TCS Daily


Patent Absurdities

By Steve Haynes - June 10, 2004 12:00 AM

Treating disease in resource poor countries is a complex and disturbing problem. Usually, debate about the issue centres on the patent life of medicines, with the pharmaceutical industry characterised as the bete noir.

A more rational analysis of the facts however repositions the industry as not a sinner but a saint.

A study in the prestigious Journal of the American Medical Association (JAMA) published two years ago concluded that it is doubtful that patents are to blame for the lack of access to medicines in resource poor countries, especially antiretrovirals for the treatment of HIV/AIDS.

The study demonstrated that patent protection for anti-retroviral medicines to treat HIV/AIDS in Africa was not extensive and that there was no apparent correlation between access to antiretroviral treatment, which is uniformly poor across Africa, and patent status.

In the past two years international concern has continued to focus on whether pharmaceutical patents interfere with access to essential medicines in lower-income countries.

The question has generated a global debate with pharmaceutical companies, governments, the United Nations (UN), World Trade Organization (WTO) and activists.

Nobody disagrees that the health outcomes of the world's poorest people should be uncompromised, yet there remains little agreement on how significant the patent threat is.

Two recent independent research reports put an end to the uncertainty.

An analysis by the Hudson Institute of the price data compiled by Médécins Sans Frontières confirms that the prices for the majority of ARVs (the latest HIV/AIDS medicines) offered by patent holders are below those offered by manufacturers that make copied versions.

This also holds true for comparisons between the prices of "fixed-dose combination" (FDC) treatments offered by some generic ARV manufacturers and the prices of the patented individual drugs offered by multinational R&D-based companies.

According to the Hudson Institute's analysis, FDCs offered by Indian and Thai manufacturers cost about twice as much as the individual patented components offered by the originator companies.

This careful analysis of data collected by independent sources shows that countries are able to obtain world-class, quality ARV treatments from the original patent-holders at prices often below those offered by generic copiers.

Meanwhile Amir Attaran, a fellow in the Royal Institute of International Affairs, London; a principal with Idealith Research in Cambridge, Massachusetts; and a barrister and solicitor with the Law Society of British Columbia, has continued his analysis of patents and their effect on access to medicines.

Attaran has recently published a further study about the relationship between patents and access to essential medicines: How Do Patents and Economic Policies Affect Access to Essential Medicines in Developing Countries?

Attaran says the study tests the extent to which pharmaceutical patents in developing countries can thwart access to essential medicines. This is done by quantifying the frequency with which "essential medicines," as defined by the World Health Organization (WHO), are patented in low and middle income countries, emphasising Africa, where access to medicines is the worst.

He examines these data by statistical methods, to identify correlates of patent practice and access to medicines. He finds that patents for essential medicines are uncommon in poor countries.

He finds that in sixty-five low and middle income countries, where four billion people live, patenting is rare for 319 products on the World Health Organization's Model List of Essential Medicines. Only seventeen essential medicines are patentable, although usually not actually patented, so that overall patent incidence is low (1.4 percent) and concentrated in larger markets.

Greater pragmatism and greater flexibility is essential so that policy may better concentrate on the greater causes of epidemic mortality, which now pose unprecedented threats to global peace and security. But it must never be forgotten that it is patent protection that in the end provides the investment for the discovery of these innovative medicines and the ongoing battle against global disease.

The author is a freelance journalist and Director with Medicines Australia.

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