As I recall the proceedings from last Thursday, the proposal was that the sponsors of the bill would be prepared to drop clauses 6, 7, 8, 11, 12, 14, 16, and 17.
Clause 6 proposes to repeal section 21.06 of the Patent Act, the website disclosure, and in its place it proposes a more limited disclosure: the name of the product; the name of the importer; and distinctive features and labels in accord with the regulation requirement, which is not yet in place.
If you drop that proposal, you would revive subsection 21.06(1) of the Patent Act, so there would be a duty to disclose the authorized quantity. That would conflict with the repeal of section 21.04 in clause 4. It revives Health Canada's review and regulation--product features, labels, and packaging. Depending on the outcome of these other things, that would also conflict with the clause 4 authorization provisions. It revives the duty to disclose the name of every known party that would be handling the product while in transit from Canada to the importing jurisdiction. It also uses WTO language, but I understand that some of the amendments probably fix that.
Clause 7 of Bill C-393 purports to repeal section 21.07 of the Patent Act. This is the provision that requires the exporter to give an export notice. It is required to give that notice to the patentee, to the importing jurisdiction, and to whoever it is within that jurisdiction, or on behalf of that jurisdiction, who has purchased the product. This would create some problems for the anti-abuse provisions. By virtue of the repeal of section 21.04, application requirements, there is no way you can verify the disclosure to the patentee, as they are not identified in the new authorization process. It also uses WTO language, which would be fixed.
Clause 8 in Bill C-393 would amend the existing royalty provisions and it would remove the Federal Court review, at the instance of the patentee, of a royalty rate, which would be determined in accordance with the regulatory scheme but nevertheless in the judgment of the patentee was inadequate in the circumstances. The revival will bring this back into compliance with that review process. The review process is not required by the waiver decision itself but there is a requirement in article 31 of the TRIPS agreement that any decision as to the remuneration given to the patentee must be reviewable by a distinct higher authority. In the Canadian case, for a federal decision, that would be the Federal Court. This provision also uses the WTO language, which may well be fixed.
Clause 11 in Bill C-393 deals with section 21.13 in the Patent Act. That is a clause that deals with termination on the happening of a statutory event. These events are things such as the expiry of the two-year term certain for an initial authorization and the expiry of a two-year term certain renewal authorization, on the happening of the Minister of Health notifying the commissioner and others that the product at issue is no longer compliant with Health Canada efficacy regulations or the labelling and appearance regulations.
It also allows for automatic termination where a country has been removed from one of the country lists. So if you revive section 21.13, as the proposal to drop would do, you revive the concept of a two-year set term for initial authorization. You also revive a reference to re-authorization for another up to two years. So there's a conflict there between what's in Bill C-393 and what would stay in the Patent Act. Well, as the trade dress issues as defined by Health Canada regulations would be revived, and it revives the concept of a named product in an authorized quantity, all of that creates some tensions within what would remain if the bill proceeds.
Clause 12 is a termination clause on the instant or the suit of the patentee for a number of reasons. The termination for failure to label accurately and failure to give export notice--that could be okay if clause 7 is dropped, because that would revive the export notice. It would also replace Bill C-393's definition of a regional trade agreement with the original version in the Patent Act that was drafted to comply with the definition used in the WTO waiver decision.
Clause 14 would repeal sections 21.17 to 21.2. Section 21.17 is on termination in circumstances where bad faith is alleged because the contract is being used for commercial purposes. Section 21.18 is on the advisory committee designed to assist the Governor in Council and ministers in determining whether a drug should be added to schedule 1.
In section 21.19, a website is to be established by Canada to disclose applications that are made to it by a non-WTO member that would not have had an obligation to give notice to the TRIPS council under the WTO scheme. Canada went beyond its strict obligations in this regard, because they thought everybody should have access to the system on equal footing. We had to design something where a focal point for the notice from the demanding jurisdiction could be made public and transparent to the world.
Section 21.2 was a requirement for a ministerial review and reporting to Parliament, and that's essentially spent, so it would be removed in a housekeeping bill and not with whatever you do here.
That's it. There are several places where Health Canada is referenced. I'm not sure in which particular clauses. Perhaps we can deal with those when we come to them.
