CONSULTANCY TO CONDUCT A SCOPING STUDY ON STRENGTHENING LEGAL AND POLICY FRAMEWORKS FOR ACCESS TO ESSENTIAL MEDICAL PRODUCTS IN MALAWI

BACKGROUND

Recently, KELIN, in partnership with the International Treatment Preparedness Coalition (ITPC‑Global) and the Community Health Rights Advocacy (CHeRA) in Malawi has been advancing strategies to challenge legal and intellectual property barriers that hinder access to medicines in Malawi. This work has included conducting Market and Patent Intelligence Studies on priority health products for HIV, TB, Cancer, as well as communicable diseases, raising awareness on the strategic use of TRIPS flexibilities to enhance access to essential health products, and spearheading a campaign for law and policy reforms.

There still exists a complex global health landscape, where patents and other Intellectual Property (IP) rights, while designed to incentivize innovation, can also exacerbate inequities in access to medicines. This is particularly acute in low‑ and middle‑income countries (LMICs), which often struggle to secure affordable health products, including during global health emergencies and for breakthrough technologies such as long‑acting (LA) formulations for HIV, TB, and emerging treatments for non‑communicable diseases (NCDs).

Against this backdrop, KELIN in partnership with CHeRA, seeks to engage a consultant to undertake a scoping study to interrogate these dynamics by examining whether TRIPS flexibilities are being effectively utilized, identifying gaps in national and regional legal and policy frameworks including national Intellectual Property Laws, assessing the impact of free trade agreements and substantive patent examination practices on access to medicines. The consultant will provide a country‑specific analysis for Malawi and situate these findings within a broader African comparative perspective towards generating robust evidence to inform advocacy for law and policy reforms.

Additionally, the consultant will examine the role and procedures of the African Regional Intellectual Property Organisation (ARIPO), which establishes a unified regional framework for patents and other IP rights across all 22 ARIPO member states, Malawi being a member. The consultant will analyse how patent applications, examinations, grants, and oppositions are handled under ARIPO’s designation-based system, while assessing the Impact on Access to Medicines. Further conducting an evaluation on how ARIPO’s approach affects access to priority health products, including whether patent oppositions at ARIPO can effectively prevent evergreening and misuse of the patent system.

Ultimately, the consultant will identify reform opportunities by highlighting areas within the Harare Protocol and ARIPO procedures where reforms or advocacy could strengthen public health safeguards. The consultant will be required to assess implications for advocacy strategies under the ARIPO regime, while providing practical recommendations and actionable insights on how civil society and policy makers can leverage on ARIPO procedures to improve access to medicines.

PURPOSE OF THE CONSULTANCY

The purpose of the consultancy is to provide actionable recommendations to strengthen legal and policy environments that balance innovation incentives with public health imperatives, advocate for trade policies that align with Constitutional obligations to uphold the right to health, and explore the potential for local pharmaceutical production  ensuring equitable and sustainable access to essential health products in Malawi.

SPECIFIC OBJECTIVES

The consultant will:

Provide an original and evidence-based desk review and analysis, drawing on credible data, previous analytical reports and studies, legislation analysis, etc. to:

1. Examine the extent to which TRIPS flexibilities are being incorporated and utilized in national legal frameworks in Malawi and identify barriers to their effective implementation.
2. Describe current implications of LDC status for patent barriers to access, Malawi’s graduation prospects and what it will mean in terms of patent barriers for access to medicines in Malawi.
3. Analyse national IP laws (all related bilateral FTAs containing IP chapters that Malawi ratified), regulations, to identify TRIPS plus provisions to be abolished or mitigated, gaps, inconsistencies, and opportunities for reform that would enhance access to medicines.
4. Conduct an in‑depth review of the African Regional Intellectual Property Organisation (ARIPO) patentability criteria rules and procedures, including patent filing, examination, grant, and opposition mechanisms under the Harare Protocol.
5. Assess how ARIPO’s designation-based system affects access to medicines in Malawi
6. Identify opportunities for advocacy and reform within ARIPO’s framework to strengthen public health safeguards.
7. Based on ARIPO’s designation‑based approach, highlight implications for regional advocacy strategies.

Synthesise the findings from the desk review and identify legal and policy reforms priorities and develop a comprehensive analysis and actionable evidence-based recommendations which will inform policy dialogues and advocacy on strengthening public health protections and strengthening legal and policy frameworks for equitable access to medicines.

KEY DELIVERABLES AND OUTPUTS

• A comprehensive analysis, outlining and highlighting key findings of the scoping study based on the scope of work outlined above.
• Provide practical recommendations actionable insights for civil society, policymakers on how to leverage ARIPO patentability rules and examination procedures to improve access to medicines and strengthen public health safeguards
• A report containing comprehensive analysis, outlining and highlighting key findings of the scoping study based on the scope of work outlined above
• High‑level presentation of findings and recommendations for use in advocacy forums.

DURATION 

The assignment will be conducted for a period of fifteen (15) consultancy days from the date of contract signing.

DESIRED QUALIFICATIONS 

The ideal consultant/firm should have:

• Advanced degree in Law, Intellectual Property, or related fields.
• Advanced degree in Law or related fields.

• Minimum 7 years relevant experience working on intellectual property in Africa
• Specialized training in Intellectual Property law, patent systems, and access to medicines will be an added advantage.
• Interest, experience, and/or academic training in HIV, TB, and public health, human rights, international development, patent law, Legal Frameworks, or related field.
• Experience working in or for the nonprofit, philanthropic sector or related field is a plus.

• Familiarity with the nexus of Intellectual Property, trade, and public health issues in Africa is a plus.
• Experience engaging with governments, civil society, and regional bodies to advance law and policy reforms in Africa
• Experience working across multiple African jurisdictions and engaging with regional institutions is a plus.
• In‑depth understanding of how ARIPO operate, including filing procedures, designation systems, opposition mechanisms, and enforcement processes is a plus.
• Excellent analytical, writing, and communication skills.

• Strong background in conducting comparative legal and policy research across multiple jurisdictions.
• The ability to work independently to produce high quality outputs and in a timely manner while understanding and anticipating the evolving client needs.

REPORTING

The consultant will report to the designated project lead.

Periodic check-ins will be held to review progress and address emerging issues.

All applications received will be subjected to a fair and competitive review process.

Only shortlisted Consultants will be contacted.

This call for Consultancy will close on Thursday 28th May 2026 5.00 PM EAT.