Health Canada to publish reasons for drug approvals

Health Canada will launch a new database this summer to provide health care professionals and the public with information about all drugs approved in Canada since 1994.

The searchable, bilingual database will list Notices of Compliance (NOC) as well as summaries of the basis for Health Canada's approval of the drugs. “It will be the most comprehensive source of Canadian NOC data ever available,” Federal Health Minister Ujjal Dosanjh said.

The database, to be posted on Health Canada's Web site, will include the name of each drug, its therapeutic class, its active or medicinal ingredient, when it was approved, its form and how it is administered.

“As long as we protect the proprietary information that companies provide Health Canada, people have a right to know the basis on which we evaluate drug submissions,” Dosanjh told the Canadian Therapeutics Congress in Vancouver in April.

With or without an early election, the database will proceed and be launched when it is ready, says Health Canada spokesperson Jirina Vlk.

The database is one in a series of measures Dosanjh announced to try to improve what he called “a system of therapeutic safety that is already one of the best in the world.” An ombudsman's office will open this summer to “assist in resolving disputes” about the way Health Canada fulfils its responsibilities under the Food and Drugs Act.

The new Office of Paediatric Initiatives will coordinate dialogue among experts interested in nutrition, as well as the safety of food, drugs, medical devices and vaccines for children. Career public servant Linda Barber became executive director Mar. 4 and will hire a senior medical advisor. “For the first time ... we're going to have a central co-ordinating point for pediatric needs and information,” says Barber.

Though the office will be small and will not have a budget for original research, Barber hopes to create incentives for pharmaceutical companies to share existing data or conduct trials on drugs prescribed to children.

Dosanjh has also promised a permanent Drug Safety Board that would permit Canadians and health care practitioners to provide input into drugs both before and after they are approved.