Developing Nations and Drug Delivery

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Developing Nations and Drug Delivery

Introduction

In the developed world, access to medicines is taken for granted, despite ongoing debate over the price of certain drugs. However, around one-third of the world's population lacks access to essential medicines, such as anti-biotics, painkillers, and drugs for HIV/AIDS, malaria, and leishmaniasis. In parts of Africa and Asia, this figure can rise to 50% of the population. Even if the drugs are available, people may be unable to afford to pay for them, or they may be of substandard or counterfeit quality, or improperly stored.

There have been some concerted efforts in recent years to improve the delivery of drugs to developing countries, led by the international humanitarian aid organization Médecins sans Frontières (MSF) and the World Health Organization (WHO). Not only do developing countries need access to essential medicines, they also need to know how to use them to gain maximum benefit.

History and Scientific Foundations

An early example of how to improve drug delivery in developing countries involved the treatment of river blindness (oncocerciasis) from 1989. The African Program for Oncocerciasis (APOC) grew out of this and was focused upon distribution of the drug ivermectin, which is known to be effective against the disease. The drug is donated by Merck & Co., the company which discovered it. To date, the APOC has protected more than 600,000 people from blindness and reclaimed more than 62 million acres (25 million hectares) of previously infested land for resettlement and agricultural cultivation.

One major guidance document for drug delivery in developing countries is the WHO's List of Essential Medicines, which was first established in 1977. This helps countries to select the appropriate medicines for their public health priorities, according to the best scientific evidence on quality, safety, and efficacy. It also provides guidance to the pharmaceutical industry on the global need for medicines.

WORDS TO KNOW

ANTIRETROVIRAL (ARV) THERAPY: Treatment with antiretroviral (ARV) drugs prevents the reproduction of a type of virus called a retrovirus. The human immunodefiency virus (HIV), which causes acquired immunodeficiency syndrome (AIDS, also cited as acquired immune deficiency syndrome), is a retrovirus. These ARV drugs are therefore used to treat HIV infections. These medicines cannot prevent or cure HIV infection, but they help to keep the virus in check.

PARASITE: An organism that lives in or on a host organism and that gets its nourishment from that host. The parasite usually gains all the benefits of this relationship, while the host may suffer from various diseases and discomforts, or show no signs of the infection. The life cycle of a typical parasite usually includes several developmental stages and morphological changes as the parasite lives and moves through the environment and one or more hosts. Parasites that remain on a host's body surface to feed are called ectoparasites, while those that live inside a host's body are called endoparasites. Parasitism is a highly successful biological adaptation. There are more known parasitic species than nonparasitic ones, and parasites affect just about every form of life, including most all animals, plants, and even bacteria.

RESISTANT ORGANISM: Resistant organisms are bacteria, viruses, parasites, or other disease-causing agents that have stopped responding to drugs that once killed them.

Applications and Research

The WHO also has guidelines on donation of medicines, to try to ensure these are of good enough quality to be used. Some pharmaceutical companies donate medicines in accordance with these guidelines. They may also have other arrangements to try to improve access to, for example, HIV/AIDS drugs. For instance, they may choose not to take out patent protection in less developed countries, or not to take action against competitors making generic versions of their drugs.

Two organizations which make major contributions to the delivery of drugs in developing countries are MSF and the International Network for the Rational Use of Drugs (INRUD). In 1999, MSF launched its Campaign for Access to Essential Medicines with the aim of improving the global availability of drugs for the treatment of infectious diseases like malaria and tuberculosis (TB). The campaign aims to find ways of lowering the price of essential medicines and bring certain cheap and effective drugs back into production. MSF is also pushing for more research into malaria, TB, sleeping sickness, and leishmaniasis.

INRUD was established in 1989 to develop strategies to improve the way drugs are prescribed, dispensed, and used, trying to therefore address the misuse of scarce resources in developing countries. The network comprises 23 groups, 18 from Africa, Asia, and Latin America, and others from the WHO, Harvard Medical School, and various other academic groups.

Most of the effort in improving drug delivery in developing countries has been focused on the major infectious diseases. In malaria, for instance, MSF has been persuading governments to consider funding the artemisinin-based combination therapy favored by the WHO. This will help address the growing problem of chloroquine resistance. Although chloroquine is relatively cheap, it will not be effective in the areas where the malaria parasites are resistant—therefore, there is a need for alternative drugs to be made available.

Leishmaniasis, a group of parasitic diseases which is spread by sandflies, can reach epidemic proportions in countries like Sudan and Bangladesh. It can be very difficult to treat and resistance is developing to existing drugs. Therefore, research efforts need to be focused upon developing new and more effective drugs. Sleeping sickness, another parasitic disease, is common in many parts of Africa and is often fatal if not treated. Melarsoprol, the standard treatment for sleeping sickness, appears to be losing its effectiveness, according to clinical trials carried out by WHO. Alternatives now preferable include eflornithine and nifurtimox.

IN CONTEXT: DISEASE IN DEVELOPING NATIONS

According to the World Health Organization (WHO), more than fourteen million people die in developing countries each year due to curable diseases (such as diarrheal diseases, tuberculosis, and malaria). The HIV/AIDS epidemic is one example of how access to affordable drugs in impoverished nations, a key component in disease intervention, is complicated by trade restrictions, policy, and the interests of the pharmaceutical industry.

