Legislation changed on generic HIV/AIDS drugs imports

Parliament has reversed an amendment to the Industrial Property Act curbing imports of generic HIV/AIDS drugs, the Kenya Coalition for Access to Essential Medicines (KCAEM) announced on Thursday.

"This is great news for all Kenyans," said Liza Kimbo, a member of the KCAEM. "We hope that this means that soon cheaper anti-retroviral drugs [ARVs] of the same quality and a wider choice will be available, so that many more people living with AIDS will have access to them," she added.

The amendment means that the price of generic ARVs - available from countries such as India and Brazil, as opposed to international pharmaceutical companies - will be halved, down to 3,000 Kenyan shillings per month (less than US $40, including distribution).

However, activists agree that even at this price many Kenyans will remain unable to afford the drugs.

"It's a progressive thing. They used to cost US $1,000 per month, now they cost about US $100, and we are pushing to get them for US $25," said Kimbo.

The United Nations estimates that 700 people die of HIV/AIDS and related illnesses in Kenya each day, and that at present only 6,000 people have access to ARVs.

Unknown to the KCAEM, the re-amendment was tagged to a Trade Marks Amendment Bill on 8 August, which is now awaiting presidential assent. "We were quite surprised when we found out. Last week it looked unlikely that it would be finalised by the end of the week," Medecins Sans Frontieres (MSF) spokesman, Wyger Wentholt told PlusNews on Friday.

"We couldn't be sure of the facts until this week, until our legal advisers had looked at the amendment, and made sure that this is what we have been fighting for," he added.

While the KCAEM welcomed the amendment, it added that other barriers remained to obstruct the widespread import and use of ARVs. Most generic medicines awaited registration by the Kenyan regulatory authority, the Pharmacy and Poisons Board, even though manufacturers had applied for registration a long time ago, dating back to 1999, the KCAEM reported.

"Registration is not handled with the speed and urgency that you would imagine, considering the numbers of people dying each day," said Wentholt.

Only three generic ARVs had been approved for use in Kenya by the Board, the KCAEM said.

Meanwhile the UN World Health Organisation (WHO), "whose process of evaluation is much more stringent and thorough than Kenya's processes", had a list of already tested and approved ARVs, which were found to have met WHO standards, Christa Cepuch, an MSF pharmacist told PlusNews.

"The WHO's testing includes bioavailability, and thorough inspections of the factory, standard operating procedures and good manufacturing procedures," she said.

Activists argue that there is no reason why ARV drugs already approved by WHO cannot be immediately registered in Kenya, and that bureaucratic and logistical delays within the Pharmacy and Poisons Board are unacceptable.