The Rocky Road to Biotech’s Success

The first Earth Day celebration, conceived by then-US Senator Gaylord Nelson, was held in 1970 as a “symbol of environmental responsibility and stewardship.” In the spirit of the time, it was a consciousness-raising experience organized, appropriately, at the grass roots level. Now, however, Earth Day offers little more than an opportunity for environmental alarmists to gain media attention, dispense anti-technology tirades, and pressure government regulators for more stringent regulation.

Government officials have been only too glad to oblige, often citing “public concerns” as the reason for “precautionary” regulation. The new biotechnology—also known as gene-splicing or genetic modification (GM)—offers a good example. For over two decades regulators around the world have crafted a patchwork of misguided rules and regulations specific to the most precise and predictable techniques of biotechnology. Their risk-averse, precautionary approach conflicts with the widely held scientific consensus that the new biotechnology is an extension, or refinement, of less precise technologies long used for similar purposes: except for wild berries, all of the grains, fruits, and vegetables in Canadian,

American, and European diets are derived from plants genetically improved by one technique or another.

Regulatory regimes specific to gene-splicing have sharply inflated the costs of research and development and inhibited its application to many classes of agricultural products, including those—such as plants that grow with less water and smaller amounts of agricultural chemicals, and that promote no-till farming—that are extraordinarily environment-friendly.

Ironically, we would have been far better off if, instead of implementing regulation specific to the new biotechnology, policy-makers had merely regulated biotech products in the same way as products—pharmaceuticals, new plant varieties, pesticides, and so on— made with older, less precise and predictable technologies. That regulators focus on the techniques used to produce gene-spliced organisms means that they often miss important similarities to, and differences from, conventional counterparts.

Climbing out of our regulatory morass will require a multifaceted solution. Some of the needed remedies are widely applicable. Regulatory policy must respect certain overarching principles: primum non nocere, that is, government policies must do no harm; sound science and common sense must be the basis for policymaking; the degree of oversight must be commensurate with risk; market forces must be allowed to complement government oversight; and institutional incentives must be changed so that regulators’ self-interest becomes constructive, rather than destructive and anti-competitive.

The public policy miasma that surrounds the new biotechnology is becoming progressively more damaging, immutable, and taken for granted. How, then, does society achieve meaningful change? We suggest six strategies for “progress”—that is, the evolution of public policy towards more scientific, risk-based approaches to regulation of the new biotechnology—that would be a good start.

First, as individuals, scientists must contribute to the dialogue on public policy issues. Perhaps surprisingly, instead of demanding rationality in public policy, most scientists have settled for “transparency,” or predictability—the predictability of delay, frustration, legal liability, public backlash, and loss of markets. Others have been seduced by the myth that “just a little” excess regulation, even if unwarranted, will assuage public anxiety, neutralize activists’ alarmist message, and bring about the technology’s golden age. Although defenders of excessive regulation have made those claims for decades, neither the public nor the activists have been appeased, and the policy miasma has only deepened.

Scientists can make unique contributions, especially when exposing unscientific arguments. They should make their influence felt in every possible forum, including scientific and “popular” articles, communication with the news media, and especially on scientific advisory panels at government agencies. It is particularly important for scientists with mainstream views to counteract the actions of the few rogue members of the scientific community who receive most of the attention.

The second strategy pertains to science in its institutional forms—the professional associations, faculties, academies, and journals. These institutions should far more aggressively explore the controversies about public policy and elevate the level of discourse on them. Scientific societies can, for example, help to create and promote a broader policy perspective by building high-profile public policy symposia into all national and international conferences.

Third, reporters—and by extension, their bosses, the editors—have tremendous power to illuminate public policy issues that have a scientific component. Too often, however, in the interest of “balance,” all of the views on an issue are presented as though they were of equal weight or value—even after the dialogue has progressed to a point where some have already been discredited. This bestows moral equivalence on all points of view. Journalists need to learn that where there’s the smoke of activists’ alarmist propaganda, there isn’t necessarily the fire of genuine controversy.

Fourth, companies and trade associations must take the long view of regulation—one motivated by a belief in science-based public policy and in competition—and resist the temptation to advocate flawed, short-term fixes.

Curiously, the biotechnology and food industries have long supported regulation that discriminates against the new biotechnology, viewing this needless layer of regulation as a consumer-friendly “seal of approval.” Unfortunately, it is just the opposite—a suggestion that gene-spliced products are different in some important way—and it ensures that agricultural and food biotech will continue to experience endless pseudo-crises like the furors over Monarch butterflies, StarLinkTM corn, “contamination” of native corn species in Mexico, biopharmed crops contaminating food, gene-spliced material “contaminating” conventional seeds, and on and on. Although none of these occurrences has actually injured a single person or ecosystem, collectively they constitute a public relations debacle.

Advocacy of fundamentally flawed, unscientific regulatory policies is tantamount to a farmer eating his seed corn. In the long run, producers and consumers will benefit most from the predictability and logic of science-based policies—and from a robust academic research enterprise. Productivity is squandered when public policy forces researchers to spend their time and resources filling out mountains of unnecessary paperwork instead of conducting experiments. Unnecessary bureaucracy is anti-competitive, lays waste to free markets, and creates potential legal and criminal liability for inconsequential violations.

Fifth, those who are not directly involved in science, but who are important stakeholders in the ultimate applications of science and technology—venture capitalists, consumer groups, patient groups, and philanthropists, for example—should commission experts to help them to advocate and advance the goal of rationality in public policy, and should join forces with organizations that already do so. The foes of scientific and technological progress are amply funded. Although the biotechnology industry has spent vast sums to improve its image, its campaign has been more cheerleader than leader.

Finally, the government/non-government balance in actually performing the mechanics of regulation—review, permit granting, commercial approvals— must shift. There is nothing sacrosanct about a government monopoly over regulation, especially given that 30 years of poorly-designed government regulation has created such a quagmire for the new biotechnology applied to agriculture and food production.

A variety of alternative institutional arrangements can and do serve to regulate and monitor the testing and marketing of products as varied as plants, microorganisms, and pharmaceuticals. Non-governmental mechanisms exist for hospital certification, organ transplantation, quality control of seeds, and tens of thousands of categories of consumer products ranging from electrical equipment to bulletproof glass. It is past time for the regulatory pendulum to swing away from government monopoly to other models that are more efficient and favorable to innovation.

These reforms and revisions of attitudes won’t happen overnight, but they are necessary if the new biotechnology is to realize anything approaching its potential.