00:00 Welcome everyone,
00:01 uh,
00:01 to the WDR seminar series.
00:04 I'm Siddhar Dikshit and I'm a member of the WDR
00:07 2025 team and part of the digital Effectiveness unit.
00:10 Uh,
00:11 today,
00:11 I'm very pleased and very privileged to welcome
00:14 Professor Gavin Yemi
00:16 and Professor
00:17 Osundu Abujii from Duke University to discuss
00:20 norms and standards in global health.
00:23 Uh,
00:24 I'll give a short introduction of
00:26 people I know very.
00:28 Very well,
00:28 I think,
00:29 but,
00:30 but I'll,
00:31 I'll,
00:31 I'll go to the formality.
00:33 But,
00:33 so Professor Yemi is the director of
00:36 the Center for Policy Impact in Global Health at Duke Duke Global Health Institute.
00:41 He's also the professor of Practice
00:44 of Global Health and professor of Practice of Public Policy at Duke University.
00:49 He currently chairs the International Advisory Committee
00:53 to The Lancet Commission on Global Hearing
00:56 Loss and co-chairs the Partnership for Maternal,
00:59 Newborn
01:00 and Child Health Finance and Economics Working Group.
01:03 As an external advisor to WHO and TDR,
01:06 Dr.
01:07 Yemi has published extensively
01:10 on global health,
01:11 neglected diseases,
01:12 and health policy and disparities in health.
01:15 Our other presenter.
01:17 Uh,
01:18 Professor Obuji is the deputy director of the Center for
01:21 Policy Impact and Global Health at Duke Global Health Institute.
01:25 He's also an assistant professor,
01:27 a research professor
01:28 of global health and an assistant professor
01:30 in population health sciences at Duke University,
01:34 a health systems researcher with a background in medicine,
01:37 public health,
01:38 and health economics.
01:39 His primary research interest is in making health systems
01:43 work better for all.
01:45 His work includes the application of quantitative models
01:48 to explore complex health system challenges
01:51 such as persistent health inequities,
01:53 child mortality,
01:54 and
01:56 inequitable health financing in low and middle income countries.
02:01 Now I'll hand over the floor to Dr.
02:03 Yemi and Dr.
02:03 Obuji.
02:04 Uh,
02:05 for the audience,
02:06 we will have about 30,
02:07 35 minutes of presentation,
02:09 then we will have about
02:10 1520 minutes for question and answer session.
02:14 Uh,
02:15 or to you,
02:15 Gavin.
02:16 Thanks so much,
02:17 Sid,
02:17 for that lovely introduction.
02:19 Let me just begin by acknowledging our first author,
02:22 Ishita Bharai.
02:23 Unfortunately she can't be with us today,
02:25 the air conditioning broke at the daycare,
02:28 uh,
02:28 where her baby is,
02:29 and so the baby's at home and is not napping,
02:31 um,
02:32 but I just wanted to acknowledge our first author.
02:35 So over the next 35 minutes,
02:38 uh,
02:38 we are going to kind of set the scene
02:41 and ask
02:42 why are norms and standards so foundational
02:45 to the global health
02:46 enterprise.
02:46 We're then going to present a framework
02:48 for standard setting in global health.
02:50 Who are health standards for?
02:51 Or
02:52 what dimensions of health
02:54 to standardize and why
02:55 are health standards used.
02:57 We're then going to discuss the implementation and
02:59 enforcement of standards with a few case studies,
03:02 international health regulations,
03:03 the framework convention for tobacco Control,
03:06 the essential medicines list.
03:08 Somebody's gonna discuss the political economy
03:10 of standard setting in global health,
03:12 including power asymmetry,
03:14 the dominance of high income countries,
03:16 national regulatory autonomy
03:18 versus global harmonization,
03:20 corporate influence and regulatory capture,
03:23 compliance costs and financial barriers and ethics
03:26 and equity and standard setting.
03:28 He's also going to discuss
03:30 the challenges of generating and using standards in global health,
03:33 then end with a set of our
03:36 recommendations.
03:38 But let me set the scene.
03:40 Why are standards so important?
03:43 The Institute of Medicine,
03:44 which is now the National Academy of Medicine,
03:47 has said that the goal of improving,
03:50 that the goal of improving health for all people in
03:51 all nations is what global health is all about.
03:54 Standards matter
03:56 because global health is a goal,
03:58 by promoting wellness and eliminating avoidable disease,
04:01 disability
04:02 and death.
04:03 And we can achieve that goal
04:05 through a combination of population-based interventions,
04:07 both inside the health sector,
04:09 like vaccination or outside.
04:11 Like reducing air uh air pollution,
04:14 together with individual level clinical interventions,
04:18 prevention,
04:18 treatment,
04:19 rehabilitation and palliation.
04:21 And critically,
04:23 to reach this goal,
04:24 this goal of improving health for all people,
04:27 interventions must be
04:29 based on and meet established norms and standards based on
04:32 the best evidence and implementable in many contexts to achieve health
04:37 for all.
04:38 And we know
04:39 from really rigorous research
04:41 that adopting evidence-based interventions that are effective,
04:44 safe,
04:45 high quality.
04:46 That's a very big driver
04:48 of global health progress.
04:50 Take for example,
04:52 WHO malaria guidelines,
04:54 now they set standards for a whole range of things from controlling
04:58 the mosquito,
04:59 vector,
05:00 malaria prevention,
05:01 how to use malaria vaccines to diagnose,
05:04 to treat malaria,
05:05 to eliminate malaria
05:07 uh for malaria surveillance.
05:10 The strength of each recommendation is given,
05:13 and the level of certainty of evidence behind
05:16 each recommendation is given.
05:19 There's no doubt that in our world,
05:21 global health,
05:22 WHO is seen as a key
05:24 norm setting agency.
05:26 Back in 2002,
05:27 I was very lucky to write a five part series for the British Medical Journal,
05:32 uh,
05:32 called Who in 2002,
05:34 and in one of the papers
05:36 called Why Does the World Still Need W,
05:39 I said it had an unrivaled reputation
05:42 in setting global standards,
05:44 and its normative products are highly.
05:47 Respected,
05:48 it's guidelines,
05:49 standards,
05:50 policy options,
05:51 and
05:51 so on.
05:53 It is also
05:54 an agency with high credibility that is based on two things.
05:57 It's inclusive governance,
05:59 it is governed by its 194 member states
06:02 and its unrivaled
06:05 convening power.
06:07 But.
06:09 Standards and norm setting in global health,
06:12 it's not just a technocratic exercise by a single agency completely divorced
06:17 from politics and ethics,
06:19 there are,
06:20 you know,
06:20 complications,
06:21 it's more complicated than that.
06:23 First of all,
06:24 the WH itself,
06:26 WHO has
06:27 faced criticism for some of its processes and standing setting.
06:31 For example,
06:32 a lack of rigor and transparency,
06:34 not always systematically reviewing the full evidence or using the right methods,
06:40 expertise,
06:41 or
06:42 focusing enough on implementation,
06:44 and not consulting
06:46 adequately
06:47 with low and middle income country er end users.
06:51 Clearly,
06:52 it's not the only agency setting standards,
06:54 Africa CDC,
06:56 the World Bank and other agencies.
06:59 Local adoption of standards depends on
07:01 country capacities or evidence-based policy making,
07:04 policy implementation,
07:06 it depends on the supportive
07:08 legislative environment
07:10 and sufficient financing to buy the recommended interventions,
07:14 such as medicines,
07:15 and there are ethical issues.
07:17 So for example,
07:18 what happens if the best available evidence
07:21 shows that the optimal treatment
07:23 is a very costly medicine.
07:25 That only high income countries can afford,
07:28 what are the ethics
07:29 of the WHO recommending that medicine
07:32 as the global standard?
07:36 So we wanted to present our framework for
07:39 thinking about standard setting in global health,
07:42 who,
07:43 what and why.
07:44 Who are global health standards for?
07:46 Now clearly every single human being
07:48 working in global health
07:50 is being guided by some kind of standard,
07:53 everybody.
07:54 You're a
07:54 pharmaceutical company,
07:56 you're being guided for example by WHO's good manufacturing practice,
08:01 if you're a clinician,
08:02 you're using clinical practice guidelines,
08:04 and we thought that one way to categorize all these different end users,
08:08 was by the level of the system where they operate,
08:11 and we developed this,
08:12 you know,
08:12 very simple
08:13 figure,
08:14 it's clearly.
