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DANIELLE MARTIN (WOMEN'S COLLEGE HOSPITAL): Well, I think it's probably not divided properly and I also think that we need to be very mindful of the ways in which advertising and marketing, whether it's direct to patients or consumers as we often consume from the American media on our television screens, or whether it's direct to physicians. So, you know, in fact, even in the U.S. under the Affordable Care Act, physicians are now required to declare any amount of money that they take from the pharmaceutical industry. We have no such sunshine law here in Canada. Don't Canadian patients want to know if your doctor has had their vacation or their last meal or their speakers' fees paid by the company that makes the drug they have just prescribed for you? WENDY MESLEY (HOST): Well, we saw in those ads they'll say: Ask your doctor. Is there a lot of pressure and is that contributing to the number of pills on the market? SAMIR SINHA (GERIATRICIAN, MOUNT SINAI/UNIVERSITY HEALTH NETWORK):

WENDY MESLEY (HOST): What are you seeing, David? DAVID HENRY (PROFESSOR, DALLA LANA SCHOOL OF PUBLIC HEALTH, UNIVERSITY OF TORONTO): I think this is right and it's a surprise to somebody from outside of Canada to find that in a country with a good comprehensive care system, there is not drug coverage. So patients with chronic disease, for instance diabetics, ironically in the city where insulin was discovered, are relying on free handouts from their physicians to provide what is really an essential medication; it's keeping them alive. WENDY MESLEY (HOST): Who do you think is falling through the cracks? What are you seeing?

CARA TANNENBAUM (GERIATRIC PHYSICIAN, PHARMACY CHAIR, UNIVERSITÉ DE MONTRÉAL): The vulnerable population in my mind are older adults with multiple medical conditions who are taking 5, 10, 15 medications at the same time and have to pay the deductible on that. And that adds up for a lot of them who don't have a lot of money to begin with, so they start making choices about will I take my drugs until the end of the month? Will I take every single medication that I have to? Do I really need those three medications for my high blood pressure, or can I let one go? And that could have effects on their health. WENDY MESLEY (HOST): Well, you mentioned diabetes, David. We heard earlier on "The National" this week from a woman in B.C. She has diabetes. That's a life-threatening disease if it's not looked after. This is what she said.

SASHA JANICH (PHON.) (DIABETES PATIENT): Roughly about 600 to 800 bucks a month. I don't get any help until I spend at last 3500 a year and then they'll kick in, you know, whatever portion they decide to cover. WENDY MESLEY (HOST): So, David, that's really common? People on diabetes aren't fully covered?

DAVID HENRY (PROFESSOR, DALLA LANA SCHOOL OF PUBLIC HEALTH, UNIVERSITY OF TORONTO): Well, they're covered to a degree in B.C., but it's what we call the co- payment level that they have to make even under an insurance program. In Ontario, they don't have any insurance at all. They're going to pay the full market price if they don't have insurance through their employer, and they may lose that if they're out of work. WENDY MESLEY (HOST): What are you seeing? What's not covered? Give me an example. DANIELLE MARTIN (WOMEN'S COLLEGE HOSPITAL):

Well, actually, one thing that I think is surprising to a lot of people is the variability in coverage among public drug plans in Canada. So something that's covered, even if you're covered under a public drug plan, for example if you have cancer and you have to take chemotherapy outside of the hospital, in many Canadian provinces that's taken care of. In Ontario, for example, it's not. And I think that many Canadians are surprised to discover, imagine the, you know, enormous stress of a cancer diagnosis, that on top of that you're going to have to pay out of pocket at least to very… sometimes to very, very high levels, in fact. WENDY MESLEY (HOST): Samir? SAMIR SINHA (GERIATRICIAN, MOUNT SINAI/UNIVERSITY HEALTH NETWORK): And even just the other day, I just was debating with a pharmacy about the cost of some vitamin D. I have a person who's under house, he's on social assistance, and they said: We'll give you a free blister pack, you know, so he can sort his meds. We'll give you this. And we were actually, you know, working out a pricing system so this guy could even afford something so that he wouldn't break bones and actually have a fracture down the road. So it's amazing how some of the basic things we think are important aren't even covered. WENDY MESLEY (HOST):

Well, we saw that the drug costs have almost doubled in the last 11, 12 years. Is part of the problem… there's only so much, it seems, money to go around for prescription drugs. Is part of the problem that there's too many… some drugs are too easily available while people who really need them are not getting them? And there's marketing playing into that. We see a lot of ads in the last ten years. Check this out. VOICE OF UNIDENTIFIED WOMAN (ANNOUNCER): (Advertisement) We know a place where tossing and turning have given way to sleeping, where sleepless nights yield to restful sleep. And Lunesta can help you get there.

UNIDENTIFIED MAN #1: (Advertisement) Anyone with high cholesterol may be at increased risk of heart attack. I stopped kidding myself. VOICE OF UNIDENTIFIED MAN #2 (ANNOUNCER): (Advertisement) Talk to your doctor about your risk. VOICE OF UNIDENTIFIED WOMAN (ANNOUNCER): (Advertisement) Ask your doctor if Lunesta is right for you.

WENDY MESLEY (HOST): It's funny, you know, we hear our health plan discussed in the United States and now you talk about our socialized medicine and it's sort of until you have a health problem, you assume everything is covered. But who falls through the cracks that you see, Samir? SAMIR SINHA (GERIATRICIAN, MOUNT SINAI/UNIVERSITY HEALTH NETWORK): Yeah, I mean, I treat a lot of older patients and those who are 65 and older generally are covered by a provincial drug plan. But, you know, I'm seeing more and more, especially after the recent recession, we have people who are closer to that age who lose their jobs and if they lose their jobs and they were relying on private drug coverage plans, they are not covered. And then they find themselves they can't afford their medications, they get sicker and they literally have to wait and be sick until they can actually get their medications.

Well, it's a huge amount of pressure, I think, you know, for… you know, if you're a doctor that relies on information or supports from pharmaceutical representatives, for example, then there is that pressure that you're put under, there is that influence that you have. But also, we know that if your patient asks you specifically and says, you know, what about this medication, you may say, well, it's easier to prescribe you that medication if that's what you really want. But there's actually five things you can do to improve your sleep and actually avoid being on that medication, but we don't get asked for that. WENDY MESLEY (HOST): But I want to be like the lady with the wings.

SAMIR SINHA (GERIATRICIAN, MOUNT SINAI/UNIVERSITY HEALTH NETWORK): And that's what I hear: Why can't I be like that? But I think it's important to think about the other options. WENDY MESLEY (HOST): David, what do you think? DAVID HENRY (PROFESSOR, DALLA LANA SCHOOL OF PUBLIC HEALTH, UNIVERSITY OF TORONTO): I would like to focus a little bit on the prices that are being paid. We talked about usage and whether drug use is appropriate. There's also the price that is paid. Canada is paying too much. And if we can just return for a second or two to the idea of a national program, there's a huge advantage in being the sole purchaser on behalf of 35 million people, as it would be with a national program in Canada. And we know from experience you can reduce drug prices by 30, 40 percent. That's billions of dollars a year. WENDY MESLEY (HOST):

That's a political debate that you have launched and I hope that it gets taken up by the politicians. Who is buying these drugs? We have seen that there are more people having trouble getting drugs, more people using drugs. Who is it? DANIELLE MARTIN (WOMEN'S COLLEGE HOSPITAL): That are taking prescription drugs in Canada? WENDY MESLEY (HOST): Yeah. DANIELLE MARTIN (WOMEN'S COLLEGE HOSPITAL):

Well, you know, interestingly over the last decade, we have seen an increase in prescription drug use in every single age category. So the answer is we all are. We're all taking more drugs than our equivalent people did a decade ago and I think… WENDY MESLEY (HOST): Teenagers? DANIELLE MARTIN (WOMEN'S COLLEGE HOSPITAL): Absolutely, teenagers and the elderly and everybody in between. And so the question really becomes: Are we any healthier as a result? You know, in some cases we're talking about truly life-saving treatment that are medical breakthroughs and, of course, we all want to see every Canadian have unfettered access to those important treatments. In other cases we may actually be talking about overdiagnosis, overprescription and as you say, Cara, sort of chemical coping of all different kinds. And I think that's what we need to kind of get at and try to tease out. WENDY MESLEY (HOST):

Well, and the largest group of all on prescription drugs right now, Cara, are the seniors. CARA TANNENBAUM (GERIATRIC PHYSICIAN, PHARMACY CHAIR, UNIVERSITÉ DE MONTRÉAL): The seniors, yes, and I'm very passionate about this topic because sometimes I see patients come into my office on 23 different drug classes, and that's when we don't talk about what drugs should we add but what drugs can we take away, and the concept of de-prescribing. And imagine if we could get people who are on unnecessary drugs, because as you get older you get added this drug and a second drug and this specialist gives you this and that specialist gives you that, but then there starts to be interactions between the different drugs that could cause side effects and hospitalization. And maybe it's time to start asking, well, what's the right drug for you at this time, at this age, with these medical conditions? And personalized medicine is something that we have been talking about. It would be nice if we could introduce that conversation into therapy and not just drug therapy, but all therapy. Maybe the drug isn't needed. Maybe physiotherapy is needed or a psychologist or better exercise or nutrition. So I think it's really a bigger question. WENDY MESLEY (HOST): Samir?

SAMIR SINHA (GERIATRICIAN, MOUNT SINAI/UNIVERSITY HEALTH NETWORK): Exactly. I mean, in my clinic the other day I had a patient who was on eight medications when she came with me, and… WENDY MESLEY (HOST): This is a senior? You deal with seniors as well. SAMIR SINHA (GERIATRICIAN, MOUNT SINAI/UNIVERSITY HEALTH NETWORK): Absolutely. And when she left my office, she was thrilled because she was only on two medications, mainly because some of the medications are prescribed to treat the side effects of other medications, for example, or the indications for those medications were no longer valid in her. But we added some vitamins and we just balanced things out appropriately. And she was thrilled because, as Cara was saying before, the co-pays, the other payments that one needs to pay for medications you don't want to take, that's a problem as well. WENDY MESLEY (HOST): We're going to take a short break, but we have one more discussion area which is: What are the next challenges that Canadians might face with prescription drugs? We'll be right back.

