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Introduction

Until recently, help for low-income countries from the developed world has focused on the provision of food and water supplies. Charities and NGOs have concentrated their efforts on fighting famine and drought in Africa, and some lesser attempts have been made at combating diseases such as TB and measles. It is only recently that people have become aware that HIV/AIDS is a problem of equal or greater gravity.

It was almost accepted that people in developing countries who were infected with HIV would die, and that the problems of food and water supplies were so pressing that disease wasn't a consideration. This was especially true in areas such as sub-Saharan Africa, where both HIV and food/water supplies were vital issues.

Eventually, when discussion started about the HIV issues in the late 90s, people started to ask why there were so many deaths occurring when the drugs existed that could prevent them, and why the drugs were so very expensive. People in resource poor countries where the medical services did not provide the drugs they needed to survive began demanding medication. In South Africa, Zackie Achmat, the leader of Treatment Action Campaign (TAC) said,

"As we speak, children are dying, mothers and fathers are ill and sick and the government is not taking any notice."¹

Since 1995 when it was introduced, the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) protected companies by stopping anyone from copying their products. When countries sign up to the World Trade Organization (WTO), they also sign up to protect the patent rights of companies who sell products within their country. With respect to drugs, the major difference between TRIPS and previous agreements is that TRIPS requires countries to grant patent protection to pharmaceutical products for a minimum period of 20 years. Companies who have patents over their products see this as an essential element in international trade, as it guarantees them income in return for the investment they have made in the development of the drugs. However, in the case of the pharmaceutical companies, many people perceive it as putting profits before patients.

With hundreds of thousands of people dying for want of drugs that they couldn't afford, pressure began to grow on the pharmaceutical companies. In November 2001, the WTO met and agreed that TRIPS 'does not and should not prevent Members from taking measures to protect public health'. This means that poor countries can manufacture, buy and import cheap generic copies of more expensive, patented drugs if there is a threat to public health. In August 2003, the WTO announced a new agreement which was intended to allow poor countries to access and import cheap generic antiretroviral drugs. This agreement was applauded by the pharmaceutical multinationals and the United States as being 'very balanced', although in practice it makes the drugs even more inaccessible to the countries who need it most. The process by which a poor country can declare that it needs the patent for a drug to be suspended as a matter of emergency is wrapped in even more red tape and restrictions than previously, and the agreement is no more than cosmetic. This means that poor countries can theoretically manufacture, buy and import cheap generic drugs if there is a threat to public health, although in reality it has proved difficult to do so.² And, once begun, treatment must continue for a person's lifetime, meaning that a supply of drugs must not only be established, but an uninterrupted supply must be guaranteed.

To find out more about the implications of TRIPS on generic production, visit our TRIPS, AIDS and generic drugs page.

What has already happened with treatment?

Globally, only 12% of the estimated 5.8 million people who need treatment were receiving it at the end of 2004.³

Africa has been hit hardest so far by the HIV epidemic. Sub-Saharan Africa has suffered particularly badly. There, HIV prevalence has remained steadily at high levels for the past few years. This does not mean that new infections are decreasing and drugs are keeping people alive longer - it means that there is a very high infection rate and a similarly high mortality rate. In Africa, where 70% of people with HIV/AIDS live, ARV treatment is available to just 8% of those in need. Some countries - Botswana⁴ , for example - have been starting to provide treatment, although they still have a long way to go before they can provide treatment for all their infected population.

Asia seems to have been hit by the main force of the epidemic more recently than Africa, and some Asian countries have reacted rapidly - Thailand, for example, although their prevalence rates are still high. The epidemic in Asia is very diverse, and in some areas the severity is not measurable due to lack of testing and reporting facilities. In many Asian countries the health care facilities are not in place to support a rollout of testing or medication.

Latin America & the Caribbean have very poor medical facilities in some countries, whereas others have responded well to the impact of HIV. Brazil, for example, reacted early to the threat in the 1980s, engaging in an aggressive media campaign to educate the public. They have further reduced the impact of the virus by producing and providing free, generic medication and promoting condom usage. Countries such as Argentina, Brazil, Chile, Costa Rica, Cuba and Uruguay now guarantee free and universal access to generic antiretroviral drugs through the public sector, and drugs have become much cheaper in Honduras and Panama. Drug prices do still vary, however, in this region and access to medication remains unequal. In the Caribbean area, however, poor healthcare infrastructure and political instability means that the spread of HIV in many countries cannot even be effectively monitored, and this area may be the second worst affected in the world.

