What Africa misses from lack of joint drugs agency

The depositing of the instruments by the six member states will be a step forward in realising the establishment of AMA.
This is in addition to the establishment of the African Medicines Regulatory Harmonisation (AMRH) in 2009 that works with AU recognised regional health organisations to facilitate harmonisation of regulatory requirements and practice among the national medicines authorities of the AU member states.

This is driven by the aspiration in meeting internationally acceptable standards and providing a favourable regulatory environment for pharmaceutical research and development, local production and trade on the African continent.

AMA will be the second continental health agency after the Africa Centres for Disease Control and Prevention (Africa CDC) that will enhance the capacity of states parties to regulate medical products. 

AMA will also promote the adoption and harmonisation of medical products regulatory policies and standards in the African Union. 

AMA will enter into force once ratified by 15 AU member states. The Treaty shall enter into Force 30 days after the deposit of the 15th instrument of ratification and ascension.

Thirty two member states have neither signed not ratified the Treaty.

According to Dr Margaret Agama-Anyetei, the head of division for health, nutrition and population at Social Affairs Department of the AU Commission, 21 member states (Algeria, Benin, Burundi, Cameroon, Chad, Egypt, Ghana, Gabon, Guinea, Madagascar, Mali, Morocco, Niger, Republic of Congo, Rwanda, Saharawi Arab Democratic Republic, Senegal, Seychelles, Sierra Leone, Tunisia and Zimbabwe) have so far signed the AMA Treaty.

“The African Union Commission encourages all its member states to sign and ratify the treaty for the establishment of AMA in the interest of public health, safety and security. The treaty is available for signature at the headquarters of the Commission in Addis Ababa, Ethiopia,” she says.

 According to Dr Agama-Anyetei, nine member states (Algeria, Burkina Faso, Ghana, Guinea, Mali, Namibia, Rwanda Seychelles and Sierra Leone) have ratified the AMA Treaty and deposited the legal instruments of ratification to the Commission. Six member states; Benin, Cameroon, Gabon, Morocco, Niger and Tunisia have ratified the Treaty but are yet to deposit the instruments of ratification to the Commission.

Asked why many countries are delaying to deposit their AMA Treaty instruments of ratification at the Commission, Dr Agama-Anyetei says: “In the past few weeks, we have seen the momentum in member states towards depositing the instruments of ratification. I would say the delay was in ratification given the various legislative and executive processes required in the different member states. However, in terms of deposit, the African Union Commission is encouraged by the momentum of many member states and so far only six need to deposit the instrument for AMA to come into force.”

Impact
 Dr Agama-Anyetei says the continued delay to ratify the AMA Treaty instruments is affecting the continent’s efforts to exploit its institutional, scientific and regulatory resources to improve access to safe, efficacious and quality medicines.

“WHO estimates that 10.5 per cent of medicines worldwide are substandard or falsified. Most of the burden falls on low-and middle-income countries because of poor pharmaceutical governance, weak technical capacity, and poor supply-chain management. Between 2013 and 2017, 42 per cent of all reports sent to the WHO Global Surveillance and Monitoring System on substandard and falsified medicines worldwide came from Africa,” she said.

Dr Agama-Anyetei adds: “This poses a serious threat to the achievement of Agenda 2063’s aspiration 1 on high standard of living, quality of life and wellbeing for all citizens and of the Sustainable Development Goal 3, which is concerned with access to universal health care services and safe, effective, quality, and affordable essential medicine.”

The president of the Pharmaceutical Society of Uganda (PSU), Dr Pamela Achii, says the different drug regulatory requirements in African countries keep away international drug manufacturers.

“The time it takes to approve and the resources needed to have packaging materials customised for each country is one of the reasons manufacturers stay away from seeking approvals in poorer and smaller markets. This directly denies the users access to qualify medicines,” Dr Achii says.

The executive director of the Uganda National Health Consumers Organisation (UNHCO), Ms Robinah Kaitiritimba, says the delayed ratification of AMA Treaty denies African states the chance to regulate medical products to improve their quality, safety and efficacy.

“The African Medicines Agency will strengthen global collaborations with African researchers and patients in clinical research trials of new medicines which will save money Africa spends on medical tourism in India, Turkey and Singapore, among others,” Ms Kaitiritimba adds.

Dr Achii also says the formation of AMA will cut red tape and corruption that manufacturers go through pursuing approvals from local agents and regulators. 

“It will attract larger manufacturers that had started exiting the African market. And it will also protect Intellectual Property when information is centralised and controlled by a single agency,” she explains.

Dr Agama-Anyetei adds that the African Medicines Agency will facilitate expeditious approval of products that address the health needs of the African populace, “especially for diseases that disproportionately affect Africa.”

“Multiple and concurrent epidemic and pandemics could take place at the same time (Covid-19, Ebola and Zika) resulting in severe strains on health systems and continental collaboration is of paramount importance,” she says.

“The Covid-19 pandemic has amplified the need for a harmonised mechanism that ensures investments in regulatory capacity development towards the achievement of improved standards in the regulation of medicines, medical products and technologies across the continent,” she adds.

Dr Agama-Anyetei also says in the face of the Covid-19 pandemic, the necessity of AMA has been amplified in coordinating joint clinical trials. 

Africa exposed
 “The ongoing Covid-19 pandemic has highlighted a number of shortcomings in securing critical medical supplies in many African countries. Global competition and inaccessibility coupled with the increase in export restrictions has contributed to critical shortages of these lifesaving supplies,” she says.

The chief executive officer of drug maker Cipla Quality Chemicals, Mr Nevin Bradford, says: “Covid-19 has presented huge challenges to healthcare systems throughout the world not just Uganda. Issues such as the number of intensive care beds, oxygen supply and PPE provision have provided significant challenges throughout the pandemic and whilst not minimising the challenges the Ugandan healthcare system has faced, it is important to remember that many other countries have faced similar challenges and not responded as well as Uganda.”

On her part, Dr Kaitiritimba says the pandemic has exposed the lack of commitment towards health by African states, especially regarding funding as recommended by the Abuja Declaration. 

“It has exposed the exploitation and capture of the private sector, hence exposing the weaknesses of the government and high commercialisation of Covid-19 treatment. It has aggravated the lack of insurance and safety nets for the poor. In Uganda, we have witnessed the abuse of human rights such as the detention of patients and bodies in hospitals due to a lack of payment of hospital bills,” Ms Kaitiritimba adds.

Milestone
AMA will be the second continental health agency after the Africa Centres for Disease Control and Prevention (Africa CDC) that will enhance the capacity of states parties to regulate medical products. 

AMA will also promote the adoption and harmonisation of medical products regulatory policies and standards in the African Union.