Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 8 - Evidence - March 6, 2014
OTTAWA, Thursday, March 6, 2014
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 10:30 a.m. to continue its study on prescription pharmaceuticals in Canada (topic: the nature of unintended consequences in the use of prescription pharmaceuticals.)
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
[Translation]
The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
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I'm Kelvin Ogilvie, a senator from Nova Scotia and chair of the committee. I'm going to invite my colleagues to introduce themselves, starting on my right.
Senator Seidman: Judith Seidman from Montreal, Quebec.
Carolyn Stewart Olsen: Carolyn Stewart Olsen from New Brunswick.
Senator Eaton: Nicole Eaton, Ontario.
Senator Enverga: Tobias Enverga from Ontario.
Senator Nancy Ruth: Nancy Ruth, Ontario.
Senator Munson: Jim Munson, number 12 Ottawa Senator, Ontario.
[Translation]
Senator Chaput: Maria Chaput from Manitoba.
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Senator Eggleton: Art Eggleton, Toronto, deputy chair of the committee.
The Chair: Thank you, colleagues. I want to welcome our guests this morning. To remind us all, we are dealing with the fourth phase of our series on studying prescription pharmaceuticals in Canada. In this part, we're dealing with the nature of unintended consequences. We have pharmaceutical industry representatives with us here today.
We're delighted to have you, and I'm going to identify you as I call you to speak. There was no pre-order, so I will call you in the order you're listed on my agenda. That would mean that, from the Canadian Generic Pharmaceutical Association, I have Jody Cox, Vice-president, Federal and International Affairs, and Dr. Colin D'Cunha, Director of Global Medical Affairs for Apotex Inc. Your presentations, please.
Jody Cox, Vice-president, Federal and International Affairs, Canadian Generic Pharmaceutical Association: Thank you very much, Mr. Chair and honourable senators, for this opportunity to participate in phase 4 of your study of prescription pharmaceuticals.
CGPA represents companies that specialize in the 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 R&D spenders across all industrial sectors. The generic pharmaceutical industry employs more than 12,000 Canadians in highly skilled scientific and manufacturing positions and operates the largest life sciences companies in Ontario, Quebec and, indeed, all of Canada.
The industry plays a vital role in Canada's health care system by providing safe, proven alternatives to more expensive brand name drugs. In 2012 alone, the use of generic prescription medicines saved governments, employers and consumers nearly $11 billion. Today, four or five prescriptions for a generic medicine can be filled for the cost of one brand name prescription. Indeed, two out of every three prescriptions in Canada are filled with generic medicines.
Some testimony from earlier witnesses appeared to question the quality and safety of generic medicines. I wish to set the record straight in this regard.
There is only one standard for drug quality in Canada. All drugs sold must be approved by the federal Therapeutic Products Directorate at Health Canada. Each product must also meet the strict regulations established by the Food and Drugs Act, and both generic and brand name drugs are subjected to rigorous, internationally accepted standards.
Generic medicines are required to have the same quality, purity, efficacy and safety profile as branded drugs.
The standards for bioequivalence in Canada are built upon internationally recognized standards, and the criteria are among the highest in the world. I should also note that bioequivalence is used in the brand name industry. When it comes to the approval of any changes, they would use a bioequivalence approach as well.
In addition, the active ingredient in a drug, whether it is a generic or a brand name product, must meet the same scientific norms and standards set out by the Therapeutic Products Directorate, TPD. The excipients or fillers used in generic and branded medicines come from a limited range of available products and, in many cases, actually come from the same suppliers.
In terms of good manufacturing practices, the evidence of GMP compliance provided to Health Canada for both domestic and foreign sites is the same for both brand name and generic medicines.
Because a generic drug does not come to the market until many years after the brand name version has been prescribed, the profile of the generic drug's safety and effectiveness is better understood by prescribers, regulators and patients than the original brand name drug.
Even so, CGPA member companies take our post-market surveillance efforts and responsibilities very seriously. As discussed in an earlier phase of your study, 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.
There are a number of interesting and important topics identified by senators for phase 4 of your study. I will speak briefly to two of them, given the time constraints this morning: drug shortages and prescription drug misuse. Of course, during the question and answer portion, we'd be happy to address any area that is of interest to the senators.
CGPA members are committed to continuing to work with all stakeholders to better understand and communicate the reasons for drug shortages, to report drug shortages and discontinuances and to minimize the potential for disruptions in supply.
CGPA has been very active in working with its members and other stakeholders to lessen the impacts of drug shortages in Canada. This includes active involvement in the steering committee of the multi-stakeholder working group and as partners with Rx&D in the www.drugshortages.ca national reporting website.
It should be noted that significant efforts have been made over the past year to improve the functionality of that website, based on feedback provided by Health Canada and others involved in the working group.
The multi-stakeholder working group is beginning to analyze the root causes of drug shortages. While many of the root causes are global in nature, policy decisions, market considerations and regulatory issues can also lead to shortages.
A "how low can you go" pricing and tendering policy approach is not a sustainable environment for any industry, but this has been the unprecedented situation facing the generic industry for more than six years. Market disruptions of this extensive nature can also have an impact on supply. A more predictable business environment for the pharmaceutical industry in Canada would positively contribute to the sustainability of the drug supply system.
I know I am quickly running out of time, but I did want to speak briefly to prescription drug misuse. CGPA commends the Government of Canada and the ministers of health and public safety for the priority that has been given to addressing prescription drug misuse.
There are three primary ways in which the generic pharmaceutical industry is supporting efforts to address prescription drug abuse and misuse.
First, we provide essential information about the safety profile, proper prescribing and use of prescription medicines, through labels and product monographs, in close consultation with and approval by Health Canada. CGPA is also supportive of Health Canada's plain-labelling initiative that is making labels easier for everyone, including patients, to understand.
Second, we operate a safe and secure supply chain for our medicines that prevents opportunities for diversion.
Third, we support the safe disposal of unused or expired prescription medications, through our support of the Health Products Stewardship Association, and we have provided input to the organizers of the National Pharmaceutical Take-Back Day, which is an excellent initiative.
At this point, I will end my presentation. Again, I want to thank senators for allowing us the opportunity to contribute to this very interesting study, and Dr. D'Cunha and I would be pleased to answer any questions you may have this morning.
The Chair: Thank you very much. I will now turn to Rx&D, and we have with us this morning Walter Robinson, Vice President, Government Relations, and Jared Rhines, Vice-president, Scientific and Strategic Affairs.
Walter Robinson, Vice-president, Government Relations, Rx&D: Thank you, Mr. Chair and honourable senators, for inviting us back before the committee today. This is our fourth appearance as part of your ongoing study, and we look forward to providing input into the specific issue here of unintended consequences of prescription pharmaceuticals. The issues that you are exploring are both timely and relevant because they speak to important concerns that affect Canadians from all walks of life.
As you know, I am Walter Robinson, seated with my colleague here, Jared Rhines, and we look forward to the discussion today.
Our association is comprised of almost 60 research-based pharmaceutical companies, both multinational and Canadian start-ups, who invest over $1.1 billion into the health research enterprise in Canada each year in concert with our partners at CIHR. Our members discover, develop and deliver innovative medicines and vaccines to Canadians, which represent some of the most advanced safe and effective medical treatments available today.
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These products help Canadians live longer, better and more productive lives.
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They also ease the burden on our health care system by avoiding more costly hospitalizations and invasive surgical procedures. When appropriately prescribed by health care professionals and properly adhered to by patients, these innovative medicines are a key enabler of long-term health system sustainability.
We appreciate that your committee acknowledged these benefits in your previous interim reports.
In addition, it is important to note that Rx&D members adhere to a strict code of ethical practices that governs our interactions with health care professionals and all other stakeholders, including elected officials and parliamentarians in Canada.
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We have followed your four-phase study with great interest and support many of your recommendations.
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For example, we agree with your recommendation in your phase 1 report on the need for strong national leadership to attract a greater proportion of global pharmaceutical R&D investment to Canada. To this end, the completion of the CETA agreement in principle with the European Union by the Government of Canada sent a positive signal to the international life sciences community.
