The Sunshine Project
Backgrounder #13
January 2004
Export Controls: Impediments to Technology Transfer Under the Convention on Biological Diversity
Introduction
The 7th Conference of the Parties to the Convention on Biological Diversity (CBD) will convene in Kuala Lumpur, Malaysia in February 2004. It is expected to establish a working group to address implementation of technology transfer obligations under the Convention. Implementing technology transfer under the CBD requires addressing export controls - the unilateral policies of withholding of biological technology that have been put in place by developed countries.
Export controls are national legal and administrative systems designed to limit or to prohibit transfer of certain types of technology, specifically: equipment, materials, and knowledge that have potential weapons uses. [1] Export controls include restrictions on transfer of many biological technologies that, in addition to being potentially weapons-related, are relevant to biodiversity conservation, sustainable use, and equitable benefit sharing. Export controlled items, especially biological manufacturing technologies and basic laboratory safety equipment, also have use in medicine, agriculture, and other industries. These uses are both in environmentally controversial applications (e.g. genetic engineering) as well as in technologies that are more generally regarded as safe and beneficial.
All governments must ensure that biotechnology is not applied to hostile purposes. Those that are States Parties to the Biological Weapons Convention (BWC) [2] have undertaken this commitment in treaty. Those that are Parties to the Cartagena Protocol to the Convention on Biological Diversity (CBD) have made important commitments that buttress the BWC by taking additional steps to ensure that modern biotechnology does not harm biodiversity and human health.
The relevance and impact of export controls (and associated patent secrecy laws) are seldom discussed outside of small national security and industry circles. This paper describes export controls, how they operate, and some of the political controversies that surround them. The paper provides concrete examples of how export-controlled technology can be used peacefully and beneficially, and demonstrates why the current export control system is an obstacle to technology transfer to fulfill the objectives of the Convention on Biological Diversity (CBD).
Resolving the problems of the present export control system requires bringing it into line with existing commitments of States Parties to the BWC and CBD. This can be accomplished through the establishment of a transparent, harmonized, and genuinely multilateral export control system including a multilateral export reporting scheme, that could facilitate safe technology transfer and thereby enhance implementation of agreements including the Convention on Biological Diversity and the Biological Weapons Convention.
The Politics of Export Controls
As the number of peaceful applications of modern biotechnology grows, particularly in the bioprocessing/biomanufacturing industries, so do the ways in which the technology can be used to cause harm. This double-edged knowledge and equipment is called "dual-use" technology. While some governments and non-governmental organizations have been urging greater intergovernmental action on dual-use technology since the biotech explosion began in the late 1980s, it was not until the anthrax letters sent in the United States in 2001 [3] that dual-use dangers rose to become international policy priorities.
| The Shadowy World of Patent Secrecy
Export controls often work hand-in-hand with little-known secrecy provisions in developed countries' intellectual property law. These laws, called "patent secrecy" or "invention secrecy", provide for government orders to seal selected patent applications, making their existence a secret and restricting access to and transfer of the invention. In the US, the lowest (least restrictive) form of patent secrecy order imposes export control restrictions. More restrictive orders can result in government seizure of the invention and a delay of decades in publication of the patent application.
Patent secrecy is far more widely applied than is generally understood. In the United States, for example, the little known "secret group" at the US Patent and Trademark Office presently oversees nearly 5,000 secret patent applications, the majority sealed pursuant to the Militarily Critical Technologies List, a classified publication of the US Department of Defense.
(For more on patent secrecy in the US, see the Federation of American Scientists website, with data from the US Patent and Trademark Office, at www.fas.org/sgp/othergov/invention/stats.html) |
In the North, where modern biotechnology research and ownership is concentrated, one reaction to newfound fears about possible abuse of biotechnology has been to bolster export control systems, [4] based on the belief that tighter controls will help prevent illicit activities by alleged "rogue states" and "bioterrorists".
In addition to restricting movement of dual-use technologies for security-related reasons, export controls also support the economic interests of developed countries. Because they prevent transfer of industry-strategic knowledge and equipment, they contribute to the continuation the North's domination of markets for modern biotechnological products While justified by the rationale that many countries may not be trusted to behave peacefully with certain technology, export controls have the additional “benefit” (from the North's perspective) of reinforcing rich countries' ability to determine how science is used.
Biological export controls cover a wide range of technologies, knowledge, and items whose peaceful uses are not restricted to controversial technologies such as genetic engineering. Export controlled items have use in such diverse areas including the food industry, industrial enzyme production, biological pest control, vaccine production, or extraction of beneficial enzymes from natural organisms, many of which are may be desirable and, indeed, sustainable uses of biodiversity. It should be noted, however, that export controls do not cover most biotechnological products, such as genetically modified crops. Instead, they generally apply to the relevant production technology.
