[Pharm-policy] Kenya: Bill May Provide A Solution to the Growing

[James Love]

This story quotes Dr. Chris Ouma, refers to MSF, and describes in some
detail the proposed new Kenya patent legislation that would expand
access to medicines, with compulsory licensing, parallel imports and the
bolar provision.  Given the signficance of this effort, I am forwarding
the entire story from the Nation, in Nairobi.  Jamie

http://allafrica.com/stories/200011010121.html


Bill May Provide A Solution to the Growing
Pandemic

The Nation (Nairobi)
November 1, 2000 

Nairobi 

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.