08:15 Just indicative it's not exhaustive,
08:17 which has
08:18 global health organizations and donors at the top and then regional
08:22 health organizations,
08:24 national
08:25 level health policy makers,
08:26 and then public health programs and providers,
08:29 clinicians,
08:30 health researchers
08:31 and those
08:32 developers of medical products
08:34 uh uh
08:35 uh and technologies.
08:36 And so.
08:38 Here are some examples of standards aimed at each,
08:41 so global health
08:42 initiatives and donors
08:44 are um
08:45 influenced uh uh uh and affected by
08:48 aid effectiveness standards,
08:50 such as the Paris Declaration,
08:52 these standards aim to
08:54 harmonize the work of different donors towards.
08:57 Common goal,
08:59 and by pooled procurement,
09:00 that is the large scale purchase of medicines and vaccines,
09:03 and
09:04 multilateral agencies like Gavi and the Global Fund,
09:07 they are bound by their rules to purchase products
09:10 that have gone through an approved standardized pre-qualification program.
09:17 An example of a standard guiding the work of a regional health
09:21 agency is Africa CDC's Public Health Emergency of Continental
09:26 Concern.
09:26 Now that is a standard that
09:28 mobilizes and coordinates a regional response
09:33 uh to uh an outbreak,
09:35 and it was used for the first time
09:37 uh in August of last year for its Epox outbreak.
09:42 National health policy makers use national essential medicines lists,
09:46 I'm gonna say more about those
09:48 a little bit later,
09:49 and universal health coverage
09:50 packages.
09:52 Here,
09:52 a very key tool is the WHO's
09:55 uh UHC Compendium
09:58 of interventions.
10:01 Public health programs and providers use
10:04 the kinds of disease guidelines I showed earlier,
10:06 like the malaria
10:07 uh guideline,
10:09 as well as the international health regulations.
10:12 I'm going to talk a lot more about the international health regulations
10:15 in a minute.
10:16 uh they require countries to detect,
10:18 assess and respond to threats
10:21 that cross borders.
10:22 Clinicians
10:24 are guided by clinical practice guidelines,
10:26 health researchers.
10:28 By
10:29 the EquATA guidelines,
10:30 this is an incredible resource.
10:32 I'm gonna show you the EquATA website in a second,
10:35 it's an amazing resource
10:37 that collects together guidelines for every single different kind
10:42 of health
10:43 research study,
10:44 randomized trials,
10:45 observational studies,
10:47 and so on.
10:48 Other examples are the Declaration of Helsinki,
10:50 providing ethical guidance.
10:52 And medical product developers are guided by
10:55 a very powerful standard called
10:58 target product profiles.
10:59 These have been quite game changing actually in global health.
11:03 A target product profile describes
11:05 the desired
11:07 characteristics of a needed product.
11:10 So what would be the ideal efficacy,
11:13 who is the target population,
11:15 and so on.
11:16 Uh TPP was really critical,
11:18 for example,
11:19 in developing the
11:20 Ebola vaccine.
11:23 Here's the website I mentioned,
11:24 the Equator Network.
11:26 It has 665
11:28 guidelines
11:30 for guiding,
11:31 uh,
11:32 and standardizing.
11:34 Providing high quality
11:36 for
11:36 all these different types of health research,
11:40 it's really an extraordinary
11:42 resource.
11:44 But that's the who,
11:44 what about the what dimensions of global health and being.
11:47 Here we used
11:49 a framework that actually
11:51 uh WGR 2025
11:53 is adopting
11:55 more broadly,
11:55 minimum quality,
11:57 compatibility
11:58 and
11:59 measurement standards.
12:02 So minimum quality standards,
12:04 they include
12:05 regulation
12:06 of medicines,
12:07 vaccines and diagnostics,
12:08 no doubt here WHO this is a core function
12:12 for WHO right,
12:14 pre-qualification,
12:15 quality
12:16 assurance and so on.
12:18 Health facilities and equipment standards,
12:20 and actually here,
12:22 the World Bank has had an interest in this,
12:24 in 2018,
12:25 it produced a report with WHO and OECD on healthcare quality,
12:31 uh,
12:32 and it noted that
12:33 facilities and equipment
12:36 was really a foundational element of healthcare quality,
12:39 and there are tools out there
12:41 uh to assess facility.
12:43 Readiness,
12:44 public health and prac practitioners,
12:47 uh we've seen the sort of guidelines,
12:50 uh for malaria and other diseases earlier,
12:53 ethical standards,
12:55 um protecting humans who participate in research,
12:58 and medical education and training standards.
13:03 Here's the report I mentioned earlier from the Bank,
13:05 WHO and OECD.
13:08 These 5 foundational elements,
13:10 and I mentioned that
13:11 healthcare facilities and ensuring
13:14 medicines,
13:14 devices,
13:14 and other technologies
13:16 are 2 of those 5
13:18 foundational elements.
13:21 And finally,
13:22 uh uh sorry,
13:23 the second,
13:23 uh,
13:24 type of standards,
13:25 not finally,
13:25 there's measurement as well,
13:26 the compatibility standards,
13:28 so
13:28 global compatibility and interoperability standards in
13:32 health informatics,
13:34 telehealth,
13:35 digital health,
13:36 and so on.
13:37 There's regulatory harmonization and reliance,
13:40 regulatory harmonization is where the regulatory authorities worldwide,
13:44 they align their activities
13:47 in ways that will lead to common technical requirements for product development
13:52 and marketing.
13:53 Uh,
13:54 so that's regulatory harmonization,
13:56 regulatory reliance is where a regulatory authority in one jurisdiction.
14:02 Takes note of,
14:03 takes into account and gives significant weight,
14:06 to the assessments that are performed in a different
14:10 regulatory authority or trusted institution.
14:14 And we also wanted to note that some
14:15 minimum quality standards also function as compatibility standards,
14:19 so for example,
14:21 medical education standards which might allow
14:23 clinicians trained in one
14:25 jurisdiction in one country to be able to work
14:28 uh in another country.
14:31 And now the final one,
14:32 the 3rd 1 is measurement standards.
14:34 So for example,
14:35 standardized health research tools like the demographic and health surveys,
14:40 incredibly important tool in global health,
14:43 these are standardized household surveys
14:45 based on nationally representative samples,
14:48 sadly terminated in February
14:52 by the Trump administration as part of its aid cuts.
14:56 International classification of diseases,
14:59 uh
15:00 extremely important
15:02 for standardizing the diagnosis of diseases and causes of death globally,
15:06 completely fundamental
15:08 in global health,
15:09 for health services research,
15:10 for health payment systems,
15:12 for health planning.
15:14 Another example is the ATC,
15:16 the Anatomical
15:17 Therapeutic Chemical Classification,
15:19 that's all about drugs,
15:20 classifies,
15:21 you know,
15:21 what drugs are,
15:22 how they work,
15:23 what they're for.
15:24 And then of course global health estimates like
15:27 disability and quality adjusted life years and health adjusted
15:31 life expectancy.
15:34 Why
15:35 use
15:35 standards in global health?
15:37 In our report,
15:39 we identified 5 reasons for using standards.
15:43 Firstly,
15:44 I mentioned this earlier,
15:45 when you adopt them,
15:47 you can improve many aspects of health and public health.
15:51 Uh,
15:51 I mentioned that adherence to guidelines
15:53 improves clinical outcomes for many diseases,
15:55 breast cancer,
15:56 pneumonia,
15:57 uh,
15:57 and others.
15:58 Another example is,
15:59 um,
16:00 surgical
16:01 checklists,
16:01 standardized safe surgical checklists.
16:03 These are checklists that you tick off before operating.
16:07 For example,
16:07 have you made sure it's the right patient,
16:09 have you marked the surgical site,
16:10 and we know that they
16:12 reduce surgical complications,
16:13 including
16:14 mortality.
16:16 A second reason for using standards that
16:18 is that they set out principles for universality
16:22 in the delivery of essential health services
16:24 through UHC.
16:26 And in that way they help promote equity.
16:29 Here,
16:30 the 2019 UN political declaration on UHC was really critical.
16:36 Uh,
16:36 it helped to establish global commitment to UHC and also to set standards for UHC,
16:42 for sort of principles
16:43 and benchmarks.
