Socio-Economic Dimensions In Drug Licensure

As overtures towards requiring pharmacoeconomic and quality of life evaluations in the drug licensure process are starting to be heard from regulatory authorities across the globe, the biopharmaceutical industry finds itself in an extremely difficult position, prepared in the main to provide such data but in considerable confusion regarding how best to approach the problem.

At a Rhone-Poulenc Rorer Foundation-sponsored event in Cologne, Germany, entitled "The Challenges In Studying the Socio-Economic Dimensions in Cancer Therapy," the debate on the issue of pharmacoeconomics raged to and fro with little evidence of a consensus opinion being reached. But this is in itself unsurprising given the fledgling nature of the discipline - more encouraging was the spectacle of health economists, oncologists, policy makers and civil servants entering into a lively exchange on the issue, at a meeting which would have been unheard of until recent years.

No doubt some sense of urgency has been engendered by regulatory authorities' moves on pharmacoeconomics; Australia now mandates economics data as part of the drug licensure process, Canada's Ontario actively encourages the practice and the UK is considering the options available. Bruce Hillner, associate professor of medicine at the Medical College of Virginia and author of many papers on the subject, noted at the meeting that it remains unclear how this tendency will disseminate further. Nevertheless, it is estimated that less than 30% of pharmaceutical industry-sponsored Phase I and II studies have pharmacoeconomic elements (Marketletter August 15, 1994).