Apotex ships first CAMR drugs to Rwanda

Apotex has announced that its first shipment of its triple combination HIV/AIDS drug, Apo-TriAvir, is to be shipped to Rwanda. The news marks the culmination of a long process to enable the Canadian firm to produce a generic cocktail comprising drugs still under patent protection in Canada for sale solely to Rwanda utilising Canada’s Access to Medicines Regime (CAMR), formerly known as the Jean Chrétien Pledge to Africa Act. So far, Rwanda has been the only country to take advantage of the regime, which Canada brought in to align its patent laws with the World Trade Organisation’s framework to enable generic copies of patented drugs to be shipped to countries in need.

Whilst Apotex has been understandably pleased with itself for seeing the process through, it has nonetheless been critical of the Access to Medicines Regime, noting that the regime is too complex and problematic. Apotex is clear that the regime needs to be changed in order for it to be workable, and has previously suggested that it would not be willing to utilise it again in the future. Indeed, the regime has come in for criticism since its conception for being too bureaucratic and long-winded by a number of organisations; the difficulties involved in using it can be seen by the fact that the law has been in place since 2004 and in force since 2005, yet this is the first time it has been used.

Clearly, the experiences of the one company that has used the regime would show that changes need to be made to it, and the Canadian Parliament would do well to take another look at the legislation, using Apotex’ experience to see what changes could be made. However, before being quick to condemn, it is worth noting that the regime was introduced after a great deal of consultation from organisations with interests across the spectrum of pharmaceutical manufacturing and distribution. It was created to try to balance the needs of access to affordable drugs against the necessity of protecting patent law, and so it is somewhat inevitable that a law that tries to keep contradictory forces balanced will be difficult to use. Whilst that does not mean that changes cannot be investigated, it does mean that the resulting process will never be likely to please all interested parties. It is also worth noting that however difficult Apotex has found the process, this is still the first time any such law has been used in the world, and Canada still deserves credit for being the first country to try to amend its laws to enable its pharmaceutical manufacturing skills to be used to help developing countries in need. Canada should move to cap this achievement by making the law more workable.i to represent it in Court in an attention-grabbing move. Nevertheless, the firm may need more than PR to help it out of its current predicament.

Ian Platts - Editor, World Generic Markets