February 21, 2005 – Canada’s Health Minister Ujjal Dosanjh is considering changing the approval procedures for new drugs in the country.
Minister Dosanjh says he wants more transparency and more public participation in how to assess the safety and efficacy of new drugs intended for the Canadian market.
Minister’s intention to make changes comes following global withdrawal of drug Vioxx in September1. Designed to relieve the chronic pain of arthritis, this drug has been linked to an increased risk of heart disease.
Rumors persist that multinational pharmaceutical companies manage to cover up studies that do not favor the drugs they are trying to bring to market. Added to this is the impression that governments are sometimes powerless to obtain all the information necessary to provide informed approval for certain drugs to be marketed.
All this context having probably undermined public confidence, Minister Dosanjh is trying to demonstrate that the government is able to ensure the safety of the population by advocating openness and transparency.
Ujjal Dosanjh would even consider creating an agency independent of Health Canada to ensure the safety of drugs after they are marketed. This idea arouses opposing reactions among the various stakeholders in the field who, nevertheless, agree in saying that a reform of the methods of Health Canada would be necessary and welcome.
Health Canada’s current approval procedures for new drugs have not been revised for 30 years.
Natural health products (NHPs) are not affected by this review. Asked about the subject, the minister’s spokesperson said that the approval of NHPs should take its course according to the procedures adopted when a regulation came into force in January 2004.
Marie france Coutu – PasseportSanté.net
According to The Globe and Mail.
1. The anti-inflammatory Vioxx could be marketed again in the United States, where the Food and Drug Administration (FDA) has just ruled that the benefits of Vioxx – and other anti-inflammatory drugs of the same type (Celebrex, Mobicox and Bextra) – justify the continuation of their sale. From now on, a warning as to the risk of cardiovascular disorders that consumers may incur will have to be placed on the product label.
