Thank you, Mr. Lobb.
Welcome everyone. Thank you for the opportunity for Canada's generic pharmaceutical industry to contribute to your study of Bill C-17, Vanessa's law. Thank you for accommodating our need to appear via video conference this morning.
I am Jim Keon, the president of the Canadian Generic Pharmaceutical Association. I'm joined today by Jody Cox, our vice-president for federal and international relations.
I'll say just a couple of words about the CGPA, the Canadian Generic Pharmaceutical Association. We represent companies that specialize in the research, development, and production of high-quality generic medicines, fine chemicals, and new chemical entities. We are Canada's primary pharmaceutical manufacturers and exporters and are among the top research-and-development spenders across all industrial sectors. The generic pharmaceutical industry employs more than 12,000 Canadians in highly skilled scientific and manufacturing positions and operates large life sciences companies in Ontario, Quebec, and all of Canada.
The generic pharmaceutical companies have an essential role in Canada's health care system. Generic pharmaceutical products provide safe and proven alternatives to more expensive brand-name prescription drugs. In 2013 alone, the use of generic prescription medicines saved governments, employers, and consumers approximately $13 billion. Today, four or five prescriptions for generic medicine can be filled for the cost of one brand-name prescription. We are proud of the fact that two out of every three prescriptions in Canada are now filled with generic medicines.
Generic drugs are approved for sale by Health Canada and are identical or bioequivalent to the brand-name version. Each product must also meet the rigorous and internationally accepted standards established by the Food and Drugs Act and its regulations. Generic medicines are required to have the same quality, purity, efficacy, and safety profile as branded drugs.
By the time a generic version is licensed for sale in Canada, the drug has generally been on the market for between 12 and 15 years in Canada and other jurisdictions, and the safety profile of the drug is generally well established. Even so, Canada's generic drug companies take our responsibilities with respect to patient safety very seriously. For us, patient safety is paramount.
I'd like to make a few comments on the bill.
On behalf of the association and our member companies we would like to congratulate member of Parliament Terence Young for championing Bill C-17 and the minister for bringing it forward.
In general, the CGPA supports Bill C-17. We note that it is enabling legislation and that many of the finer details will be provided for in regulation, which we will of course follow very carefully. I will briefly address a few certain aspects of the bill.
First, I will address the new powers for the minister. Bill C-17 provides several new powers to the Minister of Health. They give the minister expanded powers to obtain safety information, modify labelling, recall drugs or take other corrective actions, and obtain a court injunction on 48 hours' notice or no notice at all in the event of a perceived health risk.
During their testimony to the committee, the minister and Health Canada officials pointed to a specific instance where it was felt that undue delays were created in negotiations with a manufacturer. In most instances, however, manufacturers voluntarily comply with the requests from our Canadian drug regulator, Health Canada. The CGPA is of the view that a thoughtful, risk-based dialogue between the manufacturer and the regulator generally brings out the best outcome for patient safety. As such, it is our view that a voluntary approach is appropriate and should be maintained. That said, we do support the minister having the ultimate power as a last resort.
Next is adverse drug reactions, ADRs. There is no question that information is a key component of assessing the risks associated with a medicine. While drug companies have had a mandatory reporting requirement for many years, the health care professionals who are the primary point of contact for patients have had no such obligation. As such, the CGPA supports a mandatory requirement for prescribed health care institutions to report adverse drug reactions. This new requirement will help to narrow an important information gap and will improve both the quality and quantity of ADR information available.
We have a comment about post-market surveillance. As previous witnesses have testified, Health Canada has been moving towards a life-cycle approach to drug regulation for several years.
While the current regulatory scheme focuses on drug review prior to and leading to market authorization, the amendments allow the minister to order a manufacturer to “compile information, conduct tests or studies or monitor experience in respect of the therapeutic product”.
While CGPA welcomes this approach, we look forward to consulting with Health Canada on the specific details of the regulation and guidance that will be associated with these changes. In particular we recommend that the regulations and guidance specifically clarify any shared duties or actions between generic and brand manufacturers of the same drug. I'm going to stop here, Mr. Chair.
In conclusion I would like to reiterate our support for the bill, and Jody and I will be pleased to answer any questions you may have this morning.
Thank you.