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In addition, Rx&D continues to work with the Canadian Institutes of Health Research and the Association of Canadian Academic Health Care Organizations to implement the National Clinical Trials Action Plan.
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That is the national clinical trials action plan, which you also spoke about in phase 1 of your report.
We also support the recommendations in your phase 2 report to modernize Health Canada's regulatory regime. In fact, Rx&D and its members have been active participants in the government's efforts to establish a modern legislative and regulatory framework. We contributed thoughts and ideas to the recently tabled Bill C-17.
As discussed at length during your phase 2 hearings, there are extensive rules that apply to our members and all pharmaceutical manufacturers for the monitoring and reporting of adverse drug reactions, which Ms. Cox spoke to in her testimony. We continue to support and adhere to these rules as patient safety is our number one priority.
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Rx&D is also supportive of insuring approved, up-to-date, accessible and useful label information for patients, health care professionals and caregivers.
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More broadly, we agree with you that the accelerated uptake of innovation within the health system and wider deployment of electronic health records, or EHRs — a subject the chair and I had a great dialogue on during our last hearing — and their associated infrastructure are long overdue.
Further development standardization and deployment of electronic health records will also provide specific benefits and solutions related to the issues of prescription drug misuse and abuse under discussion in this phase of your study.
Equally important, however, is the adoption of e-prescribing and integrated inventory management that also supports efforts to combat the illicit trade of prescription medicines, some of the testimony you heard last evening.
As you are aware, the pharmaceutical industry, as one of the most regulated industries on the planet, if not the most regulated, fully supports mechanisms that ensure Canadians have timely access to safe, effective and high-quality medicines and vaccines.
As you heard in phase 1 of your hearings and from Ms. Cox today, Health Canada reviews medicines on the basis of scientifically demonstrated safety and efficacy and approves a medication that has a positive benefit-risk profile for a very specific approved use or indication.
It is this approved use, outlined in specific terms in the product monograph, that also includes approved labelling. In turn, the approved use and labelling information clearly determines, defines and limits the representations that can be made about a medicine to health care professionals by industry representatives. This labelling information also provides specific information instructions to support appropriate use and adherence by patients.
Many of the unintended consequences and misuse and abuse issues identified in earlier testimony during this phase of your study are complex. As you have heard from many other witnesses, contributing factors are many, and solutions must be multi-pronged, involving all stakeholders, manufacturers, prescribers, distributors, dispensers, patients and the broader community from social services to law enforcement agencies, depending on the issue in question.
In this context, Rx&D and our member companies work collaboratively with governments and other stakeholders to address these issues. In a recently submitted brief to the House of Commons Standing Committee on Health on the issue of prescription drug abuse, we noted our support for, first, health promotion and prevention strategies that mitigate the need for prescription pain medicines to treat pain, the ongoing refinement of professional guidelines for prescribing pain medications, and our members' participation in groups such as the Health Products Stewardship Association, alongside their own company initiatives, such as take-back programs to recover expired and unused medications.
We also believe that pharmaceutical innovation is a key component of any policy efforts you may recommend to address and reduce prescription drug abuse. For example, the development of controlled or extended release formulations provide more effective and extended pain relief benefits when taken as prescribed and can also improve patient adherence.
In addition, the advent of abuse-deterrent formulations, or ADFs for short, have made it more difficult to chew, crush, inhale or dissolve tablets to release the active ingredient or ingredients, which also helps to mitigate the potential misuse of these products.
Another area where Rx&D works with government and all stakeholders is in our efforts to address the prescription drug shortages, such as our leadership with the CGPA in developing and promoting notifications to all stakeholders through www.drugshortages.ca. This tool is important for practitioners and continues to improve based on Health Canada and other stakeholder feedback.
[Translation]
Moreover, we remain committed to, and active in, the multi-stakeholder steering committee headed by Health Canada that is developing systematic tools and approaches to identify, mitigate and prevent future drug shortages.
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In conclusion, Mr. Chair and honourable senators, Rx&D and its members are committed to providing safe and effective medicines and vaccines to help Canadians live longer, better and more productive lives. Our members are also committed to behaving ethically and responsibly.
This commitment guides our decisions and behaviour when we encounter adverse drug reactions, drug shortages or the issue of evolving safety profiles from the use of our medicines in real-world settings. These are complex issues in which Rx&D and its members are willing partners helping to develop solutions that drive the best health outcomes for Canadians.
[Translation]
Thank you for your invitation and your attention this morning. We look forward to your questions and discussion.
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The Chair: Thank you all of you. I will now open the floor to my colleagues for questions, and we will start with Senator Eggleton.
Senator Eggleton: The part of unintended consequences that we dealt with yesterday was counterfeit and substandard drugs coming into the country. I will pick up on that. I have a multi-part question, so I would appreciate your taking notes of it.
We heard from witnesses yesterday that in the European Union illegal medicines crossing the border increased by some 700 percent from 2010 to 2011. Apparently, we don't have any statistics on how big an issue this is in Canada. I'm sure your industry monitors the situation because you would be concerned about illegal substances, either totally fraudulent counterfeit type drugs or substandard drugs coming into the country. I wonder what you know about that and what you can tell us.
We have also heard that most of what is being supplied is coming from developing countries, particularly India, but also to some extent China, and that there are quality problems that are not properly dealt with in those countries. This is very disturbing.
What are your industries doing to combat this? What do you think government needs to do to help tackle this better?
We also heard that the Pharmaceutical Security Institute maintains a large database on various medicine crimes, but that your industry keeps most of that data secret. We heard that the lack of transparency undermines the efforts of Canadian and international law enforcement to combat these crimes. It hinders efforts to raise public awareness of the issue, stalls political action, and generally compromises patient safety. Why isn't this data being released?
Finally, we have been told that Canada has no idea how big the problem is and that we need to start generating knowledge and data about this issue in order to put us in a better position to take action. A suggestion was made yesterday that we form an inter-agency task force that would include the deputies of the relevant ministries, law-enforcement officials, representatives from both your organizations, or your industry, and researchers from academia. This task force would test and track what comes into the country so we can determine which drugs are affected and where they are coming from. It was even suggested that Canada could become an international leader in this effort. Do you agree with this? Do you think your industries would be willing to participate?
The Chair: There were four principal questions there. We should deal with each question from both teams, if they wish to participate; so we will start with the question of the number of drugs that are coming in, the first one you were talking about. Did they have any idea on that one? Perhaps, Mr. Robinson, I will start with you first.
Mr. Robinson: I was making notes, but could you succinctly rephrase the first portion of your question, Senator Eggleton?
Senator Eggleton: We heard that there were very big increases happening within the European Union, in terms of cross-border illegal medicines, some 700 percent from 2010 to 2011, we were told yesterday. We were also told there were no statistics in Canada.
We were also told that the pharmaceutical industry does, in fact, monitor this situation, and so can you help provide statistical information as to how much is coming into this country in terms of fraudulent or substandard drugs or generally comment on your concern about the issue?
Mr. Robinson: To answer that last question, fundamentally fraudulent or counterfeit medications are a concern in the context of our supply chain, and patient safety being our number one priority for our members.
I can't speak to the trends in Europe, because that's not where I focus our efforts in the context of government relations. What I can tell you in the world of counterfeit medicines and substandard medicines, where we have seen the issues in Canada has been in the world of Internet pharmacies, for the most part, of getting a sense of misrepresentations being made by some vendors that a product is legitimate or fabricated by a brand name or a generic manufacturer, for that matter, but we don't know what the active ingredient is, we don't know where it was manufactured; and usually when we saw areas of large price parity at 60- and 70-cent Canadian dollars vis-à-vis the American dollar. This was a fundamental and real issue in terms of the cross-border trade of pharmaceuticals, but more important, potential cross-border trade of fraudulent pharmaceuticals.
Some of your questions are deliberate, if I can seek the patience of the chair. The issue around quality in the pharmaceutical supply chain, in North America specifically, there is consistent and constant inspection in terms of the status of licences, in terms of production and inventory control and, again, in terms of stuff that comes into the supply chain as well.
