age/file-data-governance-act(last visited Aug 17, 2022). [8] 周晨蕙，〈日本資訊信託功能認定指引第二版〉，科技法律研究所，https://stli.iii.org.tw/article-detail.aspx?no=67&tp=5&d=8422（最後瀏覽日期︰2022/05/30）。 [9] CDEI, supra note 3. [10] Ada Lovelace Institute, Exploring legal mechanisms for data stewardship (2021), 30~31,https://www.adalovelaceinstitute.org/wp-content/uploads/2021/03/Legal-mechanisms-for-data-stewardship_report_Ada_AI-Council-2.pdf (last visited Aug 17, 2022). [11] George A. Akerlof, The Market for "Lemons": Quality Uncertainty and the Market Mechanism, THE QUARTERLY JOURNAL OF ECONOMICS, 84(3), 488-500 (1970). [12] IMDA, MOU Signing Between IMDA and CEIMIA is a Step Forward in Cross-border Collaboration on Privacy Enhancing Technology (PET) (2022),https://www.imda.gov.sg/-/media/Imda/Files/News-and-Events/Media-Room/Media-Releases/2022/06/MOU-bet-IMDA-and-CEIMIA---ATxSG-1-Jun-2022.pdf (last visited Nov. 28, 2022). [13] ICO publishes guidance on privacy enhancing technologies, ICO, https://ico.org.uk/about-the-ico/media-centre/news-and-blogs/2022/09/ico-publishes-guidance-on-privacy-enhancing-technologies/ (last visited Nov. 27, 2022). [14] U.K. and U.S. governments collaborate on prize challenges to accelerate development and adoption of privacy-enhancing technologies, GOV.UK, https://www.gov.uk/government/news/uk-and-us-governments-collaborate-on-prize-challenges-to-accelerate-development-and-adoption-of-privacy-enhancing-technologies (last visited Nov. 28, 2022); Winners Announced in First Phase of UK-US Privacy-Enhancing Technologies Prize Challenges, NIST, https://www.nist.gov/news-events/news/2022/11/winners-announced-first-phase-uk-us-privacy-enhancing-technologies-prize (last visited Nov. 28, 2022).
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