E. Richard Gold
 

E. Richard Gold is on the faculty of law at the University of Western Ontario, London, Canada, N6A 3K7 , a senior fellow of the Einstein Institute for Science, Health & the Courts, and a research associate of the Health Law Institute at the University of Alberta (e-mail: ergold@uwo.ca).

A framework for achieving compromise between industry and civil society.

Now may be the time to move the biotech patenting debate forward. Given the fact that all major Western markets grant patents over biological material, including higher life forms, our time may be better spent looking at the nature of those patents, the liability rules that accompany them, competition rules, and the regulation of biotechnology, than attempting to answer a question that is, at least in developed countries, moot¹.

Last month, I examined the arguments of industry and civil society in favor of and against biotech patenting, respectively². Given that both sides have space in which to negotiate over the strength and coverage of biotech patents, we need to find out where, within that space, they can achieve compromise. Here, I attempt to introduce some promising avenues. But simply achieving compromise is not enough. If we have learned nothing else from current debates over biotechnology, any agreement that fails to have the backing of public opinion is doomed to failure.

Public opinion
For the industry, public opinion can block entire lines of research and development despite the presence of a patent^3-5. For the critics, public opinion is a dangerous companion. Although biotechnology critics have partially succeeded in aligning public opinion in Europe and North America with their positions^{6, 7}, public opinion can be fickle. Should industry get its message across that biotechnology can help solve some important health and agricultural concerns, public opinion may change.

Neither industry nor civil society will win the biotech patent battle without public support. Nevertheless, despite its strength in affecting the markets for biotech products, public opinion with respect to biotechnology issues is both uninformed and unformed⁸. In addition, the public distrusts the information it receives from both industry and organized civil society and longs for neutral analysis. It will therefore not be sufficient for industry and civil society to reach agreement—assuming they can do so—by themselves. They will have to develop a mechanism to gain and maintain public consent to that agreement.

Moving forward
Given the importance of public opinion, we must be careful in structuring an answer to the biotech patenting debate. One component of the solution is public consultations. We must be mindful, however, not to start out with any a priori answers, because this would undermine the legitimacy of these consultations. What we need instead is a framework for discussion. To engage not only industry and organized civil society but also the public in the biotech patenting debate, we need to fashion a structured discussion.

First, we need to place the biotech patenting debate within both an ethical and a commercial framework. We must recognize that biotechnology touches on some of our most important ethical beliefs, including dignity of the person, equity, and the protection of the environment and of our descendants, to name but a few. At the same time, the biotechnology industry faces commercial imperatives of building shareholder value, competition, and the drive for efficiency. Both the ethical and commercial concerns are of importance, and how we rank them—which type of concern takes precedence over the other in a given situation—is fundamental to achieving consensus.

We must push aside hard-line positions on both sides of the debate—for example, that what industry does is generally ethical and, in those few areas where it is not we can regulate, or that industry is inherently unethical and no amount of regulation will correct for this. We need to, instead, define the goals of biotechnology. At a simplistic level, these include increasing quality of life and feeding the world.

Second, we need to connect these goals with our ethical values so that we can agree on the type and level of environmental, health, and cultural risk we are willing to accept to achieve them. We have no choice but to accept risk. After all, both going forward and failing to go forward with a new technology presents its own kinds of risk: potential harm to health, the environment, and tradition on the one hand; the failure to save lives, clean up the environment, and provide jobs on the other.

Once we have connected our goals with our ethical framework, we need to define what role industry properly has in achieving those goals. Industry cannot achieve everything. As I discussed last month, industry is not the best instrument in conducting basic science, nor is it best at solving problems in which the market either does not work or is nonexistent. For example, there is little economic incentive for industry to solve the health problems of the developing world. Although industry may, from time to time, arrive at a solution to a particular problem in the course of its research, it has no incentive to do so systematically.

To define both our goals and industry's role in attaining those goals, we need to consult the public. Given the public's lack of knowledge about biotechnology and its lack of trust in the information that both industry and the critics provide, we need to develop public consultation methods that involve education by scientists whom the public perceives to be neutral. We need to hold "town hall" or "citizen juries" in which we first educate members of the public about basic genetics, inheritance, and the basic biotechnologies before asking them to help government, industry, and organized civil society set our ethical goals and define industry's role in attaining those goals.

Third, once we demarcate industry's role, we need to ensure that we satisfy industry's commercial concerns. This means we need to increase efficiency in the granting, challenging, and enforcement of patent rights. We must examine patent laws at both the national and international levels to ensure that they provide as strong a set of incentives as possible to invent within the ambit we have assigned to industry. This means removing uncertainties over such subjects as experimental use exceptions and standards for utility and description. It means formulating efficient and quick opposition procedures. It may mean ensuring that, where some claims within a patent are in dispute, the undisputed claims in the same patent are nevertheless granted.

Fourth, we must find means to attain the other goals—the goals we have not assigned to industry—we have set for biotechnology. This means establishing public research funds and priorities. We need to discuss how to create those funds and set those priorities at the international level. It would be ethically untenable if we only pursued those goals with which industry can help without putting similar efforts into attaining our other goals.

Fifth, we must recognize that the mechanisms we have chosen to reach our goals—whether industry or public funding of research—will, from time to time, fail. We must therefore establish regulatory regimes to protect our health and environment. In doing so, we must be mindful of efficiency and commercial need. Nevertheless, these needs must be secondary to the achievement of our overall goals.

Conclusions
As I argued this month and last, we must take seriously both the needs of industry and the concerns of civil society in determining the scope and nature of biotech patents. More importantly, we must keep control over the definition of public health, agricultural policy, and environmental protection within the public sphere. To paraphrase Charles Taylor, we can neither abolish the market nor trust it to meet our objectives⁹.

Although it is important to assist industry in reaching its assigned goals, it is equally important to restrain industry from going beyond its role. The interests of the private sector are return to shareholders. Corporate law is founded on the principle that the only legitimate goal of corporate management is to protect the financial interests of the corporation's shareholders. It is not only unrealistic but against current law to expect corporate management to act in any way that does not bring financial value to their companies. Given this and the importance of achieving the public good, we must be vigilant in ensuring that, while we assist industry in working to reach our health, agricultural, and environmental goals, we do not assign to it the definition of those goals.

1. Caulfield, T.A. & Gold, E.R. FORUM for Appl. Res. & Pub. Pol. 75 (Spring 2000).
2. Gold, E.R. Nat. Biotechnol. 18, 1217–1218 (2000). MEDLINE
3. Barboza, D. Monsanto faces growing skepticism on two fronts. New York Times , August 5 (1999), p. C1.
4. Brown, P. & Vidal, J. GM investors told to sell their shares. The Guardian, August 25 (1999).
5. Whitney, C.R. Europe loses its appetite for high-tech food. New York Times, June 27 (1999), p. D3.
6. Gaskell, G. et al. Nat. Biotechnol. 18, 935–938 (2000). MEDLINE
7. Priest, S.H. Nat. Biotechnol. 18, 939–942 (2000). MEDLINE
8. Canadian Biotechnology Secretariat, Public opinion research into biotechnology issues. (Canadian Biotechnology Secretariat, Ottawa, ON; 2000).
9. Taylor, C. The malaise of modernity. (Ananci, Concord, ON, Canada; 1991).