Since its inception in 1980, the International Conference of the Drug Regulatory Authorities (ICDRA) represents a major platform for WHO and drug regulatory authorities across its member states, in their efforts to harmonize regulation and improve the safety, efficacy, and quality of medicines.
The focus of this year’s ICDRA Conference held in Cape Town at the end of November – “Patients are Waiting: How Regulators Collectively Make a Difference” – could not be more pertinent, as the question of access to medicines becomes ever more pressing.
Access to medicines can be accelerated through an efficient regulatory system in all regions of the world – yet in many African countries, progress on regulatory convergence and access to medicine has been too slow for too long. Backlogs in regulatory approvals can result in a 5-year wait for medicines, while more sophisticated technologies such as biologics and vaccines pose greater regulatory challenges and longer delays. Problems encountered in supply chain, local distribution and going the last mile mean that once approved, essential medicines cannot always get to where they are needed; and hospital and pharmacy shelves are left empty. Add to this the impact of counterfeit, sub-standard medicines, and we are talking about a major challenge for our national regulatory authorities that has a significant impact on patients.
It’s clear that getting patients access to high quality, efficacious, and safe medicines is a path littered with obstacles in some parts of the world, including Africa. But it’s a situation that has become untenable with patients in desperate medical need having to wait or be denied live-saving treatments for infectious diseases like HIV, malaria, and tuberculosis as well as chronic conditions like diabetes, heart, and lung diseases.
It’s essential that we act now and take an open-minded approach to finding solutions.
A great example of pooling resources and innovative thinking is the ZAZIBONA Collaborative Medicines Registration Process – an initiative involving Zambia, Zimbabwe, Botswana and Namibia with a vision to ensure access to good-quality medicines for those who need them; reduce time taken to grant marketing authorization in the individual countries; and ensure efficient utilization of resources within regional national regulatory authorities through work-sharing. There is huge excitement about this scheme, which we can all draw inspiration from as an incredible example of collaboration where individual sovereignty is put to one side, to ultimately benefit patients in all four countries.
We can learn from ZAZIBONA. How can we apply best practice from other markets, leveraging expertise outside our own country or find innovative solutions and new partners locally? What is certain is that to instigate the urgent pace of change required, we need closer collaboration between stakeholders – governments, regulatory authorities, and the pharmaceutical industry. We need to ask ourselves if there are other stakeholders who could help us make the difference – researchers, university pharmacy departments, and digital specialists. Solutions could involve training on inventory supply, new technology platforms to support the submission and review of drug applications, support on pharmacovigilance, and much more.
ICDRA is a unique forum for promoting exchange of information between authorities and stakeholders worldwide to find collaborative approaches as there are solutions that can be shared between the least and most developed countries. We will all gain by implementing a regulatory system that works for everyone. Let’s work together and share resources, expertise and knowledge, and truly make the difference for patients.