The other thing I can point out is that our members mostly supply for the domestic market. Some of our members export vaccines across the world, and a lot of the importation of products that come into Canada on the innovative side would be from Europe; but we are not aware of any problems in the context of any fraudulent medications with respect to the brand name industry.
Ms. Cox: I would echo many of the comments Mr. Robinson has just made with respect to the fraudulent products. Obviously it is a big concern, for both generic and brand name medicines, because you know criminals do pose their products as legitimate products.
The illegal Internet pharmacies is one of the biggest areas of concern. There were comments yesterday about whether we can make sure they can't have a Canadian flag on it. The illegal Internet pharmacies are operated by criminals, and it is very difficult to regulate the activities of criminals. Really, it is a law-enforcement issue.
Certainly our organization, when we become aware of Internet pharmacies, particularly when they're claiming to be a made-in-Canada product, or from a Canadian supplier, from one of our member companies, we do report those to law-enforcement agencies. I just wanted to make that clear to everyone.
In terms of statistics, I wouldn't have access to the kind of information that you are seeking, Senator Eggleton.
In terms of the good manufacturing practices issues of the substandard medication issue, again, any drug that is sold in Canada meets the requirements of Health Canada. So when it comes to the quality of products, there are good manufacturing practice standards that are in place; there's guidance for industry and that sort of thing.
Health Canada is not an island unto itself. It is a regulatory authority. It has a number of different agreements and constant dialogue with other regulatory authorities, via the EMA in Europe, the FDA, the TGA in Australia, and that sort of thing. There is sharing of information between regulatory authorities on a daily basis.
Senator Eggleton: Let me inject one thing in here. We heard yesterday about a company in India called Ranbaxy. It is not exactly a criminal organization; it is still operating, and a lot of its drugs are imported into this country. Some of the drugs that are imported into this country were stopped by the FDA in the United States because they were substandard, but they have not been stopped in this country.
I am trying to determine why you say you don't know anything about statistics, and yet we were told yesterday that you keep the statistics secret.
Ms. Cox: Both Rx&D and CGPA, if you looked at us when we heard that comment, I don't think we quite understand what information that is pertaining to; so either that was misinformation or a miscommunication at the last hearing, because we certainly —
Senator Eggleton: It was from the Pharmaceutical Security Institute.
Mr. Robinson: Mr. Chair, we have never heard of this organization.
Ms. Cox: We can assure you that we are not keeping their information through the institute.
Mr. Robinson: If I can go further, in terms of the institutes or para-public and government bodies that report on prescribing movements of pharmaceuticals, international organizations like IMS Brogan, the world's leading health pharmaceutical data provider that aggregates information from our members, and then the variety of things that are publicly accessible — CIHI, CHIR data, and those sorts of things — those are where we would get most of this information.
Again, I'm not aware of this information. We will try to find out who they are, but this is the first time we have ever heard of them.
The Chair: That takes us to the issue of transparency, which was one of your questions. The issue you wound up was with regard to Canada not having any idea about the issue of counterfeit, which was tied into this last comment. Do you want to refocus things?
Senator Eggleton: I mentioned the inter-agency task force; would your industries agree to that? Would you be willing to participate in it?
The other question is what do you think the government should do to fight counterfeit substandard drugs?
Dr. Colin D'Cunha, Director, Global Medical Affairs, Apotex Inc., Canadian Generic Pharmaceutical Association: I will start first. I think the idea of an inter-agency task force is good, because if you have the key players, whether it is Health Canada as regulator or law enforcement, either through the ministry of public safety or the local police and RCMP, and having academia, because academia always brings a breath of fresh air, and industry sitting there is good. It is true, because they challenge people to think outside the box. It is healthy.
On the specific issue of counterfeiting, consideration may be given to looking at initiatives such as what the FDA is doing. For example, FDA is moving to a standard where each manufacturer is required to identify its particular formulation with stamping of strength and brand. So, for instance, a company would have its brand either in short form or in logo and the strength on the other side. Europe has gone that route. I guess Canada should catch up.
I will point out, in response to your earlier question, that there are formal agreements between the regulatory industry that Ms. Cox spoke to, and they do share information and they work off each other's GMP inspections. For example, if FDA went to a plant in India, the results of that are shared and Health Canada brings it right down to each pharmaceutical company. There is another process in place with every company that's licensed to market drugs in Canada, the holder of a notice of compliance or marketing authorization. They have to have an in-house quality program by calculation, certain batches and stability and test. When they identify issues, and it's out of trend or out of specification, they are required to engage in a discussion with the inspector at Health Canada and take market action, which is why if one goes to the Health Canada website periodically you see recall notifications, and they don't single a particular company out. You will see quite a few up there if you look at last month.
Mr. Robinson: To pick up on the senator's question with respect to inter-agency cooperation, I think it was specific to counterfeiting, or was it larger with respect to misuse and abuse?
Senator Eggleton: It was with respect to counterfeiting.
Mr. Robinson: We would be supportive of participating if the relevant authorities wanted to strike something like that. Again, in the supply chain, it is not just manufacturers. It would be the relative colleges in terms of prescribing and in terms of dispensing. If you are going to have an inter-agency task force, ensure that you have all the players who touch a product or where diversion occurs with a product that moves into counterfeit or the black market. That's extremely important as well, not just manufacturers.
Senator Seidman: I would like to address a subject that came up that was very important looking at unintended consequences, when we listened to witnesses here. It has to do with drug shortages, alternatives and, as a result, the need for the development of new antibiotics. That would bring me to first look at the drugshortages.ca website, which was announced by the federal government in September 2013 and is up and running.
We had witnesses here last week who testified that the website is passive. There is no push notification for health professionals. Generally, the industry does not notify health professionals of shortages. There was a certain amount of discontent with the website. I know that Rx&D and the Canadian Generic Pharmaceutical Association invested in this website when it was first launched.
I would like to know if there is a metric in place to measure the success of the website. How do you ensure compliance in the industry so that the information is indeed posted in a timely fashion, which it is supposed to be, and these serious requirements are met? I will come back as I hear the responses.
Ms. Cox: Thank you very much. I had reviewed the testimony as well with respect to the functionality of the website, and a number of different changes have been made to improve the functionality. Some of that is still being rolled out but has been under development for some time and has taken into account the feedback from Health Canada, pharmacy and other stakeholders within the chain. I don't know if Rx&D would like to add anything regarding the improved functionality at this point.
Jared Rhines, Vice-president, Scientific and Strategic Affairs, Rx&D: I would agree that the database was set up to meet the need, we understood. I think there would be a joint commitment that if it's not meeting a need, we would continue to invest to get it to where it needs to be.
As an industry — and I think we share this with our generic colleagues — patient safety is important. Ensuring patients have access is important. That's the point and the spirit of this database.
Mr. Robinson: I reviewed the testimony of Mr. Johnston, Assistant Deputy Minister McArthur and others who appeared last week when a shortage of one specific medication was fundamentally front page in the newspapers.
For the committee's record, the site was launched by Rx&D specifically in November 2011. We joined with the generics in 2012 and it was formally announced by the federal Minister of Health and her colleague Minister Horne last year after a year of iterations and moving.
With respect to the assertion that the site is passive, is it a push or a pull? I went this morning again to test. You can be advised, as a health professional, a member of Parliament or a member of the public, by clicking that as soon as a record is posted it will be sent to your inbox. I don't know how much more assertive we could be in that respect on the website itself in terms of its functionality. I received four notifications yesterday of various shortages that were either solved or being updated by respective manufacturers.
On the shortage in question, you had the discussion on February 26, and the Rx&D member in question actually posted on February 5 in the context of a shortage — and I pulled off the record — because of a generic shortage in the supply chain. The generics posted shortly thereafter.
In terms of how it's used for professionals — this probably gets to your supplemental, Senator Seidman — in the follow-up and alternatives, this is where we can report on what we know of disruptions in supply chain, manufacturing, GMP, Health Canada, FDA inspections, which find things that are wanting; it gets posted. In terms of alternatives, for example, there are certain things we cannot do as manufacturers in the context of competition law. Other health care professionals, pharmacists and prescribers need to step up and play their role to make the website — the tool — more robust so that Canadians have earlier warning and have access to those alternatives. That needs to be stated and put on the record.
