FOCUS ON AFRICA
http://www.gmwatch.org/p1temp.asp?pid=37&page=1

"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 USaid in writing Ugandan patent laws means that it will reflect US corporate interests."

Much was made of Bush's billions to fight Aids in Africa, but when the world's stingiest aid donor comes bearing gifts, you better look out!

There are remarkable parallels between items 1 & 3 on the US, Aids and Africa, and item 2, a rerun of African biosafety lawyer Mariam Mayet's brilliant expose of how the US and the biotech corporations are working to profit from hunger in Africa.

As Mariam shows, areas like agricultural research, technical assistance, food aid, and the funding of biosafety initiatives, have all been drawn into the frame, with the Bush administration channelling big money to agencies like USAID and USDA to promote projects to "integrate biotechnology into local food systems and spread the technology through regions in Africa," as USAID's remit explicitly states.

Mariam's native South Africa has come to play a pivotal role in this industry-US marketing campaign which is aimed at removing potential regulatory hurdles and trade restrictions. This is because SA's introduction of GM crops has been so rapid - certainly amongst the most rapid anywhere outside of the US itself. The aim is to take the biosafety system that permitted this and make it the model for the rest of Africa.

What is so depressing about this is that while GM crops introduce novel risks and unertainties - ones that are particularly challenging for African countries to face - the benefits from GM, as Aaron deGrassi of the Institute of Development Studies has so convincingly shown, are much lower than can be obtained with alternatives for just a tiny fraction of the investment! See: http://www.lobbywatch.org/archive2.asp?arcid=2561

And increased costs for less efficacy brings usback to the US and AIDS:
1.How US is Turning Aids Into Big Business
2.Africa - the new frontier for the GE industry
3.France accuses US of Aids blackmail
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1.How US is Turning Aids Into Big Business
The Monitor (Kampala)
OPINION
July 20, 2004
Anne Mugisha Bwomezi
Kampala, Uganda
http://allafrica.com/stories/200407200500.html

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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2.Africa - the new frontier for the GE industry
By Mariam Mayet
African Centre for Biosafety
This email address is being protected from spambots. You need JavaScript enabled to view it.
http://www.lobbywatch.org/archive2.asp?arcid=4023

The Genetic Engineering (GE) industry is facing a shrinking global market as more and more countries adopt biosafety laws and GE labeling regulations. Moreover, as a result of widespread and mounting consumer rejection and the difficulties experienced by Monsanto in obtaining regulatory approval of its GE wheat, it has decided to pull out of the European cereal market.

Africa and Asia are the new frontiers for exploitation by the agro-chemical, seed and GE corporations. The potential for US agri-business to profit from hunger in Africa through, ostensibly the provision of food aid, technical assistance, capital investment, agricultural research and the funding of biosafety initiatives are enormous.

The United State’s Agency for International Development (USAID) is at the forefront of a US marketing campaign to introduce GE food into the developing world. It has made it clear that it sees its role as having to "integrate biotechnology into local food systems and spread the technology through regions in Africa." [1]Through USAID, in collaboration with the GE industry and several groups involved in GE research in the developed world, the US government is funding various initiatives aimed at biosafety regulation and decision-making in Africa, which if successful, will put in place weak biosafety regulation and oversight procedures.

These biosafety initiatives are designed to harmonise Africa's biosafety laws with those of South Africa's. South Africa's Genetically Modified Organisms Act is a poor example of biosafety regulation.[2] It is in effect, merely a permitting system designed to expedite GM imports into the country and releases into the environment. It specifically mandates that biosafety risk assessment involve no more than a paper audit, which entails a review of the 'safety' information generated by the corporations during product development.

USAID is also investing heavily in funding various GE research projects in a bid to take control of African agricultural research.[3]

Biosafety under threat

The Cartagena Protocol on Biosafety finally came into force, after years of negotiation, on the 11 September 2003. This international binding environmental agreement is specifically designed to protect human health, the environment and biodiversity from the risks posed by GMOs. It was countries from the South, and the African group in particular, that consistently championed biosafety and won the right for importing countries to ban or severely restrict imports of GMOs in the face of scientific uncertainty, based on the precautionary principle, as sanctioned by the Protocol.

