THE SELFISH INTERPRETATION OF THE CONVENTION ON BIOLOGICAL BIODIVERSITY BY THE UNIVERSITY OF LAUSANNE, SWITZERLAND
Community Technology and Development Association (CTDA), Zimbabwe
Zimbabwe National Traditional Healers Association (ZINATHA)
Berne Declaration, Switzerland

NGOs in Zimbabwe and Switzerland condemn the way by which the University of Lausanne gained access to genetic resources in Zimbabwe and the way the benefit sharing has been negotiated. They also reject the patent on antimicrobial diterpenes which Prof. Hostettmann of Lausanne University took out on these resources and which is based on traditional knowledge. This case is another example of how current bioprospecting in southern countries contradicts the rules defined by the Convention on Biological Diversity (CBD). "While the Swiss government supports guidelines for Access and Benefit Sharing at the CBD, a Swiss University is engaged in illegal bioprospecting activities in Zimbabwe", says François Meienberg of the Swiss NGO Berne Declaration.

On July 27, 1999, US-patent 5'929'124 on antimicrobial diterpenes was granted to Kurt Hostettmann, professor at the University of Lausanne.The patented invention relies on traditional knowledge from Zimbabwe and on the root of the tree "Swartzia madagascariensis" that can be found throughout tropical Africa. Two years before, in April 1997, an addendum to a material transfer and confidentiality agreement between the American pharmaceutical company Phytera and the University of Lausanne was signed, under which Phytera received an option for an exclusive worldwide license and in return agreed to pay royalties of 1.5% on the net sales of any product marketed under this license.Professor Hostettmann, on the other hand, is obliged to give 50% of any royalties received to the National Herbarium and the Botanical Garden of Zimbawe and to the Department of Pharmacy at the University of Zimbabwe.

The aforementioned NGOs criticize the following aspects of this deal:

· Neither the state of Zimbabwe, nor the traditional healers affected by the bioprospecting have been correctly informed or have given their prior informed consent for the search of genetic resources in Zimbabwe. The Convention on Biological Diversity, signed by Zimbabwe and Switzerland, states that "access to genetic resources shall be subject to prior informed consent (pic) of the contracting party providing such resources …". In Zimbabwe the mandate and the authority to allow access to genetic resources lies with the Ministry of Environment. But the Ministry never signed a contract with the Universitiy of Lausanne, nor is there any contract which shifts the mandate from the Ministry to the University of Zimbabwe, which helped the University of Lausanne to get access to the resources. The African Model legislation for the regulation of access to biological resources states that the pic of the state and the concerned local communities is needed. Part of the information requested for the pic should be the economic, social, technical, biotechnological, scientific, environmental, or any other benefits that are intended or may be likely to accrue and the proposed mechanisms and arrangements for benefit sharing.

· The concerned stakeholders (traditional healers, local communities, the state of Zimbabwe) were not given any of this information before the University of Lausanne gained access to genetic resources and traditional knowledge. "We have never given our consent to this deal", states Prof. G. Chavunduka of the Zimbabwe National Traditional Healers Association (ZINATHA) which had submitted a number of samples of their medicines to the University of Zimbabwe for analysis. "The idea was just to confirm the properties of this medicine which traditional healers have been using for time immemorial."

There have been no mutually agreed terms for a fair and equitable benefit sharing mechanism. An agreement signed between the University of Zimbabwe and the University of Lausanne stipulates that in the event of finding any product which may require the application of intellectual property rights, this will be subject of joint negotiation and application. Contrary to Article (F) of this agreement, as the Chairperson of the Pharmacy Department indicated, the University of Zimbabwe did not take part in the negotiation process between the University of Lausanne and Phytera. No one has consulted stakeholders in Zimbabwe on whether they agree with the amount of royalties they are to receive. Indeed, the amount negotiated between the University of Lausanne and Phytera is very low compared to other benefit sharing agreements. The average range of royalties on net sales for materials with value added data such as ethnobotanical information is 1-4% (tenKate/Laird 1999), including exceptional cases of up to 50% (in a contract between the Swiss Federal Institute of Technology and Venezuela). In the case of "Swartzia madagascariensis", moreover, a low benefit sharing percentage must be shared with an intermediary, the University of Lausanne.