Senator Seidman: Let me try to understand that. Under the description of the website, it says manufacturers will post all drug shortages, anticipated or actual, at the earliest possible date. You're saying that satisfies the requirement from your point of view.
Mr. Robinson: I'm saying that our members post on their shortages. There has been some discussion around here of people saying, "Are you anticipating a shortage, six or nine months out, of an active ingredient?" If a manufacturer is seeing a shortage of an active ingredient six or nine months out, they will work in the context of their supply chain and alternate sources to mitigate that shortage so it never becomes a shortage. That's the complexity of the pharmaceutical supply chain.
Senator Seidman: You so rightly anticipated my follow up to that, which had to do with alternatives.
Mr. Robinson: I've been reading your testimony.
Senator Seidman: That's great. You're saying that it's complicated to inform professionals about alternative drugs because there are, what? I don't want to put words in your mouth, but I got a sense from Mr. Robinson that there is a complication because many companies are involved.
Mr. Rhines: I think it's beyond the number of companies. As pharmaceutical companies, we stay out of the prescribing. This is between health care practitioner and patient, so we think it's a very important conversation. It's critically important that health care providers, pharmacists and patients are aware of drug shortages so together they can make the smart decision on the most appropriate alternative for them, whether it is a medication or some other therapy. But we're not the ones qualified to make decisions on prescribing and best alternatives. It really is best done between health care provider and patient.
Dr. D'Cunha: I will not speak as a member of the Canadian Generic Pharmaceutical Association, but as a physician. The point Mr. Rhines made is very important. Specifically, a physician or pharmacist has to sit with the patient and, knowing the patient's medical history, evaluate the alternatives. It may be that alternative A is not good for that particular patient because of preceding medical conditions. Maybe it's alternative B, which may not be the best but given the set of circumstances for that patient, it might be the best treatment option as opposed to the do-nothing option.
Senator Seidman: That helps me understand the issues. I will move to the next point, which has to do with the development of new antibiotics. We have heard here that it was not unusual that we could have anticipated the resistance problem in antibiotics because of all the antibiotic overuse, shall we say — and I won't go beyond that now — in humans and animals.
We have also heard that there has been an enormous reluctance to develop new antibiotics for all kinds of reasons, such as cost, et cetera. We've heard that there are ways to get around that; maybe industry needs incentives to develop new antibiotics as it's a very costly process. If you could speak to that, I would appreciate it.
Dr. D'Cunha: I will start first with the issue of drug resistance. This is the best public secret in town, because 14 years ago then Ontario Chief Medical Officer of Health, John Connolly, who has addressed this committee, as the chair of my science advisory committee, published a report predicting antibiotic resistance and urging society — we didn't single out any one sector — to carefully consider using antibiotics appropriately. The challenge is when a patient shows up, if the physician or nurse practitioner doesn't give them a prescription and they go away empty-handed, there's that expectation of something.
So this is a prescriber education issue; this is a patient expectation education issue: Use them wisely and appropriately. Use them when you have demonstrated sensitivity to the particular antibiotic you want to use.
Stuff has been going into animal feed for economic reasons, which has also contributed to the problem.
With regard to the issue of developing new antibiotics, the concern is that the newer ones that come on can be pretty toxic, so how do you find the right benefit-risk ratio for that particular set of circumstances? The issue is not so much one of economics, though that will be a driver; there is the issue of the benefit-risk ratio. Then how do you ensure that when you develop something specialized, you restrict its use only for those people who absolutely need that particular antibiotic?
We must have controls in place or else you will run through the entire pharmaceutical spectrum and have nothing at the end.
Mr. Robinson: I want to pick up on two things in earlier testimony and what I talked about today: the context of an electronic health record and the phenomenon that Dr. D'Cunha points out that patients can prescriber-shop if they don't get the prescription they want — they may go to another doctor looking for that prescription, wanting that antibiotic.
The other thing was on Ms. Cox's point with respect to the race to the bottom. We are an industry, and we have a virtuous innovation cycle. We have innovative medicines that are reimbursed at a certain level for their useful patent life. There is a rate of erosion, and then they move into the generic realm where generic manufacturers produce that medication when it becomes, in a sense, a commodity. And those savings should be reinvested to drive the innovation cycle again in terms of new medications and investments. We all agree. That's kind of the premise of how the innovative and generic sectors work.
The challenge is that we've seen the Canadian government wanting to pay Third World prices for First World medicines and access. There is tiered and differential pricing across the world based on countries' abilities to pay. What we're getting in exchange for that is what I spoke to: the $1.1 billion that our members continue to invest in this country, despite a challenging reimbursement and uncertain intellectual property environment, things that help foster and develop the stability that we both seek in our environment for the sector not only to meet the needs of Canadians today but also to do the research to get to those unmet medical needs, such as new antibiotics, cancer medications and the hope that the industry does bring Canadians and clinicians further medical knowledge and extend lives. That environment is extremely important, and we should not lose sight of that.
Senator Eaton: After listening to some of the testimony yesterday, I would like to put some things to bed.
Do you make all your generic drugs in Canada?
Ms. Cox: The pharmaceutical industry is global. In Canada, we have major generic pharmaceutical manufacturing facilities in Quebec and Ontario, so it's still the case that most the generic medicines sold in Canada are produced in Canada.
There are also products imported from around the world and —
Senator Eaton: Can you tell me from where and what percentage of our products would be imported from elsewhere?
Ms. Cox: In terms of the percentages per country, I'm not able to provide —
Senator Eaton: For instance, Apotex. What is the percentage that comes from outside Canada or the United States?
Dr. D'Cunha: I would say the vast majority of Apotex's products are made in the Greater Toronto Area.
Senator Eaton: That would be what — 75 per cent or 80 per cent?
Dr. D'Cunha: I don't have that number handy, but I would say the vast majority.
Ms. Cox: A few points about the generic pharmaceutical industry that might help to provide some background information.
Senator Eaton: I want to get to that, but I'm not getting an answer here.
Ms. Cox: In terms of a generic company, you would have perhaps 300 molecules within your product portfolio in thousands of different dosage forms. As a global company, you would have different sites around the world, and where they are located would depend on what your company is and where your strategic investments have been made around the world.
Some companies would have focus facilities. Sandoz, for example, has a global centre of excellence for injectable products here in Canada, but they get other products from other jurisdictions.
Senator Eaton: I'm interested in the ones where you work outside of Canada, because I don't think our problem is inside Canada. I think it's outside Canada, so I'm interested in where Apotex, for instance, manufactures drugs or has drug facilities outside Canada or the U.S.
Ms. Cox: Any pharmaceutical company, whether it's brand or generic, will have manufacturing facilities all over the world. We do have significant generic manufacturing that's occurring today in Canada; there is also manufacturing in the U.S., in Mexico, across Europe and throughout Asia as well.
Senator Eaton: I'm being very specific because we have heard that the EU, the United States, Canada and Japan have standards of production that are very high. But in some countries in Asia, China and India, they're not as high. We have also heard that they come into Canada and they are not inspected, so this is what I'm driving at.
Where do most to your ingredients come from? I know it's a broad question, but you must have certain buyers or places you can get most of your ingredients.
Ms. Cox: Some of the active pharmaceutical ingredients are manufactured in Canada. However, from a global perspective — and again we're talking brand and generic industries — there are products in Eastern Europe, India and China and other locations as well.
Given global developments in the pharmaceutical industry, there is a more limited range of producers than perhaps there was in the past.
Senator Eaton: Do you inspect those ingredients and products that you make offshore, in Asian countries, for instance?
Dr. D'Cunha: I will speak for Apotex's manufacturing facilities. We have three plants in the Toronto the area. We have one in the U.S., which is our patch technology in Florida. We have one in Bangalore, India that is FDA-, EMA- and TGA-approved, and Health Canada works off those. In fact, the Bangalore facility was inspected in July last year and got a clean pass, to address that specific point. We have one more manufacturing facility in the Netherlands.
When product comes, let's say, from India and it's destined for Canada or the U.S. market, as I stated earlier, it's put on stability. There is batch testing, and product is then released by the quality assurance department only if it meets the specifications. If it does not meet them, it's quarantined and disposed of appropriately.