Arguing for reform of the present export control system should not be construed as an endorsement of the unfettered dissemination of biotechnology. Rather, the debate over export controls in technology transfer is about unilateralism vs. multilateralism, in this case, the shape of the system to manage the global flow of many modern biotechnologies, a power that the North presently reserves unto itself. It concerns equity: Reforming export controls is about how the dissemination of science is organized, and whether power is concentrated in a few countries or if it is shared among the world's peoples.
Thus, countries that choose not to exploit some or all applications of modern biotechnology should be concerned about export controls. First, and most obviously, many export controlled technologies, such as fermenters to grow microorganisms or laboratory safety equipment, can be used in conventional (i.e. non-biotechnological) applications. Export controls not only impede spread of genetic engineering capacities; but development of high quality biomanufacturing in general, irrespective of the use of genetic engineering within those processes.
Secondly, export controls are established and applied in a fundamentally unfair, arbitrary way that is often politically-motivated. This harms the South, a fact that Non-Aligned Movement countries have repeatedly denounced. In debates over technology transfer, including at the Convention on Biological Diversity (CBD), Northern countries that apply export controls typically adopt a hypocritical position. On one hand, the North complains about Southern import controls and "technical" and "administrative" barriers to technology transfer - Northern code words for the South's caution over biotech imports - and insists that alleged Southern impediments to technology transfer must fall. On the other hand, the North continues to build up its shield of export barriers. The net effect of Northern policy is to render developing countries impotent in controlling the flow of biotechnology, while simultaneously reinforcing the North's autonomy to control the exchange through the unilateral application of export controls.
Practicalities - How the System Works
Export Controls and Related International Agreements (and Arrangements)
Dual-use biotechnology is addressed in binding international agreements including the Convention on Biological Diversity (CBD) and the Biological and Toxin Weapons Convention (BWC). Both of these agreements obligate Parties to share such technologies. [5] The purpose of dual-use technology transfer, in the case of the CBD, is to help fulfill its objectives of conservation, sustainable use, and equitable sharing of benefits arising from biodiversity. In the case of the BWC, States Parties have assumed an obligation to transfer all dual-use biotechnology if it is to be used for peaceful purposes.
In contrast to these obligations, there is no multilateral treaty providing for export control systems. Instead, there is the Australia Group, which is an unusual and non-treaty based club. Described as an "informal arrangement" by it 34 members, [6] the Australia Group is overwhelmingly composed of those rich countries in which ownership of dual-use technology is concentrated. The Australia Group, which meets annually, develops “common control lists” of technologies and works to ensure that export controls are “harmonized” among club members. Members notify one another when they deny exports of technology, and once one member denies a particular technology to a specific country, the others are expected to follow suit.
The Australia Group functions as a technology cartel that is designed to prevent export competition between biotech countries. The arrangement aims to establish the same controls among all members and to stop "technology shopping" by developing countries that are subject to denials. For example, if Germany denies a buyer a particular technology, Australia Group arrangements are intended to prevent the United States from "undercutting" Germany by selling the same technology to the requester.
Officially, the Australia Group does not maintain a list of export controlled countries (i.e. "bad guys"), although some members, such as the US, do publish such a list. The situation is somewhat different among club members. In Germany for example, no official country list exists and - at least formally -each export request from each country is judged on its own merits. It is an open secret, however, that some countries are a priori denied certain items (e.g. it is effectively impossible for an entity in Iran to import a controlled fermenter from Germany).
The system's footprint on developing countries is large. The 38 countries who currently face the tightest controls imposed by the United States together comprise more than 50% of world population. [7]The system is also secretive - denials are often based on classified information (i.e. foreign intelligence). [8] Aggrieved countries cannot dispute this information. Denied buyers can sometimes make an administrative appeal in the country that has denied them; but there is no impartial, international hearing or judgment.
Do Export Controls Really Enhance Security?
In this paper we discuss the impacts of export on peaceful technology transfer, particularly for the purposes of the CBD. It should also be noted that it is an open question whether or not the current export control regime is effective from a security point of view. It is inherently difficult to measure the success of a regime that aims at preventing illicit and secretive arms development, but so far, very little evidence has been brought forward to show that export controls actually contribute to international security.