To date, 65 countries have ratified the Protocol, with many more ratifications expected before the first Meeting of the Parties to the Protocol takes place February 2004, in Kuala Lumpur, Malaysia[4]. Only 18 countries in Africa have so far ratified the Protocol[5] but many more could be persuaded to do so, in order for them to qualify for one or other of the numerous biosafety capacity building initiatives taking place on the continent.

The hard earned victories won under the Biosafety Protocol are under serious threat from these GE 'biosafety' initiatives. These initiatives are designed to thwart the development of sound biosafety policies and laws. There is an ever present danger that African countries will be overwhelmed by the volley of technical experts they are peppered with by USAID and biotech industry money and expertise, that they will succumb, despite their valid concerns, to these formidable forces.

The fad is the drafting of national biosafety frameworks. The implementation of the Biosafety Protocol has been seized upon and exploited by proponents of GE, as an opportunity to promote and weak and ineffective legal regimes and redirect capacity building in biotechnology rather than biosafety in an attempt to garner much needed support for this dangerous technology.

Influential proponents of GE especially from South Africa have become more sophisticated and better resourced in their promotion of GE in Africa, often citing the following as impediments to the acceptance of GE 'rapid introduction of genetically modified crops, in spite of their potential positive impact on agricultural production and food security. Constraints include a lack of capacity to evaluate risk and make decisions; lack of funding and political will to implement appropriate regulatory processes, concern over the role of multinational companies and the loss of control by Africans over their own resources."[6]

Examples of USAID's Biosafety Initiatives in Africa

USAID through the Association to Strengthen Agricultural Research in East and Central Africa (ASARECA) facilitates collaborative research between those countries in Africa linked to the ASARECA[7], US public and private sectors and international agricultural research centres. The principal aim is to foster regional acceptance of GE through weak biosafety regulations, and thereby promote the technology transfer and private sector investment in GE in Africa.

USAID's Agricultural Biotechnology Support Project (ABSP) has established a partnership with seven Southern African Development Community (SADC) countries-Malawi, Mauritius, Mozambique, Namibia, South Africa, Zambia and Zimbabwe-to similarly provide technical training in biosafety regulatory implementation. Its ostensible goal is to promote conformity with the science- based standards of the World Trade Organisation's Sanitary and Phyotosanitary agreement and the Biosafety Protocol. [8]Needless to say, taking into account the US’s WTO challenge of the European Union’s de facto moratorium on GMOs, that every attempt will be made to ensure that biosafety regulations are consistent with the WTO rules rather than the Biosafety Protocol.

USAID has awarded the Program for Biosafety Systems (PBS), a consortium $14.8 million to assistance developing countries to enhance Biosafety policy, research, and capacity.[9] Included in this list of developing countries are a number of countries in East and West Africa. The International Service for National Agricultural Research (ISNAR) heads the consortium. The consortium is reported as having amongst its goals, the rendering of assistance "to governments in making science-based decisions about the effects on biodiversity of introducing GMOs into the environment" and assisting such countries in regulating and conducting experimental field trials. These goals are preposterous as they are unashamedly aimed at usurping decision-making powers of countries and their sovereign rights to perform regulatory functions.

It is ironic that the US, still not a Party to the Convention on Biological Diversity and cannot therefore ratify the Biosafety Protocol should want to promote biosafety in Africa and the implementation of the Biosafety Protocol.

It is clear that the US and the GE industry are pursuing a well-orchestrated strategy in Africa to lower resistance to GE and gain acceptance of this extremely controversial technology.

Africa's redeeming assets

While on the surface, this picture appears bleak; there is a groundswell of NGOs, consumers, farmers, government officials, parliamentarians and scientists opposing GE in Africa. Benin for example, has imposed a moratorium on the imports and cultivation of GMOs.

