The vast majority of pharmaceutical executives said they expect the incoming amendments to the Patented Medicine Prices Review Board to have a negative impact on their business plans in Canada, according to a new survey commissioned by Life Sciences Ontario.

The survey, which drew on data from 46 respondents, including leaders from 36 Canadian and global pharmaceutical companies, found the most significant anticipated impact, cited by 97 per cent of respondents, will be on product launches, commercialization and the supply of current products in the Canadian market.

This was followed by clinical research (91 per cent), patient support programs (73 per cent), compassionate access programs (70 per cent) and manufacturing (37 per cent).

Read: Feds propose regulatory changes to reduce costs of prescription drugs

The proposed amendments to the PMPRB regulations, put forward by the government in a consultation process in May 2017, will regulate maximum prices for patented medicines in Canada. Slated to take effect on July 1, 2020, the changes include an update to the reference countries Canada uses to compare its prices internationally. The list currently includes Britain, France, Germany, Italy, Sweden, Switzerland and the United States. The government plans to remove the latter two countries in favour of adding Australia, Belgium, Japan, the Netherlands, Norway, South Korea and Spain.

Almost all (94 per cent) survey respondents said they foresee both delays to product launches and decisions to suspend them altogether. In terms of the impact on specific therapeutic areas, the survey found about half (53 per cent) of respondents said they expect the changes to affect oncology, followed by biologics (47 per cent), rare disorders (44 per cent), immunology (36 per cent), gene/cell therapy (33 per cent), rheumatology (28 per cent), cardiovascular (19 per cent), infectious diseases (19 per cent), respiratory (17 per cent), diabetes (14 per cent) and vaccines (11 per cent).

Read: What will PMPRB drug pricing changes mean for plan sponsors?

“The changes will reduce the number of innovative products available in Canada and over time impact Canada’s place in the global pharmaceutical industry,” said one survey respondent. “The proposed changes to pricing of specialty and rare disease drugs can translate to reduced investment in vital and value-added patient support services for patients and will ultimately reduce access to life-saving treatment for these patients.”

Copyright © 2020 Transcontinental Media G.P. Originally published on

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