Urgent Call to Reform Approval and Access to Treatments of Lethal Diseases
Urgent Call to Reform Approval and Access to Treatments of Lethal Diseases
The Issue
Life Saving Therapies Network (LSTN)
173 Heath Street, Ottawa, ON, Canada
www.lifesavingtherapies.com
The number of people with lethal diseases (e.g., cancers) is growing at an alarming rate. For example, more than 50% of the population will experience cancer at least once. Thousands of these people die before they can be treated with life-saving therapies. The current Canadian healthcare system is to blame. It takes years for a promising treatment to be approved and to reach patients who need it.
When you are staring down the barrel of a gun, you are willing to take risks that you otherwise wouldn’t. People with lethal diseases have a different risk tolerance than those wanting treatment for a cold, flu or manageable chronic disease.
Yet, we don’t have a separate pathway to access lethal disease treatments that recognizes this and provides faster access to promising treatments. As a result, patients often do not receive these therapies that could save or extend their lives and reduce suffering.
The Catastrophe in a Nutshell
In summary, the time between when testing begins on a life-saving treatment and its availability to patients can range from 6 to 10 years, even for expedited breakthrough designations for certain high-profile drugs.
During the recent election, the Liberal Party promised to “significantly reduce wait times for life-saving medications” after Health Canada approval. That commitment offers some hope for the millions of Canadians living with cancer, rare and other diseases, who often have months to live and for whom every day without treatment counts.
The Liberals must keep that promise because the current system is not only inefficient, but it is also cruel.
We deserve better.
A Separate Track for Lethal Disease Treatments
We believe that regulatory oversight for clinical research in lethal diseases, such as cancer, should be simplified to enable the much quicker development and deployment of new approaches. Current regulation is cumbersome, costly and inefficient. The delays it causes mean that many Canadians with cancer do not get access to effective new agents that could save or extend lives, save money, relieve suffering and/or decrease hospitalizations. Effective new therapies do not just save lives and give incurable patients more valuable time with their loved ones. They can also have a very positive impact on quality of life and markedly reduce cancer-related symptoms.
We advocate for a separate and purpose-built diagnostic, regulatory, and access framework for the treatment of lethal diseases. We urge the government to establish a dedicated framework for lethal diseases (LDF) quickly. It would facilitate and support the research, approval, and treatment of deadly diseases based on disease-driven risk tolerances. This framework would enable people to lead longer, high-quality, and fulfilling lives, rather than suffering and dying prematurely.
The LDF would eliminate slow, fragmented reviews and price negotiations, poor access to diagnostics, redundant assessments spread across multiple agencies and provinces. It would trade outdated bureaucracy for a flexible, adaptive framework that gives patients the option to try promising treatments very early in the research process.
Specifically, we want the LDF to be
§ separate from the rest of the treatment, diagnostic, research, approval and accessibility bureaucracy
§ integrated Canada-wide
§ include the acquisition and deployment of quick access to diagnostic procedures to detect lethal diseases, and diagnostic medical devices to support that
§ allow pre-approval access for patients with lethal diseases to promising drugs after Phase 2a
§ catalyze the adoption of decentralized clinical trials while highlighting the critical benefits of virtual trials and improving patient experience
o mandate efficient research protocols that are tailored to the disease (e.g., precision medicine, immunotherapy, etc.)
o make each lethal disease patient a member of a distributed trial in which s/he is treated locally
o gather real-world data from these patients for use to help establish the treatments’ eventual approval
o provide “just-in-time” training for qualified physicians to administer the treatments locally
§ modernize access to approved treatments for lethal diseases
o Health Canada, the CDA, and the pan-Canadian Pharmaceutical Alliance (pCPA) must stop operating in sequence and conduct reviews in parallel under clear, binding timelines, limited to 60 days
o enable the fully reimbursed use of promising drugs while full evaluations continue, with real-world evidence collected to inform permanent decisions
o Use existing digital technologies to establish a Drug Access Navigator, a separate regulatory track for life-saving therapies that's faster and has dedicated funding, as in the UK
Primer: Key Details
The Problems Start with Diagnostics
There are too few MRIs, CT and PET scanners available, not enough people trained to use them and a very tight budget that constrains their use. Seriously ill people need to wait. In many cases, the wait turns a curable cancer, for example, into a lethal one, or forces a treatment with horribly toxic chemicals.