(Commercial break) WENDY MESLEY (HOST): Welcome back to our "National Checkup" panel. Danielle Martin, Samir Sinha, Cara Tannenbaum and David Henry are all here to talk about the next frontier. So we're hearing all of this exciting new science marches on and there's all of these new drugs, new treatments. Everyone wants them or everyone who needs them wants them, but they're expensive, right, Danielle? DANIELLE MARTIN (WOMEN'S COLLEGE HOSPITAL): They can be extremely expensive. So, you know, what we call these blockbuster drugs coming onto the market, some of them truly do represent breakthroughs in medical treatment and in some cases they can cost tens or hundreds of thousands of dollars a year. So they really are very expensive. But what I think many people may not realize is that the number of drugs coming out, even the expensive ones that are truly breakthroughs, is still a very small portion of the drugs coming out on the market. Many, many drugs that are being released and are expensive are marginally, if at all, really any better than their predecessor. So just because it's new and fancy and costs a lot doesn't necessarily mean that it's all that much better.

WENDY MESLEY (HOST): So what's going to happen, David? DAVID HENRY (PROFESSOR, DALLA LANA SCHOOL OF PUBLIC HEALTH, UNIVERSITY OF TORONTO): We need to find a plan. These drugs may cost hundreds of thousands of dollars. Nobody can afford that individually. Tens of thousands, rich people can afford them but the average person cannot. So there's really no way we can cope with these unless we've got a plan and, in my view, it has to be a national plan. And the advantage of that are that when you're buying or you're subsidizing on behalf of 35 million people, you're going to get better prices and your insurance pool that covers these costs is much greater. So the country can afford drugs that individuals can't.

WENDY MESLEY (HOST): Samir, what do you see as the new frontier here? SAMIR SINHA (GERIATRICIAN, MOUNT SINAI/UNIVERSITY HEALTH NETWORK): I think the new frontier is going to be more personalized treatments in terms of how do we actually treat cancers, how do we treat certain rare conditions with more personalized treatments. WENDY MESLEY (HOST): Because it's very exciting, right? You have this cancer that's not that common and then you hear that there's a treatment for it and you want it. SAMIR SINHA (GERIATRICIAN, MOUNT SINAI/UNIVERSITY HEALTH NETWORK): And it has the possibility of alleviating a lot of suffering from unnecessary treatments that may not actually be… you know, be effective. But I think this is the challenge. If we want to be able to afford these, if we actually work together we're actually more able to afford them when we bulk-buy these medications. But the key is going to be that, you know, this is where the future is going and we're going to have to figure out a way to pay for them.

WENDY MESLEY (HOST): What are you looking forward to? CARA TANNENBAUM (GERIATRIC PHYSICIAN, PHARMACY CHAIR, UNIVERSITÉ DE MONTRÉAL): I'm really looking forward to seeing all these new treatments that we have spent decades researching. You know what the investment in health research has been in order to find new targets for drugs, in order to increase quality of live, in order to cure cancer, and then to send a message, oh, sorry, we're not going to give them to you or you can't afford to pay for them, then I think there is a lack of consistency in the messaging that we're giving to Canadians around equity for health care. So you could get your diagnosis and you could see a physician, but we way not be able to afford treating you. So I think this is something we need to think about it. It's very exciting, I think we live in exciting times, and looking at different funding strategies to make sure that people get the appropriate care that they need at the right time to improve their health is really what we're going to be looking forward to. WENDY MESLEY (HOST):

Tricky, though. It's a provincial jurisdiction, you've got to get all the provinces to agree to a list, and the list is getting longer. DANIELLE MARTIN (WOMEN'S COLLEGE HOSPITAL): Absolutely. I mean, I think actually one of the big myths out there about drug plans is that higher-quality plans are the ones that cover everything. And, in fact, that's not true. You know, we can use a national plan or a pan- Canadian plan or whatever you want to call it to target our prescribing and guide our prescribing in order to make it more appropriate, and that's another way that we're going to save money in the long run. WENDY MESLEY (HOST): Well, I learned a lot tonight. I hope our audience did too. Thanks so much for being with us. DANIELLE MARTIN (WOMEN'S COLLEGE HOSPITAL): Thank you.

Those two drugs are not widely used in Canada. But they represent a growing problem that affects Canadians: The sudden, inexplicable price increases of older, off-patent medications are part of a global trend that threatens the affordability and accessibility of life-saving medications, according to Steve Morgan, professor of health policy at the University of British Columbia's School of Population and Public Health.

"We've seen drug prices go levels we've never conceived of," he said. And the problem isn't confined to older generic drugs. Many new patented brand-name medications are being introduced at prices so high they threaten the sustainability of the health-care system, Dr. Morgan said. When a new drug comes on the market, its manufacturer is given a patent so it can recoup development costs and make a profit.

Once the patent expires, generic drug manufacturers can make their own versions at drastically reduced prices. But in the past few years, prices for some oncecheap generic drugs have skyrocketed. Sometimes, the increase is linked to shortages of raw ingredients used to make the medication or problems in the supply chain.

But increasingly, companies are making older generics that are no longer being produced or are being made in small quantities. Typically, the drugs aren't prescribed very often, which has allowed the price increases to fly largely under the radar. No one knows exactly how often these huge price hikes occur. Philip Emberley, director of professional affairs at the Canadian Pharmacists Association, said it's relatively rare but that "it seems to be coming up more frequently."

The regulations for generic drug prices are mandated by provincial governments, which set price caps based on a percentage of the former patented drug's price. But in cases where there is only one company manufacturing a generic drug - with no branded version to calculate the price - companies are free to charge any amount they want.

Canadian experts say they are deeply concerned about affordable access to life-saving medication and that it's time for government action. "We're not dealing here with the next cool widget," said Jillian Kohler, associate professor in the Leslie Dan Faculty of Pharmacy at the University of Toronto. "We're dealing here with products that are essential to enhancing the quality of life or even saving lives." Mr. Emberley said rules must be developed to prevent companies from targeting generic drugs for price increases. "There's no regulatory capacity to address this kind of situation," he said.

Jeff Connell, vice-president of corporate affairs with the Canadian Generic Pharmaceutical Association says that, over all, the cost of generic drugs in Canada is on the decline and that numerous measures are in place to protect against unfair pricing. UBC's Dr. Morgan said he believes rising generic drug prices are following a trend set by the increasingly exorbitant costs of brand-name patented drugs. It's become increasingly common for drug companies to set high prices for new products, which is putting a strain on provincial drug plans, private insurers and Canadians who must pay out-ofpocket.

One of the most frequently cited examples is Soliris, a drug used to treat the rare diseases paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. The drug costs up to $700,000 for one year, and patients on it must continue treatment indefinitely to see benefit. Pharmaceutical companies say such prices are a reflection of the research, development and other associated costs required to bring a drug to market.

But others, such as Dr. Morgan, argue that drug companies will simply charge what the market will bear. A few hundred thousand dollars for a drug would have been unheard of in the 1990s, but it's now the norm because companies have been allowed to get away with it, he said. "Our notion of what is an exorbitant price has shifted," Dr. Morgan said. "It's an attempt from a manufacturer to seek everything the market will pay for a drug."

Prescription drug spending in Canada's private sector has increased nearly fivefold in 20 years, from $3.6 billion in 1993 to $15.9 billion in 2013 [3x[3]Express Script Canada. 2013 Drug trend report. ESI, Mississauga; 2014 (http://www.express-scripts.ca/sites/default/files/uploads/FINAL_executive%20summary_FINAL.pdf [accessed 01.06.14])See all References][3].

Private drug plans in Canada are often considered wasteful because they accept paying for higher priced drugs that do not improve health outcomes for users and use costly sub-optimal dispensing intervals for maintenance medications. As a consequence, it is estimated that private drug plans in Canada wasted $5.1 billion in 2012, which is money spent without receiving therapeutic benefits in return [4x[4]Express Scripts Canada. Poor patient decisions waste up to $5.1 billion annually, according to express script Canada. (June)Press release, ; 2013 (http://www.express-scripts.ca/about/canadian-press/poor-patient-decisions-waste-51-billion-annually-according-express-scripts [accessed 01.06.14])See all References][4]. This amount represented 52% of the total expenditures of $9.8 billion by private insurers on prescription drugs for that year [5x[5]Canadian Institute for Health Information. Drug Expenditure in Canada 1985 to 2012. CIHI, Ottawa; 2013See all References][5].

Respondents from all categories mentioned that, in contrast to employers, the over-riding objective of unions is to maximize their benefits with minimal co-payments for their employees.

The study focused on large unionized workplaces that had Administrative Services Only (ASO) plans, where the employer is responsible for the costs of benefit plans and bears the risks associated with it, while insurers are just hired to manage claims.

This study focused on ASO arrangements because they are the most common insurance option chosen by large private-sector firms [16x[16]Sanofi. Sanofi Canada healthcare survey. Rogers Publishing, Laval; 2012See all References][16]. Those organizations whose activities resided solely in the province of Québec, where the regulation of private drug plans differs [17x[17]Commissaire de la santé et du bien être du, Québec., Les médicaments d’ordonnance: État de la situation au Québec. Gouvernement du Québec, Québec; 2014See all References][17], were excluded.

Respondents from all categories indicated that consistency of benefits with other market players is of significance to employers.

Sean O’BradyxSean O’BradySearch for articles by this authorAffiliationsÉcole de relations industrielles, Université de Montréal, Montreal, Quebec, CanadaInteruniversity Research Centre on Globalization and Work (CRIMT), Montreal, Quebec, Canada, Marc-André GagnonxMarc-André GagnonSearch for articles by this authorAffiliationsSchool of Public Policy and Administration, Carleton University, Ottawa, Ontario, CanadaCorrespondenceCorresponding author at: School of Public Policy and Administration, Carleton University (RB 5224), 1125 Colonel By Drive, Ottawa, Ontario, Canada K1S 5B6. Tel.: +1 613 520 2600.xMarc-André GagnonSearch for articles by this authorAffiliationsSchool of Public Policy and Administration, Carleton University, Ottawa, Ontario, CanadaCorrespondenceCorresponding author at: School of Public Policy and Administration, Carleton University (RB 5224), 1125 Colonel By Drive, Ottawa, Ontario, Canada K1S 5B6. Tel.: +1 613 520 2600., Alan Cassels

Finally, employers were most concerned with the government's role in distributing the costs associated with drug coverage among public and private players in the system. In fact, each employer expressed concern over this. Three of the four employers expressed concern over the government's role as a plan sponsor and how governments shift costs to the private sector. As described by one employer, “the government is a very big consumer of drugs” and if the drug companies “start losing money on the government side, they pass it on to private insurance”. Thus, government regulations that help employers contain costs are desired.

the employer always has the advantage in this stuff because they have all of the information with respect to the reports and the costs from the insurer or the advisor”

According to one consultant, “no one knows the cost of drug benefit plans.” This respondent was arguing that few involved in benefit design, either in private firms, unions, or insurers, are sufficiently competent to undertake proper analyses of claims data so they do not really know how proposed plan changes could affect them. This lack of expertise has ramifications for the education of stakeholders on the outcomes of benefit design.