Typically, the shelf life of a product is two years; in some cases, it could be 18 months or more. Over the course of the shelf life, samples are statistically drawn and tested, and if they continue to meet specifications, the batch is not touched. If there are issues, it triggers a conversation — a risk assessment — and a recall if appropriate. The recalls are posted publicly.
Senator Eaton: Thank you, Dr. D'Cunha.
Dr. D'Cunha: I will reassure you that our Bangalore facility is U.S. FDA-approved, EMA-approved and TGA-approved. Health Canada has not yet gone there, but they're working off the other folks' approval until they get a copy.
Senator Eaton: For Rx&D, would you like to answer?
Mr. Rhines: We're not representing any specific member; we're representing the association. We can't speak for any one member, but we would say that we have similar processes, so any drug manufactured for use in Canada is inspected. Health Canada has inspections in place for facilities and they are tested and monitored before they enter.
Senator Eaton: Before they enter the supply chain?
Mr. Rhines: That's exactly right.
Senator Eaton: Concerning Internet operators, or drug sellers, do they take your brand and packaging? Do they try to make their counterfeit drugs look the same, so if I go on their sites I think I'm getting an Apotex drug or another Rx&D drug?
Mr. Robinson: We need to be careful — and Ms. Cox alluded to it — there are legitimate Internet pharmacies and there are criminal operations. There are some distributors that have Internet operations now in terms of wholesalers and the supply chain. It's more prevalent in the United States, for example.
It's a very specific question where each individual member may move their product in terms of their distributor, their supplier relationships. In the context of testimony and submissions we provided to the government over the last decade and to Parliament, with respect to the illegal operations, those are the ones that would be engaging for the most part, we believe, in nefarious behaviour.
Senator Eaton: You wouldn't sell your product to somebody who wasn't a bona fide distributor?
Mr. Robinson: No.
Mr. Rhines: That's absolutely correct.
The counterfeits look the same. That's where the safety risk gets introduced. It's no different than counterfeit watches. They look the same and that's where the risk is. From a chemical standpoint, they're not the same.
Senator Eaton: Are generic drugs an exact replica of the brand drug or are there differences?
Dr. D'Cunha: There may be differences in some of the non-active ingredients. Those are typically disclosed in the product monograph and in the patient information leaflet.
Mr. Rhines: There is an important point to make. Dr. D'Cunha is absolutely right. There are differences in excipient and in non-active ingredients. However, that doesn't necessarily mean all drugs act the same way in patients. Again, it's very important that health care practitioners have important conversations with their patients and pharmacists to make sure that patients are responding to medication in the same way.
Senator Stewart Olsen: Most of my questions have been answered, but I want to go back because I think it's terribly important to reassure Canadians. We have had some testimony that has questioned our drugs in Canada and that was very concerning. It's reassuring to hear this, but I want to go back to the drugs manufactured offshore.
You mentioned, Dr. D'Cunha, that they were recently inspected by one of the manufacturing plants. Who does that inspection?
Ms. Cox: Before Dr. D'Cunha responds, I think it's important to note that any product that is being brought into Canada and is being sold in Canada is required to provide evidence to Health Canada in terms of GMP compliance, the good manufacturing practices compliance. Often Health Canada is not actually the regulatory authority that's going to plants, but it could be the EMA or the FDA. There is a reliance on the foreign site inspections, and that's the kind of documentation that Health Canada would often use.
Senator Stewart Olsen: To follow up on that, that's good, but do we ever do site visits to actually assure ourselves that those inspection agencies are functioning properly and we have no reason to question their reports?
Ms. Cox: Health Canada does have some flexibility in that area. Obviously, it's costly to be traveling the world and inspecting facilities. That's why there is very strong collaboration between the regulatory authorities and there are memorandums of understanding and relationships between like-minded authorities. Again, like the Europeans, the FDA, the TGA in Australia, obviously Canada has a good relationship there. We are talking about very similar standards.
Mr. Rhines: Another important point is that while Health Canada may not inspect all foreign manufacturing sites, for the local importer they do review quality systems and make sure companies have procedures in place to ensure that the drugs they are importing have met the quality standards and manufacturing process. It's not that they don't look at all into the supply. They just may not do the actual inspection of the foreign site.
Senator Stewart Olsen: Is there any possibility that brokers could go to a questionable source? Is there any breakdown in that chain that you're assuring us of where, perhaps, brokers would go to a plant that was not favourably inspected and bring this back? I'm trying to tie it up. I was quite shocked yesterday from testimony that I heard. For my information and for Canadians' information, I would like to ensure we have a very safe pharmaceutical industry in Canada.
Ms. Cox: In order for a drug product to be approved in Canada, GMP evidence has to be provided. That's reviewed in advance of the approval.
Mr. Robinson: I would add here that there are we and our colleagues in the generic sector. We say we have a collaborative relationship with Health Canada in terms of the give and take of understanding science, regulatory discipline and the ultimate priority for patient safety in Canada.
I think Canadians should rest assured that for Health Canada, in its work with the FDA and the EMA in terms of that common standard, it's a race to the highest acceptable standard. That is, one joint inspection or mutual recognition of inspections, but no sovereignty is being lost. The Government of Canada and the Obama administration should be commended for their work in some of these areas as another area of regulatory cooperation in terms of the Regulatory Cooperation Council. It serves Canadians better and ensures that you have inspectors doing their front-line work and ensuring that can be done for patient safety.
Senator Seth: Thank you very much for your presentation. While this is a complex subject, it is very interesting and very important for us.
In the previous session we had discussions about antibiotics sometimes being purchased and sold in large quantities by health professionals. What is the percentage of these antibiotics abroad? Who is the main supplier in Canada for these antibiotics? Which antibiotic is commonly used in Canada or in the world?
Dr. D'Cunha: That's going to be a difficult one to answer.
The Chair: I'm going to rule that question out of order because that gets into areas that are simply not part of what we're dealing with here. Unless there is some aspect that you can identify that deals with the issues that are important to us, which is the overuse of antibiotics or something like that, we're not getting —
Senator Seth: Yes, because we are getting into abuse of antibiotics.
The Chair: We aren't getting into individual antibiotics by company, by jurisdiction, by province or by patient.
You have been following in the testimony. The senator is asking a question against that background. Is there anything that you can say further with regard to the abuse of antibiotics?
Senator Seth: I'm coming to that point.
Mr. Rhines: I don't think there is anything to add that we didn't say before about making sure that physicians and health care providers know the appropriate way to prescribe and the conversation that we had around ensuring there is adequate incentive to continue to research and develop new antibiotics.
Senator Seth: Senator Seidman already talked about drugshortages.ca, your website that is currently in use and shows the drug shortages. How is this data collected on the website, and who actually accesses that? Is this actually very effective in making Canadians aware of drug shortages?
Mr. Rhines: It is up to the manufacturer, as we mentioned earlier, to report drug shortages to drugshortages.ca. We believe it is effective in making sure that drug shortages are reported in a timely fashion. Drug shortages, as we mentioned earlier, are complicated, and there are a lot of causes. But we do believe it adequately captures, and we do believe, based on Mr. Robinson's testimony earlier, that it is pushed out to health care providers to make informed decisions.
Mr. Robinson: These are fundamentally important questions, Senator Seth. I would direct committee members back to what I believe was excellent testimony given by David Johnston, from the Canadian Association for Pharmacy Distribution Management, last week because he spoke to the issues around where supply and demand can cause shortages, the definition of a shortage in the context of a national shortage or regional issues of an influenza outbreak in one part of the country versus another, and the work that Dr. D'Cunha did, in his former life, and his peers do in redeploying stock and having triage and priority that ADM McArthur also spoke about. I think the answers are there.