As Dr. David J. Stewart points out, “. . . those with incurable metastatic malignancies may deteriorate to the point they can no longer even receive therapies that could alleviate suffering and meaningfully prolong life.” [i] The consequences are terrible. For just one example, Canadian survival rates indicate that of the 84,600 Canadians who died from cancer in 2021, approximately 11,400 might have survived if they had as rapid access to diagnostics and therapy as the average American.
The Pre-approval Research Process
The randomized clinical trial is generally regarded as the gold standard for clinical research. Typically, this three-phased, six-year-plus approach to proving efficacy and safety involves significant expense and a large number of people. In general, it works and makes sense, especially for proving treatments for colds, flus and the like. No one wants to take a drug with serious side effects or that could be life-threatening.
Yet, hundreds of thousands of life-years are lost[ii] during the research and pre-approval process for treatments of lethal diseases. One study, which only looked at thirteen drugs, found 192,000 life-years were lost during the process. This is an appalling situation, especially when you consider the suffering, lost precious moments, and productivity it represents.
A dedicated research, approval and treatment framework that favours action based on lethal-disease-driven risk tolerances could change that. Many of those lives could be saved.
Approval
Once the research is complete, a treatment is submitted to Health Canada or the FDA for approval. Health Canada’s target is 180 days. Even with the inevitable slippage, most treatments are approved within a year.
This, again, is too slow for people who may die if a treatment is held up by only a month.
From Approval to the Patient
According to a report by the Conference Board of Canada[iii] the wait time between Health Canada granting approval and patients receiving a new life-saving therapy through public plans is at least two years.
That is an unacceptably long and cruel delay. Every hour matters when someone has a lethal disease or suffers from a debilitating condition. Yet, the path from approval to a patient is a quagmire of bureaucratic choke points, timely reviews and bureaucratic delays. This two-year-plus lag is not about ensuring safety. The drugs have already been approved. But thousands more life-years are lost in the process of fragmented reviews, slow price negotiations, and redundant assessments spread across multiple agencies and provinces.
The Liberals must keep their promise to “significantly reduce wait times for life-saving medications” after Health Canada approval.
About Life-Saving Therapies Network
Life-Saving Therapies Network is a patient-led international network of oncologists, researchers, regulators, medical ethicists, health economists and others from North America and the EU.
- As reported in the Ottawa Citizen https://www.change.org/p/urgent-call-to-reform-approval-and-access-to-treatments-of-lethal-diseases/u/33860471
"John-Peter Bradford co-founded the Ottawa-based non-profit Life-Saving Therapies Network to quicken Canada's sluggish drug approval system.
When John-Peter Bradford’s wife was diagnosed with terminal lung cancer in 2013, he did everything possible to get treatment that might extend her life.
Doctors had given Anne Bachinski-Bradford just a few weeks to live, but armed with a self-described gift for pushiness and some contacts, the Ottawa entrepreneur helped her get special access to experimental drugs that enabled her to live more than a year.
“It became my full-time job. It was all I did,” says Bradford, himself a cancer survivor.
Before she died, Bachinski-Bradford told her husband she thought it was unfair that she was the only one benefiting from his advocacy. Bradford took that to heart.
Just before her death, he teamed up with Dr. David Stewart, his wife’s medical oncologist, to create the Ottawa-based non-profit Life-Saving Therapies Network (LSTN), which has become a national voice in the push for faster access to better treatments for patients with lethal diseases like cancer and ALS (amyotrophic lateral sclerosis)."
