IREN Workshop Paper

INTRODUCTION

Among the most widely debated topics currently relates to the issue of healthcare, globalisation and intellectual property rights (IPR). Intellectual property rights refer to the property in ideas or in their expression. This paper will mainly discuss one particular form of IPR, patents and in particular patents for medicines and the relations between this type of IPR and access to medicines.

A patent is essentially an exclusive right in an invention and is usually granted for a period of 20 years. For a patent to be granted for a particular invention, it has to be demonstrated that the invention is novel, that it has some industrial or commercial application and that it is non-obvious. It is often argued that the granting of the exclusive rights for medicines acts as a barrier to access in developing and least developed countries.

This paper argues that there is very little evidence to suggest that IPR is in fact the major barrier to drug access in poor countries and in many cases is not a barrier at all. This paper highlights the rationale for the World Trade Organisation's (WTO) agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and focuses on the more controversial aspects of the agreement. While many argue that relaxing drug patent rules rather than strengthening them as TRIPS calls for will allow greater access to essential drugs for the poor, there is little evidence in most of Africa that this is the case.

This paper will go on to highlight some of the more important barriers to healthcare in Africa and will critically assess the value that both imported generic drugs and locally produced generic drugs will have on African healthcare systems. Lastly the paper will argue that by far the most important steps towards wider access to good healthcare in Africa will come about from wealth creation. The best way to achieve this is through more open trade with rich countries and indeed between poor countries. Yet progress on some of the most critical issues, such as agricultural trade barriers are not being dealt with while the world continues to debate the TRIPS agreement.

A SHORT RATIONALE FOR INTELLECTUAL PROPERTY RIGHTS

"I have already intimated my opinion that in the world's history, certain inventions and discoveries occurred of particular value on account of their great efficiency in facilitating all other inventions and discoveries. Of these were the arts of writing and of printing - the discovery of America and the introduction of the patent laws...."

Abraham Lincoln - Lectures on Discovery

When John Locke wrote in 1698 that "every man has a property in his own person" he laid one of the most important foundations for the protection of intellectual property rights. Locke argued that whatever a man produces from his own labour and intellect belongs to him. On the basis that one's physical property is worthy of protection by the state, the same would hold true for one's intellectual property which is no less a product of one's labour (in this case mental labour). If one considers that the protection of physical property is a fundamental human right, then the protection of one's intellectual property would be worthy of just such rights too.

It could also be argued that intellectual property should be protected as long as the benefits from such protection exceed the costs. In protecting intellectual property, the owner is protected from others producing the same product and is therefore in a good position to raise prices and maximise profits. By doing this, some in society will not be able to afford the product (be it a music CD, innovative new drug or computer programme) and this will impose a welfare cost. In addition, the protection may act as a deterrent to innovation by others to produce similar products. As long as the cost is smaller than the benefit to society of having the new innovation, those that follow this sort of utilitarian argument would be in favour of IPR.

Some argue that intellectual property rights that are enforced by states are a symptom of the failure of private parties to successfully enforce a purchase and sale contract. For instance, if A has developed an innovative new machine, he could decide to sell it to B on the proviso that B does not copy the design and produce and sell his own versions of the machine. If B signs the agreement and then breaches it by making copies of the machine for his own personal gain, he would open himself up some sort of legal action under common law.

A problem arises however if B were then to sell his own original machine off to a third party. While the agreement is still valid, it is only enforceable against B and not against C, clearly creating a potential problem for A. Should the product in question be music or a pharmaceutical drug where the buyers are numerous, the potential for copying enormous and the probability that the innovator would be able to track every single purchase down the line being very low, the arguments in favour of a state sponsored system of protection, such as patent rules, strengthen. This kind of protection is also highly desirable when the costs of copying are cheap relative to the investment that is made in product development.

Once a patent is filed, the technology is then publicly known and accessible. This could in fact help to advance technological breakthroughs as other inventors and innovators would no longer have to 'reinvent the wheel'. This could disseminate the new technology widely and encourage more research and development as opposed to alternative forms of IP protection such as secrecy.

Indeed one of the most important arguments in favour of IPR, as pointed out by Abraham Lincoln, is that it acts as an incentive to undertake innovative research into new products and technologies. It is argued that the promise of large profits at some time in the future drives innovators to undertake lengthy and often extremely expensive research in order to develop a new technology or drug.

Consider a world in which a private company undertakes research and development for many years in the hope of developing a new life saving drug. The only reason that the company would undertake that research would be to secure future profits and to maximise those profits for the shareholders. If that drug could be copied at low cost by another company and sold cheaper than the innovator company could, this will drive the innovators profits down. The more companies that are able to copy the drug, the greater the price competition and the lower the innovators profit (and therefore original incentive).

It seems unlikely that the private company would undertake the original research if it were not for the guarantee that its innovation would be protected. Of course there will always be some innovators and artists that will not be driven by profit but either by the passion for their work or by altruism, yet these individuals are few and far between.

Of course there are those that argue that IPR should not exist simply because government has no place issuing monopoly powers to private individuals or corporations. This libertarian view argues that state intrusion into private affairs is seen as undesirable and among other things opens up numerous opportunities for rent seeking behaviour[2]. In addition they would argue that the length of time given for a drug patent for instance is arbitrary and therefore open to abuse. Frederick Hayek argued that patent protection creates a forced scarcity where there was none before. However to counter this point, ideas and new innovations are already scarce and this is particularly true of new medical drugs and technologies. Researching new medical technologies is very time consuming and expensive and new discoveries are scarce with or without patent protection.

