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Antimicrobial resistance (the ability of a microorganism to survive in the presence of a medicine designed to inhibit or kill it) is threatening the capacity to prevent and cure infectious diseases. In the European Union, it causes an estimated 35 000 deaths per year, and places an annual financial burden of €1.1 billion on healthcare systems. In 2019, the World Health Organization declared antimicrobial resistance (AMR) to be one of the top 10 global public health threats facing humanity. On 26 ...

This appraisal assesses two regulations for intellectual property rights applicable to the specific case of medicinal products and plant protection products – the Supplementary Protection Certificate Regulations (SPC Regulations for short). The analysis highlights the outcome of the European Commission's assessment, discrepancies in implementation between Member States, and the complexity of striking a balance between various interests, since both regulations aim to reconcile public health imperatives ...

Antimicrobial resistance (AMR) is a global, multidimensional phenomenon occurring in humans, animals, and environmental ecosystems. It is the ability of microbes, e.g. bacteria, viruses, fungi and protozoa, to survive in the presence of medicines designed to kill or inactivate them (antimicrobials: antibiotics, antivirals, antifungals and antiprotozoals). At patient level, AMR hampers the effective treatment of microbial infections, leading to prolonged, severe disease and, in some cases, death. ...

The European Commission plans to launch its revised EU pharmaceutical package in the first quarter of 2023. Ahead of its release, two recent STOA studies offer insight to inform upcoming Parliamentary discussions. Fragmentation of EU health research and development, lack of transparency and a translation gap between public investment and clinical output are among the weaknesses identified. Possible solutions include the creation of large-scale European biomedical infrastructure, and a series of targeted ...

In 2014, the Commission presented a proposal for a regulation on medicated feed with the aim to update and harmonise rules that dated from 1990 and were laid out in a directive. Patchy national implementation was causing difficulties for producers, animal holders and the single market. Due to the strong correlation between the proposal on medicated feed and the draft regulation on veterinary medicinal products, legislative work on both acts was being coordinated to assure consistency between their ...

With a focus on research and development in the area of innovative medicines, this study discusses a new European approach to pharmaceutical policy. After examining the European pharmaceutical sector's features, and the strengths and weaknesses of the current research and business model, the study explores the need for and the concept of a European infrastructure with a long-term transboundary mission. Any such European medicines infrastructure should focus on threats and areas of research and development ...

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, ...

On 1 June 2020, the European Commission published a roadmap for a pharmaceutical strategy for Europe. The strategy will have the overall goal of ensuring Europe's supply of safe and affordable medicines and supporting the European pharmaceutical industry's innovation efforts. Two consultations (on the roadmap and the strategy, respectively), are currently under way. Adoption of the strategy is envisaged for the fourth quarter of 2020.

In February 2013, the European Union (EU) and the United States of America (US) started the procedures necessary for initiating formal negotiations on a free trade agreement, referred to as the “Transatlantic Trade and Investment Partnership” (TTIP). The first round of negotiations took place in Washington D.C. in July 2013, the seventh round ended on 3 October 2014 and the eight round is taking place in Brussels from 2 to 6 February 2015. In order to monitor the on-going negotiations, the Committee ...

This report summarises the presentations and discussions at the Workshop on “Effectiveness of Medicines and Therapies”, held at the European Parliament in Brussels, on Wednesday 18 September 2013. The aim of the workshop was to exchange views on the latest developments and main challenges healthcare systems have to address while assessing risks and benefits of new drugs and therapies. The workshop was hosted by MEP Mr Alojz PETERLE (EPP, SL), Co-chair of the Health Working Group within the ENVI Committee ...