Legal aspects of prior informed consent on access to genetic resources: an analysis of global lawmaking and local implementation toward an optimal normative construction.

• Author: Ni, Kuei-Jung

ABSTRACT

Since the Convention on Biological Diversity (CBD) has been in force, national implementation of the access to and benefit-sharing (ABS) requirement on genetic resources has been flourishing. A requirement of prior informed consent (PIC) by the people controlling access to genetic resources constitutes a major instrument to deter illegal bioprospecting and to ensure fair access to genetic resources.

This Article aims to analyze the continuing global lawmaking on PIC and to conduct a comparative study on how genetically rich nations implement the PIC requirement with a view to examining whether the genuine mandate of the CBD has been fulfilled.

This Article argues that the will of local indigenous communities should be respected, regardless of whether they are entitled to give consent. Further, national operation of PIC should be under an adequate international supervision to prevent the misuse or abuse of PIC and to ensure that implementation of PIC conforms to the CBD objectives.

TABLE OF CONTENTS I. INTRODUCTION: THE CONSOLIDATION OF INTERNATIONAL MOVEMENTS TO CONTROL GENETIC RESOURCES II. THE CBD AND SUBSEQUENT LAW MAKING OF PIC ON GENETIC RESOURCES ACCESS A. The Origin of PIC and Its Incorporation in International Environmental Rules B. The CBD and Bonn Guidelines C. The Proposed International Regime 1. An Overview of the Regime to Enforce PIC 2. A Critique on the Regime's Preliminary Design of PIC Compliance III. NATIONAL PRACTICES OF GENETIC-RESOURCE-RICH COUNTRIES ON PIC REQUIREMENT A. India B. Brazil C. The Philippines D. Costa Rica E. Peru F. Australia G. Taiwan 1. Rich Genetic Resources in Taiwan and Problems Resulting from a Lack of Proper Regulation 2. The Move to Regulate ABS on Genetic Resources: The State of Play on PIC IV. CRITICAL ISSUES OCCURRING IN PIC PRACTICE: OVERALL ASSESSMENT AND SUGGESTIONS A. The Role and Status of Indigenous Peoples in Access to Genetic Resources B. The Multi-Consent System of PIC: Troubled Water? and the Problem of Anti-Commons C. Reshaping the Function and Role of Competent National Authority V. CONCLUSION I. INTRODUCTION: THE CONSOLIDATION OF INTERNATIONAL MOVEMENTS TO CONTROL GENETIC RESOURCES

The Convention on Biological Diversity (CBD) (1) provides that genetic resources (GR) originate in plants, insects, animals, and microbes. (2) As a result, human genes are practically excluded from the definition of GR. The value and significance of GR has become increasingly prominent in recent years, playing a significant role in the spheres of agriculture, bio-industries, and medicine, as well as the global economy. (3) Notably, the modern biotechnology industry substantially relies on bioresources to produce commercial products. (4)

Prior to the adoption of the CBD, there had been a push to place GR under international control so that the benefits of GR would be available or accessible to all humankind instead of being dominated by each sovereign nation alone. (5) The effort of the United Nations Food and Agriculture Organization (FAO) to preserve agricultural genetic resources represents a leading model in the movement to classify GR as international common property. (6) The International Undertaking on Plant Genetic Resources, (7) adopted in 1983, cites as its basis "the universally accepted principle that plant genetic resources are a heritage of mankind and consequently should be available without restriction." (8) In an earlier stage, the text aimed to ensure that GR would not be monopolized by the private sector but would benefit all humans. (9) The designation of GR as a part of the common heritage of mankind (CHM) would help reduce national control of GR and thus make the resources more easily accessible. (10)

The idealistic equation of GR with CHM notwithstanding, it is difficult to vindicate the universal prevalence of the move, particularly in light of current developments. First of all, the Undertaking, which is soft law in nature, is not a legally binding instrument. Secondly, the notion of equating GR with CHM has hardly been practiced by either developed or developing nations. Developed countries initially expressed reservation to the idea promoted by the Undertaking. (11) It is also clear that the doctrine of global genetic commons is no longer honored, even by the developing world. Rather, developing countries have already been inclined to argue that GR should be under sovereign domain and to favor a strong and effective national regulation of GR access within national boundaries. (12) Third, the global commons of GR would meet with difficulties in its management. Given that most GR, apart from those located under the high seas, (13) are within certain countries' boundaries, the internationalization of GR would certainly encounter resistance from GR-providing nations.

