Kenya Works To Identify IP Rights In Its Medical Research

By Tatum Anderson for Intellectual Property Watch
NAIROBI – One of Kenya’s most prestigious research institutions, Kenya Medical Research Institute (KEMRI), has begun an extensive intellectual property audit to try and identify any discoveries that should be protected. The audit comes as the government is finishing work on a new framework on traditional knowledge and IP.

KEMRI’s audit is an attempt to ensure that the commercial benefits of any drugs or active ingredients that are eventually developed from research at the institute are shared appropriately amongst all who were involved.

“There is a lot of intellectual property lying in the labs,” said Dr Jennifer Akinyi Orwa, principal research officer at KEMRI, who has been involved in the audit since it began a few months ago.

A key element of the institute-wide audit will be drawing up agreements with traditional healers. They are crucial to the institute because they provide the raw materials and knowledge on traditional plants that are being researched within its labs. Scientists hope to develop drugs from these natural products. Drugs such as those for chemotherapy and antibiotics have been developed in this way for decades.

The agreements will serve to ensure healers are more fully involved in the process to develop medicines. “Many traditional healers feel that scientists are stealing their research and not involving them and not informing them of the results obtained,” she said.

As a result, KEMRI is drafting agreements for traditional healers pledging to keep them fully informed of any progress made at each stage of the research process, especially if their material is promising, sent to another institution for further tests and becomes a candidate for a drug.

Already the institute holds weekly open mornings at one of its sites in the capital Nairobi where traditional healers can bring raw materials and discuss research being carried out.

Eventually, the plan is to come up with a proper quantitative benefit-sharing agreement that states exactly how much healers and their communities receive as a proportion of drugs that eventually sold commercially. KEMRI’s Orwa said no precise numbers have been proposed yet, because this situation has yet to arise, but the idea is to subtract the costs of research and development from – and decide how to divide – the rest.

New Framework on Traditional Medicine and IP

KEMRI is one of several institutions in Kenya that are reviewing their policy towards intellectual property.

Concurrently, several ministries within the government are putting the finishing touches to a new national framework on traditional medicine and its approach to intellectual property.

The policy, which is currently with the Kenyan Attorney General’s office, has already been broadly consulted on around Kenya, with advice from traditional healers and scientists to conservationists.

The policy, which will eventually become law, broadly lays out a strategy to conserve traditional plants, which often are over-harvested on the wild, establish the safety and efficacy of traditional remedies, and commercialise remedies on the world market. However, it also addresses intellectual property, primarily to ensure that traditional healers are assured any commercial benefits of drugs that are eventually sold by law.

Specifically, the policy states that before scientists can start work, agreements must be signed so that benefits are shared if drugs are developed. Many details still have to be hammered out, such as whether a single healer with knowledge on how to pick plants and create a remedy should benefit, or an entire community that uses that plant and how much they stand to earn.

“The existing IP rights mechanism doesn’t contain enough provisions to protect traditional medicine.” said Dr Jack Githae, a traditional healer from Central Kenya, who has contributed to the consultation. “We need to develop an African solution. Benefit sharing is very important. It is a communal resource and I think it should be approached like that.”

KEMRI says that although it is developing its own agreements, when a law is passed, it will ensure its internal policy reflects the new rules.

But benefit sharing is not as simple as ensuring traditional healers and communities benefit, said Dr Hashim Warsama Ghalib of the UN’s Tropical Disease Research group at the World Health Organization, which funds drug discovery research from natural products in Africa – including KEMRI.

There are many more people involved in the discovery of a drug – particularly in Africa – from healers, to several different types of scientists including phytochemists and clinicians. As a result, the process to decide how intellectual property is shared down the chain becomes incredibly complex.

“The chain of development of natural products is a long chain and includes a lot of steps, “he said.

The chain is particularly long in Africa because of chronic under-funding for research. Many scientists often do not have access to the right equipment or expertise to carry out different elements of research and are often required to hand over their discoveries to other institutions with the correct tools.

The most promising compounds are typically handed over to pharmaceutical companies in the west to develop into drugs that can be manufactured at large scale, for instance.

Uncertainties over intellectual property means often many potential drugs never get off the starting blocks, said Ghalib. Scientists often guard their hard work and do not want to share it if they are not convinced they will be adequately rewarded.

As a result, KEMRI’s audit will attempt to ensure that work is adequately protected even if it is handed over to another institution. To do that KEMRI plans to examine all the agreements that have been made with other institutions and pharmaceutical companies, both in Kenya and abroad, on sharing research.

“We will look at them as there are probably gaps,” said Orwa. “We have been using agreements that come from abroad but now we are in the process of developing our own contracts and agreements.”

Tatum Anderson may be reached at info@ip-watch.ch.