Access to Medicines

This response1 is being presented by a group of HIV1 and HIV2 ab+ patients who have experience of Africa and/or are African. HIV is a progressive, degenerative disease, whose effects are devastating to the patient, their family and support system, and also to national economies. With the introduction of new combination therapies there is an impression that the epidemic, at least in the West, is under control, and even that we have a “cure”. Nothing could be further from the truth. Many people taking combination therapies may lead lives that are manageable so long as they receive continual medical monitoring, can maintain compliance, and have effective side-effect management. We recognise the need for safe and effective treatments for AIDS-related illnesses, and for effective antiretrovirals against HIV itself. Even more crucially, there is a need for effective vaccines against all the subtypes and classes of HIV.

It is commonly argued that access to treatments such as antiretrovirals in developing countries is hindered by exorbitant pricing and by the current laws and regulations covering intellectual property rights. This is simplistic and fails to take into account the serious practical problems that need to be addressed to make such sophisticated therapies more accessible. It is also noteworthy that in most of the developing world treatments such as antiretrovirals are not patented and local manufacture is therefore theoretically possible.

We feel the real issues hindering access to treatments such as antiretroviral therapies include:

Lack of basic infrastructure

In many countries there is a lack of basic infrastructure - roads, clean water, electricity, etc.

Lack of healthcare infrastructure

In many countries there is a marked lack of hospitals, clinics, trained medical staff and technicians, etc. which, we believe, are essential to effective use of treatments such as antiretroviral therapies.

Lack of equipment

In many countries there is a lack of equipment from syringes and needles up to laboratory equipment for diagnostic and monitoring tests. For example: the effective monitoring of patients with HIV on antiretroviral therapies requires regular and reliable tests such as CD4 counts and viral load measurements.

National and international developmental policies

These policies often place healthcare and access to treatments low on the list of priorities when fiscal decisions are being made.

Which therapies should be put on the WHO essential drug list

The criteria used to choose “essential drugs” are sometimes controversial and not universally accepted. There is a need to use the right people to set and administer the criteria both internationally and locally in individual countries.

Lack of a WHO list of “essential diagnostic and monitoring tests”

Most diseases need tests to aid diagnosis and to monitor treatment. A WHO list would make it easier for the developing world to negotiate favourable terms for access to “essential” tests.

Potentially making available less than optimal treatments to the developing world

For example: if the criteria for essential antiretroviral therapies are set purely based on reducing mother-to-child transmission of HIV, then it is conceivable that the treatment offered to a pregnant woman with HIV would be monotherapy or dual therapy with AZT (Zidovudine) &/or 3TC (Epivir) &/or Nevirapine for a limited time at the end of her pregnancy. This is obviously sub-optimal under the current treatment guidelines used in the West.

Potentially creating multi-drug resistant organisms

When antibiotics and antiretrovirals drugs are used sub-optimally the pathogen being treated can rapidly develop resistance to the drugs being used. There are already serious treatment problems with multi-drug resistant variants of diseases such as HIV, tuberculosis and malaria.

Perceived threat to intellectual property rights jeopardising drug development

If pharmaceutical companies believe that they will not be able to patent new treatments that they develop then they may choose to avoid developing treatments in those areas perceived to be threatened.

Perceived lack of commercial demand for tropical disease remedies

Pharmaceutical companies are often reluctant to develop new treatments for tropical diseases because they believe that there is a lack of purchasing power in the developing world where these diseases are most prevalent.

Local taxes and mark-up on drugs

The level of local taxes and mark-up on drugs in many countries means that those drugs that are “available” are, in fact, largely inaccessible because of the cost to the “end-user”.

Corruption

This is a world-wide problem, which manifests itself in many ways. For example: in some countries patients who wish to be enrolled on to a clinical trial are charged for the privilege by the local administrators of the trial. Then, in some countries it is admitted that 50% or more of drugs purchased by the national authorities do not then reach the patients for whom they are intended.

Some issues that are particularly pertinent to HIV

Maternal transmission

The current antiretroviral therapies used in combination are still not a cure for HIV infection. They simply help to control the infection, possibly for a limited time. However there is good research evidence that some of the drugs are effective in significantly reducing the risk mother-to-child transmission during pregnancy and labour. This does not address the additional problem of transmission through breastfeeding, but can help to reduce the overall vertical transmission rate if used effectively. The arguments for the use of antiretrovirals in this special situation are particularly emotive. It should be remembered that for the effective use of antiretrovirals in this situation there is a need for:

There is the additional caveat that we still do not know the long-term effect of using antiretroviral drugs on the unborn baby.