To a certain extent, the pharmaceutical multinationals are themselves helping by allowing generics companies to produce patented medicines for a fraction of the price, and in some cases giving up the intellectual property rights to a drug. This, however, usually happens only with drugs which have now been replaced in Western countries by newer products.

At the end of 2004, there were only 700,000 people in developing and transitional countries accessing antiretroviral (ARV) therapy. In the year 2004 the epidemic claimed the lives of an estimated 2.3 million people in Sub-Saharan Africa alone.⁶

AVERT.org has pages looking at AIDS treatment targets and results and who is getting drugs .

What promises have now been made?

We are now in a situation where treatment for AIDS and opportunistic infections (OIs) has been promised to people in low-income, high HIV-prevalence countries.

By 2003 commitments had been made to help, the Global Fund to fight AIDS, TB and Malaria had been set up, and US President Bush, Bill Gates and others had promised large sums of money to combat the spread of the epidemic.

In December 2003 the World Health Organization (WHO) published a policy document outlining a plan to bring ARV treatment to 3 million people in developing countries by 2005. This document, the 3 by 5 Strategy, outlines how the WHO intend to work with other governments and groups to get treatment to where it is most urgently needed. The WHO will not themselves supply any money or medicines, but will provide technical assistance, upgrade health-care infrastructure and training, and help to co-ordinate efforts to scale up treatment.

Stephen Lewis, the UN's Special Envoy on AIDS said in February 2004 "Virtually every African country with medium to high prevalence rates has a treatment plan in place. Many of the countries have some money from the Global Fund, or the World Bank, or the Clinton Foundation, or the Gates Foundation or the United Nations family or bilateral donors. . . what they need is exactly what the World Health Organization can provide: the capacity to give overall co-ordination and direction so that the treatment regimens succeed. . ."⁷

An additional US$ 62 million is required to enable WHO to fulfil its plan for 2004-2005.⁸ Much of the funding pledged to the WHO 3 by 5 Project has yet to be received.

In his State of the Union address in January 2003, President Bush promised the world the President's Emergency Plan for AIDS Relief (PEPFAR), a commitment to significantly increase US spending on HIV and AIDS around the world. The United States has committed itself to reducing mother-to-child transmission of HIV by 20% by 2005 and by 50% by 2010. They also aim to provide anti-retroviral medication, with the targets of treating 500,000 people by October 2005, one million people by October 2006, and two million people by the end of 2007. President Bush has increased funding for Global HIV/AIDS, Tuberculosis and Malaria from $840 million in 2001 to a request (to Congress) of $2.8 billion in the financial year of 2005.⁹ AVERT.org has a page devoted to discussion of PEPFAR.

The World Bank has committed over $1.7 billion through grants, loans and other credits, which can be used to increase access to ARV treatment.

The Global Fund to fight AIDS, Tuberculosis and Malaria has reported that its current grant disbursements will, over the next 5 years, pay for 1.6 million people to receive antiretroviral treatment.¹⁰ AVERT.org has a page discussing the Global Fund.

The Accelerating Access Initiative, driven by the major pharmaceutical companies themselves, reports that it is currently covering over 150,000 people with ARV treatment, and could increase this figure. There have been, however recent hitches with the Accelerating Access Initiative which have lead to medication prices actually increasing for NGOs and charities in some areas - South Africa, for example.

• Industrialised countries
• Individual philanthropists
• Multinational companies
• Major funding bodies - Global fund, etc.
• The affected countries, themselves.

The question that needs to be answered is whether these promises can be kept, and what is needed to fulfil them?

AVERT.org also has a page discussing AIDS money and large funding bodies.

What is needed to set up an HIV treatment and care program?

An HIV / AIDS treatment and care program needs more than just antiretroviral (ARV) drugs.

Voluntary HIV counseling and testing (VCT) plays a key part in HIV-related treatment and care. It is particularly important as a starting point for the access of other HIV/AIDS-related services. If a person does not know they are infected, they cannot get any treatment or care. It is widely recognised that knowledge of their HIV infection can help a person to stay healthy for longer as well as preventing new infections. In too many places people are diagnosed with HIV when they are seriously ill. At this point, there are fewer opportunities for cost-effective interventions, which can improve their quality of life.

In order to begin to treat people who are HIV positive, they first need to be able to be tested in order to find out their HIV status. This initial test is an antibody test. These tests do not necessarily require laboratory facilities or highly trained staff. If people are found to be positive, a counseling program needs to be in place to give support and to educate people against transmitting the virus onwards.

