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Commercialising Kenya's Biodiversity: Legal Challanges Print E-mail
Thursday, 02 September 2010
Could Kenya generate non-tourism revenues from its biodiversity? Peter Munyi analyses Kenya’s legal and regulatory framework to develop and commercialise pharmaceutical, agricultural, industrial, or chemical end products from genetic material

In the 1990s, a US-based multinational used extremophile bacteria discovered in Kenya’s Lake Bogoria to create an ingredient for the production of a detergent. But even though this detergent went to on make multi-billion dollar sales, Kenya saw no financial or even research benefits from this. Effectively a case of bio-piracy, this highlighted the complex relationship between, and the importance of knowledge, science, intellectual property, technology and industry in bringing products from nature into the market. At the same time, this case also demonstrated the difficulties involved in safeguarding biological material, and how Kenya was legislatively ill-equipped in not only promoting bio-prospecting, but also in dealing with instances of bio-piracy.

Regulating Bio-Prospecting
Gene hunting, or bio-prospecting, describes the search for, collection, and deriving of genetic material from samples of biodiversity (excluding human ‘biodiversity’) to develop and commercialise pharmaceutical, agricultural, industrial, or chemical end products. This concept gained notoriety in the 1990s, and the term bio-piracy accordingly refers to the uncompensated or often irregular, if not illegal, bio-prospecting.

In 1991, under the auspices of the United Nations Environmental Program (UNEP), the framework convention known as the Convention on Biological Diversity (CBD) was developed. The CBD’s membership to date is 193 countries, opened for signature at the Earth Summit in Rio in 1992 and, among others, embodies principles of compensated bio-prospecting globally, but also mechanisms for protection of the environment generally.

Kenya was one of the early state parties to the CBD. Its response in giving the CBD effect was by enacting the Environmental Management and Coordination Act in 1999, the law that gave birth to the National Environment Management Authority (NEMA), the principal state agent on matters relating to environment. This law created framework provisions to regulate access to genetic resources (bio-prospecting) and benefit sharing. However, it was not until late 2006 that the Minister for Environment gazetted the regulations on access to genetic resources and benefit sharing (legal notice number 160) that enabled the implementation of the law, and this was triggered by the realisation that in the absence of such legislations, Kenya might, among others, miss out on significant revenues arising from bio-piracy – see the case of the Lake Bogoria bacteria.

Flawed Regulations
The 2006 regulations aim to achieve several objectives:
  • To put in place a mechanism to accessing the country’s genetic resources;
  • To define benefit sharing, i.e. who benefits how from the country’s genetic resources
  • To define compliance and surveillance mechanisms.
  • To create an efficient and clear mechanism for bio-prospecting, recognising that the process of incorporating science into products of biodiversity with the aim of producing novel industrial, chemical or pharmaceutical products is competitive, long and expensive.

However, several areas remained unclear in the regulations:

Consent and custodians? The regulations provide that an application to access to genetic resources must be accompanied by a research clearance permit from the National Council for Science and Technology (NCST). The process of obtaining a research clearance permit from the NCST falls under the Science and Technology Act. The application to access genetic resources is also required to be accompanied by evidence of prior informed consent from the owners and/or custodians of the genetic resource to be collected. How prior informed consent is obtained, or the parameters within which it is to be obtained, is again not specified in the regulations, not to mention that it is not clearly defined who the owners and/or custodians might be.

Renewals? Once it has received the full application with supporting documents, NEMA is then, to prior to determining the application, required to give notice of the application in a daily newspaper. Similar to the notices often given on environmental impact assessments, this announcement invites the public to comment or object on the application. Notwithstanding public comments, NEMA must determine the application within 60 days from the date of receipt of the application. If an access permit is issued, it is valid for one year and is renewable for a further one year upon payment of the prescribed fee. The matter that arises here is whether the permit is renewable for a third and subsequent years on expiry as it is very likely that a permit holder may not have completed all activities within the two year time frame.

Who can apply? The question of who may be an applicant is not as obvious as it appears. Whereas individuals and corporations, whether local or foreign, may apply to access genetic resources, a foreign applicant must have a local entity to work with. This requirement is not found in the 2006 regulations, but in the Science and Technology Act with respect to issuance of research permits to foreign applicants. Thus for a foreigner who wishes to access genetic resources, the process must necessarily start with the search for a competent local partner who is usually either one of the national research institutions or public universities. The involvement of the local partner is not just to ensure that some of the knowledge accumulated in the research process remains behind, but also for ‘gate keeping’ and ‘police’ purposes.

How to document benefit sharing? On benefit sharing, the regulations provide for a host of benefits that can be shared following access. These benefits may be monetary-upfront fees, milestone payments or royalties for example, or non-monetary. What remains obscure is where these benefits should be stated: Should they be in the prior informed consent document presented on application? Should they be contained in the material transfer agreement? Should they be in a totally different document altogether? The lack of clarity on the document in which benefits for sharing should be stated throws applicants into a quandary for it becomes difficult to discern when prior informed consent is deemed to be complete, and what provisions should be in the material transfer agreements. In countries such as Uganda, South Africa and Ethiopia, their laws are at least clear on this.