Education and compliance

Even assuming reasonable access to antiretroviral therapies and the necessary monitoring tests, there is still a major problem for HIV-positive patients with compliance to the complex dosing regimens that most combinations entail. Simply to understand some of the restrictions around taking these drugs requires a level of education that is often not available to the majority of people in the developing world. For example: ddI and Indinavir must both be taken on an empty stomach. This means that if you are taking a combination containing both these drugs then you have to understand that having an empty stomach means not having eaten for at least two hours before taking the drugs and not eating for at least an hour afterwards. In addition you need to understand that these two drugs cannot be taken at the same time as each other, and finally you have to understand that Indinavir must be taken three times daily at exactly eight hour intervals, and that you must drink at least one and a half litres of water throughout the day to reduce the risk of kidney stones. In other words you have to be able to organise your life and eating schedule remarkably strictly to attempt to achieve good compliance. There is research evidence to show that an overall compliance rate of 95% is needed to have the best chance of controlling the virus and avoiding the development of resistance. Even in the West, with all the support networks and education available there, this level of compliance has proved to be almost impossible to maintain for any length of time.

Stigma, denial and prevention programmes

HIV infection carries a huge stigma, which results in both individuals and governments going into denial about the reality of the problem. Governments will deny that HIV is seriously affecting their population for fear of losing income such as the tourist trade. Individuals will deny their own infection for reasons of personal safety, and so on. To deal with the growing epidemic of HIV infection in the developing world it is necessary to have effective Prevention and Education programmes which address all the issues including stigma, denial, routes of transmission, self-protection, etc.

Our Recommendations
  1. Include patients (and patients' organisations) in the planning of policy and monitoring mechanisms at all levels - local, national and international. (In the HIV field 42 signatory states committed themselves to doing this by signing the Paris Declaration in 1994.)
  2. Develop new international mechanisms to promote research and development into treatments and vaccines for diseases that are not already attracting the attention of the Pharmaceutical Industry.
  3. In partnership with the Pharmaceutical Industry and national governments, look at ways of implementing differential pricing, tax-exemptions and other cost-controls to improve immediate access to essential drugs.
  4. Put in place effective and enforceable guidelines and legislation to regulate the use of treatments such as antibiotics and antiretrovirals to try to minimise the risks of producing further multi-drug resistant pathogens.
  5. Establish and use mechanisms to encourage co-operation of Industry, International Agencies (such as the World Health Organisation, the World bank, the Global Business Council on AIDS, the Commonwealth of Nations, etc.) and national governments in the following areas2:
  1. Encourage research into and then use of effective alternative treatments such as traditional remedies, homeopathy, etc.

Caveat

Trade Related Intellectual Property Rights (TRIPS), the World Trade Organisation (WTO), Drug Pricing and Access to Essential Treatments

The “Access to Essential Treatments” debate also includes diseases such as tuberculosis and malaria.

There are many arguments about the necessity of changing international agreements to enable the developing world to manufacture new drugs locally and at lower cost. But most of these countries could, if they had the technology and necessary finance, produce these drugs now. Most countries seeking to enter, and already entering into the WTO agreements do not yet have patent protection in place. They can, as they implement the WTO requirements into national legislation, make appropriate exceptions in the interest of public health. If the main issue of access is cost, this can be tackled relatively quickly with “differential pricing” regimes. Other longer term mechanisms can include, “purchasing precommitments” as for some vaccines, and international orphan disease legislation and initiatives for new treatment options, etc.

However, our main concern as patients, some of whom have had multi-drug resistant tuberculosis, is the unregulated use of treatments like antibiotics. For example: in some countries tuberculosis is resistant to eleven different antibiotics. There are limited numbers of antibiotics currently available. To prevent a world-wide catastrophe with pan-antibiotic resistant tuberculosis there needs to be enforceable national and international guidelines and legislation covering use and availability. In many countries, including some EU member states, antibiotics are available as over-the-counter medicines! In other words, this is not just a developing world issue!

Notes:

1 This paper is a précis of our thought, and we have deliberately limited its size for ease of reading and comprehension among those who might not be conversant with all the issues.

2 See the Resolution of the International AIDS Conference, Lusaka, 1999, and adopted by the European Parliament on 6 October 1999.

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The Patient can be as knowledgeable as the expert, but is uniquely placed to have a holistic view of their condition

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