That IPR protection acts as a deterrent to further innovation in any particular field or product is an argument worthy of consideration. This argument however is not always valid. While in theory it may be true that some innovators may simply give up if another beats them in the race to patent a product, others may be spurred on to find other, better and more efficient products that perform the same task or treat a patient in the same way. As long as a patent is sufficiently narrowly defined, it need not act as a deterrent to further innovation and research.

IPR could therefore either be justified on the basis of natural rights or on some utilitarian basis. For a more in depth discussion of the ethics of IPR, see Morris et al, 2002)

The moral and philosophical debate over IPR will continue well into the future with strong arguments made both for and against IPR. This paper however will abandon the moral arguments surrounding IPR here and from this point on will concern itself with the arguments around IPR and access to healthcare and essential drugs.

Whatever the moral arguments in favour of IPR, they would be greatly undermined in a world where the poorest are denied access to life saving drugs and die as a result of this peculiar form of property protection. This is a debate that has in recent years sparked a great deal of emotion on all sides because of the urgency and scale of the human health crises affecting poor countries.

WHAT IS THE TRADE RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS (TRIPS) AGREEMENT?

WHAT IS THE CONTROVERSY?

Not all nations protect intellectual property rights to the same degree. Many countries, especially developed countries, offer strong intellectual property protection for trademarks, copyright and both process and product patents. Other countries offer IP protection to varying degrees and some offer no protection whatsoever.

As international trade increased and the technologies available to copy products, be they music CDS or pharmaceutical drugs became cheaper and more readily available, IP owners demanded stronger protection for their property. They did this both locally and internationally, in particular pushing for an agreement linked to trade rules. In general intellectual property protection had been increasing the world over since the 1880s and in many developing countries from 1980s[3], however there was and is a great deal of variation in the degree and scope of IP protection. The rationale of TRIPS was to strike a balance that would encourage future innovations and continued investment in research while enabling people (particularly those in poor countries) to use and exploit beneficial technologies and creations.

Article 7 of the TRIPS Agreement explains the objectives as follows:

The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare and to a balance of rights and obligations.

In the context of patents, TRIPS aims to strike a balance by offering protection to innovators, so that they are able to reap the rewards of their investment and thereby have sufficient incentive to continue to engage in innovative research, while simultaneously ensuring that new technologies are disseminated. widely. The agreement also recognises that IP protection is granted by governments and that governments should have the flexibility to tailor their IP systmes to suit the needs of the people they govern. This is of particular interest to departments of health, which seek to provide affordable medicines to their populace and could potentially lower costs by attenuating patent protection on drugs.

How does TRIPS achieve this?

First, TRIPS requires that all signatories to the WTO provide patent protection for any invention, whether it is a product or process as long as that invention is new, involves an inventive step and has industrial application. (Article 27.1).

The Agreement does not allow countries to discriminate between different fields of technology, nor between the country in which they were invented, giving equal protection to imported and locally produced inventions. (Article 27.1)

One of the important advantages of an agreement such as TRIPS is that it provides certainty to inventors that their innovative products will be protected. This in turn encourages trade and perhaps more importantly encourages the transfer of technology from developed countries, where their rights would already be protected, to developing countries.

Second, TRIPS contains limits or exceptions to the rights that can be given to patent holders. Much of the controversy surrounding TRIPS relates to healthcare and access to essential medicines. This is not surprising as there are a number of healthcare crises in poor developing countries, particularly with regard to HIV/AIDS. Although the Human Immunodeficiency Virus (HIV) and AIDS have been known about for more than 20 years, infection rates are spreading rapidly throughout Africa and as the epidemic progresses, severe illness and deaths will rise, mirroring the infection rate.

In Kenya, UNAIDS estimates that around 2.5 million people are living with HIV/AIDS and that in 2001 190 000 people died from AIDS related illnesses. In addition at the end of 2001, there were thought to be 890 000 children in Kenya that have lost one or both parents to AIDS[4].

Similar stories are told in most sub-Saharan countries with HIV infection rates ranging between around 8% in Tanzania to 20% in South Africa and to a high of 36% in Botswana (UNDP Human Development Indicators)

Although anti-retroviral drugs are not a cure for AIDS, they can greatly improve a person's living conditions and extend his or her life for many years. When used to prevent mother-to-child transmission (MTCT) of the HI virus, drugs such as Nevirapine have been shown to be enormously effective. In clinical settings in industrialised countries, the successful use of anti-retroviral therapies to prevent MTCT has been able to get transmission rates to less than 2%[5]. (Charles & Boyle, 2002)

Research and development of these drugs took many years and was enormously costly. Pharmaceutical companies made those investments because they believed that they would be able to reap the rewards that would come from selling the drugs. That belief was based on the fact that the companies held patents in the products, which gives them temporary exclusive marketing rights. Many of these drugs are still on patent in rich countries. That means the period of exclusive marketing for the drug, which formed the basis of the pharmaceutical companies' investment decision, has not yet ended. If this period is curtailed it would clearly alter the investment decisions of pharmaceutical companies.