16:46 The third reason that standards can drive
16:48 efficiency and value for money.
16:50 Here an example
16:52 is the Disease Control Priorities Project's
16:55 essential UHC package.
16:57 It has defined a package
16:59 of high value
17:00 interventions.
17:03 A 4th reason is that
17:04 compatibility and measurement standards allow you to
17:07 compare health data across place and time.
17:10 ICD DALYs,
17:12 demographic and health surveys,
17:14 and DALYs we know are really important in
17:17 showing that some diseases like neglected tropical diseases,
17:21 they may not be major contributor to premature mortality,
17:25 but are highly disabling.
17:27 That then led to policy
17:29 action.
17:30 And finally,
17:31 I gave an example earlier
17:33 of how global health standards like
17:35 these target product profiles help to stimulate
17:38 medical
17:39 product development.
17:41 The last thing I'm gonna talk about before I pass to Osondu.
17:45 Is the implementation and enforcement of
17:48 global health standards.
17:50 Now,
17:51 Standard setting bodies,
17:53 er like the WHO like the International Organisation for Standardization,
17:59 they,
18:00 you know,
18:01 don't have
18:02 the er power,
18:03 the enforcement power
18:05 er to sort of force countries to adopt standards,
18:08 and these standards are generally not
18:11 legally binding,
18:12 with some exceptions which I'm gonna show you,
18:14 right,
18:14 they're mostly
18:16 voluntary.
18:17 So
18:18 generally bodies are encouraging countries to adopt them
18:22 through
18:23 national instruments
18:25 like laws,
18:25 regulations and policies,
18:27 and through links
18:28 to global goals like the SDGs and financing mechanisms like the Global Fund
18:34 and GAI.
18:35 And we argue,
18:37 we thought about kind of why it is that
18:39 some standards are mandatory and some are voluntary,
18:42 but we thought about it,
18:43 we thought there were 4 principles
18:46 that were influencing that
18:47 kind of uh.
18:49 Determination,
18:50 the first is the severity of the risk.
18:52 International health regulations
18:54 were made legally binding given the high risks associated with epidemics
18:59 and pandemics.
19:01 The second is the degree of buy-in and consultation from stakeholders.
19:05 The framework convention on Tobacco Control made mandatory
19:09 as a result of very broad consultation
19:12 uh with member states and stakeholders.
19:16 The third is how feasible
19:18 it is for countries to adopt
19:21 standards,
19:22 you know,
19:23 can they enforce them,
19:25 uh,
19:25 and of course countries have got
19:27 very variable capacity
19:29 for adoption,
19:30 implementation,
19:31 and enforcement,
19:32 and so
19:33 some guidelines turn out
19:35 to be voluntary because of that.
19:37 Essential medicines list,
19:39 air quality guidelines,
19:40 and so on.
19:41 And 1/4 is
19:42 specifically for vaccines,
19:44 the strength of the scientific evidence
19:46 combined with the opportunity for
19:48 community-wide protection.
19:51 That
19:51 probably is what's behind
19:53 vaccine mandates in pandemics,
19:55 and here in the US
19:57 childhood vaccine mandates for school entry.
20:02 Two global health standards that are absolutely key
20:05 are mandatory.
20:06 The International Health regulations,
20:08 they are legally binding on 196 countries.
20:12 Countries are required to detect,
20:14 assess and respond to risks that cross borders.
20:17 Every country must have a focal point for IHR.
20:21 They must be able to do surveillance
20:23 and reporting
20:24 of a public health emergency of international
20:28 consent
20:29 and enforcement mechanism or a legal mechanism.
20:32 And if a fake is declared,
20:35 it does have an impact.
20:36 It mobilizes resources,
20:38 guides the international responses and influences travel and response.
20:42 But compliance
20:44 is not perfect,
20:45 there are gaps.
20:47 For example,
20:48 low and middle income countries may lack funding for surveillance.
20:52 There may be poor awareness
20:54 of your obligations under the IHR.
20:57 And in some situations,
20:58 countries may prioritize trade,
21:01 finance
21:02 and intellectual property over say medicines and vaccines,
21:05 um,
21:06 prioritize those over
21:08 disease control.
21:10 The other
21:11 mandatory global health standard is the Framework Convention on Tobacco Control,
21:14 legally binding in the ratifying nations.
21:17 Countries
21:19 are required to control tobacco use,
21:22 for example,
21:23 through
21:23 advertising bans,
21:25 tobacco taxes,
21:26 warnings on packages.
21:29 Uh,
21:29 this was adopted in 2003,
21:32 and research has shown
21:34 that.
21:35 Uh,
21:35 ratifying nations
21:38 have seen a fall in smoking prevalence.
21:41 A fall in the number of young smokers
21:43 and an increase
21:45 in quitting.
21:47 And the impact is larger
21:49 in countries that have included tobacco taxes.
21:52 But again,
21:53 there are gaps in in in compliance,
21:55 there's quite widespread interference from the tobacco industry,
21:59 uh,
22:00 and some governments want tobacco revenue,
22:03 uh,
22:03 which may make them reluctant to
22:06 uh curb smoking.
22:09 Here's an example of a voluntary global health standard,
22:12 the WHO's model list of essential medicine,
22:16 which has been key
22:18 in improving medicine access,
22:19 and it has helped shape
22:21 national
22:22 health policies.
22:23 It has encouraged many low and middle income countries.
22:27 Develop their own
22:28 national essential medicines list,
22:30 right,
22:30 they will take the WHO list,
22:33 and they will adapt it for their own
22:35 country
22:36 setting.
22:37 And to help them to do that,
22:38 WHO has an electronic
22:41 essential medicines list,
22:42 free,
22:42 comprehensive online database
22:45 on essential medicines.
22:46 And it maintains a really fascinating
22:49 database of
22:50 all the existing
22:52 national essential medicines list for 137 countries.
22:56 So here's the electronic EML.
22:59 All of the essential medicines in the WHO's
23:02 essential medicines list,
23:04 and here's this global database of national essential
23:07 medicines lists.
23:09 I wanted to just flag one thing is that
23:11 this shows you the number of differences,
23:15 the number of medicines
23:16 that are included
23:17 in the national
23:19 essential medicine list compared
23:21 with the WHO list,
23:22 right,
23:22 so
23:23 not every country's list looks exactly the same
23:26 as the WHO list.
23:29 In terms of implementation,
23:31 this has been going on since
23:33 1977,
23:34 updated every two years,
23:36 there's a consultative process,
23:37 there's an expert committee involved,
23:40 and that's the WHOL and then national emails,
23:43 as I said,
23:43 are tailored to address
23:45 specific
23:46 health priorities,
23:47 resource availability,
23:48 there are variations between country and
23:50 political commitment and health infrastructure,
23:53 but they have had a key role.
23:55 In developing standard treatment guidelines,
23:57 promoting rational medicine use,
23:59 improving healthcare quality and access to priority medicines,
24:03 and in general,
24:04 countries that implement an essential medicines list do
24:08 report better quality
24:09 use of medicine indicators,
24:11 these are indicators that evaluate,
24:13 How appropriately,
24:14 safely and effectively
24:16 medicines are being prescribed
24:18 and used in
24:19 healthcare settings,
24:20 but I said
24:22 earlier that,
24:22 you know,
24:23 there isn't perfect alignment,
24:25 uh,
24:26 I talked earlier about you know what's required for successful implementation,
24:31 and it's not always the case
24:33 that an NEML
24:35 will always improve access to and availability
24:38 of essential medicines at health facilities.
24:42 There are 3 other case studies of implementation
24:44 and enforcement of standards in our report,
24:46 we don't have time to examine them today,
24:48 but if you're interested,
24:50 case studies on nutrition labeling,
24:52 air quality guidelines,
24:53 and health workforce standards.
24:56 Now I'm going to pass on to Sodu,
24:58 who's going to talk about political economy
25:00 challenges and our set of recommendations.
25:05 Thank you,
25:05 Gavin,
25:06 and um greetings to everyone.
25:08 I'll be talking about the politics,
25:10 economics,
25:10 and um challenges.
25:12 And also like Gavin said,
25:14 I'll be sharing the uh the set of recommendations.
25:17 So in our report,
25:18 we highlighted three reasons why standards are important
25:24 from a political and economic perspective.
25:27 The first is that standards.
