The EU is revamping laws governing the $148 billion pharmaceuticals industry aimed at reviving investment and boosting access to affordable drugs at a time when health budgets have been drained by the costs of treating COVID
They say Europe is already losing out as a destination for research and development and innovation is suffering.Cuts to market exclusivity would damage work on so-called “orphan” drugs which treat rare conditions affecting fewer than five in 10,000 people in the EU, they warn.Companies may be obliged to disclose R&D costs and public funding received for a new drug when filing for regulatory approval. This information might be made public.
The agency may establish a "regulatory sandbox" to rapidly test innovative technologies and treatments, potentially easing the path to market for companies with novel products. Instead, companies want the EU to establish a bloc-wide database on medicine consumption to help forecast surges in demand like those that contributed to this winter's crisis.
Companies bringing a new antibiotic to market may get an additional year of exclusivity in the EU for another medicine they have on the market.
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