12

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What if we genetically engineered an entire species?

07-12-2018

‘Gene drives’ are best known for their capacity to suppress malaria by eradicating mosquito populations. However, its applications reach even further, including the potential to eliminate other insect-transmitted diseases, erasing herbicide and pesticide resistance in weeds and pests, and removing invasive species from ecosystems. How do we navigate the potential benefits and significant risks that are involved in gene drive use?

‘Gene drives’ are best known for their capacity to suppress malaria by eradicating mosquito populations. However, its applications reach even further, including the potential to eliminate other insect-transmitted diseases, erasing herbicide and pesticide resistance in weeds and pests, and removing invasive species from ecosystems. How do we navigate the potential benefits and significant risks that are involved in gene drive use?

What if gene editing became routine practice?

16-10-2018

The CRISPR-Cas9 system currently stands out as the fastest, cheapest and most reliable system for ‘editing’ genes. It is seen as the biggest game changer in the field of gene editing due to its high degree of reliability, effectiveness and low cost. At the same time, the use of CRISPR has generated a series of socio-ethical concerns over whether and how gene editing should be used to make heritable changes to the human genome, to lead to designer babies, to generate potentially risky genome edits ...

The CRISPR-Cas9 system currently stands out as the fastest, cheapest and most reliable system for ‘editing’ genes. It is seen as the biggest game changer in the field of gene editing due to its high degree of reliability, effectiveness and low cost. At the same time, the use of CRISPR has generated a series of socio-ethical concerns over whether and how gene editing should be used to make heritable changes to the human genome, to lead to designer babies, to generate potentially risky genome edits or to disrupt entire ecosystems.

Horizon scanning and analysis of techno-scientific trends: Scientific Foresight Study

05-07-2017

This horizon scan has identified eight major technological trends relevant for STOA. First, a scan was conducted to measure controversy on social media, and this constituted an initial controversy ranking. After more detailed analysis of the main technology trends identified, a set of STOA-relevant areas were selected, which have not yet been investigated by STOA so far. These are big data, gene technology, electric vehicles, autonomous cars and impact of algorithms. A number of additional trend ...

This horizon scan has identified eight major technological trends relevant for STOA. First, a scan was conducted to measure controversy on social media, and this constituted an initial controversy ranking. After more detailed analysis of the main technology trends identified, a set of STOA-relevant areas were selected, which have not yet been investigated by STOA so far. These are big data, gene technology, electric vehicles, autonomous cars and impact of algorithms. A number of additional trend areas with high potential impact on society were identified for analysis: screen addiction, fake news and bioterrorism. Within the eight topics selected for detailed analysis from the initial horizon scanning process, keywords, subtopics, and sentiments have been detected and analysed from social media and news articles. These eight technologies are areas for discussion amongst the STOA Panel members when considering new project activities to be undertaken.

Autor externo

Michael Baumgartner, Bijan Farsijani (Augmented Intelligence Institute; http://www.augmento.ai)

Productos sanitarios y productos sanitarios para diagnóstico in vitro

29-03-2017

El sistema actual de aprobación de productos sanitarios (PS) y de productos sanitarios para diagnóstico in vitro (PS DIV) en la Unión está basado en la evaluación de su conformidad por parte de «organismos notificados». Algunos escándalos han puesto de manifiesto la necesidad de establecer un marco reglamentario más estricto para esos productos. Las propuestas de reglamentos presentadas por la Comisión Europea sobre PS y PS DIV, que se están debatiendo en paralelo, son de gran alcance y derogan todas ...

El sistema actual de aprobación de productos sanitarios (PS) y de productos sanitarios para diagnóstico in vitro (PS DIV) en la Unión está basado en la evaluación de su conformidad por parte de «organismos notificados». Algunos escándalos han puesto de manifiesto la necesidad de establecer un marco reglamentario más estricto para esos productos. Las propuestas de reglamentos presentadas por la Comisión Europea sobre PS y PS DIV, que se están debatiendo en paralelo, son de gran alcance y derogan todas las normas actuales. Las votaciones del Parlamento en segunda lectura están previstas durante la sesión plenaria de abril I.

Medical devices and in vitro diagnostic medical devices

16-01-2017

Medical devices and in vitro diagnostic medical devices cover a wide array of products. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012, to update the framework. Following Parliament's first readings in April 2014, the Council agreed its positions in October 2015. At the conclusion of the trilogue meetings, agreement was reached on both proposals on 25 May 2016. This was endorsed by the Council's ...

Medical devices and in vitro diagnostic medical devices cover a wide array of products. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012, to update the framework. Following Parliament's first readings in April 2014, the Council agreed its positions in October 2015. At the conclusion of the trilogue meetings, agreement was reached on both proposals on 25 May 2016. This was endorsed by the Council's Permanent Representatives Committee on 15 June and confirmed by Parliament's ENVI Committee on the same day. Political agreement in the Council was reached in September. Both drafts are now undergoing legal-linguistic revision. The formal first reading of the Council is expected early this year, followed by final approval, at second reading, by Parliament. This updates a previous edition, from June 2016: PE 583.812.

Personalised medicine: The right treatment for the right person at the right time

08-10-2015

'Personalised medicine' refers to a medical approach that uses molecular insights into health and disease to guide decisions with regard to the prediction, prevention, diagnosis and treatment of illnesses. Genetic factors play a role in most human diseases, with gene variations contributing to their incidence or course. New tools harnessed by personalised medicine include '-omics' technologies, which seek to define and explain the molecular mechanisms of the human body, and biomarkers, allowing us ...

