A Gamechanger for African Health

AMA: How legal expertise helped accelerate access to safe, affordable healthcare across a continent

After a decade-long effort November 2025 saw the launch of the African Medicines Agency (AMA) – a landmark shift set to accelerate access to safe, effective, and affordable medicines for more than 1.4 billion people across Africa. 

By strengthening regulatory systems and enabling faster, more consistent approval of medicines and vaccines, the AMA has the potential to transform health security across the continent. 

Today, 31 African Union (AU) Member States have ratified the AMA Treaty. The Agency is operational, conducting joint assessments of medicines, and contributing to improved pandemic preparedness, regulatory harmonisation, and access to quality medicines. 

Behind this milestone lies a critical enabler: targeted legal expertise that helped unlock action. 

The opportunity and challenge 

The African Union first proposed the Treaty for the Establishment of the African Medicines Agency (AMA) more than a decade ago, with the aim of creating a continent-wide regulatory body – similar in ambition to the European Medicines Agency. 

The AMA would have the authority to coordinate the regulation of medicines, traditional medicine, and medical devices across Member States, while addressing persistent challenges such as limited local production capacity and the circulation of counterfeit and substandard medicines. 

The need for such coordination became especially urgent during the COVID-19 pandemic, which exposed the risks of fragmented regulatory systems and delayed vaccine access. 

In 2017, consultations were held across the continent with legal and regulatory experts regarding the draft AMA Treaty, the instrument that would lead to the realisation of the AMA.  

In May 2018, African Health Ministers from the 55 Member States of the AU unanimously adopted the AMA Treaty at the 71st World Health Assembly, the decision-making body of the World Health Organisation (WHO).  

While encouraging, this was only the first legal procedural hurdle; the AMA Treaty also needed to be ratified by at least 15 AU Member States. By late 2020, only six countries had ratified the treaty – well short of the 15 required for it to enter into force. 

One of the barriers preventing the AMA Treaty from reaching the requisite threshold of ratifications by AU Member States was a deficient understanding among domestic legislators, including Attorney-Generals and policy teams, about what the AMA Treaty would actually entail for their respective countries. IAPO discovered this to their surprise at a webinar that they hosted at the Geneva Health Forum in March 2020. 

The Legal Intervention 

To overcome inertia and to reach the target number of ratifications, A4ID’s assistance was sought by IAPO to obtain pro bono legal advice that would be used to inform government officials on the operation of the AMA Treaty.  

A4ID rapidly mobilised a barrister from the London Bar, Tom Leary, to translate the complexities of the AMA Treaty into clear, practical guidance for policymakers. 
 
The legal advice provided clarity on:   

• What the AMA Treaty was and the obligations it contained 

• The institutional, legislative, policy and practical framework of the AMA Treaty through which vaccines, medicines and health devices will be regulated. 

• The extent to which the effectiveness of the signatories’ national medicines regulatory agencies would be bolstered by the AMA Treaty. 

• The provisions in the AMA Treaty designed for the benefit of civil society, patient organisations and other non-state actors. 

The Turning Point 

The legal advice became a cornerstone of IAPO’s advocacy efforts. 

It was used to engage policymakers—particularly Attorneys General—at a high-level webinar hosted in London in partnership with the International Federation of Pharmaceutical Manufacturers and Associations. 

The impact was immediate. 

Just two days after the presentation, the AU Executive Council formally requested the appointment of a Special Envoy to accelerate the ratification process across Member States. 

A written legal opinion, grounded in credibility and clarity, provided the confidence policymakers needed to act. 

As IAPO noted, the work was “tremendously professional” and significantly strengthened the organisation’s ability to engage government stakeholders. 

At the time of A4ID’s intervention in December 2020, only six countries had ratified the treaty. Today, 31 AU Member States have ratified. 

On 5 November 2021, the AMA Treaty entered into force when Cameroon became the fifteenth country to ratify – marking what was widely described as a “historic moment.” 

Amira Elfadil, the Commissioner for Social Affairs at the AU, declared that this marked a “great milestone that opens a new chapter for harmonization and regulation of the African pharmaceutical landscape.” Whilst the AMA Treaty has now officially come into effect, the IAPO-led AMATA has not taken its eye off the ball, aware that there are still challenges up ahead to set up the AMA Treaty, calling on the AU “to prepare for the practical implementation of the Agency.”  

Impact at a Glance 

• Ratifications increased from 6 to 31 Member States  
• AMA Treaty entered into force in 2021  
• AMA officially launched and operational in 2025  
• First continental joint assessments of medicines conducted  
• Strengthened understanding of the Treaty among policymakers  
• Empowered patient organisations to advocate with confidence  Contributed to improved regulatory harmonisation and pandemic preparedness  

Enhanced Civil Society Engagement 

An unexpected impact of IAPO’s project has been the opening up of a space for civil society engagement, in this case patient groups, in the regional health sector governance.   

In this instance, benefits were also accrued to civil society more widely, beyond patient groups. On the advice from counsel, IAPO was provided with the assurance and confidence to take the initiative to convene a multi-stakeholder collective of organisations known as the African Medicines Agency Treaty Alliance (AMATA), to strengthen the African pharmaceutical regulatory system for timely access to innovative, safe, quality, and effective medicines and medical devices that are accessible for better pandemic preparedness.  

Membership of AMATA extended to health professional associations, academic and research bodies, non-state actors in official relationships with the WHO and their African Members or chapters, and public-private partnerships. This included medicines and health devices, and African and international trade associations. In February 2021, IAPO spearheaded the Alliance to issue a call to AU Member States to ratify the AMA Treaty. 

A Lasting Impact on Global Health 

The ratification of the AMA Treaty contributes substantially to SDG 3 (good health and well-being), specifically Target 3.8: “Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.” Moreover, the AMA Treaty will help to reduce inequalities among countries (SDG 10) and moves towards the goal of strengthening the implementation of the SDGs through partnerships (SDG 17).   

The African Medicines Agency is more than a regulatory milestone- it is a foundation for stronger, more resilient health systems across Africa. 

This case study shows that when legal expertise is deployed effectively, it can remove barriers, accelerate decision-making, and enable progress that impacts millions of lives. 

Get Involved: 

Law firms, corporate legal departments, judiciaries and barristers’ chambers can partner with A4ID to provide pro bono legal services to governmental and non-governmental organisations dedicated to improving human health and well-being. 

Pro bono legal expertise helped provide policymakers with the clarity and confidence to move forward with ratification.