The EU’s Orphan Regulation was introduced in 2000 and its main objective was to address the challenge of regulating medicines which treat an estimated 30 million patients with rare diseases across the EU.
The regulation introduced some incentives for the pharma industry to invest in the area of rare diseases, resulting in more than 160 new medicines. However, the Commission now wants to re-visit and amend the regulation as part of a new Pharmaceutical Strategy.
For its part, the pharma industry warns that if incentives are changed, this would negatively impact investments in innovation in this sensitive public health field.
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Report: Without orphan drugs law, 2mn patients deprived access to therapies
In the absence of the EU orphan drugs regulation, which focuses on rare diseases, approximately two million patients would not get access to therapies, a new industry-funded report has found.
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Economist: ‘Premature’ to decide changes in Orphan Drugs law
Europe needs to give EU Orphan Drugs regulation more time to show its effectiveness before reviewing the incentives it provides and putting pharma innovation to the test, economist Adam Hutchings told EURACTIV in an interview.