7.5.8 Canada‘s Future Approval of New Pharmaceuticals

Introduction

The Commission heard testimony regarding Canada‘s intended changes to the process under which certain pharmaceuticals are given approval in Canada.

Based on the testimony, the Commission has concerns that the Government of Canada intends to apply a fast-track approval system to bring other, new pharmaceutical products to Canadian markets based on a new regulatory framework that appears to limit or eliminate the need to prove safety and efficacy.

Deanna McLeod
She explains how a new, expedited pathway allows for changes in traditional clinical trial processes. These changes remove the need to prove drug safety with level 1 evidence (RCTs).
(Winnipeg: April 13, 2023)

As discussed elsewhere in this Report, normally, vaccine development has a timeline of 5–10 years which involves first demonstrating safety in cells, tissues, and animals—through in vitro and animal testing—followed by three phases of human trials. This system is intended to test and prove the safety of drugs prior to approval for use in human populations.

The NCI heard that in-vitro and animal testing—prior to human trials—is critical to demonstrate safety in non-humans prior to proceeding to test in humans. This provides some degree of safety when designing studies in humans to monitor potential safety issues. This is a cornerstone of the clinical development process. The process follows the precautionary principle to determine possible safety signals to be monitored, not only in the short-term but also over time.

When Health Canada considers approving a drug, the drug company must demonstrate safety through each of the phases of testing. Approval is generally based on randomized-controlled trials, which are the only evidence that can prove safety and efficacy. In order to receive authorization to market a drug in Canada, a manufacturer must demonstrate safety, efficacy, and that the benefits of drug outweigh the risks.

The precautionary principle that underpins today‘s approval regulations resulted from regulatory reform implemented after the drug Thalidomide caused widespread harm to women and babies—as a result of being approved to treat morning sickness without first demonstrating that it was safe.

The precautionary principle is particularly important in the area of drugs known as biologics since these products have the ability to affect the human body in a profound way. The NCI heard that an abundance of caution should govern the testing and approval of novel biologics, which include gene therapy. The standard for safety testing set out by the FDA for biologics is 15 years.

Industry-Designed Backdoor Approval

The NCI heard that starting in 2016, industry-advocacy groups pushed for changes to the regulatory framework in Canada. Pressure was placed on Canada to attract new investment by overcoming barriers to innovation. The barriers to innovation include Canada‘s high safety standards for drug approval.

This spurred the formation of several initiatives such as the Advisory Council for Economic Growth and the Health and Biosciences, Economic Strategy Table to study and produce reports relating potential reform of Canada‘s regulatory process.

A new regulatory pathway was subsequently created as a type of backdoor approval for certain drugs. The new pathway allows for expedited clinical trials and product authorizations. The new process was adopted into law by burying it in an omnibus bill in December 2020. Under this new rule, the Minister of Health can designate a drug to follow the new approval process. Notably the Minister of Health in Canada at this time had no medical background but was an economics expert.

Therefore, Canada‘s new approach to advanced therapeutic treatments is to

• Maintain appropriate, yet flexible, regulatory oversight,

• Promote innovation in drug and medical device development,

• Ensure high standards for patient safety, product quality, efficacy, and effectiveness, and

• Reduce barriers to bringing advanced therapeutic treatments to market in Canada, thus providing access to new, potentially life-changing treatments

It is notable that three of the four points above relate to promoting economic development and profit relating to therapeutics.

The COVID-19 vaccines were the first therapeutics that followed this new process. The concerns that have arisen from the safety of the COVID-19 vaccines demonstrate exactly the problem with prioritizing innovation and economics over safety.

The Commission heard testimony that the Government of Canada intends to use this expedited approval framework for more novel products in the future. The motivation behind creating this new regulatory process appears to be economic, namely, to grow Canada‘s economy and attract foreign investment. While these may be laudable goals, the Commission is concerned that prudent safety standards are being sacrificed in order to meet economic goals.

Recommendations

A. Revocation of New COVID-19 Regulations: The Commission recommends that the new regulatory process be revoked and that Health Canada return to approving all therapeutics on its historical safety requirements.

B. Maintain Rigorous Safety Standards: Prioritize patient safety by maintaining rigorous safety standards for drug approval. The safety of new pharmaceuticals should be thoroughly demonstrated through preclinical and clinical trials before approval.

C. Transparency in Regulatory Changes: Ensure transparency in any regulatory changes related to pharmaceutical approvals. Changes in the approval process should be subject to public consultation and should be clearly communicated to stakeholders, including healthcare professionals and the public.

D. Independent Expertise: Appoint experts with relevant medical and scientific backgrounds to key positions in the regulatory process. Decision-makers, such as the Minister of Health, should have a strong understanding of medical and scientific principles to make informed decisions about drug approvals.

E. Balancing Innovation and Safety: Find a balance between promoting innovation and ensuring safety. While innovation is important for advancing healthcare, it should not come at the expense of patient safety. Consider the potential long-term effects of novel drugs on public health.

F. Monitoring and Post-Market Surveillance: Strengthen post-market surveillance of approved pharmaceuticals. Continuous monitoring of drugs once they are on the market is crucial to detect and address any safety concerns that may arise over time.

G. Independent Safety Review: Establish an independent body or commission responsible for conducting safety reviews of pharmaceuticals, especially novel biologics and gene therapies. This body should be free from industry influence and focused solely on patient safety.

H. Public Health Impact Assessment: Conduct thorough assessments of the potential public health impact of new drugs, particularly in the context of pandemics or health emergencies. Consider both short-term and long-term consequences on public health.

I. Ethical Considerations: Incorporate ethical considerations into the approval process. Ensure that the potential benefits of new pharmaceuticals outweigh the risks and that patient autonomy and Informed Consent are respected.

J. Regular Reviews of Regulatory Frameworks: Periodically review and update regulatory frameworks to adapt to advances in medical science and changing public health needs. Regulatory changes should prioritize safety while facilitating timely access to beneficial treatments.

K. International Best Practices: Benchmark Canada‘s regulatory processes against international best practices. Learn from the experiences of other countries with strong pharmaceutical regulatory systems.

L. Public Awareness and Education: Enhance public awareness and education about the drug approval process, including the rigorous testing and safety measures in place. Informed patients can make better decisions about their healthcare.

M. Monitoring Economic Impact: While promoting economic development is important, closely monitor the economic impact of regulatory changes. Ensure that economic goals do not compromise patient safety, and make necessary adjustments if conflicts arise.

These recommendations aim to strike a balance between promoting innovation and safeguarding patient safety in Canada‘s pharmaceutical approval process. It‘s crucial to prioritize public health and long-term safety while fostering an environment conducive to innovation and economic growth in the pharmaceutical industry.