With support from the United Nations Development Programme (UNDP)-led global health project the Access and Delivery Partnership (ADP), Ghana is taking active measures to further strengthen the regulation of health technologies in the country.
Effective regulation is a critical component of a well-functioning health system, as it enables access to health technologies that are quality assured, safe and effective. However, introduction of new technologies into national health systems require new skills and capacities, as well as robust institutional and regulatory frameworks, and safety monitoring systems to be in place.
To address this, the African Union Model Law on Medical Products Regulation was developed in 2014-2015, and endorsed by Member States in 2016, to serve as a template for countries to strengthen and harmonize their regulatory frameworks. Strengthened and harmonized regulatory systems across Africa will be critical to improving the predictability and efficiency of regulatory approvals. It has been demonstrated that regional harmonization initiatives can avoid duplication of regulatory reviews, facilitate mutual recognition and accelerate access, so that new health technologies can be delivered sooner.
In the context of the ongoing COVID-19 pandemic, these issues take on an even greater urgency. Enabling harmonization and improving regulatory efficiency can facilitate timely access to COVID-19 vaccines and other health technologies, as well as enabling effective monitoring of safety issues.
So far, only a handful of countries have completed the process of domesticating the AU Model Law into their national legislations. ADP is working with the African Union Development Agency (AUDA-NEPAD) to ramp up the number of countries undertaking the domestication process, and in Ghana, the project is partnering with the Food and Drugs Authority (FDA) in this regard.
The FDA is the national regulatory body in Ghana mandated to regulate food, drugs, veterinary medicines, cosmetics, medical devices, household chemical substances, tobacco and tobacco products, blood and blood products, etc. as well as the conduct of clinical trials.
“This AU Model Law provides a comprehensive framework for an integrated and harmonized approach for medicine regulation,” said Angela Lusigi, UNDP Resident Representative in Ghana. “When effectively implemented at national level, it will significantly contribute to ensuring that new health technologies can become available sooner – thus improving health access and delivery for all.”
As part of the initiative, a gap analysis study was conducted earlier this year which identified differences between the Ghana Public Health Act, 2012 (Act 851) and the AU Model Law, and categorized them into three areas, namely: 1) provisions that needed substantial revisions; 2) provisions that required only minor revisions; and 3) new provisions that were needed to properly align with the AU Model Law.
Currently, parts 6, 7 and 8 of the Public Health Act (Act 851) provide the legislative framework for FDA’s operations. Ghana is keen to fully align with the AU Model Law provisions, and the FDA, with the support of the Ministry of Health, is leading this process.
Recently, a stakeholder consultative meeting was held on 12-13 August 2021 to provide additional input into the gap analysis and develop a concrete roadmap for moving forward.
In opening remarks delivered by the Chief Executive of the FDA, Mrs. Delese A.A. Darko noted: “Although Ghana was actively involved in the development of the AU Model Law, we are yet to domesticate and incorporate the Model Law fully into our national law. We are therefore most grateful to the UNDP partnership for this two-day stakeholder consultation workshop that has brought all of us together to work for a robust and effective regulatory regime in Ghana.”
After the stakeholder consultation, the next step is for the legal drafting process to commence later this year.
As part of regional efforts to strengthen capacity and advance the AU Model Law, ADP and AUDA-NEPAD have also developed a Guidance Document, which will serve as a practical resource tool for countries navigating the domestication process.