However, when speaking of for-profit insurers, participants from all groups argued that insurers have no financial incentives to cut costs for employers, as indicated by one employer saying: “from my experience on the committees, I don’t get the impression that the insurers are there to save costs for the employers. I haven’t seen it. It's always been the other direction.” This claim was also corroborated by a benefits consultant, who argued that “there has been a fair bit of inertia, you know, amongst the providers out there in actually doing something too radical, too leading edge” because “there's no direct financial incentive for insurance companies or pharmacy benefit managers to actually help employers save money”.

Expanding on this, another consultant argued that an insurer's commission structure, which is based on volumes of claims expressed in a dollar value, may in fact discourage insurance companies from proposing plan designs that reduce the volumes of claims, as doing so would adversely affect company profits. Furthermore, another benefits consultant indicated that insurers are experts who calculate risk and thereby have no aptitude for the creation of formularies. According to this respondent, the impact is that insurance companies excel at managing risk, yet fare poorly in designing cost-effective plans that rely on the design and implementation of formularies.

An interesting finding from the interview data was that respondents from all interviewed groups declared being in favor of introducing some sort of arrangement for a national drug plan. Some favored having a universal pharmacare program which would apply to all drugs, while others favored programs tailored for catastrophic drug coverage. Two of the insurers that responded to this question explicitly favored some form of universal catastrophic drug coverage while the other favored universal pharmacare.

Each of the union representatives and one employer interviewed for this study expressed their support for universal pharmacare. Three out of five consultants argued in favor of a national pharmacare plan while the other two favored some other form of national risk pooling or formulary management to address costs.

While a majority of interviewees favored some form of universal coverage, a few respondents from the insurer and employer sides expressed concerns that universal pharmacare is not feasible.

The employers indicated that their over-riding strategy is to maintain cost-neutrality in providing drug benefits – in the context of overall compensation – to employees: any increases in the costs of a particular benefits area must be off-set by cost-savings elsewhere. Controlling knowledge was also frequently reported by the union-side respondents (and by one consultant that services employers) as a strategy to achieve greater control over negotiations and plan design by firms. According to one union representative, “

Marc-Andre Gagnon has received research funding by the Canadian Federation of Nurses’ Unions for a different research project related to drug coverage in Canada. Alan Cassels is co-director of DECA (Drug Evaluation Consulting and Analysis). The authors would like to acknowledge the financial contribution of the Canadian Health Coalition in order to pay for the transcription of interviews.

But why are private plans so inefficient in Canada? We can learn a lot about why companies squander tons of money on prescription drugs by looking at how they negotiate drug plans with their employees and other players in the insurance universe. Our new study in Health Policy analyzes how drug plans are negotiated in the private sector.

Our findings show that everyone keeps each other in the dark about the drug plans they negotiate. Employers who understand the technical details of their drug plans withhold data on drug spending from employees, thus awarding them an advantage in the negotiating process. Union experts may understand that their drug plans are inefficient but they often lack sufficient detail of drug spending in order to convince employees about the need to introduce cost-containment measures.

Insurers could raise awareness to change this irrational norm of covering everything, since covered drugs often do not provide additional therapeutic value for money. One solution would be to proactively implement managed drug formularies. However, insurers’ financial incentives are not aligned with those of their clients because inefficient drug plans are unfortunately very profitable for insurers.

The problem is that insurers are paid as a percentage of the drug bill. So the bigger the bill, the more they make – a principle that runs counter to the drive to root out and eliminate waste in the compensation package. Sometimes drug companies explicitly target private drug plans for their products because such plans do not implement restrictions to get value for money.

Most of the interviewees agreed that a universal pharmacare program in Canada makes sense and we need to move in that direction.

It is not wrong for cities to care for their employees. But leaving these costs to the cities makes about as much sense as requiring every homeowner to maintain the roads and infrastructure surrounding their properties. Just as would happen if infrastructure were left to individual homeowners, the system that leaves drug coverage to individual patients and employers - including cities - creates an unco-ordinated patchwork. Most cities provide coverage, but some can't afford to. Some workers qualify for coverage, but some don't.

The same pattern plays out in cities, hospitals, schools and businesses across the country. As a result, millions of Canadians are without drug coverage and one in 10 Canadians cannot afford to fill their prescriptions. This patchwork is inequitable and profoundly inefficient because it fails to place responsibility for drug coverage and costs with the right level of government.

Provinces and the federal government are responsible for Canada's health-care system. They are best suited to manage access to medicines as an integral part of health care for all Canadians. They are also best positioned to reduce waste and overspending on pharmaceuticals. Having multiple drug plans operating in every province - including multiple private plans for public-sector employees - needlessly duplicates administrative costs. This fragmentation also diminishes Canadians' purchasing power on the global market for pharmaceuticals. Provincial governments wield about $10 billion in purchasing power when negotiating rebates for prescription drugs. This reduces public drug-plan costs by millions of dollars, but it does not lower costs for cities and other organizations that insure their workers through private drug plans that are minuscule in comparison. No matter how hard they try, cities would have about as much chance of negotiating competitive drug prices as homeowners would have of securing the best prices for infrastructure planning, engineering and construction.

Some things are best done through well-planned, population-level procurement processes. A recent study in the Canadian Medical Association Journal shows how a universal public drug plan run by the provinces could provide all Canadians coverage for prescription drugs while saving taxpayers $7 billion per year. Such a program would end the downloading of prescription drug costs to local governments and thereby allow cities to better address problems like traffic, housing and crime.

The federal and provincial governments should take responsibility for our prescription drug problem by implementing universal pharmacare for all Canadians. Doing so would support the health and wellbeing of public-and private-sector workers alike at far lower cost than Canadians are paying for our disorganized, patchwork system today. Steve Morgan is a health policy professor at the school of population and public health at the University of B.C.

Low-income adults who do not have employer-sponsored dental coverage through a publicly funded program - and most don't - must pay for their own dental care. Because the cost is often prohibitive, too many adults avoid seeking treatment at dental offices. Instead, they turn to family doctors and emergency departments for antibiotics and painkillers, which cannot address the true cause of the problem. In 2012, in Ontario alone, there were almost 58,000 visits to Ontario hospital emergency rooms due to oral health problems. Why is access to dental care essential now?

A person's oral health will affect their overall health. Dental disease can cause pain and infection. Gum disease has been linked to respiratory infections, cardiovascular disease, diabetes, poor nutrition, and low birth weight babies. Poor oral health can also impact learning abilities, employability, school and work attendance and performance, self-esteem, and social relationships. It is estimated that 4.15 million working days are lost annually in Canada due to dental visits or dental sick days. Persons with visible dental problems may be less likely to find employment in jobs that require face-to-face contact with the public.

Demand for dental care among adults and seniors will only increase as the population continues to grow in Ontario. From 2013 to 2036, Ontario's population aged 65 and over is projected to increase to more than four million people from 2.1 million. It is time all Canadians had access to dental care. This necessitates federal and provincial leadership in putting a framework together to make this possible. Dental health problems are largely preventable and require a comprehensive approach for all ages that includes treatment, prevention, and oral health promotion.

Pharmaceutical coverage in Canada remains an unco-ordinated and incomplete patchwork of private and public plans - one that leaves many Canadians with no prescription drug coverage at all. This has many negative consequences including: Three million Canadians cannot afford to take their prescriptions as written. This leads to worse health outcomes and increased costs elsewhere in the health-care system.

One in six hospitalizations in Canada could be prevented through improved regulation and better guidelines. Medicines are commonly underused, overused, and misused in Canada. Two million Canadians incur more than $1,000 a year in out-of-pocket expenses for prescription drugs. The uncontrolled cost of medicines is also a growing burden on businesses and unions that finance private drug plans for approximately 60 per cent of Canadian workers. Canada pays more than any comparable health-care system for prescription drugs. We spend an estimated $1 billion on duplicate administration of multiple private drug plans. Depending on estimates, we also spend between $4 billion and $10 billion more on prescription drugs than comparable countries with national prescription drug coverage plans.

Affordable access to safe and appropriate prescription medicines is so critical to health that the World Health Organization has declared governments should be obligated to ensure such access for all. Unfortunately, Canada is the only developed country with a universal health care system that does not include universal coverage of prescription drugs. From its very outset, Canada's universal, public health insurance system - medicare - was supposed to include universal public coverage of prescription drugs. The reasoning was simple. It is essential to deliver on the core principles of "access," "appropriateness," "equity" and "efficiency." Building universal prescription drug coverage into Canada's universal health-care system, based on the above principles, is both achievable and financially sustainable.

A public body - with federal, provincial and territorial representation - would establish the national formulary for medicines to be covered. This body would negotiate drug pricing and supply contracts for brand-name and generic drugs. Importantly, it would use the combined purchasing power of the program to ensure all Canadians receive the best possible drug prices and thereby coverage of the widest possible range of treatments. To patients, the program would be a natural extension of medicare: when a provider prescribes a covered drug, the patient would have access without financial barriers.

To society, universal access to safe and appropriately prescribed drugs and access to dental care will improve population health and reduce demands elsewhere in the health system. The single-payer system will also result in substantially lower medicine costs for Canada. In short, Canada can no longer afford not to have a national pharmacare program and a national dental care program. Disclaimer: The Guelph and Wellington Task Force for Poverty Elimination is a non-partisan organization. However, the poverty task force does have ties with two Guelph federal party candidates. Andrew Seagram, the NDP candidate, is a current member of the task force and Lloyd Longfield, the Liberal candidate, is a past member.

But their specific commitment ran out in 1996. Worse for them, some of the patents on big blockbuster drugs have begun to expire.

So the companies try to rearrange the chemical formulas in products and seek patents for drugs very similar to the ones losing patent protection.

prices fall

In addition, the PMPRB regulates prices such that patented drug prices can’t grow by more than the consumer price index over a three-year period.

When drugs lose their patents, generics replace them – sometimes produced directly by the brand-name companies or under contract, more often by a generic drug company.

