Back                                                                                                                                                                                                                Home

 

 

A (Draft) Proposal for Ph.D. Research in Law

 

 

INTELLECTUAL PROPERTY RIGHTS AND BIODIVERSITY-RELATED ISSUES

IN DEVELOPING COUNTRIES: A CASE STUDY ON CHINA

- FROM A EUROPEAN AND INTERNATIONAL PERSPECTIVE

 

by Feng (Jerry) XIA, LL.M.*

 

(Proposed) Promotor: Prof. Mr. Charles GIELEN

 

Download in Word Format

 

 

 

* LL.M., Erasmus University Rotterdam, the Netherlands

Postgraduate Certificate of Copyright Law, Utrecht University, the Netherlands

LL.B., Peking University, China

B.E., Beijing University of Chemical Technology, China

 

 

 

Revised on October 28, 2002

 

Gelkingestraat 20, 9711 NC, Groningen, the Netherlands

Tel: +31(0) 6 1548 7509  Fax: +31(0) 50 311 7087

Email: jerry_summer@justice.com

Website: https://www.angelfire.com/folk/jerry

 

 

 

CONTENTS

 

·         INTRODUCTION TO THE FIELD OF STUDY

·         RESEARCH BACKGROUND AND SIGNIFICANCE

·         RESEARCH FOCUS AND AIMS

·         RESEARCH QUESTIONS

·         ENVISAGED STRUCTURE OF DISSERTATION

·         RESEARCH METHODOLOGY

·         TENTATIVE BIBLIOGRAPHY

 

 

INTRODUCTION TO THE FIELD OF STUDY

 

The relationship between intellectual property rights (IPR) and biodiversity-related issues, including biotechnology that is developed on the basis of genetic resources has been widely touched upon in the European Union (EU) and international legal community during recent years.[1] For instance, there have been a number of concerns raised as to how the EU-Directive 98/44/EC on biotechnology patenting may affect access to the human genome data and possible restrictions on the research and applications for which this data could be used.[2] The discussion is, however, not only on the situation inside the EU or the rest of the Western world such as the United States, but much more frequently, is directed towards the cases of major developing countries in Asia, Africa and South America such as China, Brazil, Mexico, etc. because more than 80% of genetic resources worldwide are located in these developing countries. Although biodiversity is our most valuable resource, it is often least appreciated and its existence, along with other types of traditional knowledge and expressions of folklore, is increasingly endangered, for a variety of reasons. Besides, the present innovation regulations also seem to lag far behind the fast advancement of biotechnology, especially in agricultural and pharmaceutical industries. International community has therefore realized the keen need to confer an effective and internationally recognized vehicle of legal protection on genetic resources and biotechnology and there is a consensus that the assignment of property rights, inter alia, intellectual property rights may do the job well. Some most important endeavors that have been done by international IP community include the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (e.g., Art. 27.3(b)) and the 1992 Convention on Biological Diversity (CBD) (e.g., Art. 8(j)). Nonetheless, this job can never be easily done in reality as can be articulated in lines. The capability of self-reproduction of plants, animals, insects, micro-organisms and other biological material as carrier of genetic information clearly reveals the limits of claiming the ownership; once acquired, either legally or not, it is impossible for the original owner to prove that the genetic information used was exclusively his or hers, e.g., seeds recovered for use for further propagation, genes isolated for producing transgenic animals or plants, or for producing valuable proteins through cell culture, or for the synthetic production of valuable, active biochemical substances, and the like. Furthermore, not only whether or not and to what extent we should appropriate the current IP regimes in developing countries in order to accommodate biological resources and inventions have received numerous divergent voices but often beyond that, when reviewing a fact that most developing countries that host rich genetic resources have not been able to gain from their exploitation while the industrialized Western world has apparently been successful, the issue is sometimes further complicated to be a long-lasting controversy between the North and the South, and also entangled with other N-S issues such as technology transfer, environment, international trade, foreign direct investment (FDI), human rights, poverty, etc.