Prospecting in own jurisdiction? One of the issues that the rules fail to address is regulation of access to genetic resources by individuals, corporations and state agencies in their own jurisdictions. When the owner or custodian of a genetic resource becomes his own bio-prospector, what happens? For example, if a parastatal wishes to engage in bioprospecting activities involving genetic resources in its jurisdiction, does it need to apply for an access permit from NEMA? From whom would prior informed consent be obtained? Itself?

Recognising that in recent years state agencies have by accident or design, been forced to become economically self sufficient, a number of resources wealthier ones such as Kenya Wildlife Service (KWS) have been engaging in bio-prospecting activities. The ostensible exemption by the regulations, of approved research activities intended for educational purposes within recognised Kenyan academic and research institutions, which are governed by relevant intellectual property laws, is both redundant and superfluous in this and other contexts.

Intellectual property laws do not govern research and academic activities. And intellectual property laws are not research or academic regulatory tools. Rather they provide means or mechanisms through which academic or research outcomes with commercialisation potential may be packaged. Already, a suit is pending against a leading Dutch industrial giant and a state agency that entered into a bio-prospecting partnership of genetic resources in the jurisdiction of the state agency. While this suit is a highlight of some of the obscurities in the 2006 regulations, it is also shining a light on the issues in the regulations that require amendment.

New Constitution
In response to the flaws outlined above, there had been various efforts that sought to review or revise Kenya’s access to genetic resources regulatory structure. The Environmental Management and Coordination Act and the 2006 regulations were written during the era of the First Republic, and in August 2010, Kenya’s new constitution came into power. This constitution, in its articles 11 (on culture) and 69 (on environment), is explicit on the country’s obligation to protect its genetic resources generally, but also enhance their intellectual property value.

Now any efforts to review the regulatory framework for bio-prospecting must conform to the ethos and principles enunciated in the new constitution. The review effort must also take into consideration the on-going international efforts to put in place an international legally binding regime on access and benefit sharing. It is hoped that these negotiations will conclude in October 2010.

Perspectives
Currently it is difficult to decipher whether there are ongoing projects or interest exists on specific resources, and the regulations themselves are partly to blame: First the professed exemption of research and academic activities by the regulations creates a lacuna through which numerous unmonitored activities may be taking place, particularly in the public academic and research centre. It is probably safe to assume that there are numerous activities in the public sector, if the suit against the Dutch company and the extremophile bacteria issues are anything to go by. Secondly, the lack of clarity whether entities carrying out bio-prospecting activities in areas of their own jurisdiction have to obtain authorisations from NEMA provides a further loophole through which monitoring of the access activities taking place may be difficult. It may therefore be that the one notice in the local dailies that has ever appeared since the 2006 regulations were put in place, seeking public comments on an access request for aloe vera, may not be an accurate measure of the bio-prospecting activities taking place.

And in addition to the flaws in the regulations, there are a host of other issues that affect how attractive Kenya is for bio-prospecting. One of these is the current innovation landscape: The science, technology and innovation policies currently in place, if any, do not create a supportive environment for innovation. These policies have been very slow in supporting and adapting to innovation generally. In the ICT sector, there has been a lot of recent catching up in creating the right policies, but in the life sciences sector where bio-prospecting is an issue, the response has been slow.

For the last few years, there have been efforts to enact a Science, Technology and Innovation policy and overhaul the Science and Technology Act. However, whatever energies and monies have been spent, nothing in terms of a session paper or a bill has yet been tabled in parliament. And the new constitution may not necessarily accelerate the process of reviewing the policies underlying the science, technology and innovation landscape for two reasons: Using the articles 11 and 69 as the anchors for this process, this will take at least five years, not taking into account the busy parliamentary legislative schedule ahead.

Kenya’s private sector investment in research generally and life sciences in particular is dismal and the numerous science, technology and innovation indicators published annually attest to this. If science and technology is seen as one of the driving forces to achieve Vision 2030, the government’s development blueprint, then the government must commit more tangibly to research and development by investing more in the public life sciences and other research sectors.

On the continent, South Africa, for example, has been far more active in developing this sector. Their national experiences with bio-piracy issues surrounding the hoodia, devils claw, and pelargonium influenced the speed with which the innovation landscape has been shaped in the recent years. Innovation centres of excellence are being nurtured. One of the great challenges that South Africa has decided to devote attention to is the trajectory ‘from farm to pharma’, essentially a melting point of modern science, traditional knowledge and medicines with a view to create medicinal products derived from nature. These initiatives are public sector funded. Incentives to encourage private sector involvement and financing are being championed by tools such as the R&D Tax Incentive Programme.

Finally, any efforts to review the legislation on access and benefit sharing in future, whether donor driven or not, must take a holistic approach. If the intention of having the legislation in place is not just to protect Kenya’s natural assets, but also close the innovation chasm, then the review must necessarily take into account and call for attendant enactment of supportive policies in science, technology, development and innovation – and be backed by public funding. Or does Kenya feel that biodiversity revenues from tourism are sufficient?




Peter Munyi is a lawyer specialised in intellectual property rights and the Chief Legal Officer at the International Centre of Insect Physiology and Ecology (ICIPE).



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