TRIPS Flexibilities and Local Pharmaceutical Manufacturing: What Kenya Can Learn from Senegal

Senegal now hosts one of Africa’s most closely watched vaccine manufacturing projects, built on a mix of development finance and government co-investment rather than any special trade-law carve-out. Kenya, by contrast, has a full TRIPS-compliant compulsory licensing regime sitting almost entirely unused. The gap between the two is not really about intellectual property law. It is about what a country does with the flexibility TRIPS already gives it.

What TRIPS Actually Allows

The TRIPS Agreement’s Article 31 permits a WTO member to authorise use of a patented invention, including a pharmaceutical, without the patent holder’s consent, subject to conditions such as case-by-case authorisation, adequate remuneration, and predominantly domestic-market supply. A 2005 amendment, Article 31bis, went further: once it entered into force on 23 January 2017, it let a member issue a compulsory licence specifically to manufacture and export generic medicines to another member that lacks its own manufacturing capacity. Separately, the WTO Council for TRIPS extended the pharmaceutical-patent transition period for least-developed countries to 1 January 2033 under decision IP/C/73 of 6 November 2015. That extension does not help Kenya. Kenya is not on the UN’s list of least-developed countries, so its pharmaceutical patents are fully TRIPS-bound today, with none of the LDC transition relief.

Kenya’s Unused Toolkit

Kenya’s Industrial Property Act, No. 3 of 2001, already implements Article 31 in detail. Sections 72 to 75 allow an application for a compulsory licence on non-working or inadequate-supply grounds, generally after four years from filing or three years from grant, following an unsuccessful attempt to obtain a voluntary licence. Section 80 goes further, allowing the Minister to authorise government or third-party exploitation of a patented invention in the public interest, including national security, nutrition, health, or environmental conservation, with emergency provisions that waive the usual prior-negotiation requirement. On the record available, Kenya has never actually issued a compulsory licence for a pharmaceutical patent under these provisions. The statutory tools exist. The track record of using them does not.

What Senegal Actually Built

Senegal’s flagship project is Project MADIBA, based at the Institut Pasteur de Dakar in Diamniadio, one of the original spokes in the WHO’s mRNA technology transfer hub programme announced on 18 February 2022 alongside Kenya, Nigeria, Tunisia, and Egypt. What sets Senegal’s project apart is not a novel legal instrument but the financing stack behind it. The European Investment Bank agreed EUR 75 million in financing on 2 June 2022, signed by Senegal’s own Ministry of Economy, Planning and Cooperation, targeting capacity of up to 300 million doses a year. CEPI followed with a commitment of up to USD 50 million over ten years, announced 19 January 2023, explicitly co-funded alongside the Government of Senegal, the EU, and the EIB. The International Finance Corporation is also involved. In other words, Senegal did not out-legislate Kenya on patent flexibilities. It assembled a concessional-finance and state-co-investment package large enough to build a facility, and let its regulator and ministry act as a genuine counterparty to that finance rather than a passive licensor.

Kenya’s Own Manufacturing Push

Kenya is not starting from nothing. Following a presidential directive in October 2023, the Ministry of Health has advanced a Health Products and Technologies Local Manufacturing Strategy, targeting 50 percent of essential medical commodities produced domestically, backed by a production-linked incentive package, import-duty relief on pharmaceutical machinery and active ingredients, and KEMSA procurement preferences for locally made products. Kenya BioVax Institute’s mRNA technology transfer agreement with the Medicines Patent Pool, concluded 25 September 2024, is the clearest sign that Kenya’s own version of Senegal’s model is already underway. What Kenya has not yet done is match Senegal’s scale of committed, blended finance, or demonstrate that its compulsory licensing and government-use provisions can function as real negotiating leverage rather than dormant statute. Kenya’s engagement with the African Union’s broader Pharmaceutical Manufacturing Plan for Africa, and with Africa CDC’s pooled procurement discussions, suggests the ambition is continental rather than purely domestic, but ambition and a financed facility are two different things, as Senegal’s example shows. Companies weighing whether to invest in Kenyan manufacturing capacity should look past the statute book and ask the more practical question Senegal’s backers actually answered: who is putting real money behind the project, and on what terms.