Travel may be an issue in remote areas. Many people living in rural or not easily-accessed locations may have considerable difficulty in getting to healthcare facilities, which may be a long distance away. This means that a large number of people in rural areas may not even be able to access HIV testing facilities.

Food is a crucial requirement. Adequate nutrition is a crucial part of care for people with HIV, particularly in the time before they show symptoms. In some resource-poor countries people do not have sufficient food supplies, let alone antiretroviral medication, and it has been shown that a person who has HIV can remain healthy for a greater length of time if they have an ample and nutritious diet. Without a good standard of nutrition a person is at risk of developing opportunistic infections. Furthermore, even if this person is fortunate enough to have access to ARV medication, many of these drugs should be taken on a full stomach.

AVERT.org has more information about treatment and care for people with HIV in resource-poor communities.

To provide an ARV treatment program it is not always necessary to have access to laboratory or hospital facilities but it is, however, necessary to have some facilities. Volunteers and nurses can function as counseling staff and perform initial tests and counseling, but they require some training. The administration of HIV / AIDS treatment programs requires professional medical staff. This can be a challenging requirement, particularly in areas where a very high prevalence rate has lead to the deaths of many doctors.

Deciding when to begin ARV treatment is not easy, The decision can be made either on the basis of a test called the CD4 test, or because a person has certain symptoms. In many places the CD4 test is not available , as it requires a laboratory, expensive equipment and trained technicians. Also, of course, an uninterrupted supply of cheap, good quality ARV medication is essential.

The drugs themselves are also needed. Unfortunately, the problems involved in providing the correct medication to people do not end when the money is found to pay for it. There are a number of different drugs involved in treating AIDS, and the rights to these drugs are owned by different companies.

The antiretroviral drugs

Antiretroviral treatment is the main type of treatment for HIV or AIDS. It is not a cure, but it can stop people from becoming ill for many years.

In successful antiretroviral treatment, a person needs to take at least two and preferably three drugs at the same time. The reason for this is that if only one drug is taken, it will just be a short time before the drug will stop working and the person becomes resistant to the drug. If several drugs are taken together, and if the drugs are from more than one group, then it generally takes longer before someone becomes resistant.

When someone starts treatment, the combination of drugs that they begin by taking is known as 'first-line treatment'. In many low-income countries, there is only one choice of antiretroviral combination therapy, if it is available at all. WHO recommends that a standard combination of drugs is chosen to be provided for everyone to take when they start treatment. They suggest that generally a first line regime should consist of two drugs from the nucleoside (NRTI) group and one from the non-nucleoside (NNRTI) group. (Find out more about generoc AIDS drugs and specific drug treatments in low income countries.)

In general the five drugs that will be needed are :

• D4T (stavudine)
• 3TC (Lamivudine)
• NVP (nevirapine)
• AZT (zidovudine)
• EFZ (efavirenz)

It is preferable if these drugs are available as fixed dose combinations (FDC). A co-blister pack is when two or more pills, capsules or tablets are packaged together in one unit of use of a plastic or aluminium blister pack. In contrast, a fixed dose combination (FDC) is when two or more drugs are combined together in one pill, capsule or tablet.

FDCs reduce the number of pills or tablets to be taken. Also the person taking the pills cannot leave out, forget or sell one of their drugs by not taking some of the pills. This improves the ability of people to take the drugs correctly (known as adherence) and it limits the emergence of resistance. Co-blister packs help people to take the pills at the correct time by packaging them together, but the drugs can still be separated, and co-blister packs do not reduce the number of pills or tablets to be taken.

A very large number of these 5 drugs are going to be needed, preferably packaged as various FDCs.

What issues are involved in providing the drugs?

In order for the drugs to be made available, there are several factors to consider.

The numbers of drugs

The actual process of providing medication isn't as simple as just buying drugs and giving them to patients who require them. Initially, the drugs have to be manufactured. If a person has to take a capsule or tablet twice a day, this amounts to 730 tablets each year. For ten million positive people in the developing world, this requires 7,300,000,000 tablets to be made available. This is assuming that multi-drug combination tablets are being manufactured which contain three different drugs in one tablet. If this is not the case then the amount of medication needing to be produced, shipped and made available to patients will be three times the number above. In Sub-Saharan Africa alone it is estimated that about 25million people are living with HIV/AIDS.

This number of drugs may not be very significant if they are being made, for example, in the north of England and distributed to various UK cities. However, these drugs may be manufactured in India for eventual use in a rural African Village.

