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Health is a fundamental human right, and achieving equality in access to medicines is crucial for ensuring public health. The current system of innovation strongly relies on the private sector, while remuneration of innovation is mainly based on exclusivities. This system presents several issues, such as innovation being driven by market size, the partial misalignment between industry’s research and development (R&D) priorities and public health goals, access constraints, and the scarcity of disruptive ...

The proposed revision of the EU's pharmaceutical framework covers the EU's general pharmaceutical legislation and the paediatric and orphan medicines regulations ('specific pharmaceutical legislation') in an integrated manner. The merger of the orphan and paediatric regulations with the legislation applicable to all medicinal products is explained with 'simplification and increased coherence' in the explanatory memorandum of the proposed directive. The proposed revision is supported by two impact ...

On 26 April 2023, the European Commission launched a revision of the EU's pharmaceutical legislation, including legislation on medicines for children and for rare diseases. Since the early 2000s, the EU legislative framework has provided a complex set of obligations, incentives and rewards to stimulate the development of medicines for children and for rare disease patients. Over the last 20 years, the EU legislation has led to the development of new medicines for these categories of patients. The ...

On 26 Avril 2023, the European Commission put forward a 'pharmaceutical package' to revise the EU's pharmaceutical legislation and make medicines more available, accessible and affordable, while supporting the competitiveness and attractiveness of the EU pharmaceutical industry, with higher environmental standards. The package includes proposals for a new directive and a new regulation, which would replace the existing pharmaceutical legislation, including the legislation on medicines for children ...

The European Union has been regulating pharmaceuticals for over 50 years. The legal regulation aims to protect public health and ensure the proper functioning of the internal market in medicinal products. In 2020, the European Commission published a pharmaceutical strategy for Europe aimed at reinforcing the EU pharmaceutical system by making it more patient-centred and resistant to crises (such as pandemics). The achievement of these objectives requires the revision of several pieces of EU legislation ...

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 ...

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.

On 13 February 2019, Parliament and Council negotiators agreed on amending the EU rules on patent protection for generic and biosimilar medicines. Parliament is due to vote on the compromise text, approved by its Committee on Legal Affairs (JURI), at its second plenary session in April.

European health policy measures taken to date are highly beneficial to and relevant for European citizens, economies and the Member States. The EU does acquit its responsibility and utilises its capacity to act on behalf of EU citizens in this policy area. The study concludes that EU health policy clearly achieves added value.