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.
I think you can just skip the submission step. There’s no need to require submissions at all. My submitting to the FDA or equivalent, you’re automatically deemed to have submitted.
Yes, there are some context-specific elements, but they seem relatively small. Notably, once the FDA approves a drug, it is legal to use for any indication, and for any patient, in the US—even those the FDA did not label it for. I understand that there are biological differences in drug responses between different ethnic groups, but these are typically not that large, and note that the FDA already has a large population of African Americans, with ancestry from all across the continent, within its jurisdiction. Supply chain limitations in Africa, heat-resiliency, disease ecology etc. are real issues. But do they really justify multi-year delays for ordinary treatments? I think it is very unlikely that the cost-benefit analysis would come out this way. The EU runs EU-M4all, but this is focused on products that are focused on non-EMA markets—it doesn’t mean than normal drugs approved for use in the EU are inappropriate for Africa.
To the extent that post-approval surveillance is a problem, it is actually good to outsource approval to developed countries, because this would free up scarce resources for surveillance.
The idea of an accountability seems more like a rhetorical / nationalist issue than a real one to me. The current degree of accountability national african regulators face seems pretty small in practice, and your preferred solution—an Africa-wide version—would also have accountability issues. I think ordinary Africans would be better served by a competent and (relatively!) swift international drug authority with no formal accountability to them over less-competent and slower national regulators with a veneer of accountability.
It really doesn’t seem that bad to me for African countries to indefinitely rely on others? Specialization, Division of Labour and Gains from Trade are some of the most important drivers of a prosperous modern world. But even if drug-approval-capabilities was something that autarky was desirable for, these countries should build the competence first, rather than imposing onerous restrictions on their citizens—and causing many premature deaths through denying safe and effective drugs. I would rather have them build capacity by focusing on surveillance, inspections, trial oversight, and procurement integrity.
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.
Thanks for replying!
I think you can just skip the submission step. There’s no need to require submissions at all. My submitting to the FDA or equivalent, you’re automatically deemed to have submitted.
Yes, there are some context-specific elements, but they seem relatively small. Notably, once the FDA approves a drug, it is legal to use for any indication, and for any patient, in the US—even those the FDA did not label it for. I understand that there are biological differences in drug responses between different ethnic groups, but these are typically not that large, and note that the FDA already has a large population of African Americans, with ancestry from all across the continent, within its jurisdiction. Supply chain limitations in Africa, heat-resiliency, disease ecology etc. are real issues. But do they really justify multi-year delays for ordinary treatments? I think it is very unlikely that the cost-benefit analysis would come out this way. The EU runs EU-M4all, but this is focused on products that are focused on non-EMA markets—it doesn’t mean than normal drugs approved for use in the EU are inappropriate for Africa.
To the extent that post-approval surveillance is a problem, it is actually good to outsource approval to developed countries, because this would free up scarce resources for surveillance.
The idea of an accountability seems more like a rhetorical / nationalist issue than a real one to me. The current degree of accountability national african regulators face seems pretty small in practice, and your preferred solution—an Africa-wide version—would also have accountability issues. I think ordinary Africans would be better served by a competent and (relatively!) swift international drug authority with no formal accountability to them over less-competent and slower national regulators with a veneer of accountability.
It really doesn’t seem that bad to me for African countries to indefinitely rely on others? Specialization, Division of Labour and Gains from Trade are some of the most important drivers of a prosperous modern world. But even if drug-approval-capabilities was something that autarky was desirable for, these countries should build the competence first, rather than imposing onerous restrictions on their citizens—and causing many premature deaths through denying safe and effective drugs. I would rather have them build capacity by focusing on surveillance, inspections, trial oversight, and procurement integrity.
Hi!
I didn’t know about the EU medicine for all and I think that’s really cool.
I enjoyed reading through the article