13

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What if we could renew all our cells?

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.

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.

Coronavirus and international sanctions: Should sanctions be eased during the pandemic?

20-05-2020

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 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 possible humanitarian cost. Usually it does this by targeting restrictions at key individuals or organisations, and in some cases sectors, rather than a country's economy as a whole. Critics of sanctions claim that US-imposed trade restrictions have prevented Iran from purchasing essential medical supplies needed to fight the pandemic. They also argue that EU and US sanctions make desperately impoverished Zimbabwe and Sudan even more vulnerable than they would otherwise be. Both the European Union and the United States defend their policies, but acknowledge the importance of humanitarian exceptions. Although the European Union has not said that it will lift any of its restrictive measures, it has offered various forms of support to several sanctions-hit countries.

Medicine shortage in the EU during the novel coronavirus outbreak

15-05-2020

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 ...

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 with the pharmaceutical industry, amongst the Member States, and with the Commission and the Europan Medicines Agency, is key in resolving the problems of medicine shortages in these extraordinary times This paper looks into the causes of medicine shortage during the novel coronavirus pandemic in the Union, and the responses and solutions at European level.

Addressing shortages of medicines

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 ...

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. The European Commission links them to manufacturing problems, industry quotas, legal parallel trade, but also to economic aspects, such as pricing (which is a competence of the Member States). The coronavirus crisis has brought to the fore the geopolitical dimension of these shortages, that is, the EU's dependency on countries beyond its boundaries, especially China and India, for the production of many active pharmaceutical ingredients and medicines. Solutions to the problem are believed to entail collaboration and joint action, as well as the involvement of multiple stakeholders, including regulators, industry, patients, healthcare professionals, and international players. The Organisation for Economic Co-operation and Development and the World Health Organization, in particular, are conducting work to improve access to medicines. Medicines supply-chain stakeholders have all weighed in on the debate, offering explanations and recommendations for addressing the problem. Key EU institutions, several Council presidencies and the Member States have addressed the challenge of shortages and more broadly, that of safeguarding access to medicines, through various initiatives. The European Parliament has specifically addressed the issue in a March 2017 resolution. Ensuring the availability of medicines and overcoming supply-chain problems revealed by the coronavirus crisis are also expected to be important topics in the Commission's forthcoming pharmaceutical strategy.

Amendment of the 2014-2020 MFF regulation: Using the global margin for commitments to finance measures in the healthcare sector under the Emergency Support Instrument

15-04-2020

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 ...

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 proposes to amend the provisions of the MFF Regulation and lift the restrictions on the scope of application of this flexibility mechanism. Consent from the European Parliament for this urgent request is expected to be voted during the 16-17 April plenary session.

What if mini-brains could help us understand dementia?

05-12-2017

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?

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?

Towards a Harmonised EU Assessment of the Added Therapeutic Value of Medicines

08-06-2015

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 ...

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 harmonisation of the ATV assessment might be taken forward within the current legal framework.

Extern avdelning

VAN WILDER Philippe (Vrije Universiteit Brussel and SMART&BI), MABILIA Valentina (Milieu Ltd.), KUIPERS CAVACO Yoline (Milieu Ltd.) and MCGUINN Jennifer (Milieu Ltd.)

Proceedings of the Workshop on "Effectiveness of Medicines and Therapies"

12-12-2013

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 ...

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.

Extern avdelning

Tapani PIHA (DG SANCO, European Commission), Francesco PIGNATTI (Haematology and Diagnostics at European Medicines Agency - EMA), Jonathan CYLUS (European Observatory on Health Systems and Policies, London, the UK), Erik BAARS (University of Applied Sciences, Leiden, the Netherlands), Lidija GAJSKI (Croatian Association for Patients' Rights, Zagreb, Croatia)

Proceedings of the Workshop on "Childhood Vaccination and Immunisation"

16-09-2013

This report summarises the presentations and discussions at the Workshop on “Childhood Vaccination and Immunisation”, held at the European Parliament in Brussels, on Wednesday 19 June 2013. The aim of the workshop was to provide a forum for discussion on vaccine-preventable diseases (in particular measles and tuberculosis) that still pose significant threats to public health in Europe. The workshop was hosted by MEP Ms Glenis WILLMOTT (S&D, UK) and MEP Mr Alojz PETERLE (EPP, SL), Co-chairs of the ...

This report summarises the presentations and discussions at the Workshop on “Childhood Vaccination and Immunisation”, held at the European Parliament in Brussels, on Wednesday 19 June 2013. The aim of the workshop was to provide a forum for discussion on vaccine-preventable diseases (in particular measles and tuberculosis) that still pose significant threats to public health in Europe. The workshop was hosted by MEP Ms Glenis WILLMOTT (S&D, UK) and MEP Mr Alojz PETERLE (EPP, SL), Co-chairs of the Health Working Group within the ENVI Committee.

Extern avdelning

Piotr Kramarz (European Centre for Disease Prevention and Control) , Masoud Dara (WHO/Europe TB and M/XDR-TB programme) , Amy McConville (TB patient) , Daniel Brasseur (European Medicines Agency) , Radu Botgros (European Medicines Agency) , Ronald de Groot (European Society for Paediatric Infectious Diseases) , Andreas Schultz (Tropical Medicine and Infectious diseases , Médecins du Monde Germany)

Proceedings of the Workshop "Advanced Therapy Medicinal Products"

15-02-2013

This report summarises the presentations and discussions at the Workshop on “Advanced Therapy Medicinal Products”, held at the European Parliament in Brussels, on Wednesday 20 February 2013. The aim of the workshop was to exchange views on the opportunities and challenges related to advanced therapies for the future of healthcare. The workshop was hosted by MEP Ms Glenis WILLMOTT (S&D, UK) and MEP Mr Alojz PETERLE (EPP, SL), Co-chairs of the Health Working Group within the ENVI Committee.

This report summarises the presentations and discussions at the Workshop on “Advanced Therapy Medicinal Products”, held at the European Parliament in Brussels, on Wednesday 20 February 2013. The aim of the workshop was to exchange views on the opportunities and challenges related to advanced therapies for the future of healthcare. The workshop was hosted by MEP Ms Glenis WILLMOTT (S&D, UK) and MEP Mr Alojz PETERLE (EPP, SL), Co-chairs of the Health Working Group within the ENVI Committee.

Extern avdelning

Ms Sabine Jülicher, DG Health and Consumers, European Commission Prof. Stefaan Van Gool, Head of the Laboratory of Paediatric Immunology, University of Louvain (BE) Dr Jacques Mallet, Director of “Recherche Emérite” CNRS, Institute for Brain and Spinal Cord (ICM), Paris; Adjunct Professor at the University of California at San Francisco (UCSF); Member of the French Academy of Sciences (FR, US) Dr Monica Ensini, Scientific Director, European Organisation for Rare Diseases (EURORDIS) Dr Panos Kanavos, Reader in International Health Policy in the Department of Social Policy, London School of Economics (LSE) and Programme Director of the Medical Technology Research Group (MTRG) at LSE Health (UK) Dr Maria Luisa Nolli, Founder and Chief Executive Officer of Areta International (IT) Dr Christian K. Schneider, Chair, Committee for Advanced Therapies (CAT), European Medicine Agency

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