The RTT gives terminally-ill patients the power to make informed decisions, together with their approving specialist physicians, with minimal unnecessary government oversight and interference.
The RTT clearly absolves a provider of a potential life-saving treatment from civil and criminal liability in the absence of gross negligence or willful misconduct.
Health Canada’s existing Special Access Programme (“SAP”) is not geared specifically towards terminally-ill patients and their unique circumstances, and the approval process can take a long time, depending on the nature of the application – time that terminally-ill patients do not have.
A “potential life-saving treatment”, as defined in the RTT, covers a broad range of potential treatments.
The RTT contains safeguards to protect against possible exploitation by drug manufacturers: the patient must obtain the approval of a specialist physician and sign a comprehensive informed consent. As well, the Minister of Health must make regulations for the filing of all necessary information, which would presumably include, inter alia, the patient’s medical history, the nature and cost of the proposed treatment, dosing, side-effects and therapeutic efficacy, if any.
A terminally-ill patient will assume all risks associated with the treatment, including the possibility of death, an outcome which is imminent in any event. If the patient dies or experiences severe side effects, it will be obvious to the supervising physician that the drug is dangerous and/or has no therapeutic benefit, information which can then be shared with Health Canada and other physicians.
The current clinical trial system does not suit the needs of terminally-ill patients. The current system is expensive and therefore prohibitive for providers of potential life-saving treatments. Clinical trials also take many years to complete, which, as noted, terminally-ill patients do not have.
Most clinical trials have strict exclusion criteria, and often exclude patients from trials based on the length of time they have been diagnosed with the illness being investigated, thereby denying many patients access to such trials. This problem is not addressed by the SAP, as drug manufacturers would not allow access while the drug is being tested under the current clinical trial regime. The RTT does not require such exclusion criteria, and a patient who is not eligible under the existing regime could therefore participate in an experimental trial under the proposed legislation.
The RTT permits experimental trials – a novel way to test the efficacy of treatments for the terminally-ill. Currently, most trials require or use a control group - a double blind random selection of participants who are given a placebo rather than the drug or treatment being investigated. Under ordinary circumstances, the use of control groups to determine the efficacy and safety of any drug or treatment is a necessary part of the scientific process. For those suffering from ALS, for example, the use of a placebo group in drug trials is superfluous. The RTT permits the provider of a potential life-saving treatment to regard the historical population of ALS patients as the placebo group. At the end of the trial, Health Canada doctors and non-participating ALS patients could be apprised of the results and could, after being advised of any possible adverse outcomes, then have access to the treatment if they so choose. By way of contrast, the current clinical trial system and its “one size fits all” approach has consistently failed terminally-ill patients.
Experimental trials and the RTT’s elimination of bureaucratic red tape will promote and stimulate research for terminal illnesses in Canada, and gives our country the opportunity to be a global leader in the field of medical research.
The RTT permits accelerated approval by Health Canada of treatments that show efficacy, and has the potential to save thousands of lives.
TIME IS OF THE ESSENCE FOR TERMINALLY-ILL PATIENTS. THE “RIGHT TO TRY”, WITH MINIMAL GOVERNMENT INTERFERENCE, SHOULD BE CONSIDERED A HUMAN RIGHT, WHICH IS CONSISTENT WITH SECTION 7 OF THE CANADIAN CHARTER OF RIGHTS AND FREEDOMS.
Why does Canada Need the Right-to-Try Act ("RTT")?