E-DRUG: The Kenya Anti-Counterfeit Bill, 2008 - a threat to Access to Essential Medicines
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Health Action International (HAI) Africa and the Kenya Treatment Access
Movement (KETAM) have recently hosted two briefing sessions on the how the
Anti-Counterfeit Bill will affect access to medicines in Kenya if it is
passed in its current draft form. The first briefing targeted the local and
international media fraternity, while the second briefing brought together
members of parliament, government officials from the health and trade
ministries, civil society organizations, the national consumer's rights
group, and other local stakeholders. Given the ongoing debate surrounding
the ACTA negotiations, there has also been significant international
interest in the outcomes of the draft Kenyan Bill.
Kenya has recently increased its efforts to crack down on substandard goods
entering the local market. Last year, Kenya's first-ever Anti-Counterfeit
Bill was published but lapsed in Parliament. The Bill was republished on 01 July 2008 as the "Anti-Counterfeit Bill, 2008" (see
www.tradeandindustry.go.ke/documents/Anti-Counterfeit_Bill_2008.pdf ).
While this Bill has some important strategies to combat the general
availability of counterfeit goods in Kenya, it contains various ambiguities
which, if misinterpreted or abused, will be detrimental to the government's
ongoing effort to ensure access to medicines for all Kenyans.
The general areas of concern in the draft Bill include the following:
* The Bill does not distinguish medicines from other goods. Medicines are
essential and lifesaving and should be distinguished from non-essential
goods such as DVDs, batteries, pens, etc.
* The area of intellectual property rights (IPRs) (including patents,
trademarks, copyright, and data protection) is clearly distinct from
quality control issues when related to medicines. The Bill in its current
form confuses these issues to such an extent that "interested parties" may
take advantage and misinterpret generic medicines as counterfeits.
* The Bill contravenes some sections of existing legislation, most notably
the Industrial Property Act, 2001 (the IP Act), including sections 54(2) on
early working exception, 58(2) providing for parallel importation, and 80 on government use. These sections have played an important role in the struggle to increase access to essential medicines in Kenya.
* Many proposed provisions within the Bill are "TRIPS-plus" in the sense
that they go beyond the commitments required under the World Trade
Organization (WTO) Agreement on Trade-related Aspects of IPRs (TRIPS).
TRIPS-plus measures in national laws are known to hinder access to essential medicines.
* The Bill gives excessive power to the Kenya Revenue Authority (KRA) to
address counterfeits and does not seek to strengthen the national medicines
regulatory authority (the Pharmacy and Poisons Board or PPB) to fulfill its
mandate of fighting counterfeit medicines in Kenya.
To address the Bill's weaknesses and overall threat to access to medicines
for Kenyans, the following actions are recommended:
* MPs must amend the Anti-Counterfeit Bill, 2008 to protect the public
interest in health. ('Counterfeiting' and 'counterfeit goods' must be
re-defined and the WHO definition of counterfeit medicines
(http://www.who.int/medicines/services/counterfeit/overview/en/) must be
included to distinguish medicines from non-essential goods. The current
text granting excessive / irrelevant power to the Kenya Revenue Authority
must be amended. The Anti-Counterfeit Bill must be harmonized with the IP
Act, 2001.)
* The PPB must be acknowledged and supported in fulfilling its mandate to
fight counterfeit medicines.
HAI Africa and its network partners in Kenya will continue to advocate that
public health takes precedence over commercial interests in the development
and implementation of national legislation and relevant policy. More
information on HAI Africa's activities on Kenya's Anti-Counterfeit Bill,
2008 may be obtained from info@haiafrica.org
Stella Etemesi
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Health Action International (HAI) Africa
mailto: info@haiafrica.org
Website: http://www.haiafrica.org
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Health Action International (HAI) Africa is a growing regional network of
Civil Society Organizations, Non-governmental Organisation, healthcare
providers, academics and individuals in Sub Saharan Africa who are focussed
on promoting policies and practices that increase people's access to quality essential medicines that are correctly prescribed and appropriately used. HAI Africa has contacts in 30 African countries and is part of the global HAI network.