Merci beaucoup. Thank you, Madam Chair.
Thank you, committee members, for the opportunity to appear before you today.
As you mentioned, seated with me is Mark Ferdinand, our senior director of health and economic policy. He has been a key worker in terms of the working group that Jim Keon just mentioned. If there are other questions, he will certainly add to them.
Rx&D, as you know, is a national association that represents 50 companies that represent the innovative pharmaceutical industry.
Our members research, discover, develop and deliver life-saving and life-changing medicines and vaccines.
To start, let me state that patient access to the widest array of effective medicines and vaccines is of paramount importance to Rx&D and its members. Simply put, we are in the business of improving health outcomes. This is best achieved by maximizing the choice of therapies to which patients and physicians have immediate and consistent access.
I want to assure this committee that our members appreciate the anxiety and frustration that drug shortages cause Canadian patients, their families, and health care professionals.
Indeed, the drug shortages issue demands attention and collaboration from everyone—we as innovators, generics, governments, health care professionals, and all others who play a role in providing medicines to Canadians.
I believe that Canadians want and deserve answers to three very simple, specific and straightforward questions.
First, why do drug shortages sometimes occur? Second, what is our industry, along with others, doing to address this issue? Third, and most importantly, what can we do, using public policy tools and expertise of industry, to ensure that drug shortages do not occur in the future?
Turning to the first question of why and how shortages occur, let me provide some context. Each and every day, Rx&D members adhere to the highest standards of management and manufacturing practices. They are constantly refining their business continuity plans to supply, in a reliable fashion, Canadians with the medicines they need. These practices include: actively managing supply chains to ensure regional balance and access; securing backup suppliers for base components and raw materials and active ingredients; and monitoring stock throughout the wholesaler community. Nonetheless, it has long been recognized that shortages can occur, and no country is immune from this reality.
Reasons for the drug shortages, as Mr. Keon has just mentioned, can include a number of factors: unprecedented and unusual demand for product is one factor; unforeseen manufacturing, safety, and quality problems; procurement policies; interruptions in distribution networks or factors beyond anybody's control, such as accidents or natural disasters. These are all magnified due to the practice of single-source purchasing in the post-patent market.
Turning to question number two, Rx&D has worked with the pharmaceutical supply chain community, including wholesalers, distributors, physicians, pharmacists, chain drugstores, and Health Canada officials on this issue since last summer. In fact, last October Rx&D members created a public and bilingual web-based platform to inform Canadians of shortages. Our site includes key information, such as the name of the drug in shortage; strength and dosage form; its drug information number, DIN; name of the member company; the reason for the shortage; and expected duration and resupply date.
Three weeks ago, we expanded our site's capability and opened it so that any manufacturer in Canada—innovators, generics, Rx&D members or the Canadian Generic Pharmaceutical Association—could use our platform to report on shortages.
We strongly encourage them to do so, and many companies have accepted this offer. As suggested by the last speaker, this information can be found at www.drugshortages.ca
or www.penuriesdemedicaments.ca.
Two weeks ago, both Rx&D and the generic association came together to commit up to $100,000 each toward a comprehensive national and bilingual platform and plan that will do two important things: permit real-time reporting of drug shortages, and recommend potential solutions when medications are not available.
I am proud of our leadership on this joint initiative. However, while better reporting on shortages helps health care professionals deal with the immediate challenge, it does not address the root causes of drug shortages and will not mitigate by itself the risk of future drug shortages.
That brings me to the fundamental question posed at the outset of my remarks: what can we do, in terms of public policy, to better assure Canadians the medicines they need will be there for them, day in and day out? I will be unequivocal in the answer. The present Canadian policy environment does not favour better access to prescription medicines. If this environment does not change, based on what we have learned from the current situation, the potential for problems caused by future drug shortages will not diminish.
Federal, provincial, and territorial policy makers must clearly understand that procurement approaches, such as sole-source contracts or bulk purchasing of medicines in the generic, post-patented sphere, which limits competition and patient access to medicines, have real and lasting consequences, like the scarcity of supply to all Canadians.
Mike de Jong, the Minister of Health for British Columbia, recognized this fact last week when he said:
If you become overly reliant on a single source for any product, there are risks. I have to say, one of the things we are discussing, amongst provincial health ministers, in our zest to drive the cost down on behalf of taxpayers...have we inadvertently created a condition where competition has been compromised?
That is a powerful statement.
Moreover, the unintended consequences of short-term, cost-containment strategies that compromise health outcomes have been witnessed over the past few years in areas such as surgical supplies and vaccines, and now we see it in medicines too.
To protect against future shortages we recommend that a system of competitive diversity for post-patented medicines must exist to ensure there are enough companies in the market that can increase production immediately if needed. We need to guard against procurement models that run afoul of the old adage, “Don't put all your eggs in one basket.” It's a simple concept, but one that I think we have to look back on.
Our members sincerely appreciate the very serious fiscal challenges facing all levels of government across this country. We are working with governments on what we call value-demonstrating initiatives—those projects that take health care challenges and, through an evidence-based approach, identify ways to improve patient outcomes and cost-effectiveness.
Yes, government has a responsibility to manage taxpayer dollars, but we have now seen only too clearly what can happen when Canadians rely on one supplier for the medicines they need. It is not in the best interests of patients, does not account for the essential role pharmaceuticals play in our health care today, and runs contrary to the values and intent of our health care system.
Our preference is for increased choice domestically, but we have also repeated at both the provincial and national levels that more work must be done to expedite Canadian approvals for medications from jurisdictions such as Europe and the United States. We've also encouraged better fast-tracking of alternate sources of supply when shortages occur. I know that is being worked on as we speak.
On behalf of Rx&D, you have my commitment that we will continue to work in partnership with governments and our supply chain partners to report on drug shortages on an ongoing basis.
We believe that our joint efforts on a joint reporting site with all the interveners of the chain is an important first step; however, we need all policy-makers to work with us towards a long-term solution to ensure that we have a system that can respond quickly when drug shortages do occur.
Thank you very much, Madam Chair and committee members, for your attention. I look forward to your questions and a discussion following the other presentations.