Public Health and Health Systems

No more delays: Accelerating access to medicine

One step closer to an HIV vaccine
Written by Elna Schütz

Late last month, Heads of State and governments from across the continent gathered in Addis Ababa for the 28th African Union (AU) Summit writes Yolanda Moyo of PATH South Africa.

Yolanda Moyo

Leaders and policymakers discussed a wide range of issues, but one common thread ran through the meeting—the need to “strengthen the spirit of pan-Africanism and unity” to achieve shared goals.

One of Africa’s shared goals is increasing access to medicines. Leaders from across the continent have recognized that even the most promising health technologies will not have an impact if they cannot reach the people who need them. The regulation of medicines, vaccines, and other health products is a key piece of this puzzle.

Unintended delays in access

It’s the responsibility of every government to ensure that citizens have equitable access to high-quality vaccines, devices, diagnostics, and drugs. Each country has a national regulatory authority (NRA), which monitors the safety, efficacy, and quality of health technologies and approves them for use.

But because the regulatory processes and capacity differ from country to country—and many NRAs are over-burdened and under-resourced—access to quality-assured medicines is often delayed for months or years.

It’s the responsibility of every government to ensure that citizens have equitable access to high-quality vaccines, devices, diagnostics, and drugs.

New research gives us an idea of how lengthy regulatory delays typically are. In sub-Saharan Africa, for example, the approval of a medicine or vaccine comes four to seven years after the product was submitted to a regulatory authority for the first time, usually in a high-income country. These delays can have staggering health consequences, as people are unable to access new, potentially lifesaving medicine.

Fortunately, political commitment to overcome these challenges is growing, and a number of promising initiatives have been established to make this vision a reality.

The Zazibona Initiative: accelerating access to medicines

Last year, South Africa, joined the Zazibona Initiative with neighboring countries—Zambia, Zimbabwe, Botswana, Namibia and Swaziland. Through the Zazibona Initiative, these countries are working to align their regulatory systems, share resources and information, and ultimately accelerate access to quality-assured medicines for their people.

The South African Health Technologies Advocacy Coalition (SAHTAC), a civil society group, recently congratulated the government of South Africa on its decision to join Zazibona. A harmonized regulatory system will benefit researchers and manufacturers, who must currently navigate multiple application processes to register the same health technology across countries.

Moreover, pooling resources and knowledge will allow member countries to evaluate applications together, which reduces the regulatory workload, saves time, and builds mutual trust and cooperation. Joint evaluations have already proven successful—since Zazibona’s founding, 156 health products have been reviewed, and at least 50 of these products have been registered for use.

Regulatory progress throughout the continent

This success extends beyond southern Africa, and it has quickly picked up speed. In the East African Community (EAC), for example, regulatory harmonization efforts have already reduced drug approval timelines by more than 50 percent.

Additionally, at the 2016 AU Summit, Heads of State adopted the Model Law on Medical Products Regulation, a blueprint that countries can use to update often-complex and inconsistent laws that govern medicines regulation. In just one year, seven regional economic communities—including the Southern African Development Community and the EAC—have begun implementation. Through the Model Law, economic communities are standardizing regulatory legislation in order to make regulation more efficient and accelerate access to promising new health technologies.

Maintaining momentum

We still have a long way to go to ensure access to medicines for all people, but I’m incredibly encouraged by the progress we’ve made over the past year. I’m especially proud of South Africa for joining its neighbors in creating regulatory systems that better serve those who need timely access to new medicines.

The anticipated launch of the South African Health Products Authority (SAHPRA) in April 2017 is another encouraging effort by the South African government. SAHPRA lays out a framework for the South African government to recognize and align with other regulatory bodies—reducing duplication and increasing efficiency.

This collaboration, and the spirit of pan-Africanism promoted at the 2017 AU Summit, will strengthen every country’s ability to accelerate access to innovative, lifesaving health technologies.

Yolanda Moyo is a policy officer at PATH’s South Africa office. Based in Johannesburg, she leads PATH’s advocacy for improved R&D policies and investments in South Africa and oversees the SAHTAC secretariat.

About the author

Elna Schütz