A patent taken out on illegally accessed genetic resources should be declared invalid. However, as patent offices do not consider the origin of patented materials, the current patent regime in fact supports biopiracy. NGOs also request further analysis of whether Professor Hofstettmann's 'invention' actually fulfills the requirements for a patent (e.g. novelty), or if it is largely based on illegally acquired traditional knowledge. "In this case, the involved NGOs are willing to fight the patent at the US patent and trademark office" states Andrew Mushita of the Community Technology and Development Association (CTDA) in Zimbabwe. A documentary telecast by Swiss television in June indicates that other bioprospecting projects of Prof. Hostettmann (e.g. the search for a natural "Viagra" medicine on behalf of the Swiss pharma giant Novartis) have also been carried out in violation of the CBD. Phytera already made headlines in 1996, when - in an attempt to circumvent the Biodiversity Convention - they proposed plant sampling contracts to botanical gardens in the North without any provision for benefit-sharing with the countries of origin. Several botanical gardens in Germany rejected such contracts. Swiss and Zimbabwean NGOs demand that in the case at hand an access and benefit sharing agreement be negotiated that fulfills the objectives of the Biodiversity Convention and involves all the main stakeholders in Zimbabwe. The NGOs also demand that the contract between the University of Lausanne and Phytera be cancelled and the patent withdrawn.

Berne Declaration together with Community Technology Development Trust (CTDT) of Zimbabwe have since initiated a meeting for concerned stakeholders on 16 March 2001, at the University of Zimbabwe. Attending the meeting were the University of Zimbabwe, the Ministry of Tourism and Environment, the University of Lausanne and the Zimbabwe Traditional Healers Association (Zinatha) - See Berne Declaration Press Release of 28 February 2001.

In the referred press release, CTDT and Berne Declaration demand that the current research agreement between the universities concerning the open access to medicinal and poisonous plants of Zimbabwe be suspended with immediate effect for the following reasons:
a) The government is not party to this agreement as required by the Convention of Biological Diversity (CBD). The representative of the Ministry of Environment and Tourism confirmed at the meeting, that they are the only legal authority to grant access to any Zimbabwean biological resources.
b) The benefit sharing mechanisms and frameworks of the agreement are not consistent with common practice. For example, there are no provisions for a future benefit-sharing agreement if a product is commercialized.
c) Under the current agreement only the University of Zimbabwe is a beneficiary, thus marginalizing other stakeholders such as traditional healers and the government.
d) The current agreement has no mechanism to acknowledge and compensate the use of traditional knowledge systems.
e) It seems that access to medicinal plants was granted to the University of Lausanne at less than a fair value. CTDT and Berne Declaration call upon the Ministry of Environment and Tourism of Zimbabwe to take the initiative and a leading role in defining a model agreement for access and benefit sharing. Such an agreement involving all relevant stakeholders should contain provisions for prior informed consent, mutually agreed terms and benefit sharing mechanisms. To avoid shortcomings and loopholes, the new agreement should be accessible for comments by civil society.

As the terms of access to the genetic resources of Zimbabwe are renegotiated, the University of Lausanne is given an opportunity to prove its good will by supporting a fair contract. Hopefully, they will not miss it. .Ì

For further information:
Andrew Mushita: CTDA, Tel: 00263 4 30 31 60; email: tactdtms@harare.iafrica.com
François Meienberg: Erklärung von Bern, Tel : 0041 1 277 70 04; email : food@evb.ch
Prof. G. Chavunduka: ZINATHA, Tel: +263-4-77 28 80 or +263-4-75 19 02

YES, DRUGS FOR THE POOR - AND PATENTS AS WELL
Mike Moore*
(Extracted from the International Herald Tribune of Thursday, February 22, 2001)

GENEVA Every year malaria, tuberculosis and AIDS kill around 6 million people, almost all of them in the developing world. These premature deaths are a reproach to us all. They are also a huge blow to countries' hopes for development. Urgently, more needs to be done to save the lives of millions of poor people.