Drug Pricing

The companies who manufacture these drugs have generally charged prices for them which put the medicines out of the budget-range of many countries. In response to legal action and public disgust as what was seen as profiteering from the epidemic, some of these drugs are now being made available at more affordable prices, and in some cases the patents are being released so that the drugs can be produced cheaply by other companies as generic copies.

In this way the pharmaceutical companies are helping to make medication more affordable and available to people in resource-poor communities. There is, however, clearly a significant need for further change.

"Nobody can come to GlaxoSmithKline and say: 'Solve the AIDS problem in Africa,'" said Andrew Bulloch, Glaxo's general manager for East Africa. "The needs are huge. We cannot possibly meet them all."

Glaxo had a profit of E2.5 billion last year.

The cost of the actual process of manufacturing these tablets in large quantities is very low, but the amount of money required for the development and testing of new drugs is much higher. Pharmaceutical companies use this to justify the high (and regionally variable) prices for some of their medications, but it is also true that if the drugs are sold cheaply in large numbers they will make a similar profit to that realised if they are sold for a higher price in smaller numbers.

Making FDCs

The antiretroviral drugs used in more developed countries, are manufactured by a number of different companies. There have been difficulties with these companies working sufficiently together to produce, in one tablet or pill, drugs patented by different companies. Generally, it is only generic copies of these drugs which are currently available in FDC form.

Why people shouldn't have to pay for the drugs themselves

Aside from the fact that many people are unable to afford the medication they need, some can sometimes afford medication and sometimes not, as their financial position fluctuates. The consequences of interrupting a course of medication can be worse than not taking it at all. If high enough levels of the drug are not maintained in the body, then HIV is given the opportunity to replicate. Often, the new virus that is replicated is a little different from the parent virus, and the new virus can develop immunity to the drugs which are being used. If, however, the drugs are freely available through public health systems then, as long as the public health systems receive an uninterrupted supply of medication, there will be no reason for people to be unable regularly to take the medication that they need.

Transport & supply problems

It is crucial that people have access to an uninterrupted supply of medication, which, in very remote areas, can be challenging. Local production of medication can significantly increase the ability of people to access the drugs they need. In some cases the drugs need to be kept refrigerated until they are used, which presents obvious difficulties for transport to isolated areas - trucks with refrigeration units would be needed. Then, when the drugs reach their destination, they will need to be kept refrigerated until use. Whilst this is certainly not impossible, many resource-poor areas do not have the infrastructure needed to deal with this transport and refrigeration.

Political and military upheaval can also present major problems in the delivery of medication. When a country has closed its borders, it becomes increasingly difficult for medication to be imported. War and social upheaval also has destructive effects on healthcare infrastructure.

These issues illustrate one of the major advantages of locally produced medicines over imported ones. A supply chain of imported drugs is vulnerable to interruption from any of these variables, and others - foreign exchange fluctuations, for example, can make foreign medicines suddenly more expensive. Local manufacture shortens the supply chain and decreases the number of potential problems.

Are there enough drugs to go round?

Currently there are not enough drugs for everyone and what is available is not always getting to the people who need to access treatment. The WHO support the use of cheaper generic copies of medications, which the US opposes.

Both the World Bank and the WHO feel that it is best if ARVs can be produced as locally as possible in order to make transport problems easier to tackle, to maintain patients with an uninterrupted supply of medication, and thus to prevent resistant strains of HIV from spreading. Setting up factories to produce ARVs is complicated and requires expensive equipment, but already some countries, such as Cuba and Brazil, are doing this. They are now in a position to offer advice and help to African countries who need to begin this process. Indeed, both countries have already made such offers. Patented AIDS treatments from official manufacturers can cost between $10,000 and $15,000 per patient per year, far beyond the reach of a huge majority of positive people. By comparison, generic treatments can cost as little as $1 per person per day. Furthermore, these countries are producing the medicines in Fixed Dose Combination form.¹¹

Who gets the drugs first?

Even when ARV medication does begin to arrive where it's needed, initially there will not be sufficient drugs for everyone who needs them. This leaves medical staff in the difficult position of having to decide who lives and who dies. Some groups have suggested that it should be decided on the basis of 'first come, first served', others say that mothers should be treated so that they can look after their children, that wage-earners should be treated so that they can feed their families, or that medical staff should be treated so that the damage to health-care infrastructure does not become even worse. Whichever way the drugs are apportioned, at the moment demand is much greater than supply, and there are going to be inequalities in resource-poor areas, and all the anger and resentment that inequality brings.

