6

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What if we could 3D-print our own body parts

10-11-2017

The 3D-printing sector has proven its commercial viability in recent years, reaching the high street and, indeed, many homes. The technology is already used in some medical domains, such as dentistry and prosthetics, and many scientists are now exploring methods of printing biological materials – even if reports about lifesaving 3D-printed hearts are certainly premature.

The 3D-printing sector has proven its commercial viability in recent years, reaching the high street and, indeed, many homes. The technology is already used in some medical domains, such as dentistry and prosthetics, and many scientists are now exploring methods of printing biological materials – even if reports about lifesaving 3D-printed hearts are certainly premature.

What if your personal health tracker could save your life?

09-06-2017

Through advances in technology, big data has become a major asset and can open up numerous opportunities in all areas, but how can we use this in the context of health care and ensure it benefits everyone?

Through advances in technology, big data has become a major asset and can open up numerous opportunities in all areas, but how can we use this in the context of health care and ensure it benefits everyone?

Public expectations and EU policies - Health and social security

30-06-2016

Almost two thirds of EU citizens would like to see more EU engagement in the areas of health and social security. The EU's main role in these policies is to support and complement the activities of Member States, and it can encourage cooperation and best practice. EU health policy aims to foster good health, protect citizens from health threats and support dynamic health systems. Social policy promotes social cohesion equality as well as solidarity through adequate, accessible and financially sustainable ...

Almost two thirds of EU citizens would like to see more EU engagement in the areas of health and social security. The EU's main role in these policies is to support and complement the activities of Member States, and it can encourage cooperation and best practice. EU health policy aims to foster good health, protect citizens from health threats and support dynamic health systems. Social policy promotes social cohesion equality as well as solidarity through adequate, accessible and financially sustainable social protection systems and social inclusion policies. The EU encourages national pension reforms to ensure they are both adequate and sustainable. In the EU budget, the Health Programme 2014-2020 is the only programme specifically created for this policy area, but other programmes contribute in part to health objectives. EU spending on social security is tied to labour market measures.

Clinical trials: Initial Appraisal of the European Commission's Impact Assessment

15-02-2013

This note seeks to provide an initial analysis of the strengths and weaknesses of the European Commission's Impact Assessment on the Revision of the Clinical Trials Directive 2001/20/EC (SWD (2012) 200, SWD (2012) 201 (summary)) accompanying the Commission Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (COM (2012) 369).

This note seeks to provide an initial analysis of the strengths and weaknesses of the European Commission's Impact Assessment on the Revision of the Clinical Trials Directive 2001/20/EC (SWD (2012) 200, SWD (2012) 201 (summary)) accompanying the Commission Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (COM (2012) 369).

European and Developing Countries Clinical Trials Partnership (EDCTP): Lessons learnt and perspectives

22-10-2012

Since its establishment in 2003, the European and Developing Countries Clinical Trials Partnership (EDCTP) has aimed to scale up the fight against poverty-related diseases – malaria, HIV/AIDS and tuberculosis – in sub-Saharan Africa. Its main focus is on clinical trials of new medicines. The first phase 2003-2015 is coming to an end with stakeholders overall evaluating it as successful. A proposal for a second phase, EDCTP II, is due to be submitted to the EP and Council in coming months.

Since its establishment in 2003, the European and Developing Countries Clinical Trials Partnership (EDCTP) has aimed to scale up the fight against poverty-related diseases – malaria, HIV/AIDS and tuberculosis – in sub-Saharan Africa. Its main focus is on clinical trials of new medicines. The first phase 2003-2015 is coming to an end with stakeholders overall evaluating it as successful. A proposal for a second phase, EDCTP II, is due to be submitted to the EP and Council in coming months.

Clinical Trials in Developing Countries : How to Protect People Against Unethical Practices ?

27-03-2009

Executive summary European legislation regulating the marketing authorisation of medical products states that results from clinical trials that do not meet the ethical requirements of Good Clinical Practice, cannot legally be used by an applicant to justify its application, irrespective of whether the trial was done inside or outside the EU. However, earlier studies indicate that this legislation is not always properly observed: these studies identified trials with an unethical design that were part ...

Executive summary European legislation regulating the marketing authorisation of medical products states that results from clinical trials that do not meet the ethical requirements of Good Clinical Practice, cannot legally be used by an applicant to justify its application, irrespective of whether the trial was done inside or outside the EU. However, earlier studies indicate that this legislation is not always properly observed: these studies identified trials with an unethical design that were part of approved EU marketing applications. Clinical trials that are no longer accepted by Western European ethics committees are approved by the local ethics committees in countries like India, China, Argentina and Russia. Once officially approved by an ethics committee, there are no obstacles to including the trial in the technical dossier of a marketing application. In particular the ethical principles which are of utmost importance for developing countries, as reflected in the Declaration of Helsinki, are ignored by companies and regulatory authorities. The main objective of this paper is to provide the European Parliament with concrete recommendations, both at legislative and enforcement level, aimed to guarantee that trials conducted in third countries are done so in conformity with EU and international ethical standards. [...]

Autor externo

Irene Schipper (SOMO - Center for Research on Multinational Companies, Amsterdam, Holland)

Socios

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