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[eng] Within the European Union (EU), economic regulation is often used as a promotion mechanism to achieve specific objectives. In the telecommunications and the energy sectors this is observable through those regulations that promote the participation of new agents and/or new technologies Access regulation has been implemented in the EU to promote the entrance of new agents in the telecommunications sector. With the aim of stimulating competition and achieving its desired effects in markets and among consumers, new entrants have been provided with access to incumbents fixed-line infrastructure at the wholesale level. Similarly, as part of the EU 2020 energy strategy, the Climate and Energy Package undertook to implement the "20-20-20" targets. Among these, arguably the most challenging is raising up to 20% the share of EU energy consumption produced from renewable resources. Member States have embraced this target by promoting the production of electricity from renewable energy sources. Within the telecommunications sector, one of the markets affected by changes in the European regulatory framework is that of the broadband service. The rationale behind access regulation is that entrants be allowed initially to provide a service that requires minimum direct investment while relying on the incumbents existing network; however, subsequently, entrants are expected to increase their investments as they develop their own infrastructure in a process captured by the "ladder of investment" theory . This EU regulation has clear implications for the firms investment decisions and, as such, for aggregate infrastructure investment at the country level in the telecommunications sector. From a firm level point of view, in the context of the access regulation implemented in the EU, new market competitors are able to provide broadband access for customers by using the incumbents infrastructure, the prices for which are regulated. As such, firm performance is, in part, dependent on regulatory decisions, while the implementation of regulated rates directly affects firm performance in two ways: by impacting the entrants production costs through the input prices and by impacting the incumbents wholesale and retail income. In addition, a firms behavior will also be determined by the firms characteristics, and given that in most countries broadband services are now provided by a broad range of operators, including incumbents and entrants as well as national and multinational firms, these are fundamental for any regulatory analysis. Within the energy sector, following the setting of the 20-20-20 targets under the corresponding EU regulation, the feed-in tariff regulation has become the most widely adopted mechanism by Member States to encourage the take-up and development of electricity generation from renewable energy sources. Under the feed-in tariff regulation, a specific price is guaranteed per unit of electricity generated by the target technologies. In most Member States the cost of resources assigned to promoting the production of electricity from renewable energy sources is borne by the final consumer. In recent years, however, the recession has caused governments, industry and consumers alike to worry about high retail energy prices, and here some of the blame has been attributed to climate policies, in general, and to the feed-in tariff regulation, in particular. In this regard, two components of the electricity retail price can be expected to be influenced by the feed-in tariff regulation: the incentives to those firms producing electricity from renewable energy sources and the wholesale price of electricity. The two components, which act over the electricity retail price in opposite directions, are functions of the proportion and type of renewable sources in the energy mix. Technology-specific considerations are clearly therefore important for any empirical analysis of the impact of EU regulation on the energy sector. This dissertation undertakes an empirical analysis of the impact of EU regulation. More precisely, I analyze the effects of access regulation on the telecommunications sector and of the feed-in tariff regulation as a policy mechanism designed to accelerate investment in renewable energy technologies on the energy sector.

Within the European Union (EU), economic regulation is often used as a promotion mechanism to achieve specific objectives. In the telecommunications and the energy sectors this is observable through those regulations that promote the participation of new agents and/or new technologies Access regulation has been implemented in the EU to promote the entrance of new agents in the telecommunications sector. With the aim of stimulating competition and achieving its desired effects in markets and among consumers, new entrants have been provided with access to incumbents fixed-line infrastructure at the wholesale level. Similarly, as part of the EU 2020 energy strategy, the Climate and Energy Package undertook to implement the "20-20-20" targets. Among these, arguably the most challenging is raising up to 20% the share of EU energy consumption produced from renewable resources. Member States have embraced this target by promoting the production of electricity from renewable energy sources. Within the telecommunications sector, one of the markets affected by changes in the European regulatory framework is that of the broadband service. The rationale behind access regulation is that entrants be allowed initially to provide a service that requires minimum direct investment while relying on the incumbents existing network; however, subsequently, entrants are expected to increase their investments as they develop their own infrastructure in a process captured by the "ladder of investment" theory . This EU regulation has clear implications for the firms investment decisions and, as such, for aggregate infrastructure investment at the country level in the telecommunications sector. From a firm level point of view, in the context of the access regulation implemented in the EU, new market competitors are able to provide broadband access for customers by using the incumbents infrastructure, the prices for which are regulated. As such, firm performance is, in part, dependent on regulatory decisions, while the implementation of ...