Last year, several countries in Southern Africa resisted and seriously questioned the donation by the US through USAID, of GE food aid. Zambia refused to accept the food aid and effectively took a decision to ban the distribution of food aid within its borders. Malawi, Mozambique and Zimbabwe requested that all US imported GE maize be milled prior to distribution in order to prevent its inadvertent use as seed. Lesotho and Swaziland authorized the distribution of non-milled GE aid but not before it warned the public that the grain should be used strictly for consumption and not cultivation. This saga played an important role in heightening the debate within Africa on the health, social, economic and environmental impacts of GE crop.

An offshoot of this is the publication by the SADC Advisory Committee on Biotechnology and Biosafety of their recommendations regarding GE food aid. These are significant because a key recommendation is that donors GE food aid, should comply with Prior Informed Consent principles and the notification requirements of the Biosafety Protocol. This is extremely important, given that the World Food Program has admitted that it has, since 1996 been delivering food aid that included GE food products, without warning the recipient countries.[10]It also calls for the African region to develop harmonized policy and regulatory systems based on the OAU African Model Law on Safety in Biotechnology (Model Law), and the Biosafety Protocol

The Model Law is a set of holistic and stringent biosafety rules drafted by a number of African biosafety experts crafted specifically to protect Africa's biodiversity, environment and the health of its people from the risks posed by GMOs. At the AU Summit held in Maputo during July 2003, the AU pointedly encouraged African countries to use the Model Law as a basis for biosafety regulation.[11] The adoption of the Model Law in Africa will give countries leverage to resist attempts by the powerful GE industry as experimental and dumping grounds for their products. Africa's biodiversity and the health of its people, can only be protected from the risks posed by GMOs if Africa as a whole, subscribes to common and uniform biosafety standards, based on the precautionary principle.

These gems are important contributions towards maximizing Africa's chances to limit the risks posed by GE. It is clear, however, that much has needs to be done.

[1] USAID Announces international Biotech collaboration, US Department of State, June 2002
http:/www.Usinfo.state.gov/topical/glocal/develop/02021202.htm

[2] See further, Mayet, M. August 1999 Critical Review of Exiting Legislative Framework for Genetic Engineering In South Africa Biowatch South Africa. And Mayet, M. February 2000 Srutinising the Legalities of Genetic Modification in South Africa: Food Safety, Public Participation and the Conservation and Sustainable Use of Biological Diversity. Biowatch South Africa. Found at http://www.biowatch.org.za

[3] For instance, USAID funds the African Agricultural Technology Foundation, which is also supported by the Rockerfeller Foundation, OECD, Monsanto, Dow Chemicals, Dupont and Syngenta. Passing of as an 'African initiative' because its headquarters is in Sierra Leone, the role of the AATF is to use poverty and the urgent need for food security strategies in Africa to push for the opening of markets by sharing patents and seeds. However, this initiative is aimed at ensuring the firm control of African research institutions in Africa. Take note also, that because the initial predictions of the GE industry have not materialized, huge amounts of money is now being invested in the so-called 'second generation' of crops. Nigeria based International Institute for Tropical Agriculture and its parent body the Consultative Group for International Agricultural Research (CGIAR) recently announced its "Harvest Plus Plan" to embark on resources for second-generation GE crops (maize, cassava, and sweet potatoes). The Plan has received a cash injection of $US 100 million. These are only but 2 examples.

[4] See further, http://www.biodiv.org/biosafety.aspx?sts_rtf&ord=dt

[5] Ethiopia, Senegal, Kenya, South Africa, Burkina Faso, Nigeria, Ghana, Tanzania, Cameroon, Tunisia, Mozambique, Mali, Botswana, Mauritius, Djibouti, Liberia, Uganda and Lesotho.

[6] Morris, J and Koch, M. Biosafety of genetically modified crops-An African Perspective. AgbiotechNet 2002, Vol. 4 December, ABN 102.

[7] ASERECA supports research in Burundi, Democratic Republic of Congo, Eritrea, Ethiopia, Kenya, Madagascar, Rwanda, Sudan, Tanzania and Uganda.

