914 resultados para drug control policy


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Standards reduce production costs and increase products’ value to consumers. Standards however entail risks of anti-competitive abuse. After the adoption of a standard, the chosen technology normally lacks credible substitutes. The owner of the patented technology might thus have additional market power relative to locked-in licensees, and might exploit this power to charge higher access rates. In the economic literature this phenomenon is referred to as ‘hold-up’. To reduce the risk of hold-up, standard-setting organisations often require patent holders to disclose their standard-essential patents before the adoption of the standard and to commit to license on fair, reasonable and non-discriminatory (FRAND) terms. The European Commission normally investigates unfair pricing abuse in a standard-setting context if a patent holder who committed to FRAND ex-ante is suspected not to abide to it ex-post. However, this approach risks ignoring a number of potential abuses which are likely harmful for welfare. That can happen if, for example, ex-post a licensee is able to impose excessively low access rates (‘reverse hold-up’) or if a patent holder acquires additional market power thanks to the standard but its essential patents are not encumbered by FRAND commitments, for instance because the patent holder did not directly participate to the standard setting process and was therefore not required by the standard-setting organisations to commit to FRAND ex-ante. A consistent policy by the Commission capable of tackling all sources of harm should be enforced regardless of whether FRAND commitments are given. Antitrust enforcement should hinge on the identification of a distortion in the bargaining process around technology access prices, which is determined by the adoption of the standard and is not attributable to pro-competitive merits of any of the involved players.

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The issue: The European Union's pre-crisis growth performance was disappointing enough, but the performance has been even more dismal since the onset of the crisis. Weak growth is undermining private and public deleveraging,and is fuelling continued banking fragility. Persistently high unemployment is eroding skills, discouraging labour market participation and undermining the EU’s long-term growth potential. Low overall growth is making it much tougher for the hard-hit economies in southern Europe to recover competitiveness and regain control of their public finances. Stagnation would reduce the attractiveness of Europe for investment. Under these conditions, Europe's social models are bound to prove unsustainable. Policy Challenge: The European Union's weak long-term growth potential and unsatisfactory recovery from the crisis represent a major policy challenge. Over and above the structural reform agenda, which vitally important, bold policy action is needed. The priority is to get bank credit going. Banking problems need to be assessed properly and bank resolution and recapitalisation should be pursued. Second, fostering the reallocation of factors to the most productive firms and the sectors that contribute to aggregate rebalancing is vital. Addressing intra-euro area competitiveness divergence is essential to support growth in southern Europe. Third, the speed of fiscal adjustment needs to be appropriate and EU funds should be front loaded to countries in deep recession, while the European Investment Bank should increase investment.

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Macedonia is a country in deep trouble. There is a climate of mistrust between all the political parties; intolerance of minority groups is increasing and fear is also generated by the all-pervasive control of the main governing party. In 2009 the European Commission recommended that a date be set for accession negotiations to start, but since then the country's efforts to join the EU (and NATO) have been blocked. Author Erwan Fouéré sets out ten clear recommendations for both Macedonia and the EU on the way forward.

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As the final session of the day, my aim in this paper is to briefly outline the nature of exploitative abuses before turning to the question of the relationship between competition law and intellectual property law in the context of what Teubner calls the regulatory trilemma and from that draw a two-fold conclusion. First, the demands on law from the social phenomenon of markets are more acute when those demands raise issues across the different law domains of IP and competition. Second, where IP law and competition meet, the aim should be for both domains to internalise the values of the other. This however can only happen to the extent but only to the extent that there can be what Collins1 calls productive disintegration. Finally, in the specific context of exploitative abuses the overlap between IP law and competition law arises primarily in relation to claims of excessive pricing in licensing arrangements. Such claims could form the basis of a private action2 or can be made in the context of compulsory dealing decisions such as Microsoft.3 The involvement of competition agencies in pricing decisions goes to the heart of concerns about the nature of competition law and the role of competition agencies and highlights the need for the law to indirectly control rather than inappropriately attempt to directly control markets.

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From the Introduction. The pharmaceutical sector inquiry carried out by the European Commission in 2008 provides a useful framework for assessing the relationship between the patent system on the one hand and competition policy and law on the other hand. The pharmaceutical market is not only specifically regulated. It is also influenced by the special characteristics of the patent system which enables pharmaceutical companies engaged in research activities to enter into additional arrangements to cope with the competitive pressures of early patent application and the delays in drug approval. Patents appear difficult to reconcile with the need for sufficient and adequate access to medicines, which is why competition expectations imposed on the pharmaceutical sector are very high. The patent system and competition law are interacting components of the market, into which they must both be integrated. This can result in competition law taking a very strict view on the pharmaceutical industry by establishing strict functional performance standards for the reliance on intellectual property rights protection granted by patent law. This is in particular because in this sector the potential welfare losses are not likely to be of only monetary nature. In brief, the more inefficiencies the patent system produces, the greater the risk of an expansive application of competition law in this field. The aim of the present study is to offer a critical and objective view on the use or abuse of patents and defensive strategies in the pharmaceutical industry. It shall also seek to establish whether patents as presently regulated offer an appropriate degree of protection of intellectual property held by the economic operators in the pharmaceutical sector and whether there is a need or, for that matter, scope for improvement. A useful starting point for the present study is provided by the pharmaceutical sector competition inquiry (hereafter “the sector inquiry”) carried out by the European Commission during the first half of 2008. On 8 July 2008, the Commission adopted its Final Report pursuant to Article 17 of Regulation 1/2003 EC, revealing a series of “antitrust shortcomings” that would require further investigation1.