However, many activist groups have argued that high prices prevent people in poor countries from having access to these drugs and allows drug companies to profiteer from a disease that is devastating Africa. Medecins Sans Frontiers (MSF), Act UP and Oxfam, to name three groups, have argued in favour of far greater flexibility in the TRIPS agreement. They claim, for example, that if developing countries had more flexibility in issuing compulsory licenses[6] for the production of patented drugs, or were able to parallel import[7] drugs from generic producers in countries that do not offer patent protection to pharmaceutical products, they would be in a far better position to deal with their health crises. But are these claims valid?

As mentioned above, the TRIPS agreement is designed to be flexible so that countries can "balance social and economic welfare". Article 31 of the TRIPS agreement deals with the use of patented products without the authorisation of the right holder. Although the agreement does not actually contain the words compulsory licensing, the authorisation of use without the prior consent of the right holder amounts to the same thing.

Article 31 allows a country to issue a compulsory licence as long as the right holder has been contacted and attempts have been made to obtain a voluntary licence (as opposed to a compulsory licence) on reasonable commercial terms. This condition is, however, waived in the case of a "national emergency or other cases of extreme urgency", the most obvious of which would be the HIV/AIDS pandemic in Africa. The agreement also allows for compulsory licensing for "public non-commercial use" (i.e. government use). (Article 31b)

The most controversial and vexing issue relating to compulsory licensing in the TRIPS Agreement is contained within Article 31f which states that

.. any such use shall be authorized predominantly for the supply of the domestic market of the Member authorising such use.

In effect this means that the only countries that can use Article 31f as a basis for issuing compulsory licenses are those that have sufficient production capacity. However, many of the countries that currently have the highest HIV infection rates also have little or no production capacity. Indeed it is generally the case that many of the countries that are most likely to suffer from health emergencies have little or no local pharmaceutical production.

An attempt to find a solution to this problem began with the Doha Declaration on the TRIPS Agreement and public health,[8] which was adopted on 14 November 2001. This reaffirmed that the TRIPS Agreement should be interpreted in a way in which public health is promoted, including improved access to medicines, whilst also ensuring that incentives to develop new medicines remain. The Declaration also recognises the importance of intellectual property rights to the development of new medicines.

The Doha Declaration affirms that:

Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted (paragraph 5b); and that:

Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency (paragraph 5c)

In relation to the compulsory licensing issue, paragraph 6 of the Doha Declaration reads:

We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.

The Doha Declaration also extended the deadline for the least-developed countries to apply the provisions on pharmaceutical patents to 1 January 2024 from 2006.

To date the TRIPS Council has failed to reach a solution to the Paragraph 31f issue. To understand why, it helps to go back to the origins of TRIPS. This agreement was strongly promoted by the research-based pharmaceutical industry, whose investments are highly dependent on protection of their intellectual property. By contrast, the producers of generic copies of pharmaceuticals opposed TRIPS because it would prevent them from profiting from the sale of on-patent pharmaceuticals. The research-based industry (and all who benefit from its products) won the battle and under TRIPS Egypt, India and other high-income developing countries must offer patent protection for pharmaceutical products from 1 January 2006. But the generic industry did not give up the battle and it has been searching for a way to continue copying pharmaceuticals ever since.

When the Doha Declaration was announced, the research-based pharmaceutical industry was equivocal, but expressed concerns that the agreement not be used as a means of undermining its IP in key markets. In particular, the industry made it clear that the agreement should be limited to its clear purpose, which is to deal with health emergencies in least developed countries with insufficient manufacturing capacity. However, the generics producers in India, Egypt and other high-income developing countries saw the Doha Declaration as a means by which they might be able to carry on producing on-patent drugs after 2005. They pushed for a solution that would enable companies in places such as Egypt and India to continue producing generic copies of on-patent drugs - for sale to other developing countries. Unsurprisingly, the research-based pharmaceutical industry opposed this solution as it would have undermined its ability to reap returns from its investments in innovative drugs and it did not address the intent of the Doha Declaration, which was to allow the least developed countries to address their health emergencies and not to enable OECD countries or high-income developing countries, such as Saudi Arabia, to import copies of drugs for erectile dysfunction from other high-income developing countries such as Egypt.

On December 16, 2002, the Chair of the TRIPS Council, Perez Motta, of Mexico, proposed a compromise text, the main points of which are as follows:

1. The eligible countries are those least developed countries and any other "Member that has made a notification to the Council for TRIPS of its intention to use the system as in importer" The major OECD countries have stated that they will exclude themselves as importing countries, however all other countries may apply;

2. The system would apply to all products from the pharmaceutical sector (vaccines are not included as pharmaceutical products);

3. The diseases are to be those public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics;

4. The mechanism will be only transitory and provisional in nature and that further work will be done before the end of 2003.

5. The exporting country is required to identify the product with different labelling or marking so as to distinguish it from other products

6. Countries that use the mechanism do not require authorisation from the WTO, however they should inform the WTO of their intention to use the provisions

There have been many objections, to the Motta text. Perhaps the most important objection concerns the scope of diseases according to which a country could use the parallel importation provisions. Motta's text limits the diseases to HIV/AIDS, TB, malaria and other epidemics, however drug activists argue that the incidence of cancer, heart disease, and life style diseases in developing countries are high and no less deadly. However, it could be rebutted that these diseases have a very different demographic profile: they don't usually strike children and young adults and so do not undermine the economic potential of a country in the way that AIDS, TB and malaria do.

