Innovative drugs are increasingly unaffordable in developing countries, other than for a privileged elite. The ban on local copies will quite simply rule out access for the majority of the population. -- Medecins sans Frontieres
At a time when millions of lives are at risk from newly-virulent diseases, and from the increasing drug resistance to old killers, trade rules threaten to make basic medicines even less affordable to the poor. -- Oxfam
We're looking at one of the most stark acts of corporate inhumanity. At the end of the seven days of this trial, 5,000 poor South Africans will be dead who were alive at the beginning of it. In the same time, the top five drugs companies will have sold $1.3 billion worth of medicines. -- Phil Bloomer, head of advocacy, Oxfam
With a rights-based approach to care, together with local production of generic anti-retrovirals in some countries, coverage of patients is increasing in Brazil, Argentina, Chile and Uruguay, where HIV-positive people are living longer, positive lives. -- Kofi Annan
I had not been exploring Big Pharma for more than a couple of days before I was hearing of the frantic recruitment of third world 'volunteers' as cheap guinea pigs. Their role, though they may not ever know this, is to test drugs, not yet approved for testing in the US, which they themselves will never be able to afford even if the tests turn out reasonably safe. -- John le Carre
Our combined strength enabled us to establish a global private sector-government network which laid the foundation for what became TRIPs. -- Edmund Pratt, CEO Pfizer
Although we're not actually relinquishing our rights to Zerit, if somebody in South Africa infringes on the method of use of our patent, we're not going to object. -- spokesman, Bristol-Myers Squibb
We seek no profits on Aids drugs in Africa, and we will not let our patents be an obstacle. This is not about profits and patents; it's about poverty and a devastating disease. -- John McGoldrick, executive vice-president, Bristol-Myers Squibb
The big multinational drug companies are kicking the poor, especially those in poor countries, in several different ways, by refusing to develop drugs needed in the Third World (eg antimalarial drugs) because there is no profit in it, by refusing to allow the manufacture and import of cheap generic drugs, using the poor as guinea pigs for untried and untested drugs, by engaging in biopiracy in the South. Under WTO rules (TRIPs) affordable medicines will soon become a thing of the past.
In the US it costs on average $10,000 per patient to conduct a clinical trial, in Russia $3,000, and in the poorest parts of the world, much less.
Antonio Salvador Polizzi was a 60-year-old pen salesman with a heart problem. Three years ago, when he woke up in the early hours of the morning with chest pains, his family rushed him to the Pedro Mallo naval hospital. Polizzi never left hospital, five days later he was dead. Six months later his family was to learn that he had taken part in a clinical trial for a new heart drug called cariporide, that he had signed a consent form. Only he hadn't, his signature had been forged. Investigations by state prosecutors have revealed that of the consent forms for all 137 patients at the hospital who had taken part in the trials, 80% had been forged. Doctors had been offered $2,700 for each person they recruited for the trial by cariporide's German-based manufacturers, Hoechst Marion Roussel. Hoechst is now part of French-based Aventis Pharma.
Clinical trials are now a Third World growth industry. The drugs under trial are for western markets. In its May 2000 edition, CenterWatch, a newsletter for the burgeoning clinical trials business, published an exuberant article under the title Latin American Fever in which it said the continent 'may offer a unique opportunity to reach much larger numbers of study subjects.'
Eli Lilly tested 590 patients in 1994 across Africa, the Middle East and Central and Eastern Europe. This year the company expects to run tests in those regions on 7,309 patients.
It is not only the guinea pigs who are at risk. In the rush to market, poorly constructed, weakly monitored trials are releasing untried and untested drugs on the west. Concerned doctors have attempted to persuade the US National Bioethics Advisory Board to establish rules so that US government-funded medical research would have to be overseen by a US review board, but the attempt failed.
Every year infectious diseases kill two million people in the Third World, over half are children under the age of five, the vast majority are too poor to afford proper healthcare, countless millions suffer debilitating illnesses, two billion people lack access to basic health care. The availability of cheap drugs, better healthcare systems would help to reduce these figures. To keep the pharmas happy and using the threat of trade sanctions, WTO rules (TRIPs) are preventing the availability of cheap generic drugs. GATS (WTO rules under discussion) will force healthcare systems into the private sector.
