Thank you.
Good afternoon.
On behalf of the Canadian Generic Pharmaceutical Association, I would like to thank the Chair and the honourable members for this opportunity to participate in your study of addressing prescription drug abuse.
I am the president of the CGPA, and I am joined today by Dr. Colin D'Cunha, director of global medical affairs with Apotex Inc. Dr. D'Cunha is also a former chief medical officer for the Province of Ontario and an adjunct professor at the University of Toronto medical school.
I will begin with a little bit about our industy.
The generic pharmaceutical industry operates the largest life sciences companies in Ontario, Quebec, and Manitoba. We are Canada's primary pharmaceutical manufacturers and exporters, and are among the top research and development spenders across all industrial sectors.
Generic pharmaceutical companies directly employ more than 12,000 Canadians in highly skilled research, development, manufacturing, and other scientific positions. Our industry's most important role is in controlling health care costs in Canada. Generic drugs are dispensed to fill 65% of all prescriptions; approximately two out of three prescriptions in Canada are now filled with generics. However, we account for less than one quarter of the $22 billion spent in Canada on prescription medicines—two thirds of prescriptions by volume, less than a quarter by cost.
Prescription medications are generally safe, but only when they are taken as prescribed and for the intended purpose. When they are abused, they can cause an array of adverse health effects. Prescription and over-the-counter drugs may be abused by taking a drug for a purpose other than prescribed, taking a drug in a higher quantity or in a manner other than prescribed, and taking a medication prescribed for somebody else.
This committee has heard disturbing statistics from earlier witnesses with respect to the prevalence of prescription drug abuse in Canada. This is a cause for concern for all pharmaceutical stakeholders, and for all Canadians. We commend the Government of Canada and the committee for its efforts to review the appropriate roles throughout the supply chain of all stakeholders in addressing prescription drug abuse.
We hope our testimony today will help you in this regard.
On the role of the pharmaceutical industry, this afternoon I want to highlight three ways in which the generic pharmaceutical industry is supporting efforts to address prescription drug abuse. First, it provides essential information about the safety profile, proper prescribing, and use of prescription medicines; second, it operates a safe and secure supply chain for our medicines that prevents opportunities for diversion; and third, it supports the safe disposal of unused or expired prescription medications.
The first item is information. To give you a little background, the brand-name companies that develop new medicines generally promote their products to doctors during the period of patent exclusivity. Generics typically enter the market 12 to 15 years after the original-brand product has been introduced. By that time, after 12 to 15 years of use, the characteristics of the medication, including its therapeutic benefits as well as side effects, are well known and understood by doctors and pharmacists, who have been prescribing and dispensing the product to their patients for many years. As a result, generic companies do not promote or detail their medicines to doctors. There are, however, several ways in which generic pharmaceutical companies support enhanced knowledge about the products we sell.
First of all, the drug labels and packaging of our products give health care professionals the information they need to prescribe and dispense drugs appropriately. Health Canada is currently undertaking an important initiative to make drug labels and packaging information easier for the general public to read and understand—and we're participating in that exercise.
Second, we have our product monographs. A product monograph is a factual, scientific document on the drug product that describes the properties, claims, indications, and conditions of use for the drug, and contains any other information that may be required for the optimal, safe, and effective use of the drug. It includes appropriate information respecting the name of the drug, its therapeutic or pharmacological classification, its actions or clinical pharmacology, and its indications and clinical uses. A product monograph also includes many other important pieces of safety information, including contraindications, warnings, precautions, and adverse reactions. In accordance with Health Canada requirements, the generic company must follow the information in the product monograph of the equivalent brand-name product. We are not able to have different information in our product monographs.
The third area where the generics engage in active efforts for patient information is risk management plans. Companies develop risk management plans, or RMPs, for particular medicines in consultation with Health Canada. These plans include information about a medicine's safety profile, how its risks will be prevented or minimized in patients, plans for studies, and other activities to gain more knowledge about the safety and efficacy of the medicine, risk factors for developing side effects, and measuring the effectiveness of these risk minimization efforts.
Monitoring the use and effect of medicines is an essential focus for any pharmaceutical company. All pharmaceutical companies in Canada are required to monitor the use and effect of a given medication and to detect, assess, understand, and prevent any adverse reactions or any other medicine-related problems that arise. These activities and the science behind it are known as pharmacovigilance in the pharmaceutical industry. Our member companies prepare safety reports to meet regulatory obligations. We'd be happy to discuss this whole area of adverse drug reaction more with the committee. We also conduct ongoing monitoring and literature reviews on a global basis to identify any adverse drug reaction case reports.
The second area identified where generic companies operate to help prevent prescription drug abuse is in the supply chain. Having a safe and secure supply chain is a high priority for generic pharmaceutical companies. Generic pharmaceutical companies supply Health Canada with approved medicines to meet the demands of the Canadian market. The standards are the same for both imported and domestically manufactured products, and for both brand and generic products. Almost all generic medicines in Canada today are distributed through sale to wholesale distributors, who are licensed by Health Canada. These wholesalers must meet stringent standards for the safe and secure distribution of the medicines across Canada. It is the wholesalers who distribute the medicines to pharmacies in Canada.
There are four primary aspects of the pharmaceutical supply chain. They are the regulatory review approval process, the manufacturing process, procurement and delivery, and front-line delivery. I will not go through those, but Dr. D'Cunha and I would be pleased to answer any questions you may have with respect to the pharmaceutical supply chain this afternoon.
The final area I'm going to cover is the safe disposal of prescription medications. Unused portions of medications provide opportunities for abuse. Those that are left at home or are tossed in the garbage can make their way into the wrong hands and be abused. Improper storage at home may also provide opportunities for abuse. For this reason, as well as environmental concerns, the generic pharmaceutical industry educates consumers about the proper disposal of medication.
All CGPA member companies participate in the Health Products Stewardship Association. The HPSA program objective is to divert expired and/or unused health products from landfills and sewers, as well as to ensure safe and effective collection and disposal. There is no charge for the public to return medications. All costs for the collection and proper disposal of pharmaceutical products are paid by HPSA members from the pharmaceuticals and health products industries. In addition, the Government of Canada initiated the first National Pharmaceutical Take-Back Day in May 2013, where the public was encouraged to take unused medications to police and RCMP stations for safe and proper disposal. We commend the government for this initiative and we're pleased to participate in a stakeholder round table.
I will stop there, and I thank you again for the opportunity for the generic pharmaceutical industry to participate in your study. Dr. D'Cunha and I would be pleased to answer any questions