25:30 Perform a gatekeeping role and what we mean by this is that
25:34 once standards are in place,
25:36 it determines they determine who
25:39 the players in the game are,
25:40 who will be allowed to participate or not,
25:44 like
25:46 licensing for medical doctors and other health workers.
25:49 The second function is that standards have a resource allocation role,
25:53 as you will see with the national emergency medicines lists,
25:58 the TPP target product profiles that determine
26:03 that prioritize which products to
26:07 fund for research,
26:08 the national emergency medicines list that prioritize which
26:11 medicines to buy,
26:12 and also there is a resource allocation role.
26:15 And also
26:16 the third thing is that
26:19 When standards are in place,
26:20 they create some kind of
26:22 jostling for power,
26:23 power dynamics,
26:24 and this competition
26:26 creates some geopolitical
26:28 tensions.
26:29 Next slide,
26:30 please.
26:32 So as much as we would hope and wish that we live in
26:34 an egalitarian society where everyone is equal and everyone is singing kumbaya,
26:39 that's not the case.
26:40 And we know that politics significantly influences
26:43 standard setting because of the power symmetries that
26:47 exist and continue to
26:50 be.
26:52 Present
26:54 among global health actors
26:56 and this creates a system where you now have what we call
27:01 standard
27:02 makers and then the standard takers and the standard makers essentially
27:07 play active roles in determining what standards are adopted or
27:10 what standards are created and what standards are adopted,
27:13 and the standard takers essentially look to the standard makers
27:17 for
27:19 guidance.
27:20 And there has been a lot of work
27:23 to blur the lines between the standard makers
27:25 and the standard takers by organizations like WHO,
27:29 but there's still a lot more
27:30 to be done.
27:32 So,
27:32 um,
27:32 let's explore some of the political dimensions.
27:35 We have
27:37 two examples here,
27:38 uh,
27:39 power asymmetry and the dominance of high-income
27:42 countries in the standard setting process.
27:44 And here a few examples come to mind.
27:47 Here we listed three
27:50 high income countries because they are present in
27:52 most of the forums where standards are negotiated or
27:58 determined.
27:59 They use their agenda setting power to control which
28:01 issues rise to the top of the agenda,
28:04 and
28:05 in that way they can decide what's what's important and what's not.
28:10 High income countries also export
28:12 their regulatory models as gold standards
28:16 to other regions,
28:17 and sometimes these standards are many times
28:20 these standards are more high quality,
28:23 and so they are determined as gold standards.
28:26 The problem though is that not all countries
28:29 or not all jurisdictions might be able to afford
28:34 those standards.
28:35 And when low income,
28:37 low and middle income countries are invited to the table,
28:40 as is
28:41 increasingly happening,
28:44 they have challenges,
28:46 financial challenges and other challenges,
28:47 capacity challenges
28:49 that make it difficult
28:51 for them to be able to contribute as much
28:53 as they should contribute to the standards setting process.
28:58 The second point here is about the tensions that exist between national regulatory
29:03 autonomy and the responsibilities of the country actors
29:07 as contributors to the global health system.
29:09 So for example,
29:12 um,
29:12 during COVID when WHO issued emergency use listings for
29:16 the COVID-19 vaccines,
29:18 some countries,
29:19 the US,
29:20 the UK,
29:21 mostly high income countries,
29:23 reissued their own
29:26 domestic standards that were often stricter,
29:29 but that fragmentation in regulation for COVID vaccines had an impact on the global
29:36 global vaccine
29:37 rollout.
29:39 Uh,
29:39 when countries also agree on standards like Gavin talked about the IHR and the FCTC,
29:45 uh,
29:45 the implement the adoption and implementation within the country
29:49 varies widely.
29:50 So,
29:51 uh,
29:51 and that's because of some of the challenges that you will see.
29:54 So if you're supposed to do the IHR.
29:58 Countries have experienced negative
30:00 impacts from,
30:02 for example,
30:03 reporting the Omicron
30:04 strain that South Africa experienced,
30:06 and then there was a ban to many African countries
30:09 because of that.
30:11 So,
30:11 there are some inherent disincentives that countries might be
30:15 wanting to optimize for or protect themselves against.
30:19 And so you see that the implementation of these standards varies
30:22 widely
30:23 across countries.
30:25 On the economic considerations,
30:27 um,
30:28 there are setting issues.
30:30 The two main ones will be corporate influence
30:34 and then the burden of compliance.
30:36 For corporate influence and regulatory capture,
30:38 the examples that we,
30:40 uh,
30:41 some of the examples we included are the US pharmaceutical industry.
30:45 Which influenced
30:47 regulatory organizations around the world to downplay the risks of the opioid
30:53 of the opioid medications and these affected
30:55 countries that dependent on these high income countries
30:59 regulators like Gavin talked about reliance and also
31:04 of some low and middle income country regulators on others.
31:08 There's also a revolving door that exists between big businesses
31:13 and regulators.
31:14 In general,
31:14 most people who have expertise regulating once they leave the government,
31:19 big industry wants to hire them to help them navigate the regulatory process.
31:23 You see that with tobacco.
31:25 You see that in tobacco and the EPA.
31:27 You see that with
31:28 big pharma
31:29 and the FDA,
31:32 and it happens
31:34 in general.
31:35 And lobbies uh also um
31:39 have um outsized influence on,
31:41 uh,
31:42 uh,
31:42 adoption and implementation,
31:44 for example,
31:44 the FCTC.
31:46 I touched on this very briefly before,
31:48 but I'll
31:49 explain a little bit more now.
31:50 The burden of compliance and the cost and the financial barriers.
31:53 So
31:55 the expenses that are associated with
31:58 compliance
31:59 with
32:00 different standards shift limited healthcare funds
32:03 away from actual care delivery.
32:06 Into compliance.
32:07 So some studies that were done showed that
32:09 the reporting requirement for hospitals in the US
32:13 every year runs into the tens of billions of dollars.
32:16 Some will argue that rather than do that,
32:18 you could move that into
32:20 providing healthcare for people in rural areas,
32:22 right?
32:23 But those standards are also important.
32:26 Even though they are important,
32:27 it's difficult for
32:29 rural hospitals to meet those reporting burdens,
32:32 and it's the same thing
32:34 across the world.
32:35 WHO did a review in 2014 and found that on average,
32:39 countries are expected to report on
32:41 at least 600 indicators across their health programs.
32:45 This is going to be very difficult,
32:46 although this has shown to be very difficult
32:49 for many low income countries where they are barely surviving.
32:52 And have
32:54 on they spend on average less than $20
32:58 per capita on health.
33:00 And low low and middle income countries may also
33:03 lack the regulatory capacity for some of the products,
33:05 for example,
33:06 the biosimilars
33:08 that are being rolled out in many high income countries cannot,
33:12 there's no capacity to regulate them.
33:14 We didn't forget about ethics and equity
33:17 in the global health standard setting,
33:19 and we highlighted the fact that healthcare standards that were initially
33:24 developed in high income countries.
33:27 May unintentionally
33:29 be unsuitable for low income countries,
33:31 and the example here will be HPV
33:34 and the gold standard for HPV is the
33:37 DNA,
33:38 cervical cancer screening.
33:40 It will be the DNA,
33:41 HPV DNA testing,
33:43 but
33:43 many rural dwellers and also many low income countries cannot afford to do.
33:49 HPV DNA testing.
33:51 So while it might stand on its own as the gold standard,
33:54 it's still not applicable to many of the resource
33:57 poor settings.
33:59 Access to clinical trials for health products is limited
34:01 in low and middle income countries,
34:03 and this effectively limits access to new products.
34:06 We are,
34:06 we are seeing this more and more as precision medicine.
34:10 scales up around the world and
34:13 manufacturers are beginning to put on the labels that these were not tested,
34:17 these were not tested in certain populations and
34:19 so should not be used in those populations.
34:22 There's also the widely described discussed issue
34:25 of algorithmic bias where you have diagnostics,
34:29 AI-driven diagnostics
34:31 that were trained on certain populations,
34:33 mostly male,
34:34 mostly
34:36 Caucasian,
34:37 and so are not very applicable to
34:40 other populations,
34:41 women in general,
34:43 and also non-Cucasian populations.
34:48 And
34:49 recently and
34:51 it's
34:52 increasingly becoming the case that Google,
34:55 Amazon,
34:56 Microsoft,
34:56 and all the big tech giants are
34:59 interested in and playing a big
35:01 part of the healthcare landscape,
35:03 and people are becoming worried about what happens
35:07 when there's a risk of commercial exploitation and loss of privacy.
