scholarly journals Regulating The Pharmaceutical Industry In The European Union: A Dilemma Of Achieving A Single Market

Author(s):  
Aysegul Timur ◽  
Gabriel Picone

Pharmaceutical pricing and reimbursement regulations create a dilemma to achieve a single pharmaceutical market in the European Union (EU). Although considerable progress has been made in the past years in harmonization of the pharmaceutical markets, the pricing decisions or systems have continued to be operated on a national basis, which results in price differences across the member states. These price differences create opportunity for parallel trade which, in combination with the EU single market principle calling for the free movement of goods, could lead to reduction in price differences. Among the harmonization efforts by the European Commission, national decisions on pricing and controls, plus parallel trade dilemma, we attempt to analyze the bilateral drug price differences using a sample of countries that represent from strict to relatively less pharmaceutical regulations. Almost all member countries regulate pharmaceutical prices, either directly or indirectly, in the EU, which creates less or more price differences despite market integration. This paper is simply aimed at analyzing price differences in the European pharmaceutical market, employing annual 1994–2003 IMS Health Data from five EU countries (Germany, the United Kingdom, France, Italy and Spain) on prices of molecules used to treat cardiovascular disease. The analysis includes a two step approach. First, we calculate the common use of Laspeyres and Paasche weighted price and quantity indices to make comparisons for both bilaterally matched molecules (considering Spain as the base country) and diffused molecules that are available for five countries. Second, we adopt a hedonic price regression to control observable quality and market characteristics and then re-analyze price differentials. The study concludes that price differences still exist, but are decreasing over time. Even though the results are sensitive to sample and methods used, we found implicit evidence that harmonization efforts by the European Commission may ease reducing price differences in the long run, but it should not be interpreted as moving toward complete elimination of price differences due to complexities in this industry.

2020 ◽  
Vol 8 (1) ◽  
pp. 103-122
Author(s):  
Ewa Kaczan-Winiarska

The Austrian government is extremely sceptical about the accession negotiations which are conducted by the European Commission on behalf of the European Union with Turkey and calls for the negotiation process to end. Serious reservations of Vienna have been raised by the current political situation in Turkey under the rule of President Recep Tayyip Erdogan, as well as by the standards of democracy in Turkey, which differ greatly from European standards. Serious deficiencies in rule of law, freedom of speech and independence of the judiciary, confirmed in the latest European Commission report on Turkey, do not justify, from Vienna’s point of view, the continuation of talks with Ankara on EU membership. In fact, Austria’s scepticism about the European perspective for Turkey has a longer tradition. This was marked previously in 2005 when the accession negotiations began. Until now, Austria’s position has not had enough clout within the European arena. Pragmatic cooperation with Turkey as a strategic partner of the EU, both in the context of the migration crisis and security policy, proved to be a key factor. The question is whether Austria, which took over the EU presidency from 1.7.2018, will be able to more strongly accentuate its reservations about Turkey and even build an alliance of Member States strong enough to block Turkey’s accession process.


2021 ◽  
Vol 14 (2) ◽  
pp. 80
Author(s):  
Eva Eckert ◽  
Oleksandra Kovalevska

In the European Union, the concern for sustainability has been legitimized by its politically and ecologically motivated discourse disseminated through recent policies of the European Commission and the local as well as international media. In the article, we question the very meaning of sustainability and examine the European Green Deal, the major political document issued by the EC in 2019. The main question pursued in the study is whether expectations verbalized in the Green Deal’s plans, programs, strategies, and developments hold up to the scrutiny of critical discourse analysis. We compare the Green Deal’s treatment of sustainability to how sustainability is presented in environmental and social science scholarship and point out that research, on the one hand, and the politically motivated discourse, on the other, do not correlate and often actually contradict each other. We conclude that sustainability discourse and its keywords, lexicon, and phraseology have become a channel through which political institutions in the EU such as the European Commission sideline crucial environmental issues and endorse their own presence. The Green Deal discourse shapes political and institutional power of the Commission and the EU.


2018 ◽  
Vol 2 (1) ◽  
pp. 171-183
Author(s):  
Nevin Alija

In its September 13th 2017 decision,1 the Court of Justice of the European Union (CJEU) decided on a request for a preliminary ruling by the Supreme Court of Poland (Sąd Najwyższy) in proceedings between ENEA S.A. (ENEA) and the president of the Urzędu Regulacji Energetyki (Office for the regulation of energy, URE) on the imposition by the latter of a financial penalty on ENEA for breach of its obligation to supply electricity produced by cogeneration. The judgment of the Court of Justice follows many decisions of the European Commission and judgments of the EU courts assessing the involvement of State resources in support schemes in energy, particularly with the aim of switching towards more environmentally friendly sources. This case reaffirms that support schemes may, in certain circumstances, fall outside the scope of the EU State aid rules.


