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Drug Quality &Treatment Bill Brieger | 14 Aug 2010 07:04 am

No unqualified acceptance for prequalified medicines

According to the World Health Organization, its “Prequalification Programme aims to make quality priority medicines available for the benefit of those in need.” The results is a “list of prequalified medicinal products used for HIV/AIDS, malaria, tuberculosis and for reproductive health.” The list is supposed to guide purchasing decisions of all UN and development partner agencies.

dscn0689a.JPGThe Global Fund is one of the international agencies that encourages its recipient countries to buy from the prequalified list, and through the Affordable Medicines Facility, malaria (AMFm) intends that not only good quality is promoted, but reduced prices. Interestingly, this development has raised concern in Nigeria, the biggest market for malaria drugs in Africa.  As Soyombo Opeyemi explains in the Daily Independent

The proposed intervention by The Global Fund to drastically reduce prices of Artemisinin Combined Therapies (ACTs) through its Affordable Medicines for Malaria programme (AMFm), which will see ACTs from six foreign companies sell from September 2010 at a monitored price regime of between N60 and N70 a dose [between US $ 0.40-0.47], as against the current average price of N350 for most ACTs produced or marketed in Nigeria, has generated a rumpus in the last few weeks in the media.

The controversy arises over two competing development goals – making high quality medicines available to those in need at affordable prices vs strengthening local industrial capacity. As seen in the Table below, many of the manufacturing sites are in ‘developing’ countries, but as Abdullahi Mohammed points out in This Day …

(These manufacturers) also have access to cheap credit, enjoy tax reliefs and export incentives, among other forms of official assistance. All this makes it difficult for Nigerian manufacturers, who currently have practically no access to bank credit and are stuck with providing their own infrastructural requirements, to compete with their foreign counterparts.

Companies Producing WHO Prequalified Anti-Malaria Drugs

Amodiaquine + Artesunate

·         Ipca Laboratories Limited

Dadra and Nagar Haveli (U.T.), India

·         Guilin Pharmaceutical Co. Ltd

Guilin, Guangxi, China

·         Cipla Ltd

Patalganga, India; Goa, India

·         Sanofi-Aventis Group

MAPHAR Laboratories, Casablanca, Morocco

Artemether + Lumefantrine

·         Novartis Pharma

Beijing, China; Suffern, USA

·         Ajanta Pharma Ltd

Paithan, Aurangabad, Maharashtra, India

·         Ipca Laboratories Ltd

Dadra and Nagar Haveli (U.T.), India

·         Cipla Ltd

Patalganga, India; Himachal Pradesh, India

The Nigerian malaria drug market is vast. There are dozens of Arthemeter-Lumefantine ACTs approved for sale and over 100 Artesunate-Amodiaquine formulations. Some of these are produced by actual Nigerian manufacturers while others are imported by a Nigerian Company from India and elsewhere. It would be important to identify the actual indigenous manufacturers who are losing out to the six big international pharmaceutical producers.

dscn1575a.JPGIt is not clear whether there are actual foreign assistance efforts aimed at building the capacity of malaria endemic countries in Africa to produce their own pharmaceutical products.  If such a longer term project were started in parallel with efforts like AMFm, there may be more acceptance for temporary set backs in the local market, knowing that in good faith, the international community is trying to strengthen countries’ abilities to fight malaria into the future.

the challenge though is which aid program can address the infrastructural problems facing Nigerian manufacturers – lack of reliable electricity, water supply and roads – as well as a legal framework that protects intellectual property and gives the local companies a fair chance to compete.

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