The other point in that is that, with respect to manufacturers, as Mr. Johnston and even some your other witnesses have pointed out, there will be times when they know, at the same time or perhaps earlier than a manufacturer, in the context of local prescribing practices or a local supply-chain disruption, independent of not being able to get an active pharmaceutical agreement out of a global chemical manufacturer. So I would commend you, if I could guide the writing of phase 4 of your report, to look at some of his suggestions and his context-setting for drugshortages.ca. I would also point out that, on the drug shortages website, which I would direct members of Parliament and Canadians and senators to, there are two fundamental background documents on that site. One is a 23-page document that explains, in plain English, how, when and why shortages can occur. This is not a new phenomenon. I'm not belittling the issue when somebody can't get a prescription filled. It also explains the protocol for reporting and what the responsibilities are of different stakeholders in the system, just not the industry seated before you today.
That's extremely important for your research and your writing as well.
Senator Seth: Still, I didn't get how the data is being collected.
Ms. Cox: It's an online form that the individual companies would upload to the system. There's a user interface.
Senator Seth: Thank you.
Mr. Robinson: I had screen captures on the products. It will speak to the name of the product, the manufacturer, why the shortage, when it started and when they anticipate resolving it. Many of these are in the context of a week or a month. Some are longer, based on ingredient issues. The other thing to point out — and it is important — is that there may be one medication that is listed six times but that's because there's a 10-milligram dose, a 20-milligram dose or, as Dr. D'Cunha pointed out, a solid or an oral or suspension dosage for pediatric use. It is very rich, and those improvements have been because of what we've heard from and through the multi-stakeholder working group from Health Canada and other professionals at that table.
The Chair: I would urge senators to look at the website. We have gotten a very good explanation here. One of the most important points was the automatic alert that gets to the fundament aspect of informing the community that needs to be aware of it.
Mr. Robinson: From a privacy point of view, the prescriber has to seek permission for that automatic alert. We can't spam. The Parliament of Canada has already said that you can't spam people. Other legislation has dealt with that.
The Chair: Absolutely. That's very helpful.
Senator Enverga: Actually, before I go to my first question, when one of the name brands expires, how does it work for you? Suddenly, it expires today. Everybody will have a free for all to duplicate medicine? Is that how it works for the generic manufacturers?
Dr. D'Cunha: Typically, for a generic or —
The Chair: Just simple. Again, please, these things are well known in the industry and in society, so just a very quick answer on this.
Ms. Cox: The system is designed so that, essentially, there has to be litigation before a generic can enter the market, unless a patent does expire. Essentially, there would be a patent linkage proceeding, a court proceeding. Then, there would be a determination as to whether the generic can enter the market or not. I should note that, in the Canadian context, that doesn't actually end the litigation because generic companies are actually sued when we enter the market for patent infringement, which creates an enormous risk for generic manufacturers bringing product to market.
The Chair: We're not going any further. This is a very complex legal, competitive, industry issue.
Senator Enverga: Let's make it simple. Actually, the question is this: Being an association, do we have anything to do with who's going to be taking this medicine? Do you have any control at all, being an association?
Mr. Robinson: We represent the interest of our members at a policy level, not on product or specific commercial issues.
Senator Enverga: Does the association have any control at all over any of the manufacturing part? Nothing like that?
Mr. Robinson: No, those are commercial entities that are subject to Health Canada, GMP, good laboratory practices. We are a trade association, representing the broad, unified and policy-level interests of our membership at Rx&D.
Senator Enverga: You have nothing to do with the manufacturing, no inspection. You are basically just —
Mr. Robinson: We would work with our association, and there are times when we work with the CGPA, with the regulator, in this sense Health Canada, on the policy framework around inspections and notification and mutual recognition and those sorts of things.
Senator Enverga: Do you have any standard on what manufacturers are going to be joining your associations? Is there any standard at all? Will it be anybody that will pay the initial fee or something like that?
Mr. Rhines: The members of our association are the innovative pharmaceutical manufacturers, and, if they're Canadian-based, they are welcome to join our association.
Mr. Robinson: As long as they adhere to our code of ethical practices, correct. We would like to point out that we are the innovators, and our colleagues here are the imitators. But that is the nature of the cycle.
Senator Enverga: Is there any chance, at a certain point in the life of your association, that you have kicked out any member of the association?
Mr. Rhines: I don't recall it. There are processes in place. If our members don't follow our code of ethical practices, there are procedures in place to address that.
Senator Chaput: I would like to have your view on the following statement: Canada is behind in many aspects and has some catching up to do in regard to monitoring, whether it be misuse or overuse of drugs, counterfeit, drug shortage or compliance, and also on the issue of lack of data because we have heard so many times, "We just can't get any data." Would you say that Canada is behind in those two aspects, the two examples that I have given? What is your view on this situation, and what can or should Health Canada do in regard to that, if that's the case?
Dr. D'Cunha: Let's start first with the lack of data. As my colleagues at Rx&D pointed out, we do collect information on adverse reactions, and, in Canada, we are relatively advanced compared to Europe, as an example, because we are required, for every molecule that we have in our portfolio, to write a Canadian annual safety report, which includes global literature on the molecule if your company is global and Canadian literature if your company is only Canadian.
On the other hand, in Europe, the periodic benefit evaluation reports cover time spans of three years or five years unless there are unusual safety issues with a particular molecule, in which case it may be annual. So, in terms of the data, the data is collected, analyzed and available to the minister on request. Quite often the Department of Health has asked manufacturers to please provide the last so many years of Canadian annual reports. As pertains to data on usage, the best place to look is at pharmacy and other distribution system data because manufacturers can only tell you how much they shipped out or how much they sold in a particular period of time.
In terms of catching up, every country can do better. One would be naive to suggest that we can't do better.
Senator Chaput: How are we doing in Canada?
Dr. D'Cunha: I've seen certain initiatives and investment where work is in progress in terms of collecting information on, say, prescription drug misuse. Are we fully there? Not yet, but some good work is being done by the Canadian Centre on Substance Abuse. I know my colleagues from Rx&D and the generics are working with them. We're working collaboratively with the pharmacy group, the physician group and the nurse practitioner group, and we're now hoping to outreach into the communities because they are impacted by some of the misuse.
Senator Chaput: In Canada, we're working together and not in silos. Is that what you are saying?
Dr. D'Cunha: We are, but there's more we can do.
Senator Chaput: I understand.
Mr. Robinson: I would direct senators to a speech that the chair of this committee gave on the question of silos and health care and other things last November in Montreal.
Senator Chaput: He gives many good speeches.
Mr. Robinson: It applies to the back end of that question, which I thought was eloquent.
[Translation]
I will give a two-part answer to that question.
[English]
On the question of drug shortages, this is a global issue in terms of global industry, global supply chains and global manufacturing. Health Canada, to its credit as it has led this in terms of convening the multi-stakeholder working group and the role that Health Canada can play in building the big table of the important stakeholders, has worked with its FDA and EMA counterparts and collaboratively with industry and the other stakeholders. For the drug shortages website and the improvements being made there, these are positive steps, not belittling the problem of somebody not being able to access their medicine. We talked about other environmental issues with respect to reimbursement, health technology assessments and other issues that we share across the sector between the innovators in the generic sectors.
Specific issues of prescription drug misuse or abuse are also a global problem, but sometimes more concentrated geographically, nationally or sub-regionally. That is why I asked Senator Eggleton in response to his first round of questioning if he was going at both issues, but he was more on the counterfeit. On the issue of prescription drug misuse, substance abuse and other things, interagency cooperation is needed as well as federal-provincial cooperation. That is more so specifically when you look at the structure of our health care system and reimbursement in the provinces. The province is the main delivery vehicle for health care in Canada, not discounting the federal government's five drug programs. That's where you already see ministers of justice, chiefs of police, deputy health ministers and social services people working with industry and other providers at the provincial tables.
Coming back to earlier testimony, the advent of standardization around electronic health records, monitoring and inventory management, and syncing of those systems together will provide a better understanding of the issue.
Further to Dr. D'Cunha's answer, another thing is important. We have the safety network and the National Prescription Drug Utilization Information System under the PMPRB, the Patented Medicine Prices Review Board. There's a lot of data out there. It is actually accessing it and using it for proper management and public policy purposes.
The other thing that industry would like to do more of is to put some pieces together. Ms. Cox pointed out that when we have a new medicine that comes to market and we learn more about its safety profile, Health Canada pronounces a medicine safe and clinically effective for use in Canada. If it is not safe, it should not get a notice of compliance. Period. Full stop.
