Question

Sample questions for Econ 3308-W 2020

1. Why should generic drugs matter to Canadians? Discuss the issue.

Answer 1

Generic drug is a copy of the pharmaceutical name. The generic drug is pharmaceutically equivalent to the brand name drug: it contains the same medicinal ingredients in the same quantities and in a similar form of dosage. Generic medicines may have different non-medicinal ingredients than the brand name medicine, but the company must demonstrate that these do not affect the drug's safety, efficacy, or quality compared to the brand name.

Health Canada regulates drugs and other health products to make sure they are safe, effective, and of high quality. Companies must submit information to Health Canada before their health product can be sold. The information required depends on the type of product and its level of risk. Once a product is approved for sale, Health Canada continues to monitor its safety, effectiveness, and quality.

A generic drug is made to act in the same manner as a brand name medicine. A company must prove its generic drug to be 'bioequivalent' to the brand name drug. When two drug products are bioequivalent, this means that there is no significant difference in how quickly their medicinal ingredient is absorbed and a certain blood level (bioavailability) reaches. They should act the same way in the body when the products are bioequivalent, and have the same safety and efficacy. Drug companies are conducting clinical trials to compare two drug products 'bioavailability, to see if they are bioequivalent.

Healthy human volunteers in these trials take the brand name drug and the generic drug at the same dose in the same manner. The blood level of the medicinal ingredient is measured to see if the generic drug delivers the same quantity of medicinal ingredient at the same rate as the brand name medicine.