Brazil's National AIDS Program (NAP) is regarded as a successful model of combating the HIV/AIDS epidemic. Since its inception, HIV death rates in Brazil have dropped fifty percent. Despite spending $232 million by 2001 to implement this national health initiative, Brazil has estimated a savings of more than $1.1 billion in healthcare costs. Many researchers urge immediate action using this model of intervention in other developing nations in Asia and Sub-Saharan Africa. However, others are more cautious and argue that a methodical approach (slower to enact) is necessary to implement a system that is sustainable and effective for the long term. Often, developing countries lack the resources and infrastructure to assure adequate delivery of the drugs to the population targeted for prevention and treatment. Factors such as intellectual property rights and trade policy further cloud the issue. With a market worth more than $65 billion per year, some human rights organizations ask why drug companies aren't investing more research and development dollars where it's needed most, on diseases that primarily affect poor nations.

Health disparities are exacerbated as this disease continues to thrive in marginalized populations (i.e. developing countries, drug users, the poor, rural areas, and minorities). HIV infection in American infants has nearly vanished due to prophylactic (preventative) therapy with antiretroviral (ARV) drugs. In North America and Europe, death rates within ten years of diagnosis for those with HIV have dropped almost eighty percent with ARV use. However, in developing countries, of the six million in need of treatment, only 400,000 actually received ARV therapy in 2003. Fifty percent of the population requiring treatment is located in sub-Saharan Africa and India. Moreover, most of the fourteen million HIV/AIDS orphans in the world reside in Africa. Without timely intervention, this figure is estimated to climb as high as twenty-five million by the year 2010. According to the WHO, “immense advances in human well-being co-exist with extreme deprivation. In global health, we are witnessing the benefits of new medicines and technologies. But there are unprecedented reversals. Life expectancies have collapsed in some of the poorest countries to half the level of the richest—attributable to the ravages of HIV/AIDS in parts of sub-Saharan Africa and to more than a dozen ‘failed states.”

In 2003, UNAIDS established a Global Reference Group on HIV/AIDS and Human Rights. The result is that access to HIV/AIDS therapy is now a human rights issue (as well as a financially sound strategy). In the end, an integrated approach is needed using medical, structural, and cultural interventions, with the cooperation of politicians, governments, private industry, and others.

Impacts and Issues

It is now well established that antiretroviral (ARV) therapy for HIV/AIDS is effective treatment, enabling people to live with the condition rather than almost inevitably dying from it. Therefore, improving access to ARV for patients in developing countries has become a top priority.

A program begun by MSF in 2003 showed that giving ARV therapy in even the poorest countries of the world was feasible; people adhered to the complex treatment regimes and benefited from them, just as HIV/AIDS patients in the West did. Therefore, the UN World Summit in 2005 made a pledge to achieve universal access to ARV therapy by 2010. However, there is some way to go before this is achieved. As of December 2006, only two million out of seven million people in need of treatment were actually receiving ARV drugs.

Fortunately, the price of ARV drugs has fallen sharply in developing countries—from several thousand dollars for a year of treatment, to just a few hundred dollars at most and possibly as low as 150 dollars. One of the main reasons for this has been the relaxing of patent rules in certain places to allow for the production of cheap, generic ARV drugs. Funding to support the infrastructure needed to provide the drugs and monitor their use has come from organizations such as the Global Fund for AIDS, TB and Malaria, the U.S. President's Emergency Fund for AIDS Relief, the World Bank, governments in developed countries, and various non-governmental organizations.

There have been many challenges involved in trying to get ARVs to those who need them. For instance, there must be a reliable supply chain from the factory where the drug is manufactured to the patient, as the drugs must be taken every day. In many developing countries, transport and communication systems are chronically weak. The funding organizations have been trying to address this by commissioning experts in supply chain management to work in this area. Efforts are also being made to increase the number of health workers in areas severely affected by HIV/AIDS—both by recruiting trained volunteers from developed countries and by training local people.

Today, many developing countries have their own policies that are intended to make essential medicines available to their populations—an approach strongly encouraged by the WHO. These policies also focus on how to distribute drugs to where they are needed and how the safety of medicines can be guaranteed. Pharmaceutical pricing is a complex issue. Companies cannot necessarily be expected to follow the Merck ivermectinexample and distribute drugs free, when they have to take their shareholders’ interests into account. One way around this is for developing countries to establish their own pharmaceutical industries, focusing upon making cheaper generic copies of essential drugs.

Supplying drugs to developing countries is just one aspect of ensuring universal access to medicine. Education is also needed in the best way of using these medicines and the local infrastructure must be improved to ensure a reliable supply chain. Standardizing the quality of the medicines and their secure storage are also current challenges.

BIBLIOGRAPHY

Web Sites

Avert: Averting HIV and AIDS. “Providing Drug Treatment for Millions.” April 19, 2007. <http://www.avert.org/drugtreatment.htm> (accessed May 26, 2007).

INRUD. “International Network for the Rational Use of Drugs.” <http://www.inrud.org> (accessed May 26, 2007).

Médicins sans Frontières. “Campaign for Access to Essential Medicines.” <http://www.accessmedmsf.org> (accessed May 26, 2007).

World Health Organization. “WHO Model List of Essential Medicines.” April 2007. <http://www.who.int/medicines/publications/EML15.pdf> (accessed May 26, 2007).

Susan Aldridge

Infectious Diseases: In Context