Traduction de «reçu original de médicaments » (Français → Anglais) :

Even though Health Canada can access information about country of origin for every drug product on the Canadian market through the drug submissions it received over the years, in 2004, Health Canada started collecting such information when sponsors apply in a format that is more easily accessible.

With regard to the final remark concerning the Commission’s proposal to retain the medicine’s initial name in the event of extending authorisation, I support keeping the initial name, since frequently changing the names of medicines may confuse patients who need, in any case, to see a doctor before receiving any treatment, and the doctor will be up to date with the medicine’s new therapeutic indications.

Four years on, not a single patient has received a single drug.

Question No. 138 Hon. John McKay: With respect to Canadians with diabetes who suffer severe and life-threatening adverse reactions to synthetic insulin and are unable to obtain domestically, an alternative animal-based insulin: (a) what actions has Health Canada taken or will take to ensure that Canadians who require such medication will continue to have access to it; (b) is the government (i) investigating methods of producing the medication via public funds or public-private partnership, (ii) initiating a process seeking approval of the drug for domestic production and distribution, (iii) initiating a consultation process with the manufacturers of animal insulin seeking domestic production and distribution, (iv) providing incentives to m ...[+++]anufacturers to produce animal insulin domestically, (v) securing a guarantee from the manufacturer that the drug will be permanently available, (vi) stockpiling the medication to ensure near-term supply; (c) what has Health Canada done or what will it do to ensure that these Canadians receive financial assistance due to high costs as a result of provincial health insurance plans not covering certain medications or treatments; (d) what action has Health Canada taken or will take to ensure (i) that people who suffer negative effects from synthetic insulin are aware of and have access to proper treatment as well as expanded choice in treatment options, (ii) that medical professionals who are responsible for treating Canadians with diabetes are aware of the availability of alternative forms of medication such as beef and pork based insulin; (e) what action has Health Canada taken or will take to ascertain how many Canadians suffer adverse reactions from synthetic insulin; (f) has Health Canada investigated or will be investigating the implementation of a protocol to address this issue, if not, why have steps not been taken to address this issue; and (g) does the lack of the availability of this type of medically necessary treatme ...

We have therefore developed a package of regulatory amendments intended to restore the original balanced policy intent behind the regulations (1835) The amendments, which were pre-published in the Canada Gazette Part I, on December 12, 2004 will facilitate the market entry of generic versions of brand name drugs immediately following expiry of relevant patents as the bill originally intended, while at the same time allowing brand name companies to duly promote improvements to the original form of the drug that are genuinely accepted.

To paraphrase the crux of the debate, as articulated in 2001 around Bill S-17, which was to implement the WTO findings, on the one hand, generics claim that innovator companies are routinely adding new patents to the register in order to delay generic competition on the original product well past expiry of the basic product patent. On the other hand, innovators insist that subsequent patents only serve to protect incremental innovation and that there is nothing they can do to prevent generics from coming to market on the original product once the basic patent expires.