WHO & African Union Sign MOU To Expand Access To Medicines & Bolster Epidemic Preparedness

The World Health Organization and African Union have signed a sweeping Memorandum of Understanding to collaborate on improving access to medicines, strengthening epidemic preparedness, and expanding universal health coverage across the African continent.

These are the three main pillars of the MOU signed Monday by the WHO Director-General Dr Tedros Adhanom Ghebreyesus and African Union Chair Moussa Faki Mahamat at a two AU meeting in Geneva.

Moussa Faki Mahamat (left) and Dr Tedros Adhanom Ghebreyesus (right) hold the signed MOU

The MOU commits WHO to providing technical expertise to the newfound African Medicines Agency (AMA), in order to support regulatory approvals and local production of essential medicines, hopefully increasing access to quality-assured drugs. The African Union voted just last year to endorse a treaty to establish the AMA, and officially adopted the treaty in February 2019.

It is hoped that the AMA’s creation will foster more uniform drug rules and regulations across the continent, also fostering faster approval for new medications and cheaper prices. Up until now, most African countries wait until a new drug is approved by a developed country regulatory authority, such as the US Food and Drug Administration or the European Medicines Agency, and then a number of regional African entities, or each country individually, considers if to approve the drug for use.

“The three pillars of our new MOU pose three challenges that we must address together if we are to realize our shared vision for a healthier, safer, fairer Africa,” said Dr Tedros in a statement to the AU Commission Chair and AU ambassadors on Sunday.

“First, we must invest in access to medical products that are high-quality, safe and effective. Second, we must invest in preparedness, not panic. And third, we must invest in primary health care.”

Once it is up and running, the AMA will be responsible for assessing the safety and efficacy of new health products proposed for use in Africa, issuing guidance to African Union countries regarding regulatory approval and use. It will be modeled after the European Medicines Agency, which provides regulatory guidance for new health products introduced on the European continent.

The next steps are to define more precisely the scope of activities for the new regulatory body. In particular, Tedros says, the AMA should also focus on “creating an enabling environment to foster local production,” noting that “too many of our brothers and sisters don’t have access to the medicines they need, or use medicines that are substandard or falsified.”

About 1 in 10 medical products in low- and middle-income countries is either manufactured or packaged in substandard ways or falsified, according to a 2017 WHO report. The WHO African Region contributed 42% of the substandard or falsified product reports to this analysis.

The AMA will also provide a continental approach towards harmonizing existing regional initiatives to regulate new health products,  including those by the Economic Community of West African States (ECOWAS), the South African Development Community (SADC), and the East African Community Medicines Regulatory Harmonisation (EAC MHR).

Civil Society Pushes ARIPO to Use More TRIPS Flexibilities

The MOU announcement between WHO and the AU coincided with an open letter published by over 90 civil society organizations demanding reform of the African Regional Intellectual Property Organization (ARIPO), which handles patent applications for pharmaceutical products for 18 countries contracted to the Harare Protocol.

The civil society organizations signed an open letter to Ministers of ARIPO asking them to take bolder actions in leveraging TRIPS flexibilities to promote access to generic medicines at the ARIPO Ministerial Meeting from November 18 – 20 in Liberia.

ARIPO’s patent practices are largely dictated by the Harare Protocol, and the patents issued apply to the ARIPO region, which includes countries such as Kenya and Zimbabwe. The letter urges Ministers to update the Harare protocol to incorporate more TRIPS flexibilities at the regional level to allow generic versions of new drugs to enter the market earlier.

TRIPS flexibilities, which allow countries to remedy anti-competitive practices in situations of public health need, are currently not being implemented in the ARIPO patent process, the letter says. Specifically, key TRIPS flexibilities such as the Least Developed Country (LDC) patent exemption, which gives the LDCs maximum flexibility in patenting pharmaceutical products until 2033, have not been implemented through the Harare Protocol. Some 13 of the 18 ARIPO member states are classified as LDCs according to UN.

Experts say that establishing the AMA and reforming ARIPO patent practices together could improve access to cheaper, quality assured generic medications.

“IP reform has to go hand in hand with regulatory reform and coordination to remove two of the main barriers to robust generic competition in quality assured medicines,” says Brook K. Baker, professor at Northeastern University School of Law and senior policy advisor at Health GAP (Global Access Project), an HIV advocacy organization that works in several ARIPO countries.

Setting high standards for issuing patents could allow generics to be produced for more medicines, and having the regulatory mechanisms that can assess the safety and efficacy of these products will provide the regulatory approval needed to to speed their entry to market, he says.

Epidemic Preparedness and Universal Health Coverage on MOU  Agenda

The other two pillars of the WHO-AU MOU also focus on building capacity in the African continent, to respond more strongly to epidemic threats and to expand primary health care.

Tedros called the ongoing Ebola outbreak in the DRC as “a stark reminder than many AU countries are vulnerable to the impact of epidemics.”

Dr Tedros delivering a statement at the Sunday meeting with the AUC Chair and AU ambassadors

For too long, he said, the world has “invested in panic, rather than in epidemic preparedness,” noting that the global health community has largely responded to outbreaks reactively, instead of preemptively investing in health systems to prevent epidemics.

Working with the African Center for Disease Control, the WHO will support efforts to strengthen the health workforce in AU countries and establish a Volunteer Health Corps for Africa, and support the development of national action plans for emergency preparedness.

Lastly, the MOU commits the WHO to support the implementation of the Addis Ababa Call to Action on universal health coverage, endorsed by the African Union Summit in February. The WHO will help facilitate dialogue between Health and Finance Ministers to help countries increase domestic financing for primary health care by at least 1% GDP.

Image Credits: Twitter: @WHO, Twitter: @DrTedros.

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