The European Commission, European Medicines Agency and the U.S. Food and Drug Administration recently adopted a common application form for drug makers seeking orphan designation for their medicines. This will simplify the drug approval process and spur innovation by allowing companies to apply for approval of their new product in both the US and across Europe at the same time. In addition, this new process will help the regulatory agencies to better understand each other's systems. [1]

Canadian consumers continue to pay high prices for generic drugs according to a recent report by the Competition Bureau. [1] Generic drug manufacturers vying for shelf space in pharmacies often offer deep rebates to pharmacies as incentives to select a particular manufacturer's product. These rebates are not typically reflected in amounts paid for drugs by public or private drug plans, or out of pocket by consumers.

The World Health Organization (WHO), which has been intensely debating intellectual property (IP) rights issues, has restructured its management of the issues, elevating IP to the director general’s office. A new team for public health, innovation and intellectual property has been created. (1)

This move follows the close of the second meeting of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), which adjourned with no agreed strategy or plan of action amidst concerns raised by patient groups that the issue has become polarized and that the IGWG process has gone off-track.