Chapter 3 lays out the book’s central theory as well as the theory’s observable implications. It argues that powerful producers seek to use their privileged knowledge of the risks and benefits of their products (and regulators’ dependence on that knowledge) to systematically push their own out-of-patent products and those of generic sellers off the market via regulation, in favor of more expensive, patented alternatives. Producers accomplish this first by strategically revealing negative information about out-of-patent products as a means of convincing regulators that these products require stricter regulations. Second, producers support regulatory institutions that require existing products to be reevaluated under a precautionary standard, meaning that failure to prove an existing product is safe leads to the assumption it is dangerous. These precautionary institutions help innovative producers eliminate out-of-patent products more systematically, allowing them to acquire stricter standards not via the provision of damaging information, which carries some reputational risks, but through the withholding of favorable information. This chapter also lays out expectations for where we might expect these precautionary institutions to be adopted, given the distribution of preferences across countries, and it shows why such precautionary institutions should tend to be supported by developed countries and opposed by developing ones. Finally, the chapter argues that because international standard-setters ought to be susceptible to the same sorts of information problems as domestic regulators, and given the distribution of national power within these organizations, we can expect international standard-setters to replicate the precautionary institutional preferences of their wealthier members. We can additionally expect this to create the same tendency on the part of international standard-setters to arbitrarily impose stricter standards on more affordable products, despite the fact that this creates trade barriers that disadvantage poorer members and that directly conflict with these standard-setters’ stated mission.

Chapter 1 provides an introduction to the book. Motivating the book with examples of various regulatory barriers to agricultural trade that have proven particularly contentious, this chapter asks what might explain these barriers and whether we should expect current international solutions to resolve them. The chapter provides a brief overview of the book’s argument regarding how producers leverage private information to acquire the sorts of regulatory barriers that the opening examples describe. In addition, it previews the book’s main contribution and gives a brief chapter outline.

This chapter sets the stage for the remainder of the book by providing a broad overview of the sorts of information asymmetries that exist between producers of potentially dangerous products and those who are tasked with regulating them. Leveraging insights from a diverse set of industries -- aerospace, direct-to-consumer products, pharmaceuticals, and industrial chemicals -- and spanning a wide range of countries, this chapter establishes the surprising degree to which regulators not only are at a disadvantage relative to firms when it comes to acquiring information about product risk but also, as a result, depend on firms to be the primary source of information required to regulate. The chapter then investigates the conditions under which this might allow producers to influence the timing and direction of regulatory change. After establishing the pervasiveness of information asymmetries and dependencies at the domestic level, as well as the resulting opportunities for regulatory bias, the chapter demonstrates why we should expect the very same information asymmetries and biases to be replicated and even exacerbated at the international level.

Focusing on firm-level behavior in the US pharmaceutical and agrochemical industries, Chapter 4 provides evidence that companies do indeed seek stricter standards on their own, out-of-patent products in order to boost sales of newer, patented substitutes, even providing negative information about their own products in pursuit of this goal. In order to show this, the chapter leverages petitions submitted by pharmaceutical and agrochemical companies to the US FDA and EPA, respectively, requesting that the agencies place stricter standards or all out bans on products that these companies themselves developed. In the case of the pharmaceutical petitions, the chapter provides evidence that all but one of the requests for a product ban has targeted a drug that is about to lose or has already lost patent protection and for which the company had a more recently patented substitute. This suggests that such requests are not publicly minded attempts to ensure dangerous products remain off the market but, instead, are strategic gambits to boost profits of exclusively produced alternatives. In addition, the chapter provides a statistical analysis of petitions submitted by agrochemical companies and farm groups to show that, whereas farmers are no more likely to seek stricter standards on out-of-patent pesticides, agrochemical companies systematically request stricter standards on these products while requesting more lenient standards on products still enjoying patent protection.

The final chapter concludes by first re-outlining the book’s central arguments. The chapter then revisits how the preceding chapters help shed new theoretical light on the source of regulatory barriers while also answering several empirical puzzles, including why similar risks frequently receive dissimilar regulatory treatment, why some nations impose more precautionary regulatory rules than others, and finally what is behind some of the most contentious agricultural trade barriers. Finally, the chapter explores the ethical implications of the book’s central findings and offers several concrete policy recommendations for addressing both the broader information asymmetry problems outlined in the book and the resulting biases that were identified.

Chapter 5 takes a deep dive into the history of US agrochemical regulation in order to show that innovative companies were a major force behind the adoption of institutions that required the precautionary reevaluation of existing products, in opposition to generic producers who stood to lose out from such institutions. Using an original dataset that tracks changes to US agrochemical regulations over a two decade period, the chapter then provides evidence that in the wake of these institutions’ implementation, regulations have become stricter on older, less profitable products over time for reasons that cannot be attributed to health, safety, or obsolescence alone. In addition, the chapter provides evidence that the mechanism behind this outcome is not the political power of producers but rather their ability to leverage their information advantages under a regulatory regime in which products are subject to precautionary reevaluations.

The final empirical chapter turns to the international level in order to determine whether delegation to an international standard-setter alters the regulatory dynamics identified. Looking at the Codex Alimentarius Commission, the chapter asks whether this institution has been able to ameliorate the regulatory biases found domestically. In order to answer this, the chapter replicates the analysis conducted on agrochemical regulation in the United States, this time looking at changes to standards under Codex. The chapter shows that even though Codex standard-setters are substantially more removed from the domestic political process than regulators in the USA, the Codex Commission has shown as much of, if not a greater tendency to systematically impose stricter standards on out-of-patent agrochemical products. As such, the international standard-setter has ended up placing more onerous rules on more affordable products for reasons that are less based on science than they are based on the absence of scientific information. In addition to showing that international standards have been vulnerable to similar biases as domestic regulations, this chapter also explores how developing countries and generic producers have sought to combat the regulatory barriers that have arisen at the international level and how innovative firms have successfully blocked them.