Making Meaning, Legitimacy, and Policy:

Real Influence in the Governance of Biotechnology

A Smith :: June 2002

To understand power, one must never limit it to its most raw or explicit expressions.  Policies are the end result of many choices made.  While such expressions of ‘hard’ power are often well critiqued, instances of ‘soft power’ [1] typically receive less scrutiny.  To better understand the relationship between hard and soft power, this paper will explore two under-discussed types of choices made by policy-makers. 

Governments make explicit choices in the terminology, definitions, and metaphors they use and promote.  These word-choices are expressions of their soft power to make meaning.  They also choose, explicitly and implicitly, how to build and from who to solicit support for their policy-level choices.  These instrument-choices [2] are expressions of their soft power to make the influence of certain actives [3] legitimate.  Choices to legitimate the influence of certain definitions or organizations and not others simultaneously acknowledge and create differential levels of real influence [4] among those definitions or organizations competing for dominant influence over the policy-choices made by Government. [5]

The central question of this paper is twofold: Who can influence biotechnology policy decisions in Canada? Can Canada influence biotechnology policy decisions internationally?  In order to situate and answer these questions in the Canadian context, I will explain the ‘transactional cost framework’ analysis as a means of understanding the political economy of instrument and policy-choices.  I will then present a short history of Canadian biotechnology policy choices.  I will briefly review various international agreements under which Canada is bound.  In order to better establish the terms under discussion, a history of Government and international ‘word-choices’ in biotechnology policy will follow a brief exposition on the terms ‘biotechnology policy,’ and ‘biotechnologies.’

Historically, in Government usage, biotechnology policy referred to the degree of financial support for scientific research offered by federal government.  It meant agenda setting, and involved simply deciding where money should go.  Only recently has the term been invested with secondary reference to the regulation and restriction of research endeavours and their marketable products.  It will become apparent that the economic paradigm continues to inform and influence Government definitions and policies today. [6]

Notwithstanding certain idiosyncrasies among definitions of biotechnologies promoted by national and international institutions or organizations, [7] a common distinction is drawn between old biotechnologies, such as fermentation processes and traditional husbandry, and ‘new’ or ‘applied biotechnologies.’ All are agreed that these biotechnologies involve the application [8] of science and engineering [9] using biological agents, [10] systems, living organisms, or derivatives thereof, [11] to make or modify products or processes for specific use. [12]   Such uses are commonly specifed as the provision of goods and services, [13] though they have also been expanded to uses which serve social, scientific or economic purposes. [14]  

These points of commonality reveal how the economic, market- and product-oriented paradigm presented by the OECD in their 1982 definition [15] of the term has influenced the definitional word-choices of both Canadian policy-advice-giving bodies, and governmental strategies, [16] as well as those of international agreements. [17]   The Canadian Environmental Protection Act (CEPA) and UNEP’s Cartagena Protocol on Biosafety of the Rio Convention on Biological Diversity (Cartagena Protocol) stand unique in that their definitions do not presuppose market values in the ‘specific uses’ of the ‘products or processes’ ‘made or modified.’

Thus, a primary tension is apparent between perspectives which invest biotechnologies with their own market-driven philosophy, and those which, for various reasons, imbue the term with some alternate philosophy.  Some may hold a vested interest in not over-defining the term, [18] while others may hold a perspective that diverges from the prevailing market philosophy. [19]   This tension is further evinced by the competition between the widely-used terms, ‘genetic materials,’which refers to any material of plant, animal, microbial or other origin containing functional units of heredity, [20] and ‘genetic resources,’ which means genetic material of actual or potential value. [21]  

Those who want to explicitly refer to the primarily financial [22] value derived from genetic materials use the latter term.  In this context, it is most interesting to note which international organizations [23] adheres to this concept in exclusion of all others that are available.  It is similarly telling, how such organizations give a nod to the Rio Convention on Biological Diversity, point to its definition of the term, which is subtly inclusive of social and ecological values, and then proceed to employ the concept in exclusively economic terms.  By drawing an analogy between genetic resources and ‘natural resources’ [24] they have since made policies that extend the scope of nations’ right to manage its own resources. [25]

The alternative, genetic material, is used more broadly among organizations whose stated goals are primarily scientific or sociological. [26]   Many definitions of related terms found in the documents of international standard-setting bodies [27] rely implicitly on this definition and its philosophy. 