With prices held down by the PMPRB and patented drugs losing market share, it’s hard to explain why drugs cost so much. Part of it relates to the absurd Canadian system whereby each province negotiates prices; part of it is because drug use overall has skyrocketed; and part of it is tied to these new patents for drugs being not very different from the previously patented ones. Drug expenditures in Canada from 2000 to 2008 grew at twice the growth in the economy (6.4 per cent), faster than anywhere else.

While sales rise, R&D declines. The ratio of R&D to sales rose from 2000 to 2008 in France, Germany, Italy, Switzerland, the United States and Britain, but fell in Canada.

Countries with pharmaceutical head offices definitely get more R&D than branch plant countries such as Canada.

In some of these countries with much greater R&D, patented drug prices are below those in Canada, meaning that no link exists between research intensity and domestic prices.

Canada has the worst of both worlds: high prices, internationally speaking, with a low R&D intensity

Brand-name drug companies have been extensive users of the research tax credits on offer from federal governments (augmented sometimes by provincial ones). These have come under assault from two federal studies into Canada’s lagging innovation. It would appear the Harper government is prepared to shake up this credit

country is being short-changed relative to what it pays for drugs, how it protects them under patent, and compared with what happens in comparable countries

And in case anyone rushes to the defence of generic (off-patent) drug companies, Canadians pay among the highest prices for generic drugs in the world

Today, the program is partially dismantled. Half of the provinces have scaled back their seniors' drug benefits. The rest of the system looks shaky. There has been no nationwide analysis and very little public commentary, just snippets from individual provinces. Now a Montreal think-tank has pulled it all together. The Institute for Research on Public Policy has just released an informative study, "Are Income-Based Public Drug Programs Fit for an Aging Population?"

The institute commissioned three health-care specialists - two from the University of British Columbia and one from Harvard - to track the retrenchment, analyze its impact and offer advice to the provinces that haven't ratcheted back seniors' drug benefits. The authors acknowledge that financial pressures the provinces face are real. Canada's population is aging, drug expenditures are escalating and the economy is no longer robust enough to accommodate rising costs.

What they question is the wisdom of restricting access to medicine for the highest-needs segment of the population

Former B.C. premier Gordon Campbell was the first Canadian politician to curtail drug coverage for seniors. Shortly after taking power in 2001 he imposed a three-year budget freeze on his province's health ministry. The following year, he raised the co-payment on seniors' prescriptions to $25. In 2003, he implemented an income-tested plan - "Fair PharmaCare" - requiring better-off seniors to contribute up to 3 per cent of their annual income to the cost of their medications.

Over the next decade, four of his counterparts followed his lead, imposing restrictions on seniors' drug benefits. In 2012, former Ontario premier Dalton McGuinty went part-way. He reduced public drug coverage for seniors with incomes over $100,000. They are now required to pay the first $100 of their annual drug bill and a $6.11 co-payment (triple the standard seniors' fee of $2) for each prescription. In 2013, Alberta indicated it was considering the B.C. model. That is where things now stand.

The appeal of eliminating universal drug coverage is obvious. It reduces the burden on the public purse. It makes medicare more sustainable. It targets benefits to those who really need them. What's not to like? Three things, the authors say:

It is detrimental to the health of seniors. The more financial barriers governments put in front of elderly residents, the less likely they are to fill their prescriptions. Seniors in B.C. forgo drug treatment at twice the rate of their Ontario counterparts. Although they pay the highest price, taxpayers lose, too. Providing older people with medically necessary drugs is much cheaper than paying their hospital bills when their conditions become unmanageable.

It penalizes Canadians over 65 with chronic conditions or serious disabilities. "In effect the deductibles under income-based programs are tantamount to imposing a specific income tax on people with the highest medical needs," the authors say. This violates the spirit of medicare. And it is financially inefficient. By unloading the cost of medications on seniors and private insurers, governments reduce their leverage in the pharmaceutical marketplace. The fewer citizens they buy for, the less bargaining power they have.

There is a fourth drawback the authors don't mention. The premiers are pushing a full-fledged pharmacare plan out of reach, in defiance of the will of their citizens. Public opinion polls consistently show that 75 to 90 per cent of Canadians want medically necessary drugs brought into medicare. That was part of the vision forged by Saskatchewan premier Tommy Douglas and chief justice Emmett Hall, chair of the Royal Commission on Health Services half a century ago. They recommended that the cost of hospitalization be lifted from families' shoulders first; physicians' fees would be covered next; and finally prescription drugs would be publicly insured.

Today Canada is the only country in the developed world with a universal public health-care system that excludes coverage of prescription drugs. Policy-makers were inching in the right direction until the turn of the millennium. As of 2000, seniors, social assistance recipients and aboriginal people had full drug coverage.

Now the premiers are moving backward, creating an inequitable patchwork of drug coverage for seniors and lowering the likelihood of pharmacare for everyone else. The short-term savings may look appealing. The long-term costs will add up in ways Canadians haven't begun to contemplate.

Carol Goar'

"How can a medicine be too dangerous to import but safe enough to consume? This makes no sense," said Amir Attaran, a law professor and health policy expert at the University of Ottawa. By not ordering a recall, he said, "Health Canada is knowingly leaving adulterated medicines on the pharmacy shelves."

Health Canada said it has restricted imports from the Indian plant as a "temporary precautionary measure," and, so far, a recall is unwarranted. "At this time, no specific safety issues have been identified with these products currently on the market," a government spokesman said in an email.

"If at any time health or safety issues are detected, the department takes immediate action, including a recall, if necessary." Spokespeople for Shoppers, Rexall, Walmart and Costco emphasized that no recall has been made and the regulator has deemed the drugs safe to stay on their shelves. "We will continue to monitor this situation closely," Rexall said in a statement. "If a patient has any concerns or questions about any medications they are taking, we would encourage them to speak with their Rexall pharmacist."

In all the packages the Star purchased in January and early February, the drugs were labelled under the store's own brand, with the name of the tablets' Canadian manufacturer - Pharmascience - in small print. No store had any disclaimer stating products from the company are now under quarantine. Pharmascience, which voluntarily agreed to the government's quarantine, said it retests all of the ingredients it imports and is confident the allergy tablets are safe.

"Safety is our priority. The desloratadine products that have been released on the Canadian market have passed strict quality control tests and have also been deemed safe by Health Canada," company spokeswoman Maria Angelini said. The company said it has secured a new supplier of the chemical ingredients used to make the allergy medication. The problems at the India facility, Dr. Reddy's Laboratories in Srikakulam District, were troubling and numerous, according to an inspection report obtained by the Star.

During a November inspection, agents from the U.S. Food and Drug Administration (FDA) found Dr. Reddy staff repeatedly retested raw materials found to have unacceptable levels of impurities and did not document or report the undesirable results. These problems date back to January 2012. The name of the specific products that failed purity tests are redacted by the FDA from the inspection report, making it impossible to tell which specific drugs are affected.

The inspectors' review of one company hard drive "uncovered evidence that analytical raw data had been collected throughout the month of November 2014 and had been deleted," according to FDA inspectors. "The identity of the product(s) analyzed could not be determined." The first day of the inspection, agents found more data and test results sitting in the trash room, tucked in bags listed as waste material.

The U.S. agents also raised concerns about the water used to manufacture the drug ingredients. A probe of the microbiology lab found "significant growth of both bacteria and mould, and appeared to be TNTC (too numerous to count)." The company's data used for detecting worrisome trends did not mention the problem, inspectors found. Meanwhile, the facility failed "to have adequate toilet and clean washing facilities supplied with hot water, soap or detergent," inspectors found.

A spokesman for Dr. Reddy's said the company agreed to a quarantine and no drug ingredients are currently being exported to Canada. Nick Cappuccino said the firm has conducted its own internal review and has "no reason to question the safety of the products involved. "We are now working collaboratively with (Health Canada) to address their concerns with the goal of lifting the voluntary quarantine as quickly as possible," Cappuccino said.

The University of Ottawa's Attaran, however, said the inspectors' findings should be treated more seriously. "The cheapest greasy spoon in Toronto would be shut down if it had these conditions, but the pharmaceutical company sending stuff to Canada is allowed?" he said. He questions why the government is allowing products originating from the facility to remain on pharmacy shelves, considering Canada's Food and Drugs Act prohibits the sale of any drug manufactured under unsanitary conditions. "The law is very clear on this," he said. "We have evidence here that the product was manufactured under unsanitary conditions, and they're selling it. What more does Health Canada want?"

The government said its decisions about regulatory actions are made on a case-by-case basis and can be "deployed in a graduated and proportional fashion, and tailored to the specifics of individual circumstances." Since a Star investigation in September revealed drug products banned from the U.S. market have been allowed by Health Canada into Canadian pharmacies, the government has banned or quarantined imports from at least nine Indian drug manufacturing facilities. The facilities make more than 100 drugs and drug ingredients imported into Canada. © 2015 Torstar Corporation

"In our view, recent proposals for a universal pharmacare plan under which governments would pay essentially all drug costs with only very limited patient charges, are not realistic," Busby and Blomqvist argue. "We believe it is time to start moving toward a model that makes important inroads into the biggest shortcomings of the expensive and flawed system we have today." They point to five critical deficiencies:

Too many low-income people can't afford to fill their prescriptions. All Canadians pay too much for essential medications. The provinces have no common formulary, meaning the list of insured drugs varies across the country. People with rare diseases who need exceptionally expensive drugs have to beg the government or the manufacturer for help.

Fortuitously, the report - written before this week's election - dovetails nicely with the approach of Canada's new Liberal government. Prime minister-designate Justin Trudeau has promised to "improve access to necessary prescription medications" and "work with the provinces and territories to buy drugs in bulk." That isn't quite pharmacare, but it is similar to what Busby and Blomqvist are recommending. Under the C.D. Howe plan, Ottawa would top up health transfers to the provinces allowing them to ensure that drug costs do not exceed 3 per cent of family income anywhere in Canada. (For a single working parent with two children earning $30,000, the ceiling would be $900. For a two-earner family with two children with an income of $115,500 - the national average - the maximum would be $3,450).

There is no mechanism to improve the quality of prescribing by physicians. The key to addressing all these problems, the authors say, is an increased role for the federal government in drug financing. Ottawa wouldn't run the program or deliver the drugs; it would provide the cash and co-ordination to bring the existing provincial programs up to an acceptable national standard.

