Establishments that produce substandard or counterfeit antimalarials 
will find it harder to sell their products to developing countries 
after the World Health Organization published new guidelines this week 
spelling out how to buy quality-made artemisinin-based combination 
therapies (ACTs), the gold standard in treatment.
The WHO has only ever produced one guideline on procurement - for 
condoms - and now it has decided to extend the idea to antimalarials 
as it too is a highly unregulated market, particularly in the private 
sector in endemic countries.

"Pharmaceutical markets in malaria endemic countries are often 
unregulated and national authorities need practical help to assess the 
quality of malaria medicines before they buy them. Procurement 
channels are highly fragmented and so there are too many antimalarials 
of varying quality on the market," says Dr Andrea Bosman, the WHO's 
coordinator of the medicines and diagnostics unit at GMP.

Globally there are more than 800 different brands of antimalarials on 
the market, of which around 200 are artemisinin-based medicines, yet 
there are only 17 WHO prequalified antimalarial formulations (see 
Table 1). 18 more malarial formulations are currently under evaluation by the WHO.

The publication of the procurement guidelines - as well as an update 
(second edition) of the WHO's malaria treatment guidelines - is timely 
as the multilaterally-funded Affordable Facility for Malaria, which 
will fund ACTs in seven African countries plus Cambodia, will be launched in June.

"The procurement guidelines will streamline the antimalarial market 
which is highly unregulated with clearly defined procurement 
procedures [for bulk buyers of medicines]," Dr Bosman told Scrip.

The quality of ACTs is important as the use of ineffective or unsafe 
substandard products may be harmful to patients. If parasites are 
exposed to low levels of antimalarial medicines in the blood, this can 
encourage the emergence of resistant strains. As no new class of 
antimalarial medicines is expected to come to market for at least a 
decade, the effectiveness of these medicines must be protected.

The 108-page guidelines provide a 16-step checklist for drug 
procurement bodies, including how to select safe and effective ACTs, 
defining product specifications, selecting procurement methods and 
evaluating a product's quality.

few WHO recommended treatments have approved products. Out of the 12 
treatments recommended by the WHO for malaria (see Table 2), only four 
have product formulations that have been approved by the WHO (through 
its prequalification programme) or by a stringent regulatory authority 
(SRAs are those specified under the ICH, that is, regulators in the 
EU, Japan, US, Australia, Canada etc).

The four therapies are: amodiaquine+artesunate, 
artemether+lumefantrine and artemotil (for treatment of severe 
malaria) - the WHO has prequalified formulations for these three 
treatments, see Table 1 - while
artesunate+mefloquine has been approved by a SRA (Drug Regulatory
Authority
of Portugal).

This means that developing countries buying products for the remaining 
eight malaria therapies recommended by the WHO are using products not 
WHO prequalified or approved by an SRA.

Dr Bosman says the guidelines should help developing countries assess 
"suspicious" tender submissions when they follow the product 
specification checklist . "As a first choice, developing countries 
should buy drugs that have been approved by the WHO or an SRA, but if 
this is not possible, the guidelines will help them assess the quality 
of other medicines and compliance to Good Manufacturing Practices 
(GMP) of their manufacturing sites."

Novartis and Sanofi-Aventis: leaders on malariaHe adds: "A lack of 
WHO/SRA approved formulations for recommended treatments has always 
been a problem for malaria drugs as there has been a lack of interest 
by R&D pharmaceutical companies investing in malaria. Only Novartis 
and Sanofi-Aventis are present in the global ACT malaria 
pharmaceutical market." Luckily, Novartis and their Chinese partners 
have not made any patent claims for the generic versions of 
artemether+lumefantrine in developing countries, he says.

(GlaxoSmithKline, which has the most advanced malaria vaccine 
currently in development (RTS,S), said early this year that it would 
make data "freely available" for 13,500 potential malaria compounds on 
scientific websites; scripnews.com, January 22nd, 2010.)

Dr Bosman believes manufacturers of the remaining eight recommended 
antimalarial treatments do not always have the "resources or the capacity"
to submit dossiers to the WHO or a SRA. "This requires a lot of 
investment on their part."

He estimates that should the 600 million malaria treatment courses 
used worldwide every year actually be converted into one of the ACTs 
recommended by WHO - rather than ineffective and cheap chloroquine or 
SP
(sulfadoxine-pyrimethamethanime) - the antimalarial market would be 
worth over $500 million.

The procurement guidelines were based on a lot of the normative work 
done by the WHO in the prequalification unit. "The document ... pulls 
together a lot of WHO work and presents it from the point of view good 
procurement practices for a specific group of products," Dr Lembit 
Rägo, WHO coordinator quality assurance and safety: medicines, 
Department of Essential Medicines and Pharmaceutical Policies Health 
Systems and Services, told Scrip.

The international R&D-based pharmaceutical industry association, the 
IFPMA, which did not contribute its views (they also were not sought) 
on the two guidelines, told Scrip: "Medicine quality is a core 
principle for the IFPMA, which is why we are broadly supportive of the 
WHO prequalification program. This programme is making a positive 
contribution to raising the quality of medicines around the world, and 
the IFPMA has an effective technical collaboration with it."

Concerns about the high proportion of fake or substandard 
antimalarials have been noted by the USAID-sponsored survey of the 
quality of antimalarials in selected African countries, which was 
published in November, the IFPMA added.

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