Bill May Provide A Solution to the Growing Pandemic

The new Bill might offer a solution to the Aids pandemic ravaging the country. The Kenya Industrial Property Bill, 2000, soon to be tabled in Parliament, may pave the way for local industries to manufacture cheap Aids drugs with a provision on compulsory licensing, and allow importation of medicines from countries where they are cheaper.

"It would also enable the Government to act in the public interest in case of an emergency, which the HIV/Aids pandemic clearly is," said Dr Chris Ouma, the National Aids Programme Coordinator for Action Aid.

The Bill, however, requires some amendments, especially in relation to essential drugs.

These are mainly being pushed for by the Medicins Sans Frontieres- led Kenya Access to Essential Medicines Coalition.

Medicins Sans Frontieres is the organisation spearheading a campaign for easy access to essential medicines worldwide.

Dr Ouma said there are many factors that affect access to medicines.

These include quality of diagnosis, accurate prescription, selection, distribution and dispensing of medicines.

"But one of the most significant barriers to access is the price of drugs," he explained.

Most essential drugs are manufactured by multinational pharmaceutical companies, and many of the drugs are patented under intellectual property law against exploitation until the patent expires.

This gives the companies a monopoly and ensures high prices.

In Kenya, for instance, only two per cent of the population can afford the high cost of the drugs.

It is this situation that the coalition seeks to address through amendments to the Bill.

It has analysed the Bill and come up with a document offering suggestions to the Kenya Industrial Property Office (Kipo), the government body concerned with incorporating the amendments.

The head of Kipo, Dr Nora Olembo, said the organisation is open to suggestions that can be incorporated into the Bill before it is tabled in Parliament.

Kipo has been looking into intellectual property law so that it conforms with requirements under the World Trade Organisation Agreement on Trade Related Intellectual Property Rights (Trips), which form the basis of the amendments to the Bill.

"As a member of the World Trade Organisation," explained Mr. Robert Lettington, of the coalition and an expert in intellectual property law, "Kenya is obligated to amend her intellectual property legislation by writing Trips’ safeguard provisions into its national laws."

According to the Trips Agreement, the country is obliged to grant a 20-year patent protection for drugs.

This minimum standard should have been enshrined in the national laws by next January.

Prior to this, the country’s patent law, under the Industrial Property Act of 1989, was connected to patents granted in the United Kingdom.

They were granted for seven years from the filing date as opposed to 20 years.

Thus the Trips safeguard provisions, with their extended patent protection, may neutralise the negative consequences of granting monopoly rights.

The first of these safeguard provisions is compulsory licensing under Trips’ Article 31.

According to this article, WTO members may allow the use of a patent by a third party, say, a local manufacturer, without the owner’s consent.

Although the Trips Agreement does not limit the grounds that may justify the granting of compulsory licences, the 2000 Bill seems to considerably restrict these grounds as compared to the 1989 Act.

"It strengthens the rights of patent owners at the expense of the public interest," says Mr. Lettington.

Compulsory licences are usually included to ensure that patent owners make good use of their rights.

The second critical safeguard is parallel imports under Trips Article 6, which is based on the principle of exhaustion of rights.

When enshrined in law, parallel imports allow countries to import products from countries where they are sold by the patent holder or licensee at lower prices without the manufacturer’s permission.

National laws should include Bolar Provisions - they allow generic manufacturers to begin preparing production and completing regulatory procedures before patents expire so that upon expiration they can immediately begin selling their products.

This provision allows for local research and it also means less expensive generic products can be available much more rapidly after patents expire. The coalition has suggested some amendments to ease access to the patented products.

An important amendment to be incorporated in the Bill is the banning of the patenting of new uses for existing products. For instance, if a patent expires, companies are known to patent the same product again and use it for something else, thus prolonging their patent ownership.

Another crucial incorporation regards government use. This will guarantee that the Government will have the right to make use of any protected intellectual property to address critical problems, or in instances where the holder of a monopoly privilege is found to be abusing it.

While this remains to be seen, there is a certain assurance that this may not come to be. In May this year, to the annoyance of the pharmaceutical companies, the Clinton adminstration issued an executive order saying that the government would not interfere with African countries that violated American patent laws to obtain cheaper AIDS drugs.

Pandemic costs its economy £1.8m a day

James Astill in Nairobi Tuesday November 7, 2000

A proposal by the world’s leading pharmaceutical companies to slash the cost of Aids drugs in Kenya is "cynical and hypocritical", the chairman of the country’s Aids control council said yesterday.

Even if the cost of HIV and Aids drugs was reduced by up to 85%, as the "big five" companies - including Britain’s Glaxo Wellcome - were suggesting, it would only bring prices down to European levels, and would make almost no difference to the number of people able to afford treatment, said Dr Mohammed Abdullah, after meeting representatives of the companies in Nairobi.

Earlier this week the Kenyan minister of state, Marsden Madoka, estimated that the Aids pandemic was costing Kenya’s barely solvent econ omy more than £1.8m a day in medical care, lost labour and funeral expenses. In less than five years the figure would be almost £17.5m a day, he said.

Given that Aids drugs made up a only tiny fraction of those costs, the proposed price reduction could not touch the problem, Dr Abdullah said.

"If the international mafia - the drug companies - really mean business, they should waive their patent rights and let developing countries make the drugs themselves under their supervision. Kenya already has the capacity to make most of these drugs. It is the big five who are stopping us."

In the west, anti-retroviral drugs have delayed the development of full-blown Aids by up to 10 years, turning a killer disease into a chronic illness. But in sub-Saharan Africa, where 90% of the infected people live, they are out of reach and unknown to the vast majority.

Government figures show that up to 25% of Kenyans are HIV positive, but only 2% can afford the recommended cocktail of anti-retroviral medicines.

At about 432,000 Kenyan shillings (£3,800) for a year’s course, the cost of treating all the infected Kenyans would exceed the national budget.

"Instead, our people are left to succumb to what doctors in Kenya have become adept at doing : simply managing their decline and death," Dr Chris Ouma of the charity Action Aid said.

"The ministry of health cannot provide the most basic medicines," Dr Abdullah said. "It cannot treat malaria, it cannot treat diarrhoea, and it will never be able to treat Aids at any western price."

The World Trade Organisation (WTO), which draws more than three-quarters of its members from the developing world, sets the patent controls that have, in part, maintained current price levels.

In January Kenya must agree to extend its patent protection from the seven years stipulated in British colonial law to the WTO’s 20 years, sealing the western pharmaceutical companies exclusive rights to anti-retroviral treatments for several generations of Aids patients.

Dr Sophie-Marie Scouflaire, head of the Access to Essential Medicines campaign for Médecins sans Frontières (MSF), agreed that price cuts were not the answer.

"Price reductions are just a tool of the multinationals to try to stop Africa producing its own drugs," she said.

"We want to see patent law change entirely, to see all drugs produced locally or imported from cheaper producers, currently outside patent law. A Kenyan drug company has offered to start making anti-retrovirals for us for free, but our hands are tied by the WTO."

MSF estimates that an annual course of anti-retrovirals could be produced in Brazil or Thailand for $200 (£140).

"Extraordinary means call for extraordinary measures," Dr Abdullah said. "We must [re-examine] the whole patenting issue. If the disease continues unchecked it will be like exploding a neutron bomb in our country. There will be buildings but there will be no human beings."