Drug Industry Price-Setting "Should Be Transparent"

Pharmaceutical companies are great advocates of transparency innational drug registration procedures, yet they themselves practice no transparency in their pricing procedures, Jan Bultman, secretary of the Health Insurance Council of the Netherlands, told the annual Conference of Medicines Agencies last month in The Hague, the Netherlands (Marketletters April 28 and May 5).

Dr Bultman said that details of decisions concerning drug approvals by national authorities are revealed only to the product's sponsor; the rest of the world never gets to hear why a drug has or has not been registered for a particular indication. Yet this information is very valuable, for prescribers, researchers, pharmacists and government, he said, and called for more information on these decisions to be made publicly available. He acknowledged that regulatory authorities would have to be careful with sensitive information provided by the company, but added: "I think that, at least for the Dutch evaluation board, this will be no real problem."

He also said that for regulatory authorities to be able to judge a new drug thoroughly, efficacy studies should begin pre-registration, or in Phase III of the drug's clinical trials. Manufacturers should be informed as far as possible about the approval criteria and requirements of the various national authorities, he added.