Superbugs: changing regulations can help save lives

Imagine a future where critical medical procedures like organ transplants or heart surgeries are deemed to be hazardous to public health, and are reserved only for use as a last resort because the risk of drug-resistant infections outweighs the benefits of the procedure. This may sound like science fiction, but the reality is that drug-resistance (also known as antimicrobial resistance or AMR) is already on the rise, driven in part by the widespread overuse of medicines like antibiotics. Experts suggest that if AMR continues to rise at its current pace, it will result in 10 million deaths annually by the year 2050, costing the world economy $100-trillion USD. Given this considerable impact, the need for governments globally to prioritize AMR as a public health concern and implement action plans to curb its spread is critical. This is where Canada stands out. As a country, we are actively monitoring the presence of antimicrobial resistant infections and have committed to supporting the World Health Organization’s Global Action Plan. Canada has also implemented its own Pan-Canadian Framework for Action, which outlines a coordinated approach from federal and provincial governments, as well as private and public partners. The success of this Framework will depend on our country’s ability to deliver on four core elements: surveillance to detect and monitor drug-resistant infections; infection prevention and control to contain the spread of resistant organisms; stewardship to provide regulatory oversight to reduce inappropriate use of antimicrobials; and research and Innovation to facilitate further drug discoveries. The first three components depend largely on public sector action. To this end, Health Canada and the Public Health Agency of Canada have led the charge. The fourth component, research and innovation, is bigger than any one sector in Canada. The challenge, put simply, is a lack of new medicines to treat AMR infections. In the face of this crisis in healthcare, more collaboration between the public sector and private partners is needed to incentivize new drug discovery. However, there are significant challenges to bringing a new antibiotic to market. For one, when it comes to novel antibiotics, the measure of “value” to patients is difficult to demonstrate due to clinical trial design and small patient populations, which result in limited clinical data. We need to explore alternative policy options that curb these challenges, and address an unmet medical need. There is little research into the economic costs of AMR in Canada, and because of that there is a lack of economic modelling available to properly evaluate potential drugs. We know that the economic burden of AMR includes impacts on healthcare systems and labour force productivity due to the increased costs of treatment, longer illness, and higher death tolls, but without a market access framework and research to reflect these realities, there is a lack of incentive for discovery, meaning manufacturers may forego AMR altogether. So, what is the solution? How can we bring potentially life-saving drugs to patients? A first step is to amend current regulations related to new drug submissions in Canada to reflect clinical trial challenges. Amendments should allow for additional information to be used as supportive evidence when assessing a potential new drug, including real-world data and alternate clinical trial designs. In addition, regulators must review and adapt health technology assessments for measuring the value of antibiotics (in the context of AMR), so reimbursement decisions reflect the true value of the potential new drug. The reality is that antimicrobial resistance is already here. We, as a society, have the opportunity to lead with Canadian-made solutions that could save thousands, if not millions of lives. However, Canada needs collaborative policies and regulations to help (not hinder) the development of new antimicrobial treatments. The public and private sector both have a role to play, and our ability to work together will ultimately determine whether we succeed. Ilona Torontali is vice-president of regulatory affairs and market access at Hoffmann-La Roche Limited (Roche Canada).