Mr. Speaker, I am pleased to speak to this important issue. Primarily, though, I know a lot of this is under provincial jurisdiction, but this is an emergency debate that has to be addressed.
It is important to understand the issue of drug shortages and the roles and responsibilities of all the groups involved in the aspect of drug shortages. This involves many people, industry health professionals, provincial and federal governments and third-party people.
Drugs are manufactured and supplied by industry. It is generally accepted throughout the world that industry is most appropriately placed to understanding the supply needs for its product, for managing its inventory to meet these needs and understanding the potential impacts of supply interruptions on its customers. It is up to customers, which include governments, to get the right deal with the right guarantees to meet their needs.
Health Canada has no authority to require manufacturers to bring products to the Canadian market or to require them to maintain adequate supplies to meet the needs of patients. These are very important decisions in the supply chain, but they rest with manufacturers. As a regulator, Health Canada's primary role is to ensure that drugs sold on the Canadian market meet high standards with respect to safety, efficacy and quality. This includes: reviewing product submissions for market authorization; inspecting and licensing facilities that manufacture, distribute, import, test, label or package health products; enforcing good manufacturing standards; and conducting post-market safety surveillance. Most of these activities are very technical and involve a wide variety of scientific and medical experts. I will explain each activity in simple ad clear terms without all the confusing technical jargon.
Before a drug is authorized for sale in Canada, it must undergo a pre-market assessment of safety, efficacy and quality by Health Canada. When a manufacturer decides it would like to market a drug in Canada, it files a submission with detailed information about a drug's safety, efficacy and quality. Health Canada does not solicit submissions for market authorizations. Aside from the basic administrative details, a drug submission has three important elements.
The first is the data and information about the safety and efficacy of the product. This includes detailed results of studies conducted on animals and humans to identify the potentially beneficial and harmful effects of the drugs. I am told that these studies are usually conducted over several years and can involve hundreds or even thousands of patients.
The second element of a submission is the quality information. This includes details of the product development, method of manufacturing and the controls and tests to be used to measure the drug's quality.
Finally, the third element is the product information. This is the information that will be given to patients and health professionals to explain when and how a drug should be used, as well as outline possible side effects that patients might experience.
I am told that a drug submission typically consists of between 100 and 800 binders of data that have to be carefully evaluated by the department's scientific experts. Evaluation of the submission is typically done in three stages, and that is screening, scientific review and then finally the label review. During this process, Health Canada may request additional information from the applicant to clarify information in its submission. For many instances, Health Canada will seek the advice of domestic and international experts, including trusted regulatory agencies in other parts of the world, such as the United States or Europe.
All drugs have side effects and risks associated with their use. The goal of this review is to determine that the product's benefits outweigh the risks. Only when they do, it has market authorization, including a drug identification number or notice of compliance issued to permit the sale of the drug in the Canadian market. Most submissions are reviewed in the order they are received. However, in exceptional circumstances, Health Canada has the discretion to expedite the review of a drug submission. This is a submission management tool that can be used to help maintain access to critical drugs in Canada.
I would also like to talk about the review process for generic drugs, since this is where most shortages seem to occur.
I have just outlined the main elements of a submission for market authorization. These elements are the same for generic and brand drugs. All products must have filed sufficient evidence of their safety, efficacy and quality before they can be sold in Canada. However, the type and amount of data required to demonstrate this are quite different for brand and generic drugs.
For generic drugs, a manufacturer must demonstrate that the drug product is comparable to a Canadian brand name counterpart. This means that the generic product must contain the same active medicinal ingredient, strength, dosage form and route of administration as a brand name product. This ensures that the generic drug will have the same clinical effects as a brand name drug.
In addition to the pre-market assessment done by Health Canada for each drug, all facilities that manufacture, package, label, distribute, import or test a drug must hold a valid Canadian establishment licence. The purpose of establishment licensing is to make sure that what was approved when the market authorization was granted is made consistently and to safety standards. For example, each and every pill must have the same consistency and contain no contaminants. This is achieved by making sure that everyone involved in the supply chain, including manufacturers, is following an internationally recognized standard for manufacturing practices known as good manufacturing practices, or more commonly as GMP.
The key elements of good manufacturing practices include, among many other things, qualified personnel, validated equipment to prove procedures, suitable storage and transportation, and proper record keeping. Drug establishments in Canada are inspected by Health Canada and an establishment licence is only issued if Health Canada is satisfied that the site meets the good manufacturing requirements.
For foreign sites, Health Canada uses its mutual recognition agreements or other similar instruments to assess and access the quality of products that are imported for sale in Canada. It is important to note that the companies doing business in Canada that supply foreign markets must meet that foreign jurisdiction's requirements.
Health Canada does not have responsibility there and has no authority to manage how industry addresses these requirements. Once an establishment is licensed, however, it is inspected by Health Canada on a cyclical basis. The inspection cycle is variable, depending on the activities conducted at each manufacturing facility and their track record. These inspection cycles are in keeping with those of our international regulatory partners.
During the course of an inspection an inspector may face situations where the facility does not comply with Canadian standards. All compliance and enforcement actions to be taken are assessed on a case-by-case basis according to the principles outlined in Health Canada compliance and enforcement policies. The primary objective of any compliance and enforcement strategy is to manage the risk to Canadians and to use the most appropriate level of intervention to ensure that the responsible party comes back into compliance.
Several factors are used by Health Canada to determine appropriate enforcement action, including risk to health and safety, compliance history of the regulated party and the degree of co-operation involved. In very exceptional circumstances and without compromising health and safety, Health Canada may also consider the potential impacts of enforcement action on product availability. In general, when a non-compliance issue is identified, it is brought to the attention of the company or individual involved, who is then responsible for proposing an action plan to resolve the non-compliance issue.
Health Canada assesses the acceptability of the action plan in order to grant compliance with Canadian requirements. It is the company's responsibility to take action in a timely manner to resolve all issues identified during the course of an inspection and ultimately to meet Canadian legislative and regulatory requirements. If a company is unable or unwilling to comply with Canadian requirements, enforcement actions are considered.
There are several measures that Health Canada can use when a regulated party does not comply with the regulations. Health Canada may cancel, refuse, suspend or amend an establishment licence, or issue a warning or publish a public communication to all Canadians.
In addition to post-market activities related to the establishment licences, manufacturers must monitor the safety of their product on an ongoing basis. Health Canada plays an instrumental role in monitoring the safety and effectiveness of health products once they are on the market.
To facilitate adverse drug reporting, Health Canada has developed a website, set up a toll-free number, as well as reporting centres across Canada. Health Canada also receives and considers safety information from around the world. This is important because some safety issues are very rare and can only be detected in larger populations.