The terminologies and definitions used by governments are indicative of the kinds of ideas they are willing to accommodate, the kinds of influence they are willing to legitimate, and the kinds of policy they are willing to make.  The second aspect of soft power involves the selection of means to legitimate their policies, by legitimating the influence of certain actives within the policy-making process.  A brief exposition of ‘the transaction cost framework,’ will help explain the Government choices to ‘buy’ themselves and their policies some legitimacy. [28]  

The organizational structure of any active determines its range of possible economic relationships.  A small private non-profit will not have the same capacity to meet all of its own needs by producing what it needs internally, as compared to a large multi-national corporation, or a federal department of government.  In any case, if production costs are the sum of procurement and exchange, then the ‘rational economic actor’ must make an economic choice to make a good, or to buy it; this is the ‘make or buy dilemma.’ [29] Sometimes even a Government cannot produce its own legitimacy, and since it cannot simply buy its legitimacy in the Market, it must select certain instruments to legitimate its policies.  In so doing, it must legitimate the influence of certain actives in the policy-making process. 

‘Inputs are bought when they are widely available and procurement can be organized easily and cheaply, as on the market; inputs are made when they are specific to a given economic task and procurement is costly enough on the market such that economies of scale and scope can be established through hierarchical organization…’ (Rubin 1990).  … [Inputs are procured through] Networks … when resources are more specific than can be dealt with by the market, but less so than would require procurement by the hierarchical organization.  (Macdonald, 2000, 163) 

Any decision to make or buy will fall within a continuum, between two formal extremes: external—buy in the Market, and internal—make somewhere within the Hierarchy of the organization.  There is also a third option: procurement through the informal arrangements of ‘Networks,’ which lay somewhere in the centre of the continuum. [30]

Mark MacDonald contends that when this framework is applied to Government, “alternative organizational forms to govern exchange will be evident” there.  (Macdonald, 2000, 161)  He explains how those who are ultimately responsible for policy-making in a democracy, our legislators, face the make or buy decision as regards ‘policy resources.’ [31]   These decisions will ultimately supply any resources needed to make a policy, but sometimes the needed resource is available neither within the organization, nor on the market.  Thus “informal organizations such as the policy network will also be organized when the resources being procured are not marketable, or easily 'made' in the public sector.” (Hindmoor and MacDonald in MacDonald, 2000, p.162) 

By policy network, MacDonald refers to an ad-hoc structure of experts and others with sufficient influence to ensure that policy-makers have continued support come election-time.  As official policy networks are created by act of Government fiat, they are perfect examples legitimacy-making instrument-choices of the Government.  They are usually created when policy-makers do not have the expertise or resources at their disposal to be able to make or buy effective policy-choices. [32]   Thus, “transaction cost research looks at the organizational choices that legislators make for the procurement of vote-productive policy resources.” (MacDonald, 2000, p.  162)

Knowing that Governments are often in need of ‘policy resources,’ and wanting to discover who can influence biotech policy in Canada, it will be interesting to turn to a historic review of both the policies themselves and the means used to legitimate them. 