March 2001, 40 of the world's largest drugs companies took action against South Africa to stop the use of generic drugs. At issue, South Africa's right to import and manufacturer cheap generic drugs from India and Brazil. The drug companies are asking the Pretoria High Court to invalidate a South Africa law (Medicines and Related Substances Control Amendment Act) that permits the import and manufacture of cheap generic drugs. The case was expected to last one week. On the second day the case was postponed for six weeks. During that period the case was scheduled to be heard, ie one week, drugs companies would have sold $2.2 billion of drugs, made a profit of $560 million. By the end of the week 5,000 sick South Africans would have died. 5,00 sick South Africans would have paid the price of corporate greed.
The judge hearing the case decided to allow Treatment Action Campaign to act as a friend of the court and provide evidence on behalf of Aids sufferers. The judge also ordered the drug companies to provide details of their business structures and pricing policies.
The drug companies have been isolated by foreign governments. The US, the EU and the WHO say they do not oppose South Africa's right to implement the new legislation. Even the WTO has said that the law under contention does not infringe international patent protection. Initially Clinton opposed the action of South Africa, then backed down. George W Bush has gone further and said the US has no problems with the action of South Africa.
In South Africa, a quarter of a million people died from Aids in 2000 and one in 10 of the population is HIV-positive. By 2010, life expectancy in South Africa will have fallen by 20 years.
A knock on effect of the case is that Kenya has decided to follow the example set by South Africa and not recognise the patents held by the pharmas for essential drugs. Kenya is under pressure to extend its 7 year patent protection inherited from Britain to WTO/TRIPs 20 years. Father Angelo d'Agostino, head of a Nairobi orphanage, has added to the pressure by threatening to disregard existing Kenyan patent law and order Aids drugs direct from Cipla in India. Buying cheaper aids drugs would allow Father Angelo d'Agostino to treat an additional 20 children every month. The Kenyan challenge poses as important a challenge to TRIPs and the pharmas as does the case in South Africa.
Antibiotic Ciprofloxican, considered an 'essential medicine', costs South Africa's public health sector 52p per pill and the country's private health care providers more than £3 a tablet. If the new law is implemented, a generic of the drug could be imported from India for just 4p a pill.
Diflucan, Pfizer's anti-fungal drug, effectively treats severe forms of oral and oesophageal thrush, common illnesses in people with Aids, and frequently lead to painful death by dehydration, because of the difficulty of swallowing. Several pills must be taken every day, but at a cost of £3 to £12 per pill, most can't afford them. Effective generic versions, which cost less than 17p per pill, cannot be imported legally because Diflucan is under patent. Thus people die because of Pfizer's unflinching defence of market exclusivity for a drug that has sales of more than $1 billion per annum, almost all in developed countries.
Kenya wished to import fluconazole, used to treat cryptococcal meningitis (an opportunistic infection associated with HIV/Aids), from Thailand. The cost of treatment would have dropped from $3,000 to $104. Pfizer, the patent holder, blocked the imports.
Cipla, the Indian drugs company established under Indira Gandhi's 30 year old policy of cheap generic drugs, is offering a three-drug anti-Aids cocktail of stavudrine, lamivudine and nevirapine for just $600 to governments and $350 to Medecins sans Frontieres, provided MSF distributes the drug free. The drug cocktail sells for between $10,000 and $15,000 in the west. GlaxoSmithKline has warned Cipla off from selling its cheap copy of Combivir - a combination of AZT and 3TC (lamivudine) - in Ghana and Uganda, saying it has patent rights in these countries.
India exports vast quantities of cheap generic drugs to the Middle East, Latin America and Africa. Cipla now faces new patent legislation enforced under trade deals which threaten its export business.
In addition to the case in South Africa being brought by the pharmas, the US is taking Brazil to the WTO, and there is the threat of trade sanctions against more than 15 developing countries, including India, The Dominican Republic, and Thailand.
Bangladesh is seeing a rise in multi-drug resistance diseases. Bangladesh is totally dependent upon cheap imports of generic drugs from India. From 2006 Bangladesh will be prohibited under TRIPs from importing cheap generic drugs from India. Inability to pay for an effective course of drug treatment is accelerating the spread of multi-drug resistance. Bangladesh has been strong-armed into signing TRIPs by the threat of WTO trade sanctions and withdrawal of aid and soft loans.
In 1982 Bangladesh implemented an essential drugs policy, a text book implementation of the WHO essential drugs policy. It was pro-people, anti-poverty. The government licensed the production and import of 10 essential drugs, quality and price were controlled, price was determined by raw material costs and production costs. Bangladesh took on the pharmas and won. Under WTO rules on investment and intellectual property protection (TRIPs) all aspects of the policy are illegal, putting Bangladesh at risk of WTO imposed trade sanctions. Corporate greed comes before the health of the poor.