 

The EU, as one most important component of the North, has been extensively involved in such issues since it plays a key role in world’s research and development (R& D) of biotechnology for agriculture, food and pharmaceuticals and accounts for a considerable portion of international trade in such industries, especially with developing countries. Once upon a time, for example, some bio-industries within the EU were alleged by a few bio-diverse developing countries on “prospecting” for their species in order to patent or sell them without offering concessions or benefits for local people, which we sometimes refer to as “bio-piracy”. Thus, the EU has on many occasions expressed its sensitivity to the concerns raised by developing countries with respect to genetic resources, traditional knowledge and expressions of folklore, particularly in the context of intellectual property protection.[3]

 

However, the collective term “developing countries” is sometimes in itself already too sweeping: it takes in countries so different in economic and social terms and neglects such important specific political and cultural circumstances as to preclude generalizations. Hence, focusing becomes an absolute necessity for a fruitful study in this field. Based on such an understanding this research will look into the topic by conducting a specific case study on China, the world’s largest developing country with a tremendous amount of biodiversity. Even more specifically, discussions will be made primarily from a European and international perspective, i.e., the paper will seek to examine the state of biodiversity and biotechnology in China against the existing Chinese IP regime and study how the emerging international instruments in this regard may compare with and fit into the present situation in China, particularly in contrast to the current practice and opinions of the EU and, last and also most importantly, analyze how some possible approaches to the issues, mostly in the context of IP protection, may affect technology development, agriculture, relevant industry, environment, international trade, legal reform as well as international relations and other relevant mutual policies between the South and the North.

 

Back to Contents

 

RESEARCH BACKGROUND AND SIGNIFICANCE

 

China has been selected as a case study country for a number of reasons. First, China is the largest developing country and also one of the countries with richest biodiversity in the world. There are more than 30,000 species of higher plants and 6,347 species of vertebrate, accounting for 10% and 14% respectively of the world total.[4] In particular, such abundant biological resources have contributed significantly to the development of Traditional Chinese Medicine (TCM), which serves a natural remedy for a variety of illnesses for individuals in both rural and urban communities locally and worldwide. Therefore, China is a most representative country for the study of biodiversity conservation. Second, biodiversity in China is now under serious threat due to its large population, economic underdevelopment, contradictions between conservation and exploitation, excessive utilization of biological resources and fragmentation of the natural habitats. Therefore, it is very timely and important for lawmakers and scholars, within and outside China, to think about new and appropriate regulatory measures to ready the crisis, for example, under the IP regime. As an evidence of China’s endeavors in this respect, on February 19, 2002, China, together with Brazil, India, and nine other of the world's most bio-diverse countries, signed an alliance for fighting bio-piracy and pressing for rules protecting their people's rights to genetic resources found on their lands.[5] Third, China is a developing country with a large agricultural sector and also one of the biggest providers of agricultural products and food in international markets. China plays an important role in the R&D and commercialization of agricultural biotechnology. For example, China is one of the first countries that commercialized the Genetically Modified (GM) crops and now ranges as the fourth largest country in term of sown area of GM crops, just after USA, Argentina, and Canada. Therefore, to study how to shape an appropriate vehicle of legal protection such as IP law in order to offer necessary incentives for further biotechnology development in China has proven to be a very meaningful initiative. Fourth, with China’s accession to the World Trade Organization (WTO) in 2001, tailoring Chinese IP regime into conformity with the requirements of the WTO TRIPS Agreement has been a widely concerned topic by global legal scholars and international investors while so far little has been written on how this should respond to and affect the protection of biodiversity and biotechnology and as a result, how it may in turn influence the further economic and legal reforms, international trade, foreign investment, human rights situation, etc., in China. So from a scholarly point of view such a case study may generate added values and have implications for other developing countries and relevant international institutions.