In 1980 the Government of Canada identified Industry and Academia as the actives whose expert opinions merited inclusion in the formulation of a federal approach to biotechnologies.  Based upon the recommendations and advice of this industry/academia Task Force, the government launched the National Biotechnology Strategy (NBS) in 1983, supported by $ 11.9 million annually to pursue its objectives. [33]  

Government gave Industry Canada the lead in the NBS, and subsequently established the National Biotechnology Advisory Committee (NBAC) as an advisory body, comprised of appointed experts to advise the Minister of Industry on policies required to promote the development of biotechnology in Canada under the NBS. [34]

In 1989, parliament established the Royal Commission on New Reproductive Technologies.  Commissionaires were experts in the field of reproductive technologies, ethics, and biotechnologies.

In the following year, 1990, NBAC was requested to develop a business plan for biotechnology.  The NBAC Report [35] recognized that the commercialization stage of biotechnology and the regulatory process in particular had become a flashpoint for public debate.  Consequently, the Government of Canada formed several interdepartmental working groups in order to inform public awareness, while several government departments held workshops in the early 1990s to allow those they had identified as ‘stakeholders’ to discuss their socioethical perspectives. [36]

Later that year, the Government-commissioned review of the second phase of the NBS by Ersnt & Young. [37]   The review suggested that the Government ought to focus on regulatory issues, as “uncertainty in how biotechnology products would be regulated created a hurdle to commercialization.” [38]

After consultations with Industry representative earlier in 1992, Cabinet approved the Federal Regulatory Framework for Biotechnology in December of that year. [39]   The following year, in 1993, the Royal Commission on New Reproductive Technologies, after extensive consultations with expert ‘stakeholders,’ [40] issued the Baird Report, which included over 400 recommendations for legislation and regulation, including the criminalization of certain research areas. 

Over three years later, in June 1996, based on the Report’s recommendation, the Minister of Industry introduced ‘an Act respecting human reproductive technologies and commercial transactions relating to human reproduction,’ which was to outlaw certain research, and regulate all gene technologies in human reproduction.  However the Canadian Government was content to allow Bill C-47 to die on the Order Paper and, in the following Session, chose not to reintroduce it and also to quietly smother a similar private bill (C-247) in Committee. 

Subsequent to agreements between relevant Departments in 1997, the Canadian Biotechnology Strategy Task Force was formed to spearhead renewal of the NBS, allowing this internal initiative to be propelled by Departmental personnel and resource contributions. [41]

The Taskforce chose to carry out two ‘public consultations,’ each comprised of five regional sessions.  The First set of consolations was with ‘appropriate sectors,’ which submitted their views in writing to the appropriate Department.  A number of Industry representatives were then selected and invited to the session to voice their positions.  The second set of consultations were termed ‘Round Table’ Consultations, in which a proportion of industry (40%), ‘knowledge-based community members’ (36%), and ‘larger community’ members (24%) was fixed, and a number of representatives from organizations representing each group were selected and invited to attend.  The invitees were also welcome to submit their views in writing.  In both Sector and Round Table Consultations, all topics of conversation and all questions requiring participant response were pre-selected.  By both vetting participants and limiting the kinds of ideas under consideration, the Government not only exercised soft power, but simultaneously secured a degree of legitimacy for its pending policies.

The substance of these consultations ostensibly formed the basis for the 1998 renewal of the NBS as the new Canadian Biotechnology Strategy (CBS), which would again be coordinated by the Minister of Industry.  The seven original Ministers of the CBS Task Force, with the addition of the Minister of Foreign Affairs and International Trade, became the Biotechnology Ministerial Coordinating Committee (BMCC), and were charged with the responsibility of overseeing strategic and intersectoral issues and advising the CBS coordinator.  Later that year, Government established the Canadian Biotechnology Advisory Committee (CBAC), to act in advisory capacity to the BMCC.

The CBAC was established by the federal government on September 27, 1999 as an independent advisory body, whose members are not interest-representatives, but experts in their respective fields.  CBAC was formed recognizing that public involvement is needed to counteract the real problem of a widespread legitimacy vacuum in public perceptions of the Government and its biotechnology policies.  As an advisory council, CBAC exists to inform and consult the public at large, while at the same time informing the full spectrum of Government-determined actives and policy-makers.

