Info Service on Health Issues (July 07/02)
New HIV/AIDS drugs 500% more costly, says MSF
The new HIV/AIDS drugs
recommended by the WHO raise the cost for patients by nearly 500%, according
to Medecins Sans Frontieres. This could affect the availability of these
drugs in developing countries.
The article below details
the problem and is reproduced with the permission of South-North Development
Monitor (SUNS) #6299, 24 July 2007.
Health: New first-line
HIV/AIDS drugs 500% more costly, says MSF
By Kanaga Raja, Geneva,
23 July 2007
The use of newer, less toxic
first-line HIV/AIDS anti-retroviral combinations, now recommended by
the World Health Organization (WHO), has raised the cost for patients
by nearly 500%, according to a new report by the international medical
humanitarian group Medecins Sans Frontieres (MSF).
This finding by MSF was in the latest edition of its report "Untangling
the Web of Price Reductions" released Monday at the fourth International
AIDS Society Conference taking place in Sydney,
While there have been dramatic price reductions for second-line anti-retroviral
treatment over the last year - largely stimulated by a compulsory license
issued by Thailand - a worrying trend is that using less-toxic first-line
combinations, newly recommended by the WHO, raises the cost for patients
by nearly 500% - from $99 to up to $487.
"It's encouraging to see the price of second-line regimens finally
starting to come down," said Karen Day, pharmacist with MSF's Campaign
for Access to Essential Medicines.
"But we are worried that the lack of competition and dramatically
higher prices for the newly-recommended WHO first-line could mean that
people in developing countries may not be able to benefit from improved
treatment that has been widely available in wealthy countries for years."
According to the MSF report, whereas most of the regimens previously
recommended included stavudine (d4T) or zidovudine (AZT), the 2006 WHO
treatment guidelines have added an improved first-line treatment based
on combinations including Abacavir (ABC) and tenofovir disoproxil fumarate
(TDF) as new Nucleoside Analogue Reverse Transcriptase Inhibitor options.
TDF is now becoming an emerging preferred first-line option because
of its toxicity profile and increased availability in developing countries.
It should be administered in combination with two drugs - one being
either lamivudine (3TC) or emtricitabine (FTC), the other being either
efavirenz (EFV) or nevirapine (NVP), said MSF.
MSF said that competition among multiple manufacturers is the main factor
that has made prices of older anti-retrovirals (ARVs) come down. Treating
an adult patient for one year with a triple anti-retroviral first-line
regimen may now be as low as $99.
However, the improved first-line and second-line regimens now recommended
by WHO include newer drugs that are more expensive, as few generic competitors
exist and demand is still low. There is therefore a serious risk that
the price crisis seen five years ago, with life-saving ARVs priced out
of reach of those in need, is set to return, added MSF.
This is the case in Thailand,
which issued compulsory licenses for three medicines, including the
AIDS drugs EFV and LPV/r (Lopinavir/ritonavir) in November 2006 and
January 2007, respectively, and Brazil, which did the same for EFV
in May 2007.
[According to an article in the International Herald Tribune on 22 July,
the pharmaceutical company Roche in June announced a global recall of
its AIDS drug Viracept after it found that due to a flawed manufacturing
process at its plant in Switzerland, some batches of its drug
had been contaminated with a carcinogen.
[According to the article, the recall did not cause a great stir in
Europe as the drug had fallen out of use there and been replaced by
newer more expensive alternatives. The article noted however that tens
of thousands take Viracept around the world, most of them poor people
living with HIV/AIDS in developing countries. For instance, in Panama, the substitute
drug Kaletra costs ten times more than Viracept. The Tribune article
said that the situation has now left patients with the choice of either
discontinuing the drug, or continuing to use the drug that might contain
The MSF report said that most originator companies offer their most
discounted prices only to a certain group of countries, usually to Least
Developed Countries (LDCs) and countries in sub-Saharan Africa.
However, the companies do it differently: Merck extends "first
category" prices to countries ranked as "low" and "medium"
on the Human Development Index with HIV prevalence rates greater than
1%; GlaxoSmithKline offers differential prices for their products to
all Global Fund grantees; and Gilead
has established its own list of eligible countries using mixed criteria,
including some middle-income countries.