Perhaps the most crucial point about the system is that it is arbitrary. At any time, the less than three dozen members of the Australia Group may add to or delete from their lists of countries (and private or public entities within countries) that are denied technology. Any country that is not a member of the Australia Group, even if it does not presently encounter problems with export denials, could become subject to tight controls. These controls could be imposed due to faulty intelligence or political reasons unrelated to security.
Cuba is an instructive example of export controls' susceptibility to political manipulation. Cuba possess an advanced biomedical sector. Since early 2002, Cuba has been the victim of allegations made by the United States that it is developing biological weapons. The charges are unsubstantiated and independent visitors (including former US President Jimmy Carter) to Cuban biotechnology facilities do not support the US claims. When pressed by the US Congress to produce evidence, Bush administration officials suggested that the mere presence of dual-use technology in Cuba is sufficient reason to suspect illicit activity . [9] , [10]Most independent observers believe that the US allegations are false and that they stem from (mainly domestic) political considerations having little to do with biological weapons. Despite the lack of evidence and international support for the allegations, the charges against Cuba are a basis for continuing tight export controls to that country, controls which could hurt further development of Cuba's successful biomedical industries. [11]
This paper does not dismiss the necessity of technology transfer agreements that prevent Biological Weapons Convention violations by, for example, corporations that have deliberately aided biological weapons programs in countries who have not followed the Biological Weapons Convention. History proves that regulatory controls are needed to restrain the greed of those few that are willing to undermine arms control treaties. Thus, what is needed is a fair, transparent and truly multilateral scheme that is not subject to political or economic abuse by some countries. Additional measures such as an export reporting (see section below) or the "Vaccines for Peace" idea discussed in the early 1990s [12]may contribute to sustainable non-proliferation efforts.
An Overview of Export Controls on Hard and Soft Technologies [13]
| Control Type |
Item Example(s) |
Indicative Peaceful Uses |
|
|
Biological Items |
|
| Human, animal, and plant diseases [14] |
anthrax, botulinum bacteria |
pharmaceutical and vaccine research, diagnostic laboratories |
| Genetically-modified pathogens, pathogen genes |
microbes containing genes from controlled pathogens |
pharmaceutical and vaccine research, diagnostic laboratories |
| Types of medical, analytical, & diagnostic tests and mixtures |
test kit for potentially dangerous toxins in food |
ensuring safe storage conditions for food supplies, testing imported food |
| Toxins |
drugs containing ricin or botulinum toxin |
tumor therapy (experimental), cosmetic pharmaceuticals |
| Vaccines [15] |
anthrax vaccine |
protecting persons who handle raw wool from anthrax |
|
|
Hard Technology |
|
| Microbiological production equipment |
co 2 incubators |
cell culture, virus culture |
|
|
Certain biological fermenters (bioreactors) |
production of microorganisms for use as biological pest control or bioremediation, or for the production of industrial or food enzymes. |
|
|
centrifugal separators, flow filtration equipment |
separating wastes and purifying cultures of microorganisms, cells, or their products. |
|
|
freeze dryers |
drying any biological product |
| Laboratories and laboratory equipment |
BSL-4 (P4) labs |
facilities to safely study very dangerous, easily transmitted diseases, e.g. Ebola. |
|
|
BSL-3 (P3) labs |
facilities to safety study more moderately dangerous diseases, e.g. antibiotic-resistant tuberculosis, anthrax. Also used to produce some biopharmaceuticals. |
|
|
safety cabinets, isolators, hoods, etc. |
Laboratory equipment appropriate for (safe) use inside BSL-3 and BSL-4 containment |
|
|
"space" suits |
protective clothing for scientists working in BSL-3/4 labs |
|
|
aerosol chambers |
vaccine or drug testing |
| Disposal equipment |
autoclaves, laboratory ovens |
lab equipment to render harmless pathogenic cultures, (infected) lab animals, and other hazardous wastes. |
|
|
Other / Future Tech. |
|
| "Catch All" provision |
“undefined |
countries are implementing "catch all" provisions to prevent transfer of new dual-use technologies. |
|
|
Knowledge |
|
| Technical assistance |
consultancy services |
Assistance in the design, installation, operation, repair, refurbishing, etc. of facilities containing controlled items. |
| Technical data |
blueprints |
"blueprints, plans, diagrams, models, formulae, tables, engineering designs and specifications, manuals and instructions written or recorded on other media or devices such as disk, tape, read-only memories." related to development or production of export controlled agents or equipment. |
| "Technology" |
(see at right) |
"Specific information necessary for the ‘development', ‘production', or ‘use' of a product" |
|
|
Proposed Controls |
|
| Clean rooms |
microprocessor manufacture |
Used in microelectronics manufacturing, clean rooms share characteristics with BSL-3 and BSL-4 laboratories |
| Microencapsulation technology |
pharmaceuticals |
Used to achieve/maintain particle size and stability, to carry active ingredients across biological membranes. |
| Self-contained HEPA air filtration systems |
any application needing clean air |
Used in a variety of manufacturing and offices to control smoke, dust, fumes, and other contaminants. |
The Least Trusted
(US CB3 list, plus states with
country-specific export regimes)
Afghanistan
Armenia
AzerbaijanBahrain
Belarus
Burma
China
Cuba
EgyptGeorgia
India
Iran
Iraq
IsraelJordan
Kazakhstan
Korea, DPRKuwait
Kyrgyzstan
Lebanon
LibyaMoldova
MongoliaOman
Pakistan
Qatar
Russia
St. Kitts & Nevis
Saudi Arabia
Syria
TaiwanTajikistan
Turkmenistan
Ukraine
United Arab Emirates
UzbekistanVietnam
Yemen
38 countries, total population:
3.24 billion, or 51.4% of world population in 2003 .