Author(s):  
Petr YAKOVLEV

The decision on Britain’s secession from the European Union, taken by the British Parliament and agreed by London and Brussels, divided the Union history into “before” and “after”. Not only will the remaining member states have to “digest” the political, commercial, economic and mental consequences of parting with one of the largest partners. They will also have to create a substantially new algorithm for the functioning of United Europe. On this path, the EU is confronted with many geopolitical and geo-economic challenges, which should be answered by the new leaders of the European Commission, European Council, and European Parliament.


Author(s):  
Michał Pietrzak ◽  
Marcin Mucha

In the period 1990–2013 sugar industry in Poland faced numerous legal transformations, shifting from nearly free-market conditions into a strongly regulated sector. Changes of the sugar industry regulations had a significant impact on the structure of the sugar market, companies’ actions and, as a result, on their performance. Accession to the European Union and the reform of the sugar regime conducted from 2006 to 2010 on the initiative of the European Commission involved deep restructuring and modernization of the factories, which caused growth of their productivity. However, prices of sugar in the EU and in Poland are much higher than prices on the world market.


Author(s):  
Neil Parpworth

The aims of this chapter are threefold. It first briefly considers the events that have led to the creation of the European Community (EC) and the European Union (EU). Secondly, it introduces the reader to the principal institutions of the Union: the European Council; the Council of Ministers; the European Commission; the European Parliament; and the Court of Justice of the EU and General Court. The nature and functions of each of these bodies is considered. Thirdly, the chapter indicates, where appropriate, the nature of the institutional reforms which have occurred following the ratification of the Lisbon Treaty by the member states.


2000 ◽  
Vol 28 (1) ◽  
pp. 133-145
Author(s):  
Ursula G. Sauer ◽  
Roman Kolar

In 1999, the European Commission presented its second report on the numbers of laboratory animals used in the European Union (EU). The plausibility of the data and the usefulness of the format of the registration tables remain questionable, for reasons previously discussed in connection with the Commission's first statistical report. In addition, it is impossible to derive sound information on trends in animal use in the EU and its Member States from the second statistical report. The European Commission and the Member States have agreed on new tables to be used for future statistics on the use of experimental animals in the EU. These new tables have been significantly extended and improved. Several categories of little relevance have been revised, and ambiguous expressions have been clarified. However, several problems either persist or have been newly created. Moreover, some important data (i.e. categories for pain and distress, as well as for several specific purposes of use; the origin of some animal species; types of institutions; and the use of genetically engineered animals) are still not required. Nevertheless, these are highly relevant to animal welfare and must be regarded as indispensable for a well-aimed application of the statistics to set priorities concerning the Three Rs.


2001 ◽  
Vol 4 (2a) ◽  
pp. 325-336 ◽  
Author(s):  
Jo Hautvast ◽  
Ibrahim Elmadfa ◽  
Mike Rayner

Summary of recommendations1.A new Nutrition Committee for the European Union1.1 A new Nutrition Committee for the European Union, should be created to give independent scientific and policy advice on nutrition, diets and physical activity to the Commission. This should be supported by a strengthened Nutritional Unit within the Commission.2.Policy development2.1 There needs to be a comprehensive and coherent nutritional policy for the EU2.2 The development of European dietary goals should continue after the completion of the Eurodiet Project.2.3 The European Commission should revise its Recommended Daily Allowances for vitamins and minerals using a systematic, evidence-based approach. Recommended Daily Allowances should be set at a level which would prevent deficiencies and lower the risk of disease.2.4 The European Commission should produce, preferably every four years, a report on the state of nutrition, diet and physical activity in the EU. This report should contain proposals for action3.Components of a nutrition policyEducation3.1 The European Commission should not be involved in the direct delivery of lifestyle advice to the public.3.2 The European Commission should continue to support networks whose members are involved in educating the public and in training professionals about nutrition, diets and physical activity.Research3.3 European Community funding of health-related research should better reflect the Community's public health priorities.3.4 The European Community should ear-mark funds for large, multi-centre studies into nutrition, diet and physical activity with a duration of up to 10 years.Consumer protectionFood labelling3.5 The European Commission should draw up proposals for the regulation of health claims.3.6 The European Community should agree rules for the use of nutrition claims along the lines agreed by the Codex Alimentarius Commission.3.7 The European Commission should review the 1990 Nutrition Labelling Directive particularly with a view to making nutrition labelling more comprehensible and it should encourage the development of other ways of providing consumers with information about the nutrient content of foods though, for example, the Internet.Food composition3.8 The European Commission should review the Novel Food Regulations, particularly with a view to ensuring that the nutritional consequences of consuming novel foods are better assessed and to making approval procedures more efficient.3.9 European Community rules on food fortification and on food supplements should be harmonised but in such a way that the interests of consumers are paramount.Agriculture policy3.10 The Common Agriculture Policy should be subject to a regular and systematic health impact assessment.3.11 Given that there are subsidies under the Common Agricultural Policy designed to increase consumption of surplus food, these should be directed towards promoting the consumption of foods for which there is strong evidence of a need for increased consumption in the EU for health reasons.Special issuesFruit and vegetable consumption3.12 The promotion of increased fruit and vegetable consumption across the EU should be a key aspect of the European Union's proposed nutrition policy.Breast feeding3.13 The European Union should review its policy on breast feeding including assessing and, if necessary, improving its legislation on breast milk substitutes and maternity leave.Physical Activity3.14 The European Union should have a policy for promoting physical activity in Europe. This should be part of, or at least closely integrated with, the European Union's proposed nutritional policy.


