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‘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?

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 ...

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 ...

The current EU approval system for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) is based on conformity assessment by 'notified bodies'. A number of scandals stressed the need to tighten the regulatory framework for such devices. The European Commission's proposals for regulations on MDs and IVDs, being discussed in parallel, are extensive and will repeal all existing rules. Votes in Parliament at second reading are expected during the April I plenary.

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 ...

'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 ...

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 ...

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 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.

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 ...