If a technology is export-controlled, it may be transferred only upon the issue of a license granted by the national export control authority. For transfers between members of the Australia Group club (see Appendix B), licenses are generally easily obtained. For non-members, the process is more difficult, if at all possible. In the US, and perhaps other countries, a third category of countries is subject to the tightest controls, including the legal presumption of technology transfer denial.
The number of export denials imposed each year cannot be determined, because the denials are usually highly secret. For example, the US Department of State refused to provide a full accounting of diplomatic activity related to export denials to the General Accounting Office, a US government agency that conducts research for the US Congress. [16]
In addition to the unknown number of denials, export controls have the effect of preempting technology transfer. If potential importers know they are likely to be denied a technology, they don't ask for it. Australia Group club members including France, Japan, and Australia promote this effect, by "informally discouraging" applications for technology transfer if denial is a significant possibility. [17] Technology transfer is thereby stopped without the actual issue of a denial. Thus, the preemption of applications adds another layer of opacity, making it even more difficult to calculate export control impacts .
Defenders of export controls, such as US Department of Commerce, focus on the cash value of denied sales. They publicly assert that the overall economic impact of export controls is small. But these conclusions cannot be verified, and do not take into account that importing countries simply do not apply for items likely to be denied - thereby avoiding potential embarrassment and wasted effort. Nor do they take into account that denied items may be destined for manufacturing and could themselves generate trade. For example, if export controls deny a country biomanufacturing technology, the major economic impact is not the denied equipment; but the products that were never made and sold.
Some countries subject to high scrutiny do, however, receive export-controlled items. This happens in cases when a license is granted because the end use of the technology is deemed acceptable. For example, a technology transfer license is more likely to be approved to a tightly export controlled country if a multinational pharmaceutical company controls the manufacturing plant where the equipment will be used. Even though some entities in an export-controlled country may receive approvals, other entities may be refused. For example, the US selectively approves export controlled technology for India, approving some recipients while denying others.
Finally, export controls are imposed internally in some countries. So-called "deemed exports" occur when a company operating in an Australia Group country is controlled by foreign nationals of an export controlled country. For example, many US subsidiaries of Chinese-owned companies are subject to export controls, even if the technology is to be used in the United States. Similarly, Australia Group members will sometimes deny technologies to one another's entities. This can occur if the technology purchaser is thought to be linked to an export-controlled country. For example, the US list of "denied persons" (who may not receive any export controlled technology) includes several companies in Europe alleged by the US to pose risks of transshipping technology to "rogue states".
Illustrative Case:
How Export Controls Impact Construction of an Experimental Vaccine Lab
Prior to discussing export controls in the specific context of the Convention on Biological Diversity, to make a complex system more concrete, the following real-world case illustrates how basic research capabilities can be impacted by export controls:
As this example shows, nowhere is the bite of export control felt more strongly than in biomedical research. The example is a modestly-sized new laboratory at a university health research center in Dallas, Texas. The lab was funded in late 2003 by the US National Institutes of Health. The lab will produce antibodies and experimental vaccines to prevent a variety of diseases. These products might or might not be genetically-engineered. The lab will use high production standards so that its output may be used in human experimental trials.
