Okay.
I'm sure everyone is familiar with the fact that in 2007 Rwanda took a landmark step of notifying the WTO of its potential interest in importing a fixed dose combination of AZT, 3TC, and nevirapine from Apotex.
Beyond the global significance of being the first and in fact only country to benefit from this compulsory licensing possibility, the step carried a lot of significance in the national context, in that it was a necessary and unprecedented demonstration of the country's political commitment to the fight against HIV. It came at a time when Rwanda was transitioning to optimal treatment guidelines in keeping with the latest developments in international best practice; that is, moving away from D40-based regimens for HIV treatment to AZT-based regimens and shifting the threshold for initiation on ARV treatment from 200 to 315.
Rwanda was one of the first countries on the continent to adopt these guidelines and was therefore immediately faced with the significant cost implications that they entailed. At the time, best untried, best-priced ceilings—the shift from D40 to AZT—would entail a more than 30% increase in the cost of the drugs alone.
In 2007, although there were three Indian pharmaceutical companies manufacturing a combination of this nature that had been prequalified by the WHO, only one of these suppliers had agreed to charge low-price ceilings. So Apotex presented as the only competitive supplier for the tender.
Following the process, which was widely regarded as extremely cumbersome and quite prohibitive for future possibilities, the licence was ultimately granted, which allowed Apotex to successfully bid for the ARV tender at a competitive price, and that put Rwanda's efforts to accelerate treatment to the point at which it is now one of only two countries on the continent that have achieved better access to HIV treatment based on WHO guidelines.
I know that everyone is probably extensively familiar with this story, but I'm telling it to you again to emphasize the central point of my message today, which is that access to affordable ARVs often presents the critical catalyst or the critical inhibitor in realizing political ambitions to scale up universal access to HIV services.
James Orbinski, a Canadian academic, wrote in the Public Library of Science last year that for many in developing countries who live on less than $2 U.S. a day, access to health care technology is little more than a dream. Further, if a treatment is too expensive, other factors that can affect a medicine's availability, such as drug distribution systems and national drug use policies, become moot. It was only when generic competition lowered the price of antiretroviral therapy for HIV that the policy debate shifted from whether such therapy was possible in resource-poor settings to how to strengthen health infrastructure to provide comprehensive health care for people in such settings.
And I think this ties into the point that was made by the previous speaker about how a health care official in Botswana said that he could deliver all the best medicines in the world, but that without the infrastructure those medicines would mean nothing. I think that point is quite intuitive, just as the contrary to that point is intuitive, namely that you could have the best infrastructure, but without affordable medicines the infrastructure would not mean much.
I think the caution here is that we shouldn't get drawn into a whole dichotomy. Of course we need good health systems, but at the same time, without affordable medicines the country's ability to commit to scaling up systems to provide services—if it doesn't have the drugs that define the line between life and death—often greatly inhibits their political commitment to doing so.
When affordability is not certain, countries are forced to make compromises that can significantly affect the success of their programs. Recently, the chair of the South African national AIDS commission, introducing the country's new guidelines, stated that a tricky balance had to be struck between the top-range drug regimens, which are costly, versus some regimens that are cheaper but have more side effects. I think the point to realize here is that we're not only looking at how drug affordability affects a country's ability to scale up treatment, but also at decisions on what quality of treatment is scaled up from these countries.
For example, D40, which in many developed countries is not being used in treatment protocols anymore, is still being used in many sub-Saharan African countries simply because the cost of switching to AZT is prohibitive for many health systems. The spinoff of this is that many patients.... Recently a study in South Africa showed that within three years 21% of patients on D40 stopped taking the treatment because the toxicities are unbearable. But the more tolerable drugs, such as AZT, are less affordable, and therefore we are insisting on maintaining drugs that are not optimal.
It is similar to increasing treatment thresholds for initiation: whether someone is initiated at a CD4 of 200 or a CD4 of 315 is to a large degree affected by affordability of medicines.
Currently the global funding situation for HIV is looking quite dire. The recent replenishment of the global fund has left deep-seated anxiety in many people, because the amount that was pledged is barely going to be enough to sustain treatment programs, let alone to scale up.
Even before the global funding crisis for HIV that we witnessed over the past year, countries have begun to call the sustainability of treatment programs into question because of the cost of the medicines.
In Botswana, which for many years has been the poster child of the ARV rollout on the African continent, two years ago the president publicly stated that continued enrolment of new patients in treatment must be guaranteed beyond 2016, because it's possible treatment can be sustainable.
In this time of financial austerity, it's really crucial that we take every measure possible to reduce the cost associated with HIV programs, and one of the most critical opportunities to navigate this cost is in the area of drug procurement. Many countries are now looking to reduce the nine-drug cost associated with provision of ART. But while health systems can be changed through task-shifting and through decentralization to adapt to the changing economic context, the simple, concrete need for the drugs to keep people in these systems will not change, and it's just as critical as it was five years ago when this legislation was introduced. The only difference now, I guess, is that the role of Canada in the global generics field is even more crucial than it was in 2004.
Frankly, we're generating added competition that will even further drive down the prices of medication, something that is desperately needed given the funding crisis that I mentioned as well as the potential threat to accessing generics from Indian companies, which could possibly result from the free trade agreements that are currently being discussed between India and the EU.
