The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.

BACKGROUND: The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. METHODS: A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). RESULTS: Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. CONCLUSIONS: As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.Peer reviewedFinal Published versio

The Environment and the World Trade Organization

The meeting of the members of the World Trade Organization ( WTO ) in Seattle in late 1999 was seriously disrupted by street demonstrations which turned the meeting into a disaster. Prominent among thedemonstrators were people purporting to be from environmental non-governmental organizations (or NGOs ). A number of these protestors costumed themselves as sea turtles and received considerable attention on television as well as from the Seattle police department. Dissemination by the media of images of people masquerading as sea turtles was expected to, and did, seriously taint the image of the WTO, causing it to be seen as the headquarters of forces hostile to the environment. The purpose of this article is not to defame environmental NGOs. Indeed, so far as the author knows, they did nothing more in respect of the Seattle fiasco than to countenance, or subsequently to refrain from disavowing, the antics of protestors cavorting as anthropoid sea turtles. Rather, the purpose of this article is to argue that the WTO was badly used by the Seattle demonstrators, that its role as regards sea turtles has been quite the opposite of what those demonstrators were suggesting, and that environmental NGOs should exert informed efforts on behalf of the WTO, because it is the very type of multilateral body that they should support if they expect to succeed in protecting the world\u27s environment

Legal Services in the Doha Round

As a subcategory of professional services and a sub-subcategory of business services, legal services, when supplied transnationally, are the subject of negotiation in the current round of multilateral trade negotiation known as the Doha Round. The negotiations on legal services that take place in the Doha Round have considerable potential for affecting the economics and activities of lawyers and law firms, and for influencing the content of local professional rules governing the practice of law. This article examines that potential

Legal Services and the Doha Round Dilemma

This article examines the nexus between two international topics, namely, trade negotiations, and regulation of the cross-border practice of law. Admittedly, this nexus is not found at a conventional crossroads. Legal services lie somewhat at the periphery of international trade measured in terms of the global value of goods, services and investment used to define major international economic relationships, or to define priorities in the formulation of national and transnational economic policies. Moreover, trade negotiators hardly figure amongst the principal regulators having responsibility for the professional conduct of individuals and firms engaged in the practice of law. Notwithstanding the somewhat peripheral nature of legal services in the overall calculation of balances of trade, and notwithstanding the traditional disjunction between responsibility for formulating trade policy and responsibility for supervising legal practitioners, the interaction of trade and legal services, carefully examined, can provide a useful analysis of its two components: of efforts to advance international trade in legal services, and of proposals to develop rules designed to facilitate cross-border legal practice. Such an analysis can prove instructive for policy-makers and interested participants not only in these two areas, but also in the broader context of formulating global rules governing trade and investment generally

The Asbestos Case and Dispute Settlement in the World Trade Organization: The Uneasy Relationship Between Panels and the Appellate Body

This article deals with dispute settlement in the World Trade Organization (WTO) and, in particular, with the relationship between panels and the Appellate Body. Its point of departure is the Asbestos case initially decided by a WTO panel in September 2000 and, on appeal, by the WTO Appellate Body in March 2001