The government must take over the manufacturing of critical care drugs

The Context

COVID-19 has ravaged our country, pummelled our economy, upended our daily lives and exposed cracks in our healthcare system.

One near disaster narrowly averted was a shortage of critical drugs. Yes, even the drugs needed for the most critical of patients very nearly ran short.

The National Emergency Strategic Stockpile was exhausted, already atrophied from funding cuts over the preceding decade. Health Canada urgently coordinated with partners such as the Canadian Medical Association to create a list of the most essential medications needed to fight COVID-19 that were at risk of running short or were already scarce. Plans were drawn up to ration these Tier 3 drugs or find suitable alternatives.

We are still seeing medications like ketamine, propofol and ventolin experience shortages to the extent that Health Canada is urgently importing these medications from other jurisdictions without changing their labels.

These shortages are likely to continue or get worse as the battle to control the pandemic continues. We will face increased production needs over the next year as our usual sources of generics, India and China, are limiting exports to prevent shortages in their own countries.

The causes of shortages are multi-faceted and have been explored by our group in previous HealthyDebate and Toronto Star pieces and range from a shortage of active pharmaceutical ingredients (API) that are the precursors needed to make drugs to the lack of transparency around the supply chain on the front lines. While there has been tremendous consolidation in the global generic drug manufacturing industry, our domestic manufacturing has been hollowed out after years of offshoring. Currently only Sandoz’s facilities in Quebec are capable of manufacturing generic injectables.

In fact, an internal powerpoint circulated by HealthPro, a group-purchasing organization, included API shortages and noted that the leading cause of shortages is quality-related manufacturing issues. These shortages have likely become more prominent with the increased needs during the pandemic. The end result is that manufacturers’ drive to cut costs has meant that quality is often compromised. Katherine Eban’s best-selling Bottle of Lies is a harrowing account of the corners cut and risks taken.

Drug shortages have somehow become a fact of life in Canada for more than a decade. Despite committees and position papers, little has materialized. Meanwhile, drug shortages have become more frequent (with 77 per cent of those being generic drugs) and COVID-19 has put added pressure on critical care and the injectable drugs that are used heavily in ERs, ICUs and palliative care wards.

A short while ago, I wrote a piece arguing for the nationalization of drug manufacturing to prevent drug shortages. I see this as the only rational means to take the profit motive out of generic drug manufacturing that causes many of the quality-related shutdowns and as a concrete step towards funding National Pharmacare. Proceeds from these drug sales could help fund pharmacare. Canada once led the world in this regard with its homegrown Connaught Labs that shipped insulin across the globe for minimal mark-ups.

Yet, I also recognize that it is worthwhile to have some epistemological humility on a topic as complex as drug manufacturing. To this end, I asked my good friend, Ahsan Irfan, a management consultant and conservative political activist, to debate the following proposal:

“Be it resolved that the government must take over the manufacture of critical care drugs to prevent shortages.”

To read Irfan’s arguments, click here

 

Introduction

We have come far in the past 100 years, yet in certain senses we have progressed little. We have made technological advances beyond the imaginations of science fiction writers of earlier eras, yet our moral imaginations have failed us. COVID-19 is the crisis to bracket the end of neoliberalism; to put to rest the idea that private is best. And while previous crises have been used to enforce more punitive austerity and privatisation, as Naomi Klein has warned us time and time again, I sense that something is shifting in the zeitgeist. This pandemic, like the Spanish flu at the height of the Progressive era, is a chance for a burst of creativity in policy-making and a commitment to building new institutions.

The Economic Structure of the Generic Drug Market

The market for generic pharmaceuticals is arguably a captive market with consolidation bringing about a near-oligopoly. Canada’s domestic market for generics is highly concentrated as internal government documents as far back as 2010 show and Competition Bureau documents as recent as 2018 have noted that costs continue to be an issue.The bureau suggests lowering drug prices by encouraging competition through regulation and warns that doing so should be done in a way that “manufacturers cannot manipulate the regulatory process to deter price competition.”

I would instead argue that regulation is not enough. We should  simply take the profit motive out of the matter, reduce the poor behaviours consequent to it, and treat generics as a public good. We already regulate prices partly through the Patented Medicine Prices Review board but solely for brand-name medications. We could extend this practice to generic drugs and perhaps even go further by creating a public utility commission, similar to those for electricity and water but repurposed for generic drugs and committed to ensuring an equitable, cost-effective distribution of essential drugs.

Public ownership can work

We can afford and have the means to be even more radical. What would public ownership of drug manufacturing look like? It could mean a Crown corporation that acts as the producer that group purchasing organizations have to buy from. Or there could be provisions for “Buy Canadian” built into contracts in which a minimum percentage of drugs must come from the manufacturer. At the very least, a Crown corporation could act as a producer of last resort for the most essential of medications such as propofol and ketamine. We lack significant domestic production capacity for injectable medicines (the Sandoz facility is a notable exception), which explains why we are, as of recent estimates, paying seven times more for propofol than we used to pay. Domestic production would save costs, especially in times of crisis.

