Second Wave of the Access to Treatment Cricis

[Guest guest]

The Second Wave of the Access Crisis: Unaffordable AIDS Drug prices.Again

A few years after the historic fall in first-line AIDS drug prices from over

$10,000 to $175 per patient/year, people living with HIV/AIDS are again facing

the possibility that life-saving drugs will be priced out of their reach.

Doctors Without Borders/Médecins Sans Frontières (MSF) warns that urgent action

is needed to ensure a continuous supply of affordable medicines to those who

need them.

The Looming 'second-line' Problem:

Since 2003, there has been a push to offer antiretroviral treatment (ART) to

people living with HIV/AIDS in resource-poor settings. Today, the World Health

Organization (WHO) estimates that 1 million people are on ART in the developing

world. But these patients are facing a looming crisis.

Experience from places where ART has long been widely available, such as Brazil,

the US or Europe, shows that after a few years, the " first-line " of ART no

longer works for many patients, who must then switch onto a " second-line "

regimen. However, second-line drugs are far more expensive than first-line

drugs. In Kenya,

for example, MSF pays $1400 per patient/year for a second-line regimen, compared

to only $200 for first-line drugs - that's a seven-fold price difference. In

middle-income developing countries that price difference can be even more

dramatic. In Guatemala, a second-line regimen costs $6500 - 28 times more than

the first-line treatment.

What do these price differences mean?:

For example, in Guatemala, providing second-line drugs to 10% of all

patients in the MSF program would increase total drug spending by 360%. In South

Africa, treating the 58 patients on second-line drugs in the MSF program costs

the same as treating over 550 patients who are still on first-line. Clearly,

high prices for providing just a few patients with second-line drugs can quickly

outstrip a program's or health facility's ability to pay. The number of patients

requiring second-line therapy is only expected to rise as people living with

HIV/AIDS will need access to newer

treatment.

What does the WTO have to do with it?

Affordable and available ART became a reality because there were no

pharmaceutical patents in key producing countries, like India and Brazil.

But the WTO's patent rules are causing generic sources of new medicines to dry

up. In early 2005, the WTO's Agreement on Trade-Related Aspects of Intellectual

Property Rights (TRIPS) was fully implemented in India and other developing

countries that had not yet granted pharmaceutical patents.

As a result, access to affordable new drugs is likely to become much more

difficult. From 2005 onwards, all new drugs are subject to at least 20 years of

patent protection, except in least developed countries where existing production

capacity is limited. This widespread patent-protection is already stifling

generic competition, making much-needed second-line ARVs nearly 30 times more

expensive than the most affordable first-line drugs.

Is voluntary differential pricing the answer?:

To get access to newer drugs that are still under monopoly, many programs rely

on a system called " voluntary differential pricing " from the large drug

companies. In principle, this means that developing countries can buy drugs at

lower prices than wealthy countries. But MSF's experience trying to access drugs

at these reduced prices has made clear that the system is seriously flawed - it

does not get medicines to all who need them.

A survey conducted in MSF projects in nine countries showed that when medicines

are only available from a single producer, they are still very expensive.

For example, GlaxoKline's price for abacavir in the poorest countries is

about $ 890 per patient/year - this single drug costs four times more than the

three drugs of a first-line treatment combined. Second, prices that

pharmaceutical companies announce are often not available in reality, because

companies have not registered or marketed the drugs in countries eligible for

differential pricing. For instance, Gilead's tenofovir (brand

name Viread) is fully registered in only 6 Bahamas, Gambia, Kenya, Rwanda,

Uganda, Zambia. of the 95 countries where the company offers it for a

differential price. And third, some companies do not offer discounts to

middle-income countries - this is the case with lopinavir/ritonavir (brand name

Kaletra) in Thailand, Latin America and Ukraine, where programs pay $4,000 to

$6,000 per patient/year for this one drug alone. Didanosine E.C., a drug used in

many second-line regimens, costs about $400 in Cameroon (a median price in the

survey), even though a WHO study recently found production costs are about 1/4

of that ($94), including a 14% profit margin.

Clearly, there is room for prices to fall further if robust generic

competition were to take place.

What are the solutions?:

In light of these new challenges, countries that have the capacity to

manufacture generic drugs (such as Brazil, Thailand, India and China) need to

routinely exercise their right to do so despite patents. Safeguards like

compulsory licenses and government use that were affirmed in the 2001 WTO Doha

Declaration enable the production of more affordable medicines.

However, to ensure access to medicines for all, an easy and economically viable

mechanism is needed for export of generic medicines produced under a compulsory

license. But the recent decision of the WTO to amend the TRIPS Agreement, based

on a mechanism that has failed to prove it can increase access to medicines,

shows that the WTO is ignoring the day-to-day reality

of drug production and procurement.

The so-called 'August 30th decision,' which was designed in 2003 to allow

production and export of generic medicines, has long been viewed by MSF and

public health groups as overly cumbersome and inefficient. To date there is no

experience using the mechanism - not one patient has benefited from its use -

despite the fact that newer medicines, such as second-line AIDS drugs, are

priced out of reach of poor patients. Delaying the amendment would have been a

far better option, as it would have ensured the possibility of

testing and improving the mechanism in practice. The amendment has made

permanent a burdensome drug-by-drug, country-by-country decision-making process,

which does not take into account the fact that economies of scale are needed to

attract interest from manufacturers of medicines. Without the pull of a viable

market for generic pharmaceutical products, manufacturers are not likely to want

to take part in the production-for-export system on a large scale. And without

competition among several manufacturers, MSF fears

it will be extremely difficult to ensure that prices of newer medicines will

fall the way first generation AIDS medicines did - patients the world over will

have to pay the price.

MSF is therefore asking WTO Members to:

1. Re-affirm their political commitment to the Doha Declaration on TRIPS and

Public Health, issued at the 2001 WTO Ministerial, and fully implement the

declaration in national law and drug procurement policies.

2. Provide evidence by the end of 2006 demonstrating that the amendment ('August

30') to the TRIPS agreement can effectively meet global needs for affordable

generic medicines.

3. Assess the existing measures put in place by the WTO to facilitate access to

medicines, identify the barriers to full implementation of the Doha Declaration,

and propose robust and workable ways to eliminate the negative effects that drug

patents have on access to essential medicines.

Doctors Without Borders/Médecins Sans Frontières (MSF) began offering

antiretroviral therapy (ART) in its programs in 2000. As of December 1, 2005,

MSF is providing ART to more than 57,000 patients in over 50 projects in a total

of 29 countries. Since 1999, MSF has also been campaigning internationally for

better access to essential medicines.*

A formatted version with graphs is available at:

http://www.doctorswithoutborders.org/news/hiv-aids/briefing_doc_12-10-2005.cfm

For more information, see www.accessmed-msf.org.

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Leena Menghaney

Project Manager-India

Campaign for Access to Essential Medicines

Medecins Sans Frontieres - Holland (in India)

Tel: +91 11 24337225, + 91 1151552413

Fax: +91 11 24336834

E-mail: msfh-india-medco-assist@...

http://www.doctorswithoutborders.org/

http://www.accessmed-msf.org/