 

From the EU side, as envisaged, a case study on China with regard to the relationship between biodiversity, biotechnology and IP protection will be able to serve a valuable reference in many aspects. As to trading relations, China is the EU’s third trading partner after the US and Japan, and the EU is China's second largest export market. Mutual agricultural and food trade is even the largest sector. Over the last three years the EU restrictions on imports of some Chinese biological products, for example, animal products and GM crops, including the health and environment concerns involved therewith, have raised extensive trade disputes between the two sides; EU companies have also invested considerably in China during recent years (new annual flows of utilized FDI of around USD 4.5 on average in the last 5 years), bringing up stocks of EU FDI to over USD 25 billion.[6] Understandably, China’s biotechnology policies will accordingly affect EU’s FDI flows to biotechnology-related industries in China; In the field of R&D, cooperation between the EU and China in biotechnology has already been among the most fruitful areas during the past few years. Important initiatives and projects include, for example, EBNIC (European Biotechnology Node for Interaction with China) and EFBIC (European Focus on Biotechnology in China)[7]. Moreover, the legal reform in China, especially the shaping of Chinese IP regime according to the international standards, has draw tremendous attention from the EU at various levels with reference made to the EU external policy to China. For example, the European Chamber of Commerce in China (EUCCC), in association with the EU-China IPR Cooperation Programme, issues annual working paper on IPR situation in China.[8] At another point, looking into the patenting possibilities for biological inventions in China may also bring meaningful implications for further modification and implementation of the EU Bio-patenting Directive (98/44/EC). Taking all this collectively and in order to allow the Commission and member states to balance their IPR and biodiversity objectives within the broad range of national and EU interests, the EU has been recommended by many relevant advisory bodies to study such a relationship in non-EU jurisdictions with different socio-economic conditions, particularly in bio-diverse developing countries and if necessary, also provide these countries with assistance to develop appropriate regulatory measures, for example, sui generis systems for plant variety protection.[9] Against this background, such a research shall be deemed quite timely and of significance.

 

Back to Contents

 

RESEARCH FOCUS AND AIMS

 

This research will focus on the discussion on tailoring IP protection in China in the context of biodiversity and biotechnology. In addition to looking into the legal nature of biological things under Chinese regulatory system, particular but not exclusive focus will be on the ethical and ecological aspects as well as the likely legal, cultural, social and economic effects of applying relevant international IP rules to biodiversity and biotechnology in China. Major references will be made to environmental, health, agricultural, industrial considerations that this topic may raise. With much comparison made with the current EU practice and opinions, both at the Union level and the national level, for example, the Netherlands[10], Belgium[11], etc. the paper will also in-depthly analyze how this issue may relate to China’s external policy and international trade with the Western world.

 

The proposed study aims, based on a comprehensive examination of the biodiversity status, legal background and present regulatory systems in China, to study the need, feasibility and appropriation of incorporating international IP standards regarding biological resources protection in major bio-diverse developing countries and to come up with recommended approaches to the key issues for relevant authorities from legislative and practical points of views. Since such a case study will be conducted on a specific country, China and primarily from an EU perspective, it has been hoped that the study will in the first place be able to provide a reference for China and the EU in formulating their biotechnology regulations and policies; secondly, offer implications for other developing and industrialized countries and international organizations concerned about the issue and also enrich the global scholarship in this area; last but not least, contribute to some degree to the developing bilateral relations and understanding between the EU and China.

 

Back to Contents

 

RESEARCH QUESTIONS

 

Within the general framework specified above, the main but non-exhaustive research questions include:

 

1)      What are the general linkages between IPR and biodiversity-related issues? What international and regional endeavors have been taken in this respect? For example, TRIPS, CBD, UPOV (The International Union of New Varieties of Plants), IU (The International Undertaking on Plant Genetic Resources), etc.

2)      What is the present state of biodiversity and biotechnology in China? What roles do they play in China’s society and economy?

