Rwanda's approach proves perfect antidote to counterfeit drugs

Posted in the Guardian by Agnes Binagwaho and Amir Attaran

Wednesday 3 July 2013  i

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Rwanda's integrated solution to combating fake drugs could inform a global treaty on medical safety

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

Partnerships to Accelerate Progress in Global Health: The Case of Cervical Cancer

Rwandan health minister hits back at critics of drug company deal

The debate must move on from seeing pharmaceutical companies as evil predators and poor people as hapless victims

Published in the  guardian.co.uk, Tuesday 21 May 2013 16.31 BST
http://www.guardian.co.uk/world/2013/may/21/rwanda-health-minister

A hero of mine wrote from prison that “human progress never rolls in on wheels of inevitability; without hard work, time itself becomes an ally of social stagnation.”  Dr. Martin Luther King Jr.’s words have long resonated with Africa’s struggle against global cynicism in the fight against AIDS. At the turn of the millennium, while I practiced as a pediatrician in Rwanda, international experts brandishing computer-generated prescriptions of cost-effectiveness told us then that the time just wasn’t right to provide access to the effective treatment widely available in their own countries. In short, African lives were worth less than American or European lives. Costs were just too high, they said (never mind that activists soon drove AIDS drug prices down from $12,000 to $100 per year). African governments and patients simply weren’t prepared, they cautioned (never mind that studies show Africans have far higher adherence to treatment than North American counterparts).

Dr. King’s words came to mind again last week, when I read with interest a recent commentary in The Guardian on pharmaceutical company donations in Africa. As an example of the pitfalls of corporate philanthropy in global health, author Adam Green cited Rwanda’s partnership with Merck to provide universal access to the human papillomavirus (HPV) vaccine for the prevention of cervical cancer. He echoed claims made two years ago by some experts that Rwanda jumped the gun, allowing itself to be used as a pawn by a predatory multinational corporation.

Most in global health have moved on from this debate, as the world came to recognize the mounting burden of cervical cancer in Africa, as the price of the HPV vaccine dropped from $16.95 to $5 per dose by mid-2011, and as the GAVI Alliance added the vaccine to its portfolio of support. And despite skepticism from some about the feasibility of nationwide HPV vaccination in Africa, Rwanda reached more than 93% of eligible girls with all three doses through a school-based program in 2011. When Rwanda already had 90% or higher coverage for vaccines against 10 other diseases, when cervical cancer now rivals HIV and maternal mortality as a leading killer of our women, and when GAVI’s budget grew 42% last year, it is difficult for me to see this as some kind of dangerous precedent.

Yet such arguments keep recurring (for HIV, drug-resistant tuberculosis, cancer, cholera, and so on) because of a larger divide in global development. Many who advance or tacitly endorse the claims echoed in Green’s piece often do so because they believe ideological purity (that is, the view that drug companies often pursue only self-interest) is a moral imperative, and that cost-effectiveness (that is, poor people should get cheap things) should always trump other considerations.

But do we truly live in such a zero-sum world that a win-win outcome from a public-private partnership for health is unimaginable? Certainly, competition is better for promoting access to medicines than voluntary donation programs. Yet there are already two companies making the HPV vaccine, and generic versions are not so far off. Furthermore, the historical gap between new vaccine introduction in rich and poor countries is two decades; by working with Merck, Rwanda reduced it to four years and showed the world one possible strategy for reaching universal coverage. Just this past week, GAVI made international news by announcing even lower prices for the HPV vaccine (down to $4.50 per dose) through agreements with two manufacturers, and approved a grant to continue Rwanda’s national program after Merck support stops in 2014.

So much can be achieved in global health with shared commitments to teamwork and humility, a willingness to grapple with complexity, and a big dose of imagination. Indeed, for the very health issues that Green argued should rank higher than the HPV vaccine, Rwanda (and many other nations) are already engaged in novel collaborations to address. On top of the HPV vaccine rollout, we are working with groups around the world to build synergistic screening and treatment programs for cervical and many other cancers. In tackling maternal and child mortality, we’re strengthening health and sanitation systems in addition to teaming up with development partners on a mobile-based notification system for community health workers. With the support of GAVI, we’ve rolled out three new childhood vaccines against pneumonia, diarrhea, and rubella nationwide since 2009. With two-dozen American schools, we are training hundreds of nurses and specialist physicians.

And it seems to be working: while spending less than $60 per capita on health, Rwanda is now on track for the Millennium Development Goals. Indeed, to those interested in working here, we like to say, “Don’t come for charity. Come for partnership.”

Adam Green’s piece voiced concerns about programs like those described above serving as “market priming to create the conditions for adoption.” From Rwanda’s view, the jury is in: with more women dying of cervical cancer than in childbirth worldwide, the market is quite primed and demand readily apparent. Supply of the HPV vaccine and many other tools of modern medicine, on the other hand, remains in doubt for those who need them most. But with no global solidarity fund for cancer today, how else should we get started but to forge smart new partnerships? One lesson from AIDS is that if the world stalls, you just need to act and show that it can be done.

As Dr. King said, in the face of challenges like growing global health inequalities, “We must use time creatively, in the knowledge that the time is always ripe to do right.” Let’s use our time and talents—as health workers, researchers, and journalists—to work together towards a future in which where a patient lives doesn’t determine if they live.

Agnes Binagwaho is Minister of Health of Rwanda, Senior Lecturer at Harvard Medical School, and Clinical Professor of Pediatrics at the Geisel School of Medicine at Dartmouth.