Publications by authors named "Volker ter Meulen"

COVID-19 has shown that international collaborations and global data sharing are essential for health research, but legal obstacles are preventing data sharing for non–pandemic-related research among public researchers across the world, with potentially damaging effects for citizens and patients.

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Regenerative medicine has great potential. The pace of scientific advance is exciting and the medical opportunities for regeneration and repair may be transformative. However, concerns continue to grow, relating to problems caused both by unscrupulous private clinics offering unregulated therapies based on little or no evidence and by premature regulatory approval on the basis of insufficient scientific rationale and clinical evidence.

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While there is abounding literature on virus-induced pathology in general and coronavirus in particular, recent evidence accumulates showing distinct and deleterious brain affection. As the respiratory tract connects to the brain without protection of the blood-brain barrier, SARS-CoV-2 might in the early invasive phase attack the cardiorespiratory centres located in the medulla/pons areas, giving rise to disturbances of respiration and cardiac problems. Furthermore, brainstem regions are at risk to lose their functional integrity.

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An EASAC working group on genome editing recommends that regulators should focus on specific applications of these new techniques rather than attempting to regulate genome editing itself as a new technology.

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A working group on gain-of-function research set up by the European Academies Science Advisory Council (EASAC) has emphasised the importance of ensuring that the necessary safeguards and policies are in place.

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Gain-of-function (GoF) studies to understand factors affecting transmissibility of potentially pandemic pathogens are controversial. The European Academies Science Advisory Council (EASAC) recently published consensus recommendations relating to GoF research review and management on self-regulation and harmonization; bioethical considerations; benefit-risk assessment; biosafety, and biosecurity advisory options; and publication of sensitive information. A layered approach to integration of responsibilities must include conforming to the stringent rules and guidance already existing.

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Enhanced antibiotic innovation depends on many things--defining and validating new and better targets, resourcing and facilitating high-quality preclinical and clinical research, streamlining regulation and solving market problems so as to provide incentives to the private sector. Further detail is provided in our recent report (see further information). Acting on these critical steps in concert to provide long-term solutions requires that urgent attention be paid to tackling policy disconnects.

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The introduction and spread of plant pests and diseases has significant consequences for agriculture, horticulture, forestry, and natural habitats. Opportunities arising from scientific advances must be better used to inform regulation of trade and underpin chemical and alternative controls and breeding of plants resistant to biotic stress.

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Direct-to-consumer (DTC) genetic testing services raise scientific, regulatory and ethical questions. A report was prepared by consultation with an expert Working Group and published by the academies of science (European Academies of Science Advisory Council, EASAC) and medicine (Federation of European Academies of Medicine, FEAM). This report reviews current scientific evidence, ascertains the principles that should underpin the options for action by policy-makers, and discusses the potential for devising proportionate and flexible regulation that enables future innovation, taking account of the work of other expert groups, most notably the European Society of Human Genetics.

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