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BRUSSELS (Reuters) – The European Commission proposed on Wednesday to temporarily relax rules on trials of drugs involving genetically engineered organisms as an emergency measure to speed the development of a vaccine against the new coronavirus.
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The proposal is part of a wider EU strategy, which also includes investing around 2 billion euros ($2.3 billion) for the advance purchase of vaccines under development, in a bid to secure enough doses for the bloc as it fears lagging behind the United States and China.
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European countries have more stringent rules about research involving genetically modified organisms (GMOs) than in many other parts of the world. Reuters already reported last week that the EU\\\’s executive Commission was considering easing those rules for COVID vaccines.
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A Commission document published on Wednesday confirmed the new proposal. It would reduce member states\\\’ power to impose extra requirements on drugmakers when they conduct clinical trials on medicines and vaccines containing or consisting of GMOs.
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The proposal, which needs to be backed by EU governments and lawmakers, would be valid only during the COVID-19 emergency.
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EU officials said many promising vaccines under development against the new coronavirus could face delays in European trials if rules were not relaxed. EU countries now impose extra requirements on vaccines and drugs containing GMOs, under rules that also cover the publicly sensitive area of GMO crops.
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In Italy and France, for example, treatments must receive authorization from government environment or research departments, as well as from health and drug authorities.
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Unless changed, the legal framework would be “likely to cause significant delay, particularly for multi-center clinical trials in several member states”, the commission document said.
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Candidate COVID-19 vaccines are being trailed in several countries to increase the efficacy of the trials.
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The Commission is also proposing laxer rules on language and packaging requirements for medicines and vaccines to facilitate their quick distribution during the pandemic.
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($1 = 0.8881 euros)
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(Reporting by Francesco Guarascio @fraguarascio; Editing by Peter Graff)
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