Another objection concerns the eligibility of the country that wishes to import generic drugs. According to the Motta text, least developed countries (LDCs) will be allowed to import drugs, however there would be a two part test for all other countries. The first part of the test would be to determine whether or not a country has any manufacturing capacity and the second is to determine whether this capacity is insufficient to meet the country's needs. (Love et al, 2001) It is argued that the Motta text would exclude countries like Brazil and South Africa from being able to import cheap generic drugs because they have sufficient local capacity to produce themselves. Brazil, the activists argue, would not have been able to extend its free anti-retroviral therapy to all that require it had it not been able to import generics.

By contrast, the US has argued that the provisions in the Motta text are far too wide on countries that would be eligible to take advantage of the system. The US and the pharmaceutical industry argued that there is not an adequate mechanism to screen the countries that could take advantage of the provisions and that this would greatly undermine the rights of the pharmaceutical industry. The US Trade Representative announced the provisions would seriously undermine the "..WTO rules on patents that provide incentives for development of new pharmaceutical products, including those to treat diseases of a non-epidemic nature."[9]

The US had already proposed a moratorium on challenges to countries that would seek to break WTO patent rules in order to deal with public health crises.[10] The moratorium, according to the US, would allow agreement more easily than an amendment to the TRIPS agreement, that would be open to legal interpretation. After the failure of the planned Motta text, the US announced that it would be implementing the moratorium, a move designed to allow the other WTO negotiations to continue, although a permanent solution to the anomaly of Article 31f of the TRIPS Agreement is still to be reached.

The legal wrangling, lobbying and political debate over how to deal with the problem highlighted in Paragraph 6 of the Doha Declaration look set to continue for some time..

While the negotiations on Paragraph 6 have been continuing, it has delayed negotiations on other, perhaps more important aspects of the WTO, such as the negotiations around agricultural barriers to trade. It is therefore important to take a step back and examine how important IPR and drug patents are in blocking access to medicines. Given the amount of debate and the column inches devoted to the ongoing TRIPS negotiations and the role the research-based pharmaceutical industry is playing, one would imagine that it is the most important barrier to effective healthcare in LDCs. However, this is simply not the case. The rest of this paper will assess the degree to which IPR blocks access to drugs and will use as examples the cases of Nigeria, Zimbabwe, Botswana, South Africa and India.

DO PATENTS MATTER IN THE FIRST PLACE?

It has been very widely argued that a system of intellectual property protection allows drug manufacturers to make unfair and excessive profits from their patented drugs. Furthermore these drug patents prohibit generic competitors from producing their own versions of these drugs, hence prices remain high and out of reach of the world's poor.

Yet on closer examination, one finds that in Africa, the continent worst hit by the HIV/AIDS crisis and home to the world's poorest people, there is little relationship between the degree of drug patenting and access to those drugs. In a study completed in October 2001 and published in the Journal of the American Medical Association (JAMA), researchers Amir Attaran from Harvard University and Lee Gillespie White from the International Intellectual Property Institute find little or no relationship between drug patents and access to drugs.

Attaran and Gillespie White asked a simple question: If drug patents are an important barrier to ARV drug access, how widespread are the ARV drug patents in Africa? The researchers surveyed the extent of patenting of 15 ARV drugs in the 53 African states. They found that out of the 795 patents that could exist (15 drugs multiplied by 53 countries), only 172 actually exist. In other words, only 21.6% of possible patents actually exist in Africa.

The country with the most drugs patented is South Africa, with 13 patents, followed by Zimbabwe (8) and Kenya, Sudan, The Gambia and Uganda (7). Crucially, the authors found little relationship between the degree of drug patenting and access to drugs, pointing to other factors such as a lack of donor funding, poverty and poor health infrastructure as reasons for low or non-existent access to ARV therapies.

The arguments put forward by many that Africa would be able to deal with its health crises if only it had the power to import cheap generic drugs or to issue compulsory licences is greatly undermined by this finding. A country such as Kenya, where fewer than half of the available ARVs are actually patented and which has a local pharmaceutical industry, would have been able to allow local production of ARVs for many years. Indeed the country would have been able to import generic drugs from countries such as India, which does not respect patent laws, perfectly legally. Kenya and most African countries do not have to wait for the TRIPS negotiations to come to a conclusion before they start importing generic drugs, they can do so right now for those drugs that are not patented and remain within international law.

Yet most countries are not doing this. Perhaps the reasons for failing to do this can be found in both Nigeria and Zimbabwe.

Nigeria's Generics Debacle

One of the world's largest and most successful generic drugs manufacturers, the Mumbai-based Cipla, announced in 2001 that it would offer the three drug cocktail of lamivudine®[11], stavudine®[12] and nevirapine®[13] at a price of only USD 350 per person per year. As India has no pharmaceutical product patenting laws at the moment, Cipla can perfectly legally produce these drugs that are patented in other countries.

The ideal treatment strategy involves using a combination of three drugs in a cocktail, including a protease inhibitor and a non-nucleoside reverse transcriptase inhibitor. The use of this triple therapy has proved extremely successful in developed countries with an estimated 75% drop in mortality rates within three years[14].

According to UNAIDS, Nigeria had approximately 3.5 million adults and children living with HIV/AIDS by the end of 2001 and that during that year 170 000 people died as a result of AIDS. In addition, the country has approximately 1 million children orphaned as a result of the disease[15].

