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Law and ethics of switching to biosimilars in Canada

Biosimilars/Research | Posted 31/01/2020 0 Post your comment

With healthcare budgets in mind, governments and financial institutions across the globe are planning or implementing non-medical or ‘forced’ switches by cutting drug coverage for reference biologicals and funding only less expensive biosimilars. This is a subject fraught with issues related to both the law and the ethics of switching. Authors Blake Murdoch and Timothy Caulfield of the Health Law Institute, Faculty of Law, University of Alberta, Edmonton, Alberta, Canada, try to address how such issues might affect Canada [1].

In Canada, the province of British Columbia (BC) introduced a policy in May 2019 stopping coverage of originator biologicals and switching patients to biosimilars for certain indications. Rheumatology patients in BC had six months – until 25 November 2019 – to switch from the originator biological (Enbrel) to the etanercept biosimilar (Brenzys or Erelzi). After that time, the province’s healthcare system, PharmaCare, no longer provided coverage for the originator biologicals for these indications, except for exceptional cases [2]. Then, in November 2019, the province of Alberta also announced a similar policy that would apply to the approximately 30,000 patients in Alberta living with inflammatory bowel disease (IBD) [3].

Murdoch and Caulfield, however, believe that ‘switches raise numerous ethical and legal challenges’. This, they say, is because the drugs are ‘not identical’ and, ‘despite strong evidence for non-inferiority of some biosimilars, there is controversy over whether switching can sometimes lead to adverse events’.

Canadian law generally requires physicians to give priority to the needs of the patients rather than social interests, such as saving money. The number one position of patients’ interests is also clearly reflected in professional policies and codes of ethics. Moreover, physicians are obligated to disclose everything a reasonable person in the patient’s position would want to know when obtaining informed consent for treatment, including addressing not only scientific information but also relevant social controversy about non-medical switches.

One such controversy over switching is raging in Alberta, where concerns have been raised about the safety of a policy to switch patients stable on their current treatment. There has been a campaign of letter writing organized by Crohn’s and Colitis Canada. In addition, Dr Remo Panaccione, an internationally recognized expert in IBD at the University of Calgary, said that switching could cause patients to relapse and even put their lives at risk. Although he admits that ‘biosimilars are good drugs’, he added that ‘anywhere between 20 to 30 per cent of patients in the first year may have an adverse effect’ [3].

Murdoch and Caulfield point out that ‘under Canadian law, physicians may be obligated to tell patients about the ability to access unfunded biologicals, even if patients lack the resources to obtain them’. They conclude that ‘while there is no inherent right to funding for reference biologicals in Canada, physicians in some circumstances may have a legal obligation as fiduciaries to advocate on behalf of patients to remain on a reference biological. At a minimum, the controversy surrounding switching will necessitate, as part of the consent process, a robust and thorough disclosure of relevant risks, benefits and reasonable alternatives’.

It is not all negative in Canada, however, the Canadian Biosimilars Forum and Green Shield Canada have pointed out that ‘biosimilars have been used across Europe for more than a decade and at present, 13 countries support policies to implement biosimilar transitioning’. They also say that ‘this form of policy has been supported by scientific literature as being safe and effective. It can improve access to medicines by vastly reducing healthcare spending through replacing the use of reference biologicals with cheaper biosimilars’ [4].

Conflict of interest
The authors of the research paper [1] did not provide the conflict of interest statement.

References
1. Murdoch B, Caulfield T. The law and ethics of switching from biologic to biosimilar in Canada. J Canadian Assoc Gastroenterol. 2020;gwz043. doi.org/10.1093/jcag/gwz043.
2. GaBI Online - Generics and Biosimilars Initiative. Canada’s British Columbia to switch patients to biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 31]. Available from: www.gabionline.net/Policies-Legislation/Canada-s-British-Columbia-to-switch-patients-to-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Concerns raised as Canada’s Alberta plans to switch patients to biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 31]. Available from: www.gabionline.net/Policies-Legislation/Concerns-raised-as-Canada-s-Alberta-plans-to-switch-patients-to-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Praise for Canada’s BC after it adopts biosimilar transitioning policy [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 31]. Available from: www.gabionline.net/Policies-Legislation/Praise-for-Canada-s-BC-after-it-adopts-biosimilar-transitioning-policy

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