In Ghana and Uganda the pharmas have prevented the import of cheap generic drugs. Imported copies of GlaxoSmithKline Combivir, an anti-retroviral HIV/Aids drug, would have been available at half the GSK price.
The pharmas claim they need to charge high prices, need patent protection, to cover their high R&D costs. This is nonsense, they spend far more on marketing, 'bribing' journalists and 'independent' researchers than they do on R&D. The pharmas most closely guarded secret is their pricing policy and what they spend on lobbying. PhRMA, an organisation that represents all the big drug companies, has one of the biggest lobbying budgets in Washington.
Much of the research on which the pharmas make their money was carried out with public money at universities and in public laboratories. Students at Yale are calling on the university to forgo its royalties on Aids drugs that are being used in the Third World. The Yale students are contacting other students and asking them to follow their example.
Since launching their campaign, students at Yale have already notched up an historic victory. Bristol-Myers Squibb has said it will not contest patent violations of two of its Aids drugs in South Africa. Bristol-Myers Squibb is relaxing its patent protection on Aids drugs Zerit and Videx. The key component of Zerit and Videx, d4T, was developed at Yale. The action at Yale has been backed by Professor William Prusoff who pioneered the research on d4T. Yale earns $40 million a year royalties on d4T.
Following the adjournment of the South African drugs case several pharmas announced discounts on their drugs, but this has been dismissed for what it is, empty gestures delivered under pressure. The pharmas are losing the PR battle and they know it.
The world's drugs companies do occasionally provide cheap drugs to the Third World. These are drugs long superseded, drugs it is cheaper to dump on the Third World than to warehouse or dispose of.
Africa accounts for 1% of the pharmas profits. The case against South Africa is thus not about profit, the pharmas could easily lose South Africa and not notice the difference. The fear is that a precedent will be set. In a report presented to the UN General Assembly special session on HIV and Aids, Kofi Annan highlighted that in many African states, more than half today's 15-year-olds will die from HIV/Aids if present rates of infection continue. Only adults who escape HIV infection can expect to survive to middle and old age.
The UN is preparing to challenge the approach to generic drugs adopted by the pharmas and backed by WTO. The UN is backing the call by Oxfam and MSF that cheap generic drugs should be made available to developing countries. The UN is ready to back states such as Brazil, Thailand and India where national laws allow them to override drug patents in cases of dire emergency. Kofi Annan has praised Brazil, where reported Aids deaths have been reduced by a quarter.
Triple drug HIV/Aids therapy costs $4,000 in Brazil (cf $15,000 in the US). Brazil has managed to provide free treatment to around 90,000 Brazilians diagnosed HIV positive.
TRIPs, Trade Related Intellectual Property Rights, is the set of WTO rules that lie at the heart of the problem. By enabling the patenting of living biological material, DNA, cells, micro-organisms, seeds, plants, animals, etc, TRIPs encourages biopiracy. TRIPs is forcing all signatories to extend patent protection to at least 20 years. Those who fail to comply face WTO trade sanctions.
All developing countries have to comply with TRIPs, that is amend their own national patent laws to allow the patenting of their own indigenous genes by global corporations and stop the manufacture or importation of cheap generic drugs, by the year 2000 (least-developed countries by the year 2005). The US, WTO and World Intellectual Property Organisation (WIPO) are applying intense pressure to ensure full compliance.
India, Thailand, Egypt and Brazil have built up their own pharmaceutical industries making them self-sufficient and no longer dependent on expensive imports. The big pharmas want to destroy these home-grown industries and are using TRIPs to do so. The market capitalisation of the big five pharmas exceeds the GNP of India, Mexico, the least developed countries and sub-Saharan Africa.
Patent protection, intellectual property rights does nothing to safeguard cultural knowledge held in common for the benefit of all. TRIPs needs to be revised to stop the patenting of life and to bring it into line with the Convention on Biodiversity.
TRIPs, patent protection and intellectual property rights, has no role in the Third World protecting the profits of pharmas. Profits that are insignificant compared with the profits made in the West, and immoral when it is a life and death situation for millions of people. These countries should be free to produce their own cheap, generic drugs for Third World use.
Patents is about maintenance of monopoly rights. Twenty years is a very long time to maintain a monopoly. As the chemical and dye industries in Germany and Switzerland moved to pharmaceuticals there was no patent protection. It was felt at the time that patents would hamper innovation and development of the emerging pharmas.
TRIPs was drafted by PhRMA, an aggressive Washington lobbying organisation that represents the big pharmas.
People's health should be set before corporate greed.
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