Hi Larks, really appreciate your question. A few thoughts:
This directly addresses review delay but not submission delay. Outsourcing decisions to the FDA/EMA/etc would speed things up once an application is submitted by the manufacturer, but the manufacturer still needs to apply in the first place. The AMA tries to address both by making Africa more attractive as a unified continental market. You could argue that guaranteed automatic approval would give manufacturers every reason to submit (this feels intuitively right), but the EAC pilot undermines this somewhat, since Roche only registered its drugs in 3 of the 6 participating countries, even under a streamlined framework, so other market forces are clearly at play.
Drug approval is a context-specific risk-benefit judgment. The FDA approves drugs with American patients in mind, the EMA for Europeans. That decision may not translate to other contexts. This is why the EMA runs a separate program called EU-Medicines for All (EU-M4all) to assess medicines specifically for LMIC contexts. That said, it would be worth examining the actual data. It would be cool to have a list of drugs where approval decisions genuinely diverged based on population-specific factors, to get a sense of how often this is really a deciding issue in practice. I’ll look into it!
Outsourcing approval doesn’t outsource post-market surveillance. This matters especially in Sub-Saharan Africa, where substandard medicines are a serious problem.
The accountability gap is tricky. If a country gives up on doing their own drug approvals and solely relies on e.g., the FDA’s decisions, it inherits the outcomes without much recourse. The FDA bears no responsibility for what happens in markets it didn’t regulate for, so if something goes wrong, there’s no clear mechanism for response.
One of the AMA’s long term goals is to strengthen national agencies by increasing their regulatory capacity. Outsourcing approvals could help with access in the near term, but without a complementary solution, African countries would indefinitely rely on others.
Hi Larks, really appreciate your question. A few thoughts:
This directly addresses review delay but not submission delay. Outsourcing decisions to the FDA/EMA/etc would speed things up once an application is submitted by the manufacturer, but the manufacturer still needs to apply in the first place. The AMA tries to address both by making Africa more attractive as a unified continental market. You could argue that guaranteed automatic approval would give manufacturers every reason to submit (this feels intuitively right), but the EAC pilot undermines this somewhat, since Roche only registered its drugs in 3 of the 6 participating countries, even under a streamlined framework, so other market forces are clearly at play.
Drug approval is a context-specific risk-benefit judgment. The FDA approves drugs with American patients in mind, the EMA for Europeans. That decision may not translate to other contexts. This is why the EMA runs a separate program called EU-Medicines for All (EU-M4all) to assess medicines specifically for LMIC contexts. That said, it would be worth examining the actual data. It would be cool to have a list of drugs where approval decisions genuinely diverged based on population-specific factors, to get a sense of how often this is really a deciding issue in practice. I’ll look into it!
Outsourcing approval doesn’t outsource post-market surveillance. This matters especially in Sub-Saharan Africa, where substandard medicines are a serious problem.
The accountability gap is tricky. If a country gives up on doing their own drug approvals and solely relies on e.g., the FDA’s decisions, it inherits the outcomes without much recourse. The FDA bears no responsibility for what happens in markets it didn’t regulate for, so if something goes wrong, there’s no clear mechanism for response.
One of the AMA’s long term goals is to strengthen national agencies by increasing their regulatory capacity. Outsourcing approvals could help with access in the near term, but without a complementary solution, African countries would indefinitely rely on others.