Refocusing regulatory exclusivities: Regulatory data protection and marketing exclusivity as forms of pharmaceutical innovation policy

Protection of innovation in the pharmaceutical industry has traditionally been realised through protection of inventions via patents. However, in the European Union regulatory exclusivities restricting market entry of generic products confer tailored, industry specific protection for final, marketable products. This paper retraces the protection conferred by the different forms of exclusivity and assesses them in the light of recent transparency policies of the European Medicines Agency. The purpose of the paper is to argue for rethinking the role of regulatory data as a key tool of innovation policy and for refocusing the attention from patents to the existing regulatory framework. After detailed assessment of the exclusivity regime, the paper identifies key areas of improvement calling for reassessment so as to promote better functioning of the regime as an incentive for accelerated innovation. While economic and public health analysis necessarily provide final answers as to necessity of reform, this paper provides a legal perspective to the issue, appraising the current regulatory framework and identifying areas for further analysis.

Investigation of the applicability of LVDC microgrids in utility distribution in Russia

The research towards efficient, reliable and environmental-friendly power supply solutions is producing growing interest to the “Smart Grid” approach for the development of the electricity networks and managing the increasing energy consumption. One of the novel approaches is an LVDC microgrid. The purpose of the research is to analyze the possibilities for the implementation of LVDC microgrids in public distribution networks in Russia. The research contains the analysis of the modern Russian electric power industry, electricity market, electricity distribution business, regulatory framework and standardization, related to the implementation of LVDC microgrid concept. For the purpose of the economic feasibility estimation, a theoretical case study for comparing low voltage AC and medium voltage AC with LVDC microgrid solutions for a small settlement in Russia is presented. The results of the market and regulatory framework analysis along with the economic comparison of AC and DC solutions show that implementation of the LVDC microgrid concept in Russia is possible and can be economically feasible. From the electric power industry and regulatory framework point of view, there are no serious obstacles for the LVDC microgrids in Russian distribution networks. However, the most suitable use cases at the moment are expected to be found in the electrification of remote settlements, which are isolated from the Unified Energy System of Russia.