35:11 For example,
35:11 the gene.
35:12 Uh,
35:13 a company that just folded up,
35:15 declared for bankruptcy.
35:16 There's an issue now.
35:17 What happens to all the genetic data that already resides with that company?
35:21 Next slide,
35:22 please.
35:23 So I'll talk about the challenges of
35:26 moving standards.
35:28 Uh,
35:28 agencies in general try to do the best they can,
35:31 but there is a practice where people tend to
35:34 rely on expert advice rather than looking at systematic reviews
35:38 and not looking at the whole picture but just relying on what people
35:44 tell them to do,
35:45 and that is not the best way to approach
35:48 um standard setting,
35:49 and we make a recommendation about this.
35:52 Next.
35:55 Uh,
35:55 it's also difficult to find evidence even though we're advocating for evidence.
36:00 We also acknowledge the fact that some types of evidence are hard to get.
36:03 So for example,
36:04 how do you
36:06 evaluate the impact of WHO?
36:08 WHO does a lot.
36:10 But it's very difficult for you to be able to
36:12 um regulate the impact
36:14 of,
36:14 uh,
36:14 sorry,
36:15 to um evaluate uh properly the full impact
36:18 of WHO.
36:19 There's too little data,
36:20 incomplete data,
36:21 and so a lot of the resource constraints will make it impossible.
36:24 Next.
36:27 The challenges with using standards are also very
36:32 important.
36:32 So for example,
36:34 if
36:35 there's a good standard,
36:36 we talked about HPV as a gold standard,
36:39 if it is truly a good standard,
36:41 how do you implement this in diverse settings,
36:44 right?
36:44 Some countries may have the right institutions and structures,
36:47 some may not.
36:48 But how do you ensure that Everyone has access to the best standards,
36:53 but at the same time,
36:54 you do not exclude some people
36:56 from getting access to some form of
36:59 uh regulation
37:02 that they would
37:03 benefit from rather than getting the top.
37:06 And that needs a lot of time and human resources.
37:09 So there was a study that was done to look at
37:12 whether there were independent agencies in countries
37:16 to look at the adoption
37:17 and the adaptation and adoption of child health guidelines.
37:22 And they found that several countries did not,
37:24 notably Nigeria and Malawi did not have
37:27 standard agencies or clearing houses to look at child health guidelines,
37:31 even though they had standards organizations that looked at other things
37:35 for the whole country,
37:36 but for children's health,
37:38 that was not the case.
37:40 And so this
37:42 may lead to situations where there are inconsistent regulations across countries
37:46 and can lead to disparities.
37:48 We are already seeing a lot of that with access to blood,
37:52 human products like blood coa,
37:54 and the human milk.
37:55 Next slide.
37:58 Um
38:00 So this
38:01 this slide just talks about the
38:04 the further challenges in
38:07 using standards,
38:08 and we are,
38:10 we,
38:11 we look at the global measurement standards,
38:13 for example,
38:14 the burden of disease.
38:15 We talk extensively about the dalis,
38:19 the use of dli and
38:22 its derivatives
38:24 in measuring the burden of disease and how that might introduce some.
38:28 Issues.
38:29 The fact that not all countries contributed d
38:33 data to the measurement of to the creation of the dlis also raises some ethical
38:40 issues and challenges in adopting those standards.
38:43 Next.
38:47 So we have 8
38:49 recommendations,
38:49 and I'll just quickly go through all of them.
38:51 The first is to make the standard setting process more robust.
38:54 We should use more of the evidence,
38:56 less of the experts.
38:57 I mean,
38:58 the experts can guide the use of the evidence,
39:00 but we should have a systematic process that would incorporate all of them.
39:04 The second is to improve interlinkages between
39:07 different standards to increase their value.
39:09 So for example,
39:10 using the WHO emergency medicine,
39:12 essential medicines list and also linking that to the
39:15 universal healthcare benefits benefits packages
39:18 strengthens that connection and also
39:21 increases the likelihood of use.
39:24 Develop new.
39:25 The 3rd will be to develop new approaches to
39:27 impact evaluation and evaluate the importance of normative evaluation
39:31 by global health agencies.
39:33 We talked about the example of WHO.
39:36 The 4th is to innovate in diffusing standards.
39:39 So WHO currently recognizes that it could do better
39:42 in developing new ways for countries to adopt,
39:46 to know about the standards,
39:48 participate in the process,
39:49 and also adopt.
39:50 Next slide please.
39:53 So the 5th is to strengthen country capacities
39:55 in contextualizing and implementing global norms and standards,
39:59 and here we're looking at the IHR,
40:02 the FCTC,
40:03 but also other standards that may be developed because it
40:06 is possible to have standards like we talked about,
40:08 but countries not able to adapt them to the local context.
40:12 The 6th is to increase
40:14 the inclusion of local end users,
40:16 especially from low middle income countries in
40:19 the generation of global health standards,
40:21 and that might include funding,
40:23 providing technical capacity building and all that so that they are
40:26 active contributors to the standard setting process and not just passive standard
40:32 takers.
40:34 The 7th
40:35 recommendation will be to encourage nations to comply with the IHR.
40:39 This is easy to say,
40:41 very hard to do.
40:42 And the 8th is to promote a global agenda on diagnosis,
40:46 measurement,
40:46 and management of disease in diverse populations.
40:49 This is a very important
40:51 recommendation,
40:52 and we included it here because of the increasing.
40:55 dominance of precision medicine where
40:58 healthcare standards will no longer be applicable
41:00 on the population level but will now more
41:03 and more be applicable at the individual level and even at the cellular level.
41:07 So we need to create systems that will promote this
41:10 global agenda but account for those differences and account
41:14 for the diversity that exists within and across populations.
41:19 Thank you very much.
41:20 Uh,
41:21 thank you,
41:22 Gavin.
41:22 Thank you,
41:23 Sundhu,
41:23 uh,
41:23 for the presentation.
41:25 So if you're in the audience,
41:26 please
41:27 feel free to raise your hands to ask
41:29 a question.
41:30 Uh,
41:31 before that,
41:31 I have a quick question actually to you and,
41:34 uh,
41:34 Gavin and Sundu.
41:35 So,
41:35 so,
41:35 Gavin,
41:36 uh,
41:36 I mean,
41:36 I know that I worked with you,
41:38 so I know your work on
41:39 the 4D's,
41:40 uh,
41:40 the diseases,
41:41 demographic,
41:42 domestic resource mobilization,
41:44 and donor transition.
41:45 And a lot of countries in Africa,
41:47 in Asia,
41:47 many developing countries
41:49 moving,
41:49 changing from communicable to non-communicable diseases.
41:52 There is
41:53 a demographic transition of a lot of young people there,
41:57 and now
41:58 the donor transition or even
42:00 donor funding even stopping.
42:02 So my,
42:03 my question is on,
42:04 on
42:05 these standards for,
42:06 let's say these,
42:07 these countries are becoming maybe richer or,
42:09 or,
42:10 or moving through this,
42:11 this transition.
42:12 So now they don't have
42:14 enough funds,
42:16 so.
42:17 Do they follow a higher standard like you talked about
42:21 in high income countries,
42:22 the gold standard,
42:24 or
42:25 do they,
42:26 based on the situation,
42:27 they adapt to certain lower standards based on the situation they are in this.
42:33 The
42:34 sort of universe.
42:36 No,
42:36 I,
42:37 I'm very,
42:37 I mean,
42:38 I look at,
42:39 as you said,
42:39 severity.
42:41 I mean,
42:41 because health standards are not like technology standard or
42:44 your television screen or you have bad standards,
42:47 so it's OK because you're screened,
42:49 your quality of
42:51 Television might not be good,
42:52 so it's OK,
42:53 you can live with it,
42:54 but in health,
42:55 uh,
42:56 it's,
42:56 it's,
42:57 it's life or death.
42:58 So
42:59 for a country like Malawi or The Gambia,
43:02 in fact,
43:02 I was going to talk about the Gambia cough syrup case when
43:05 where the cough syrup imported from India in 2022 led to the death of 60 children,
43:11 and there was an argument from India that oh we,
43:14 it's,
43:14 it's Gambia who has to figure out the compliance and regulation when,
43:17 when we send the medicine.