As of 1998, the Canadian Government has attempted to ‘harmonize’ and ‘clarify’ the regulation of biotechnology products, consolidating them in three departments, the CFIA, [42] Health Canada, [43] and Environment Canada. [44]   Industry Canada remains indirectly involved because it houses the Canadian Intellectual Property Office and is responsible for decisions under the Canadian Patent Act, though it also continues to play a significant role in translating the momentum of lobby pressure throughout Cabinet and in relevant Departments.

This brief policy history has detailed not only policies and their outcomes, but also their structure and the means by which they were legitimated—the people who influence biotechnology policy decisions in Canada.  While Canadian legislators have made various instrument-choices through time, their favoured instrument for dealing with sensitive biotechnology issues today are policy networks, like the CBAC, and the various Task Forces.  Governments buy legitimacy with legitimacy.  Industry and Expert lend their credibility to Government policies, and in return, Government legitimates their influence and perspectives within the policy-making process.  Only lately has public opinion also been legitimated in the process, and then only in a limited scope and form.

To see whether Canada can influence biotechnology policy decisions internationally, I will now turn to a brief overview of some international agreements that bear significant influence upon national biotechnology policy-making.  The WTO’s Agreements on Trade-Related aspects of Intellectual Property, (TRIPs), [45] Sanitation and Phytosanitary measures (SPS), [46] and Technical Barriers to Trade (TBT) [47] explicitly determine rules for national regulations regarding international trade.  Agreements [48] under the Rio Convention, the Cartagena Protocol, [49] establish rules for cross-border transportation of ‘Living Modified Organisms.’  Alternative policy instruments like the Declaration on the Human Genome and Human Rights [50] of UNESCO are entirely voluntary, and are only required if member nations share the principles articulated within the declarations or statements. 

Despite good epistemic reasons to question the paradigm of scientific knowledge, each of these agreements shares a certainty in science and the scientific method.  None question the scientific analysis of risk-versus-benefits in comparative testing for the certification of product safety.  Consequently, national governments must have verifiable scientific justification for setting standards high and maintaining traditional sources of foodstuffs, industrial, and therapeutic products.  As such, it would be almost impossible for Canada to ban imports of biotechnologies, or strike down patents on life. 

Canadian biotechnology policy and regulation commonly face several critiques.  Inasmuch as international agreements are binding, their terminology and conceptualization of issues becomes entrenched, and unavoidable.  It would seem that nations no longer have the latitude to frame issues in truly a representative manner.  Approaching policy with a purely economic perspective has already proved to be problematic in Canada, as evidenced by the early years of biotechnology policy, and the eventual crisis of the early 1990's..  Though they have since adjusted their approach, Government has not discarded its underlying perspective.  Their conceptualization of the issues retains its economic bias, and consequently certain ways of thinking are simply not entertained.  The fact that this bias is shared by many international organizations in which Canada is a member and agreements to which Canada is a signatory has implications for national policy.  The trend towards harmonizing policies with international standards is similarly telling, as the economic imperative of removing barriers to trade becomes the rationale behind policy choices.

The process of selecting and structuring legitimacy-making instruments is also troubling.  The CBAC, while it ostensibly exists to gather and relay public sentiment, may serve its true purpose regardless of how well it does that job.  Governments have proven altogether too willing to rely on the structure of an instrument, or the fact that the process of a public consultation has occurred, and less on the substance of its outcome, often ignoring altogether the limitations imposed by their chosen structures. [51]

A related critique concerns access to the policy-making process.  The transactional cost framework reveals how a seat at the table, or a voice in the process is ultimately an economic consideration.  Certain actives, which may not be resource-rich, or influential enough to matter to the overall legitimacy of a policy, may yet have a primary and valid interest in the matter.  However, without first achieving some sort of critical mass of legitimacy, perhaps by forming a well-funded interest group, they will have little or no influence.  To some, this reveals a disturbing vulnerability of representative democracy and a critical vacuum of legitimacy.