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China’s Anti-Monopoly Law, adopted in 2007, is largely compatible with antitrust law in the European Union, the United States and other jurisdictions. Enforcement activity by the Chinese authorities is also approaching the level seen in the EU. The Chinese law, however, leaves significant room for the use of competition policy to further industrial policy objectives. The data presented in this Policy Contribution indicates that Chinese merger control might have asymmetrically targeted foreign companies, while favouring domestic companies. However, there are no indications that antitrust control has been used to favour domestic players. A strategy to achieve convergence in global antitrust enforcement should include support for Chinese competition authorities to develop the institutional tools they already have, and to improve merger control by promoting the adoption of a consumer-oriented test and enforcing M&A notification rules.

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Following the financial crisis that commenced in 2008, the relationship between migration and social benefits has become increasingly contested in a number of large EU member states. The Eastern expansion of the EU in 2004 and 2007 has added a new dimension to the relationship. Concerns have spread across a number of member states about the 'costs' and 'financial burdens' of migration and intra-EU mobility and there have been calls for restrictions of existing EU rights and freedoms in the areas of EU free movement, social security coordination, asylum and migration laws.

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In an ageing world with demographic and economic imbalances, the number of international migrants is likely to rise during the twenty-first century. The geography of migration flows is changing, however. Mobile people will be increasingly attracted by faster-growing economies. Therefore, some traditional destinations in western Europe will face stronger competition for skilled labour-not least from countries like China where the working-age population will shrink after 2020. At the same time, the sentiment in many European receiving societies is turning against migration and intra-European Union mobility.

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Immigration and freedom of movement of EU citizens are among the main issues debated throughout the European Parliament election campaign and have some potential in determining who tomorrow’s EU leaders will be. This Policy Brief looks at how the two policies are debated at national level – in France, Germany and the UK – and at EU level between the ‘top candidates’ for European Commission Presidency – Jean-Claude Juncker (EPP), Ska Keller (Greens), Martin Schulz (PES) and Guy Verhofstadt (ALDE) – who have participated in several public debates. Two different campaigns have been unfolding in front of EU citizens’ eyes. The tense debate that can be identified at national level on these issues, is not transferred to the EU level, where immigration and free movement are less controversial topics. Furthermore, although participating in European elections, national parties present agendas responding exclusively to the economic and social challenges of their Member State, while the candidates for the Commission Presidency bring forward ‘more European’ programmes. Hence, several aspects need to be reflected upon: What will the consequences of this discontinuity be? How will this impact the future European agenda in terms of immigration and free movement? What institutional consequences will there be? Answering these questions is not a simple task, however, this paper aims to identify the parameters that need to be taken into account and the political landscape which will determine the future EU agenda in terms of immigration and free movement.

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The European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (Frontex) was created to improve border management cooperation between Member States. Seen from its inception as a security-oriented body, tools and rules have been gradually developed to enhance the human rights dimension and protection regarding Frontex activities. However, this step has not been accompanied with the explicit recognition of Frontex’s legal responsibility regarding violations of human rights occurring during joint operations it coordinates. Despite Frontex position rejecting such a responsibility, it is no longer clear whether this position can be maintained, as Yves Pascouau and Pascal Schumacher demonstrate in this Policy Brief.

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European countries, like the United States, Canada, and Australia before them, are becoming lands of immigrants. While the percentage of foreign-born residents in the EU is still relatively low, immigration is a significant factor in European societies and their labour markets. Therefore, the question whether or not we need migrants is moot. Instead, we should focus on how to make the most of migration and how to make Europe attractive to the migrants we need.

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Despite the conflicts and frictions in their bilateral relations, Russia has for years regularly invested in Belarus. Moscow’s support has become an important factor allowing the Belarusian economic model to continue, which in turn helps maintain the stability of the Belarusian political system. Russia's continued readiness to offer assistance to its neighbour reflects the importance Moscow attaches to Belarus.Belarus also features prominently in Moscow’s current policy objectives – especially with regard to the expansion of the Customs Union. The implementation of this project is seen as crucial in Russia, particularly in relation to Ukraine. For this reason, since 2011 we have been witnessing a rise in Russian aid for Belarus. In 2012, the support intensified and moved beyond purely financial help to include political assistance also. Russia’s support, however, has come at a price. Moscow’s long-term goal is to establish control over the Belarusian economy, which would also, in effect, allow the Kremlin to influence the way other areas of the Belarusian state are governed. As Minsk’s dependence on Russian support deepens, Alexander Lukashenko will ultimately have no choice but to gradually accede to Russia’s demands.

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The ‘reset’ policy proposed by the USA has brought Russia a number of geopolitical, prestigious and economic benefits. The most important of those are: the resumption of arms control, the USA’s withdrawal from plans to locate elements of its strategic missile defence system in Poland and the Czech Republic, and the entry into force of the so-called 123 Agreement. In response, Russia has assisted the United States in resolving the Iranian crisis, and offered help with the Afghanistan operation, covering the transit of supplies and supporting the Afghan government. Moscow has also eased up on its anti-American rhetoric. The changes which have taken place in Russian-US relations are not durable. The two parties have not resolved their major disputes (for example, regarding missile defence), and any differences are hushed up for tactical reasons.

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Even though the economic crisis proved harmful to the Russian economy and people's living standards, it has nonetheless failed to make the elite revise its policy. Despite some problems, the government has managed to sustain economic and political stability, thanks to the reserves it amassed in the times of prosperity, and to the propaganda campaign that protected it, above all Vladimir Putin. The crisis failed to force the elite to implement deeper structural and political reforms. Moreover, it has actually reinforced existing tendencies, such as state control over the economy and its oil-oriented character, the elite's economic expansion at the expense of private businesses, and the preservation of political power. Thus, the crisis has so far failed to dismantle Putinism, indeed quite the reverse - it has in fact contributed to its becoming 'set in stone'.