Alexandra Calmy

Donnelly

Felipe Garcia de la Vega

Fernando Pascual

Gilks

Marseille

Nathan Ford

Sheila Shettle

Williams

English

Crossref

Calmy, A

Pascual, F

Shettle, S

de la Vega, F G

Ford, N

MSF Field Research

Correspondence
(The Lancet)
Red: a missed 
opportunity
The  past  5 years  have  been  essential 
to  increasing  access  to  antiretroviral 
treatment  in  resource-poor  countries, 
and  this  experience  has  raised  many 
challenges. The ﬁ  rst was simply to start 
treating patients in the face of criticism 
and doubts expressed by the scientiﬁ  c 
community
1  and  major  donors,
2 
with little support from UN agencies. 
Although  we  welcome  The  Lancet’s 
initiative to devote an issue to HIV/AIDS, 
we are disappointed that so much space 
was  devoted  to  uncontroversial  and 
apolitical statements by UN agencies.
Behind  the  self-congratulation  of 
multilateral agencies lies the fact that 
universal  access  is  far  from  within 
reach,  and  strategies  to  ensure  long-
term  quality  care  in  resource-limited 
settings  hardly  exist.  Ensuring  free, 
long-term treatment access will require 
more  than  goodwill,  and  aﬀ  ordable 
medicines do not suddenly appear with 
the publication of new formularies.
WHO‘s  public-health  approach  to 
antiretroviral  therapy  focuses  on 
the “Fours Ss”: when to Start, when 
to  Substitute,  when  to  Switch,  and 
when to Stop.
3 But who will pay the 
price of this strategy? Most countries 
are  barely  managing  with  the  ﬁ  rst 
and  last  S  (starting  and  stopping). 
Although basic ﬁ  rst-line therapy costs 
are  as  low  as  US$132  per  patient 
per  year,  the  main  substitution  for 
toxicity  requires  tenofovir,  which  is 
rarely  registered,  at  least  2·5  times 
more  costly,  and  not  available  as  a 
triple  ﬁ  xed-dose  combination.  Basic 
second-line  regimens  currently  cost 
at  least  ten  times  more  (ﬁ  gure).
4 
At these  prices,  10% of  patients on 
second-line therapy would represent 
over 60% of the national drug budget. 
What  is WHO doing to  address this 
issue?
Price is only a part of the problem. Of 
the 13 drugs recommended by WHO, 
only six have been prequaliﬁ  ed. There 
are  no  generic  prequaliﬁ  ed  versions 
of  any  of  the  ﬁ  ve  antiretrovirals 
speciﬁ  cally recommended for second-
line treatment (didanosine, atazanavir, 
lopinavir/ritonavir,  saquinavir,  and 
ritonavir),  and  only  two  originator 
companies oﬀ  er a diﬀ  erential price for 
these products. 
With the World Trade Organization’s 
TRIPS Agreement now in full force in 
major  generic-producing  countries 
such  as  India—on  whose  generic 
medicines  around  half  of  those 
receiving antiretroviral treatment in the 
developing world currently depend—it 
is  unlikely  that  generic  versions  of 
these  and  other  new  drugs  will  be 
produced  without  a  serious  political 
struggle.  The  recent  removal  of  the 
WHO  representative  in  Thailand  for 
suggesting  that  compulsory  licensing 
should  be  considered  an  option 
for  securing  aﬀ  ordable  second-line 
medicines  shows  how  little  progress 
has been made to confront these major 
political  barriers.
5 That  none  of  these 
issues  were  addressed  by  the  major 
multilateral  agencies  who  dominated 
The  Lancet’s  special  issue  provides 
further  conﬁ  rmation  of  the  lack  of 
political  courage  where  it  is  needed 
most.
We declare that we have no conﬂ  ict of interest.
*Alexandra Calmy, Fernando Pascual, 
Sheila Shettle, Felipe Garcia de la Vega, 
Nathan Ford
acalmy@stvincents.com.au
MSF Campaign for Access to Essential Medicines, 
78 rue de Lausanne, 1202 Geneva, Switzerland; and 
Médecins sans Frontières, Bangkok, Thailand
1  Marseille E, Hofmann P, Kahn J. HIV prevention 
before HAART in sub-Saharan Africa. Lancet 
2002; 359: 1851–56.
2  Donnelly J. Natsios called racist; ﬁ  ring sought. 
Boston Globe Sept 6, 2001.
3  Gilks C, Crowley S, Ekpini R, et al. The WHO 
public health approach to antiretroviral 
treatment against HIV in resource-limited 
settings. Lancet 2006; 268: 505–10.
4  Campaign for Access to Essential Medicines. 
Untangling the web of price reductions: a 
pricing guide for the purchase of ARVs for 
developing countries, 9th edn. Geneva: 
Médecins sans Frontières, 2006. http://www.
accessmed-msf.org/documents/
untanglingtheweb%209.pdf (accessed 
Sept 12, 2006).
5  Williams D. World health: a lethal dose of US 
politics. Asia Times June 17, 2006. http://www.
atimes.com/atimes/Southeast_Asia/
HF17Ae01.html (accessed Aug 31, 2006).
For the website of the 
Prequaliﬁ  cation Programme 
managed by WHO see 
http://mednet3.who.int/prequal/
Figure: Average prices paid for ﬁ  rst-line and second-line antiretroviral drugs in 
low-income and middle-income countries in 2005
Data from WHO Global Price Reporting Mechanism on Antiretroviral Drugs.
5000
4500
4000
3500
3000
2500
Second-generation drugs (no competition)
2000
Low-income countries
Middle-income countries
1500
Lamivudine+stavudine 
+nevirapine
Lamivudine
+zidovudine
Efavirenz
Abacavir
Enteric-coated
didanosine
Tenofovir disoproxil
fumarate
Lopinavir/ritonavir
Ritonavir
1000
500
U
S
$
 
p
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r
 
p
a
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a
r
Old ﬁrst-line drugs
(competition)
0
Exceptional responses or 
TRIPS over red tape?
Peter Piot’s Viewpoint (Aug 5, p 526)
1 
was commendable in its recognition of 
HIV/AIDS as an “exceptional” challenge 
and its call for action. Such a challenge 
undoubtedly  requires  an  exceptional 
response,  yet  despite  Piot’s  emphasis 
on “momentum and achievement”, it is 
clear that the global response remains 
ordinarily lacking. 
It  is  right  to  celebrate  the  genuine 
successes  so  far—because  they  have 
saved  lives  and  restored  hope—but  if 
universal access to treatment by 2010 
is to be more than rhetoric, we must 
shake oﬀ   any hint of complacency. The 
facts  are  stark. Only  20%  of those  in 
urgent need of treatment are receiving 
it.
2  More  than  4  million  additional 
health workers are needed.
3 On current 
trends,  we  will  spend  only  half  the 
US$20–23  billion  needed  annually 
by  2010.
1  Clearly  momentum  is  not 
enough: a change in pace is necessary.
In  these  areas,  Piot  outlines  many 
positive  steps,  but  like  others,  does 
not  mention  one  crucial  piece  of the 
puzzle:  increasing  the  manufacture 
and  distribution  of  aﬀ  ordable  generic 
drugs, particularly expensive patented 
second-line and third-line treatments. 
Compulsory  licensing  again  remains 
the  mechanism  so  sorely  needed  yet 
so rarely spoken of. The fundamental 
importance of generic competition to 
www.thelancet.com   Vol 368   September 23, 2006  1063

(The Lancet)red: a missed opportunity.

(The Lancet)red: a missed opportunity.

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