Patients Versus Patents
Big Pharma / GENERIC DRUGS
A mere 28 kilograms. That’s all Suwanee Chainuan, a 34-year-old hiv-positive woman from the northern Thai province of Phayao, weighed a few months ago.
Suwanee had grown increasingly sick in recent years, plagued by chronic respiratory tract infections, fevers and skin eruptions which spread like wildfire over her body. She had become unrecognizably thin, dropping over 30 kilos.
‘I thought my daughter could never be saved,’ remembers Wandee Chainuan, her mother, who works as a seamstress. ‘It was impossible for us to buy the drugs needed to treat her. We were helpless.’
That was until, almost miraculously, a cheap and affordable antiretroviral (ARV) treatment suddenly became available last year. At just 20 baht (50 cents) the indigenously produced GPO-VIR pill, taken twice a day, costs $29 for a month’s supply. A far cry from the $490 per month for similar treatment at the end of 2001.
Suwanee got access to the pills three months ago through a government scheme and the impact has been tremendous. ‘She is already feeling much better,’ explains her mother, adding that Suwanee’s overall health has improved and she has already put on six kilos since starting the medication.
Though cheaper generic aids drugs are now more easily available in Thailand and new government policies promise to put them within the reach of all who need them, Suwanee is one of the lucky ones actually to get such treatment. Of the 160,000 people in Thailand who need the lifesaving ARVs, only 23,000 will receive them by the end of this year – and that’s if everything goes according to plan.
Cost of living
‘I would not like to guess how many people in Thailand have died because they could not access treatment,’ says Paul Cawthorne, Country Co-ordinator for Thailand of Médecins Sans Frontières. ‘For most people treatment is just too expensive.’
Eleven years ago when Suwanee Chainuan contracted the virus from her late husband, antiretrovirals had not been developed. Current forms of ARV therapy combining three to five different medicines only came into play in 1996. They have been tremendously effective – reducing viral load by as much as 99 per cent. But the high cost of the therapy – up to $10,000 a year when it was first introduced – meant it was inaccessible for most patients in countries like Thailand. By 2002 a year’s treatment for a single patient in Thailand was still $5,880.
It was this high-priced inaccessibility that sparked the Government Pharmaceutical Organization (GPO) to look for more affordable substitutes for the expensive, imported antiretrovirals. The GPO, established over 60 years ago to produce cheap, reliable generic drugs, set out to manufacture the same medicines locally.
‘It is absolutely essential for Thailand to produce cheap drugs because most Thai people are poor,’ says a senior official in the Ministry of Public Health who wished to remain anonymous. ‘We must tackle the problem of patents in the near future, so that we can produce a wider range of medicines.’
The GPO’s ability to produce generic drugs has been hampered since 1992 when the Government, under pressure from drug transnationals and the United States, modified the Thai Patents Act to allow patenting of pharmaceutical products. Until then Thailand, like India and several other developing countries, granted patents only for processes and not products – thus allowing domestic companies to make cheap copies of drugs patented abroad, using modified processes.
In principle the Act includes public-health safeguards such as ‘compulsory licensing’ and ‘parallel importing’ to keep prices down. However, fearful of US trade retaliation, Thailand has yet to invoke these clauses explicitly and has instead chosen to provide generic copies of antiretrovirals not patented in the country.
While the Act was being massaged to suit the interests of global drug companies, the GPO had already begun to develop generic drugs for Thailand’s burgeoning hiv-positive population. By 1995, the GPO was selling a whole range of antiretroviral drugs and by 2002 had produced its first ARV cocktail – combining drugs yet to be patented in Thailand into the lifesaving GPO-VIR pills.
But the strategy does have some drawbacks. The biggest is the fact that antiretroviral treatment is far more complicated than just one or two triple-drug cocktails. Often there are severe side effects or drug resistance and patients sometimes have to test different combinations.
In Thailand there are presently up to eight different ‘cocktails’ being used by aids patients. So while GPO-VIR is a good start, many patients may eventually require therapies combining patented drugs which can’t be manufactured locally.
The drug was first developed in the US in 1989 by the National Institute of Health which subsequently licensed the marketing rights to BMS. The company then quickly patented an ‘improved’ formula for the drug. The improvement was to combine ddI with an antacid to counter stomach acid that was reducing the drug’s potency.
Though a similar patent claim in the US was rejected on grounds of obviousness, in Thailand BMS successfully managed to obtain patent rights in 1992, giving the pharma giant exclusive marketing rights to ddI tablets in the country. In its original application BMS patented ddI at dosages from 5 to 100 milligrams. When the patent was renewed in 1997 the company expanded its claim to all dosages beyond this range.
Meanwhile, the GPO had developed its own low-cost formulation of ddI as a powder. But the state agency was prevented from making the drug in the more convenient tablet form, which has fewer side effects, because of the BMS patent. The Thai Government, fearing negative trade repercussions from industrialized countries, also turned down a GPO request in 1998 for a compulsory license to manufacture ddI.
In late 1999, a massive demonstration outside the Thai Public Health Ministry, organized by non-governmental organizations like the aids Access Foundation and the Network of People Living with hiv, protested against both the US Government and Thai authorities.
The protest coincided with global campaigns by organizations like Médicins Sans Frontières – demanding that drug multinationals reduce the price of antiretroviral drugs to help save the lives of millions of poor people across the Majority World. Of the nearly 30 million people living with hiv/aids in sub-Saharan Africa, fewer than 30,000 were estimated to have benefited from ARVs by the end of 2001.
In 2001, the aids Access Foundation, along with two local activists, launched a legal challenge to the wider monopoly that the patent description justified.
In a landmark judgment on 1 October 2002, a Bangkok court ruled that the 1997 modification of the dosages was unlawful and instructed BMS to stick to making ddI within the dosage range allowed in 1992. The decision meant, at least in theory, that other manufacturers – like the GPO – could now produce the drug in pill form at dosages different from that sold by BMS.
Thailand’s aids activists then filed another suit seeking to invalidate completely the BMS patent. A decision is still awaited.
Meanwhile, the GPO swiftly announced plans to produce ddI tablets at half the BMS price. But so far that’s not happened. Despite pleas from hiv/aids groups in Thailand, Bristol-Myers Squibb lodged an appeal in December 2002 against the Bangkok court decision – a move that effectively blocked any production of cheaper generics.
‘Though the case is still dragging on, this is the first legal victory for hiv/aids patients and we expect this ruling to set a precedent for other aids advocacy groups and patients to follow,’ says Nimit Tienudom, executive director of aids Access Foundation. Nimit is confident that the BMS appeal will be turned down by the courts and that production of generic ddI tablets will begin by the end of this year.
Thailand’s activist groups seem to be on course for a major victory against Big Pharma. But without changes in global patent rules, for every such victory there are likely to remain several obstacles on the road to access to treatment for all.
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