This type of lab is necessary to conduct many kinds research to develop and test treatments for infectious diseases that are of concern worldwide. In fact, so-called "emerging infectious diseases", often most prevalent in the South, are the major focus of its research. Obviously, the lab is a type of facility that has use in most and perhaps all countries. The lab, by current standards for such facilities, is relatively inexpensive - the budget for equipment and major supplies (for 5 years) totals US $965,000, plus $115,000 to renovate 45.5 square meters (500 square feet) of BSL-3 (P3) lab space.
As the table below indicates, despite the many worldwide peaceful uses for such a lab, virtually all of the core components are export controlled:
Example: Export Controls and a (Relatively) Modest Lab for Infectious Disease Research [18]
| Item |
Cost (USD) |
URL (For the exact item to be purchased, when specified, or for the manufacturer and product line indicated in the lab budget.) |
Export Control? [19] |
|
45.5 m2 BSL-3 lab (renovate) |
$115,500 |
YES |
|
| Hollow fiber systems |
$220,000 |
YES |
|
| Chromatography & supplies |
$262,890 |
YES |
|
| Self-sterilizing 80l. fermenter |
$104,000 |
YES |
|
| Continuous flow centrifuge |
$35,260 |
YES |
|
|
co2 incubators |
$14,350 |
possibly [20] |
|
| Autoclaves |
$42,000 |
possibly |
|
| Laboratory oven |
$10,233 |
possibly |
|
| Water purification systems |
$25,200 |
possibly |
|
| Biological safety cabinets |
$36,000 |
possibly |
|
|
|
|
|
|
| Totals for Export-Controlled Technology: |
$865,433 |
Approximately 89% of the budget for major equipment and supplies is earmarked for items subject to explicit export controls or which have a significant likelihood of falling under "catch all" control provisions. |
|
Export Controls and the CBD: Another Example
Diversa: Using the South's Resources to Fuel Export-Controlled Prospecting and Manufacturing in the North
Based in San Diego, California, Diversa focuses on microbial bioprospecting - sampling and testing microorganisms from across the world, particularly from extreme environments such as hot springs. It looks for patentable characteristics of these organisms that it can turn into commercial products, presently holding approximately 650 patents and patent applications. Diversa's goods are microorganisms (or products thereof, such as enzymes) that are grown and purified in a laboratory.
Adept at overcoming suspicions about biopiracy, Diversa has cut access deals to collect microbes across the world, amassing a huge microbial diversity library. In October 2003, its director of drug research told the US business review Forbes Magazine that "What we have within Diversa is one of the greatest collections of naturally occurring enzymes that I've ever heard of ." [21] An impressive feat for a company whose operations began less than a decade ago (in May 1994).
Diversa's product pipeline includes biochemicals for a myriad of uses, such as animal feed additives, in food processing, as research reagents, etc. Diversa often licenses its patents in order for others to manufacture products it controls. Presently valued at US$350 million, the company's annual sales are approaching US$40 million, a figure that Diversa says will grow. Syngenta owns 15% of Diversa, and the company has agreements with industry heavyweights such as GlaxoSmithKline, Dow Chemical, DuPont, and Aventis. Diversa has also entered into a partnership with the US Department of Energy that is screening and manipulating soil microbes with an eventual goal of producing bioremediation microorganisms. [22]
Diversa is based in the US, where it has access to any technology it can pay for. Export controls come into play because in Diversa's business, obtaining and patenting an enzyme or a microorganism is only part of the commercial equation. Diversa's markets are for lab-manufactured products for pharmaceutical, food, and scientific testing customers
Because its customers must have a refined and consistent product (biological impurities could shut down its customers or even result in liability claims) and, in some cases, its technology uses microbiological mass production techniques, Diversa and its partners typically require facilities with finely manufactured, advanced bioreactors, filtration and separation equipment, waste disposal systems, and other high-end hard technology. It is this critical biomanufacturing technology that is most tightly export controlled. Thus, while Diversa uses the world as its biological base for discovery of patentable genes and organisms, the technology required to commercially exploit Diversa's “inventions” is subject to export controls and, hence, unavailable to many countries.
It isn't only intellectual property that stands in the way of biodiversity research that is more responsive to the developing world's needs. So long as the core technology, knowledge, and facilities necessary for such research remains tightly controlled by the North - and export controls have a major role in establishing and maintaining that control - benefits will accrue to the North and not the owners of the biodiversity upon which it may be based. All countries have a stake in how the technology is used. Presently, unless countries can develop the hard technology and related skills indigenously, they are at the not-so-tender mercies of the Australia Group.