43:19 Uh,
43:19 uh,
43:19 we try,
43:20 but it's the importing country.
43:22 So I'm just saying,
43:23 how,
43:23 how is,
43:24 do you suggest,
43:25 uh,
43:25 sort of a,
43:26 a scale that,
43:27 OK,
43:27 based on your income level or these 4 D's,
43:30 you adopt a standard
43:31 or you do a higher standard where you save lives.
43:36 Sorry,
43:37 thank you.
43:37 That,
43:38 that's all.
43:42 Sunday,
43:42 do you want to take that and then I can add?
43:44 Sure,
43:45 yeah.
43:46 Thank you very much to that.
43:47 And,
43:47 and yeah,
43:48 you raised very important questions,
43:49 and I think that it's something that we try to address in the paper,
43:53 um,
43:54 but I'll also share a little bit more
43:56 uh here.
43:57 So in healthcare,
43:58 well,
43:59 in health
44:00 and in general,
44:01 in healthcare,
44:01 we tend,
44:02 we tend to prioritize safety
44:04 above all.
44:05 In fact,
44:06 in the,
44:06 um,
44:07 in the physician's oath,
44:08 there's,
44:08 um,
44:09 some,
44:09 uh,
44:10 there's a part that says we will not do no harm,
44:13 right?
44:14 So like you said,
44:15 it's not like
44:16 looking at standards like for
44:17 for
44:18 for a car,
44:19 a television or something,
44:21 but in healthcare we tend to prioritize safety.
44:23 So to the extent that the minimum safety guidelines are met,
44:28 um,
44:29 then that will be a good standard for that population,
44:31 right?
44:32 And so,
44:32 but there are other things if resources permit,
44:35 if there are more resources,
44:36 you could do better.
44:38 So in general you can provide care that will be life
44:41 saving care in a rural area without having a CT scan,
44:45 but in a case where there is a CT scan,
44:48 there are certain things that you need to use,
44:50 you need to do with that CT scan and not to improve care.
44:54 We talked about the HPV DNA
44:57 as a gold standard.
44:58 It doesn't mean that that's the only thing that can be used
45:02 to diagnose
45:04 to screen for cervical cancer.
45:06 So there are other alternatives,
45:08 and WHO is moving towards,
45:10 has made
45:11 significant efforts to move towards having tiered
45:15 levels and recommendations for different
45:19 organizations,
45:20 jurisdictions,
45:21 and populations,
45:22 and part of that
45:23 is having everyone and everyone's voice.
45:27 At the table where the standards are being set
45:30 and that's why one of the recommendations we we made was
45:33 have everyone at the table,
45:35 but not just having them at the table,
45:37 right.
45:38 Ensure that they are competent enough and have the capacity to contribute.
45:43 Sometimes you have people who are competent,
45:45 but they don't come with all the studies that are needed
45:48 from that population to be able to contribute to the discussion.
45:51 So even though they are competent,
45:54 they can talk about these things,
45:55 but
45:56 the studies were not done in the country,
45:59 and so
46:00 they fall back to using other,
46:02 other data.
46:03 The other thing you talked about,
46:04 for example,
46:05 for
46:06 The case with Gambia and India.
46:09 I don't think we addressed
46:11 this explicitly in the paper,
46:12 but what we,
46:15 it's it's an important issue,
46:16 and I think it goes to the issue of responsibility assignment.
46:19 Who is responsible
46:21 for
46:22 monitoring
46:23 the standards,
46:24 and I think that here again there needs to be intercountry collaborations.
46:29 We talk about that in one of
46:30 the recommendations without mentioning this case explicitly.
46:34 But there needs to be
46:35 a lot of cooperation across jurisdictions to ensure that this happens,
46:40 and
46:41 there needs to be a way to incorporate the cost,
46:44 right?
46:44 The cost of
46:46 Um,
46:47 uh,
46:48 failing the standards,
46:49 right?
46:49 Someone should bear the cost.
46:51 If you incorporate that cost
46:53 and assign that to the person who is,
46:55 then it makes it easier,
46:57 um,
46:57 to take care of,
46:58 uh,
46:58 the situation.
46:59 Yeah.
47:00 Gavin,
47:01 yeah,
47:01 just a two very quick points just to echo Asandu,
47:04 there are increasingly initiatives.
47:07 That are aimed at
47:09 tailoring guidance to different income
47:12 levels and different
47:14 settings.
47:14 I mentioned Disease Control priorities,
47:16 DCP 3,
47:18 and
47:19 they,
47:19 for example,
47:20 have defined different UHC packages for different income
47:24 levels,
47:26 and.
47:27 And then the other thing to say is uh just about
47:32 prioritization I think is really important
47:35 in this transition,
47:37 uh,
47:37 discussion.
47:39 Sondo and I were both very lucky to be.
47:41 Commissioners for The Lancet Commission
47:43 on investing in health,
47:45 um,
47:46 the 3rd edition.
47:48 Uh
47:50 Has the goal of 50 by 50,
47:52 a 50% reduction in,
47:54 uh,
47:55 achieving um premature,
47:57 in reducing
47:58 the probability of premature mortality by 2050,
48:01 and that goal,
48:02 in our report
48:04 can be achieved by prioritization.
48:07 15 priority conditions that we defined
48:10 for all
48:11 low and middle countries
48:13 with interventions
48:15 that
48:16 are affordable,
48:18 should be affordable to all,
48:20 provide high value for money.
48:21 So I think
48:22 that,
48:23 that,
48:23 that's part of the conversation
48:25 is around
48:27 uh prioritization as well.
48:29 OK,
48:30 thank,
48:30 thanks,
48:31 Gavin.
48:31 Thanks also do,
48:32 uh,
48:32 shabby,
48:32 you,
48:33 you,
48:33 you
48:34 question.
48:35 Yeah,
48:36 thank you.
48:36 Thank you so much for uh this very,
48:39 very,
48:39 very interesting and,
48:40 and,
48:41 you know,
48:41 comprehensive presentation.
48:42 I,
48:42 I,
48:42 I really,
48:43 I really appreciate it.
48:45 Um,
48:45 so I have
48:46 two questions that are completely unrelated,
48:48 uh,
48:49 uh,
48:49 maybe one for Gavin,
48:51 uh,
48:51 uh,
48:52 about,
48:52 uh,
48:52 EMLs,
48:53 um,
48:54 and another one on,
48:55 on data compliance and,
48:57 and the need for data,
48:58 OK.
48:58 So that maybe,
48:59 maybe as soon that you can,
49:00 you can take on.
49:01 So,
49:01 on the EMLs,
49:03 so one of the things that we've,
49:04 we've,
49:04 um,
49:06 realized is,
49:07 you know,
49:07 it's sort of,
49:08 if you plot the number of medicines in the national EML
49:12 on across GDP per capita,
49:14 what you find is that richer countries tend
49:16 to have more medicines in the national EML
49:19 compared to poor,
49:20 poorer countries.
49:21 Now,
49:21 this might make sense because of all the reasons you've said
49:24 about capacity and so on.
49:26 However,
49:27 um,
49:28 what you do realize is that actually richer countries tend to have
49:33 Many,
49:33 many more medicines that are even included in the WHO EML.
49:37 And so,
49:38 I don't know whether that's,
49:39 you know,
49:40 whether WHO is playing a catch-up,
49:42 uh,
49:43 you know,
49:43 because,
49:44 you know,
49:44 it takes time and,
49:45 and a process to include
49:47 medicines in the WHO and so,
49:49 and so it's just a matter of time and,
49:51 uh,
49:51 um,
49:52 till,
49:52 till,
49:53 you know,
49:54 some of these medicines that are not in the WHO
49:56 but are in the national EML especially for richer countries,
49:59 will be,
50:00 um,
50:01 will be incorporated.
50:03 But also,
50:04 um,
50:04 if we think about,
50:05 um,
50:06 low,
50:07 you know,
50:07 low-income countries that have smaller,
50:10 you know,
50:10 have
50:11 both an overall,
50:12 uh,
50:13 overall
50:14 fewer medicines and also
50:16 fewer medicines that are in the WHO
50:19 when you contrast that with then,
50:21 um,
50:22 Some,
50:22 some studies,
50:23 actually,
50:23 very interesting studies that look at uh compliance with the EML.