All of the provinces currently have upper limits but they vary from 3 per cent to 12 per cent of family income. Ontario's is 4 per cent. Ottawa would become a partner in the Pan-Canadian Pharmaceutical Alliance launched by the premiers and territorial leaders in 2010 to bulk-purchase prescription drugs. This would increase its financial muscle - the federal government supplies medications to the prison population, First Nations, soldiers and veterans - when negotiating drug prices. It would also allow the federal government to play a co-ordinating role in creation of a single national drug formulary, based on transparent clinical evidence of cost-effectiveness.

Ottawa would work with the provinces to design a national strategy for rare and high-cost diseases. Similarly it would help them build incentives into their drug plans for doctors to take responsibility for the cost of the prescriptions they write. There would be no fundamental restructuring. A substantial share of drug costs would continue to be privately funded. The disruption would be minimal. Work could begin immediately. Politically the stars are as well-aligned as they are likely to be. The provincial premiers invited Ottawa to join the Pan-Canadian Pharmaceutical Alliance in June. Their health ministers agreed that Ottawa should play a role in improving access to prescription drugs and coverage for low-income Canadians. Trudeau has promised to negotiate a long-term health accord with the premiers and budgeted an additional $415 million for health care next year rising to $1 billion by 2019. And more than 90 per cent of Canadians support universal access to prescription drugs.

"Canadians need improvements to the existing arrangements," Busby and Blomqvist point out. "What we propose would go a long toward achieving the same objectives as those of the federally funded universal drug plan." The question facing Canadians who have waited decades for a national publicly funded pharmacare program is: Do they settle for watered down version or hold out for the gold standard? They could wait a very long time. Carol Goar's column appears Monday, Wednesday and Friday.

In their recent CMAJ article, Morgan and colleagues present just such a study.2 Using recently available national data on drug use and costs, they report an economic model that estimates the cost of implementing national public drug coverage. The model anticipates several key evidence-based consequences of universal pharmacare. Patients who were previously unable to access drugs would now receive them, which would drive up costs. However, the greatly enhanced purchasing power of a single national third-party payer would be expected to confer an ability to negotiate substantial reductions in the prices of many drugs, as other countries have experienced and as Canadian provinces are already trying to achieve through collaboration. The model also assumes that patients would incur modest copayments, as is the case in other countries with universal pharmacare.

The bottom line? The best estimate would require the federal government to spend an extra $1 billion per year. That’s a lot of money, but considering that federal transfers for health care to the provinces and territories amount to $35 billion — not to mention everything the federal government spends directly on health — relatively speaking, it’s not that much of an increase. As with all modelling studies, these estimates rely on assumptions, and the associated uncertainties mean that costs could be higher — as much as $5.4 billion per year in the worst imaginable case. Equally, though, national pharmacare could well result in net savings for government — perhaps as much as $2.9 billion per year.

Morgan SG, Law M, Daw JR, et al. Estimated cost of universal public coverage of prescription drugs in Canada. CMAJ 2015;187:491–7. Abstract/FREE Full Text

A small number of drug classes are key drivers of overall costs and would continue to be so with or without pharmacare. Some (e.g., biologic agents) represent classes in which many emerging new therapies are expected to arise. Thus, the $1 billion estimate might not be stable going forward. But knowing this information may now enable policy-makers to develop specific interventions focused on reducing the impact of these key cost drivers even further.

Although the Canada Health Act has long enshrined the value of equitable, public health care coverage for all Canadians, its enactment by governments to date has been hypocritical in the absence of pharmacare. Canada has the dubious distinction of being the only country with universal health care coverage, but not universal pharmacare. As we have said before,3 the time to end this hypocrisy is long overdue; all of our peer nations have already done so. The moral case for universal pharmacare has always been apparent. With a strong economic case for pharmacare also evident, there can be no more excuses for delay. In this election year, it is especially timely for Canadians to demand that their next government enact national pharmacare.

Tang KL, Ghali WA, Manns BJ. Addressing cost-related barriers to prescription drug use in Canada. CMAJ 2014;186:276–80. FREE Full Text

Even more striking are the potential benefits to the private sector: no matter what, it would save a lot of money from pharmacare. Currently, nearly half of all drug expenditures in Canada are incurred by the private sector, divided almost evenly between individuals, whose costs would drop by more than half under pharmacare, and private drug plans, whose current costs for nearly all prescription drugs would disappear completely. Of note, a big chunk of public savings would arise from what governments presently spend on private drug coverage, such as for civil servants. With projected savings like these, one would expect that private companies, governments and individuals alike should be clamouring for pharmacare.

tanbrook MB, Hébert PC, Coutts J, et al. Can Canada get on with national pharmacare already? CMAJ 2011;183:E1275. FREE Full Text

Imagine if a Canadian diagnosed with cancer were told she could receive chemotherapy paid for by the health-care system, but would have to cough up the cash herself if she needed radiation. Or that she could have a few weeks of treatment, and then be sent home even if she needed more. That would never fly. If doctors, say, find a tumour in a patient's colon, the government kicks in and offers the mainstream treatment that is most effective. But for many Canadians diagnosed with a mental illness, the prescription is very different. The treatment they receive, and how much of it they get, will largely be decided not on evidence-based best practices but on their employment benefits and income level: Those who can afford it pay for it privately. Those who cannot are stuck on long wait lists, or have to fall back on prescription medications. Or get no help at all. But according to a large and growing body of research, psychotherapy is not simply a nice-to-have option; it should be a front-line treatment, particularly for the two most costly mental illnesses in Canada: anxiety and depression - which also constitute more than 80 per cent of all psychiatric diagnoses.

Why aren't we providing evidence-based care?" .. The case for psychotherapy Research has found that psychotherapy is as effective as medication - and in some cases works better. It also often does a better job of preventing or forestalling relapse, reducing doctor's appointments and emergency-room visits, and making it more cost-effective in the long run.

Therapy works, researchers say, because it engages the mind of the patient, requires active participation in treatment, and specifically targets the social and stress-related factors that contribute to poor mental health. There are a variety of therapies, but the evidence is strongest for cognitive behavioural therapy - an approach that focuses on changing negative thinking - in large part because CBT, which is timelimited and very structured, lends itself to clinical trials. (Similar support exists for interpersonal therapy, and it is emerging for mindfulness, with researchers trying to find out what works best for which disorders.) Research into the efficacy of therapy is increasing, but there is less of it overall than for drugs - as therapy doesn't have the advantage of well-heeled Big Pharma benefactors. In 2013, a team of European researchers collated the results of 67 studies comparing drugs to therapy; after adjusting for dropouts, there was no significant difference between the most often-used drugs - selective serotonin reuptake inhibitors (SSRIs) - and psychotherapy.

The issue is not one against the other," says Montreal psychiatrist Alain Lesage, director of research at the Douglas Mental Health University Institute. "I am a physician; whatever works, I am good. We know that when patients prefer one to another, they do better if they have choice." Several studies have backed up that notion. Many patients are reluctant to take medication for fear of side effects and the possibility of difficult withdrawal; research shows that more than half of patients receiving medication stop taking it after six months. A small collection of recent studies has found that therapy can cause changes in the brain similar to those brought about by medication. In people with depression, for instance, the amygdala (located deep within the brain, it processes basic memories and controls our instinctive fight-or-flight reaction) works in overdrive, while the prefrontal cortex (which regulates rational thought) is sluggish. Research shows that antidepressants calm the amygdala; therapy does the same, though to a lesser extent.

But psychotherapy also appears to tune up the prefrontal cortex more than does medication. This is why, researchers believe, therapy works especially well in preventing relapse - an important benefit, since extending the time between acute episodes of illnesses prevents them from becoming chronic and more debilitating. The theory, then, is that psychotherapy does a better job of helping patients consciously cope with their unconscious responses to stress.

According to treatment guidelines by leading international professional and scientific organizations - including Canada's own expert panel, the Canadian Network for Mood and Anxiety Treatments - psychotherapy should be considered as a first option in treatment, alone or in combination with medication. And it is "highly recommended" in maintaining recovery in the long term. Britain's independent, research-guided scientific body, the National Institute for Health and Care Excellence, has concluded that therapy should be tried before drugs in mild to moderate cases of depression and anxiety - a finding that led to the creation of a $760million public system, which now handles therapy referrals for nearly one million people a year.

In 2012, Canada's Mental Health Commission estimated that only about one in three adults and one in four children are receiving support and treatment when they need it. Ironically, anti-stigma campaigns designed to help people understand mental illness may only make those statistics worse. In Toronto, for instance, putting up posters in subway stations in 2010 had the unexpected effect of spiking the volume of walk-ins at nearby emergency rooms by as much as 45 per cent in 12 months. Dr. Kurdyak treated many of them at CAMH. The system, he says, "has been conveniently ignoring this unmet need. It functions as if two-thirds of the people suffering won't get help." What would happen if the healthcare system outright "ignored" two-third of tumour diagnoses?

Essentially, argues Dr. Lesage, adding therapy into the health-care system is like putting a new, highly effective drug on the table for doctors. "Think about it," he says. "We have a new antidepressant. It works as well as many others, and it may even have some advantages - it works better for remission - with fewer side effects. The patients may prefer it. And [in the long run] it doesn't cost more than what we have. How can it not be covered?" ..

A heavy price This isn't just a medical issue; it's an economic one. Mental illness accounts for roughly 50 per cent of family doctors' time, and more hospital-bed days than cancer. Nearly four million Canadians have a mood disorder: more than all cases of diabetes (2.2 million) and heart disease (1.4 million) combined.

Mental illness - and depression, in particular - is the leading cause of disability, accounting for 30 per cent of workplace-insurance claims, and 70 per cent of total compensation costs. In 2012, an Ontario study calculated that the burden of mental illness and addiction was 1.5 times that of all cancers, and more than seven times the cost of all infectious diseases. Mental illness is so debilitating because, unlike physical ailments, it often takes root in adolescence and peaks among Canadians in their 20s and 30s, just as they are heading into higher education, or building careers and families. Untreated, symptoms reverberate through all aspects of life, routinely trapping people in poverty and homelessness. More than one-third of Ontario residents receiving social assistance have a mental illness. The cost to society is clearly immense.

Yet, when family doctors were asked why they didn't refer more patients to therapy in a 2008 Canadian survey, the main reason they gave was cost. For many Canadians, private therapy is a luxury, especially if families are already wrestling with the economic fallout from mental illness. Costs vary across provinces, but psychologists in private practice may charge more than $200 an hour in major centres. And it's not just the uninsured who are affected.