Part of the problem is poor countries' lack of access to drugs. The poor cannot afford expensive medicines. Keeping an AIDS patient alive for a year can cost up to $15,000 - 24 times the average annual income in Zimbabwe, where one in four adults is HIV-positive.

Critics of the World Trade Organization say its agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) makes matters worse. They argue that by requiring developing countries to enforce pharmaceutical patents, the agreement enables drug companies to charge exorbitant prices that the poor cannot afford.

Clearly, we need to find new ways of improving access to existing drugs in developing countries. But we also need to give pharmaceutical companies an incentive to develop new drugs. Industry puts the average cost of developing a new drug at around $500 million. Were it not for a patent system that rewards companies for risking millions on research, anti-AIDS drugs would not exist.

That is why the TRIPS agreement tries to strike a healthy balance between the short-term need to make vital drugs available to those who need them and the long-term, equally vital need to encourage research into new drugs. To reward research, the agreement protects patents for 20 years (although, since it usually takes years to test and approve new drugs, a patent's effective life is much shorter). To improve access to drugs, it imposes some conditions and allows certain restrictions on patent rights.

For one thing, patent holders have to disclose their invention. This allows others to use information about a patented drug to research new drugs during the patent's life, and ensures that it is truly in the public domain once the patent expires. Second, if a patent holder refuses to license a patented drug on reasonable commercial terms, a government is allowed to license it to other companies or use it itself without the patent holder's authorization, so long as adequate compensation is paid.

Third, as a recent WTO panel has concluded, governments can facilitate the "early working" of patented pharmaceuticals by generic competitors. Fourth, if governments authorize parallel imports of a patented drug from countries where it is sold more cheaply, this cannot be challenged at the WTO.

Developing countries have generally had to enforce the TRIPS agreement since Jan. 1, 2000, when a five-year transition period ended, but those which do not already provide patent protection for pharmaceuticals have until 2005 to introduce it. The transition period for least-developed countries ends in 2006 (with the possibility of an extension).

But most developing and least-developed countries already grant patent protection for pharmaceuticals. For them, the real significance of the TRIPS agreement may be less the requirement to protect new drugs and more the explicit enshrining in international law of the flexibility I have described.

One promising idea is differential pricing; pharmaceutical companies would charge less for drugs in poor countries than in rich ones. This is consistent with the TRIPS agreement and is backed by, among others, the World Health Organization, the European Commission, Médecins sans Frontières and some industrialists. It is already starting to happen. The WTO and WHO secretariats are organizing a workshop to explore how it could become more widespread. Important issues are how to prevent low-priced drugs from leaking back from poor countries to rich ones and how to convince rich-country consumers and taxpayers of the fairness of lower prices in poor countries. Of the 300-odd drugs deemed essential by the WHO for basic health care in developing countries, fewer than 20 are under patent protection anywhere.

There are no effective treatments for some ills that affect people in poor countries only, because developing them is not commercially viable. Only 10 percent of global research funds target diseases that affect the poorest 90 percent of the world's population. Donors urgently need to stump up funds to finance research, for instance, into vaccines against malaria and AIDS.

Funds are also needed to ensure that companies have a credible market for new drugs and vaccines that they develop for such diseases, as well as to help pay for existing essential drugs, insecticides and anti-malaria bed nets.

Nor should providing the basics, such as clean water, good sanitation, better nutrition and more condom use, be neglected. Lower tariffs and taxes and more efficient distribution channels are also important.

Most of this is outside the WTO's remit. But by promoting free trade we can make a difference. Openness is essential for economic growth, which can help pay for better health care and sanitation.

*The writer is director-general of the World Trade Organization. He contributed this comment to the International Herald Tribune.Ì

A HARSH CAMPAIGN TO PREVENT AFFORDABLE AIDS TREATMENT
Kevin Watkins*
(Extracted from the International Herald Tribune of Monday, February 12, 2001)

OXFORD, England Welcome to the new drug war. Not the one being fought against cocaine barons in the jungles of Latin America but the one being waged by the American government and the global pharmaceutical industry against the world's poor.

The question at the heart of the conflict is whether world trade rules should be used to defend at all costs the drug patents and associated exclusive marketing rights of powerful companies, or whether governments should retain the right to put affordable medicine before corporate profit.