50:26 So,
50:27 so basically,
50:28 you know,
50:28 whether,
50:29 you know,
50:30 doing some audit studies,
50:31 you know,
50:31 you send people randomly people to,
50:34 to various health providers and,
50:35 and check basically whether
50:37 certain medicine is in,
50:39 you know,
50:39 they have it in stock or not.
50:41 Uh,
50:41 so,
50:41 so you,
50:42 you find the availability of,
50:43 of,
50:43 of,
50:44 of,
50:44 of said medicines.
50:45 What you've actually find,
50:46 which is,
50:47 which is interesting is that
50:48 actually availability.
50:50 does not really
50:52 increase also with income,
50:53 right?
50:53 And so,
50:54 so they've,
50:54 they've somehow been able to tailor
50:57 the medicines to basically
50:59 make sure that uh whatever medicines are in the,
51:02 in the national EML
51:04 they,
51:05 they tend to have actually.
51:06 And so that's,
51:06 I think that's,
51:07 that's very good,
51:08 right?
51:08 Because they could,
51:09 you know,
51:09 they could boast
51:10 a very large national EML but then,
51:13 you know,
51:13 none of those medicines would,
51:15 would make it into.
51:15 So,
51:16 so,
51:16 I guess the question,
51:17 so,
51:18 so,
51:18 so the question is,
51:19 you know,
51:21 What is the objective in setting a national EML precisely to make sure that they,
51:25 they can comply with them and then
51:27 as countries grow,
51:28 as the capacity grows,
51:30 then increase the number of,
51:32 of,
51:32 of,
51:33 of,
51:33 of,
51:33 uh,
51:34 medicines in the EML,
51:35 uh,
51:36 and then what is the downside of,
51:38 of actually,
51:39 um,
51:40 you know,
51:40 not finding,
51:41 so
51:42 once it,
51:42 once a medicine makes it into the EML,
51:45 um,
51:45 you know,
51:47 You know,
51:48 can,
51:48 can,
51:48 can.
51:50 Can patients sue the,
51:51 the health department?
51:52 Can,
51:53 you know,
51:53 can,
51:53 can they raise an outcry in,
51:55 in the press?
51:55 I mean,
51:56 you know,
51:56 what are the,
51:57 I guess,
51:57 what are the downsides
51:59 for the authorities
52:00 to not providing,
52:02 uh,
52:02 or not making access available,
52:05 uh,
52:05 of.
52:05 For a medicine that's that's in the national EML,
52:08 OK,
52:08 so that's,
52:09 that's,
52:09 yeah,
52:09 so
52:10 yeah,
52:10 I mean,
52:11 you know,
52:11 Gavin,
52:11 please,
52:12 you take it on and um,
52:12 I don't know the answer to the legal status
52:16 of whether there's anything legally binding because I,
52:19 I,
52:19 I just don't know that,
52:20 um.
52:21 That,
52:22 uh,
52:22 legal landscape,
52:23 I mean,
52:23 what is it for is a great question.
52:25 I mean ultimately,
52:26 the WHO put so much effort into this
52:30 essential medicines list,
52:32 updating it every two years,
52:34 going through this,
52:35 you know,
52:35 quite rigorous process,
52:37 uh,
52:38 with,
52:39 you know,
52:39 many different kinds of stakeholders who can,
52:41 who can,
52:41 you know,
52:42 make submissions to the committee,
52:44 um,
52:46 because it's defining,
52:47 you know,
52:47 medicines that are essential.
52:50 And,
52:50 and then of course countries
52:52 can be guided by that
52:54 essential medicines list,
52:56 but tailor it to their own.
52:59 Uh,
53:00 their own epidemiology,
53:02 demography,
53:03 you know,
53:03 health concerns,
53:05 capacity,
53:06 financing,
53:07 so,
53:08 so
53:08 in,
53:09 in,
53:09 in creating the national essential medicines lists,
53:11 they're being guided by,
53:13 you know,
53:14 the kind of the gold standard
53:16 from the WHO,
53:18 um.
53:19 Uh,
53:19 and then tailoring it towards their own situation and capacity,
53:23 and as you already mentioned,
53:25 there is evidence that that will then translate
53:29 to
53:29 availability
53:31 and to access,
53:32 so I think that is what it is ultimately,
53:35 uh,
53:35 for.
53:37 OK.
53:38 Sorry.
53:38 Uh,
53:38 I,
53:38 I,
53:39 before Claudia,
53:39 before you jump in,
53:40 so,
53:41 so Sundu,
53:41 so,
53:42 uh,
53:42 so,
53:43 again,
53:43 very nice presentation.
53:45 Um,
53:45 but I,
53:45 I sense a bit of a tension,
53:47 right?
53:47 So on the one hand,
53:48 and I'm very sympathetic
53:50 with what you raised about the burdens of compliance,
53:53 right?
53:53 So the fact that
53:54 health providers are spending a lot of time
53:57 filling in certain indicators,
53:59 uh,
54:00 um,
54:01 uh,
54:01 and so on.
54:02 On the other hand,
54:03 you,
54:03 you talked about a lot
54:04 Lack of data,
54:05 especially when,
54:06 uh,
54:06 you know,
54:06 around Dali,
54:07 right?
54:07 So Dali requires data and sometimes Dali are computed based on
54:12 imputed data.
54:13 So,
54:14 so in a way,
54:14 kind of what gives,
54:15 right?
54:15 So is it,
54:16 is it,
54:17 is it that these guys are filling in,
54:20 uh,
54:20 you know,
54:20 mindless forms that nobody uses
54:23 or is it that the,
54:25 so,
54:26 so,
54:26 you know,
54:26 so,
54:27 sorry,
54:27 you know,
54:27 help us,
54:28 you know,
54:28 help us,
54:29 you know,
54:30 should,
54:30 should,
54:31 um,
54:32 You know,
54:32 should compliance with standards be streamlined,
54:34 uh,
54:34 but then make sure that there's,
54:36 you know,
54:37 uh,
54:37 you know,
54:38 certain data that's needed to compute dallies and,
54:40 and qualities
54:42 that,
54:42 that,
54:42 you know,
54:42 that,
54:43 that we need for
54:44 to make data comparable across regions and across countries.
54:48 Uh,
54:48 So,
54:48 you know,
54:49 so if you can speak a bit,
54:50 uh,
54:50 to,
54:50 to this tension,
54:51 right,
54:51 uh,
54:52 cause I'm,
54:52 I'm very sympathetic with,
54:54 you know,
54:54 we don't want,
54:55 you know,
54:55 we don't want healthcare providers spending half their time filling up forms,
54:58 right,
54:59 uh,
54:59 especially if nobody's gonna use that.
55:00 So,
55:01 so,
55:01 so what,
55:02 you know,
55:02 yeah,
55:02 what kind of gifts,
55:03 right?
55:03 I mean,
55:03 what,
55:04 what are the,
55:05 yeah,
55:05 sorry,
55:05 uh,
55:06 yeah,
55:06 if you can,
55:06 if you can,
55:07 uh,
55:07 sure,
55:08 um,
55:09 yeah,
55:09 thanks,
55:10 Javier.
55:10 Just before that,
55:11 I'll just say that
55:12 to your first question,
55:13 there are,
55:14 um,
55:15 some Latin American countries have
55:17 A constitutional right to healthcare,
55:20 and in those countries,
55:22 individuals can sue the government for not providing healthcare,
55:25 and people have actually sued the government for not providing
55:28 healthcare for rare diseases.
55:30 So,
55:30 and there's extensive work on that that you could consult if that's
55:35 a question if that's a concern for you in the report.
55:37 I know they've done a lot of work on that.
55:39 Some,
55:39 some,
55:39 some,
55:40 some researchers at Harvard.
55:41 To your question on
55:43 to your question on
55:46 data.
55:47 So
55:48 I just want to say first of all that we are not advocating for
55:52 no collection of data.
55:54 It is important to collect data because if you're flying blind,
55:57 then you cannot make adjustments,
55:59 right?
55:59 Whatever you don't measure,
56:00 you cannot improve.
56:01 So we're not saying,
56:03 saying that.
56:04 What we're saying is that
56:06 the burden of data collection needs to be context specific
56:11 and if
56:13 there is a gold standard on how to collect data,
56:16 right.
56:17 Um,
56:17 that was developed in one region.
56:19 If you want to transfer that to another region,
56:22 you need to think about the context.