Although about 60 per cent of Canadians have some form of private insurance, the amount available for therapy may cover only a handful of sessions. Those with the best benefits are more likely to be higherincome workers with stable employment. Federal public servants, notably, have one of the best plans in the country - their benefits were doubled in 2014 to $2,000 annually for psychotherapy. Many of those who can pay for therapy are doing so: A 2013 consultant's study commissioned by the Canadian Psychological Association found that $950-million is spent annually on private-practice psychologists by Canadians, insurance companies and workers compensation boards. The CPA estimates t

These are the patients that family doctors juggle, the ones who eat up appointment time, and never seem to get better, the ones caught on waiting lists. Sometimes, they have already been bounced in and out of the system, received little help, and have become wary of trying again. A 40-something mother recovering from breast cancer, suffering from chronic depression post-treatment, debilitated by fear her cancer will return. A university student, struggling with anxiety, who hasn't been to class for three weeks and may soon be kicked out of school. A teenager with bulimia removed from an eatingdisorder program because she couldn't follow the rules. They are the ones dangling on waiting lists in the public system for what often amounts to a handful of talk-therapy sessions, who don't have the money to pay for private therapy, or have too little coverage to get the full course of appointments they need.

Canada's investment does not match that burden. Only about 7 per cent of health-care spending goes to mental health. Even recent increases pale when compared to other countries: According to a study by the Canadian Mental Health Association, Canada increased per-capita funding by $5.22 in 2011. The British government, meanwhile, kicked in an extra 12 times that amount per citizen, and Australia added nearly 20 times as much as we did. Falling off a cliff, again and again

In Winnipeg, Dr. Stanley Szajkowski watched for months as his patient, a woman in her 80s, slowly declined. Her husband had died and she was spiralling into a severe depression. At every appointment, she looked thinner, more dishevelled. She wasn't sleeping, she admitted, often through tears. Sometimes she thought of suicide. She lived alone, with no family nearby, and no resources of her own to pay for therapy. "You do what you can," says Dr. Szajkowksi. "You provide some support and encouragement." He did his best, but he always had other patients waiting.

hat 30 per cent of private patients pay out-ofpocket themselves. When the afflicted don't seek help, the cost isn't restricted to their own pocketbook. People with mental-health problems are significantly more likely to abuse drugs and alcohol, and to become physically sick, further increasing health-care costs. A 2014 study by Oxford University researchers found that having a mental illness reduced life expectancy by 10 to 20 years, roughly the same as did smoking and obesity. A 2008 Statistics Canada study linked depression to new-onset heart disease in the general population. A 2014 U.S. study found that women under the age of 55 are twice as likely to suffer or die from a heart attack, or require heart surgery, if they have moderate to severe depression. The result: clogged-up doctors' offices, ERs, and operating rooms. And an inexorable burden for the patients' families forced to fill the gaps in caregiving - or carry on when they lose a loved one.

Patients refer to it as falling repeatedly off a cliff. And they can only manage the climb back up so many times. Family doctors interviewed for this story admitted that they are often "handholding" patients with nowhere else to go. "I am making them feel cared for, I am providing a supportive ear that they may not get anywhere else," says Dr. Batya Grundland, a physician who has been in family practice at Toronto's Women's College Hospital for almost a decade. "But do I think I am moving them forward with regard to their illness, and helping them cope better? I am going to say rarely." More senior doctors have told her that once in a while "a light bulb goes off" for the patients, but often only after many years. That's not an efficient use of health dollars, she points out - not when there are trained therapists who could do the job better. However, she says, "in some cases, I may be the only person they have."

Family doctors aren't the only ones struggling to find therapy for their patients. "I do a hundred consultations a year," says clinical psychiatrist Joel Paris, a professor at McGill University and research associate at the Montreal Jewish General, "and one of the most common situations is that the patient has tried a few anti-depressants, they have not responded very well, and from their story it is obvious they would benefit from psychotherapy. But where do they go? We have community clinics here in Montreal with six-to-12-month waiting lists even for brief therapy." A fractured, inefficient system

"You fall into the role that is handed to you," says Antoine Gagnon, a family doctor in Osgoode, on the outskirts of Ottawa. He tries to set aside 20-minute appointments before lunch or at the end of the day to provide "active listening" to his patients with anxiety and depression. Many of them are farmers or self-employed, without any private coverage for therapy. "Five of those minutes are spent talking about the weather," he says, "and then maybe you get into the meat of the problem, but the reality is we don't have the appropriate amount of time to give to therapy, even to listen, really." Often, he watches his patients' symptoms worsen over several months, until they meet the threshold of a clinical diagnosis. "The whole system could save on productivity and money if people were actually able to get the treatment they needed."

But these issues aren't insurmountable, as other countries have demonstrated. Britain, for instance, has trained thousands of university graduates to become therapists in its new public program, following research showing that, as long they have the proper skills, people don't need PhDs to be effective therapists. Australia, which has created a pay-for-service system, also makes wide use of online support to cost-effectively reach remote communities.

Except for a small fraction of GPs who specialize in psychotherapy, few family doctors have the training - or the time - to provide structured therapy. Saadia Hameed, a GP in a family-health team in London, Ont., has been researching access to psychotherapy for an advanced degree. Many of the doctors she has interviewed had trouble even producing a clear definition of therapy. One told her, "If a patient cries, than it's psychotherapy." Another described it as "listening to their woes." A 2007 survey of 163 family doctors in Ontario found that almost four out of five had not received training in cognitive behavioural therapy, and knew little about it. "Do family doctors really need to do that much psychotherapy," Dr. Hameed asks, "when there are other people trained - and better trained - to do it?"

What further frustrates treatment for physicians and patients is lack of access to specialists within the system. Across the country, family doctors describe the difficulty of reaching a psychiatrist to consult on a diagnosis or followup with their patients. In a telling 2011 study, published in the Canadian Journal of Psychiatry, researchers conducted a real-world experiment to see how easily a GP could locate a psychiatrist willing to see a patient with depression. Researchers called 297 psychiatrists in Vancouver, and reached 230. Of the 70 who said they would consider taking referrals, 64 required extensive written documentation, and could not give a wait-time estimate. Only six were willing to take the patient "immediately," but even then, their wait times ranged from four to 55 days. Psychiatrists are in increasingly short supply in Canada, and there's strong evidence that we're not making the best use of these highly trained specialists. They can - and often do - provide fee-for-service psychotherapy in a private setting, which limits their ability to meet the huge demand to consult with family doctors and treat the most severe cases.

A recent Ontario study by a team at CAMH found that while waiting lists exist in both urban and rural centres, the practices of psychiatrists in those locations tend to look very different. Among full-time psychiatrists in Toronto, 10 per cent saw fewer than 40 patients, and 40 per cent saw fewer than 100 - on average, their practices were half the size of psychiatrists in smaller centres. The patients for those urban psychiatrists with the smallest practices were also more likely to fall in the highest income bracket, and less likely to have been previously hospitalized for a mental illness than those in the smaller centres.

And those therapy sessions are being billed with no monitoring from a health-care system already scrimping on dollars, yet spending a lot on this care: On average, psychiatrists earn $216,000 a year. There is nothing to stop psychiatrists from seeing the same patients for years, and no system to ensure the patients with the greatest need get priority. In Australia, Britain and the United States, by contrast, billing for psychiatrists has been adjusted to encourage them to reduce psychotherapy sessions and serve more as consultants, particularly for the most severe cases, as other specialists do.

As the Canadian system exists now, says Benoit Mulsant, the physician-in-chief at CAMH and also a psychiatrist, the doctors in his specialty "can do whatever they please. If I wanted, I could have a roster of actor patients who tell me entertaining stories, and I would be paid the same as someone who is treating homeless people. ... By treating the rich and famous, there is zero risk of being punched in the face by a patient." Left out in all this, by and large, are other professionals who can provide therapy. It doesn't help that the rules are often murky around who can call themselves psychotherapists. While psychologists and social workers are licensed under their professional associations, in some provinces a person can call himself a marriage counsellor or music therapist with no one demanding they be certified. In 2007, Ontario passed a law to regulate psychotherapists, requiring them to register with a provincial college that would set standards and handle complaints. Currently, however, the law is in limbo, although the government has said it will finally bring it into force by December. The brain keeps many secrets

Science, however, has yet to find depression's equivalent of insulin. Despite being scanned, poked and stimulated over and over and over again, the brain keeps its secrets. The "chemical imbalance" theory is now viewed as simplistic at best. It may not do much for patients, either: A 2014 study published in the journal Behaviour Research and Therapy suggested that, rather than reassuring them, focusing on the biological explanation for depression actually made patients feel more pessimistic and lacking in control. SSRIs work by increasing the amount of serotonin, a chemical that helps deliver messages within the brain and is known to influence mood. But researchers aren't sure why the drugs help some patients and fail with others. "Basically, it's like we have a bucket of water and we pour it over the patient's head," says Dr. Georg Northoff, the University of Ottawa's Michael Smith chair of Neurosciences and Mental Health. "But you want a drug that injects the water in a very specific brain regions or brain system, which we don't have."

Critics of therapy have argued that it's basically "good listening" - comparable to having a sympathetic friend across the kitchen table - and that in the real world of mercurial patients and practitioners of varying abilities, a pill just works better. That's true in many cases, especially when the symptoms are severe and the patients is suicidal: a fast-acting medication is safer, and may even be necessary before starting talk therapy. The staunchest advocates of therapy do not suggest it should be the first course of treatment for psychosis, or debilitating chronic depression, or mania - although, in those cases, there is evidence that psychotherapy and medication work well in tandem. (A 2011 meta-analysis found that patients with severe depression who received a combination approach had higher recovery rates and were less likely to drop out of treatment.) But drugs also don't work as well as the manufacturers would like us to think. Roughly one-third of patients given a drug will see no benefit (although they often respond to a second or third medication). In randomly controlled trials, drugs often perform only marginally better than sugar pills.

Yet it's talk therapy that the public often views most skeptically. "Until you go to a therapist, or a member of your family has a serious psychological problem, people are unsympathetic [about therapy]," says Dr. Paris, the Montreal psychiatrist. "They are very skeptical, and they don't believe the research. It's amazing, because pharmaceutical trials will get approval for a drug on the basis of two clinical trials that they paid for. And we have 100 clinical trials and no one believes us."

Dr. Ajantha Jayabarathan, an assistant professor at Dalhousie University's medical school, spent her early years as a family doctor in Spryfield, N.S., trying to manage an overload of mental-health cases. Most of her patients had little insurance; there was one reduced-cost counselling service in town, but the waiting lists were long. In 2000, her group practice became a test site for a shared-care project, which gave the doctors access to a mental-health team, including weekly in-person consultations with a psychiatrist. "It was transformative," she says. "We looked after everything in-house.

