Canadians and the access to life saving new medicine

by Maj (ret'd) CORNELIU. CHISU, CD, PMSC, FEC, CET, P. Eng. Former Member of Parliament Pickering-Scarborough East You may have noticed lately, that the federal Liberal Government is shoveling hard-earned taxpayers' dollars overseas by the billions, while at home, health situation of Canadians is grossly neglected. Canadians have access to fewer new drugs than Americans and Europeans, and consequently may endure undue suffering from ailments and disease. We also have to wait much longer for drugs that are approved and available here. This unfortunate situation is due to a complexity of factors, namely bureaucratic incompetence, and an open hostility towards new and advanced medicines, repeatedly demonstrated by various levels of governments and public agencies. Indeed, to obtain approval from Health Canada to market a new medicine, drug companies enter a similar process as in the United States (US) and the European Union (EU). However, for 215 drugs approved in both the United States and Canada between 2012/13 and 2018/19, it took 464 days (on average) longer to obtain approval in Canada than it did in the US. The delay for receiving approval in Canada compared to the European Union was 395 days (on average, for 191 drugs). It is a fact that Canada's market is relatively isolated and covers a huge area with low population density having widely-dispersed health professionals and care facilities, that pose unique marketing, delivery and distribution challenges in expense and time. However, this is not a valid excuse for federal, provincial and territorial governments to exacerbate this natural disadvantage by erecting impediments that make Canada's pharmaceutical environment less attractive. These impediments include the lack of a dedicated drug policy to incentivise manufacturers to develop drugs for rare disorders, few incentives to accelerate innovative medicines through the regulatory process, weaker intellectual property protection, and significant price evaluation hurdles. We have experienced these issues in the recent past. During the Covid-19 pandemic when we were unprepared to cope with the pressures put on the system due to a lack of professionalism on the part of the people in charge with public health and safety. It is well known that drug companies prioritize drug submissions to countries with favourable environments. These include incentives that shorten regulatory review times, strong intellectual property rights, policies and criteria put in place by public insurance providers for coverage that doesn't inhibit patient access to new medicines, and less burdensome cost-effectiveness assessment, price negotiation and price regulation processes. Canada does poorly in all these areas. Added to existing disincentives for submitting drugs for approval, the Liberal federal government made matters worse in 2017 with proposed revisions to the Patented Medicine Prices Review Board, the government's quasi-judicial tribunal tasked with preventing time-limited drug patents from being abused. The proposals caused an extraordinary degree of uncertainty among manufacturers, which resulted in even fewer new medicines submitted for approval in Canada. Between 2006 and 2014, 80 per cent of new drugs submitted for regulatory approval in the US and EU were submitted for approval in Canada. By 2020, that number dropped to 44 per cent. If the intention of the Liberal federal government is really and truly to reduce drug prices in Canada, then the government should spend more money on our own citizens instead of generously spending overseas on uncertain projects. Consequently, they should establish a healthy environment for manufacturers of medicines. Furthermore, if they are still intent on spending money on corporate welfare, maybe that should be a first priority, rather than fashionable politically correct EV batteries, for example. Again, the negative results of these actions will continue-perhaps even escalate-delays in medicines being submitted for marketing approval in Canada. When policymakers only see new medicines in terms of high prices and not the benefits they can bring to patients, our access to innovative medicines is definitively at risk. In conclusion, everyone would like the new drugs to be cheaper, but not at the expense of having pharmaceutical companies and their innovative medicines bypass Canada entirely. Several adversarial barriers to launching novel medicines already exist in this country. Canadians don't need further deterrents from their governments. Without a collaborative relationship between manufacturers and government, Canadians with unmet health-care needs will continue to suffer. Let's convince our elected officials that it is time to put the health of Canadian citizen first on the priority list. What do you think?