[Ip-health] Kenya Pressured To Implement Anti-Counterfeit Law Despite Access Fears

[Sarah Rimmington]

http://www.ip-watch.org/weblog/2009/07/02/kenya-pressured-to-implement-anti=
-counterfeit-law-despite-access-fears/
2 July 2009
Kenya Pressured To Implement Anti-Counterfeit Law Despite Access Fears
By Nicholas Wadhams for Intellectual Property Watch @ 10:18 am

NAIROBI - An influential manufacturers=92 lobbying group in Kenya is
pushing the government to start enforcing an anti-counterfeiting law
within weeks, despite fears from public health advocates that the new
rules will impede access to generic drugs and set an unwanted precedent
in East Africa.

The Kenya Association of Manufacturers says it wants the
Anti-Counterfeit Act to come into force by mid-July and is in talks with
the government to make sure that happens. The law was passed last year
but has not yet taken effect because of budgeting and procedural delays.

KAM and other advocates say counterfeiters peddle fake batteries,
cosmetics, pens and numerous other products - including live-saving
drugs - across Africa, with estimates of counterfeit penetration ranging
up to 40 percent for some items. The association claims that
counterfeits cost companies 50 billion shillings ($650 million) and the
government 19 billion shillings ($250 million) in taxes in 2008.

=94We needed legislation that was to give backing to the fight against
counterfeits,=94 said Joseph Wairuko, who served on KAM=92s
anti-counterfeiting committee. =93All other laws there before were
fragmented and could not support the fight against counterfeits.=94

Yet public health advocates argue that the act=92s definition of what
constitutes a counterfeit product is too vague, and could be used to
block the import and local manufacture of generic drugs. If the law goes
into effect, they say, similar laws under consideration in Uganda and
elsewhere in East Africa could face a smoother ride.

Health Action International (HAI) and other domestic groups fought to
amend the act and scored minor success, but are not satisfied with the
result. They argue that the act=92s language could lump generic drugs -
both those that infringe on patent rights and those that do not - in the
counterfeit category. They say the two issues of counterfeiting and
patent rights must remain separate.

Generics are legal and are not considered counterfeits because they are
not pretending to be a known brand.

=94We basically said, =91If you can assure us that this act will not preven=
t
the seizure of a legitimate shipment of generic medicines, then we=92ll be
more than happy to go ahead, but there=92s no consensus on how to
interpret that definition,=94 said Christa Cepuch, a pharmacist with HAI
Africa. =93Nobody could assure us that it was going to be OK and that
access to generics was not going to be undermined by this act.=94

Officials at HAI and elsewhere fear that pharmaceutical companies which
have backed the passage of the act could use it as a weapon to clamp
down on generic drugs, though they acknowledge not having seen any
evidence of such tactics so far in Kenya.

The Act is so broad that it could, for example, allow a pharmaceutical
company to charge legitimately produced generics as counterfeits in
Kenya even if its patent is not registered there.

=94It means one does not have to have IP rights registered in Kenya for it
to be enforced in Kenya, which is against the whole principle of
territorial application of IP rights,=94 said Peter Munyi, an intellectual
property rights lawyer who works with HAI.

The Kenya Association of Manufacturers says the law is clear. In the
meantime, the association says there has been an uptick in the incidence
of counterfeit products on the Kenya market as illegal importers rush to
get their products on the market before the act goes into effect.

=94There=92s no blockage of generic drugs. These are recognised as not
counterfeits,=94 said Wairuko. =93The law is very clear. Let them consult
first and they can then go and talk about something they know.=94

As the debate continues, the stakes could not be higher. The US
government=92s PEPFAR program and the Global Fund to Fight AIDS,
Tuberculosis and Malaria, import hundreds of millions of dollars in
drugs, almost all of them generic, into Africa each year. Often, those
drugs are the only hope for the continent=92s poor.

Indian companies have been in an uproar about the Kenyan move. In
response to the legislation, the Indian government called a meeting of
African ambassadors to note its concern about Kenya=92s move.

GlaxoSmithKline, which is a member of the Kenya Association of
Manufacturers, says it welcomes the anti-counterfeiting act and
=93supported its development through local trade association activity,=94
Lisa Behrens, director of product communications, said in written
answers to questions from Intellectual Property Watch.

Behrens said she believes the act=92s language does not confuse
counterfeits and generics, and said that =93even illegal,
patent-infringing generics should not be viewed as =91counterfeits.=92=94

=94Clearly generics have a role to play in improving affordability of
medicines to some of the world=92s poorest countries and peoples,=94 Behren=
s
said. =93This is why we have provided 8 voluntary licences for ARVs
[antiretrovirals] to African generic companies. But the main challenge
is less now about the price of medicines but getting products of
appropriate quality to the people who need them. We support the
importation of generics from India, China and elsewhere so long as they
are legal and quality standards are adhered to.=94

While HAI Africa and others acknowledge that the act has yet to slow the
traffic of generics into East Africa, they fear it could set a
precedent. For example, Uganda and Tanzania are both considering bills
with similar language. A policy to harmonise anti-counterfeit laws in
the East African community also is being discussed.

They also say that whether or not pharmaceutical companies are involved,
legally produced generic drugs are being seized in European ports. They
point to several recent cases in which customs agents in Europe have
impounded legitimate antiretrovirals and other drugs destined from Asia
to South America and Africa on suspicion that the drugs violated
European patent rights. In January, for example, a shipment of the
blood-pressure drug losartan headed from India to Brazil. Merck, which
held the patent on the drug, demanded the destruction of the shipment,
according to media reports at the time.

=94The action has exacerbated the concerns of a number of developing
countries that several initiatives to address counterfeit drugs might
have a =91hidden agenda=92 to attack legitimate trade in generics,=94
Frederick Abbott, an international law professor at the Florida State
University College of Law, wrote in an essay published by the
International Centre for Trade and Sustainable Development. =93Once again,
the public legitimacy of the WTO is under attack as a consequence of a
hyper-extended approach to intellectual property law by some of its
developed country members.=94

As the debate continues, public health advocates say the real problem is
substandard medicines - ones that have expired, or were not manufactured
properly - and access to good medicines. Because the Kenyan public
health sector routinely faces drug shortages, people must buy their
drugs in shops, where the incidence of substandard drugs is much higher.

=94We all agree that there is a need to fight counterfeits, but it should
really be done in a way that public health and access to generic quality
drugs is not impaired,=94 said Alexandra Heumber, IP Policy Adviser, MSF
Access to Essential Medicines Campaign.

Nicholas Wadhams may be reached at info@ip-watch.ch.

Categories: Biodiversity/Genetic Resources/Biotech, Developing Country
Policy, Development, Education/ R&D/ Innovation, Enforcement, English,
Features, Human Rights, IP Law, Lobbying, Patent Policy, Public Health

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: +1 (202) 387-8030
Cell: +1 (202) 422-2687
www.essentialaction.org/access/