Good Regulatory Practices Research Articles

Registration pathways to accelerate regulatory assessment of innovative medicines in Latin America.

Countries worldwide have introduced new regulations to accelerate drug regulatory review to afford faster access to medicines, mainly for patients with no or limited therapeutic alternative without compromising the quality, efficacy, and safety of the drug. We mapped and analyzed accelerated regulatory pathways in 19 countries from Latin America (LATAM). Pathways included acceptance of Phase II studies, when justified, and requirement of a Certificate of Pharmaceutical Product (CPP) for regulatory submission or approval for a drug. We present a regional regulatory overview of innovative pathways to accelerate assessment of medicines by regulators to benefit patients in need. Most LATAM regulators we surveyed have implemented accelerated pathways. Adoption of good regulatory practices is key for success (World Health Organization, WHO, Good Regulatory Practices: guidelines for national regulatory authorities for medical products(World Health Organization, WHO, Good Regulatory Practices: guidelines for national regulatory authorities for medical products. World Health Organization QAS/16.686. WHO, 2016. https://www.who.int/medicines/areas/quality_safety/quality_assurance/GoodRegulatory_PracticesPublicConsult.pdf ).

Origins of banking crises revisited: Evidence from Developed and Developing Countries

This paper revisits the causes of the 2008 global financial crisis. It focuses on the causes of the crisis, ignoring cross-country contagion effects. The study uses an assortment of financial, regulatory and macroeconomic variables to estimate a logit econometric model for a large sample of developed and developing countries. Findings indicate that lower bank liquidity, higher inflation rates, greater credits to the private sector are all correlated with an increased risk of banking sector problems. In addition, results stress the role of microeconomic variables in explaining the 2008 banking and financial crisis. Surprisingly, results prove that good regulatory practices are likely to enhance the probability of banking crisis, which contradicts the theory prediction. This positive finding makes us skeptical about the role of regulation in promoting banks' stability during the 2008 financial crisis.

Preventing the Bad from Getting Worse: The End of the World (Trade Organization) As We Know It?

Recent survey evidence and proposals made in long-running negotiations to improve WTO dispute settlement procedures illustrate that many stakeholders believe the system needs improvement. The Appellate Body crisis could have been avoided but for the use of consensus as WTO working practice. Resolving the crisis should prove possible because the matter mostly concerns a small number of more powerful WTO members. We make several proposals to revitalize the WTO appellate function but argue that unless the WTO becomes a locus for new rulemaking, re-establishing the appellate function will not prevent a steady decline in the salience of the organization. A key challenge is that plurilateral cooperation go beyond a focus on good regulatory practices and coordination failures and address sources of major trade spillovers. Doing so will depend on resolving the dispute settlement conflict given the need for new plurilateral agreements to be enforceable.

China and Global Regulatory Coherence: An Uneasy Relationship?

The last two decades have witnessed various governance initiatives across institutions, domestic and international, in response to mushrooming regulatory trade barriers. Among the efforts to balance regulatory autonomy and international cooperation, “regulatory coherence” or “good regulatory practices” seems a promising solution that centers upon bottom-up domestic regulatory rationalization. While existing literature has documented how recent mega-regional trade blocs seek to harness regulatory barriers through mechanisms of international cooperation, it has arguably overlooked certain crucial issues. In particular, how has regulatory coherence emerged as a new global norm vis-a-vis the default international economic and legal order? What are the limits to the global normative diffusion of regulatory coherence when considering the diverse contexts and agendas of emerging economies, most notably China? This article aims to enrich the existing scholarship by making two major claims. First, drawn upon a historical approach, this paper traces the trajectory of the development of regulatory coherence. With the United States being the primary driving force, the concept of regulatory coherence mirrors the key elements of Administrative Procedure Act and has diffused across various jurisdictions through multiple venues, such as APEC and OECD. Yet, despite its penetration, the entrenchment of regulatory coherence as a new global norm is conditioned upon complex political economy issues, particularly the role of China. By exploring the evolution of legal and political underpinnings for the past decades, this article contends that China has taken what we describe an “experimental approach” by prudently addressing regulatory coherence at both domestic and international levels, largely due to the democratic implications of regulatory reforms. Such an approach may, in the end, define the boundary of regulatory coherence as an emerging global norm.

