Canada: Pharmacapsules - December 2004

Last Updated: January 10 2005

Edited by Adrienne Blanchard and Jennifer Wilkie


  • Federal Government Proposes Changes To Pharmaceutical Regulations
  • Health Canada Report On Clinical Trials
  • Federal Government Response To Internet Pharmacy Developments
  • Who's Tobacco Treaty Law In Force In February 2005
  • UNICEF's "Children Under Threat" Report Released

Federal Government Proposes Changes To Pharmaceutical Regulations

In the December 11, 2004 publication of the Canada Gazette, the Government of Canada published proposed amendments to the Patented Medicines (Notice of Compliance) Regulations, a system of patent enforcement, and the Food and Drug Regulations. The proposed amendments would codify Canada's data protection commitments under international trade rules, allowing innovative drug manufacturers to protect their substantial investment in the clinical trials and other data needed for the development of a drug product.

To view to the proposed amendments to the Patented Medicines (Notice of Compliance) Regulations, please see:

To view to the proposed amendments to the Food and Drug Regulations, please see:

Health Canada Report On Clinical Trials

On December 14, Health Canada released its 2003-2004 Summary Report of inspections of clinical trials. Health Minister Ujjal Dosanjh drew attention to the objectives of this year's report. The objectives include ensuring the safety of Canadians that participate in clinical trials and the promotion of public disclosure of all clinical trial results. As a result of these inspections, Health Canada can determine whether the clinical trials are being conducted within the regulatory requirements of the Food and Drugs Act and Regulations.

Health Canada is confident that the purpose of the inspections "allows us to maintain the highest level of scientific and ethical standards for the conduct of clinical trials in Canada, which results in more effective therapies for Canadians." Areas of research and ethics are being considered for the 2004-2005 inspections.

Further information is available at:

Federal Government Response To Internet Pharmacy Developments

The Manitoba Pharmaceutical Association (MPA) has decided that Internet pharmacies can operate legally if they follow stricter standards. It is still not decided what new rules the Internet operators would need to follow. However, Gary Cavanaugh, the president of the MPA, is optimistic that Manitoba can become the first province to amend its regulations such that Internet pharmacies can circumvent the usual requirement that Canadian doctors see a patient before writing a prescription.

Federal Health Minister Ujjal Dosanjh said that provinces should not lower their regulatory standards to help Internet pharmacies. He also warned that his government might amend federal law to restrict the cross-border drug trade. Mr. Dosanjh recently said that Canadian doctors and pharmacists who fill prescriptions to Americans without meeting with them first are unethical and unprofessional. The concern is that Canadian doctors who are paid by Internet pharmacies to co-sign or countersign prescriptions written by U.S. doctors do not have a doctor-patient relationship before approving the prescriptions.

Minister Dosanjh said that federal officials have developed three options for taking action against Internet pharmacies. One option is to amend the Food and Drugs Act to forbid doctors from co-signing prescriptions or pharmacies from accepting them. Another option is to ban Canadian doctors from writing prescriptions for foreigners unless they are visitors or immigrants. A third option would be to add a clause to the Food and Drugs Act allowing federal officials to place certain drugs on a "protected list" in case of shortages.

Further information is available at:

Who's Tobacco Treaty Law In Force In February 2005

The World Health Organization Framework Convention on Tobacco Control (WHO FCTC) will enter into force on February 28, 2005. In less than a year and a half, the WHO FCTC has become the first international legally binding public health treaty under the auspices of WHO. As of February 28, 2005, the 40 Contracting Parties will be legally bound by the provisions of the Treaty, including provisions setting international standards on tobacco price and tax increases, tobacco advertising and sponsorship, labelling, illicit trade and second-hand smoke.

The WHO FCTC intends to control what has now become the single leading preventable cause of death. Tobacco consumption will prematurely end the lives of 10 million people a year by 2020 if current trends are not reversed.

Further information is available at:

UNICEF's "Children Under Threat" Report Released

According to UNICEF's 10th annual report on The State of the World's Children, more than half the world's children are growing up hungry and unhealthy, schools have become war targets, and entire villages are being affected by AIDS, thereby slowing the development of nations. The report stresses that the failure by governments to live up to the standards of the 1989 Convention on the Rights of the Child causes permanent damage to children and in turn blocks progress toward human rights and economic advancement. The report also points out that in 11 of 15 industrialized nations for which comparable data are available, the proportion of children living in low-income households during the last decade has risen.

Further information is available at:

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