Star Phoenix Article October 19, 2021

Regulations give dose of protection to drug companies

By Carly Weeks CanWest News Service

OTTAWA — Prime Minister Stephen Harper’s government quietly unveiled controversial new regulations Wednesday that will extend market protection for some drugs produced by brand name firms in a move critics predict will lead to higher costs for consumers and provinces already facing skyrocketing medicare bills.
The new rules, which took effect earlier this month, increase exclusive selling rights for all brand name drugs to eight years from five, with an additional six months of protection granted to drugs involved in pediatric studies.
The change will affect 25 per cent of manufactured drugs — those that are not protected by the usual 20-year patents that exist on the majority of pharmaceuticals.
That means major pharmaceutical companies that produce brand name drugs will have, for eight years, exclusive right to sell certain products before generic companies — which sell cheaper versions of brand name goods — can step in.
The move is a “gift” to major pharmaceutical corporations and will result in dramatically higher drug costs for Canadians, said New Democratic Party health critic and former British Columbia health minister Penny Priddy.
“I just think that this is the betrayal of Canadian citizens and will deny them access to drugs longer,” Priddy said. “I think it puts the health of Canadians at risk.”
“Why the Canadian government would feel it necessary to grant brand name drug companies eight years of data protection in Canada is beyond us,” said Jeff Connell, director of public affairs for the Canadian Generic Pharmaceutical Association.
If the changes had been in effect over the last five years, it would have meant an additional $600 million in drug costs and blocked companies from producing generic versions of about 20 drugs, including Zoloft, Pravachol, Wellbutrin and Celexa, he said.
“It will delay the introduction of some generic drugs,” Connell said. “They (companies) automatically get eight years of government-sanctioned and enforced market monopoly.”
However, the association representing Canada’s research-based pharmaceutical companies said the regulatory changes will serve to put Canada in line with other countries and will be an incentive for companies to produce new and innovative drugs here.
“I think this is an important step in bringing in new medicines, innovative new medicines for patients and it will help Canada become much more competitive on the global scene,” said Russell Williams, the president of Canada’s Research-Based Pharmaceutical Companies.
The changes were first proposed by the former Liberal government in December 2004, but were not finalized and put into effect until two weeks ago.
Health Minister Tony Clement said in a statement the new rules will make it easier for cheaper generic versions of brand name drugs to enter the market in a “timely fashion” by setting out clear, enforceable guidelines for market protection rules.
But Priddy said the changes cater to the interests of big pharmaceutical companies and will limit the access Canadians have to cheap, affordable generic drugs.
“I think that it is a huge gift to pharmaceutical companies and I think it is a huge takeaway for Canadian citizens. It is going to do huge harm,” Priddy said. “This is really quite appalling.”
The changes will only add to an already dangerous situation in which drug prices are rising and major pharmaceutical companies control the agenda, said Dr. Gordon Guyatt, spokesperson for the Medical Reform Group of Ontario, a nonprofit association of physicians.
“It will be harmful to the extent that it delays the genericization and, as a result, keep prices inflated for a longer period of time,” he said. “It appears to be more pandering to an already extremely profitable industry.”