Mainland drugs sector in need of cure

PUBLISHED : Friday, 11 August, 2006, 12:00am
UPDATED : Friday, 11 August, 2006, 12:00am

The Anhui drugs scandal is one of the worst nightmares of those responsible for running a health-care system: patients have died after being given an antibiotic that was supposed to help make them better. Two weeks after the first report of trouble, mainland authorities have blamed 'production faults' and cited incomplete production records kept by the manufacturer. It is not an isolated incident. In April and May, 11 people died after injecting a drug containing a chemical that causes kidney failure.

The antibiotic tragedy has unleashed scathing criticism in the official mainland media of drug regulators and quality control in manufacturing plants. The State Drug and Food Administration has defended a delay in warning of adverse reactions to the drug as good administrative practice to avoid 'interfering in normal social life and causing social panic'. Rightly, a Beijing medical academic has branded such caution in regulating drug-makers as socially irresponsible.

These incidents are a reminder that the mainland's huge and lucrative market for pharmaceutical drugs is not backed by international best practice. Nothing is more important than the consequent loss of human life. But shortcomings in standards of research, trials, manufacturing, quality control and reporting of adverse reactions also stand in the way of the mainland pharmaceutical industry taking on the multinational giants, or even reaping the benefits of world-recognised achievements.

For example, the mainland's contribution to the most effective treatments for malaria, called Artemisia combination therapies (ACTs), is widely acknowledged. But the two main ACTs are marketed by foreign multinationals. The use of artemisinin, a compound from the Artemisia annua shrub, was a result of research begun on the mainland during the Vietnam war. The research was intended to help North Vietnam and the Viet Cong, who were losing too many combat troops to malaria.

Chinese attempts to bring ACTs to market have been blocked by a failure to meet international standards. Hangzhou-based Holley Pharmaceuticals, a key source of the raw material, hopes to break into the world market with its version Artekin. But a World Health Organisation official says information and documentation is inadequate and WHO approval far off. Another mainland drug developer, Artepharm, claims its ACT Artequick works within 24 hours and has been used successfully in Cambodia. But it says the WHO is withholding approval because the company has yet to meet good manufacturing and agricultural practices.

David Ubben, research director for a Geneva-based malaria research organisation, says Chinese drug firms lack quality controllers prepared to stand up to managers and say a batch of substandard medicine cannot leave the factory. In other words, the drive to reach production and profit targets can compromise ethical pharmaceutical practices.

Ineffective regulation of the pharmaceutical industry only compounds the damaging effect of market reforms on the mainland's health-care system. Access to health services has diminished as user charges have displaced state funding. This has led to a corrupt system where those willing to pay more for care get treatment first, and drugs are prescribed to maximise profits, rather than for medical needs.

Far-reaching reforms are needed to maintain health standards and protect patients' rights. Given that drugs are an essential but easily abused commodity, the central government should tighten control over the country's 4,800 self- regulated drug firms. The suggestion that they be consolidated to reduce competitive pressure and refocused on research and development seems sensible. And the State Food and Drug Administration should recognise that more transparency and public confidence in its oversight of drug manufacturing will improve people's health and not harm social stability.