3)      How do the existing Chinese national rules and policies regulate the use and access to TCM and its genetic resources? What attempts and measures has China taken in order to implement the CBD in terms of its equitable sharing objective?

4)      What is the legal nature of biological resources and indigenous knowledge under the current Chinese IP system? Do they have property rights? If yes, who can claim for ownership and who shall benefit from their exploitation? etc. In China a traditional point of view is that genetic resources are a common heritage available for free use by all interested parties. How does this tradition contrast to the international trend of assigning property rights to traditional knowledge? What kind of political concerns shall be taken into account?

5)      What are the difficulties and benefits of patenting biological materials in China? Can a biological invention such as a product or process of genetic engineering be patented under the current Chinese patent law? What about human genetic materials? What moral and social concerns may be raised here? What environmental effects of patenting genetically engineered agricultural products shall be weighed? How does it compare with the EU bio-patenting directive?

6)      How does Article 27.3(b) of the TRIPS Agreement apply to China? Has China developed a sui generis system, for example, Plant Breeders’ Rights (PBR), for plant variety protection based on its current plant variety regulations? What are the social effects of applying plant variety protection (PVP) regimes on farming systems in China?

7)      Did restrictions in access to certain plants, animals, designs, or processes arise from a concern to protect intellectual property or did they come from a need to conserve scarce resources or to allocate social responsibilities within communities? What is the point of view of China?

8)      Should China’s IP regime develop its own norms governing biodiversity and biotechnology under the framework of TRIPS, or completely follow a developed country’s approach, for example, the EU approach considering their similar civil law jurisdiction?

9)      How would IP protection affect the R&D and investment in biodiversity-related industries in China, such as agriculture, pharmaceuticals, etc.? For example, some have argued that China has been absorbing the greater part of the FDI boom of recent years without developed IPR systems but extending strong IP protection to cover biological product and process may nevertheless play some adverse effects on the economic development: for example, prices in certain sectors such as seeds and medicines may rise; monopoly conditions may constrain national firms; and the costs for R&D will rise; in the long-term, the socio-economic fabric that supports innovation in these developing countries is likely to erode. Then what risks and benefits of biotechnology in such industries and the role of IPR in China shall be weighed?

10)   What policies does China take in the imports of foreign biological products or transfer of foreign biological technologies that in nature do not qualify for IP protection under Chinese IP law but do under foreign or international law?

11)   How should we consider biodiversity and IPR issues in China from the perspective of competition law?

12)   How should “compulsory licensing” play effects on biological technologies and industry in China? For instance, there is much interest in the use of compulsory licensing to obtain lower prices pharmaceuticals for AIDS, various vaccines and other essential medicines.

13)   What is the connection between economic development, biodiversity conservation as well as sustainable development in China? Some have already argued that the rapid pace of economic development in China could lead to the tragic deterioration of its own cultural and environmental heritage.[12] It has been worried, for example, that the recent China state policy to “open the west” and some imminent attempts to incorporate developed countries’ standards after its accession to the WTO will bring pressure to bear on its already fragile ecosystem. Then how would the assignment of property rights, inter alia, IPR, under the existing regulatory measures in China and according to modern international environmental law, play a role in relation to this connection and impact upon biodiversity policy in China?

14)   What is the connection between biodiversity and public health in China? How does China address the issues of food security and bio-safety in the context of IPR?

15)   How do CBD and TRIPS interact with each other in the legal context of trade and environment? Also how do they compare with other international instruments such as UPOV Act and IU? How should such interactions and comparisons relate to China?

16)   What efforts at national and international level has China taken or planned to take to fight bio-piracy, particularly the so-called reverse piracy? How would policies on this issue affect China’s international trade and foreign relations with the North, for example, with the EU?

