Failing the AIDS test
Health campaign groups have attacked pharmaceutical companies for using patents to deny AIDS drugs to the poorest people in the world, but recent research suggests other factors may play a bigger role.
Health campaign groups have attacked pharmaceutical companies for using patents to deny AIDS drugs to the poorest people in the world, but recent research suggests other factors may play a bigger role.
In recent months, there has been controversy about access to antiretroviral medicines to treat HIV/AIDS in poor countries1. This debate has focused on the role of intellectual property (IP) law – specifically patents – which activists blame for creating monopolies that keep drugs inaccessible or unaffordable, and which pharmaceutical companies extol as a necessary incentive for expensive research and development. But are patents really a leading barrier to widespread AIDS treatment in Africa2?
Between October 2000 and March 2001, researchers at Harvard and the International Intellectual Property Institute in the US issued inquiries about the patent status of antiretroviral drugs in the African market from major pharmaceutical companies. The data are summarised in figure 1. A total of 15 antiretroviral drugs marketed by eight pharmaceutical companies were screened for patent status in 53 African countries. Where a patent is shown, some form of legally enforced market exclusivity exists.
What the researchers found was that most antiretroviral drugs are patented in only a few African countries and that where one or more patents exist, the number of patented antiretroviral drugs is typically only about four. Two exceptions, however, were found: South Africa, where a large proportion of antiretroviral drugs are patented (13 out of the 15); and the products of Agouron, Boehringer Ingelheim and GlaxoSmithKline, which are patented in a large number of countries (up to 37 out of 53 countries).
But overall, patent protection for antiretroviral drugs in Africa is not extensive – of a potential 795 instances of patenting, only 172 (21.6%) actually exist.
While this means certain antiretroviral drug regimens for combination therapy are not free of patents (especially those containing AZT or 3TC), several other regimens 'strongly recommended' by the US department of health and human services are unpatented in as many as 52 out of 53 African countries. There is thus considerable latitude in these cases to use either brand-name or generic drugs, as cost and quality recommend.
no evidence
It is an interesting question why there are not more antiretroviral drug patents in Africa. It is not simply because the requisite patent laws have been lacking, and while some African countries do not permit pharmaceutical patents, most have offered inventors that option for many years (especially the former colonies of France and the UK). Accordingly it seems that even where the option to patent exists, patents are not often sought.
This suggests two important conclusions. First, it is doubtful that patents can be blamed for the lack of access to antiretroviral drug treatment in most African countries. This is because there is no apparent correlation between access to antiretroviral treatment, which is poor in all of Africa, and patent status, which varies extensively by country and drug.
There is no evidence, systematic or anecdotal, that antiretroviral treatment is more accessible in countries with few or no antiretroviral patents (e.g., Mozambique and Namibia), compared with other countries with patents.
Similarly, there is no evidence that the antiretroviral drugs of, for example, Abbott, which are not patented at all, are consumed in any greater numbers than those of GlaxoSmithKline, patented in up to 37 countries.
These observations are necessarily qualitative, but based on the consensus that very few of the 25m HIV-positive Africans now receive treatment (perhaps as few as one in 1,000 uses one antiretroviral drug)3, this scarcity of treatment cannot rationally be ascribed to antiretroviral patents that are few – or non-existent – in most African countries Other factors unrelated to patents must therefore have a greater role to play.
The second conclusion that may be drawn is that it is doubtful that pharmaceutical r&d will always require the incentive of patentability in poor countries, because the option to patent antiretroviral drugs in Africa has usually gone unexercised. The lucrative North American and European markets drive the profitability of antiretroviral drug research. The African antiretroviral market, at 0.5% of global sales, is commercially negligible. Patenting in poor countries therefore yields very small financial return.
So if patents are not the leading impediment to treatment, then what is? One factor is undoubtedly the ubiquitous poverty of African countries. Access to treatment can be impeded in many ways—by a lack of political will; by poor medical care and inadequate infrastructure; by inefficient drug regulatory procedures that exclude competing products from the marketplace; by high tariffs and sales taxes; and, occasionally, by patents – but none of these is more fundamental than the frailty of African economies.
