“Patients could lose access to their medication because of the Dubé reform,” headlined an article by The Canadian Press published in The duty of April 21. In question, the amendments proposed in section 336 of Bill 15 which would withdraw health care institutions’ power to provide a particular patient with a drug whose therapeutic value has been the subject of a negative evaluation by INESSS (National Institute of Excellence in Health and Social Services) for the indication (medical condition) considered. To say that this article of law would limit access to medication for certain patients is a very simplistic and problematic way of posing the debate.
Indeed, it makes the basic question invisible, which is that of the structuring of our exceptional access to medicines, while personalized medicine treatments are in full expansion and involve dizzying costs which represent a real threat to the maintenance of the public system of health. To better understand these questions and form an opinion, one must first understand what is currently happening and, second, put this access into perspective with pharmaceutical development, which has changed radically in recent years.
The subject of the debate started from article 336 of bill 15, which concerns drugs that can be administered to patients in cases of “special medical need” (NMP). The previous law of 2015 established the possibility of using this “necessity” procedure for drugs that are not normally accessible in health establishments. Because to be accessible “normally”, a drug must have been approved by the Minister, on the recommendation of INESSS.
It is then possible that a drug is not accessible because of an unrecognized therapeutic value or limited efficiency (cost/benefit ratio). It is also possible that a medicine has simply not had the opportunity to be evaluated or to obtain an indication (the manufacturer himself must submit an evaluation request for his medicine).
At present, it is the oncologists who, in the overwhelming majority of cases, find themselves using the NMP mechanism for exceptional access to medicines, whose requests are reviewed by the pharmacology committees in each of the 34 establishments health in Quebec. This process ends up placing on the shoulders of dedicated clinicians the weight of decisions with major ethical and political implications that go beyond them, without any provincial authority getting the slightest bit wet and without any systematic clinical and budgetary follow-up being carried out at the provincial level.
On the other hand, patients may be accepted for a drug in one facility, but refused in the next facility. The equity problem is glaring.
More generally, new treatments are changing, in particular by moving towards personalized medicine, which is changing our relationship with what we have hitherto considered “special”. Indeed, in the context of personalized medicine, characterized by the growing development of immunotherapies and gene therapies, the individual is in a way called upon to become the norm.
Treatments are so specific that some cancers are considered “rare diseases”. However, oncology drugs represent approximately 50% of the drug costs of establishments, and their prices are increasingly dizzying. The pharmaceutical and economic pressure will be greater and greater.
In this context, it is therefore important that these exceptional and parallel access routes do not become bypasses of a proper evaluation. Indeed, if we are not careful, exceptional programs could become ways of accelerating the marketing of new, ultra-expensive, specialized drugs for which the evidence is limited. Although Health Canada has accelerated its processes and validated the compliance of a drug, the appropriateness of use is and must be assessed by an approved agency whose work and expertise this is, such as INESSS in Quebec.
At a time when “personalization” is becoming widespread, with major implications for the maintenance of a public system, the question becomes that of the reinforcements necessary for effective and equitable pharmaceutical policies.
No one is against maintaining exceptional access to drugs. However, the current context invites us to think about ways to structure these exceptional accesses, without however falling into an extreme standardization that no one wants.
This is one of the questions that should now enter into public debate and in the National Assembly in the examination of Bill 15, pending the construction of a real pharmaceutical policy in the sense understood by the World Health Organization. Health (WHO), i.e. a policy to guarantee universal and equitable access to quality, safe, effective and affordable medicines.