Healing an ailing pharmaceutical system: prescription for reform for U.S. and Canada

By Adam Gaffney, instructor in medicine, Harvard; Joel Lexchin, professor emeritus, York; US, Canadian Pharmaceutical Policy Reform Working Group
BMJ, May 17, 2018

Key messages

The US and Canadian pharmaceutical systems are dysfunctional

Costs are exorbitant, commercial goals distort drug development, misleading promotion fosters misuse, and medications are too often unaffordable for patients

We propose reforms that would provide universal drug coverage without fees at the point of use while reducing prices through negotiations with drug firms and, when needed, compulsory generic manufacture

Innovation would be enhanced through patent reform and by establishing new public agencies to fund drug development and clinical trials

Drug safety, efficacy, and prescribing quality would be improved by raising standards for approval and safety monitoring

While the proposals face formidable political obstacles, a popular mandate exists for pharmaceutical reform in both nations

Drugs are among medicine’s most powerful tools. Yet the pharmaceutical systems of the United States and Canada are mired in dysfunction. The industry’s pricing practices—charging whatever the market will bear, especially in the US—strain budgets and put vital medicines out of reach for many patients. Despite some notable advances, the industry’s overall rate of real innovation remains incommensurate with our vast drug spending; many new drugs are marketed each year but few represent substantial clinical improvements. And commercial imperatives distort drug trials, research priorities, and drug regulation.

While many recognize the need for change, proposed remedies vary and would fall short of achieving the fundamental reform that these deficiencies call for. The advocacy organization Physicians for a National Health Program therefore encouraged a working group of US and Canadian doctors, scholars, and advocates (the US/Canadian Pharmaceutical Policy Reform Working Group) to come together to craft a wide ranging reform proposal for both nations.

Although some of our recommendations could be implemented within the existing US healthcare financing framework, full implementation would require a universal single payer system. Canada already has a single payer system but it would still require reforms because the system fully covers hospital and doctors’ services but not drugs out of hospital.

Our proposal rests on six principles

• Medical needs, not financial means, should determine access to medications

• Drugs must be affordable to society

• Drug development should be geared toward real innovation that maximizes population health

• The human right to health must take precedence over intellectual property rights (patents)

• The safety and effectiveness of medications must be independently and rigorously evaluated

• Comprehensive and unbiased information on drugs should be available to prescribers and patients.

Achieving change

Jonas Salk, inventor of the polio vaccine, eschewed patenting, declaring: “Could you patent the sun?” Today, in contrast, profiteering too often reigns, to the detriment of population health.

Our proposal calls for a fundamental reorientation of drug policy: it would make drugs more affordable for patients and society, promote innovation, strengthen efforts to assure the safety and effectiveness of medications, and upgrade the evidence available to prescribers and the public. Because drugs developed through the proposed new public pathways would remain in the public domain, they could be produced generically throughout the world, benefiting many nations.

The reforms we advocate face formidable political opposition, especially from drug firms, which made total profits of $67.7bn in 2016. However, most Americans—both Democrats and Republicans—now favor government action to lower drug prices, and 91% of Canadians support a universal pharmaceutical benefit. These are unmistakable popular mandates for change. The trail from sentiment to policy will doubtless be arduous. Yet history is replete with examples of sweeping reforms—often enabled by unpredictable shifts in political circumstances—that overcame entrenched interests. We aim with this proposal to provide a blueprint for reform that anticipates—and may kindle—transformative changes in our nations’ pharmaceutical systems.

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For the full proposal as published in BMJ:
PNHP: https://pnhp.org/pharma
or BMJ: https://www.bmj.com…

For PNHP’s press release (identifies the seven critical areas for reform):
https://pnhp.org…

For an economic analysis and supplemental materials:
https://pnhp.org/pharmatables

For a 2 minute video introduction and media coverage of the proposal:
https://pnhp.org/pharmamedia

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Comment:

By Don McCanne, M.D.

Physicians for a National Health Program (PNHP) and Canadian Doctors for Medicare have produced a comprehensive reform proposal for pharmaceuticals which would make essential drugs accessible and affordable for everyone.

This proposal could not be more timely. Last week President Trump delivered his long-awaited speech on his proposal to supposedly control price gouging of drugs. Pharmaceutical stock prices immediately spiked – a response confirming that Trump supports Big Pharma while neglecting patients desperately in need of therapeutic drugs.

Let’s let the people of the United States and Canada know that there is a way that we can fix this problem. Share this great news with others.

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