This chapter considers how innovation policy and health law – including food and drug regulation, healthcare reimbursement, and direct R&D subsidies – have both encouraged and impeded the development and allocation of new technologies in the fight against COVID-19. First, an expansive diagnostic testing program for COVID-19 is critical both to slow the spread of the disease and to ensure that future outbreaks can be detected early. The disastrous US testing response represents both an individual regulatory failure and a failure of coordination among agencies including the Food and Drug Administration (FDA), Centers for Disease Control (CDC), and Centers for Medicare and Medicaid Services (CMS). On the treatment side, drugmakers have rushed to identify new and existing compounds for potential COVID-19 efficacy against the backdrop of potentially lengthy and expensive clinical trials. In response, the FDA has granted Emergency Use Authorizations for several of these drugs, which requires balancing risks and harms on only minimal evidence. The intersection between incentives and regulatory oversight has profoundly shaped the innovation landscape for new COVID-19 treatments, such as by permitting widespread use in ways that do not improve the evidence base about which therapeutics are most effective. Finally, extinguishing COVID-19 will require the development of a broadly effective vaccine. This is an opportunity to develop and implement novel ex post rewards, including reimbursement incentives per vaccination to promote vaccine uptake. Each of these areas reveals important lessons to help policymakers better prepare for the next pandemic.

Corruption is a current and complex problem with significant effects on trade. For example, at the time of writing the US Justice Department was intervening in a case against a large a pharmaceutical company. It was alleged that the company was responsible for a scheme of drug price increases in the US, as it “ … bribed doctors and their staffs to increase sales.” The price of the drug, addressing infant seizure disorder, had increased 97,000% since the year 2000. Also, many of the affected sales were driven by Medicare reimbursements.1 This case suggests that corruption may:Corruption is also a concern in a global perspective. The UN Secretary-General António Guterres, when addressing the UN Security Council on the issue of corruption in post-war territories, stated that “Corruption robs schools, hospitals and others of vitally needed funds,” with negative effects on people’s rights, foreign investment, and the economy. Based on the World Economic Forum, the cost of corruption is at least $2.6 trillion, or five percent of the global gross domestic product (GDP). According to the World Bank, businesses and individuals pay more than $1 trillion in bribes every year.2 Finally, the Organisation for Economic Co-operation and Development (OECD), through its Clean Government Initiative, has identified at least four negative effects of corruption, namely:The Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) builds upon international instruments on corruption. It addresses them differently, by adhering to their principles, encouraging their observance, or mandating their ratification or accession. The list of instruments includes (Art. 26.6)

In today’s broader context of resistance to the expansion of international trade, particularly in the United States (with its rejection of the Trans-Pacific Partnership (TPP)) and the United Kingdom (with its rejection of the European Union), the regulatory coherence chapter of the TPP is highly relevant. Its cross-cutting sectoral approach and use of industry-specific annexes to reduce technical or regulatory barriers to trade is likely to serve as the model for all future multilateral trade treaties. Moreover, even though the TPP was rejected by the Trump administration, it later rose as the CPTPP. The United States may still participate in some form. Recently, the United Kingdom expressed an interest in becoming a party. Ambitious trade deals like the TPP sometimes take decades to finalize. In any case, both the substantive provisions and the architectural structure of a highly negotiated free trade agreement (FTA) like the TPP are quite enduring, so the TPP’s regulatory coherence mechanics are likely to re-surface in future FTAs. In other words, the current form of the TPP will serve as a model for any future TPP or similar mega-regional FTA.