For a patient, a clinical trial can be the difference between waiting and being treated. Trials, the EU’s health commissioner Olivér Várhelyi told an industry audience, “shape where and when new medicines are launched first and how quickly the patients will actually be able to access them.” His Biotech Act would change the trials regulation to speed up multi-country studies “with the use of artificial intelligence,” and add “an extra year of patent protection provided key clinical trials and manufacturing takes place here in Europe.” In practice, he says, that means cutting trial authorisation from 106 days today to a target of around 75 days, turning the tide on clinical trials.
Ireland, holding the Council presidency since 1 July, has made trials its opening move. Presenting the health programme to the European Parliament, Health Minister Jennifer Carroll MacNeill said the presidency would “initially focus on the amendments to the clinical trials regulations,” and progress them first, “before opening other chapters.” “We want those trials to occur in Europe,” she said.
Her case is about patients, not market size. She wants trials “for people in Ireland, for people in Bulgaria, for people in small countries and countries at the edges of Europe as much as for large markets at the centre of Europe.” The point of reform, she argued, is to reach a place where “the size of the market is not what’s attractive,” but the efficiency and availability of researchers and clinicians is, “so that everybody is on an equal playing field.”