To ensure new medicines reach the people who really need them, new ideas are needed says Michelle Childs of Medicins Sans Frontieres. She calls for 'innovation plus access', with innovation steered towards 'unprofitable diseases'

April 8, 2009 -- A decade ago, 39 of the world's biggest drug companies mounted a legal bid to stop the South African Government in its attempts to provide generic medicines to its people. At the heart of the matter lay the politically loaded question of access to medicines. Who pays for medical research? And what happens to those who can't afford the price of the drugs?

A quick scan of today's news might point to a new era of collaboration – rather than confrontation – in getting drugs to the world's poor. Last month, the UK's biggest drug company trumpeted its decision to slash prices on a number of its drugs and open up its patents on neglected diseases to researchers; last year, the world's governments concluded complex negotiations at the World Health Organization (WHO) and agreed on a global strategy that recognises that new ways need to be found to reward drug development, alternatives to the patent system that prices drugs out of the reach of so many.

But while these are promising signs, the reality is that in a number of key areas the question of access to medicines and of medical innovation is as polarised as ever.

As I write, a number of disputes between drug companies and civil society groups or the government threaten to boil over in India, a country whose production of legitimate and affordable generic medicines has been so key to millions of patients around the globe that it has been dubbed the 'pharmacy of the developing world'. In the last months, legitimate generic medicines being transported from India to Brazil were seized in transit by Dutch customs authorities, in a move that could have a disastrous impact on the flow of legitimate medicines from generic manufacturers to patients.

Two sides of the same coin

These concerns are not new for Médecins Sans Frontières (MSF). Our doctors speak of how they are unable to provide good care for people with tuberculosis, due to the lack of good diagnostic tools and drug regimens that every day lose yet more of their effectiveness. Despite the successes of treating HIV in the West, our HIV/AIDS projects are still desperately lacking drugs for children. And we lack the research that could tell us which drugs are suitable for pregnant women and people co-infected with HIV and other diseases, like tuberculosis and malaria. Multi-drug resistant tuberculosis is spreading rapidly, but insufficient research means we don't have the new drugs and diagnostic tests so urgently needed. We need medical innovation that responds to the medical needs of patients.

Yet research alone will not ensure access to drugs for the poorest people. The stark reality is that even if research does take place, access to the fruits of innovation is far from guaranteed because it depends on pricing or registration policies. When appropriate tools do exist, MSF all too often struggles to access them – with devastating consequences. For example, our teams in Asia tell of HIV/AIDS patients going needlessly blind because of a virus – a treatable condition, but one that continues to maim because exorbitant prices keep the best drug out of reach. And nine years after the US Food and Drug Administration (FDA) approved a pneumococcal vaccine able to dramatically reduce the number of children dying, the vaccine remains expensive, is marketed in a highly impracticable form and is not available in the vast majority of least-developed countries where it could reduce unnecessary deaths. We need medical innovation, but innovation is meaningless if the medicines it produces are not affordable enough for us to access.

These two needs are very much two sides of the same coin. They are the product of an entrenched system: the way we pay for the development of new medicines today.

The investments poured into medical research by drug companies are recouped through high prices – high prices that companies can charge because patents prevent generic competition. The consequences of this system – the ones that prompted MSF to create the Campaign for Access to Essential Medicines 10 years ago – are twofold. On the one hand, those who cannot afford to pay for life-saving medicines must simply go without. On the other, medical innovation is driven towards areas of likely profit, and not towards areas of greatest medical need, meaning that research into many diseases is left dormant.

Urgent need for change

Unless we come up with systemic change, the problem can only get worse. MSF's HIV programmes, heavily reliant on generic medicines from India, see their source of affordable drugs drying up. More and more patients will need access to newer drugs as resistance emerges to their existing regimens, but many of these drugs are under patent in India, so generic production is not guaranteed in the future. A clear strategy is needed to address this looming crisis.

Worse, developing countries that do take action – like Thailand, which made use of internationally approved flexibilities in patent laws to increase access to needed medicines – are met with harsh criticism, retaliatory measures from the drug giants and threats of trade sanctions from Europe and the USA.

More money is needed for research and development into the diseases of the poor, but funding is not the only answer. We also need to challenge existing thinking and create a new model for the medical research and development paradigm.

Numerous comprehensive analyses or high-level commissions, be they sponsored by the UK Government or hosted by the WHO, for example, agree on the need for change.

The systemic change needed lies in finding new ways to finance research and development in a way that steers medical innovation so that it no longer neglects 'unprofitable' diseases, and so that it also ensures that patients can access the finished product. What we need, in sum, is innovation plus access.

To deliver innovation plus access, we need to separate the cost of medical research – the investments by drug companies, researchers, academics and others – from the price of the final product. In other words, the research must be rewarded in ways other than by charging high prices protected by patent monopolies.

For this to happen, we need big ideas and we need concerted will. The ideas are already there. As a part of the WHO Global Strategy, governments have clearly signalled the need to split cost from price. They are open to exploring entirely new ways of financing essential health research, in such a way that the products of innovation are accessible to those who need them most. New mechanisms are also being promoted that could allow for the development of urgently needed medical products that are more affordable.

The international drug procurement agency UNITAID is exploring the idea of a patent pool for medicines, which could usher in a collaborative model and allow generic manufacturers to speed up the production of affordable versions of newer HIV medicines and new combination therapies. Discussions are moving ahead on prize funds to spur the development of sorely needed diagnostic tests for tuberculosis and new treatments for Chagas disease, at the same time ensuring access to the resulting products.

So, the ideas are there, and governments have recognised the problem. What we now need is real commitment to make the changes that are necessary. But recent disputes – be it the retaliation faced by Thailand, the patent lawsuits in India, or the drug seizure in the Netherlands – are exactly the reverse of change: they are merely efforts to prop up a system that is seen to be failing to meet the health needs of the world's poorest.

Action is needed today to ensure lower prices for existing medicines and other health products. But real change will only happen once new financing mechanisms are adopted that stimulate research into the areas of greatest need, not greatest profit.

In the coming months, solutions to the very real problem of addressing the health needs of those who have been most neglected will be discussed at the World Health Organization. This is a unique opportunity to promote innovation and access. It must not be wasted if we are serious about addressing the problem of access to medicines for the world's poorest people.