'Personalised medicine' refers to a medical approach that uses molecular insights into health and disease to guide decisions with regard to the prediction, prevention, diagnosis and treatment of illnesses. Genetic factors play a role in most human diseases, with gene variations contributing to their incidence or course. New tools harnessed by personalised medicine include '-omics' technologies, which seek to define and explain the molecular mechanisms of the human body, and biomarkers, allowing us to subdivide patients into groups according to their likely response to a specific treatment, and so decide on the best-suited medication. Integrating advances in molecular technology into clinical practice comes with challenges, namely the translational gap, data protection, regulatory clarity and cost. Moreover, it is considered essential to educate patients (to acquire health literacy) as well as healthcare professionals (both in terms of providing them with undergraduate education and with continuous opportunities to advance their skills). EU initiatives in the field of personalised medicine include the Innovative Medicines Initiative (IMI), financial support to major research projects, and participation in international consortia. The Luxembourg Council Presidency has made personalised medicine one of its health priorities.

Technology options for deep-seabed exploitation - Tackling economic, environmental and societal challenges: Study

19-03-2015

Exploration and exploitation of the deep-seas in search of marine minerals and genetic resources have over the past fifteen years received increased attention. Developments in sub-marine technologies, rising raw material prices and scarcity, and advancements in biotechnology, are changing the business-case for further investments in the marineenvironment.This report provides a state-of-play overview on exploring and exploiting deep-sea resources. A Cost-Benefit Analysis identifies the main potentials ...

Exploration and exploitation of the deep-seas in search of marine minerals and genetic resources have over the past fifteen years received increased attention. Developments in sub-marine technologies, rising raw material prices and scarcity, and advancements in biotechnology, are changing the business-case for further investments in the marineenvironment.This report provides a state-of-play overview on exploring and exploiting deep-sea resources. A Cost-Benefit Analysis identifies the main potentials and challenges in a scenario where exploitation increases. Policy options are suggested to balance trade-offs between economic, social and environmental aspects associated with future developments.This STOA project 'Technology options for deep-seabed exploitation - Tackling economic,environmental and societal challenges' was carried out by Triple E Consulting and Milieu Ltd. at the request of the Science and Technology Options Assessment (STOA) Panel, within the Directorate-General for Parliamentary Research Services (DG EPRS) of the General Secretariat of the European Parliament.

Autor externo

Koen Rademaekers, Oscar Widerberg, Katarina Svatikova, Roel van der Veen, Triple E Consulting, Eleonora Panella, Milieu Ltd

In vitro diagnostic medical devices

20-11-2014

In vitro diagnostic medical devices are tests used on biological samples to determine the status of a person's health. The industry employs about 75 000 people in Europe, and generates some €11 billion in revenue per year. In September 2012, the European Commission (EC) published a proposal for a new regulation on in vitro diagnostic medical devices, as part of a larger legislative package on medical devices. The proposed legislation aims at enhancing safety, traceability and transparency without ...

In vitro diagnostic medical devices are tests used on biological samples to determine the status of a person's health. The industry employs about 75 000 people in Europe, and generates some €11 billion in revenue per year. In September 2012, the European Commission (EC) published a proposal for a new regulation on in vitro diagnostic medical devices, as part of a larger legislative package on medical devices. The proposed legislation aims at enhancing safety, traceability and transparency without inhibiting innovation. In April 2014, the European Parliament (EP) amended the legislative proposals to strengthen the rights of patients and consumers and take better into account the needs of small and medium-sized enterprises (SMEs). Some stakeholders consider that a provision for mandatory genetic counselling interferes with the practice of medicine in Member States and violates the subsidiarity principle. Device manufacturers warn that the proposed three-year transition period may be too tight.

Proceedings of the Workshop on "Proposal for a Regulation on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (Nagoya Protocol)"

15-04-2013

In the context of the legislative procedure related to the Commission proposal for a Regulation on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (COM(2012) 576), the European Parliament requested the organisation of a workshop to discuss the Commission’s legislative proposal putting special emphasis on the challenges of implementing the Nagoya protocol both at global and EU level, and on future perspectives.

In the context of the legislative procedure related to the Commission proposal for a Regulation on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (COM(2012) 576), the European Parliament requested the organisation of a workshop to discuss the Commission’s legislative proposal putting special emphasis on the challenges of implementing the Nagoya protocol both at global and EU level, and on future perspectives.

Autor externo

Hugo-Maria Schally (DG Environment, European Commission), Pierre du Plessis (Centre for Research Information Action in Africa), Emile Frison (Bioversity International), Axel Braun (European Federation of Pharmaceutical Industries and Associations), François Meienberg (Berne Declaration), Andreas Drews (ABS Capacity Development Initiative), Cornelia Löhne (Botanic Garden Berlin-Dahlem), Maria Julia Oliva (Union for Ethical Biotrade) and Matthieu Mellul (Collectif pour une alternative à la biopiraterie)

Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union: Initial Appraisal of the European Commission's Impact Assessment

15-03-2013

This note seeks to provide an initial analysis of the strengths and weaknesses of the European Commission's Impact Assessment accompanying its Proposal for a Regulation of the European Parliament and of the Council on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization in the Union (COM (2012) 576). Genetic resources are used for research and development purposes in many economic sectors, for example plant and animal breeding, food and beverage ...

This note seeks to provide an initial analysis of the strengths and weaknesses of the European Commission's Impact Assessment accompanying its Proposal for a Regulation of the European Parliament and of the Council on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization in the Union (COM (2012) 576). Genetic resources are used for research and development purposes in many economic sectors, for example plant and animal breeding, food and beverage, pharmaceuticals and cosmetics.

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