Reproduced from Health and Development Networks SEA-AIDS Forum coverage of the 7th International Conference on AIDS in Asia and the Pacific
The rapid scale-up of antiretroviral (ARV) treatment programs around the Asian region is underway. In a plenary address to the 7th ICAAP conference in Kobe, the World Health Organisation's (WHO) Jim Kim praised treatment progress made in Asia, saying that the number of people on ARVs had grown by more than 50% in the last six months, from 100,000 to 155,000.
However, with that rapid scale-up will come the inevitable growth of drug resistance and the need for second line ARV therapy. Much of the developing world currently depends on Indian generics to support its treatment scale-up, but with the recently revised Indian patent law restricting the production of generic ARVs, treatment advocates now warn of a looming 'ARV access crisis' that could sabotage efforts to control the epidemic.
Implications of the new Indian Patent Law
The new Indian patent law was revised in order to satisfy conditions of India's WTO entry. It is not clear how some of the law's provisions will be interpreted, but what is clear is that it will end the largely unrestricted copying of ARVs, on which PWHA in developing countries now depend. There were a number of 'safeguards' added to the law, however, that Indian officials say will ensure that necessary medicines continue to be produced.
Dr Quraishi, director-general of the National AIDS Control Organisation in India [NACO], says that there are sufficient first-line ARVs, but that "The problem will come when we need second line drugs...I'm personally very worried about the second line drugs."
He says that India "can resort to price control or compulsory licenses if necessary.The fact that it [compulsory licensing] has been provided for in the act after great debate is a sign that we will consider it."
Treatment advocates are even stronger in their criticism of the new patent law. Leena Mengharey of the Affordable Medicines and Treatment Campaign, at the Lawyers Collective in India, says that the Indian government has "played into the hands of the pharmaceutical companies", and that leaders must be held accountable.
Can China step forward to fill the gap?
The passage of the Indian patent law means that, at present, two countries appear to be possible candidates to replace India as producers of generic ARV drugs for the developing world: China and Brazil.
Dr Quraishi at NACO says India isn't scared of Chinese competition: "We are not worried about competition...whoever produces cheap drugs is welcome."
Suerie Moon, who works in Beijing for the MSF Access to Essential Medicines Programme, says there is no doubt China could fill the ARV gap in the future.
"From what we know, there is very impressive technical ability in China," Moon said. "Chinese producers are already making the raw materials for a wide array of second line drugs. There is no Chinese producer that has been WHO qualified, but we know that the raw material production is the most technically demanding part of the process, so
we're fairly confident."
She adds that whether or not China will actually be able to produce the newer ARVs used in second-line regimens "will very much depend on whether China is willing to use the TRIPS flexibilities" in the Doha accord.
Thomas Cai, a Chinese PWHA activist, says that China, which already produces so many of the raw materials for ARV drugs, now has the chance to become the ARV factory for the world.
"If China does choose to produce generic copies of second-line drugs," Cai says, "there will be a huge market. China could take the lead to start producing second-line drugs at a reasonable price. They could sell them around the world."
Cai also warns that China's own treatment plan will be threatened if affordable drugs are not available: "If China doesn't produce second line drugs," Cai says, "it could be the same as five years ago, when I started my first treatment [in China]. We had to pay over $1000 a month - much more than my monthly salary. Most people cannot afford this, and
they will die."
Nobody seems to be worried. Isn't there a crisis?
People outside of India have largely ignored the new patent law, and Suerie Moon says that's a big mistake. "If people don't start paying a lot more attention to how the act is being enacted, we may find ourselves in a position where we have no affordable generic second-line drugs."
While there are some discount pricing schemes offered by big pharmaceutical companies, "the thing about generic production is the competition, it's dynamic, it continually drives down the price" while discount pricing schemes are static. To those companies who say their prices are already affordable, Moon replies: "What is 'affordable enough' if you're a farmer in China making $100/year?"
Moon says we should "absolutely" be in crisis mode: "Access to second-line drugs is something that is extremely urgent. Even if we figure it out tomorrow, it will take another year or two to get the drugs. We should be very worried, because patients need them today."
Leena Mengharey of the Lawyers Collective says that people do not realise the long-term threat that the law poses for AIDS treatment efforts: "Why aren't people talking about the patent law?" she says, "Where are your drugs going to come from in the next decade?"
India, China or Brazil?
Like India, China made concessions in order to enter the WTO that will directly impact its ability to produce generic ARVs. Despite the flexibilities contained within the TRIPS agreement, both countries now appear to be backing away from breaking patents and copying drugs such as tenofovir (Viread)or lopinavir/ritonavir (better known as Kaletra) that are key ARVs in treatment scale-up.
Speaking at the Kobe meeting, China's vice-minister of health, Wang Longde, refused to endorse generic production of second-line ARVs. When asked by a Chinese PWHA how his government would handle the rapid growth of drug-resistance that is being seen in China, Wang said only that "China made commitments when it joined the WTO, and China will keep its word" not to break patents. "China is currently in negotiations with pharmaceutical companies about second-line drugs," he added.
Brazil has continually stood up to pressure from both the United States and pharmaceutical companies, threatening to issue compulsory licenses for ARVs that it uses in its free treatment program. Though the strategy has resulted in deep price concessions from branded pharmaceutical companies, the country has yet to actually break any patents. At present, there is an impasse between the Brazilian government and Abbott, which has refused to further lower the price for Kaletra, but it remains to be seen if Brazil will act on its threat to cancel Abbott's patent, or on its threat to invalidate patents on all ARVs.
It boils down to TRIPS
At the core of much of this debate - and of the Brazilian's argument - is the TRIPS accord, a WTO agreement that, in short, permits countries to override drug patents in the name of public health. It is seen by treatment advocates as a key tool in the struggle to lower drug prices and make ARV treatment universally accessible, a goal that is also
stressed by the WHO.
Also speaking at the conference, Jim Kim, the Director of the HIV/AIDS department at WHO, said that the cost of ARVs is still too high - well above the WHO target of $250/year - and called for countries to be "creative and relentless to drive down the costs of drugs so they will be affordable for all."
"WHO has long supported the rights of countries," Kim said, "to exercise the full flexibilities available to them under international trade agreements so that they can protect the health of their populations."
Kim did not specify precisely how the WHO would support countries' use of TRIPS flexibilities, but treatment advocates say pressure from both the United States and big pharmaceutical companies has seriously hampered willingness of China, Brazil, and India to issue compulsory licenses for ARVs.
It is also unclear which country the WHO might support, but many of those familiar with the ARV industry have concluded that China is a key candidate, as it is both a large producer of the raw materials for ARVs and under pressure for its less-than-perfect intellectual property record.
"We are very aware of the risk of a gap in terms of the production of ARVs," said Bernard Fabre-Teste, WHO Regional HIV/AIDS Advisor, "WHO and UNAIDS are committed to go further in discussions with China to assess the possibility of China entering the process."