The CAMR report was released on December 14, 2007. In essence, the report does not suggest fundamental change. The report concludes that insufficient time has passed and insufficient evidence has accumulated since the coming into force of CAMR to warrant legislative changes to the regime. The conclusion is that the Government should focus on non-legislative measures to improve access to medicines in the developing world, until a more definitive assessment can be made (p. 7).
Summary of input from review deals with the following issues, but does not make specific recommendations; the report outlines the positions of those who submitted comments on these topics:
- Eligible importers
- Eligible pharmaceutical products
- Health Canada's Drug Review
- Application process
- Voluntary licence request
- Duration of licence
- Royalties paid to patent holders
- The good faith clause
- Quantities exported
- Anti-diversion measures
- Termination of licence
Other considerations were noted. These included a discussion of the following topics:
- Global burden of HIV/AIDS, tuberculosis and malaria
- International initiatives and partnerships
- Country based initiatives
- ARV therapies as a model to treat HIV/AIDS
In the Analysis section, the report notes that there are a number of WTO members that have amended their laws, but that no two regimes are perfectly aligned and CAMR contains a number of measures that have not been emulated elsewhere. These include reliance on pre-approved lists of products and countries, and the grant of a licence being contingent upon the health and safety review of the product. Also, whereas many other regimes waive the requirement for a voluntary licence request, in cases of national emergency, CAMR does not (p. 29).
It is noted that divergent approaches can be equally compliant with the TRIPs obligations. There are operational advantages to scheduling of products and countries. The process is clarified and expedited, with minimal discretion of the Commissioner, and the outcomes are far less vulnerable to legal challenge. The Apotex licence is noted, and specifically, the fact that the licence was granted less than three weeks after the paperwork was filed. However, it is noted that the schedules require regular upkeep. It remains to be seen if the intended operational advantages outweigh the drawback in time and resources required to maintain them.
Similar reasoning was applied to the requirement for health review of exported products by Health Canada.
The report notes that the voluntary licence requirement is more complex. Canada believed it was necessary. The extent to which this is consistent with Article 31(b) remains the subject of debate. Even if this aspect were eliminated, notification of the importing country remains a requirement. The Apotex example is noted, and, in respect of the requirement for a voluntary licence stage, it was noted that "To the extent that one can assert that there was a delay between these two steps, it was relatively insignificant." (at page 32, in speaking of the voluntary licence and compulsory licence stages).
The report states at page 35 as follows:
"In light of all of the above, the view that certain unique feature of CAMR make it less permissive or operationally sound than the legislation subsequently adopted in other countries to have implemented the waiver does not appear to be substantiated by the available evidence at this juncture. While there may be room to improve CAMR, as there is with any legal framework, more time, evidence and analysis is needed to determine if changes to these features, along the lines of the amendments proposed by various stakeholder groups, would make a meaningful difference in the volume and frequency of exports...'
'Furthermore for the moment at least, the granting of the first and only export licence under the waiver to Apotex, and the circumstances surrounding it, suggest that CAMR works reasonably well and quickly, provided an importing country has made the requisite notification to the WTO. "
In conclusion, the report notes that more could be done to address the underlying economic barriers and will undertake further analysis of this issue, once greater experience with the waiver is gained. Outreach on awareness, and other initiatives, such as the Budget 2007 new tax incentive to encourage pharmaceutical donations are noted. Direct governmental targeted initiatives in providing medicines and vaccines to developing countries were also noted.
For more information, please see: http://camr-rcam.hc-sc.gc.ca/review-reviser/camr_rcam_report_rapport_e.html