Attempt at Reform:
Export Controls and the Failed BWC Verification Protocol
From the late 1990s and into 2001, export controls figured prominently in negotiations of the Biological Weapons Convention (BWC) which, at the time, was developing a protocol to strengthen the treaty. The Protocol aimed to alleviate potential mistrust or misunderstanding of biological research activities by establishing a multilateral system of declaration and inspection of biodefense and related facilities. Under the proposed agreement, all member countries would detail their relevant biological capacities and research in annual declarations to an international inspectorate. Biological labs and other facilities would be periodically visited by international inspectors who would verify the accuracy of the declarations and, if necessary, could be empowered conduct a more probing "challenge inspection" if a member of the Protocol suspected illicit activities.
In view of the proposed transparency protocol, countries from the Non-Aligned Movement (NAM) put forward arguments that export controls should be reformed. If labs and activities were open to inspection by an international inspectorate, they reasoned, then the end-use of technology was permanently open to verification. Hence, they argued, export controls should be placed on a genuinely multilateral footing. NAM members asked, in effect, for export controls to be administered internationally, that they be fully internationally "harmonized" in lieu of the "informal arrangement" of the Australia Group club. The NAM's efforts were not welcomed by some countries in the North, particularly the US.
Countries including Brazil led attempts to broker a compromise on export controls (which was one of several sticky issues in the negotiations); but differences remained in 2001 when the Protocol negotiations collapsed. The failure was prompted when the US abruptly withdrew its support for the negotiations, a policy shift made by the Bush administration. Since that time, the BWC negotiations have been hindered by political differences and unable to make progress on the issue.
One Way Forward: Export Reporting
The rationale behind export controls is that by preventing acquisition (i.e. transfer) of certain technology, security is enhanced. An alternative (or additional) measure is comprehensive export reporting, Instead of a focus on acquisition and transfer per se , export reporting would shift focus to make it more difficult to hide illicit activity. If international transfers of biological technologies, goods, and agents are comprehensively reported and filed in an international database, impediments to technology transfer may be reduced while, at the same time, the unusual import patterns generated by abuse would give indication of clandestine activities.
Export reporting or monitoring is not a new concept to non-proliferation. A similar, albeit voluntary, scheme has been established on the UN level for conventional arms. Similarly, imports and exports of chemicals are monitored to a certain extent by the Organization for the Prohibition of Chemical Weapons (OPCW), established by the Chemical Weapons Convention. It was export monitoring that provided the first hard evidence of the illicit biowarfare program that existed in Iraq prior to the first Gulf War. In that case, UN inspectors determined that Iraq had imported more than 40 tons of bacterial growth media - a quantity far beyond its civilian need.
Export reporting is not about approving or denying exports, but is about monitoring and data sampling. Most imports and exports of biological items are already registered, often by more than one government authority (e.g. customs, trade, or sanitary authorities, among others.). While it may require a substantial effort to set up a global system to sample, compile and store this data in a uniform way, maintaining the system would pose only a small burden, because the data is already generated and collected by governments for other purposes. Compared to export controls, export reporting has two major advantages:
in view of the limited administrative burden of export reporting, the system can be much broader in its scope, including additional laboratory equipment, such as glassware, growth media, and "low tech" biological production equipment, items that are poorly covered by current controls.
as a monitoring scheme, it is less prone to political abuse and may be more easily be agreed upon on a truly multilateral level.
Conclusion
Facilitating Safe Technology Transfer on a Multilateral Basis
Virtually all governments concur that controls over the movement of modern biotechnology are necessary in order to ensure biosafety and biosecurity. [23] Despite this important consensus on principle, a practical agreement on a fair and effective multilateral system to ensure safe technology transfer has proven elusive. The dominant system, the "informal arrangement" of the Australia Group club, is explicitly designed to be a cartel that reinforces unilateral Northern control over biotechnology. The Australia Group lacks international support and is prone to political and economic manipulations unrelated to the nonproliferation goals of the system. This system is fundamentally inequitable and conflicts with governmental obligations under the BWC and CBD, which oblige technology transfer for peaceful purposes. Neither the claimed - and unproven - benefits of the Australia Group nor statistics on its economic impact can be verified.
The 7th Conference of the Parties to the Convention on Biological Diversity will convene in Kuala Lumpur, Malaysia in February 2004. It is expected to establish a working group to discuss technology transfer. This group could, as is the view of developing countries such as Colombia, take steps toward a new international mechanism to facilitate biological technology transfer. In contrast, in preliminary discussions held in Montreal, Canada in October 2003, some Northern countries, particularly the United States, appeared eager to use the CBD's technology transfer discussion as a stage for attacks on Southern import controls and to kick up debate on "technical" and "administrative" barriers to US export of biotechnological products. This negotiating tactic - focusing the debate on the South's laws - conveniently deflects attention from the North's two-track policy. That is, the North insists on the one hand that the South must drop the defenses that it has developed to protect against undesired biotechnology while, on the other hand, it is building an increasingly far-ranging export control system. Thus, the North will almost certainly seek to avoid discussion of export controls.
