[Ip-health] Canada's Intervention to TRIPS Council: Experience using the System (Apotex-Rwanda Case)

Thiru Balasubramaniam thiru at keionline.org
Sun Oct 31 01:51:14 PDT 2010



Canada's Intervention to TRIPS Council: Experience using the System  
(Apotex-Rwanda Case)

Created 31 Oct 2010
On Wednesday, 27 October 2010, Canada delivered the three  
interventions to the WTO TRIPS Council related to the review of the  
Paragraph 6 system. The first intervention below details the Canadian  
experience using the Paragraph 6 system in the case of Apotex and  

CANADA Intervention: (1) Experience using the System (Apotex-Rwanda  
As we recall, the 2003 WTO Decision on TRIPS and Public Health was an  
intensely negotiated decision that garnered unanimous support from all  
WTO Members.

Canada was very pleased with this historic and multilateral solution.  
In response, Canada implemented its Access to Medicines Regime, known  
as Canada’s Access to Medicines Regime (CAMR) in 2005 to facilitate  
the export of affordable generic drugs to developing countries.

As Members know, Canada, under CAMR, was the first, and to date, the  
only WTO Member to ship generic medicines under the Waiver. An HIV  
antiretroviral drug—Apo-TriAvir—was sent to Rwanda in two shipments in  
September 2008 and 2009 by the Canadian pharmaceutical company Apotex  

This example clearly shows that Canada’s Regime and the Waiver are  
efficient, effective and timely – if a need is identified.

As you will note in the Apotex-Rwanda example, the Government of  
Canada and CAMR played a limited role in the overall process. This  
process can be divided into three components: (1) the issuance of an  
export authorization under CAMR; (2) the role of Apotex; and, (3)  
Rwanda’s own domestic requirements.

Apotex took it upon itself to develop Apo-TriAvir before any recipient  
country was identified, and sought Health Canada safety and efficiency  
review of the drug, as per CAMR’s requirements.

	• In December 2005: Health Canada received a submission from Apotex  
to manufacture Apo-TriAvir, a new triple combination HIV/AIDS drug. No  
recipient importing country was identified.
	• In June 2006: Health Canada completed the review of Apotex’s Apo- 
TriAvir submission—in less than six months, rather than the allowable  
12 months. Please note that at this point, there was still no  
importing country identified.
After an eligible importing country identified its needs to the WTO,  
the CAMR process was completed in just over two months, starting with  
a request for voluntary licences and ending with the granting of the  
export authorization [also known as compulsory licence]. The following  
are key dates in the Apotex-Rwanda case:

	• July 13, 2007: Apotex sends letters to three pharmaceutical  
companies, GlaxoSmithKline, Boehringer Ingelheim and Shire BioChem  
Inc., seeking voluntary licenses to use their relevant patents to  
produce and export 15,600,000 tablets of Apo-TriAvir to Rwanda.
	• July 19, 2007: Under WTO rules, Rwanda becomes the first country to  
notify WTO of its intention to import 15,600,000 tablets of TriAvir  
under the Waiver. Please note document IP/N/9/RWA/1.
	• September 4, 2007: Apotex files an application with Commissioner of  
Patents for authorization under CAMR to produce and export Apo-TriAvir  
to Rwanda.
	• September 19, 2007: 15 days after having received the application  
from Apotex, Canada’s Commissioner of Patents grants Apotex  
authorization under CAMR.
It is important to note that once such an authorization is given, the  
role of the Canadian Government and CAMR in the process, are  
substantively complete (pre-export inspection by Health Canada).

Once the authorization is given, any additional steps are solely in  
the hands of the importing country and the supplier.

In the Apotex-Rwanda case, the following steps took place after the  
granting of the export authorization:

	• On October 4, 2007, Canada notified the WTO of the first  
authorization issued under the Waiver. Please note document IP/N/10/ 
	• In October 2007, Rwanda opened a public tender for the supply Apo- 
TriAvir. [Note: tender closed Nov 27th]
	• On May 2008, Apotex announced that it had won the Rwanda public  
tender to supply Apo-TriAvir. (This tender process took eight months.)
	• May-September 2008 - Apotex manufactured Apo?TriAvir.
	• September 2008: Apotex sent its first shipment of 6,785,000 tablets  
to Rwanda, which was approximately half of the authorized amount.
	• September 2009: Apotex sent its second shipment of 7,628,000  
tablets to Rwanda, thus completing the country’s order.
Therefore, as the Apotex-Rwanda case suggests, CAMR was a small part  
of the more than 2 years between the WTO notification by Rwanda and  
the final shipment by Apotex. The shipments of Apo?TriAvir to Rwanda  
occurred within the timelines specified in the export authorization  
that was granted by the Canadian Commissioner of Patents.

In evaluating CAMR and the WTO Waiver, we therefore need to return to  
the basic premises. The purpose of the Waiver and domestic  
implementation mechanisms, such as CAMR, is to ensure that TRIPS and  
patent rules do not stand in the way of exports for humanitarian  
purposes of more affordable generic medicines to those countries that  
do not have manufacturing capacities.

A few conclusions can be drawn from the Apotex-Rwanda case and  
Canada’s experience:

CAMR or any similar exporting regime that a WTO Member may implement  
under the Waiver can only assist in supplying low-cost drugs if there  
is a demand made by a country for generic drug(s) that requires use of  
the Waiver i.e. a WTO notification from an eligible importing country.

The Waiver is designed to be a demand driven process by countries in  
need, and only applies to instances where countries are seeking a  
generic version of the patented drug.

However, as Members know, since the adoption of the WTO 2003 Waiver  
there are now many more options available to importing countries.

For example, the international environment for procurement of drugs  
has changed significantly with the introduction of a variety of global  
mechanisms and alliances now offering greater choice to countries to  
obtain medicines.

Evaluating the role, potential for broader use, and the effectiveness  
of Waiver needs to be understood in this broad global context. To  
recall our negotiations, the Waiver was never intended to solve the  
issue of access to medicines on its own, but rather be part of a  
broader international strategy to combat diseases that impact the  
developing world.

In Summation:

	• The challenges and delays in Apotex’s export of medicines to Rwanda  
were separate from CAMR. CAMR worked efficiently, effectively and in a  
timely fashion.
	• In the end, it took 3.5 years for Apotex to develop the drug,  
identify a recipient country, secure a supply contract and then  
manufacture it. As outlined, just over two months of that time was  
taken up by CAMR procedures.
	• On the front end of the process, the year which elapsed between the  
completion of Health Canada’s safety and efficiency review of Apo- 
Triavir in June 2006 and the Voluntary License negotiations and  
Rwanda's notification to the WTO in July 2007, can be attributed to  
the fact that no country had come forward requesting drugs under the  
Paragraph 6 system.
	• On the back-end of the process, Rwanda’s purchase of Apo?TriAvir  
was through a public tendering process which Apotex won by offering a  
competitive price.
	• In closing, the WTO Waiver and CAMR function well, but they are to  
play a supporting role and are not a panacea to the challenges faced  
on global access to medicines and are not designed to generate global  


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997

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