960 resultados para Medicines alternatives


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Following the inclusion of the Common Commercial Policy in the exclusive competences of the European Union, a handful of policy adjustments have occurred. Among these adjustments, investment protection has been a remarkable one - given its new, exclusive framework and an already established, state-level practice. As the new policy stands, Bilateral Investment Treaties, which had been negotiated and executed by the EU Member States in the pre-Lisbon period, can now only be negotiated and executed by the EU. These prospective ‘EU BITs’, inter alia, aim for an even stronger mechanism for the protection of investors both in the EU and in third states. A strong protection mechanism inevitably calls for a strong Dispute Settlement Mechanism, and the establishment of a DSM may prove to be challenging. The EU currently faces several questions on its path to a tangible and reliable ‘EU BIT’, and arguably the most outstanding one is the question of the DSMs to be incorporated in these new agreements. What are the alternatives of a DSM for these new BITs? Which alternatives are currently utilizable and which ones are not? What are the current problems that the EU face, and how can those problems be tackled? Is the International Centre for Settlement of Investment Disputes an alternative, and if not, why? Following a thorough overview, this paper aims to analyse the DSM alternatives for the EU to be used in the new EU BITs and ultimately provide a solid DSM proposal.

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It is striking that there is little or no mention in the TTIP debate so far of the US-EU Mutual Recognition Agreement (MRA) concluded in 1998. At the time, expectations of the gains from the MRA were high. One should expect the MRA to be instructive for TTIP and entail some lessons to be learned for today’s attempt to lower technical barriers to trade (TBTs) across the North Atlantic. We offer an analysis of the 1998 MRA, the difficulties in the prior negotiations and those during the implementation phase, the subsequent and present status of sectoral approaches. The MRA experience revealed clearly how difficult it is to accomplish the acceptance of all relevant aspects of conformity assessment of the trading partner for the mere purpose of testing and certifying export goods on the requirements of the importing economy. The MRA has succeeded only in a few sectors. However, the ambition in TTIP with respect to TBTs is said to go so much further. It is therefore important for all those involved or interested in TTIP to learn the lessons of this early exercise in lowering TBT costs. This paper reaches two main conclusions: i) the US-EU MRA was only partially successful and only for some one-fifth of the export flows at the time: a disappointing outcome and a far cry from the expectations of business and political leaders; and ii) the EU’s attempt to ‘balance’ the negotiations in 1995 by bringing in three relatively competitive sectors did not work out – it was precisely there that problems accumulated. It is critical that domestic regulators must be satisfied during and after the negotiations that their pursuit of health, safety, environment and consumer protection objectives will not be watered down in any way. Lessons drawn include, among others: MRAs are not about regulatory change (by definition), but if initial regulatory cleavages between trading partners are too wide, conditions become so restrictive that parties may regard them as a denial of the very purpose of the MRA. There are incentives to opt for alternatives in the market for the formalised designation of conformity assessment bodies in the MRA and these are often cheaper and faster, while equally qualified. Even in heavily regulated sectors such as medicines and medical devices, the narrow MRA has been superseded by near-global forms of effective cost-reducing cooperative (i.e. not treaty-based) regulatory alignment, a confirmation of the OECD approach that governments should think in terms of an entire spectrum of forms of regulatory cooperation.

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Upon request by the LIBE committee, this study examines the reasons why the Dublin system of allocation of responsibility for asylum seekers does not work effectively from the viewpoint of Member States or asylum-seekers. It argues that as long as it is based on the use of coercion against asylum seekers, it cannot serve as an effective tool to address existing imbalances in the allocation of responsibilities among Member States. The EU is faced with two substantial challenges: first, how to prevent unsafe journeys and risks to the lives of people seeking international protection in the EU; and secondly, how to organise the distribution of related responsibilities and costs among the Member States. This study addresses these issues with recommendations aimed at resolving current practical, legal and policy problems.

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For several decades, the European Union has been at the forefront of significant progress in the struggle towards equality between women and men, among others in the fight against sex-based discriminations. The contemporary EU approach to gender has however become much more interested in representations and social norms. This paper analyses this stance and highlights its deficiencies – more specifically, it looks at the flaws entailed in an excessive focus on “gender stereotypes”. Finally, it briefly sketches out the principles of an alternative.

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At head of title: 93d Congress, 1st session. Committee print.

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Mode of access: Internet.

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Mode of access: Internet.

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Mode of access: Internet.

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Mode of access: Internet.