[8] USAID launches Biotechnology Initiatives with Africa: programs foster improved regulation, research, development. March 2, 3001.
http://www.biotech-info.net/USAID.html

[9] Consortium to support biosafety in developing countries 9 June 2003 http:www. Futureharvest.org/pdf/Biosafety_Final1.pdf

[10] Pearce, F. 'UN is slipping modified food into aid' New Scientist, 19 September 2002.

[11] See further, Mayet, M. Why Africa should adopt the OAU Model Law on Safety in Biotechnology
http://www.biowatch.org.za/oau_modlalw.htm
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3.France accuses US of Aids blackmail
Sarah Boseley in Bangkok
Wednesday July 14, 2004
The Guardian
http://www.guardian.co.uk/international/story/0,3604,1260695,00.html

America was yesterday accused by France of blackmailing developing countries into giving up their right to produce cheap drugs for Aids victims. In a move that may strain already tense relations between the two countries, the French president, Jacques 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?" Mr Chirac wrote in a statement that was read to the International Aids conference in Bangkok yesterday.

Although the president did not name the Bush administration in his attack, French officials later explicitly named the US as being at the heart of the problem.

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."

The US has been pursuing bilateral trade agreements expected to close the loophole allowed by the World Trade Organisation's agreement on drug patents last year. At Doha, it was agreed that poor countries in need of medicines could disregard the 20-year patents on new drugs owned by the multinational drug companies, most of which are based in the US.

The deal, completed at Cancun, lets poor countries buy cheap, generic copies of patented drugs from the makers, in India, Brazil and Thailand. Aids drugs were hugely expensive before such firms made their copies and brought the prices down from $10,000 (GBP5,400) a patient a year to under $300 (GBP162).

According to the World Health Organisation, six million people in poor countries need antiretroviral treatment but only 440,000 are getting it.

On Monday, a report from Oxfam warned that bilateral agreements were set to do great damage to the fight against Aids in Thailand, where the government has so far been able to administer generic versions of Aids drugs made by its own government pharmaceutical organisation (GPO). Thailand has said it intends to export its copies to neighbouring countries.

But the US launched negotiations on a free trade agreement with Thailand on June 30. Other similiar agreements, signed by the US with Singapore, Chile and central American countries, contain stringent intellectual property provisions, said Oxfam. If Thailand is forced down the same road, its government may not be able to license the GPO to make new, cheap Aids drugs as the older ones lose their efficacy.

The agreements already signed extend patent protection beyond 20 years, Oxfam said, and limit a government's ability to allow its own generic companies to make copies of patented drugs and import generic versions.

"Oxfam shares the concerns of Thai NGOs that a free trade agreement with the US, containing unnecessarily high intellectual property standards, will seriously undermine future access to affordable medicines in Thailand," says the report.

Xavier Darcos, the French minister for cooperation and development, said France wanted to see a global agreement on access to medicines and favoured any that allowed "the countries in most need to access drugs, ideally free, or else produce them".

Mr Chirac, in his statement, also called for the US to put more money into the Global Fund for HIV/Aids, Tuberculosis and Malaria. "We should ensure the sustainability of the fund's financing and raise its resources to $3bn a year by sharing this effort among Europe, the United States and all the other donors."

The UN secretary general, Kofi Annan, said he thought that the US contribution of $500m to the global fund should have been $1bn of the $15bn the Bush administration had pledged for Aids projects.

Yesterday the UN said there would be 50 million orphans in sub-Saharan Africa by 2010, of whom 18.4million would have lost one or both parents to Aids. Yet it was a crisis that had been ignored. A report from Unicef, the children's fund, revealed that from 2001 to 2003 the number of children worldwide orphaned by Aids rose from 11.5 million to 15 million. Most of the Aids orphans were in Africa, which has been hardest hit by the pandemic.

* José Manuel Barroso, the president-designate of the European commission, yesterday attacked American "arrogance" but insisted the EU had to keep good relations with the US. The former prime minister of Portugal, who backed the Iraq war, said he admired the nation but he hated "their arrogance, their unilateralism", But it was very much in Europe's interest " to try to have a constructive relationship".
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For more on USAID:
http://www.gmwatch.org/profile1.asp?PrId=165&page=U