We see an evolving safety profile through practice. We know it very well when the product is off-patent due to its end of life or we can talk about litigation at another time in terms of the two industries and where we differ. In the reimbursement environment, especially for new indications for rare diseases, smaller patient populations and areas that you have talked about before in the context of pediatric clinical trials in phase 1, we need to be able to do, and we want to do, more real-world evidence generation of not just how it's prescribed but what we're hearing back as the medicine is being used in real-life settings.
The challenge at the moment, whether it be on the generic side or the brand side, is that we have our provincial authorities engaged in what some would call a bit of a race to the bottom to get a sense of how low a price they can pay to reimburse for medication, and it is focused on price and volume — price and volume alone. That is not allowing industry to bring value-added service offerings in terms of our people, our processes and our ability to generate and collect data in context with health professionals respecting privacy to inform health authorities and governments of different profiles and different uses of medicine.
To pick up on Ms. Cox's comments, that is a fundamental concern and, we believe, a misplaced public policy priority focusing on price and volume and not understanding the broader impact and value that medicines bring or the impact they can have on the health system. That's where we need to do better at the provincial level.
Senator Munson: Thanks for being here today. I'm replacing Senator Cordy, who has been part of this study much longer than I. Whether it is generic or brand, according to some statistics from a group called the Natural Resources Defense Council in the U.S., the presence of pharmaceuticals in America's waterways are contaminating drinking water and forms of vegetation. It is interesting what they say, because we do have some questions dealing with environmental concerns in this country. As the chair has talked about, there are silos when it comes to regulation of this sort of thing.
In this particular document, they talk about improving drug design, tightening up the FDA approval process and improving pharmaceutical production processes. In layperson's terms, there's a big gap, according to this document, such that instead of flushing into our systems, there's a better way of doing this. You are probably all familiar with this. Programs can involve permanent collection boxes set up by pharmacies, one-day events in special envelopes and this sort of thing. I was not aware of just how much, but in the United States of America, 24 major metropolitan areas serving 41 million people detected drugs, including antibiotics and so on and so forth. It seems to be quite an alarming figure.
In our questions that we have for you, the pharmaceutical industry in British Columbia is required to fund medication disposal programs, but it is on a volunteer basis in other provinces. Why isn't it mandatory, whether for a generic or a brand name drug, for companies to abide by certain rules and regulations and have a better way of getting rid of these drugs that are not used — that are excess?
Dr. D'Cunha: I can't speak for provincial policy across the country. From a manufacturing standpoint, there are municipal and provincial bylaws governing the disposal of water into the sewer. For example, in the city of Toronto, where Apotex is located, we're not allowed to discharge anything into the general sewer. That part of the chain generally across the country is safe and secure. When we human beings take medicine, we metabolize it and we put it out three ways: perspiration and the other two organs. However, your point is not lost. There are major sources and a lack of public will to dispose of it safely.
I guess I would encourage all of you, as a committee of senators, to push and advocate for collection systems. Personally, if you want to go mandatory, do. I won't give you my opinion. At minimum, make it voluntary and accessible. It should be at the local pharmacy, the local fire hall or the local community centre. Some good initiatives in this country are around diabetic needles. Because we saw a whole rash of needle stick injuries in the garbage a few years ago, as a community and as a society, we started to get smart about it. Why not the same for unused pharmaceuticals?
I am familiar with the USEPA numbers of pharmaceutical contaminants in drinking water. They're similarly modelled on Australia's numbers. For the most part in Canada, the Canadian drinking water guidelines mirror image them; but we have not created that outlet where the community can take its unused medications.
Mr. Robinson: As I mentioned in our opening remarks, our members do participate in the Health Products Stewardship Association, and our members actively participate in Alberta, with Envirex, which is a pharmacy-driven initiative. We have producer responsibility that we self-fund. It is self-funded by members that participate in terms of collection, take-back and stewardship of the waste. Dr. D'Cunha already spoke to manufacturing processes. I can tell you from my former life as a chief of staff to our mayor that the local bylaws were very tough with respect to the discharge of industrial effluent into the waste water system and general sewage.
The other thing we can point out is that Ontario has moved in that direction with what were called eco fees at the time, but again, producer post-consumption responsibility in which it was a regulatory initiative, industry-funded, and our members participate and fund.
Dr. D'Cunha has already spoken to the issues of human digestion of pharmaceuticals, but I want to come back to the other point in terms of appropriate use. Some of these take-back days don't just happen because someone passed away, and they have a medicine cabinet full of unused medicines. They happen because Canadian patients, in and of themselves, need to accept more responsibility to follow their prescriptions appropriately.
It moves back to Senator Seidman's point. It is a smaller issue, but on the issue of antibiotic resistance. I'm sure, as a parent, I have been guilty of it. I'm better after eight days of my antibiotic. I don't need it. I'm going back to work, as opposed to taking it for the full time.
These are fundamentally important issues, and I would encourage you to speak to the accountability of Canadians in terms of our cherished health care system, in terms of provincial reimbursement plans, for us to be more responsible collectively for our health outcomes, to address a lot of these issues.
Not to simplify it, but if somebody is actively and properly taking their pain medication, and they take it for the full prescription, and they keep it in an appropriate space, then it cannot be diverted, or it has less of a chance of being stolen and abused by someone else.
Senator Munson: Speaking of accountability, is it enough just to leave it to individual municipalities, or should Health Canada and other regulatory bodies — would you be involved in this sort of thing, because these seem to be alarming figures, and in the sense of a nationwide approach to this? Individuals can take responsibility, but I think governments and the pharmaceutical industry have a responsibility as well.
Mr. Robinson: Senator, I would speak on behalf of our members, that they have lived up to their responsibility through their active participation and voluntary participation in industry-funded programs in terms of stewardship of post-consumer product and waste.
With respect to the larger question, should this be a national role or federally sanctioned, I think there would be issues around waste water and constitutional questions of the role of cities, provinces and the federal government. I would let you and your colleagues divine with drafting and justice folks on how to drive that.
Senator Munson: There are no borders when it comes to the environment.
Senator Eggleton: We have been told with respect to antibiotics that they're overused, misused and non-medically used. For example, in the United States, and I suspect in Canada, 80 per cent of antibiotics are used for animals, primarily for promoting growth in the animals when marketing meat products. All of this has accelerated strains of bacteria resistant to antibiotics.
The World Health Organization describes this as a global crisis. Dr. Frieden, Director of the U.S. Centers for Disease Control and Prevention, said, "If we're not careful, we will soon be in a post antibiotic era. And, in fact, for some patients and some microbes, we are already there."
Now, we have also been told that drug companies have little or no interest in investing in research needed to produce new antibiotics, because it's more lucrative for them to produce drugs that can be taken every day, as opposed to an antibiotic that is taken occasionally or every now and then.
I understand. It costs a lot of money to bring a new drug onto the market. We have seen some of the numbers on that.
What do you think we should to do to kick-start the research that is needed to deal with this crisis?
Dr. D'Cunha: A couple of policy approaches that should be nurtured and sustained. There's the Canadian centre for infectious diseases located in Winnipeg and at the University of Western Ontario headed by two top-notch scientists. More investment and encourage one of the two of them to focus on developing new antibiotics. For instance, the AIDS vaccine research being done in Canada is being done in London, whereas some other antibiotic research is being done in Winnipeg. So that's one start.
The second start is to encourage industry, keeping in mind the comments that Mr. Robinson made on the right reimbursement environment, if I may use the phrase, to kind of encourage industry to also come there. You can develop something in a lab, but then from the bench you have to take it out to the manufacturing environment. So ensure that you have the bridges.
The CIHR process kick-started a few, and more recently, they have not received, as a global budget, the funding that they got perhaps a decade ago. So that's something as a committee you may want to consider to look at some more investment there with the view of kick-starting.
The last policy piece, from my perspective, is to try to put in place strict controls on inappropriate use of antibiotics, because, as Senator Eggleton has correctly pointed out, a lot of it is going to create huge animals. For example, it's more lucrative from a commodity standpoint.
