StemCell Therapy

Many valuable initiatives are outlined in the ambitiousmandate letterfrom Justin Trudeau to his newly appointed health minister, Patty Hajdu. These include important responsibilities relating to effective, affordable medicines. While these plans have the potential to benefit all Canadians, a pharmaceutical policy viewed primarily through the current governments signature middle-class lens risks short-sightedly perpetuating serious existing issues.

These potential shortcomings are readily illustrated by a decidedly un-middle-class disease: tuberculosis. Thearchetypal disease of poverty, tuberculosis is generally found where the basic social determinants of health, from proper housing to adequate nutrition, are not. Vulnerable populations who already find themselves outside the remit of the Minister of Middle Class Prosperity are doubly failed when the Minister of Healths mandate for pharmaceutical policy overlooks them as well.

Take the mandates long-overdue inclusion of national universal pharmacareand implementing a national formulary and a rare disease drug strategy. Drugs that will eventually appear on the national formulary are presumably going to be drugs that are actually approved for sale in Canada. Yet approval isnt simply a matter of meeting certain standards for safety and efficacy. In the case of tuberculosis, many medicines considered the global standard of care, including the majority of medicines used to treat the more serious condition of drug-resistant tuberculosis, remain unavailable in Canada. This is in part because the process relies upon drug companies being willing to go to the effort of applying for approval in a country where there are too few cases of TB to make drugs profitable, regardless of whether the drugs are vital for patients and public health.

Virtually all of these missing medicines can be found on the World Health OrganizationsModel List of Essential Medicines, which outlines drugs every health system should have. Many countries, in keeping with WHO guidance, have created their own tailored essential medicines lists. Canada has not. The establishment of a Canadian list, as a prelude to a broader national formulary, was recommended in the recentFinal Reportof the Advisory Council on the Implementation of National Pharmacare. Hopefully its omission from the mandate letter does not mean this idea has been abandoned. Engaging directly with the WHO list when drawing up the Canadian list, as recommended in the report, would draw much-needed attention to important medicines absent from Canada, many of them for conditions like TB that disproportionately impact the most vulnerable Canadians.

Unfortunately, when the mandate letter highlights a rare disease drug strategy, it is not talking about ensuring access to globally recognized treatments for diseases that are uncommon in Canada even as they remain a public health scourge elsewhere. What, then, makes a disease rare? Health Canada has used a definition of a rare disease as one affectingfewer than 5 in 10,000Canadians. The annual rate of tuberculosis is about5 per 100,000; drug-resistant TB accounts for less than 10 percent of this total. However, rare disease in practice is used in relation to chronic genetic disorders like cystinosis and cystic fibrosis. These, not TB, are the diseases encountered in the heart-wrenching news stories we have all read about families advocating fiercely for treatment for a child or other family member requiring a sometimes unapproved, almost invariably expensive medicine.

In practice, TB and rare genetic disorders can face similar treatment barriers. Research into new treatments is underfunded in both cases. Similarly, in both instances, drug companies have been reluctant to take the steps necessary to enter the Canadian market. In turn, medical practitioners and their patients face similarbarrierswhen navigating bureaucratic mechanisms, such as theSpecial Access Programme, to access drugs not officially available in Canada.

However, these shared barriers have not been effectively recognized as such in reforming pharmaceutical policy.Progresson improving access to drugs for rare diseases, including bringing more rare disease drugs to the Canadian market and shouldering at least some of their often exorbitant costs, is a real success story for effective advocacy with a middle-class face. By contrast, ensuring proper tuberculosis treatment has not received similar attention, even though for too many Canadian communities, particularlyin the North, TB is in reality an all too common disease.

A better approach to pharmaceutical policy would involve taking steps to ensure that any drugs forming the global standard of care for any condition are available in Canada. Instead, federal action to provide access to otherwise unavailable TB drugs has been through temporary stopgap measures rather than structural reforms. One such drug, rifapentine, has been widely accessed by the majority of provinces and territories over the past few years under theAccess to Drugs in Exceptional Circumstancesmechanism, which has permitted temporary bulk importation in response to what has ended up being officially listed as the tuberculosis crisis. That rifapentine is nevertheless still not officially available in Canada has even drawninternational attentionto the inadequacies of Canadas system.

Similarly, even those tuberculosis drugs that are officially available in Canada are not always available in practice.Like many other drugsfor a wide range of conditions, tuberculosis drugs have been prone to recent shortages. Of particular concern, over the past year Canada hasfaced shortagesof both rifampin and ethambutol, two cornerstones of tuberculosis treatment. It is thus welcome news that another key element of the Ministers mandate is to ensure that Canadians have access to the medicines they need by taking actionto address drug shortages.

Such action, which should be undertaken promptly, must include seriously examining options like stockpiling and alternative sourcing; in another sign of policy incoherence, even though Canada has been a majorfunder of the Global Drug Facilityto ensure access to essential medicines for tuberculosis in low- and middle-income countries, it does not draw upon the mechanism itself for drugs in shortage, let alone drugs not otherwise available in Canada, even though all countries areencouraged to do so. Furthermore, the response must reflect the fact that not all shortages are created equal; while structural reforms are necessary, drugs for conditions like TB that have serious public health consequences and that do not have effective, accessible substitutes must be prioritized.

Ironically, tuberculosis also offers a stark reminder for a third component of the Ministers mandate, to address the serious and growing public health threat of antimicrobial resistance. Drug-resistant tuberculosis exists only because insufficient attention was paid to tuberculosis treatment in the first place; prioritizing its prevention (through ensuring an uninterrupted supply of basic tuberculosis drugs) and treatment (through removing barriers to patient access to drugs for treating drug-resistant TB) is an essential component of successfully addressing the public health threat of antimicrobial resistance.

Tuberculosis was the leading cause of death in Canada at thetime of Confederation; better living standards and access to effective medicines drove its precipitous decline over the next century. Unfortunately, attention from policy-makers has similarly declined. That rates of this curable disease in Canada have remained relativelysteady since the 1980s, and that numerous drugs for theworlds top infectious killerare in shortage or simply not officially available here, underscore the fact that pharmaceutical policy that fails to identify the particular needs of those outside the middle class can be at best a middling success.

Adam R. Houston isa PhD student at the University of Ottawa. Ryan Cooper is an assistant professor in the Faculty of Medicine and Dentistry at the University of Alberta. Richard Long is a professor of pulmonary medicine in the Facult yof Medicine and Dentistry.

This opinion-editorial orginally appeared Jan. 14 in Policy Options.

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COMMENTARY || Pharmaceutical policy excludes the most vulnerable - Folio - University of Alberta

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