Deep and Comprehensive Free Trade Agreements

This paper reviews elements of the history of association agreements between the EU and countries that are covered by the European Neighbourhood Policy (ENP). It considers the rationale for negotiation of Deep and Comprehensive Free Trade Areas with neighbouring countries based on research that assesses the design, salience and incentive effects of such agreements. It makes a case that developments in the global economy and the experience with using trade agreements to pursue deeper integration of markets suggest that alternatives to DCFTAs may be more effective instruments for cooperation for both sides. The 2015 review of the ENP creates new opportunities to consider such alternatives. These could span sectoral agreements, more focused efforts targeting specific policy areas that have a significant impact on trade costs, and initiatives that centre on the adoption of international standards and internationally recognized good regulatory practices.

The TTIP As a Key Factor of Convergence between US and EU Regulatory Models

The Transatlantic Trade and Investment Partnership represents a great chance to reduce or eliminate trade's barriers between the US and the EU. It is also a crucial opportunity to intensify the regulatory cooperation between the two biggest economic areas in the world. Its goal is to level out commercial standards and eliminate unnecessary regulatory differences. The main innovation from this point of view would be the institution of a permanent mechanism for future cooperation on all the regulatory measures that could produce transatlantic effects. Through the institution of a stable Regulatory Cooperation Body able to identify the areas in which to enforce the cooperation, the agreement would facilitate the exchange of regulatory experiences and principles between the parties. Overtaking harmonization and mutual recognition, this deal aims at establishing a permanent dialogue to prevent the emergence of regulatory differences. This paper tries to understand if the TTIP could be the first step towards the creation of a global regulatory network characterized by the implementation of good regulatory practices. Moreover, it is aimed at understanding how the treaty is going to impact the way the US and the EU make and think regulation.

Regulatory Coherence and the Trans-Pacific Partnership

The Trans-Pacific Partnership includes a chapter on regulatory coherence and measures to reduce trade costs arising from divergent standards. We review the substantive content of the TPP’s measures in light of existing processes in international organizations addressing good regulatory practices, and the track record of mutual recognition as a tool to reduce trade costs, and comment on the extent to which claims made on behalf of the TPP for significant cost reduction in goods trade can be sustained, and the extent to which fears concerning the impact of the TPP measures on democratic choice on regulatory matters are warranted.

The TPP and Good Regulatory Practices: An Opportunity for Regulatory Coherence to Promote Regulatory Autonomy?

AbstractChapters relating to regulatory coherence or cooperation are likely to be significant features of new preferential trade agreements, including the Trans-Pacific Partnership (TPP). While the potential for harmonization of standards or institutional cooperation to impact on the regulatory autonomy of treaty parties has been well considered, this article focuses on those elements of regulatory coherence that relate to domestic processes for the development of regulations. It examines whether the adoption of ‘good regulatory practices’ in accordance with the TPP will help to ensure that measures states enact to protect non-economic interests (such as the environment or public health) are consistent with other key obligations of international trade and investment law. Although many elements of good regulatory practice mirror the criteria used to distinguish legitimate regulatory measures from disguised protectionism, there is no guarantee that a tribunal will come to the same conclusions as those reached during a domestic impact assessment.

21. World Trade Organization (WTO)

The WTO celebrated its twentieth anniversary in 2015. Since 1995, the WTO has enhanced global prosperity by liberalizing trade barriers and eliminating discriminatory treatment in international trade relations. In addition, sustainable development and protection and the preservation of the environment have been fundamental goals of the WTO since its inception. At the historic juncture of the twentieth anniversary of the WTO, the organization launched various symposiums and events with other international organizations to promote the goals of environmental protection and to underline how close co-operation between them can help achieve new global targets for securing sustainable development. Specific trade and environment issues were discussed in the committees. Such issues included clean energy governance, energy efficiency, illegal logging, standards on safety, and good regulatory practices. The committee negotiations aimed to ensure that trade and environment policies are mutually supportive and to promote the collective efforts towards achieving sustainable development.

An Appraisal of Good Regulatory Review Practices in the Gulf Cooperation Council States

The aim of this study was to evaluate how each Gulf Cooperation Council (GCC) regulatory authority is building quality into the assessment and registration process and to establish opportunities for the exchange of best practice between the GCC states. A questionnaire was completed by the 7 Gulf States (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates [UAE], and Yemen), which provided details of the quality attributes that characterize the extent of the scientific assessment in the region. The results showed that each authority has its unique practices that characterize their 7 milestones in comparison with the other GCC authorities. Bahrain uses good review practice (GRP) guidelines and has placement arrangements in competent authorities, while Kuwait has separate pricing and registration departments. Oman engages external audit programs from accredited bodies, while Saudi Arabia and UAE conduct formal training for their assessors.