Given this crisis, it was encouraging that the Nigerian government announced in November 2001 a plan to increase access to ARV therapy. The government announced that it would import generic drugs from both Cipla and Ranbaxy at low cost and that it would subsidise the treatment to Nigerians. The plan was to provide treatment to 10 000 adults and to 5 000 children, which although only a fraction of those that probably required treatment would have been a good start. The scheme was to make ARV therapy available at a cost of USD 10 per patient per month and would be available at 100 designated hospitals around the country.

Tragically for those that require treatment, the generic drug treatment plan appears to have failed. By May 2002, reports emerged that only 800 people had actually begun to receive treatment[16]. Reports also emerged that some of the patients were suffering from severe side effects and had decided to discontinue treatment[17].

The importation of generic drugs was supposed to increase access to drugs, yet it is clear that only a fraction of those that were intended to get the drugs actually received them. One possible reason for this failure is that although the drugs were cheap and subsidised by the Nigerian government, the diagnostic tests to determine whether or not a person is HIV positive or to assess his or her viral load and CD4 count were not subsidised[18]. Apart from having to bear the costs of these tests, it has also been pointed out that the stigmatisation of HIV positive people in Nigeria is so severe that it would deter people from seeking treatment that could save their lives¹⁶. Accusations of corruption and administrative problems also seem to have dogged the programme from the start[19].

The fact that people stopped treatment because of the side effects could point towards poor explanations and guidance given to patients. It may also indicate that some patients were not taking their drug regimens properly. For instance, most ARV therapies require that the patient be well fed and that the treatments are taken on a full stomach. With the levels of extreme poverty in Nigeria and poor food security, it is likely that at least some of the patients on the ARV programme did not have enough nutrition in order to comply with the drug regimen.

While Cipla and Ranbaxy may be in a position to produce ARV drugs very cheaply as, for one reason they did not incur the research and development costs, they are not known for providing logistical support and training to health systems. It now seems clear that the kind of support required in storing, distributing the drugs and ensuring that they are taken properly with the right level of supervision was lacking in Nigeria. Relying on cheap generic drugs may have seemed like a workable proposition, however because of the poor state of Nigeria's health infrastructure, a seeming lack of knowledge about the drug regimens and stigmatisation, it has tragically failed those that desperately need treatment.

Zimbabwe - Another Property Rights Disaster

In recent years, Zimbabwe has shown that it is not a country that has any respect for private property rights. The country's experimentation with land reform that was based upon a disregard of the rule of law, the brutal suppression of political opposition and outrageous abuses of human rights has all but destroyed the country's economy and has failed the citizens of this once hope-filled nation. The strategy of disregarding property rights was extended to intellectual property rights for pharmaceutical drugs in May 2002. The government announced a state of emergency in its effort to deal with its HIV/AIDS crisis which meant that the country would not respect drug patents and that it would allow the importation of generic drugs that are patented in Zimbabwe.

In Zimbabwe only 8 of the 15 or so ARVs are actually patented and those that are patented have been offered to the government at discounts of up to 90% or in the case of Nevirapine (Boehringer Ingeleheim) entirely for free. At the time of the declaration, Zimbabwean Aids activist Jefter Mxotshwa questioned whether the six month emergency would result in wider access to drugs. According to Mxotshwa the country would have been better off by concentrating on improving health infrastructure and ensuring that the skilled medical staff stopped leaving the country[20].

In a surprising move, many activists, including MSF chose to ignore the opinion of the local AIDS activists and "fully supported" the decision of the Zimbabwean government, one of the most tyrannical and abusive in southern Africa[21].

According to Dr. Owen Muguriungi[22], head of the TB and AIDS Programme at the Zimbabwean Department of Health, the declaration was not meant to undermine the rights of the research based drug companies that hold the drug patents, but was rather intended to mobilise the bureaucracy into dealing with the unfolding human tragedy. Yet is seems curious that the only way in which to mobilise support within the bureaucracy would be to threaten to import generic drugs. It points to a startling lack of will to deal with the HIV/AIDS emergency if the government has to resort to these tactics and if it does not see the offers of free drugs with the support of the research based drugs industry as sufficient motivation to deal with the crisis.

Sceptics perhaps would not be surprised that the declaration of the AIDS emergency in Zimbabwe has not improved access to drugs. They would recall that in one homophobic attack after another, President Robert Mugabe has blamed AIDS, among many other things, on homosexuals.

To date, no generics have been imported into Zimbabwe and it appears as if no one has actually benefited from the move that received such support from around the world. Unfortunately this is not surprising given that the government of Zimbabwe has focused more on land seizure and political harassment than on building the country's health infrastructure.

South Africa - A lack of political will

South Africa has one of the highest HIV infection rates in the world and as has been widely reported in the press, has one of the least effective government responses to the crisis. Getting the exact figures on how many people are infected with the HI virus, how many people need ARV therapy, how many people have died and how many AIDS orphans there are is very difficult.

UNAIDS estimates that at the end of 2001 there were approximately 5 million adults and children living with HIV/AIDS and that in 2001 alone, 360 000 people died as a result of the disease[23].

In South Africa, the continent's most industrialised country that also has the most advance health infrastructure, the statistics of HIV infection are mostly based on HIV prevalence among pregnant women that attend public health facilities. Most statistics on AIDS should therefore be treated with caution, however the overwhelming message from researchers, physicians and other health workers is that the epidemic is advancing and that is it already taking its toll in terms of illness, loss of life and economic disruption and cost.

