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2009/4/27

China: Important role risks backfiring - By Anna Wang

-= Copyright: The Financial Times Limited 2009 =-
 

While the US is contributing to the fight against malaria with high-profile publicity and Europe is taking the lead on funding, China has provided some of the most potent drugs for treatment – but in a way that could backfire.

No kiosk in rural Africa would be complete without a colourful array of antimalarials. Lucky patients can find and afford the most effective class of antimalarial, artemisinin combination therapy (ACT).

Artemisinin is a chemical synthesis of the antimalarial agent in an ancient Chinese herbal remedy for fever.

Since 2007, in an orchestrated effort to win hearts and business in Africa, the Chinese government has built a number of clinics and donated an estimated 3m of doses of Chinese ACTs throughout Africa.

Some 30 countries have received antimalarial donations including Nigeria, Liberia, Kenya, Tanzania and Uganda.

“These donations are a blessing,” says Dr Richard Ndyomugynyi, Uganda’s National Malaria Control Programme manager.

The donated drugs also often appear in pharmacies across Africa. Sold at premium prices even with evidence that they are donated clearly visible on the boxes, they are in direct competition with other ACTs, angering local marketing agents.

One donated ACT, Arco, is according to its maker, Kunming Pharmaceuticals, a one-dose or one-day cure. Other ACTs on the market require a three-day course.

Dr Ndyomugynyi says a clinical trial at the Mulanga Hospital in Uganda’s capital showed a high efficacy rate, but he could not comment on its long-term safety.

However, this one-day treatment is in direct conflict with World Health Organisation recommendation. The new WHO malaria treatment guideline, due out at the end of May, strongly recommends completion of three days of treatment.

“Particularly in a high transmission area, a drug like Arco, taken for only one day, is more prone to develop resistance because of its long half-life,” says Andrea Bosman, Medical Officer of the WHO’s Global Malaria Program.

He also indicates that although it has good potential as a new ACT, the efficacy and safety data for Arco is very limited.

Approved in China, Kunming has yet to apply for WHO prequalification for Arco, a required stamp of approval for donor funding.

Kunming has, however, gained approvals with nine national drug authorities.

Dr Timothy Wells, Chief Scientific Officer of Medicines for Malaria Venture (MMV), a non-profit organisation and a global leader in antimalarial development, estimates that to develop Arco up to international standards will take at least six years, if it is successful.

Dr Claude Faurant, a consultant to HolleyPharm, a majority shareholder of Kunming, admits that pharmaceutical development is still not very well understood by Chinese pharmaceutical companies.

MMV and its Korean and Italian pharma partners are now preparing two new ACTs for regulatory approval. Both of the drugs originated in China.

Today the Chinese-branded ACTs are mainly in private pharmacies. The number of treatments sold is less than a few million, a tiny market against the estimated public sector market of 150m ACT treatments needed in 2009.

HolleyPharm, one of the three main Chinese ACT manufacturers, sells its ACT across Africa and south-east Asia. It has also supplied 1m treatments, about half of its total sales, to the Chinese Ministry of Commerce over the past two years.

“This is an effort by the Chinese government to show the African people that ACTs are invented by Chinese scientist and it is our major contribution to the fight against malaria,” says Charles Lu, chairman of of HolleyPharm.

“We do not see donation as a tactic to penetrate the market,” Mr Lu says. “Our number one priority is to penetrate the GMP Club.”

Good Manufacturing Practice (GMP) is a term often used to describe drugs that are produced to international quality standards.

China has a number of GMP generic drugs, but only one patented drug that has gained international regulatory approval. It is, in fact, the most widely used ACT, Coartem, the product of a partnership between pharma giant Novartis and the Academy of Medical Military Sciences of China.

“Not only is the best antimalarial on the market now a Chinese drug, in the foreseeable future, all of the new antimalarials will also have originated in China,” says Rob Ridley, director of the WHO’s tropical diseases research arm, TDR.

“You cannot under-estimate the impact of Chinese science on malaria treatment. If we did not have that, we’d be in a big mess now,” he adds.

However, another factor in the battle against malaria is the counterfeit business. “Counterfeits and substandard drugs are widespread,” says Mr Bosman, “They are not only extremely dangerous to the patient, but also to the community because they contribute greatly to resistance.”