MIND THE GAP – INCREASING COMPLIANCE – BURDEN AND REGULATORY MISALIGNMENT

Since the dawn of the new constitutional supremacy, untold pieces of legislation have been promulgated. This led to an increase in legal and regulatory measures which increased the compliance burden, compliance risk and cost of businesses in South Africa, particularly in the financial sector. The objective of this note is to provide a snapshot of the increasing compliance burden on the financial sector between 1996 and 2011. It further highlights the incidence of misalignment among different pieces of legislationwith possible negative effects, using the Consumer Protection Act (68 of 2008) and the insurance industry as a case study. The author examines the generally accepted goals of good regulation and argues for an appropriate regulatory-assessment model that may alleviate the problem of misalignment and so prevent regulatory arbitrage.

The Normative Land Valuation Impact on Rural Development in Ukraine through the Prism of Taxation and Role of Auditing in its Determing

The article examines the impact of the new regulatory assessment of agricultural land on the amount of land tax and rent. The comparative analysis with the preliminary normative estimation is resulted. One of the mechanisms for confirming or refuting the availability of information of qualitative and quantitative characteristics, which are determined by the circumstances and results of formalization and application of regulatory land valuation, is to provide its users with the results of audit tasks. Purpose. The purpose of the article is to study the impact of land valuation on the development of rural areas of Ukraine through the prism of taxation and the role of audit of its definition. Results. It is proved that the demand and supply in the market, the level of solvency of the population, conditions of sale, the nature of possible competition, the distribution of property rights to land, obligations and restrictions on land use, etc. are of great importance for market valuation of land. The introduction of a new normative monetary valuation of agricultural land will lead to the loss of the revenue base of budgets for certain territorial communities. Tax revenues to local government budgets will also decrease by a percentage reduction in the regulatory monetary assessment. The expediency, validity and effectiveness of the decisions of the subjects of state regulation on the implementation and updating of regulatory assessments of land resources can be assessed on the basis of the implementation of audit measures. Conclusions. We propose to apply a risk-oriented audit approach at the stage of determining the feasibility of regulatory assessments. We believe that the current neglect of the problem of risk has led to unpredictable consequences of the application of regulatory assessment of land resources. In the context of agricultural reform in Ukraine, the role of audit is determined by the information needs of different groups of information users both in relation to the functioning of the industry as a whole and in relation to the activities of individual enterprises. Keywords: agriculture, arable land, normative monetary valuation, land tax, agricultural lands, rent, audit.

3rd Colombian educational workshop on regulatory assessment of biosimilars 2019 – Report

Introduction: Biosimilars have the potential to improve access to medicines for many across the globe. However, work is required to ensure adequate regulation, pharmacovigilance and education about biosimilars. Colombia implemented biosimilars regulation in 2017 and a 3rd Colombian Educational Workshop was organized by GaBI and the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in 2019 to follow up on progress and provide a forum for further discussion. Methods: The 3rd Colombian Educational Workshop on Regulatory Assessment was held in Bogotá, Colombia on 30 April 2019. The format included expert speaker presentations, a panel discussion, Q&A sessions and case study workgroup discussions. Participants included regulators, clinicians, pharmacists, academics and healthcare professionals from Colombia who are involved in biological/ biosimilar medicines evaluation, and expert speakers from Canada, Europe and the US. Results: Presentations and topics of discussion included the current status of biosimilars regulation in Colombia, how to carry out a quality assessment of a biological/biosimilar, pharmacological and clinical studies, and extrapolation of indications. Conclusion: The meeting helped to clarify many regulatory concepts and concerns, and highlighted Colombia’s initial successes since the implementation of its regulatory guidelines. In addition, the meeting acted as a forum to exchange knowledge on best practice, and to discuss pharmacovigilance and the future plans for education regarding biosimilars in Colombia. Several key action points were concluded following the discussions.