South Africa's fight against HIV/AIDS was dominated for some time by the public dispute between the South African government and the major research based pharmaceutical companies. The issue concerned the Medicines and Related Substances Control Amendment Act No 90 of 1997 and the discretionary powers given therein to the Minister of Health to issue compulsory licences without consultation with the drugs industry.

The South African Pharmaceutical Manufacturers Association (SAPMA) and 38 research based drug companies started legal proceedings against the government as they felt the provisions in the Act unfairly prejudiced them. The government was supported by many activist groups who portrayed the drug companies as being interested only in profit and accused them of profiteering while many millions of Africans were denied treatment.

The case was subsequently dropped by the drug companies and in a statement made shortly after the withdrawal of the case, the Minister of Health, Dr. Manto Tshabalala-Msimang said that she was glad that the drugs industry had recognised the legitimacy of the governments "struggle" for affordable health care. The minister went on to say that she considered the settlement "a victory in the sense that it unfreezes our law and restores us the power to pursue policies that we believe are critical to securing medicines at affordable rates and exercising wise control over them."[24]

However after the so called victory, the South African government has consistently refused to provide any anti-retroviral therapy to those that need it. The government has not used any of the provisions contained within Act 90 of 1997 and the drug activists that supported the government during the drug company trial, turned their attention to the government. Successive legal actions, brought by the Treatment Action Campaign against the government has led both High Court and Constitutional Court rulings that the government is required to address the HIV/AIDS crisis by providing ARV therapy. The government has failed to respond to these rulings and to date its policy seems to be one of intransigent neglect of those requiring treatment.

Not only is the government unwilling to spend its own funds on the purchase of ARV therapies, but it has not taken up many of the offers of free or discounted drugs that have been made from the research based drug companies. In response to the unfolding catastrophe and after international pressure, mostly from activist groups, many of the multinational drug companies reduced their drug prices dramatically or in the case of Boehringer-Ingelheim offered them for free to government. To date the government has also refused to issue a state tender for ARV therapies and so the pharmaceutical industry has not been able to compete for the supply of drugs to the state. There is however progress in the private sector where increasing numbers are receiving treatment either through employer programmes or with insurance cover. Several NGO projects, such as one run by MSF in Cape Town, are also providing treatment to individuals.

A low point for the governments AIDS treatment policy was reached in February 2002 when Dr. Thuys von Mollendorf was suspended from his position of superintended of Rob Ferreira Hospital, a large state hospital in Nelspruit, Mpumalanga Province. The reason for his suspension was his refusal to eject a non-governmental organisation, the Greater Nelspruit Rape Intervention Project (GRIP) from the hospital premises. GRIP had not only been counselling rape victims, but had been providing them with ARV therapy to reduce the probability that they would become infected with HIV. This action by the government shows that not only are they unwilling to provide ARV therapy where it is feasible, but that they will actively, and it appears with some malice, prohibit private groups from providing the therapy.

Given the situation, it seems entirely reasonable and justified that Treatment Action Campaign is now implementing a plan of peaceful civil disobedience in order to force the government to take action and provide ARV therapy. Civil disobedience has not been a tactic employed since it was used to protest against the grossly unjust Apartheid laws.

This debacle shows clearly that without the political will to provide ARV therapy, or indeed any other kind of public health service, the likelihood that cheap generic drugs, parallel importation or compulsory licences will not provide any kind of benefit to those in desperate need of medicines.

The situation in South Africa's neighbour to the north, Botswana could not be more different. That country has shown that something can be done about the HIV/AIDS crisis, that drug therapies can be delivered to those that need them and that the quality of life of AIDS victims can be vastly improved.

Botswana - Southern Africa's Leading Light

Botswana is the most economically free country in Southern Africa[25] and between 1990 and 2000, the annual compound growth in Gross Domestic Product was 4.4%, far higher than any other Southern African country and very impressive by global standards. Per capita income has risen during that period from USD 3,259 to USD 3,951 and the country has managed to maintain a stable and accountable democracy. (Heritage 2003) The country seems not only to have got its economic and political policies right, but has Southern Africa's most impressive HIV/AIDS treatment plan.

Unlike Zimbabwe and South Africa that have chosen a combative approach with research drug companies, Botswana has chosen to work with the research based drug companies in an effort to roll out ARV therapies. In July 2000, the government of Botswana announced its intention to begin a public private partnership called the African Comprehensive HIV/AIDS Partnerships (ACHAP).

The goals of ACHAP are:

1. Reduction of HIV infection and transmission

2. Improved access to comprehensive HIV care and support across a continuum from home to hospital

3. Improved access to prophylaxis and treatment of opportunistic infections (OI) and highly active anti-retroviral therapy (HAART) in the public sector for all people living with HIV/AIDS and eligible for treatment according to the nationally established guidelines.

4. Strengthen sustainable improvements of health care systems and mitigate the impact of the epidemic.

(ACHAP, Background Information, 2002)

ACHAP is a joint initiative between the Botswana government, the Bill and Melinda Gates Foundation and the Merck Company Foundation/Merck & Co. Inc. This unique partnership has secured a USD 50 million donation each from the Gates Foundation and the Merck Company Foundation over 5 years and Merck & Co. Inc. has undertaken to donate all ARV treatments for the duration of the programme.

The ACHAP plan is not simply to provide people with drugs, but is to build up the healthcare infrastructure and technical expertise to run a successful ARV programme well into the future. The plan consists of a great deal of capacity building and training and in November 2002, ACHAP established resource centres at Maun and Serowe District Hospitals so that patients and families will be able to access information on HIV/AIDS. In addition, the centres will provide medical staff with invaluable information and support and will provide an effective environment in which to counsel people living with HIV/AIDS.

