競争規制当局と薬事規制当局が共同して"Canadians’ access to safe, effective and affordable medicines"取り組む通知がなされたそうです。
今までも共同した取り組みはされていたそうですが、最近ジェネリックやバイオシミラーの開発にあたり先発薬が参照薬を提供しないことについて大きな問題として取り組んでいるようです。
Quick facts
The Bureau and HPFB have independent, but complementary, mandates and roles in the pharmaceutical sector.
As administrator and enforcer of the Competition Act, the Bureau oversees competition issues in the pharmaceutical industry.
The Bureau and HPFB have collaborated on a variety of issues, such as mergers and acquisitions, deceptive and misleading claims and claims of abuse of dominance. More recently, the ability for generic manufacturers to access samples of reference products has been an area of ongoing collaboration.
Given the guidance and warnings provided from the Bureau and HPFB on this issue, branded drug manufacturers should continue to anticipate that the Bureau will treat any explanation for a failure to supply reference products, in a timely manner, with an extremely high degree of skepticism.
Should generic manufacturers face similar issues in the future, they are encouraged to bring any concerns to the Bureau's attention at an early stage.