Kenya Fights To Retain IP Flexibilities For Medicines Imports

By Tove Iren S. Gerhardsen

A second attempt in Kenya to restrict intellectual property flexibilities meant to safeguard access to medicines has most likely been defeated, largely due to opposition from an interagency task force and civil society groups, local sources said.

But although key politicians have indicated that proposed changes to Kenya’s intellectual property law should not be adopted, the final verdict will not be clear until October, when the parliament returns from recess, sources said.

The proposed changes would make it more difficult to import cheaper off-patent medicines into Kenya without the consent of the patent holder, and would put restrictions on the government to issue compulsory licenses on patents to serve the public interest, according to a task force set up by the ministry of health. Task Force conclusions here

This could impact access to medicines and “significantly increase” the cost of many essential medicines, the task force concluded. The changes were seen as restricting Kenya’s flexibilities granted under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

The changes targeted Kenya’s Industrial Property Act, which was adopted in June 2001 and came into force in May 2002. Attempts to change the act were “soundly rejected” by President Daniel arap Moi in August 2002, the task force said (he was replaced by Mwai Kibaki in a December 2002 election after 24 years in power).

The task force said the 2001 IP Act had helped HIV/AIDS patients in Kenya. “Immediately following the IP Act’s enactment in 2002, the first more affordable good quality generic antiretroviral medicines were imported into Kenya – these importations continue today,” it said.

Strong Opposition

In its recommendations to the health ministry, the task force firmly opposed changes to the act:

“Because Kenyans’ lives come before corporate profits, because the proposed amendments threaten Kenya’s treatment programs, because the government should not surrender its right to limit the privileges it has granted when it addresses critical public health issues facing the people it serves, because thousands of Kenyans fought for this law in 2001, and because thousands more are benefiting from it today,” the group said.

But while ministers say that the changes should not be made, the case is not over as the Kenyan Parliament departed for recess on 3 August without taking a final action, and will not reconvene until October, Christa Cepuch of HAI Africa Collaborations, who was a member of the task force, told Intellectual Property Watch.

Cepuch said that on 27 July, Kenyan Justice Minister Martha Karua “announced in parliament these amendments were not in the interests of the government or Kenyans and should be deleted.” Cepuch added: “To those opposing the changes, “that was incredibly good news.”

She said the parliament’s recess means that the IP Act remains in its 2001 form, without the changes, adding that she is not afraid the changes will resurface on the agenda when the parliament resumes its work in October.

“From our contact inside parliament, he pretty much assures us that it can’t really go wrong at this point, after all that has been said and promised. It does seem like it’s just procedure for now, but civil society wishes to remain vigilant, just in case.”

Cepuch emphasised that the opposition has been strong. A civil society coalition issued “massive pressure” through press conferences, briefing papers for MPs and media, the collection of protest signatories and protests outside the parliament, she said.

Also, in addition to the task force’s opposition, the Kenya Industrial Property Institute wrote a position statement to the ministry of health, advising it not to make the changes, she said.

Legal Changes Seen Leading to Limitations

The task force said the 2001 IP Act is fully compliant with the TRIPS agreement, and the task force particularly focused on the TRIPS flexibilities relating to “government use order” (a type of compulsory license, Cepuch said) and parallel importation. In the 2001 Kenya IP Act, parallel importation is referred to as “the import of branded products,” Cepuch said, often from a lower-cost country. The proposed IP changes are found in the Miscellaneous Amendments bill, said Cepuch.

The proposed changes on parallel importation refer to Section 58(2) of the IP Act, related to “exhaustion of rights.” While currently anyone (the patent holder, the license holder or an independent third party) may “parallel import” medicines into Kenya, under the new amendments “medicines would only be imported into Kenya which were put on the market abroad by the patent holder or its licensee: essentially, one foreign company would control the import, stocking and sale of any patented medicine in Kenya,” the task force said.

The task force emphasises that parallel import is not counterfeits, as these are products that have been marketed legitimately in the market of origin and various licenses are needed. It says that this flexibility is provided for in Article 6 of the TRIPS agreement on “exhaustion,” which allows countries flexibilities from the agreement.

The TRIPS agreement, reinforced by the 2001 Doha Declaration, leaves it to national governments to decide for themselves when a patent may be exhausted, such as with parallel imports (IPW, Public Health, 30 April 2006).

The task force also refers to the proposed changes of Section 80(1A)(1B)(1C) of the Kenyan act, relating to Article 31 of the TRIPS agreement (“Other use without authorization of the right holder.”) On 6 December 2005, amendments were made to this TRIPS paragraph, allowing countries to export medicines under compulsory license to countries without adequate production facilities (IPW, Public Health, 6 December 2005).

The task force said that under the proposed changes, the “government would be required to negotiate with a patent holder, even in cases when they have abused their rights,” and its ability to address serious shortages of medicine supply emergencies would be “unnecessarily limited,” it concluded.

Tove Iren S. Gerhardsen may be reached at tgerhardsen@ip-watch.ch.