This paper examines recent policy issues relating to foreign investment incentives in the regulatory domain. By ‘regulatory incentives’ in this context we mean those administrative conditions offered by governments to foreign firms other than special fiscal (e.g. tax) or financial (e.g. subsidies) treatment. The key issue addressed in this paper is whether competition between host countries for...

Clinical next generation sequencing (NGS) technologies are challenging existing regulatory paradigms. We advocate a coordinate policy approach, which first requires a comprehensive understanding of the existing regulatory and legal structures. This paper introduces four key policy domains - including quality assurance, insurance coverage, intellectual property management, and data sharing - tha...

Center for Biologics Evaluation and Research enhances and supports regulatory decision-making and policy development. This work contributes to our regulatory mission, advances medical product development, and supports Food and Drug Administration's regulatory response to public health crises. This review presents some examples of our diverse scientific work undertaken in recent years to support...

We explore the implications of risk-based capital requirements, à la Basel, for the conduct of monetary policy. A “bank balance-sheet channel” of monetary policy is identified, which operates through bank capital and influences the bank’s loan decision. Using a dynamic banking model, we endogenize the capital decision and show that banks are likely to hold capital above the regulatory minimum t...

Regulating health care is a pre-eminent policy challenge in many low- and middle-income countries (LMIC), particularly those with a strong private health sector. Yet, the regulatory approaches instituted in these countries have often been reported to be ineffective-India being exemplary. There is limited empirical research on the architecture and processes of health care regulation in LMIC that...

The definition and implementation of risk management strategies is at the core of several management system standards. This paper shows why and how these standards can provide guidance for policy-makers and which elements of management systems are not yet present in regulatory systems. It then addresses risk govenance deficits, and concludes by policy recommendations on filling in the gaps and ...

We examined whether access to US-approved orphan drugs in Canada has changed between 1997 (when Canada chose not to adopt an orphan drug policy) and 2012 (when Canada reversed its policy decision). Specifically, we looked at two dimensions of access to US-approved orphan drugs in Canada: (1) regulatory access; and (2) temporal access. Whereas only 63% of US-approved orphan drugs were granted re...

While regulatory policy is well defined for orphan drug development in the United States and Europe, rare disease policy in China is still evolving. Many Chinese patients currently pay out of pocket for international treatments that are not yet approved in China. The lack of a clear definition and therefore regulatory approval process for rare diseases has, until now, de-incentivized pharmaceut...