If the issue of export controls is not firmly placed on the agenda, however, no matter what the CBD ultimately decides, broad ranges of technology and knowledge that are highly relevant to the convention will remain subject to the arbitrary "informal arrangement" of the Australia Group. Gene-extractive industries such as Diversa's and others, including biopharmaceutical manufacturers, will continue to enjoy the unadvertised protection of export controls, which help prevent competition. And Northern compliance with any CBD agreements on technology transfer will be conditioned by the unilateral application of Australia Group controls.
Thus, the CBD must address export controls in order to avoid decisions that contain significant flaws that will allow Australia Group club members to continue to unfairly limit access to technology that may be used for the purposes of the Convention. Concretely, Parties to the Convention on Biological Diversity should place the issue of export controls high on the agenda for the Working Group's discussions. Parties should request the Secretariat of the Convention to prepare a study that identifies CBD-relevant technologies that are export controlled, and which outlines options for ensuring that such technologies are available for transfer in accordance with Parties' commitments under the Convention. Parties may additionally consider how the possible new international technology transfer mechanism may be structured so as to facilitate reduction of export control barriers to technology transfer, for example, through the establishment of comprehensive export reporting systems.
APPENDIX A: The Technology Transfer Provisions of the CBD and BWC
1. The Convention on Biological Diversity
Article 16: Access to and Transfer of technology
1. Each Contracting Party, recognizing that technology includes biotechnology, and that both access to and transfer of technology among Contracting Parties are essential elements for the attainment of the objectives of this Convention, undertakes subject to the provisions of this Article to provide and/or facilitate access for and transfer to other Contracting Parties of technologies that are relevant to the conservation and sustainable use of biological diversity or make use of genetic resources and do not cause significant damage to the environment.
2. Access to and transfer of technology referred to in paragraph 1 above to developing countries shall be provided and/or facilitated under fair and most favourable terms, including on concessional and preferential terms where mutually agreed, and, where necessary, in accordance with the financial mechanism established by Articles 20 and 21. In the case of technology subject to patents and other intellectual property rights, such access and transfer shall be provided on terms which recognize and are consistent with the adequate and effective protection of intellectual property rights. The application of this paragraph shall be consistent with paragraphs 3, 4 and 5 below.
3. Each Contracting Party shall take legislative, administrative or policy measures, as appropriate, with the aim that Contracting Parties, in particular those that are developing countries, which provide genetic resources are provided access to and transfer of technology which makes use of those resources, on mutually agreed terms, including technology protected by patents and other intellectual property rights, where necessary, through the provisions of Articles 20 and 21 and in accordance with international law and consistent with paragraphs 4 and 5 below.
4. Each Contracting Party shall take legislative, administrative or policy measures, as appropriate, with the aim that the private sector facilitates access to, joint development and transfer of technology referred to in paragraph 1 above for the benefit of both governmental institutions and the private sector of developing countries and in this regard shall abide by the obligations included in paragraphs 1, 2 and 3 above.
5. The Contracting Parties, recognizing that patents and other intellectual property rights may have an influence on the implementation of this Convention, shall cooperate in this regard subject to national legislation and international law in order to ensure that such rights are supportive of and do not run counter to its objectives.
2. The Biological and Toxin Weapons Convention
Article X
(1) The States Parties to this Convention undertake to facilitate, and have the right to participate in, the fullest possible exchange of equipment, materials and scientific and technological information for the use of bacteriological (biological) agents and toxins for peaceful purposes. Parties to the Convention in a position to do so shall also cooperate in contributing individually or together with other States or international organizations to the further development and application of scientific discoveries in the field of bacteriology (biology) for prevention of disease, or for other peaceful purposes.
(2) This Convention shall be implemented in a manner designed to avoid hampering the economic or technological development of States Parties to the Convention or international cooperation in the field of peaceful bacteriological (biological) activities, including the international exchange of bacteriological (biological) agents and toxins and equipment for the processing, use or production of bacteriological (biological) agents and toxins for peaceful purposes in accordance with the provisions of the Convention.