Among the other projects, ACHAP has, in partnership with the Botswana Ministry of Health, the US Centres for Disease Control (CDC) and the Public Health Laboratories has assessed clinical laboratories and is ensuring that quality standards are maintained. In addition, ACHAP purchased and installed equipment for CD4 and viral testing at the Botswana-Harvard AIDS Institute.

Apart from building of infrastructure and improving the professional capacity of health workers in Botswana, ACHAP has begun providing ARV therapy to Botswanans. The Ministry of Health is planning to create the infrastructure to treat 19 000 patients and currently 6 000 patients have been enrolled in the free treatment programme and 3,900 are receiving therapy. The collaboration extends to the private sector too, where Debswana and other enterprises provide treatment to nearly 500 Botswanans. In total, there are some 4,400 Botswanans receiving therapy today, accounting for 1 in 10 Africans estimated to be receiving treatment

While this may not appear to be a very impressive figure, given that nearly 36% of Botswana's adult population is living with HIV/AIDS, it is in fact a good start and a very sound foundation in order to ensure that more and more people have access to treatment.

The political will to deal with the disease has been very good, with the Botswana President, Festus Mogae prominently supporting all efforts to treat patients and reduce the spread of infection. The provision of drugs means hope for many thousands of Botswana people and it appears as if the success of the programme will continue into the future. Whether or not the country would have been in a position to deal with the AIDS crisis in such a comprehensive manner without the support of the research based drug company Merck is doubtful.

Reports that have been Zimbabweans trying to enter Botswana in order to receive ARV therapy is perhaps the most poignant reminder that cheap generic drugs from India are worth little, without the systems to administer them and monitor patients. Botswana has successfully shown that countries do not have to undermine drug patents in order to strengthen their public health systems. Indeed their example shows that in resource poor environments with a compromised health infrastructure, undermining patents and opting for cheap generics could do more harm that good and could even cost lives.

India - Patent Free Nirvana?

It is informative to contrast the experiences of these three African countries with the situation in India. In 1972 Indira Gandhi announced that there would be "no profiting from life and death" and scrapped the country's drug patent laws. This led to the establishment of one of the most successful generic drugs industries in the world. It is estimated that there are around 22 000 generic drug manufacturers in India, however of the majority of them are not in a position to either produce the quality or the quantity of generic drugs in order to export them.

With HIV infection increasing steadily in India, UNAIDS estimates that there were around 4 million people living with HIV/AIDS at the end of 2001[26]. Yet despite the lack of patent protection, the enormous numbers of generic drug producers and the competition between them, access to essential drugs, be they for HIV or for any other disease for that matter is abysmally low. In India, the United Nations Development Programme estimates that in 1999, only 35% of the Indian population had access to essential medicines. (UNDP 2001) According to unofficial UNAIDS estimates less than 1% of those that require ARV therapy in India are actually receiving it.

It seems clear that in India, patents are not the barrier to accessing drugs and that poverty and a lack of decent health infrastructure are the more important issue. While Indira Gandhi's pronouncements on profit making and healthcare may have suited the highly profitable generic drugs industry, it clearly has not helped India's poorest gain access to essential drugs. Indeed as Susan Feinberg and Sumit Majurndar point out in a paper published in Journal of International Business Studies in 2001[27], the lack of intellectual property protection is an important factor in reducing technology transfers between multinational corporations and Indian companies. By reducing the security that research based drug companies have over their technologies and intellectual property, Indian companies have not benefited in terms of more advanced technology or expertise and the Indian population has not benefited in terms of greater access to drugs. Indian pharmaceutical companies have also failed to make a meaningful contribution to scientific or medical discoveries, as the nature of the system encourages companies to merely reverse engineer existing innovations.

WHAT ARE THE REAL BARRIERS TO HEALTHCARE?

At an AIDS conference held in Botswana in November 2002[28], the issue of intellectual property rights was raised only twice during three days of intense debate and discussion. The researchers that presented various papers highlighted among other issues, poverty, a lack of healthcare infrastructure, stigmatisation and a lack of political will as the major reasons for people in Africa not having adequate access to essential AIDS therapy.

During two workshops held in Kenya by the Inter-Region Economic Network (IREN Kenya) in November 2002 and again in February 2002, similar themes were raised with regard to access to healthcare. In Kenya, it was noted, corruption and theft are also important reasons that people are unable to access essential and much needed drugs.

The President of the Global Health Council, Nils Daulaire succinctly expressed the basic problem relating to access to ARVs in Africa when he said:

"Even if AIDS drugs were free, no more than 10 to 20 percent of Africans would benefit as the health infrastructures do not exist to manage infections in each individual." (Gillespie White, 2001)

In addition to the work by Attaran and Gillespie-White that undermines the thesis that drug patents are blocking access to drugs, one only has to consider the fact that most (around 99%) of the WHO list of essential drugs are not patented and yet are out of reach to those in poor countries. It would be entirely legal for any African country import generic versions of the off patent essential drugs in an effort to improve drug access. Yet few countries do because the reason that people don't have access to drugs is not related to intellectual property rights, but to poverty.

