[DEBATE] : SOUTH AFRICA: Question marks over ARV tender

[MFleshman at aol.com]

SOUTH AFRICA: Question marks over ARV tender

JOHANNESBURG, 29  February (IRIN) - The South African health department has 
called on drug  manufacturers to submit bids to supply the government's 
antiretroviral (ARV)  treatment programme, just days before the current ARV tender is 
due to expire.  AIDS experts and activists said decisions on which drugs to 
include were made  with little consultation. 

"The tender specifications were simply  released - many of the 
recommendations made were either ignored or shot down.  There has been a severe lack of 
transparency or participation," said Jonathan  Berger, a senior researcher at the 
AIDS Law Project (ALP), which submitted  recommendations for the 2008 tender 
in September 2007. 

"Had there been  more openness, there was certainly the expertise available 
to help the tender  look much stronger than it does," he said at a presentation 
to the Southern  African HIV Clinicians Society in Johannesburg on Thursday. 

The Joint  Civil Society Monitoring Forum (JCSMF), a body made up of health, 
human rights  and law organisations, which monitors implementation of the 
government's  National Strategic Plan for HIV and AIDS, has also complained that  
recommendations it submitted to the government in January were ignored.  

"We are concerned that there are serious shortcomings with the tender  
process and the specifications," wrote the JCSMF in a letter sent to the  government 
on Thursday. "Issuing [the tender] is also premature, given that  national 
treatment guidelines are in the process of being revised." 

The  ARV tender represents big business for pharmaceutical firms: South 
Africa has  the highest number of HIV infections in the world, and ambitious 
targets to more  than double the roughly 400,000 patients already receiving ARVs 
from the public  sector in the next few years. 

It calls for bids on 10 drugs, and for the  first time includes tenofovir, 
recently registered in South Africa, which will  provide an important 
alternative to patients at high risk of lactic acidosis, a  potentially severe side 
effect of the first-line drug, stavudine. 

The  government called for bids for the previous tender in February 2004, 
just prior  to launching the ARV programme in April 2004, but only awarded 
tenders over a  year later. Provincial procurement mechanisms had to be put in place 
in the  interim. 

The 2004 tender ran for three years and locked the government  into paying 
the same prices for drugs for the duration. As new generic versions  of ARV 
drugs came onto the market and prices dropped, by the end of 2007 the  government 
was paying almost twice as much as the private sector for first-line  drugs 
like nevirapine. 

In its September 2007 recommendations, the ALP  suggested that the new tender 
last only 18 months, to allow the country to take  advantage of possible 
price reductions and the possibility of new, more  effective medicines becoming 
available. Instead, the tender will run for two  years, starting from June 2008, 
and will not allow for the procurement of new,  better or cheaper drugs that 
may come onto the market in the meantime.  

The 2004 tender allowed companies to bid, providing they had applied to  re
gister their drug with the Medicines Control Council (MCC), South Africa  
regulatory authority; the new tender excludes companies from bidding to supply  
drugs that have not completed MCC registration by 20 March, the date when  
submissions are due. 

Long delays in registering new drugs at the MCC  have prompted calls by the 
JCSMF for the government to waive the process for  drugs already registered by 
stringent regulatory bodies such as the US Food and  Drug Administration and 
the World Health Organisation. The ALP's Berger feared  that the tender's 
strict registration requirement would result in many drugs  still awaiting 
registration not making the cut. 

Stavros Nicolaou, a  senior executive with local generic drug manufacturer, 
Aspen Pharmacare, told  IRIN/PlusNews his company was comfortable with the 
registration requirements and  would be bidding to supply eight of the drugs, but 
had hoped for a heavier  weighting towards local manufacturers in the tender's 
preference point system.  

Companies will receive preference points for local manufacturing  capacity 
and black ownership, but the largest number of points will be awarded  for 
pricing. Aspen obtained just over half of the last tender, with one local  and five 
multinational importers making up the remainder. A second local generic  
manufacturer, Adcock Ingram, has since entered the field and is likely to  compete 
with Aspen in bidding. 

Those pushing for greater ARV access  argue that competition between generic 
drug manufacturers offers the best hope  of further driving down ARV prices, 
but according to Berger, South Africa's  patent laws do not favour such 
competition. 

Brazil and Thailand have  taken advantage of exemptions in international 
intellectual property law that  allow developing countries to license generic 
manufacturers to produce essential  drugs, regardless of patent restrictions, but 
South Africa's Patent Act favours  patent protection. 

The ALP has fought patent restrictions on ARVs by  using South Africa's 
constitution to file complaints against pharmaceutical  companies with the 
Complaints Commission. This approach has achieved a number of  successes, with several 
of the companies agreeing to issue voluntary licenses to  generic 
manufacturers, but Berger argued that it was slow and unsustainable.  

"That's why it's so important that we have a Patents Act that's more  
friendly towards generic companies," he said. "We need a health department  that's 
prepared to do what the governments of Thailand and Brazil have done. We  just 
can't keep doing it one by one." 

The 2008 tender includes estimates  of the numbers of patients who will be 
taking each of the 10 ARV drugs over the  next two years, for example, a 
projected 507,000 patients will be taking  Lamivudine (also known as 3TC), a 
component of all first-line ARV regimens.  

However, Andy Gray, a pharmacist at the Centre for the AIDS Programme of  
Research in South Africa (CAPRISA), at the University of KwaZulu-Natal, said  
this figure suggested that fewer new patients would be initiating treatment in  
the next two years than expected. 

South Africa's National Strategic Plan  for HIV and AIDS set a target of 
providing ARV treatment to 80 percent of those  in need of it by 2011, a figure 
that translates into about 1.3 million people.  

The health department did not respond to questions from IRIN/PlusNews  about 
the tender. 



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