Making drug data more transparent
Joel Lexchin discusses the importance of informing people about medicines so that they can be knowledgeable about the risks and benefits of various drugs1 [full text]. Although it recognizes that there is an element of risk in all medicinal products, the Pharmaceutical Manufacturers Association of Canada (PMAC) has always advocated that information about medicines be made available to both health care professionals and patients.
As Lexchin notes, the processes and procedures of the Therapeutic Products Directorate concerning disclosure of data are less transparent than those in the US. The PMAC supports a renewal of the Canadian system, and the objective of this exercise should be harmonization with the practices in other major developed countries. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project. It brings together regulatory authorities from Europe, Japan and the US, as well as experts from the pharmaceutical industry in these regions, to discuss scientific and technical aspects of product registration. Canada currently holds observer status within the ICH, but the PMAC believes this country should become an ICH cosponsor. We have made that request to the organization.
Judith A. Erola