Proposed Ontario drug regulation changes worry policy experts

The Ontario government is proposing drug regulation changes that it says will remove red tape and barriers for pharmaceutical companies, allowing some drugs to bypass the normal approval process during a shortage.

Drug shortages, including the often-used breast cancer drug tamoxifen, have been wide-spread and increasing in recent years.

The move, the Ontario government says, would allow alternative drug products to quickly enter the market during a shortage.

However, the move is being met with resistance by some drug policy experts who say more information is needed to ensure the changes are good for consumers — and whether the changes will actually help prevent long-term drug shortages.

The changes, part of the government’s larger push to reduce red tape, would also make it easier for companies to raise or lower drug prices in other cases, depending on the market.

In a document about the proposed changes, the government says they would ensure that Ontario remains “open for business” for the pharmacy and pharmaceutical industry.

The proposals, called “Reducing Administrative Burden to Drug Manufacturers and Pharmacies,” are part of an omnibus red tape reduction bill that was introduced at the end of October while the legislature was recessed. They affect prescription drugs, mainly generics.

Some drug policy experts fear the changes would remove some consumer protections, are being introduced with little publicity and will do little to address long-term drug shortages. Pharmaceutical policy expert Dr. Joel Lexchin, who teaches at York University’s School of Health Policy and Management, said he is concerned about the lack of consultation and transparency around the changes. Some of the proposals respond to requests from the pharmaceutical industry with apparently little or no input from consumers or healthcare providers.

More details are needed, he said, before the changes go ahead.

“It should not be the job of the Ontario Ministry of Health and Long-term Care to advocate on behalf of the pharmaceutical industry. The job of the Ministry of Health should be the protection of the health of Ontarians,” wrote Lexchin in a submission to the Ministry of Health.

“Before the ministry goes ahead with these changes it needs to provide much more information and show that these changes will put the health of the people of Ontario above the interests of the commercial entities that are advocating for them.”

Jacalyn Duffin, professor emerita and Hannah Chair of the History of Medicine at Queen’s University, said she only learned about the proposals when a law firm blogged about them. She said she finds some of them shocking. “They will remove some consumer protections and probably will not help the shortages.”

The proposed changes include an amendment that would make it easier for generic drug companies to adjust their prices if the number of competitors on the market changes.

Under the current model, generic drugs are priced at a percentage of the brand price, depending on how many competitors there are.

For example, if a brand label drug costs $10, generic makers could charge $7.50 or $8, but that price would decrease based on the number of competitors.

The proposed changes allow drug companies to more easily adjust their prices when competitors come in and out of the market, something the government says should reduce the price of generic drugs.

However, it could also allow companies to increase the price of generics, especially at a time of consolidations of drug companies and shortages.

Justin Bates, Chief Executive Officer of the Ontario Pharmacists Association, said the change enables Ontario pharmacies to operate on a level playing field with pharmacies in every other province, except Quebec. Ordinary commercial terms are a normal part of business, he said, and do not increase drug costs, which are regulated by a Canada-wide system.

The proposed changes would also exempt certain drugs from drug submission requirements, allowing quicker funding of a drug that could fill in during a shortage. Funding of the alternative drug would be temporary, the government says.