[ii]https://theoncologist.onlinelibrary.wiley.com/doi/epdf/10.1634/theoncologist.2019-0314
[iii] https://www.conferenceboard.ca/wp-content/uploads/2022/10/access-and-time-to-patient_jan2024.pdf
2,090
The Issue
Life Saving Therapies Network (LSTN)
173 Heath Street, Ottawa, ON, Canada
www.lifesavingtherapies.com
The number of people with lethal diseases (e.g., cancers) is growing at an alarming rate. For example, more than 50% of the population will experience cancer at least once. Thousands of these people die before they can be treated with life-saving therapies. The current Canadian healthcare system is to blame. It takes years for a promising treatment to be approved and to reach patients who need it.
When you are staring down the barrel of a gun, you are willing to take risks that you otherwise wouldn’t. People with lethal diseases have a different risk tolerance than those wanting treatment for a cold, flu or manageable chronic disease.
Yet, we don’t have a separate pathway to access lethal disease treatments that recognizes this and provides faster access to promising treatments. As a result, patients often do not receive these therapies that could save or extend their lives and reduce suffering.
The Catastrophe in a Nutshell
In summary, the time between when testing begins on a life-saving treatment and its availability to patients can range from 6 to 10 years, even for expedited breakthrough designations for certain high-profile drugs.
During the recent election, the Liberal Party promised to “significantly reduce wait times for life-saving medications” after Health Canada approval. That commitment offers some hope for the millions of Canadians living with cancer, rare and other diseases, who often have months to live and for whom every day without treatment counts.
The Liberals must keep that promise because the current system is not only inefficient, but it is also cruel.
We deserve better.
A Separate Track for Lethal Disease Treatments
We believe that regulatory oversight for clinical research in lethal diseases, such as cancer, should be simplified to enable the much quicker development and deployment of new approaches. Current regulation is cumbersome, costly and inefficient. The delays it causes mean that many Canadians with cancer do not get access to effective new agents that could save or extend lives, save money, relieve suffering and/or decrease hospitalizations. Effective new therapies do not just save lives and give incurable patients more valuable time with their loved ones. They can also have a very positive impact on quality of life and markedly reduce cancer-related symptoms.
We advocate for a separate and purpose-built diagnostic, regulatory, and access framework for the treatment of lethal diseases. We urge the government to establish a dedicated framework for lethal diseases (LDF) quickly. It would facilitate and support the research, approval, and treatment of deadly diseases based on disease-driven risk tolerances. This framework would enable people to lead longer, high-quality, and fulfilling lives, rather than suffering and dying prematurely.
The LDF would eliminate slow, fragmented reviews and price negotiations, poor access to diagnostics, redundant assessments spread across multiple agencies and provinces. It would trade outdated bureaucracy for a flexible, adaptive framework that gives patients the option to try promising treatments very early in the research process.
Specifically, we want the LDF to be
§ separate from the rest of the treatment, diagnostic, research, approval and accessibility bureaucracy
§ integrated Canada-wide
§ include the acquisition and deployment of quick access to diagnostic procedures to detect lethal diseases, and diagnostic medical devices to support that
§ allow pre-approval access for patients with lethal diseases to promising drugs after Phase 2a
§ catalyze the adoption of decentralized clinical trials while highlighting the critical benefits of virtual trials and improving patient experience
o mandate efficient research protocols that are tailored to the disease (e.g., precision medicine, immunotherapy, etc.)
o make each lethal disease patient a member of a distributed trial in which s/he is treated locally
o gather real-world data from these patients for use to help establish the treatments’ eventual approval
o provide “just-in-time” training for qualified physicians to administer the treatments locally
§ modernize access to approved treatments for lethal diseases
o Health Canada, the CDA, and the pan-Canadian Pharmaceutical Alliance (pCPA) must stop operating in sequence and conduct reviews in parallel under clear, binding timelines, limited to 60 days
o enable the fully reimbursed use of promising drugs while full evaluations continue, with real-world evidence collected to inform permanent decisions
o Use existing digital technologies to establish a Drug Access Navigator, a separate regulatory track for life-saving therapies that's faster and has dedicated funding, as in the UK
Primer: Key Details
The Problems Start with Diagnostics
There are too few MRIs, CT and PET scanners available, not enough people trained to use them and a very tight budget that constrains their use. Seriously ill people need to wait. In many cases, the wait turns a curable cancer, for example, into a lethal one, or forces a treatment with horribly toxic chemicals.