APPENDIX B: Country Lists
The Australia Group
Argentina
Australia
Austria
Belgium
Bulgaria
Canada
Czech Republic
Cyprus, Rep. of
Denmark
European Commission
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Japan
Korea (ROK)
Luxembourg
Netherlands
New Zealand
Norway
Poland
Portugal
Romania
Slovak Republic
Spain
Switzerland
Sweden
Turkey
United Kingdom
United States
Total: 34 members.
"Buddies" and the Least Trusted in the US Export Control System for Biotechnology
"Buddies" (CB1 list)
Argentina
Austria
Belgium
Bulgaria
Canada
Cyprus
Czech Republic
Denmark
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Japan
Korea (ROK)
Luxembourg
Netherlands
New Zealand
Norway
Poland
Portugal
Romania
Slovakia
Spain
Sweden
Switzerland
Turkey
United Kingdom
(Exactly the Australia Group, less the EC.)
The "Untrusted" (CB3 list + countries with specific regimes)
Afghanistan
Armenia
Azerbaijan
Bahrain
Belarus
Burma
China
Cuba
Egypt
Georgia
India
Iran
Iraq
Israel
Jordan
Kazakhstan
Korea (DPRK)
Kuwait
Kyrgyzstan
Lebanon
Libya
Moldova
Mongolia
Oman
Pakistan
Qatar
Russia
St. Kitts & Nevis
Saudi Arabia
Syria
Taiwan
Tajikistan
Turkmenistan
Ukraine
United Arab Emirates
Uzbekistan
Vietnam
Yemen
All countries not listed above are on the CB2 list, meaning that they are subject to all export controls listed in the export controls overview chart, except those that apply to test kits and vaccines.
Source: US Export Administration Regulations (EAR), Commerce Control List Overview and the Country Chart, 22 October 2003.
NOTES
[1] Generally, biological, chemical, and nuclear weapons, as well as certain missile, aeronautical and conventional weapons technologies, and certain strategic materials.
[2] Signed in 1972, and with 151 States Parties. Full text of the BWC and official documents at www.opbw.org.
[3] Which used sophisticated microbiological preparation and, presumably, containment technology.
[4] For example, the most recent meeting of Australia Group agreed, for the first time, to create export controls specifically on knowledge as well as "catch all" export controls for biotechnology.
[5] See Appendix A for the full texts of BWC Article X and CBD
[6] See Appendix B for the list of members of the Australia Group.
[7] See Appendix B for the US "CB3" export control list of countries.
[8] The quality of foreign intelligence and risk assessments of several Australia Group countries, as well the political independence of their intelligence agencies, has recently been questioned, most notably due to the failure to find any biological, chemical, or nuclear weapons in Iraq, as well as incorrect and distorted intelligence cited by senior US officials as a cause for war and, in the UK, embarrassing incidents of plagiarism and "sexing up" of purported foreign intelligence.
[9] For an account of some of the twists and contorted language of the allegations, see Ruppe D, Cuba: No Biological Weapons Program, Bush Administration Official Says, in Global Security Newswire, 6 June 2002, URL: http://www.nti.org/d_newswire/issues/2002/6/6/9s.html
[10] Failing, to date, to locate any part of the biological weapons program that it alleged to have existed in Iraq as of 2002, US officials have begun to take a similar stance with Iraqi biologists, suggesting that academic scientists - who are knowledgeable about biotechnology, but against whom the US has no evidence - are sufficiently dangerous to merit repeated interrogation and detention. (See Gellman, B. Iraq's Arsenal was only on Paper , in Washington Post, 9 Jan 2004, p. A-01.)
[11] In addition to other, long-standing, US trade sanctions.
[12] E. Geissler, J. Woodall (1994) Control of Dual-Threat Agents: The Vaccines for Peace Programme (Sipri Chemical & Biological Warfare Studies, No 15), Oxford University Press
[13] See the Australia Group website, http://www.australiagroup.net. US export control regulations are online at http://www.bxa.doc.gov.
[14] It is important not to confuse export controls with (phyto)sanitary measures. Sanitary measures exist for protective purposes in most countries and standards for them are developed by bodies such as the OIE and the IPPC. Export controls on pathogens are distinct.
[15] The Australia Group Common Control List (http://www.australiagroup.net/en/control_list/bio_agents.htm) exempts vaccines, however, the United States (and possibly other countries) imposes controls on vaccines at ECCN 1C991 (in conjunction with ECCN 1C351-354). See the relevant sections of US regulations at http://w3.access.gpo.gov/bis/ear/pdf/ccl1.pdf ).
[16] US General Accounting Office, 2002. Nonproliferation: Strategy Needed to Strengthen Multilateral Export Control Regimes, p. 32. (Note that "multilateral" here