NAIROBI – Kenya is one of the leading African countries yet to ratify the African Medicines Agency Treaty (AMA) – but a senior official in the Ministry of Health has said that the move  should come soon. 

According to Susan Mochache, the country’s Principal Secretary in the Ministries of Health (MoH), Kenya has already undergone the induction process, and is now waiting for details on operational modalities, which need to be worked out, before ratifying the treaty.

 “The country is now waiting for clarity on whether payments will be made directly to the suppliers and on information on the tax exemption modalities,” Mochache told Health Policy Watch in an interview.

She was referring to questions arising among some African countries about whether the AMA would take on bulk procurement functions – alongside its regulatory role. 

Proponents of the continent-wide approach to medicines regulation say that it will help streamline medicines and vaccines reviews and approvals – also ensuring a better COVID-19 response. 

A unified regulatory mechanism could also pave the way for more efficient bulk procurement of medicines and vaccines, through the African Union or regional blocs of countries – and more local production, its advocates say. 

However, the functions assigned to the AMA through the pending treaty, requiring ratification, are strictly regulatory in nature, the treaty’s architects and proponents underline. 

“It’s important to focus on Article 6 and what the African Medicines Agency’s specific role would be,” said Dr Margaret Agama-Anyetei, of Head of the Health, Nutrition and Population Division Africa Union, in a panel session on the AMA Wednesday at the African Health Agenda International Conference 2021. She underlined the need for caution in assuming that the AMA could do everything that is needed on the continent – in terms of procurement and production – even though it can set the stage.

Article 6 lays out the primary functions of the African Medicines Agency, which include: coordinating and strengthening initiatives to harmonize medical product regulation; providing guidance on regulation of traditional medical products, and evaluating and deciding on medical products for treatment of priority diseases and conditions, as determined by the African Union and WHO.

African Union Agreed To Create AMA Two Years Ago – But 7 More Countries Need To Ratify Treaty.  

A resolution to create the AMA was adopted at the 32nd African Union Assembly two years ago. However, among Africa’s 54 countries, only 19 countries have so far signed the treaty and only eight countries, mostly in West Africa, have ratified it. 

While that is still three more ratifications since October, the treaty needs to be signed by at least 15 countries to become operational. And meanwhile,  the continent’s biggest countries like South Africa, Nigeria,… and Kenya  remain outliers. 

 In terms of its regulatory function, the agency would function much the same way as the European Medicines Agency (EMA) operates – offering a region-wide umbrella for countries to use in review and approval of drugs and vaccines. 

It may however, also play a role in managing bulk medicines and vaccines procurement – ensuring that the process is cheaper, simpler and faster for the countries that have joined, while also guaranteeing safety in a region where fakes often proliferate.

Kenya Medical Association – AMA Ratification Will Help Expand Vaccines Access 

 In a separate interview, Dr. Elizabeth Gitau, CEO of the Kenya Medical Association (KMA), also expressed hopes that the national government will soon ratify the AMA Treaty, saying it would also help improve COVID-19 vaccines access. 

“So, we are waiting and actually do hope that at the end of the day the government will ratify the treaty so that we have more access to vaccines,” she said in a separate interview. 

But, she added, “The Ministry is still going through the decision making process.” 

The KMA has been a key partner in the government’s COVID response, providing technical support to the Ministry of Health, including on prioritization of people who should receive vaccines, advocacy and rollout.  

Its members are participating in the COVID-19 vaccine administration training programmes currently under way in the country – as part of the rollout of the first AstraZeneca vaccines, which were received through the WHO co-sponsored COVAX global distribution facility last week .

AMA would help Kenya Fight Fakes & ‘Grow’ Its Pharma Industry 

Whereas cross-boundary harmonization of the regulatory standards and guidelines in accordance with global standards, and specifically those mandated by the WHO, will be the core function of the AMA, Kenya also stands to benefit in other ways, should it join the agency.

Notably, AMA membership could also help link up Kenya’s pharma producers to a much larger purchasing block, should the AMA’s functions also extend to the supervision of pooled medicines procurement. 

Said Dr. Fred Siyoi, CEO of the country’s Pharmacy and Poisons Board (PPB): “It will help Kenya nurture its growing pharmaceutical industry leading to the realization of the provision in the constitution of the right to health by guaranteeing safe, quality and efficacious locally manufactured medicines.”

For instance, “pooled procurement will enable countries to receive medicines from WHO prequalified, or from AMA prequalified manufacturers,” explained Dr. Siyoi. The PBB Board regulates the pharmaceutical practices in the country in addition to the manufacture and trade of drugs and poisons.

Dr. Gitau concurs, adding:  “Negotiating as a block as opposed to going it alone as individual countries, we are bound to benefit in terms of economies of scale, but also we are more likely to get better access to vaccines with the initiative and possibly better pricing.”

Pooled AMA Procurement Also Would Help “Fight the Fakes” 

Even though the PPB has its own mechanisms in place for detection and prevention of substandard and falsified products (SF), pooling resources together within the AMA framework will serve to strengthen its programmes further, Siyoi said.

For instance, the national board would benefit from “information sharing from regional blocks on substandard and falsified products,” he says, something which will ensure timely response to risk alerts on medicines of substandard quality and safety.

Dealing with fake medicines has been one of the biggest challenges facing many African countries.

Up to a quarter of the continent’s medicines are substandard or falsified, according to the African Union Development Agency New Partnership for Africa’s Development (AUDA-NEPAD).

One reason why this continues to be a problem for Kenya – just like other countries on the continent – is the lack of adequate personnel.

Understaffing is a big challenge facing the PPB, according to Dr. Siyoi. The limited number of inspectors manning the border points, leaves the agency ill-equipped to cope with vast areas laced with informal border crossings between neighbouring countries through which smuggled drugs find their way.

“This is in addition to modified transport vehicles for concealment of [counterfeit] medicines,” says Dr. Siyoi.

Should the AMA come into being, the PPB hopes to benefit greatly from the technical assistance drawn from the pool of experts at the continental level.

In addition, the Agency will also enhance PPB’s capacity for dossier evaluations and the undertaking of joint Good Manufacturing Practices inspection of drugs being manufactured in Kenya itself. 

Some of these challenges, other pharma sources admit, would indeed be “better be addressed” through the AMA mechanism. 

At no time has the existence of AMA been so critical as today, observed Oksana Pyzik, Global Engagement Lead and founder of the University College London Fight the Fakes initiative, during a Wednesday panel session on ‘Why AMA’ – held under the auspices of the African Health Agenda, International Conference 2021 (AHAIC).     

“AMA is critical now more than ever and ties into the WHO’s patient safety plan directly,” she said. This, she explained further, is a concept which Dr. Tedros Adhanom, WHO’s director general, has been pushing, that without quality medicines, there is no universal health coverage for patients.

Image Credits: MOH_Kenya, AHAIC, Wish FM Radio, Inquirer, Marco Verch/Flickr.