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W kwietniu 2023 r. Komisja Europejska przyjęła wnioski regulacyjne wprowadzające jednolite dodatkowe świadectwo ochronne (SPC) oraz scentralizowaną procedurę oceny SPC dla produktów leczniczych. W niniejszym badaniu przeanalizowano potencjalny wpływ tych wniosków na dostęp do leków, obciążenie administracyjne dla wnioskodawców i koszty dla krajowych systemów opieki zdrowotnej. Niniejszy dokument został przygotowany przez Departament Tematyczny ds. Praw Obywatelskich i Spraw Konstytucyjnych na zlecenie ...

The coronavirus pandemic has rekindled the global debate on whether the multilateral trade regime for intellectual property rights (IPR) protection limits access to essential medical products. Despite embedded flexibilities in the World Trade Organization (WTO) Agreement on Trade-related Intellectual Property Rights (TRIPS), India and South Africa, co-sponsored by a large number of developing countries, submitted an initial proposal for a temporary waiver in response to Covid-19 in October 2020, ...

13 lutego 2019 r. negocjatorzy Parlamentu i Rady osiągnęli porozumienie w sprawie zmiany przepisów UE dotyczących ochrony patentowej generycznych i biopodobnych produktów leczniczych. Podczas drugiej kwietniowej sesji plenarnej Parlament ma głosować nad tekstem kompromisowym zatwierdzonym przez Komisję Prawną (JURI).

This document summarises the presentations and discussions of the workshop on access to medicines, held at the European Parliament in Brussels on Thursday 14 July 2016. The purpose of the workshop was to discuss the latest trends and the current situation as regards the availability of affordable medicines in Europe, to present a range of EU initiatives, and to raise awareness on prices, accessibility, acceptability, affordability and availability of medicines in the EU. During the first part of ...

Today the internet is at the heart of the new digital society. It is a communication tool but it can also be used to offer and to access online a vast range of commercial and cultural services or content. Policy-makers are trying to clarify the respective rights and obligations of consumers, creators of content and intermediaries who interact on the internet, and to make sure that innovation and fair competition can flourish. This note has been prepared for the European Youth Event, taking place ...

This study describes the challenges for competition policy in relation to the digital economy. It explores the specific characteristics of digital economy markets and how these characteristics impact competition policy. The study focusses on competition policy and its instruments such as anti-trust laws, merger regulation, State aid and sector regulation. Neighbouring policy fields such as copyright and data protection are outlined where important but not analysed in detail. This study was prepared ...