African medicines agency AMA

Leveraging AMRH Success – a firm foundation for African Medicines Agency

Nepad Agency Healthcare

Improving timely access to drugs for all patients in Africa

1.0 Introduction
At present, drug approval processes in African countries operate separately and each country prioritizes its own processes, except in a few regions that have embraced harmonized processes i.e. East and Southern Africa. This means that drug companies seeking to register new drugs in Africa have to make individual applications to several African countries for the same medical product and incur the cost. Additionally, many countries have different systems and processes in place. This results in delays for approvals of medical products and consequently delayed access to medicines.

Drawing on examples from other developed regions (i.e. Europe), there is a way that African countries can turn around this situation to ensure that people on the continent have access to the right medical products at the right time in order to save lives. The answer lies in the African Medicines Agency (AMA) – a single continental agency to oversee the safety, quality and efficacy of medical products in Africa and spur the growth of the local pharmaceutical industry. AMA will not only benefit the pharmaceutical industry, it will also contribute to strengthening public health delivery systems and will ensure African people have sustained access to life-saving, life-prolonging medicines. This will be done through harmonizing regulatory standards and guidelines according to internationally accepted standards set by the World Health Organization (WHO). AMA will complement and not replace the work of existing national medicine regulatory agencies (NMRAs) and ongoing medicines regulatory harmonization (MRH) projects implemented by Regional Economic Communities (RECs).

AMA will be established through the African Union (AU) Treaty system and is intended to address the following key areas:

Key messages
• Fight the proliferation of Substandard and Falsified (SF) medical products and devices;
• Provide technical guidance to AU Member States and the RECs;
• Improve the coordination of different partners and stakeholders undertaking medicines; regulatory systems strengthening and harmonization work;
• Provide an enabling regulatory environment for the production of medical products that meet internationally acceptable quality standards;
• Mobilize financial and human resources for optimal utilization of limited resources and sustainability;

2.0 Problem statement
Despite progress made in the pharmaceutical sector to improve the availability of medicines, access to essential medicines still remains a huge challenge in Africa. The problem is widespread on the continent and the majority of those affected are poor households. Half of the population in the poorest places have no access to medicines at all. Africa still accounts for over 25% of the world’s disease burden, yet its share of global health expenditure is less than 1%.

Over 70% of the pharmaceutical industry in Africa is largely foreign-dominated, and worse still only 2% of the medicines consumed on the continent are locally manufactured (Ref). Forecasts predict growth in the African pharmaceutical industry, which will be worth between 40 to 65 billion US dollars by the year 2020 (Ref). Africa needs a single, and strong continental medicines regulatory agency to fill the gap in providing the required leadership in the regulation of medicines, and to speak with one voice to ensure the continent benefits from this expected pharmaceutical industry growth. This approach is one of the added values that AMA brings to help create jobs and ignite socio-economic development on the continent.

In addition, about 25 – 30% of medical products on the continent are Substandard and Falsified (SF), and illicit trade in drugs remains persistent. The global counterfeit drug trade has blossomed into a billion-dollar industry that is thriving in Africa, and the price to pay is the detriment of our healthy population and breakdown of the health systems. A 2016 report on counterfeit medicines in Central Africa indicates that illicit trade in drugs accounts for 25% of the pharmaceutical market size in countries where it is poorly developed and up to a high of 55% in countries where it is well developed. This problem is not just in Central Africa, it spans across the continent and affects other regions as well. This challenge poses a series of threats to public health that require an urgent coordinated response. No single country can mount a successful fight against SF medical products and counterfeit drug trade, this can only be achieved as a concerted effort involving all the affected African member stay Harmonization (AMRH) Initiative, current efforts have managed to reduce drug approval times – directly or indirectly.

A lack of coordination in regulatory affairs and efforts to strengthen regulatory systems has undermined Africa’s ability to support the growth of the legitimate pharmaceuticals industry in Africa and to tackle the proliferation of SF medical products in medicines markets on the continent. Africa has witnessed a sharp increase in the number of organizations involved in medicines regulatory systems strengthening work on the continent over the past two decades. While the continent stands to benefit as niche streams of work emerge, lack of coordination to harmonize effectively the different interventions may have a negative impact. As a result, the already inadequate human and financial resources have taken a knock. Existing capacity and resources are thinly spread, reducing expected impact and leading to duplication of similar work by different organizations on the continent using different regulatory standards. This has the potential to negate the hard–fought gains in the medicines regulatory space. Indeed, approval timelines of applications to register essential medical products or for granting authorization for clinical trials in African countries are marred by unprecedented delays ranging from 4 to 7–years compared to developed countries. This results in patients having limited, or no access to innovative drug regimens that could help save their lives at the earliest possible time. The primary cause of these delays includes weak or non-coherent regulatory standards and varying regulatory requirements among African countries, lengthy medicine registration processes that lead to delays in approval decisions, inadequate technical capacity, resource constraints, and failure to leverage regulatory review activities already performed by better-resourced regulatory authorities and the WHO. Bringing different players to work together in a well-coordinated manner will help to ensure the countries receive the kind of technical and financial support in areas that require it the most to deliver the best results.

