Understanding the process for obtaining Nagoya protocol approval in Uganda: an engagement with the Uganda National Council of Science and Technology

Atuhura Carolyne

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Are you a researcher or a research team wondering if you will need the Nagoya protocol approval to transfer genetic samples outside Uganda for whatever reason? You may find our experience of obtaining the Nagoya protocol approval to transfer snail and worm genetic material valuable.

We are a strong team of scientists at different career levels and research administrators at the Uganda Virus Research Institute (UVRI) and the Vector Control Division (VCD) at the Ministry of Health, in partnership with other international universities, exploring why there is a difference in Bilharzia severity among Ugandan populations living beside Lake Albert and the Albert Nile in West and Northern Uganda (LA region), compared to those of the Lake Victoria (LV region) in Central and Eastern Uganda.  Funded by the National Institute of Health (NIH), capacity building is a vital aspect of our work, and as such our enthusiastic students obtain placements to study and work abroad in world class laboratories of our partners institutions such as the University of Leiden and University of Glasgow. Likewise, we warmly welcome students seeking placements from the region and the rest of the world.

Foreign lab placements may require the students to carry certain genetic materials from Uganda to their respective countries, in our case our students will be required to ship snail and worm genetic material to our partners in Belgium and the UK. We had earlier obtained all the local research clearance for our study to start data collection in the field but were ambivalent about if we were exempted from the Nagoya protocol.

Subsequently, we invited Mr Innocent Akampurira, the Access, Benefit and Sharing (ABS) Coordinator at the Uganda National Council of Science and Technology (UNCST) to enlighten the team about the process for obtaining the Nagoya protocol approval in Uganda. UNCST is at the forefront, issuing permits for research and ABS, ensuring that agreements contain adequate provisions for sharing benefits, and establishing a database to track these agreements. The regulatory body is also in charge of monitoring the use of genetic resources within and outside Uganda, ensuring that the country keeps representative samples and specimens, and overseeing compliance regarding technology transfer and information exchange.

The captivating half- day engagement started with the U-SMRC project summary from the study Principal Investigator, Prof. Alison Elliott, followed by a presentation from Mr Akampurira. He stated that in Uganda, the Nagoya protocol had been in effect since 2014, and is operated in conjunction with other regulations, such as the national access to benefit-sharing guidelines and the national access to genetics regulations. Its primary purpose is to regulate both academic and non-academic/commercial research involving the transfer of genetic material outside Uganda. The Nagoya protocol, he explained, was not just another set of rules but rather a legal framework aligned with the Convention on Biological Diversity’s objectives: the fair and equitable sharing of benefits arising from the utilization of genetic resources.

The process for approval was rather perplexing at the start, but Mr Akampurira outdid himself by explaining all that is required of us to obtain the approvals. First, we had to obtain all the ethical approvals from UNCST, which we had done. Second, we needed to fill in the relevant forms including the “Prior Informed Consent” (PIC), a formal agreement between the researchers and the resource owners, ensuring that the resources were being used with respect and fairness; the Mutually Agreed Terms (MAT) to ensure fair and equitable benefit sharing; the Material Transfer Agreement (MTA), negotiated between the holder of an access permit and a relevant lead agency or community on terms of transfer and use of genetic material and ultimately, the  Access Permit. All these form templates can be found at https://wipolex-res.wipo.int/edocs/lexdocs/laws/en/ug/ug021en.html

The complex part, he emphasised, for our study would be identifying the owner of the snails and the worms. The resource owner could be an individual, government entity or the community. For our study, we agreed to record the VCD as the owner, for they hold the surveillance mandate for all vector borne diseases.  We are currently in the process of filling in the required forms and hope to obtain our approvals in the shortest possible time. We are excited to keep you posted about how our approval process turned out with UNCST in our next installment.

Special thanks go to Mr Innocent Akampurira and the entire team at U-SMRC.  A recording of this is insightful session can be accessed at; https://zoom.us/rec/play/gOiFOEx9ya8rnqePcrjrnVP34hQ3Wqc13rl1GUsGJxXKr7eFZDN4HK-XCnCMx5eGInfIu0xK6Q5h_7yt.IasejaC92ULkl19i?autoplay=true&startTime=1696226323000

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Written by

Victoria Bukirwa and Ritah Namagembe



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