The Monitor (Kampala)
OPINION
July 20, 2004
Posted to the web July 20, 2004
Anne Mugisha Bwomezi
Kampala
The reason for President Museveni's renewed vigour to support US ideologies in the battle against HIV/Aids is becoming clearer after Bangkok, Thailand.
Its roots can be traced back to Cancun, Mexico and while the journey is filled with acronyms, and quasi-legal verbiage we must look closely at the World trade agreements in order to understand what the government is getting us into. In a recent article titled "WTO: Uganda to Lose Out on Drugs" by David Kaiza which was published in The East African, the author alludes to the problem of allowing the United States mentor our trade policy under the WTO. Specifically with regard to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), he notes that; 'Under the WTO agreement, the implementation of patent rules will commence in January 2006. Countries like India and Brazil, which currently observe no patent rules, will either cease to produce generic drugs or will price them above the purchasing power of the poor countries that they target.
Advocates of drug access say that Uganda has allowed its patent legal review process to be commandeered by the United States Agency for International Development (USaid) ... The NGO coalition for Health Promotion and Social Development (HEPS) has continuously pointed out that the involvement of US aid in writing Ugandan patent laws means that it will reflect US corporate interests.
On June 27, 2002, the WTO council responsible for intellectual property rights approved a decision extending the transition period during which least-developed countries (LDCs) do not have to provide patent protection for pharmaceuticals to 2016.
The Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) also approved a waiver that would exempt poor countries from having to provide exclusive marketing rights for any new drugs in the period when they do not provide patent protection. That waiver was to have been submitted to the WTO General Council for approval on July 8, 2002. That Uganda did not take advantage of this waiver should not surprise anyone if it is true that Americans are our advisers.
Under the patent protection rules, if a country's health authority approves a new drug for sale, the patent applicant has to be given exclusive marketing rights for five years even though there is no patent (Article 70.9). The waiver exempts least developed countries from having to give these exclusive marketing rights. But Uganda appears to have opted out of taking advantage of this waiver.
Nonetheless, flexibilities are written into the TRIPS Agreement so that governments can issue compulsory licenses to allow other companies to make a patented product or use a patented process under licence without the consent of the patent owner, but only under certain conditions aimed at safeguarding the legitimate interests of the patent holder.
The African Group at the WTO pushed for clarification on this provision and on August 30, 2003 an agreement was reached allowing any member country to export pharmaceutical products made under compulsory licences within the terms set out in the decision.
The United States has however been working to ensure that its industries with patents on antiretroviral drugs do not lose out and to ensure that developing countries cannot benefit from the flexibility given by the August 2003 Agreement. First, the US government poured $ 15 billion into its own HIV campaign, outside the control of the Global Aids Fund.
Obviously a huge proportion of this money will be spent to purchase US patented drugs thereby circumventing the use of US dollars to purchase the generic drugs promoted by WHO and the Global Fund for Aids.
In a move reminiscent of the exclusion bilateral agreements that the US signed with regard to the jurisdiction of the International Criminal Court; the US is now entering bilateral agreements with developing countries that produce generic drugs to opt out of the August 2003 waiver agreement.
This bribery and blackmail was the focus of a statement made by France's President Jacques Chirac at the recent Aids conference in Bangkok. The Guardian of U.K. reported that Chirac accused America of blackmailing developing countries into giving up their right to produce cheap drugs for Aids victims.
Chirac said there existed a real problem of favourable trade deals being dangled before poor nations in return for those countries halting production of life-saving generic drugs. These cheap drugs compete with identical but more expensive patented varieties made by the world's largest pharmaceutical companies.
"Making certain countries drop these measures in the framework of bilateral trade negotiations would be tantamount to blackmail, since what is the point of starting treatment without any guarantee of having quality and affordable drugs in the long term?" Mireille Guigaz, France's global ambassador on Aids, said: "It is a question between the United States and developing countries, and the way the US wants to put pressure on developing countries who try to stand up for their own industries. We do not wish countries' hands [to be] tied by bilateral agreements".
Aids drugs were hugely expensive before countries like India and Thailand made copies and brought the prices down from $ 10,000 (£ 5,400) a patient a year to under $ 300 (£162).
According to the World Health Organisation, six million people in poor countries need antiretroviral treatment but only 440,000 are getting it. The New York Times reported in a July 14 article that: 'Many critics see big pharmaceutical companies behind the Bush administration's preference for costlier brand-name drugs... and hard-line unilateralists behind its decision to bypass the Global Fund to Fight Aids, Tuberculosis and Malaria in creating its own plan. The report also reveals that not all African nations have allowed the United States to bully them into using patented drugs. Mozambique and other African officials have resisted the distribution of brand name drugs as first-line therapy.
"We are using generics here because they are cheaper," Mr Songane of Mozambique said. "And apart from being cheaper, they are prepared in a manner which is simple for our patients, and even simpler for our staff."
Like Mozambique, many countries prefer generics because they can be used to treat more people and because, given patent problems, only generics now come in fixed-dose combinations, which combine three drugs in one tablet, improving adherence to pill-taking schedules. Foreign-made 3-in-1 pills have been approved by the WHO. But the Bush administration is insisting on brand-name antiretroviral drugs. With countries like Mozambique, Namibia and Rwanda holding fast to their positions that generics would be their first-line drugs, American officials realised that their assistance in those places would be limited.
Uganda's hands are already tied and patients have already started feeling the effect of using the drugs distributed under Bush' ambitious 15 billion dollar HIV/AIDS program. Warnings are regularly issued through the press that these FDA approved antiretroviral treatments must be taken with close supervision of a medical practitioner. And how is this to help our remote rural population who live miles away from the nearest dispensary?
Obviously the drugs do not allow for the flexibility and ease of the generic drugs. By allowing the US to determine our national AIDS policy we have laid our bed and now we must lie in it.
Uganda's government could use a word of advice from Mozambique as reported in the New York Times " In Maputo, health officials said that they were struck by the Americans' obsession with numeric goals. "To see an increase in numbers of people on antiretrovirals, that was their only concern," said Songane, the health minister. "But this is a complex disease. We cannot judge the success of our fight just by the numbers of people on treatment."
The Mozambicans wanted to move gradually and to strengthen their health sector at the same time. They did not want to use nongovernmental organisations where the Americans would pay the salaries, buy the drugs and purchase the vehicles that would travel to the villages to distribute the drugs.
"In one year, two years' time, who is going to follow those people?" he asked. "When the N.G.O. is gone, who is going to take over?"
Ms Mugisha is Secretary, International & Regional Affairs, Reform Agenda and she is resident in the US.
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