Author(s):  
Neil Parpworth

This chapter has three aims. It first briefly considers the origins of the what is now the European Union (EU). Secondly, it discusses the institutions of the Union, the European Council, the Council of Ministers, the European Commission, the European Parliament, and the Court of Justice of the EU and General Court. The nature and functions of these bodies is considered. Thirdly, the chapter indicates the nature of institutional reforms which have occurred following the ratification of the Lisbon Treaty.


2021 ◽  
Author(s):  
Christophe Geiger ◽  
Bernd Justin Jütte

Abstract The Directive on Copyright in the Digital Single Market (CDSM Directive) introduced a change of paradigm with regard to the liability of some platforms in the European Union. Under the safe harbour rules of the Directive on electronic commerce (E-Commerce Directive), intermediaries in the EU were shielded from liability for acts of their users committed through their services, provided they had no knowledge of it. Although platform operators could be required to help enforce copyright infringements online by taking down infringing content, the E-commerce Directive also drew a very clear line that intermediaries could not be obliged to monitor all communications of their users and install general filtering mechanisms for this purpose. The Court of Justice of the European Union confirmed this in a series of cases, amongst other reasons because filtering would restrict the fundamental rights of platform operators and users of intermediary services. Twenty years later, the regime for online intermediaries in the EU has fundamentally shifted with the adoption of Art. 17 CDSM Directive, the most controversial and hotly debated provision of this piece of legislation. For a specific class of online intermediaries known as ‘online content-sharing providers’ (OCSSPs), uploads of infringing works by their users now result in direct liability and they are required undertake ‘best efforts’ to obtain authorization for such uploads. With this new responsibility come further obligations which oblige OCSSPs to make best efforts to ensure that works for which they have not obtained authorization are not available on their services. How exactly OCSSPs can comply with this obligation is still unclear. However, it seems unavoidable that compliance will require them to install measures such as automated filtering (so-called ‘upload filters’) using algorithms to prevent users from uploading unlawful content. Given the scale of the obligation, there is a real danger that measures taken by OCSSPs in fulfilment of their obligation will amount to expressly prohibited general monitoring. What seems certain, however, is that the automated filtering, whether general or specific in nature, cannot distinguish appropriately between illegitimate and legitimate use of content (e.g. because it would be covered by a copyright limitation). Hence, there is a serious risk of overblocking certain uses that benefit from strong fundamental rights justifications such as the freedom of expression and information or freedom of artistic creativity. This article first outlines the relevant fundamental rights as guaranteed under the EU Charter of Fundamental Rights and the European Convention of Human Rights that are affected by an obligation to monitor and filter for copyright infringing content. Second, it examines the impact on fundamental rights of the obligations OCSSPs incur under Art. 17, which are analysed and tested also with regard to their compatibility with general principles of EU law such as proportionality and legal certainty. These are, on the one hand, obligations to prevent the upload of works for which they have not obtained authorization and, on the other, an obligation to remove infringing content upon notification and prevent the renewed upload in relation to these works and protected subject matter (so-called ‘stay-down’ obligations). Third, the article assesses the mechanisms to safeguard the right of users of online content-sharing services under Art. 17. The analysis demonstrates that the balance between the different fundamental rights in the normative framework of Art. 17 CDSM Directive is a very difficult one to strike and that overly strict and broad enforcement mechanisms will most likely constitute an unjustified and disproportionate infringement of the fundamental rights of platform operators as well as of users of such platforms. Moreover, Art. 17 is the result of hard-fought compromises during the elaboration of the Directive, which led to the adoption of a long provision with complicated wording and full of internal contradictions. As a consequence, it does not determine with sufficient precision the balance between the multiple fundamental rights affected, nor does it provide for effective harmonization. These conclusions are of crucial importance for the development of the regulatory framework for the liability of platforms in the EU since the CJEU will have to rule on the compatibility of Art. 17 with fundamental rights in the near future, as a result of an action for annulment filed by the Polish government. In fact, if certain features of the article are considered incompatible with the constitutional framework of the EU, this should lead to the erasing of certain paragraphs and, possibly, even of the entire provision from the text of the CDSM Directive.


Sign in / Sign up

Export Citation Format

Share Document