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
Health Action International (HAI) Africa
mailto: info@haiafrica.org
Website: http://www.haiafrica.org