The tendency during recent decades has been to shift from the global commons approach to GR to the sovereign dominance approach. In particular, developing countries continue to voice intolerance and resentment toward biopiracy and misappropriation of their GR. (14) These nations consider tighter regulation of GR access and fair benefit sharing to be essential in preventing the injustice of biopiracy and assuring equity in bioprospecting.

The conclusion of the CBD in 1992 echoed the call for proper control of GR mainly by requiring a fair and equitable sharing of GR interests as one of its three objectives. (15) Concerning its authority and competence to regulate GR access, the CBD confers power to contracting parties while reaffirming the sovereign rights of states over GR. (16) Though skepticism toward the CBD mandate remains, (17) the sovereign control of GR is arguably a reflection of customary international environmental law. (18) Further, given the worldwide accession to the CBD (19) and the irreplaceable function of national governments in this regard, national authority has already played a crucial role in regulating GR.

More importantly, the CBD stipulates the regime of access to and benefit sharing (ABS) of GR. (20) The prior informed consent (PIC) requirement, borrowed from a restriction on doctors' ability to treat patients, (21) is incorporated into ABS. A PIC requirement that obliges GR users to seek consent from GR providers before accessing the resources in question may reduce the effects of biopiracy and unchecked bioprospecting that disrespect the free will of GR providers. The mechanism can also ensure 'fair access' to GR. Most national legislatures use PIC as a core element and condition of the approval of applications for GR access. (22)

A variety of national and international stakeholders are interested in GR access; it is essential to take their interests into account in implementing the PIC mandate. Local GR providers, indigenous peoples, and local communities should be allowed to voice their concerns on any access project because GR in their territories are often integral components in their traditional life and culture. (23) Bioprospecting researchers and companies have an interest in GR exploration because the value of GR can hardly be realized or commercialized without the use of their advanced biotechnology. (24) In effect, they may assert that the freedom of bioprospecting and research should be recognized, and they oppose unnecessary restrictions on GR exploration. (25) Of course, as major and dominant GR providers, national governments may consider themselves indispensable actors in regulating activities under their jurisdiction, including exploration of GR. (26)

In practice, because political and social structures in individual nations differ, there seems to be no entirely consistent pattern of PIC requirements. Some legislatures recognize the decisive role of indigenous or local communities in the operation of PIC, making access to GR impossible without their genuine consent. (27) However, to ensure more efficient access, several governments control the PIC process so as to make the will of local people relatively marginal or to treat their wishes only as one factor in the determination of whether to grant final consent. (28) The different practices have drawn criticism and complaints from scholars, researchers, and GR users. Some critics are skeptical of an overly burdensome PIC procedure that could make a desirable bioprospecting project collapse unreasonably. (29) Critics have also targeted the neglect of local voices by national authorities in obtaining PIC. (30) Further, there is a grave concern that access-restrictive regimes inspired by the CBD "have driven companies away from bioprospecting." (31) Thus, not surprisingly, it is argued that the increasingly excessive protection of GR by national authorities should be replaced by a more access-friendly system of GR regulation. (32)

After the CBD, which confirmed states' authority to regulate GR access, international efforts to ensure better implementation of ABS continue to make progress. In addition to the CBD Bonn Guidelines, (33) which promise capacity building for contracting parties, especially developing countries, efforts have focused on negotiating and elaborating an international regime on ABS with possible enforcement power. (34) Of course, the treatment of PIC in the current draft of the proposed international regime merits assessment given the document's potentially binding nature. (35)

The increasing global concern over the GR access system cannot produce a satisfactory outcome without proper enforcement on a local basis. This Article will, therefore, engage in a comparative study concerning how genetically-rich nations implement the PIC requirement with a view toward examining whether the objectives of the CBD have been fulfilled. Following the analysis of the legal implications of PIC embodied both in national and international contexts, this Article argues for an optimal normative construction of PIC, either locally or globally.

After reviewing PIC's origin and...