Health Canada

This project will build new review pathways for those drugs shown to meet health care system needs. The outcome for the people of Canada will be faster access to drugs, including drugs for rare diseases.

This project will result in Health Canada and Health Technology Assessment (HTA) organizations working together. This will allow them to give scientific advice to manufacturers at the same time early in the drug development process.

The Health Canada and Health Technology Assessment (HTA) review processes are independent of each other. Aligned reviews project will make sure that the timing of Health Canada and Canadian HTA reviews are better aligned.

These amendments would introduce a regulatory framework for Drug Shortages within the Food and Drug Regulations.

Below are some of the unique features of Canada's Access to Medicines Regime, many of which resulted from negotiations between the Government of Canada, the private sector and various non-governmental organizations.

It presents WTO-Member Countries and Non-WTO Member Countries Eligible to Import Under the Regime.

It presents the list Least-Developed Countries Eligible to Import Under the Regime.

To participate in the Regime, an eligible importing country must declare that it has insufficient or no pharmaceutical manufacturing capacity in relation to the specific product it is requesting. It is up to each country to determine for itself the level of its manufacturing capacity.

Canada's Access to Medicines Regime includes a number of measures to prevent diversion of drugs and medical devices to unintended markets.

The Government of Canada regards non-governmental organizations (NGOs) as valuable resources and actively consulted with them when designing Canada's Access to Medicines Regime.

Instructions for complying with the Requirements of Canada's Access to Medicines Regime specify how to notify the World Trade Organization or the Government of Canada, and how to request the addition of a particular drug or medical device to the list of eligible products.

The patent holder may seek an order from the Federal Court of Canada to terminate a compulsory licence, if the patent holder can establish that any information in the application by the licence holder is inaccurate or that the licence holder has failed

The legislation establishing Canada's Access to Medicines Regime contains a "Good Faith Clause" that provides patent holders with the right to challenge a compulsory licence in the Federal Court of Canada. A challenge can be mounted if the patent holder believes the licence is being used for...

Within 30 days of the end of the two-year period of the original compulsory licence, a pharmaceutical company may apply to have it renewed. A renewal will only be granted if the full shipment of the original authorization has not yet been shipped. Only one renewal is allowed for each original...

Within 15 days of the day on which the compulsory licence was granted or the supply agreement was signed, whichever is later, the pharmaceutical company must complete and submit to the patent holder and the Commissioner of Patents a "Solemn or Statutory Declaration Under Paragraph 21.16(1)(b) of...

The pharmaceutical company must complete and submit to the Commissioner of Patents a Solemn or Statutory Declaration Under Paragraph 21.04(3)(c) of the Patent Act. The form sets out the information that must appear in the declaration.

The pharmaceutical company must complete and submit to the Commissioner of Patents one of the forms listed below. The company should choose the form that corresponds to the schedule on which the importing country appears, as well as the patent status of the pharmaceutical product in that country.

The company must submit the application package to the Commissioner of Patents at the Canadian Intellectual Property Office (CIPO).

A pharmaceutical company that holds a compulsory licence under Canada's Access to Medicines Regime is required to pay royalties to the patent holder. The company must make payments within a prescribed amount of time and in accordance with a prescribed formula.

This process map provides a visual overview of the steps that need to be followed by a pharmaceutical company to meet the terms and conditions of a compulsory licence under Canada's Access to Medicines Regime.