Globalisation has brought people many wonderful things, but occasionally it brings them death, thanks to the growing international trade in bad medicines. At least 100,000 people each year succumb to medicines that are negligently made, or sometimes deliberately faked with bogus ingredients. The solution demands local and global measures to improve regulation and make penalties tougher for medicine criminals. We simply cannot afford the cost of inaction.
This week, we published research in Public Library of Science Medicineshowing that tuberculosis drug quality is variable in low- and middle-income countries. Of 713 samples of the tuberculosis medicines isoniazid and rifampicin collected in 17 countries, 9.1% contained insufficient quantities of the active pharmaceutical ingredient, and failed basic quality control tests. The situation is even worse in some African countries, where 16.6% of medicines failed; 7% were outright fakes, containing no active ingredient. These failing medicines won't cure tuberculosis infections and could even fuel drug resistance, which makes the disease much more difficult and expensive to cure.
Yet one encouraging result stood out: no fake tuberculosis drugs were found in the sample from Rwanda. This is consistent with other recent studies, which found that the east African state has few substandard and no obviously falsified malaria medicines. So what is Rwanda doing right?
First, over the past decade the government has taken legal and technical steps to secure the whole of its medicine supply chain. It buys high-risk drugs, such as those for tuberculosis, exclusively from manufacturers certified by the World Health Organisation (WHO), and distributes them in a dedicated, controlled supply chain to hospitals and clinics.
Second, the Rwandan government has trained the healthcare workers who handle the medicines how to spot and report substandard and falsified products.
Third, a taskforce of health regulators and customs officials inspects all medicines entering the country at the border, notifying the police (who in turn notify Interpol) when something is amiss. The Rwandan approach is holistic, and draws on resources from across the government.
It is tempting to say that Rwanda does all this because – unusually forAfrica – it has a strong publicly funded health system to treat tuberculosis. Yet, without a holistic approach, the system would be undermined by criminal activity and collapse. It is not just the healthcare workers and the quality of programme management that make the system function; in terms of medicines, it is the police and regulatory officials too. "Health is too important to leave to doctors," people say around Rwanda's health ministry.
Unfortunately, there is opposition to fighting fake and substandard medicines in this holistic way. Some countries, such as India, vocally oppose commingling public health and policing at an international level. Setting up that conflict seems a tactical mistake, because, as we know from many examples – food safety, airline safety, road safety – regulation and policing are necessary to prevent accidents and protect wellbeing. In fairness, India's parliament now acknowledges (pdf) the country has medicine quality problems that "can harm patients".
But for Rwanda to fix problems outside its borders, it needs the co-operation of other countries. A global treaty is needed to make medicine safety a priority, both by building the capacities of drug regulators and by making medicine falsification an international crime.
One perspective on the problem is that the world has done a dangerously imbalanced job of globalisation. Starting with the WTO agreements in 1995, free trade in legitimate medicines has helped patients who have access to quality drugs at affordable prices, but free trade in falsified and substandard medicines is hurting and killing many others. Without reversing the good half of this equation, countries need to clamp down on criminal activity. An international law that sets standards for medicine quality and safety in international trade – which, today, it does not – is essential.
Precedents abound: you can board an aircraft in country X and land safely in country Y because there are treaties on flight safety to which all countries agree. Likewise, you cannot print the banknotes of country X and pass them off in country Y without being arrested, because there are treaties criminalising counterfeiting. If international law can promote safe flights and criminalise fake money, surely it does not take too much imagination to negotiate and agree a treaty to promote safe medicines and criminalise fakes to protect people in low- and middle-income countries.
• Agnes Binagwaho is Rwandan health minister, senior lecturer at Harvard Medical School, and clinical professor of paediatrics at the Geisel school of medicine, Dartmouth University. Amir Attaran is Canada research chair in law, population health and global development policy, and professor in law and medicine at the University of Ottawa
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