PharmD ; Innovative medicines in the EU must follow regulatory requirements appertaining to the centralised procedure for registration. The study of the evolvement of EU regulations on centrally authorised products (CAPs) could shed light on the impact of the regulations on the access to innovative medicines. The methodology consisted of two parts: 1) A review and an analysis of the use of EU regulatory early access tools including the compilation of a glossary of regulatory terms, 2) An assessment of impact on public health through the non-availability of CAPs, identification of accessibility challenges of innovative medicines, and identification of alternative existing legislative tools to increase access to innovative medicines. Part 1: The early access tools selected for analysis were conditional marketing authorisation (CMA) and marketing authorisation under exceptional circumstances. The glossary compiled defined 280 regulatory terms. The results of the review and analysis have shown that between 2001 and 2016 a total of 65 innovative medicines were centrally authorised using CMA (35) and marketing authorisation under exceptional circumstances (30); 28 given a new active substance status, 33 an orphan designation and 7 withdrawn. Part 2: Between 1995 to 2015 a total of 822 CAPs covering 522 Anatomical Therapeutic Chemical (ATC) Codes were authorised in the EU. The Maltese NHS formulary does not include 322 (61%) of the 522 ATC Codes. Identified challenges with importation of CAPs in Malta are the low volumes required and the costs of the innovative medicines. In 2015-2016, 5 CAPs were imported as unlicensed medicines on a named patient basis and 19 CAPs as exceptional cases according to Article 20 of the Malta Medicines Act to increase access to innovative medicines in Malta. Until 2015, the parallel distribution system was not used to import CAPs in Malta. A one-year pilot project with fee reductions for parallel distribution notifications for CAPs which resulted in the importation of 5 parallel distributed CAPs, was launched by the European Medicines Agency (EMA) in 2016. Early access tools specified in EU regulations such as CMA and marketing authorisation under exceptional circumstances require more awareness, and intelligent interpretation and application. The pilot parallel distribution project involving notification fee reductions specifically authorised by the EMA specifically for Malta, was beneficial to accessibility of medicines in practice. This study is being used as an example by the European Commission to show that, in the interest of European citizens, flexibility in the regulation is possible, confirming an innovative concept of changing the perception of the EU that regulations are not biased towards safety and efficacy at the detriment of accessibility. ; N/A

Risk regulation is a major task of the EU. In this context, scientific knowledge and advice is critical to the preparation, formulation, legislation and later revision of EU risk regulation. However and with some notable exceptions (e.g. some EU Agencies, DG SANCO), there seems to be no systematic view, let alone, organisation for the 'use of science' for EU policy–making. It is in this light that the new function of Chief Scientific Advisor (CSA) to the President of the European Commission can best be appreciated. The authors first sketch how 'science' is used in the EU regulatory regime and what is or has become problematic about it. Subsequently, an informal SWOT analysis of the 'use of science' for EU policy is conducted. The contribution ends with an attempt to evaluate the CSA's accomplishments to date and how it can contribute to improving EU regulation. This is followed by a few recommendations on how the role of the CSA could be strengthened in the near future.

The growth in statutory provisions in the UK requiring employers to inform and consult employee representatives has been driven primarily by EU law rather than domestic policy. The 2002 EU information and consultation Directive was widely seen as having far-reaching implications for UK law and employment relations practice, but the 'reflexive' design of the UK regulations transposing the Directive has limited its impact to date. An assessment of the available evidence suggests that the regulations have prompted considerable voluntary activity in terms of reviewing, modifying and introducing information and consultation arrangements but that this has been largely employer-led. The article argues that the reform of key aspects of the UK regulations is necessary to overcome trade union ambivalence towards the legislation and the low uptake of its provisions by employees.