European Notebook: Clinical Trial Fatality; Affordable Medicines Debate; Physician Payment Disclosure

One death and five healthy volunteers hospitalized in a Phase I study in France; EU Council looks set to debate patient access to medicines; and the two Mercks set to continue litigation in Europe and the US over use of the Merck word, straining their 60-year-old agreement. Generics/biosimilar trade group adopts physician payment disclosure policy.

2016 began with some tragic news in Europe, the death of one volunteer and severe adverse reactions in five others in a clinical trial being conducted in France. The Phase I study was being conducted by local company Biotrial on behalf of Portugal’s Bial-Portela & CA SA, and involved an investigational drug BIA-10-2474 being developed for CNS indications.

The last drug trial disaster in Europe was back in 2006 in the UK, and led to a tightening of...

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