Senator Eggleton: Encourage industry to be —
Mr. Rhines: Also, to address one of the initial premises, our members invest a lot of R&D in vaccines to eliminate disease, so the premise that we benefit from just allowing diseases to continue and give daily medications, I wouldn't say that is supported by our behaviours. We also spend a tremendous amount of effort on disease awareness and prevention programs. So that is just a backdrop.
I also think — and this was earlier testimony, so we don't need to go into it again — there needs to be considerable work on restoring Canada's competitiveness in the clinical-trial arena. We struggle there. We have lost ground to our international colleagues for the conduct of clinical research. I would say there needs to be considerable effort, and there's some under way. There needs to be more effort, and I think this requires industry, academia, government, federal to drive these efforts forward, to really drive the innovation.
The Chair: Thank you.
Senator Seidman: I would just like to go back to these take-back programs that I think you referred to, Mr. Robinson, and you discussed in response to Senator Munson's question.
I do believe that as a Canadian and as a consumer, I have a certain amount of responsibility for myself, to educate myself and to protect myself.
As you mentioned before, the growing issue of resistance and ineffectiveness of antibiotics has many reasons, and one is the dispelling into the environment.
I would like to ask you about the take-back program, particularly, and whether you think there's a role for pharmacists to play, because they are right there at the front line, whether we could have some kind of patient information leaflet that goes with the medication, and whether there is an awareness campaign approach to help educate Canadians that when they consume drugs, medications, they have a responsibility also to themselves and to other Canadians and to the environment.
Mr. Robinson: I think the question is best specifically directed to the Canadian Association of Chain Drug Stores and its counterparts in Quebec for any campaigns they may be taking on across the Shoppers, the Rexalls, the London Drugs, Jean Coutu, many of their members.
As a consumer filling prescriptions, I have seen many of those things piloted; for example, they have needle dispensing. They have orange bins like you see in health care institutions. They are working through some of those things, and pharmacy is more and more becoming the centre of community care in terms of age and place, primary care reform. We're not building as many mega-hospitals anymore.
I was speaking to our members' participation in the context of the post-consumption stewardship, in terms of whether that be waste, in response to Senator Munson's question, or individual members also participating in their own education and advocacy campaigns.
It is similar to other social marketing and social awareness campaigns that have been undertaken in this country, and it is not an easy change. It is like seat belts. It is like drinking and driving. It is now like texting and driving. It is going to take multiple efforts by multiple stakeholders to drive this message home.
I apologize if that's a "mother and apple pie" answer, but that's probably the best policy answer to drive.
The Chair: I'm going to sum up here a bit.
There were several questions to you today that are really sharply focused with regard to our protection against counterfeit on the one hand and substandard pharmaceutical products on the other hand.
You are probably far more aware than we are of the reports of these kinds of events worldwide and in North America when they occur. However, it seems to me that the Ranbaxy situation presents a case study in how I would term criminal activity, organized crime the way we normally think of them, but this was a highly organized operation that dealt with a number of the issues that lead to concerns in the public with regard to the safety and security of their pharmaceuticals. On the one hand we all want them for nothing, but, on the other hand, we want them now when we have any kind of illness. You have helped us a little bit with real issues in how you go from zero to an actual pharmaceutical, although we haven't got into it in detail today.
The Ranbaxy case illustrated a number of the substructure issues of regulation as well that indeed, when products or even components of products are produced in countries with lower regulatory standards, the issues of even the fact that a regulator from outside may need to announce in advance that it is going to appear on the scene is an issue that arose during that particular situation. Even the FDA had difficulty until a whistle-blower appeared who provided the kind of information that allowed the FDA to ask the right questions to get the information they needed to protect the supply chain.
I'm wondering, given that that was really a remarkable case study situation — it's ongoing to some degree as we know — do you think that whistle-blower regulation would be of any benefit to us here in Canada? You've described your own processes. I understand your approaches to them completely and I'm not questioning that in any way. What those examples do is raise questions about how alternate supplies get into the system within a border.
We have on the one hand the possibility of whistle-blowing on a bad source to begin with, and, at the other end, we have the idea of the deliberate, random inspection of bulk products entering the country from other sources.
Would you care to comment on either of those two aspects?
Dr. D'Cunha: Starting with the random inspection, that should be sustained and maintained. The frequency has to be determined by the risk assessment of the operation in question because you can't write a cookbook to say you will go once a month or once in two years or once in six months. It has to be risk-based.
In my personal view, whistle-blowing is good because it is an alternate source for information to come on the table that may be missed if there is systematic concealment of information. Inspectors are generally good. When they come into a facility they'll look back, but if there is conscious manipulation and document fraud, no inspector will find that easily. I'm not suggesting it won't be found. It is a bit of a challenge. To the extent that society would like to open up more avenues for information, it has to be considered seriously.
I stress that these are my personal views.
The Chair: Thank you very much. I really wanted these issues on the table, and I know the depth to which good manufacturing process that you referred to several times here are a requirement of your own industries, but these are heavily regulated ethical pharmaceutical issues. These questions arise from the non-ethical parts of society that enter this particular area.
Ms. Cox: In terms of foreign sites, certainly regulatory authorities are seeking to increase inspections of foreign sites. Certainly we see the FDA moving in that direction, EMA, and so, again, Health Canada as a partner with those regulatory agencies benefits from information found within those inspections because they do have to be reported.
The Chair: Thank you.
I'm now going to sum up a little bit here. One of the things we noted — and it's somewhat pleasing on the one hand — is that in our four-part series we've almost come full circle with regard to one critical aspect, and that's the clinical trial process and that's the issue of how drugs get identified, evaluated and then ultimately approved and the need for us to make considerable progress here in Canada. I think we're pleased to see that real efforts have been accelerating in the last 12 months, but that is a critical issue to this whole aspect.
You have also helped the committee to have a little bit of an understanding of the complexity of the ethical pharmaceutical industry as opposed to the quick and dirty news article on the whole area. It is a complex area. I was really pleased to hear you summarize. You didn't go into it extensively but, Mr. Robinson, you identified it and it has come up in little pieces subsequently, the effort to work with the medical system with regard to the painkiller issue. We heard in previous testimony about the fact that there are many cases where these addictive painkillers may well not be necessary to be prescribed in certain situations, that indeed the physician, knowing the character of their patient as well, can have a significant influence in what product they prescribe in these areas because the addiction issue is one we're concerned about, as you know. I was very pleased for you to mention that aspect, Mr. Robinson, because clearly there are a number of things that need to be dealt with here, but that area you touched on is a very positive area.
The issue into antibiotic research: Again, I think society, of course, can't know, since the first discovery of penicillin, the tremendous evolution of science and scientific activity, both from natural isolation and the modification of chemical structures to continuously provide the antibiotics over time. We are seeing the adverse events that have occurred from our abuse of that in the sense of overuse, the improper disposing and so on.
Where it may well be that the next generations of antibiotics — we are already seeing it, in fact; it's in progress — require far more original research to develop new discoveries that lead to new lines of chemical structures or biologics that will lead to benefits in these particular areas, and that research is very expensive. However, I think there is an expectation, and we've seen that in documents, that it's up to the pharmaceutical industry to do all of that original research.
We know, in fact, that much of the original science that leads to the pharmaceutical industry moving to substantial investments in applications of the research comes from fundamental research and universities, CIHR-sponsored kind of research, and I think your points made there today are very important. It is critical for us as a society to realize that there has to be more investment in research, and your recommendations in that area are very important to us. Your testimony today has helped clarify some of these issues, as you nearly always do when you appear before us.
As well, you've touched on the issue of the complex supply line and have helped us understand that. We do know your requirements for the best practice issue and the proper laboratory practice with regard to your industry, but we have to be concerned about those that enter the supply chain elsewhere. We do need to ask the questions of you to ensure that your testing of your own offshore supply line is going to ultimately protect Canadians in that area. Those are the basics for our questions in these areas today.
On that note, I want again to thank you for appearing before us and being very frank with us today, and sitting here representing really almost the totality of the Canadian pharmaceutical industry. On behalf of my colleagues I want to thank you, and again I want to thank my colleagues for exploring these very important questions with you.
With that, I declare the meeting adjourned.
(The committee adjourned.)