Quality control

If cheaper generic drugs are to be used, they must be of a good quality, and neither poorly manufactured or fake. Counterfeit drugs have been sold on occasions, which, if used, can have terminal effects or can cause resistance to develop when the genuine drugs are used again. The WHO has started a quality and sourcing project intended to ensure that medication is tested and reliable. At the end of 2003 the WHO estimates that up to 25% of the medicines consumed in poor countries are counterfeit or substandard.¹² The WHO and MCC has assessed Indian generics as being of good quality.

Language issues and instructions

If a generic drug is manufactured in India, it must be comprehensible for a HIV positive person and medical staff in Africa. This means that the drugs must either be packaged at their source, with the packaging and instructions in the language of the area in which it will be taken, or that they must be packaged at their destination with the instructions printed locally and the drugs produced elsewhere. This necessitates good communication between source and recipient areas, and is one of the reasons that the WHO has recommended that generic antiretrovirals be produced locally.

Trained medical staff

On November 4, 2004 Dr. Lee Jong-wook, the director of the World Health Organization, warned that there was a serious shortfall of healthcare workers in the parts of the world most seriously affected by HIV and AIDS. Sub-Saharan Africa has merely 600,000 health-care workers for a population of 682 million people, Lee said. Canada, with less than five per cent of the population of that portion of Africa, has 500,000 health-care workers for 31 million people.

An additional 85,000 health workers will be trained in the next 18 months, but keeping workers in areas where they are needed is a challenge.

Doctor shortages in countries like Canada, Europe and the United States have led to the international poaching of doctors and nurses. Medical staff are lured to these countries by lower taxes, better working conditions and much better pay. Nurses and doctors from countries such as South Africa, with their qualifications recognised as being of a high standard, are much in demand in richer countries.

Conclusion

It is currently not feasible to install a treatment program to 'reasonable standards' - including CD4 testing and other clinically demanding services - many of the areas most desperately in need do not have the medical infrastructure in place. Currently, in this crisis situation, it seems better to go with whatever is 'good enough'. In this situation there will still be preventable deaths, but less than there otherwise would be. Resistance and poor adherence in unsupervised situations is always a risk, so in this situation there has to be even more of an emphasis on teaching people to take the drugs properly.

Antiretroviral medications are powerful and can have unwanted side-effects, some of which can be life-threatening. Some countries can now or will soon be able to access medication but have poor healthcare infrastructure and an inadequate number of trained staff. In this situation one possible choice will be delaying the provision of medication until a support structure can be put in place, by which time many people will have died preventable deaths. The other choice will be to provide the medication without the ideal monitoring facilities, in which case a few people may be harmed or even killed by drug-failure or toxicity. The second choice would lead to a much smaller number of deaths.

Clearly, there are major challenges involved in organising provision of medication in resource-poor countries, but it is very positive that an attempt is finally being made. Over the next two years, a few hundred thousand lives should be saved, and although this is a fraction of those who might be helped, we are now in a situation where some progress could being made, given the political motivation. Unfortunately, by late 2004, the WHO 3 by 5 plan to bring ARV treatment to 3 million people in developing countries by 2005 appeared to have stalled due to insufficient political motivation to provide the necessary funding. Whilst many promises have been made, not enough countries have shown any willingness to provide financing to the WHO to carry out its 3 by 5 plan. The UK, Spain, Sweden, the United States and Canada are the only countries to have given the promised amount of funding to the WHO. An additional US$ 62 million is required to enable WHO to fulfil its role as described in the WHO HIV/AIDS Plan for 2004-2005.

In his 2003 State of the Union Address, President Bush announced the Emergency Plan for AIDS Relief, a five-year, $15 billion initiative, $9 billion of which was to be new money. But, after one year, less than one percent of these two million¹⁴ people were receiving treatment via US programs.

AIDS killed 3.1 million people during 2004, and this is not a figure that looks likely to be reduced during 2005, in spite of the good intentions of wealthier countries and the promises that have been made. If this shocking and preventable death rate is to be reduced then promises must be turned into action, money must be released to the agencies who need it, and these agencies must work together deliver the drugs, care and education to the people to whom they have been promised.

Stephen Lewis, Special Envoy for HIV/AIDS in Africa, said in February 2004 that urgent action was needed, now more than ever.

'If 3 by 5 fails, as it surely will without the dollars, then there are no excuses left, no rationalisations to hide behind, no murky slanders to justify indifference.

'There will only be the mass graves of the betrayed.'⁷

Last updated March 21, 2005

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