17)   Should China along with other countries in the South ask compensation from the North for the use of its biological resources? Then who should pay? On what grounds? How much? etc. What international contractual agreements, for instance, has China concluded with technology rich countries on the payment for the right to analyze indigenous material from plant and animal origin? How should disputes on these issues be settled under some international instruments after China joined the WTO in 2001?

18)   What technical and financial assistance can China and other developing countries expect from the industrialized world such as from the EU with regard to initiatives on IPR and biodiversity?

19)   What implications can be drawn for the EU as well as other developed and developing countries from a case study on biodiversity and IPR in China? etc.

 

Back to Contents

 

ENVISAGED STRUCTURE OF DISSERTATION

 

An envisaged structure of dissertation will consist of five parts, each of which contains several topics (the order of chapters and sub-chapters not duly organized yet):

 

Part I      Introduction to the subject, research background, focuses, goals, etc.; basic theories of the interrelationship between IPR and biodiversity-related issues; summary of major international endeavors and instruments governing the subject; introduction to current Western practice; etc.

 

Part II     Examination of the state of biodiversity and biotechnology in China; general evaluation of the existing Chinese national strategies, measures and rules concerning biodiversity and biotechnology; general evaluation of Chinese current IP regime; introductory remarks on China’s emerging concerns over the relationship between IPR and biodiversity-related issues; etc.

 

Part III    Discussions on Biodiversity / biotechnology and IPR in China:

1.       Protection of genetic resources vs. requirements of Chinese IP laws;

2.       Biodiversity piracy, protection of traditional knowledge (TK) and IPR;

3.       Case study: Traditional Chinese Medicine (TCM);

4.       Bio-patenting: feasibility and consequences;

5.       Plant variety protection (PVP);

6.       Industry reports on biotechnology: agriculture, food, medical treatment, etc;

7.       Moral and ethical concerns;

8.       Social effects (e.g., on Chinese farming system, etc.)

9.       Case study: compulsory licensing of medicinal biotechnology in China;

10.    Economic issues: R&D, FDI, technology transfer: risks and benefits;

11.    Discussion: biodiversity, IPR and competition policy in China;

12.    Ecological, public health and environmental effects; etc.

 

Part IV    International Aspects:

1.       Harmonization? TRIPS, CBD, UPOV, etc. and China: a feasibility study;

2.       Summaries and comparisons of some regional and national policies;

3.       Biodiversity/biotechnology, IPR and international trade;

4.       North-South: compensation for bio-use? - Equitable sharing objective;

5.       International contractual agreements on biodiversity analysis;

6.       Official Development Assistance (ODA);

7.       Cast study: EU-China: Biodiversity/biotechnology and IPR;

8.       International anti-bio-piracy alliance;

9.       Implications for other countries; etc.

 

Part V     Conclusions

 

Back to Contents

 

RESEARCH METHODOLOGY

 

The methodology to be used will be a comparative study on the basis of original empirical research. More specifically, the parts of examination of facts and regulations will be written by means of conducting empirical research on current international and national resources concerning the subject. Literatures of fundamental theories, international instruments, reports and working papers, EU, Dutch, Belgian and other European national legislation and case law are mainly available from libraries and the Internet. Chinese laws, policies, cases, articles, legal opinions and industry reports are mostly within good reach in terms of the researcher’s Chinese background, although sometimes necessary translation work needs to be done. Under circumstances interviews and investigations will also be taken for collection of first-hand information and data. Based on such an empirical study many comprehensive or executive evaluations and discussions as regards certain selected topics will then be made by a comparative method, for example, often under the framework of some unified international instruments.

 

The researcher will commit himself four years to accomplishing the goals of this study and writing a dissertation.

 

Back to Contents

 

TENTATIVE BIBLIOGRAPHY (NOT REPRODUCED)

 

A number of literatures and references have been collected and partly studied. The full list is, however, always non-exhaustive and therefore has not been reproduced here.

 

Back to Contents

 

Back                                                                                                                                                                                                                     Home