Tag: pharmaceutical

  • Bill to help Canadian companies ship generics has uncertain future

    Bill to help Canadian companies ship generics has uncertain future

    From Nature Medicine. Published online 7 March 2011.

    Backed by nongovernmental organizations and the generics industry, the left-of-center New Democratic Party has championed a bill that set out to improve Canada’s Access to Medicines Regime (CAMR), a law that enables drug manufacturers in the country to make generic medications for shipment to developing countries to treat illnesses such as tuberculosis and AIDS. The bill, C-393, was introduced to the House of Commons in 2009 and aimed to eliminate many of the CAMR procedures that its supporters consider unwieldy and extend the list of eligible drugs. But the bill has been so gutted that many global health advocates say they cannot support it in its current state, and it is floundering in Canada’s parliament.

    Under the existing legislation, generic manufacturers that are unable to negotiate a voluntary license from the patent holders can ask the Canadian Commissioner of Patents for a compulsory license to produce an eligible product to address public health problems in another country. If the commissioner says yes, the law then authorizes a one-time license for a named product, along with the country to which it is to be shipped and order size.

    Read the full article at Nature Medicine (subscription required).

    Photo by Takkk.

  • Cancer drugs should add months, not weeks, say experts

    From Nature Medicine. Published online 7 January 2011.

    In the last decade, the world’s drug regulatory agencies have approved dozens of new anticancer therapies for everything from lung carcinoma to skin melanoma. Some of these new drugs add months to a patient’s life. But others may offer only an extra week or two, on average, often with considerable toxicity and at a cost of thousands of dollars.

    Now experts are questioning whether these outcomes provide meaningful benefit to people’s quality of life and are urging regulatory agencies to toughen the criteria for drug approval. Such a measure would push pharmaceutical companies to modify the design of clinical trials—a move that some drug makers and doctors worry could shrink the drug market.

    Read the full article at Nature Medicine (subscription required).