Next month a new front in the war will be opened in a South African court. Some 40 drug companies, including corporate giants such as GlaxoSmithKline and Bayer, are contesting a 1997 law which allows the government to import cheap drugs, thereby bypassing the monopoly granted to patent holders.**

The principal defendant, and architect of the law in question, is Nelson Mandela. His crime: insisting on his country's right to purchase anti-AIDS drugs at the lowest possible price in order to maximize treatment for the country's 4 million sufferers.

South Africa is not alone. Four years ago Brazil waived patent rights on HIV/AIDS drugs, allowing local companies to produce cheap versions. Prices fell by more than 80 percent. Today almost every Brazilian AIDS patient gets free of charge the same triple therapy cocktail that has improved survival prospects in the United States. The HIV/AIDS death rate has been halved, and the savings to the health budget are estimated at $400 million.

Good news for public health? Maybe, but Brazil has just been put in the dock at the World Trade Organization, courtesy of the United States.

At stake is a public health law that allows the Brazilian government to insist that patent holders either produce drugs locally at a controlled price or allow a local manufacturer to do the same. To U.S. trade negotiators, this represents a violation of intellectual property rights. In the eyes of Brazilian public health groups, the U.S. actions amount to a gross violation of the right to health.

So far, recourse to the WTO has been the exception rather than the rule. This is partly because the United States has a far more potent weapon in its arsenal: namely, the threat of trade sanctions under the "Special 301" trade law provision. Sixteen countries - including India, Egypt, the Dominican Republic and Thailand - have been invited to strengthen patent protection. The poor in those countries will face the consequences. In the case of the Dominican Republic, these will include withdrawal of trade preferences for textile exports, an outcome that could cost 200,000 jobs.

In effect, developing countries are negotiating on pharmaceutical patents with a loaded gun pointed at their heads.

The legal issues vary, but there are three common themes in these Special 301 cases. First, they have all been initiated by the U.S. trade representative after complaints from Pharmaceutical Research and Manufacturers of America.

Second, they have been directed at countries with strong generic drugs industries, capable of producing low-cost copies of patented drugs.

Third, the aim is to overturn national legislation allowing governments to give priority to affordable medicine for the poor over the patent rights of drugs companies.

All of which raises some disturbing questions about world trade rules and public health.

Ultimately, patents are a contract between inventors and the rest of society. Inventors are rewarded for the commercial risk they take with a temporary monopoly, lasting 20 years under WTO rules, during which they have the right to sell their inventions at whatever price they choose. Governments have to balance potential conflicts between the public good and private monopoly.

The wrong balance is being struck. This year 11 million people in developing countries will die from preventable infectious diseases, many of them because they are unable to afford basic medicines. More stringent patent protection threatens to make such medicines even less affordable.

The facts speak for themselves. Companies in Brazil and Thailand are able to market a version of the drug fluconazole, used in the treatment of meningitis, at annual treatment prices of $100, compared to $3,000 for the patented product price. In India, companies market ciprofloxacin, an anti-infective drug used in the treatment of bloody diarrhea, at one eighth of the price charged in Pakistan, where only the patented version is available.

In theory, the WTO agreement allows for public health safeguards, but these are being progressively eroded through the combined efforts of Washington and the pharmaceutical industry. It is bad enough that the world's most powerful industrial lobby has adopted such harsh standards. Far worse is the willingness of the U.S. government to back such demands with gunboat trade diplomacy recalling 19th century Britain.

Pharmaceutical companies maintain that the way to deal with the public health threat posed by patents is through philanthropic price discounts, negotiated on a product-by product and country-by-country basis. But while philanthropy has a positive role to play, this is too limited a response.

What is needed is a fundamental reform of the WTO intellectual property rules, starting with a reduction in the period of patent protection, reinforced health safeguards and a comprehensive ban on the threatened use of trade sanctions. .Ì

(*The writer, senior policy adviser at Oxfam, contributed this comment to the International Herald Tribune.)

**The case has taken three years to be heard

Produced by the International South Group Network (ISGN) Director and Editor: Y. Tandon; Advisor on SEATINI: B. L. Das
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