E-DRUG: Kenya's Anti-Counterfeit Bill, 2008
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Dear all,
The Anti-Counterfeit Bill, 2008 may be read in Kenya's Parliament later this week. As noted in a previous posting, the Bill (a) confounds issues of counterfeiting with patent infringement and (b) proposes to establish a
new "Anti-Counterfeiting Agency" and to give excessive power to the Kenya
Revenue Authority, thereby undermining the Pharmacy and Poisons Board
(Kenya's national medicines regulatory agency) in their mandate to combat
counterfeit medicines.
The civil society prepared and submitted textual amendments to the Bill
which would help to protect the public interest and access to medicines.
This Bill has featured frequently in the media and the latest article is
pasted below for your interest. We continue to follow the proceedings and
will share the outcome.
Of note, there is a similar Bill under discussion in Uganda, and apparently
in Tanzania too.
With kind regards
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Peter Munyi, Christa Cepuch
Health Action International (HAI) Africa
www.haiafrica.org
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http://www.nation.co.ke/News/-/1056/483956/-/view/printVersion/-/g2nqey/-/index.html
Ministry moves to protect local firms By Owino Opondo
Posted Saturday, October 25 2008 at 21:28
Kenya is in the midst of hard times, and all sectors of the economy are
balancing fickle books of accounts.
This is why I cast my lot with members of the Kenya Association of
Manufacturers when they warned of the imminent collapse of their businesses
due to unfair competition from cheaper but untested imported goods that have flooded the market.
Three things concern me here. The first is that most institutions tasked to
test local and imported goods are either suffering from selective inertia or have collapsed altogether. Either way, it is unacceptable.
Secondly, you only have to visit small kiosks, open-air markets and retail
stores to witness all forms of cheaper, sub-standard goods like detergents,
toys, clothes and foods that have forced locally produced alternatives into
warped price wars.
Finally, Kenya's high tax levels have made doing business here an uphill
task. As usual, manufacturers pass that burden to consumers, resulting in
prohibitive prices.
These three reasons explain why locally made goods are more expensive than
their imported alternatives. And this is happening at a time when low and
medium income earners are suffering the pain of runaway inflation.
*Big commerce*
In my view, the government left the consumer at the mercy of big commerce
and the vagaries of the concomitant forces of demand and supply when it
embraced the so-called free market economy over two decades ago. This
arrangement, however, is in most parts of the world.
However, we must urgently find a way of delicately balancing benchmarks that enable local business to thrive through quality and fairly-priced goods.
For this, I toast the ministry of Industrialisation for publishing the
Anti-Counterfeit Bill, 2008. Parliament will this week begin discussing the
proposed law.
The Bill aims at prohibiting trade and all manner of dealings in counterfeit goods. This it seeks to achieve through the proposed Anti-Counterfeit Authority (ACA), with far reaching-powers to check the quality of goods and penalise producers of copy-cat and fake ones.
These are good intentions, for they would address a number of concerns
rightfully raised by local manufacturers. This is only achievable if the
suggested ACA does not suffer the influenza of shoddy performance like most
existing similar entities.
*To injure*
However, the Bill contains some provisions that are likely going to injure – if not to throw into total confusion – the provision of essential medicines to the public.
I support the line of caution and free advice the House departmental
committee on Health has so far got from the civil society groups, including
the Health Action International Africa (HAI) and Kenya Treatment Access
Movement (KETAM).
For example, the Bill does not distinguish medicines from other
non-essential goods such as pens, shoes, cups, clothes and many others.
This is a definition lacuna likely to be exploited by big and influential
multinational pharmaceutical companies to block manufacturing of cheaper,
yet equally effective, generic medicines.
Big transnational pharmaceutical companies have for long peddled twisted
wisdom to the effect that because they spend a lot of money on research
before coming up with "original" medicines, they should be allowed to reap
full benefits.
*Twisted wisdom*
Kenya is a member of the World Health Organisation (WHO), which roots for
essential medicines with regard to public health relevance, based on
efficacy, safety, and comparative cost-effectiveness.
Surely, you cannot make expensive drugs readily available to society's
majority.
Studies show that a large number of low-income earners in Kenya quietly
suffer – and indeed die – from treatable diseases in the privacy of their
homes because they could not afford medicine. It is getting worse by the
day.
The Anti-Counterfeit Bill, 2008 is also in conflict with provisions of the
Industrial Property (IP) Act, 2001 on conditions under which patents can be
breached by other parties.
The proposed law gives sweeping definitions of counterfeiting and suggests
all-applying penalties without taking into account special circumstances
under which patents could be exploited for public good such as when there is a disease outbreak.
The IP Act, among other things, allows the government or its authorised
appointee to exploit a patent in the interest of the public regarding
health, nutrition, national security, environment and development.
It is this section that allows third parties to import or manufacture
patented items without permission from the patent holder as long as the
minister gives notice of intention.
*The benefits*
Indeed, Kenyans began enjoying the benefits of cheaper life-prolonging drugs for HIV/Aids patients and other essential medicines in 2002 when the IP Act took effect.
Generics cost 20 to 80 per cent less than innovator brand equivalents.
And despite past government attempts to tinker with the IP Act in ways that
betrayed official intention to deny the public access to affordable
medicines, Parliament is yet to accept amendments to this law.
The Anti-Counterfeit Bill is an important and timely law, but MPs should
exclude essential medicines from its provisions.
*Owino Opondo is Nation's parliamentary editor. *