Quality

Here’s an example of why quality and registration have been selected as one of four key areas of data disclosure:

A survey found that 40 per cent of artesunate drugs (based on the wormwood plant) bought in Southeast Asian markets to treat malaria contained no active ingredient. The drugs, in other words, were useless. Instead of receiving treatment for a debilitating and sometimes fatal illness, patients were putting their damaged health at even greater risk by unknowingly doing nothing. Worse, they were paying for nothing – with money that poor families might otherwise have spent on food. And because the drugs were counterfeit, the money paid for them was diverted from pharmaceutical companies that would have used part of the revenue to research and develop other potentially useful drugs.

Crime and corruption damage systems in other ways, too. In Nigeria, drug counterfeiters bribed drug regulation officials to get access to the market, weakening the entire health system.

Overall, up to a third of medicines on the market in developing countries are fakes, according to one study.

That is why quality matters. But while counterfeit drugs are a major problem in countries around the world, and at their worst are lethal, the issue of the quality of medicines is even wider: one-third of countries either have no regulatory authority of their own or have only limited capacity to regulate the market.

Regulatory authorities are needed to ensure implementation of good manufacturing practices, combat substandard products, inspect distribution channels (checking, for example, that out-of-date medicines are not on sale) and monitor new information on serious adverse effects of pharmaceutical products. As with counterfeit drugs, ineffective, poor quality, harmful medicines can lead to therapeutic failure, exacerbation of disease, resistance to medicines and sometimes death.

One cure for these and other ills is the availability of information. Which is why MeTA is based on the disclosure of data about policies, practices and outcomes. The action that countries take as a result will depend on local circumstance:

• in Tanzania drug inspectors were given hand-held computers with a database of all legally-registered products; products not on the list would therefore be illegal and could be impounded by inspectors
• in the case of Nigeria’s anti-counterfeit campaign, measures included not only tighter surveillance at ports and the dismissal and retraining of regulatory staff, but radio and television jingles to raise public awareness and encourage people to report suspicious drugs and the listing of counterfeit products in the newspapers.