Comparing the cost of antiretroviral drugs with the wealth of African economies illustrates this. Even the cheapest AIDS drugs cost US$350 (€392.4) a year for a suboptimal, three-drug combination of stavudine, lamivudine, and nevirapine (from Cipla, an Indian generics maker), up to perhaps US$1,000 (€1,121.4) for a more medically recommended regimen containing a costlier protease inhibitor or non-nucleosidal drug, which might cost US$600 (€672.7) itself (e.g. indinavir from Merck).
The impossibility of poor countries paying those prices – or, hypothetically, even half or a quarter, if prices drop as others predict – cannot be over emphasised: the median country in sub-Saharan Africa has a health budget of only US$10 (€11.2) per capita, divided among malaria, tuberculosis, vaccination, prenatal care, postnatal care, and of course, AIDS. Even at the low generics prices, the annual bill for drugs alone, to say nothing of operational costs, exceeds the per capita GNP of many African economies!
impoverished economies
Even if health budgets were radically expanded and all waste or corruption abolished, Africa's impoverished economies could simply never afford more than a tiny proportion of the cost of treatment. Though cheaper drugs are, of course, important, harbouring a fetish about low-priced generics being the 'solution' to antiretroviral drug access is a 'let-them-eat-cake' solution.
And what about the situation where antiretroviral drug patents do exist and generics cannot ordinarily be used? An equitable balance is that countries ought to respect patent laws, but that patent holders ought reciprocally to supply medicines to the global poor on concessionary terms – without profit, but also without loss.
Various solutions to achieve this exist. Merck, Bristol-Myers Squibb and Abbott have discounted antiretroviral drugs to prices not above their stated costs of production and distribution. Brand-name pharmaceutical companies might also consider voluntarily licensing patents, at modest or no royalty, to high-quality generic manufacturers willing to serve geographically restricted, poor country markets, as GlaxoSmithKline recently did for an antiretroviral in South Africa.
lack of aid
Arrangements like these would signify ethical business leadership, and would have a negligible effect on revenues, given that the African pharmaceutical market is diminutive (1.1% of the global whole). Only once such consensual arrangements are refused should coercive remedies, such as compulsory licensing of patents, be invoked, as the US and Canada recently threatened when leveraging Bayer to cut its price on Cipro, an important antibiotic against anthrax.
The fatal barrier to AIDS treatment access in Africa now is not patents, but the lack of international aid finance, which is needed not only for drugs but for the infrastructure and training needed to implement treatment successfully. The inexcusable nonfeasance of the rich countries of Europe, Japan and North America has been silently tolerated, even as campaigners have raised a successful hue and cry against inflated drug prices.
Recent research at Harvard, published in the Lancet, portrays how outrageous this lack of aid finance really is4. The world's 23 richest nations together set aside only US$74m (€82.97m) specifically for African AIDS in 1998 – or just US$3 (€3.36) per HIV infected African. Such sums do not come close to financing the physicians, clinics and infrastructure needed to administer antiretroviral therapy, much less to screen patients for HIV infection5. This has the lamentable result that even in cases in which pharmaceutical companies discount or freely donate antiretroviral drugs, poor African countries still cannot afford to use them. Lack of finance thwarts not only 'expensive' AIDS treatment but the 'cheap', highly cost-effective use of antiretroviral drugs in preventing paediatric HIV infection at birth – one such drug, nevirapine, is freely donated by Boehringer Ingelheim but is rarely used in Africa, as recent protests in South Africa have highlighted6.
These data suggest that industries under threat for their intellectual property may be overlooking a fundamental point: without international aid to meet operational costs, even the most charitable concession (i.e. free drugs) cannot be taken up by poor countries to any meaningful extent. And to the extent that corporate charity is a response to campaigners' pressure, there will be no results to show to mollify that pressure until international aid is delivered. Part of industry's strategy must therefore be to lobby governments in London, Washington, Ottawa and elsewhere to increase their international aid funding for AIDS by billions, which is readily affordable by wealthy countries.
unprecedented test
AIDS is now the most numerically lethal pandemic since the Black Death 650 years ago – a pandemic so rare that it presents a literally unprecedented test to Western democracy. Activists, industry, physicians, and media who have so successfully raised public awareness of the patent issues around AIDS treatment now need to challenge more forcefully the other treatment barriers, chiefly the financial one. No other response is likely to be judged kindly by tomorrow's historians of this new plague.