Over time, Dr. Jayabarathan says, she learned how to properly assess mental illness in patients, and how to use medication more effectively. "I just made it my business to teach myself what to do." It's the kind of workaround GPs are increasingly experimenting with, waiting for the system to catch up. Who would pay - and how?

The case for expanding publicly funded access to therapy is gaining traction in Canada. In 2012, the health commissioner of Quebec recommended therapy be covered by the province; it is now being studied by Quebec's science-based health body (INESSS), which is expected to report back next year. A new Quebec-based organization of doctors, researchers and mental-health advocates called the Coalition for Access to Psychotherapy (CAP) is lobbying the government.

In Manitoba, the Liberal Party - albeit well behind in the polls - has made the public funding of psychologists one of its campaign platforms for the province's spring 2016 election. In Saskatchewan, the government commissioned, and has since endorsed, a mental-health action plan that includes providing online therapy - though politicians have given themselves 10 years to accomplish it. Michael Kirby, the former head of the Canadian Mental Health Commission, has been advocating for eight annual sessions of therapy to be covered for children and youth in need.

There are significant hurdles: Which practitioners would provide therapy, and how would they be paid? What therapies would be covered, and for how long? Complicating every aspect of major mentalhealth change in Canada is the question of who should shoulder the cost: the provinces or Ottawa. In a written statement in response to questions from The Globe and Mail, federal Health Minister Rona Ambrose lobbed the issue back at her provincial counterparts, pointing out that the Canada Health Act does not "preclude provinces and territories from extending public coverage to other services or providers such as psychologists."

One result can be overloaded family doctors minimizing mental-health problems. "If you have nothing to offer someone," asks Dr. Anderson, "how much are you going to dig around to find out what is going on?" Some doctors also admit that the lack of resources can lead to physicians cherry-picking patients who don't have mental illness. And yet family physicians alone bill about $361million a year for counselling or psychotherapy in Canada - 5.6 million visits of roughly 30 minutes each. This is a broad category, and not always specifically related to mental health (some of it includes drug counselling, and a certain amount of coaching is a necessary part of the patient-doctor relationship). When it is psychotherapy, however, doctors admit it's often more supportive listening than actual therapy.

So how would Canada pay for access to such therapy? It wouldn't be cheap, in the short term. The savings would come from what Canadians would not have to spend in the long term: in additional medical and drug costs, emergency-room visits and hospital stays, and in unnecessary disability payments, to say nothing of better long-term health outcomes for patients given good care earlier. Some of the figures being tossed around sound staggering. Rolling out a version of Britain's centre-based program across Canada would cost $950-million. Michael Kirby's plan would amount to $1,000 annually per patient. A 2013 report commissioned by the Canadian Psychological Association calculated that, based on predicted need, and assuming no coverage from private health-care plans, providing an average of six sessions of therapy a year would cost an estimated $2.8-billion annually.

But any of those figures would still be a fraction of the roughly $210-billion that Canada spends annually on health care. Figuring out how to make the system most costeffective is, according to sources, currently delaying the INESSS report to the Quebec government. "You need to facilitate the government," says Helen- Maria Vasiliadis, a professor of community health at the University of Sherbrooke. "You can't be going to policymakers and showing them billions and billions of dollars. People start having heart attacks. With evidence in hand, we have to present possible solutions."

An insurance-based plan is the proposal that has emerged from the Quebec-based CAP group, which sent its proposal to Quebec's health minister last month. In its design, the system would work much like Quebec's public drug plan - Quebeckers not covered through work plans would contribute to a provincial insurance program for therapy. That would be similar to the system that Germany has used for decades. One step forward, one step back

Last year, the Sherbrooke clinic where Marie Hayes works received provincial funding for a part-time psychologist and a full-time social worker. With a roster of 25,000 patients, the clinic team laid out clear guidelines for the psychologist, who would consult on cases and screen patients, and be limited to a mere four sessions of actual counselling with any one patient. "We wanted to be careful she didn't become a waiting list - like everything in the system," says Dr. Hayes. The social worker helps guide patients into services such as housing and addiction counselling. They have also offered group sessions for depression management at the clinic. As stretched as those new professionals are in such a large practice, Dr. Hayes says the addition of that mental-health team is improving the care she can provide patients. Recently, for instance, the 32- year-old mother with anxiety attended sessions with the psychologist. "She is making progress," says Dr. Hayes, "slowly."

At Women's College Hospital in Toronto, Dr. Grundland is not so lucky. Asked to describe a difficult case, the family-practice physician mentions a patient suffering from depression after a lifechanging accident. Every month, doctor and patient would repeat the same conversation they'd already had more than a dozen times - and make little real headway. Her patient, says Dr. Grundland, needs a trained therapist: someone she can see regularly, to help her move past her frustration, counsel her about addiction, and ease the burden on her family.

But there's no extra money in the patient's budget for a psychologist. "I do my best," Dr. Grundland says, "but it's not my area of expertise." Meanwhile, the patient isn't getting better, and in the time that it takes to make it through one appointment with her, Dr. Grundland could see three other people with problems she was actually trained to treat. "But," says Dr. Grundland, "she has nowhere else to go." Erin Anderssen is a feature writer at The Globe and Mail. OPEN MINDS How to build a better mental health care system

The Centre for Addiction and Mental Health has purchased advertisements to accompany this series. While CAMH professionals are quoted in this story, the organization had no involvement in the creation or production of this, or any other story in the series. $20.7-billion The cost, according to a 2012 Conference Board of Canada report, of lost productivity each year due to mental illness. What else does $20-billion represent?

$20B: Canadian spending on national defence, 2012-13 $20B: Market valuation of Airbnb, 2015 $21B: Kitchener-CambridgeWaterloo region's GDP, 2009 $21B: Amount food manufacturing contributed to the economy, 2012

However, according to a recent study in the Canadian Medical Association Journal, a universal public drug plan, one facilitated by the federal government and run by the provinces, would be cost-saving. Such a plan could provide coverage for all Canadians, ensuring access to the prescription drugs they need, while saving Canadians $7.3 billion a year - a 32 per cent reduction in total drug expenditures.

Individuals and businesses would save $8.2 billion while government expenditures would increase by $1 billion, which is considerably less than 1 per cent of current government expenditures on health care. The cost to governments could be even less because these figures don't account for the potential savings from reduced use of publicly-funded hospital and physician services resulting from improved access to safe, effective and appropriate medications. Let's stop for a minute and imagine: a social program that improves health and saves Canadians several times the added cost to the public purse. What's not to like?

A national pharmacare plan would yield substantial benefits for municipalities such as Hamilton. Approximately two-thirds of municipal employees in Canada, including those in Hamilton, receive supplemental health care insurance through their employer. In Hamilton, prescription drug coverage represents over half the cost of employee health benefits. Cities across Canada spend more than $500 million each year on drug plans. Imagine what it would mean to have that money available for other municipal priorities. Council's recent support of a national pharmacare plan clearly makes good economic sense. Hamilton has joined other cities across the country in its call for such a plan. Organizations and individuals are adding their voices through the Campaign for National Drug Coverage (www.campaign4nationaldrugcoverage). It's time to add prescription drugs to Canadian medicare. Dr. Brian Hutchison, Professor Emeritus of Family Medicine and Clinical Epidemiology and Biostatistics at McMaster University, is a retired family physician and is on the board of directors of Canadian Doctors for Medicare.

These are very good first steps, but still more needs to be done on a number of fronts. The committee heard compelling evidence that there is an urgent need for substantially improved physician training in prescribing "off-label" and addictive pharmaceuticals. "Off-label" refers to drugs that are prescribed for use beyond the approved criteria; our report reveals that the extent of off-label prescribing is not known and, in fact, physicians are frequently unaware that they are prescribing off-label. Consequently, little is known about the most common types of off-label use. We need improved data collection and for the Drug Safety and Effectiveness Network to take an active role in assessing off-label drug uses. We also need an enforcement of the prohibition on off-label drug promotion by drug manufacturers. The report also emphasizes the need for regular and accessible "take back" programs to collect unused prescription drugs to keep them from being discharged improperly into the environment. Drug shortages are not a new phenomenon, but they have been increasing in frequency and duration over the last decade.

Ms. Rius said there were six problem areas - from MSF's perspective - in the early leaked versions of the TPP. Three have been eliminated in the final text, although she said some of those were "absurd" in the first place. Among them was a provision that would have made it illegal to oppose a patent before it was granted and another that would have forced governments to allow surgical techniques to be patented. There are three key remaining problem provisions, according to the MSF analysis. One would allow pharmaceutical companies to "evergreen" their product patents, essentially making small changes to a drug's use to extend its protection from competition. Another would extend patent protection if there are delays in regulatory approval of a new product.

More broadly, allowing greater monopoly protection for brand-name drug makers will diminish innovation at other firms, Ms. Rius said. "If you are trying to develop a pediatric formulation of a product, if you are trying to combine different pills into one pill, ... if you are trying to improve a medicine and create a second generation, all of that technology and knowledge is going to be protected by secondary patents." The final text of the sweeping trade pact, which has been in the works for eight years, was released in early November. Canada is one of 12 countries that have negotiated the pact, although it was the former Conservative government that signed on. Prime Minister Justin Trudeau said his government will wait for parliamentary hearings on the TPP before deciding on ratification. Each country has to ratify the agreement before it comes into effect.

For generic drug makers, she said, the TPP will create additional legal barriers that will get in the way of making new products, and that will stunt the industry. The TPP will actually raise drug prices, especially in developing countries, she said, and this "will affect our capacity, and the capacity of the ministries of health with whom we work, to scale up treatment programs and reach as many people as needed."

A third would allow developers of certain advanced drugs - called biologics - to keep their clinical data private for up to eight years. That would make it much tougher for competitors to create similar drugs, or at least delay that from happening. This "data exclusivity" rule would be new for some of the countries that are part of the TPP group, although Canada already has a similar provision in place. Indeed, many of the provisions of the TPP are already part of the Canadian scene, at least in some form, said trade lawyer Larry Herman, of Herman & Associates in Toronto. The former Conservative government had said the TPP was "in line" with Canada's existing patent laws, and this appears to be true from his read of that part of the text, Mr. Herman said.

