A new review of all New Chemical Entities (NCEs) approved during 1982-2003 contradicts the widely-held view that the USA has eclipsed Europe in drug research productivity - in fact, Europe is pulling ahead, says its author.

Other large studies show that most new drugs add few, if any clinical benefits, over previously discovered medicines, adds author Donald Light of Stanford University and the University of Medicine and Dentistry of New Jersey, who published his findings on-line on the journal Health Affairs yesterday (August 25).

US pharmaceutical research investments grew 5.2 times from 1990 to 2007 compared to 3.3 times in Europe, and a previous examination of all NCEs discovered between 1982–1992 and 1993–2003 concluded not only that US firms had overtaken their European counterparts, but also that while the number of NCEs had declined, their quality was high and had increased. “In other words, most new drugs that are discovered are better than existing drugs, and most come from the United States,” writes Prof Light.

However, he notes that research productivity and total funding are often confounded, and suggests that overall research productivity can be measured by the proportion of NCEs to the proportion of R&D investment made in the three major research regions – the USA, Europe and Japan.

An examination of how the three regions performed in terms of developing global and first-in-class NCEs during the periods 1982-1992 and 1993-2003 reveals that, in terms of global NCEs, European research productivity was about the same as USA’s in the first period but increased 30% in the second, while US research productivity declined 26%,says Prof Light. In first-in-class drugs, Europe’s relative innovativeness moved from well behind the USA in the first period to well ahead in the second.

His analysis also shows that, in biotechnology products, European researchers became much more innovative in the second period but did not catch up with their US counterparts, even though US productivity declined, and that, for orphan drugs, proportional European research productivity gains and US declines resulted in Europe moving from well behind the USA to about even in the second period.

“This reanalysis provides strong, general evidence that US firms have not overtaken their European counterparts in pharmaceutical innovation,” says Prof Light. “European research productivity has actually increased in proportion to funds received and would prove stronger still if new first-in-class and orphan drugs launched in Europe but not the United States had been included. Given the new institutes in European countries that bring together applied scientists from industry and academe to translate discoveries into drugs, such as Top Institute Pharma in the Netherlands, Karolinska Institutet Innovations in Stockholm, Sweden and the broader European Innovative Medicines Initiative, returns on R&D investment in Europe may increase further during the next decade of 2004–2014,” he forecasts.