Through the African Medicines Regulatory Harmonization (AMRH) Initiative, current efforts have managed to reduce drug approval timelines in the East African Community (EAC) to a median of seven (7) months since implementation of regional joint assessments compared to the previous 1–2 years characterised by national applications. This represents a 40 – 60% reduction. The Zazibona collaboration procedure implemented under the Southern African Development Community (SADC) MRH Project has registered a reduction in the approval time to a median of 8 months over the last five years. However, more needs to ensure streamlined approached across all RECs and the proposed establishment of AMA will be critical not only in providing the required support to address the current challenges faced by NMRAs and RECs in Africa. AMA will build on the existing firm foundation of the AMRH Initiative to strengthen and promote regional joint activities to accelerate outcomes and ensure Africans have access to quality assured, safe, and efficacious medical products and technologies.

3.0 How did Africa get here?
In 2005, the Pharmaceutical Manufacturing Plan for Africa (PMPA) was endorsed by the AU Assembly for implementation under the NEPAD Framework. The overall aim is to strengthen the ability of African Member States to produce quality and affordable essential medicines and contribute to improved health outcomes and the realization of direct and indirect economic benefits. One of the key pillars of PMPA is for Africa to have a sound and conducive regulatory environment for the production of quality medicines hence the conception of AMRH Initiative.

In 2014, WHO and AUC jointly convened the 1st meeting of African Ministers of Health. It was during this meeting that the Luanda Commitment was adopted, setting out milestones for the establishment of AMA. In 2015, the Luanda Commitment was encapsulated in Executive Council Decision EX.CL/DEC.857 (XXVI). The Executive Council Decision represented the commitment by African leaders to strengthen medicines regulatory capacity, and harmonize medicines regulatory systems as a foundation for the establishment of a single regulatory agency – the African Medicines Agency.

The Executive Council Decision requested AUC and NEPAD Agency, with technical support from WHO to undertake two tasks; (i) establish a Task Team for establishing AMA (ii) and define its scope. Consequently, the AMA Task Team was established with the aim of building consensus on the key milestones and working out detailed modalities towards the establishment of AMA, with clear financial implications and legal frameworks. In addition, the AMA Joint Secretariat comprised of AUC, WHO and NEPAD Agency was set up to provide oversight of the work of the Task Team. Delivering on its mandate, the AMA Task Team facilitated the drafting of key AMA documents, namely; (i) the Legal Framework (ii) Institutional Framework (iii) and Business Plan.

This was followed by a series of continental stakeholder consultations with legal and regulatory experts from AU Member States to deliberate on the key AMA documents. The 1st and 2nd consultations took place from 20 to 22 February 2017 in Midrand, South Africa and on 20 March 2017 in Addis Ababa, Ethiopia on the margins of the 2nd Session of the AU Specialised Technical Committee on Health, Population and Drug Control (STC-HPDC) respectively. The 3rd continental stakeholders’ consultation on the AMA Treaty took place from 12 to 14 July 2017 in Tunis, Tunisia.

After continental stakeholder consultations with legal and regulatory experts, the feedback received was incorporated and the AMA Draft Treaty was finalized by the AMA Task Team and Secretariat. Furthermore, the AMA Draft Treaty was presented to the African Ministers of Health meeting as a Working Group of the AU STC-HPDC on the margins of the WHO-AFRO Regional Committee Meeting in Victoria Falls, Zimbabwe on 29th August 2017.

On 18th May 2018, African Ministers of Health meeting as a Working Group of the STC-HPDC adopted the Treaty for the establishment of the African Medicines Agency in Geneva, Switzerland on the margins of the WHO World Health Assembly. After the successful adoption, the AMA Treaty will be presented to African Heads of State and Government in January 2019 for endorsement at the AU Summit. Thereafter, the endorsed AMA Treaty will be ready for ratification by AU Member States.

4.0 What will AMA do for Africa?
AMA will improve Africa’s forecasts for prosperity and well-being through its contribution to improved public health systems by ensuring that African people have faster access to safe, good quality and efficacious health products. As a result of more reliable medicines being available, more patients will turn to national health services for their healthcare. This will allow national health insurance schemes to develop a virtual cycle that will protect the poorest from catastrophic expenditures in health and provide more market certainty for suppliers alongside better-negotiating power for buyers.
In this way, Universal Health Coverage (UHC) can become a reality, healthcare industries can flourish and everybody on the continent can have a much greater chance of having affordable, timely access to the medicines, diagnostics, vaccines and devices that they need.

