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

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 Rwanda.

CANADA Intervention: (1) Experience using the System (Apotex-Rwanda Case)

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 Inc.

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/CAN/1.
  • 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 supply.