This means that if a country qualifies for the discounted prices offered
by one company, it may not necessarily be included in the list of eligible
countries of another company.
The report also noted that products provided under these schemes frequently
remain unavailable in countries because the products are not registered
or marketed. It stressed that the pace of registration of ARVs (including
generic formulations as they become available) is of critical importance.
It is strongly recommended for countries to accelerate registration
of needed ARVs, applying fast-track procedures for WHO pre-qualified
products, and thus avoiding unnecessary delays. Offers of differential
prices, however loudly trumpeted, are meaningless if a manufacturer
does not take the step of registering the product in countries where
it is needed, said the report.
The report also said that although some patients benefit from differential
prices, prices for new drugs are still too high, mainly because there
is no or not enough competition. In the absence of competition, prices
of new drugs will never drop to the level of first-line drugs.
An MSF analysis of Brazil
efforts at providing universal access to anti-retroviral therapy shows
that compulsory licenses have been far more effective in bringing prices
down than negotiating price reductions with companies or relying on
companies' differential pricing schemes.
In January 2007, Thailand
issued a "compulsory license" to overcome the patent barrier
on the important drug for use in second line treatment, lopinavir/ritonavir,
allowing the country to legally either import the drug or produce it
"Just one year ago, treating a patient with a second-line regimen
containing lopinavir/ritonavir in Thailand cost $2,800 per year, said Kannikar Kijtiwatchakul,
MSF Campaigner in Thailand.
"Thanks to competition since the compulsory license, treating that
same patient with a second-line regimen will now cost $695 - four times
less. But this is still far too expensive for the majority of people
in Thailand, where
the average annual salary is $1,600."
MSF's experience trying to obtain newer AIDS medicines over the past
two years has shown that significant delays persist between when newer
treatments become available in wealthy countries, and when they become
available in the developing world.
"I work in Sydney and also have
been treating patients with AIDS in countries like Malawi
and the gaps I have witnessed are alarming," said Dr Alexandra
Calmy, HIV/AIDS Advisor for MSF's Campaign for Access to Essential Medicines.
"At this conference in Sydney,
we're seeing presentations on several promising drugs. These drugs should
be available in Africa, Asia and Latin America
at the same time as they are marketed in rich countries, not only after
years of fighting for access to them. This means including the needs
of people living in developing countries into the R&D plans from
The MSF report also noted that until recently, most small children were
treated with liquid formulations. These syrups or oral solutions are
ill-adapted for use in remote settings, as they are complex to reconstitute
and administer; can have an unpleasant taste; and are cumbersome to
transport and store. They are also expensive.
Developments in the course of the last year have brought some improvement,
said the report. Several generic manufacturers have introduced paediatric
Fixed Dose Combinations (FDCs) for first-line therapy (such as the FDC
d4T/3TC/NVP manufactured by both Cipla and Ranbaxy).
However, not all problems have been resolved by this move. The dosages
of these existing FDCs differ from each other, since guidance from WHO
on recommended dosages came too late for manufacturers.
The slowness of WHO in giving clear recommendations has created a problem
that risks delaying the development of paediatric FDCs, and, ultimately,
the administration of adequate treatment for children, said MSF.
Another major problem for which no solution is on the horizon is that
there are no second-line formulations in the pipeline for children and
more formulations are needed to complete the spectrum of regimens needed
in an AIDS programme.
The report urged donors and international organisations to prioritise
paediatric AIDS therapy, and work pro-actively to encourage much-needed
R&D for this neglected group of patients.
According to UNAIDS and WHO, an estimated 250,000 to 350,000 deaths
were averted in 2005 because of expanded access to AIDS treatment, but
this picture must be balanced with the 2.9 million people who died of
AIDS-related illnesses in 2006.
Patents should not be a barrier to accessing affordable medicines, increasing
generic competition and assuring that the appropriate fixed dose combinations,
including those for children, are developed. Flexibilities in both international
and national patent rules exist to allow for this and there is no excuse
for obstructing the use of these safeguards, said the MSF report.
MSF currently provides anti-retroviral treatment to more than 100,000
patients in over 30 countries, including to over 7,000 children.
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