CONCLUSIONS

The experience in Nigeria has shown that when a government has shown the political will to implement an ARV treatment programme where health infrastructure is poor, but relies solely upon generic drugs is not likely to succeed. Zimbabwe's experience indicates that the removal of the so-called patent barrier to drug access is pointless in a situation where the drugs were on offer for free and where the country is in no position to either import or produce generic drugs or indeed to distribute them.

South Africa is possibly the one country in Africa where drug patents might conceivably play a more important role in blocking access to drugs. The country is the most advanced in Africa and has the best placed health infrastructure to run a successful ARV programme. It also has the highest number of ARVs on patent. Yet the government has spurned offers of free drugs and has consistently refused to take any concrete action to ensure that people that need ARV therapy receive it. The experience in South Africa shows how important political will and leadership is in ensuring that people have access to drugs.

Botswana has shown how in a resource poor environment with inadequate health infrastructure, the best way of ensuring that people have access to ARV therapy is to work with the private sector and, in particular, with the research based drug companies. By going against the received wisdom that drug patents block access to drugs and that drug companies profiteer at the expense of the poor, Botswana is now providing more and more people with life saving drugs and is creating hope for those who may need treatment in the future. Indeed it seems as though the country is running the largest free HIV/AIDS treatment programme in Africa.

India has failed to demonstrate the removal or weakening of drug patents will have any beneficial impact on drug access. While the vested interests in the generic drugs industry may have benefited, few others have and the country may have lost important opportunities to advance its drug research and medical technology due to its weak intellectual property protection.

The debate surrounding TRIPS and access to healthcare will continue into the future and strong statements will be made by both drug activists and the research-based industry, each defending their position. The moral legitimacy of intellectual property protection may be a matter for continuing debate, however the empirical evidence is mounting that drug patents are not acting as a barrier to drug access in poor countries. Indeed, most African countries would be in a far better position if drug patents really were the major barrier to access as this would be a far simpler problem to remedy than the host of issues that are blocking access to drugs.

The damage that is done by the continuing focus on TRIPS at the WTO is that attention is being diverted away from some of the more important issues. Little progress is being made in reducing the barriers to trade in agricultural products and this is a great shame. Most African countries would be able to grow much faster, increase incomes and wealth and be in a better position to deal with their health crises in the long term if they had better access to the rich markets in the North. The TRIPS impasse seems to be favourable to some countries, particularly France, Belgium, Spain and Italy, as it allows them to delay any reduction in subsidies to their politically important farmers and looks set to harm only the pharmaceutical sector, which is increasingly concentrated in the US, Britain, Germany and Switzerland. All in all, this is not a state of affairs that will leave African countries or those living with HIV/AIDS better off.

REFERENCES

ACHAP (2002) Background Information, October 2002, African Comprehensive HIV/AIDS Partnership (ACHAP)

Attaran, A & Gillespie-White, L (2001) "Do Patents for Antiretroviral Drugs Constrain Access to AIDS treatment in Africa?" Journal of the American Medical Association JAMA, October 17, 2001, Vol 286, No. 15, pp 1886 - 1892

Ayodeke, F, (2002), "Dilemma of Aids Patients" Newswatch, Lagos, Nigeria, February 25 2002.

Charles, M & Boyle, B, (2002), "Excess and Access: The Continuing Controversy Regarding HIV and Health Care in Africa, AIDS Read 12(7): 288-292, 2002, Cliggott Publishing.

Daily Trust, (2003) "HIV/AIDS Cases Rise in Nyanya," Daily Trust, 21 January 2003, AllAfrica.com

Department of Health, South Africa, (2001) Minister of Health's Comment on Drug Companies' Withdrawal, 19 April 200,1 https://www.doh.gov.za/docs/pr-f.html

Dow Jones International News (2002), "Nigeria Pres: AIDS Puts Nation at 'Edge of Precipice', 2 December 2002, Dow Jones & Company Inc.

Feinberg S & Majurndar S, (2001), Technology Spillovers from Foreign Direct Investment in the Indian Pharmaceutical Industry, Journal of International Business Studies, 33, 3 (pp 421 - 437)

Financial Gazette, (2002) "Question Mark Greets New AIDS Initiative," Financial Gazette, Harare, 30 May 2023

Gillespie-White L, (2001), "Patent Protection & Patients' Access to HIV/AIDS Drugs in Sub-Saharan Africa," Fraser Forum, February 2001, pp 12 - 14

O'Driscoll, G, Holmes, K & O'Grady, M (2003), 2003 Index of Economic Freedom, The Heritage Foundation, www.heritage.org

Lanjouw, J.O & Cockburn, I, (2000) "Do Patents Matter: Empirical Evidence After GATT" National Bureau of Economic Research, Working Paper 7495,

Love, J, Mayne, R, 't Hoen, E, Gombe, S, (2002) Joint NGO Letter to WTO Delegates, December 19, 2002, CPTech, https://www.cptech.org/ip/wto/p6/ngos12192002.html

Morris, J, Mowatt, R, Reekie, WD, Tren, R (2002) Ideal Matter: Globalisation and the Intellectual Property Debate, Centre for the New Europe, Brussels.

United Nations Development Programme (UNDP), (2001), Human Development Indicators 2001, www.undp.org

United Nations Development Programme (UNDP), (2002), Human Development Indicators 2002, www.undp.org

UNAIDS, Joint United Nations Programme on HIV/AIDS, Country Epi Fact Sheets, https://www.unaids.org/hivaidsinfo/statistics/fact_sheets/index_en.htm

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