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European Medicines Agency mandate extension

Накратко 01-07-2021

On 11 November 2020, the European Commission adopted a proposal to strengthen the European Medicines Agency (EMA). The proposed regulation would allow the EMA, among other things, to better anticipate possible shortages of medicinal products and ensure their timely development, with the aim of improving the EU's capacity to respond to health emergencies. The European Parliament's Committee on the Environment, Public Health and Food Safety adopted its report on 22 June 2021. This is due to be voted ...

Access to medicinal products

Проучване 01-05-2021

There are many factors that can prevent a patient from being able to obtain the medicine they need, ranging from selective marketing decisions by companies to products being too expensive or pharmacy stock-outs. Because of national differences in health systems and market characteristics, access to medicine is not evenly distributed across the European Union. In response to observed problems with access to medicine, in 2017 the European Parliament adopted a resolution containing 58 recommendations ...

What if we could renew all our cells?

Накратко 20-11-2020

Regenerative medicine (RM) is an interdisciplinary field that applies engineering and life science techniques to restore tissues and organs damaged by age, disease or trauma, as well as those with congenital defects. Promising data supports the future capability of using RM across a wide array of organ systems and contexts, including surface wounds, cardiovascular diseases and traumas and treatments for certain types of cancer.

The coronavirus pandemic has raised concerns that international sanctions may be exacerbating the risk of a humanitarian crisis. In March 2020, United Nations Secretary-General António Guterres called on world leaders to waive restrictions on food and medicines that are affecting the world's most vulnerable countries. Especially since the suffering caused by the international trade embargo against Iraq in the 1990s, the European Union has sought to design its sanctions for maximum effect at the least ...

The novel coronavirus outbreak is an unprecedented public health crisis with far-reaching consequences. It has highlighted the EU’s long-existing structural problems related to the supply of medicines, and the dependency on third-country import for certain essential and critical medicines and ingredients. While public health policy, including the organisation of the delivery of healthcare and the sales of medicines remains in the competence of the Member States, it has also become clear that cooperation ...

Addressing shortages of medicines

Briefing 28-04-2020

Medicines shortages have been a growing problem in the European Union (EU) in recent years. As the coronavirus outbreak unfolds, the risk of bottlenecks in the supply of medicines to patients has become particularly high. More broadly, problems with the availability of, and access to, new medicines – most frequently associated with high-priced medicines – have also been a central topic in political debates for some time now. The causes underlying medicines shortages are complex and multi-dimensional ...

On 2 April 2020, as part of the EU response to the needs resulting from the coronavirus outbreak, the European Commission proposed to activate the Emergency Support Instrument and reinforce the Union Civil Protection Mechanism (rescEU). Provision of funding for these measures (€3 billion) requires mobilisation of flexibility and last resort mechanisms available under the 2014-2020 Multiannual Financial Framework (MFF). In order to use the global margin for commitments for this purpose, the Commission ...

Organoids are artificially grown organs that mimic the properties of real organs. What new possibilities for treating diseases, drug development, and personalised and regenerative medicine do organoids provide?

TThis study, produced for the ENVI Committee by Policy Department A, investigates the possibility of a harmonised EU approach concerning the assessment of the added therapeutic value (ATV) of medicinal products. It reviews the current EU legal and policy framework and looks at the state-of-play within all 28 Member States. In addition, it presents the results of an in-depth analysis on the use of ATV in six selected EU countries. The study closes with policy recommendations on how a possible European ...

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 ...