As Dr. David J. Stewart points out, “. . . those with incurable metastatic malignancies may deteriorate to the point they can no longer even receive therapies that could alleviate suffering and meaningfully prolong life.” [i] The consequences are terrible. For just one example, Canadian survival rates indicate that of the 84,600 Canadians who died from cancer in 2021, approximately 11,400 might have survived if they had as rapid access to diagnostics and therapy as the average American.
The Pre-approval Research Process
The randomized clinical trial is generally regarded as the gold standard for clinical research. Typically, this three-phased, six-year-plus approach to proving efficacy and safety involves significant expense and a large number of people. In general, it works and makes sense, especially for proving treatments for colds, flus and the like. No one wants to take a drug with serious side effects or that could be life-threatening.
Yet, hundreds of thousands of life-years are lost[ii] during the research and pre-approval process for treatments of lethal diseases. One study, which only looked at thirteen drugs, found 192,000 life-years were lost during the process. This is an appalling situation, especially when you consider the suffering, lost precious moments, and productivity it represents.
A dedicated research, approval and treatment framework that favours action based on lethal-disease-driven risk tolerances could change that. Many of those lives could be saved.
Approval
Once the research is complete, a treatment is submitted to Health Canada or the FDA for approval. Health Canada’s target is 180 days. Even with the inevitable slippage, most treatments are approved within a year.
This, again, is too slow for people who may die if a treatment is held up by only a month.
From Approval to the Patient
According to a report by the Conference Board of Canada[iii] the wait time between Health Canada granting approval and patients receiving a new life-saving therapy through public plans is at least two years.
That is an unacceptably long and cruel delay. Every hour matters when someone has a lethal disease or suffers from a debilitating condition. Yet, the path from approval to a patient is a quagmire of bureaucratic choke points, timely reviews and bureaucratic delays. This two-year-plus lag is not about ensuring safety. The drugs have already been approved. But thousands more life-years are lost in the process of fragmented reviews, slow price negotiations, and redundant assessments spread across multiple agencies and provinces.
The Liberals must keep their promise to “significantly reduce wait times for life-saving medications” after Health Canada approval.
About Life-Saving Therapies Network
Life-Saving Therapies Network is a patient-led international network of oncologists, researchers, regulators, medical ethicists, health economists and others from North America and the EU.
- As reported in the Ottawa Citizen https://www.change.org/p/urgent-call-to-reform-approval-and-access-to-treatments-of-lethal-diseases/u/33860471
"John-Peter Bradford co-founded the Ottawa-based non-profit Life-Saving Therapies Network to quicken Canada's sluggish drug approval system.
When John-Peter Bradford’s wife was diagnosed with terminal lung cancer in 2013, he did everything possible to get treatment that might extend her life.
Doctors had given Anne Bachinski-Bradford just a few weeks to live, but armed with a self-described gift for pushiness and some contacts, the Ottawa entrepreneur helped her get special access to experimental drugs that enabled her to live more than a year.
“It became my full-time job. It was all I did,” says Bradford, himself a cancer survivor.
Before she died, Bachinski-Bradford told her husband she thought it was unfair that she was the only one benefiting from his advocacy. Bradford took that to heart.
Just before her death, he teamed up with Dr. David Stewart, his wife’s medical oncologist, to create the Ottawa-based non-profit Life-Saving Therapies Network (LSTN), which has become a national voice in the push for faster access to better treatments for patients with lethal diseases like cancer and ALS (amyotrophic lateral sclerosis)."
[ii]https://theoncologist.onlinelibrary.wiley.com/doi/epdf/10.1634/theoncologist.2019-0314
[iii] https://www.conferenceboard.ca/wp-content/uploads/2022/10/access-and-time-to-patient_jan2024.pdf
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Petition created on June 30, 2025