An alternative to a publicly run enterprise could be a non-profit consortium. Canada had something similar in the Connaught Labs that were later sold to Sanofi. Recently, a group of American hospitals have come together to create CivicaRx, their own non-profit drug manufacturer.

Centralized production is efficient

The old fears of centralized production are overblown in the 21st century. Massive (and obviously predatory) corporations like Walmart and Amazon have almost complete internal transparency on their supply chains and effortlessly produce enough to meet the needs of their customers. The provocative book The People’s Republic of Walmart makes the case that these companies already engage in highly efficient central planning. We should seek to emulate their remarkable inventory management systems (while continuing to protest their exploitation of essential workers).

In fact, many of the problems in the drug supply chain are problems of communication. Many hospitals still use spreadsheets for inventory management, which are then submitted monthly to group purchasing organizations. They in turn determine how much to allocate to their partner hospitals from the supply they have coming in from their last tender. It is the twisted fate of late stage capitalism that it leads to rationing whereas centralized production could have fulfilled everyone’s needs.

Conclusion

We both acknowledge that Canada must take action on drug shortages. The status quo is not tenable and the risks are very real as we brace for a second COVID-19 wave in the fall.  There is certainly much work that still needs to be done and questions to be answered. For example, we do not know how much the government is spending to deal with current critical drug shortages. And although we have Tier 3 assignments, it is not clear which drugs would qualify as essential for hospitals and would benefit from domestic manufacturing. This all must be the subject of further research, much of which must be done in an evidence-based fashion.

While both of us have varied personal and professional experiences that influence how we approach this issue, we acknowledge that reasonable people can disagree. Whatever the right solution is, we must act. Before it’s too late.

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2 Comments
  • Claude Ferguson says:

    To assume that a monopoly (public or private) will be more responsive and forward thinking than a dynamic and competitive market is contradicted by a long list of failings, including the latest lack of preparedness for the COVID crisis, for which the playbook had already been written following the SARS pandemic – and that was written less than 10 years ago basically by the same public health managers are in charge today. As you-know-who said it so well: the only lesson from History is that mankind take no lesson from History. Our duty to the public is to manage markets to make sure that they remain or become more competitive and fair – that’s it!

  • Joel Lexchin says:

    We need to get over the myth that key public services like building and running hospitals, maintaining public school buildings, supplying drinking water and running long-term care homes can be done more efficiently by the private sector. Just read the summary of an article about public-private partnership hospitals in Australia, Spain and the United Kingdom (https://www.who.int/bulletin/volumes/84/11/06-030015.pdf?ua=1):

    “New facilities have, in general, been more expensive than they would have been if procured using traditional methods. Compared with the traditional system, new facilities are more likely to be built on time and within budget, but this seems often to be at the expense of compromises on quality. The need to minimize the risk to the parties means that it is very difficult to “future-proof” facilities in a rapidly changing world. Finally, such projects are
    extremely, and in some cases prohibitively, complex.”

    A new report (https://www.policyalternatives.ca/publications/reports/partnership-name-only-0) from the Saskatchewan branch of the Canadian Centre for Policy Alternatives documents what workers in P3 schools have to say about maintenance. The conclusion of the report is that “what became evident as we listened to all of the problems and frustrations with the P3 model by the employees who work in them, is the extent to which public sector workers are constantly called upon to remedy the failures of the model.”

    Hamilton Ontario signed a 10-year deal (http://www.ontariohealthcoalition.ca/index.php/flawed-failed-abandoned-100-p3s-canadian-and-international-evidence/) with Philip Utilities Management Corp. to manage its water treatment in 1994. When the contract came up for renewal in 2004 all of the private sector bids were higher than the cost of running the facilities inhouse. In the mid-1990s, the P3 was the site of the largest ever sewage spill in Lake Ontario to that date. The full cost of cleanup fell to the City of Hamilton.

    In the midst of the COVID-19 outbreak, death rates in private for-profit long-term care homes are much higher than in private non-profit and municipally run homes: 9% in for-profit homes, 5.25% in non-profit homes and 3.62% in municipal homes (https://www.ontariohealthcoalition.ca/index.php/death-rates-in-long-term-care-by-ownership-release/).

    The situation is no better in drug manufacturing plants run by the private sector. In 2010, the British drug giant GlaxoSmithKline had to pay a fine of US $750 million to settle criminal and civil complaints arising from selling 20 drugs with questionable safety that were made at a plant in Puerto Rico that for years was known to be producing contaminated products (https://www.nytimes.com/2010/10/27/business/27drug.html).

    Relying on the private sector to solve drug shortages is not the answer.

Author

Saad Ahmed

Contributor

Saad Ahmed is a rural physician, lecturer at the University of Toronto, and co-founder of the Critical Drugs Coalition. He has worked in remote and rural settings, in ERs and inpatient wards, which have informed and influenced his passion for action on the social determinants of health.