A sweeping and controversial reform of Canada’s 30-year old regime overseeing patented medicine prices is already creating negative impacts in the life sciences sector and reducing patients’ access to medicines, according to a new report from Innovative Medicines Canada and Life Sciences Ontario.
The regulations, drafted by Canada’s Patented Medicine Prices Review Board (PMPRB) were published in Canada Gazette2 (CG2) in August 2019, signs of its negative impact are already becoming apparent. Among its findings:
- Many therapeutic areas will be impacted by the new PMPRB regulations: These include oncology, biologics, rare disorders, immunology, gene/cell therapy, rheumatology, and other areas; according to a survey of pharmaceutical executives.
- New drug submissions are down: In the 9 months following CG2, there was a decline in timely submissions made in Canada to 24% of global submissions, compared to 35-40% in the 3 previous 12-month periods.
- New drug launches are increasingly delayed: In the 9 months following CG2, delayed or cancelled launches doubled to 42% of approvals, compared to the 3 previous 12-month periods.
- Clinical drug trials are down: As of early June 2020, Informa data suggest that there was a decline in the share of global industry-funded clinical trials that were started in Canada in the 9 months following CG2 down to 9.2% from 10.5% in the 3 previous 12-month periods.
- Patient advocacy organizations are opposed to the PMPRB changes: representatives from the 30-group Best Medicines Coalition, the CF Treatment Society, the Sickle Cell Disease Association, and others have registered their strong opposition to the changes. According to the Canadian Organization for Rare Disorders:
“The Canadian government and particularly Health Canada have completely forgotten about the people it should be serving and helping: Canadian patients. There will be delayed access or, worse, no access to new medicines as a result of these changes, and this will harm patients.”
The report combines data from an opinion survey of pharmaceutical manufacturers with objective metrics on clinical trials, new drug submissions and launches obtained from publicly-available government and commercial databases such as Informa Citeline, Health Canada’s NOC, Drug Product and Drug and Health Product Submissions Under Review databases, and EMA and FDA databases.
Read the full report here.