opinion: stiff price controls will hurt access to ground-breaking drugs

by: dr. david j. stewart and dr. john-peter bradfordimpressive research breakthroughs are producing therapies that extend lives and alleviate suffering. they are being developed and deployed at an accelerating rate. yet canadians risk being left behind in gaining access to them, thanks to regulations from the federal patented medicine prices review board (pmprb) that are scheduled to go into effect july 1.save for a few unannounced exceptions, pmprb price controls will severely curtail the availability in canada of new, effective drugs to combat lethal diseases such as cancer and alzheimer’s. compared to the old rules, pmprb-mandated price reductions will reduce what manufacturers could charge for many cancer and rare disease drugs by more than 50 per cent.the pmprb believes that companies would be happy to sell canada their new drugs for much less than they get in about half of the other 36 oecd countries. it doesn’t look like they’re right. virtually every senior executive surveyed by research etc. for life sciences ontario indicated that pmprb regulations would have a significant negative impact on product launches and supply, compassionate access programs, research, employment and manufacturing. this threatens not only access to innovative, effective lethal disease treatments but also our economy.until recently, canada ranked fourth in new medicines approved and launched, just behind the united states, germany and the united kingdom. the situation is changing rapidly. in 2018, companies commercialized 22 new drugs in canada out of 23 globally; in 2019 it was 13 out of 31. as of april 2021, fully 51 medicines approved in the u.s. have not been submitted for consideration in canada because of the coming new price regulations, initially announced in 2019.this means that canada doesn’t have access to promising new agents such as tecentiq for metastatic breast cancer and viltepso for duchenne muscular dystrophy, a life-shortening childhood disease.a 52-per-cent decline in canadian clinical trials since 2018 also indicates that many companies don’t expect to market their drugs here. in a 2020 review, 44 of 49 systematic studies found that more trials mean better access to drugs. trials allow canadians compassionate access to drugs before they are approved.pmprb’s regulations may accelerate canada’s plummeting relative life-expectancy. we were seventh in the world in 1995 in life expectancy but are projected to fall to 27th by 2040. diagnostic and treatment delays are partly to blame for this decline in relative life expectancy. we have too few ct scanners, radiotherapy units and specialists — all way below the oecd median. even if we rectified these deficiencies, inadequate access to effective new drugs would probably mean that our relative life expectancy would keep dropping.canada’s covid-19 disaster in long-term care facilities should be a lesson. we played catch-up, finally exempting vaccines from the pending pmprb price controls. yet, we plan to set an aggressive ceiling on prices for the new medicines that could help canadians with lethal diseases.many canadian seniors have died tragically from covid. our aging population means that more people will have lethal diseases like cancer. pmprb’s changes will reduce access to effective new drugs that can improve both life expectancy and quality of life, disproportionately threatening our seniors.pmprb says its pricing rules will bring us down to where we “should be.”  how does this square with a fair, high quality national pharmacare system?do we really want our seniors — and others —to be roadkill on the lethal disease superhighway? how many premature deaths and how much suffering will it take for us to understand the price of mediocrity?dr. david j. stewart is a medical oncologist at the ottawa hospital and a professor of medicine at the university of ottawa. dr. john-peter bradford is the ceo of lstn (www.lifesavingtherapies.com), a cancer survivor, caregiver, patient advocate and scientist/businessman. the views expressed here are those of the authors, and do not represent those of the ottawa hospital or the university of ottawa.bradford has no links to pharmaceutical companies. lstn has received funding from them to carry out its independently conceived and directed projects. stewart receives less than three per cent of his annual income for advising pharmaceutical companies on how to make their therapies more effective for patients.