Government also experiences profound conflicts of interests between their service mandates and their regulatory activities.  This reality goes to often unacknowledged.  Critics ask: Who do Health Canada, [52] the CFIA, [53] and DFAIT [54] really represent? Is their ‘client’ industry, or the Canadian citizenry?  Apparently Government remains confident that public interest is best served by accommodating, prioritizing, and promoting Industry interests.  The transactional cost framework explains this reality pragmatically; in terms of the economic choices government makes to maintain their legitimacy. 

Another critique regards the manner in which the Canadian Government has chosen to pursue a diffuse rather than a united approach to the regulation of biotechnologies.  By locating regulatory responsibilities within several Agencies and Departments, government has fractured the ‘block’ of regulatory oversight.  Where a single federal legislation regulating biotechnologies would be more resolutely insoluble in the agitating solution of interest-based lobbying, the current degree of diffusion among existing departments gives licence to whoever can most effectively mobilize their influence to target regulators and policy-makers on more fronts. [55]  

Finally, there currently exists no federal statutory prohibition on a range of human reproductive and gene technologies. [56]   Legislators justify their inaction in tabling and passing new laws by pointing to a voluntary moratorium [57] on developing certain gene technologies by the ‘scientific community.’ [58]   Apparently a self-regulating research community is sufficient reason not to pass legislation. [59]  

The Canadian Government is active in both national and international biotechnology policy-making.  In Canada it is Industrial and secondarily Expert [60] interests that hold the primary position of influence vis-à-vis Government policy-choices, with Public interests coming in a distant third.  In the international context, only nation-states are members in the aforementioned international organizations.  These organizations have structures in place to bar certain actives from officially and effectively influencing the policy-choices at this level. [61] As such, the WTO, WIPO, World Bank, and the UN appear to operate primarily as arbiters of Industrial influence, under the assumption that public interest is thus served. 

National governments similarly legitimize some actives and marginalize others.  This is a particularly salient issue in the regulation of biotechnology, for several reasons.  First, in Canadian biotechnology policy, there has been an official acknowledgement of a need for public involvement, though there has been less of an effort to effectively engage the public.  Second, this legitimization is not an abstract choice, unrelated to other choices in the meaning- legitimacy- and policy-making environment.  Rather, it is profoundly related, as the transactional cost framework suggests, to the need of the Government to create and shore up its own legitimacy, to ensure continued voter support.  Finally, the underlying problem of democracy remains; the problem of those voices which are not legitimated or those that, though legitimate, can exert no measurable impact on the outcomes of biotechnology policies.

The question of legitimization is tied closely to that of meaning-making, as an instance of ‘soft power.’  Both are apparently arbitrary choices, which, upon inspection, reveal the paradigmatic bias of the legitimating power, and also the flaws of the system.  The question of meaning-making, is implicated further implicated by the notion of ‘expert knowledge,’ which has been key in legitimating actives in both national and international contexts.  It is at this point that ‘arms-length’ bodies of expert opinion, or policy networks, are introduced, to complement the legitimacy of Departmental and Legislative meaning-, decisions-, and policy-makers, but which, on closer inspection proves to be nothing more than the appointment of experts over which no directly democratic control can be exerted, from which citizens voices are excluded, or through which they are highly mediated.

Given the constraints of the international agreements of which Canada is a part, its relationships with trading partners, and its own pursuit of an historic and long-established agenda that can no longer be subject to debate, Canada is not in a position to become an international leader in innovative or progressive policies to regulate biotechnologies.  Any Government evaluation of its own role in the system is strictly self-justifying of its own position, with an eye at convincing enough just the right actives so as to retain their positions of authority.  Ethical, environmental, and social concerns are seriously upstaged by the brilliance of the international investment dollars and by the plaintive cries of an industry in which the government has invested too much in to ignore.

NOTES