Madam Chair, I am pleased to have this opportunity to update the committee on the progress that Health Canada has made in support of the ongoing national effort to manage the shortage of medically necessary drugs supplied by Sandoz Canada. I would like to begin with a brief explanation of Health Canada's role in the country's drug approval and supply system.
Health Canada's primary role is to ensure that drugs bought or sold in Canada, whether in shortage or not, are safe, effective, and of high quality.
Once Health Canada has authorized a drug, producers and purchasers are free to enter into commercial contracts for supply. Drug companies manufacture and supply needed medications; provinces and territories make the arrangements with suppliers to purchase them. Drug makers are the first to know when the production may be interrupted; provincial and territorial health authorities are the first to know the impact of a shortage on patients, and can plan accordingly if given enough time.
The term of supply contracts, the cost, the amount of production, the rate of usage, the number of suppliers required, distribution, and penalties for non-delivery are all worked out between the purchasers and the suppliers. Health Canada has no role or involvement in this regard.
When a shortage arises, Health Canada, consistent with its mandate and authority, works closely with purchasers and suppliers to ensure that any new supplies of needed drugs are safe, effective, and of high quality. Madam Chair, I'm pleased to report to the committee that we have made significant progress in this regard.
Health Canada is currently reviewing 35 drug submissions on an expedited basis. Of those 35, Health Canada has already approved 11. As of this morning, we have also approved 59 requests for emergency access to needed drugs through our special access program.
In order to ensure that the support we provide is of greatest use, Health Canada prioritizes drugs for review based on the needs identified by the provinces and territories. I want to assure the members of the committee that at no stage of our expedited review process has safety ever been compromised, nor will it be.
I must also caution members that an authorization does not mean immediate arrival of additional drugs in hospital pharmacies. Manufacturing capacity has to be ramped up, and safety and quality have to be confirmed at every step of the manufacturing process.
Hereto, Health Canada has provided prompt support. We have approved 10 sites additional to Sandoz's list of approved sites. These sites perform manufacturing and product testing for the Canadian market. Purchases and suppliers, including Sandoz Canada, are expediting the manufacturing and supply process.
Finally, purchasers must decide whether or not to buy, once a new supply has been authorized.
We have to be clear that it is unlikely that these new drugs will be in the Canadian supply system for some weeks yet. In the meantime, the focus of health professionals and of Sandoz will be on minimizing the impact of the shortage on patients. In this regard, it is important to note that the Public Health Agency of Canada has made available to the provinces and territories needed drugs from the limited stocks available in the national emergency stockpile system. To date, no requests have been received.
Madam Chair, in addition to expediting drug approvals, Health Canada is focused on encouraging better information-sharing between suppliers and purchasers. Through the various networks supported by the health portfolio, we are bringing purchasers and Sandoz together on a weekly basis to exchange the latest supply information and to foster national coordination in the shortage response.
As the committee will know, the Minister of Health has long made it a top priority to encourage companies to fill information gaps around actual and potential drug shortages. Doctors and pharmacists need enough advance notice of a shortage for treatment plans for patients to be smoothly adjusted if needed.
Health Canada's collaborative work with industry has begun to pay off. It has resulted in a commitment from Canada's research-based pharmaceutical companies and the Canadian Generic Pharmaceutical Association, of which Sandoz is a member, to communicate potential and actual drug shortage information to Canadians via two existing public websites.
Industry, together with the health professional associations, has also committed to the development of a national one-stop drug shortage monitoring and reporting system in 2012.
The impact of the Sandoz shortage has made it clear that getting this one-stop information site up and running is more important than ever. The minister was pleased to note that Rx&D and CGPA have recently come forward with a commitment to support funding for one national site.
The committee also heard a few minutes ago the desire of the Canadian Agency for Drugs and Technologies in Health to play a helpful role in drug shortages going forward.
Madam Chair, Health Canada supports making public reporting of potential or actual drug shortages a requirement. The minister was pleased to note that in the response to her letter seeking increased transparency around shortages, industry associations have clearly committed their members to public reporting of anticipated and actual shortages. In addition, reporting obligations can be made formally binding if purchasers of drugs on behalf of provincial and territorial clients embed this reporting obligation in their supply contracts, as well as a requirement that suppliers have contingency plans in place in the event that they are unable to fill orders.
Indeed, one of the main bulk purchasers, HealthPRO, told the committee this week that starting this fall it will be awarding multi-supplier contracts for hospital-specific items, and that when there is only one supplier, they will be actively pursuing other suppliers.
I would just like to reaffirm for the committee that Health Canada will continue to play its part on this important issue by approving alternate sources of supply during the Sandoz shortage, and we are working with our partners to find longer-term solutions that help cushion patients against possible future shortages.
That concludes my remarks, Madam chair.
I would like to thank the committee for inviting me to appear today to discuss a topic of paramount importance. I would now be happy to answer your questions.