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Innowacyjność sektora farmaceutycznego

100%

Nowicka K.

nr 11-12

70-86

The article discusses the involvement of pharmaceutical companies in the development of new drugs and therapies. The analysis shows that eight of the world’s 10 best-selling pharmaceuticals have originated in the United States, and two have been developed in Western Europe. Innovative brand-name drugs accounted for only 15 percent of the new pharmaceuticals registered in the United States in 1989-2000. All the other pharmaceuticals were generic drugs and modifications of pharmaceuticals already available on the market. Taxpayers and research institutes cover 85 percent of the costs of research into the development of new treatments. The role of generic drugs is growing-chiefly because f their more affordable prices compared with those of patented drugs. Not only private consumers, but also public sector institutions obligated to provide health services to citizens, have appreciated the attractiveness of generic drugs. After Poland’s accession to the European Union on May 1, 2004, Polish pharmaceutical producers have gained new opportunities to increase their competitive position. However, Poland is still far behind highly industrialized countries in the level of expenditure on research into the development of new pharmaceuticals and therapies. This means that decision makers in Poland must work to upgrade the legal system and encourage businesses to focus on pharmaceutical research, the author concludes.

Anticompetitive Patent Settlements – Where Are We Ten Years After the European Commission’s Pharmaceutical Inquiry?

75%

Laszczyk A.

tom 13

nr 21

129-160

En 2009, la Commission européenne a publié un rapport final sur son enquête de marché concernant le secteur pharmaceutique. Le rapport a révélé les préoccupations de la Commission concernant les pratiques de marché des laboratoires pharmaceutiques visant à retarder l’entrée sur le marché de produits pharmaceutiques génériques moins chers. L’une des pratiques retardatrices identifies par la Commission européenne était les règlements de brevet entre un laboratoire et un fabricant de produits génériques, notamment : (i) un transfert de valeur du laboratoire de vers un fabricant de génériques, et (ii) l’obligation pour un fabricant de génériques de ne pas entrer sur le marché. Ces accords de brevet étaient qualifies d’accords de paiement pour retard, puisque le paiement était apparemment effectué en échange de l’obligation de ne pas entrer sur le marché. La Commission européenne a poursuivi l’enquête sur les accords de brevet en exerçant une surveillance continue. Elle a également lancé des procédures antitrust qui se sont terminées par l’imposition d’amendes considérables aux sociétés pharmaceutiques. Les recours sont maintenant en cours devant les tribunaux de l’UE. Dix ans après la publication du rapport final sur l’enquête de marché, cet article vise à résumer l’évolution de la jurisprudence et à fournir une analyse critique. L’article se concentre sur l’analyse des accords de paiement des retards en tant qu’infractions à l’article 101 du TFUE uniquement et ne considère pas la conclusion de ces accords comme un abus de position dominante.

In 2009, the European Commission published a final report on its market inquiry into the pharmaceutical sector. The report revealed the authority’s concerns regarding market practices of pharmaceutical originator companies aimed at delaying the market entry of cheaper generic pharmaceutical products. One of the delaying practices identified by the European Commission were patent settlements between an originator and a generic company including: (i) a value transfer from the originator to a generic company, and (ii) an obligation of a generic company not to enter the market. These patent settlements were called pay-for-delay agreements since the payment was allegedly made in exchange for the non-mark-entry obligation. The European Commission continued the investigation of patent settlements by its continuous monitoring. It also initiated antitrust proceedings that terminated with huge fines imposed on pharmaceutical companies. The appeals are now pending before the EU courts. Ten years after the publication of the final report on the market inquiry, this article aims to summarize the development of the case law and provide its critical analysis. The article focuses on the analysis of pay-for-delay agreements as infringements of Article 101 TFEU only and does not consider the conclusion of these agreements as an abuse of a dominant position.

Nanotechnology: legal and ethical issues

63%

Baran A.

nr 1

New European rules regarding the approval of clinical trials, the role of Ethics Committees and the Protection of Subjects

63%

Nys H.

nr 6