Still, he said, from a global perspective "there is no doubt that the agreement increases patent protection and enhances the monopoly rights of the patent owner." From the perspective of Canada's generic drug industry, the TPP has to be looked at in conjunction with the Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union, said Jim Keon, president of the Canadian Generic Pharmaceutical Association.

CETA, which has not yet taken effect, would extend patent protection for drugs and cut into the business of Canadian generic drug makers - thus boosting drug costs - Mr. Keon said. But it also contains some specific protection for the generic industry to mitigate that impact. It is not clear yet whether the TPP will allow those mitigating measures to be implemented in Canada, he said. And because of the immense complexity of the TPP, "you've got all sorts of potential for misinterpretation here," Mr. Keon added.

At Chartwell, a chain of 27 homes, chief operating officer Karen Sullivan said the pharmacy that services the chain, MediSystem, pays for "many additional valued-added services" such as employee education, nurse leadership sessions and conferences for leaders of homes. MediSystem also pays for Wi-Fi systems and therapeutic care equipment at the homes, Sullivan said in an email. The Star asked pharmacies what they are told the money is used for. Among the responses from pharmacies were "staff education," "resident programs" and payments toward Wi-Fi systems. Classic Care, a pharmacy, said the money it pays covers monthly rent of an area in the nursing home, staff education, technology and "donations and sponsorships" for conferences and other training. Other pharmacies, such as Rexall, say their fees have paid for diabetes education, for example. The largest pharmacies serving long-term-care homes in Ontario include Medical Pharmacies Group, MediSystem (owned by Loblaw), Classic Care (Centric Health) and Rexall. The fees are not new. Pharmacies have willingly offered money or agreed to demands for years. But there's a growing outrage among some who say homes are more interested in "inducements" than "clinical excellence" that pharmacies can provide seniors. Last year, after the Ontario government cut each dispensing fee by $1.26 (it is now $5.57 per prescription in nursing homes), sources said some pharmacies wanted to stop paying the fees. The problem was, the sources said, that the homes refused to give up the extra cash flow and other drug companies were willing to pay, so nothing changed.

It's usually the larger companies that can afford to pay. One insider said smaller pharmacies now ask the homes, "Do you want the money or do you want good service? Because we can't afford to give both." Sources said the Ontario Ministry of Health and Long-Term Care knows the money changes hands but does nothing to stop it. Instead, pharmacies are "held hostage" by the homes, the source said. One home that no longer charges the fees is John Noble Home in Brantford, a municipally operated 156-bed facility. The Star obtained a 2010 request for proposals (RFP) that noted "only proposals with a minimum rebate of $20,000 annually will be considered for the project." A spokesperson for the city said the RFP "references a previously approved practice employed by several long-term care homes." A recent RFP did not ask for a rebate, though some offered to pay. The city spokesperson, Maria Visocchi, said it chose a pharmacy that "demonstrated qualifications and experience, project understanding, approach and methodology, medication system processes and quality control." This pharmacy did not offer a rebate. Not all pharmacists pay. Teresa Pitre runs Hogan Pharmacy Partners in Cambridge and serves long-term-care homes that don't ask for money. Instead, she signed contracts with several homes in the People Care chain to provide a "highly personalized approach." Pitre sends a registered pharmaceutical technician into each home daily to relieve nurses of much of their work regarding medication, confusion over communications and extensive paperwork. Her company also puts a bookshelf-sized dispensing machine in each home, which holds medication (pain relievers, antibiotics or insulin) that residents need on short notice but, in the traditional system, often can't get for hours. "I really wanted our pharmacy to be a partner with homes instead of servicing them and just meeting the requirements," she said. Meadus says the added cost of bed fees means pharmacies have no reason to reduce their rates, either by lowering dispensing fees or not charging the $2 co-payment.

A recent Star story revealed that pharmacies serving nursing homes typically charge dispensing fees for drugs once a week, rather than once a month as they typically do in a community pharmacy. Long-term-care pharmacies told the Star they charge the weekly fee because the medication for frail residents can change weekly. That was a claim hotly disputed by some family members the Star spoke to, including Margaret Calver, who has spent years documenting the costs of dispensing fees at Markhaven Nursing Home, where her husband is a resident. "This needs oversight and that's the problem," she said. "Nobody is doing the checks and balances." Moira Welsh can be reached at mwelsh@thestar.ca.

In fact, only Americans, at $1,147 per capita, spend more on drugs than Canadians, at $890.

unlike citizens of most other developed countries, Canadians pay for the majority of their prescription drugs with private insurance or out-of-pocket.

About 39 per cent of prescription drug costs are financed by the public sector in Canada, compared to 85 per cent in Britain.

Public spending on prescription drugs was $12.1-billion last year, up just 2.2 per cent; private spending was $15.1-billion, up 6.8 per cent.

Their trust would be further hit. Within two weeks, the Star reported that health-care companies are allowed to mix drugs for hospitals without federal or provincial oversight, prompting top health officials — Ontario health minister Deb Matthews and federal health minister Leona Aglukkaq — to scramble to close that regulatory grey area.

Since the crisis, all the hospitals involved have stopped outsourcing gemcitabine and cyclophosphamide mixtures and brought it in-house, mixing their own medications.

The federal government has new rules defining who can be a drug producer, adding that any facility supervised by a licensed pharmacist can do the job. The province has said that hospitals can only purchase drugs from accredited suppliers.

The Ontario College of Pharmacists has passed legislation that allows it to inspect any premises where a pharmacist works — not just licensed pharmacies.

All of the changes taken together would have seen Marchese Hospital Solutions still able to supply drugs as it did but subject to inspection by the college.

This week Jake Thiessen, the founding director of the University of Waterloo school of pharmacy, submitted a final report of his investigation into the issue. There has been no formal indication when it will be made public. Hospital administrators say they have been told it will be two to three weeks before they or the public see this report.

There is very little clinical evidence to indicate what might happen to a cancer patient who receives an underdose of chemotherapy.

At the same time, many of the more recent advances in chemotherapy have been in drugs that alleviate side effects like nausea.

In an oncology pharmacy, strange is not good. And on March 20, one week before Marley’s last cyclophosphamide treatment, Craig Woudsma, a 28-year-old pharmacy assistant, and a colleague at the Peterborough Regional Health Centre, had a bad feeling.

In this case, it was a shipment of new gemcitabine chemotherapy bags that required refrigeration, according to the label. Previous batches, from a different supplier, had not.

When preparing the solution, staff at Marchese Hospital Solutions, in Mississauga, Ont., dissolved the medication into a pre-filled 100 mL bag of saline. These bags typically contain between 3 to 20 per cent more solution than 100 mL,

The new bag’s label did not contain enough information for him to accurately mix the patient’s dose. He needed to know the specific concentration.

Woudsma noticed more differences. The bags from Marchese only had a total volume and concentration on the label — 4 grams of gemcitabine in 100 mL of saline — instead of the specific concentration, the amount of drug per single mL of saline, as the old bags indicated.

“I told the pharmacist in the area. And then it kind of went above me at that point ... They came to me saying, this is kind of a big deal; teleconferencing with the minister of health, that kind of stuff,” said recently, sitting on the front steps of his red-brick, semi-detached home in the village of Millbrook, Ont. “It’s kind of a foreign concept, to think that what we do, in our corner of the hospital, is going to get that kind of exposure.”

referred to in the industry as overfill, included to account for possible evaporation.

People have asked Woudsma why he was able to catch a problem that went undetected at other hospitals for more than a year. Simple, he says. He had something to compare it to.

The company’s pharmacy workers did not remove the known overfill when mixing the medication because they thought each bag was going to a single patient

This means that the bag Woudsma was holding contained 4 grams of gemcitabine in more than 100 mL of solution. The concentration of the medication wasn’t what the label would have made him think. It was weaker than advertised.

The hospital had switched that very day to a new supplier — Marchese Hospital Solutions. A bag of the old supply from Baxter CIVA was still on site.

Medbuy, a group purchasing company for hospitals, starting in 2008, had a contract with Baxter Central Intravenous Admixtures to provide drug-mixing services. The two drugs in question, cyclophosphamide and gemcitabine, were outsourced because they come in powder form and are tricky to mix. It takes about four hours to reconstitute them in liquid, and in that time they must be shaken every 20 minutes.

As that contract was about to expire, Medbuy issued a request for proposals for drug-mixing services: Baxter CIVA, which wanted its contract renewed, Quebec-based Gentes & Bolduc and Marchese all stepped forward.

Marita Zaffiro, president of Marchese, testified at Queen’s Park that the Medbuy contract did not indicate the hospitals wanted the labels on these drugs to cite a specific concentration. The reason she included it that way in the RFP was simply to show what could be done.

The details of the new arrangement remain known only to Medbuy. It was founded in 1989 to get better deals for hospitals buying products like scalpels, bed pans and even some medications in bulk. The company’s 28 member hospital organizations in Ontario, New Brunswick and Prince Edward Island spent a combined $626-million on contract purchases in 2012.

Sobel ran the calculations in his office. For a single patient to require a 4,000 mg dose of cyclophosphamide, on a common breast cancer treatment regime, that patient would need to be about 7 feet tall and weigh 2,200 lbs.

“The chance of 1,200 patients getting 4,000 mg exactly — it’s just impossible.”

Four Marchese pharmacists who played a role in the new contract work revealed to the Queen's Park committee in June that they had either limited or no background in oncology.

Marchese Hospital Solutions began as Marchese Pharmacy, a Hamilton-area community drugstore that expanded beginning in 1998 when Zaffiro became president. In 1999 the company obtained a contract to supply the Hamilton Niagara Haldimand Brant Community Care Access Centres, business they did until the contract expired in 2011, shortly before it was awarded the Medbuy contract.

It lost the CCAC contract in 2011, shortly before the Medbuy deal, and shed employees. Fifty-seven were either laid off or left the company during this troubled time, according to internal newsletters. But then things started looking up.

Zaffiro attempted to get accreditation for the site, according to her Queen’s Park testimony, approaching both the Ontario College of Pharmacists and Health Canada, neither of which took steps to regulate the fledgling business because each thought the other had jurisdiction.

Medbuy, Marchese and Jake Thiessen have maintained that cost was not a factor in the error. Marchese’s bid on the request for proposal came in at about a quarter of the cost of previous supplier Baxter Corporation. Bags from Marchese cost from $5.60 to $6.60; Baxter charged $21 to $34.

CEO David Musyj thinks about what went wrong. The problems, he says, go far beyond Marchese and Medbuy. “All of us are culpable,” he says. “We could have done some things internally that could have prevented this. We could have weighed the bags when they came in.”