5.0 Sovereignty of National Regulatory Authorities and AMA’s added value
The aim of AMA is to fight Substandard and Falsified medical products and ensure that all medicines meet internationally-recognized standards of quality, safety and efficacy. AMA will also ensure that all Africans have access to affordable medical products for the diseases that affect them the most. AMA will achieve this by working together, and in collaboration with African NMRAs and RECs based on an agreed framework of division of labour. The NMRAs at the national level will maintain their sovereignty and perform core regulatory activities such as registration of medical products; review and approval of clinical trials; inspection and licencing; import and export control; post-marketing surveillance and vigilance; vaccines lot release and medicines information, including control of advertising and promotion. On the other hand, RECs MRH Programs and AMA will be responsible for harmonization of regulatory processes, including activities such as joint review of dossiers and inspection of manufacturing sites for agreed priority products; review of multi-country clinical trials; regional alert system and vigilance; medicines information sharing; and a regional integrated system for controlling imports and exports.

Details on the functions of AMA are stipulated in the Treaty and will include the following:

• Strengthening existing medicines regulatory systems in AU Member States.
• Providing technical support to NMRAs during market authorization and evaluation of medical products for the treatment of priority diseases, as determined by the AU.
• In efforts to ensure the safety and efficacy of medicines across the African continent, AMA will be the knowledge hub that regularly inspects, coordinates and shares information about products that are authorized for marketing. AMA will also share information to alert AU Member States on Substandard and Falsified medical products for safety monitoring and market surveillance.
• In addition, AMA will work with NMRAs and Regional Economic Communities (RECs), as well as other partners and expert stakeholders to effectively coordinate joint reviews of applications for conducting clinical trials in an ethical manner. AMA will provide the required oversight for clinical trials.
• Furthermore, AMA will improve the quality of pharmaceuticals by strengthening the work of quality control laboratories in the AU Member States.
• Building on the AMRH Initiative, AMA will continue to promote medicines regulatory harmonization efforts in Africa by developing common standards, guidelines and regulations at continental, regional and national levels.

6.0 Way forward and what you can do to support AMA
Working together, AU member states can build stronger medicines systems premised on the AU vision for continental integration. To do this AMA needs the support of AU Member States. Essential next steps include:
• Heads of State and Government endorsed the AMA Treaty at the AU Summit in January 2019.
• A minimum of AU Member States signing (ratifying) the AMA Treaty, to establish AMA through the AU Treaty System.
Endorsement and ratification of the AMA Treaty by AU Member States in January 2019 will transform the continent’s pharmaceutical industry and pave way for the establishment of AMA. This is a Call to Action – we need all African Member States to ratify the AMA Treaty to ensure that the right to health becomes a reality in Africa.

References
Access to Medicines Index (2017). Available on URL: http://accesstomedicineindex.org/

African Medicines Regulatory Harmonization (AMRH) Strategic Framework 2016 – 2020 Available on URL: http://www.nepad.org/resource/amrh-summarized-strategic-framework-2016-2020

African Union Heads of State and Government of January 2016 – AU Model Law available for access on URL: http://www.nepad.org/resource/african-union-au-model-law-medical-products-regulation

Carlos Lopes (2015) Making Medicine in Africa – the untapped possibilities that could save millions of lives. Published in Mail and Guardian, Available on URL: http://mgafrica.com/article/2015-02-17-manufacturing-pharmaceuticals-in-africa-the-untapped-opportunity-that-could-save-countless-lives

Carlos Lopez (2014) Manufacturing Pharmaceuticals: An Untapped Opportunity. Available on URL: http://www.uneca.org/es-blog/manufacturing-pharmaceuticals-untapped-opportunity

McKinsey & Company (2015) Africa – A continent of opportunity for pharma and patients. Available on URL: http://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/africa-a-continent-of-opportunity-for-pharma-and-patients

Situation Analysis on Counterfeit Medicines in Central Africa (2016) Report

United Nations Development Programme (2016) How Local Production of Pharmaceuticals Can Be Promoted in Africa – The Case of the United Republic of Tanzania. Available on URL: http://adphealth.org/upload/resource/Tanzania_Local_Production.pdf

Ian Schofield (2017) African Regulatory Harmonization Project Cuts Drug Approval Times and Saves Scarce Resources. Available on URL: https://pink.pharmamedtechbi.com/PS119932/African-Regulatory-Harmonization-Project-Cuts-Drug-Approval-Times-And-Saves-Scarce-Resources

Written by

NEPAD Agency is the implementing agency of the African Union, facilitating and coordinating the development of continent-wide programmes and projects, mobilising resources and engaging the global community, regional economic communities and countries in transforming Africa. NEPAD Agency is contributing to Africa’s Agenda 2063 goals, the continent’s long-term development framework for socio-economic transformation.