56:24 And the context will include the
56:26 need for the data to be collected in the first place,
56:29 right?
56:29 And not just the form that everyone feels,
56:31 but the people do not need that.
56:33 The second will be the capacity of the people to collect the data,
56:37 right?
56:38 And then the third is to think about
56:39 how intrusive that data collection effort will be,
56:42 right?
56:43 We have seen extensively around the world that
56:46 if you do not tailor the data collection tools
56:49 to Mapped nicely with the function of the person who is doing the work,
56:53 then it's more likely not to be collected
56:56 or collected as an afterthought
56:57 or collected wrongly.
56:59 So the classic example would be
57:02 asking physicians to collect data
57:04 while they are taking care of the patient.
57:06 A physician will be able to collect data very well for you
57:10 if that data is needed for the decisions that they
57:12 will make for the patient that they are seeing.
57:15 But if they are,
57:16 if they are asked to fill forms afterwards for that same patient,
57:20 right,
57:20 it's not going to be
57:22 good quality.
57:22 So what we're saying is that
57:24 data is essential because that's the way you,
57:27 you can't,
57:27 you can't enforce standards.
57:28 You cannot measure standards without data,
57:31 but it needs to be context,
57:33 context-specific.
57:35 Uh,
57:36 I hope that answers your question.
57:37 I'm happy to follow up later on.
57:39 Thank you so much.
57:40 Thank you.
57:41 We have one last question from Claudia,
57:43 so maybe we're out of time,
57:44 but
57:45 Yeah,
57:46 since we're out of time,
57:47 I just wanted to check if anybody else in the
57:50 audience uh wanted to jump in and ask a question cause I saw we have a few
57:55 colleagues from the
57:57 health,
57:57 uh,
57:58 team.
58:03 OK.
58:06 Um,
58:08 Yeah.
58:08 So,
58:09 what was I gonna,
58:10 so,
58:10 uh,
58:10 first of all,
58:11 thank you so much for your,
58:12 uh,
58:13 background paper,
58:13 uh,
58:14 on,
58:15 for the report because,
58:16 I mean,
58:17 I learned a lot reading through the
58:19 paper and your presentation also,
58:21 um.
58:23 illuminated it even further for me.
58:26 So,
58:26 uh,
58:26 the question I wanted to raise was to piggyback on Sid's,
58:29 um,
58:30 example of,
58:31 uh,
58:32 the cough syrup,
58:33 um,
58:34 uh,
58:35 situation because
58:36 I had learned about it from him and then reading up on it,
58:40 it's like,
58:40 it's not an isolated incident.
58:42 India apparently has been having something 5 or 6 mass,
58:46 um,
58:47 cough syrup cases going back to,
58:50 um,
58:52 the 1990s.
58:53 And I'm just wondering,
58:55 like,
58:56 Oundo mentioned,
58:57 um,
58:58 assigning a responsibility is one step,
59:01 but I'm just wondering about some of the upstream.
59:04 Solutions because in the process chain,
59:07 like
59:08 testing the inputs and testing the,
59:11 like,
59:12 Um,
59:12 end product.
59:13 It's like the capacity to
59:16 guard against
59:17 this kind of recurring
59:19 problem,
59:20 uh,
59:21 on the one hand,
59:22 because
59:23 in,
59:23 uh,
59:23 I had read that the US had had a similar case back in 1937,
59:28 and since then,
59:30 um,
59:31 after an overhaul of the,
59:33 uh,
59:33 regulation,
59:34 that particular,
59:36 uh,
59:37 cough syrup.
59:39 Poisoning has not recurred.
59:41 Um,
59:42 so I'm just curious,
59:43 like what kind of,
59:44 in terms of.
59:46 Beefing up enforcement because it is a high-risk situation cause as Sid said,
59:51 it's,
59:51 it is life and death,
59:52 so.
59:54 Back to you.
59:56 Yeah,
59:57 thanks,
59:57 Claudia.
59:57 I can,
59:58 I can share um
59:59 with you and then ask David um
1:00:01 to contribute as well.
1:00:03 The
1:00:05 When it comes,
1:00:06 there is a solution in place right now,
1:00:08 but it's not being enforced.
1:00:10 In general,
1:00:10 countries have
1:00:12 exclusive control
1:00:14 over
1:00:15 what is,
1:00:16 what drugs and medications are sold within their jurisdictions,
1:00:19 and so the FDA equivalent of whatever country
1:00:23 would determine needs to give approval before a drug can be sold commercially
1:00:29 within the country,
1:00:29 and that approval process.
1:00:33 Requires a lot of testing,
1:00:34 a lot of paperwork.
1:00:36 Now,
1:00:37 does it happen
1:00:38 as it should
1:00:40 be?
1:00:41 Not always,
1:00:42 right?
1:00:43 So in this case,
1:00:44 there are lots of failure points,
1:00:46 right?
1:00:46 There is the fact that in Gambia,
1:00:49 Gambia
1:00:50 was not able to
1:00:51 regulate
1:00:53 what was being sold in the country because
1:00:55 there's also part of the regulation and regulation includes
1:00:59 market.
1:00:59 Entry and also sequential
1:01:03 market surveillance to make sure that there is no
1:01:05 adverse drug reaction.
1:01:07 There's also
1:01:08 the failure on the Indian side
1:01:11 for allowing
1:01:12 medications to be exported.
1:01:14 Now there are very few regulations that many countries
1:01:18 do not have those kinds of regulations for export.
1:01:21 But they handle that by having standards organizations.
1:01:25 So within the country in terms of export,
1:01:27 you're not supposed to produce something that fails the standards.
1:01:30 In this case,
1:01:31 there was a failure on the exporting side and
1:01:33 there was a failure on the importing side.
1:01:35 Now the big question is these things are traditionally
1:01:39 dealt with at the
1:01:42 WTO as dispute.
1:01:44 Or dealt with by country to country,
1:01:46 and that is inefficient in the sense that we wouldn't wait
1:01:49 for 50 children to die before we bring up this case,
1:01:53 bring up a case
1:01:55 like this,
1:01:55 and it's happened,
1:01:56 it's happened a lot and it seems like it's going to continue to happen.
1:02:00 So I think
1:02:01 one way to handle this,
1:02:03 just like the case you gave for the US
1:02:05 is to ensure,
1:02:06 and it's not easy to do,
1:02:08 but it's to ensure that countries
1:02:10 have the capacity
1:02:12 for regulation.
1:02:13 And not just regulation,
1:02:15 but for not just
1:02:17 regulating market entry,
1:02:18 but
1:02:19 ongoing regulation after market entry to ensure
1:02:21 that adverse drug reactions do not happen
1:02:24 and that the quality of what was approved
1:02:27 is the same quality as what is actually imported and sold.
1:02:31 And so it still goes back to one of our recommendations for strengthening capacity
1:02:36 within the countries and there's been a lot of investment in that space.
1:02:41 The Gates Foundation has invested a lot
1:02:43 in strengthening regulatory capacity in East Africa
1:02:46 and um trying to do regulatory harmonization
1:02:49 like Gavin talked about in East Africa,
1:02:51 West Africa,
1:02:51 and Southern Africa,
1:02:52 and I'm hoping to hope
1:02:54 to collapse that into the
1:02:56 African Medicines Agency.
1:02:57 um,
1:02:58 agency work so that there is a regulatory component at the continental level.
1:03:03 Gavin,
1:03:04 you want to add to?
1:03:04 No,
1:03:05 I mean that's exactly what I was going to talk about really,
1:03:07 if I'd,
1:03:07 um,
1:03:08 gone first,
1:03:08 it's about strengthening regulatory capacity,
1:03:11 ultimately,
1:03:12 that's really what it's all about.
1:03:15 Yeah,
1:03:15 because that would crosscut not just manufacture of medicine,
1:03:18 but also
1:03:20 supervising the doctors and the hospitals and throughout the
1:03:24 health system.
1:03:25 Yeah,
1:03:25 it has many dimensions exactly.
1:03:28 OK,
1:03:28 uh,
1:03:28 well,
1:03:28 we are out of time,
1:03:29 but thank,
1:03:30 thank you,
1:03:31 Gavin.
1:03:31 Thank you,
1:03:31 Asundu,
1:03:32 for the great,
1:03:33 great presentation,
1:03:34 and I,
1:03:34 I learned a lot as always.
1:03:36 And thanks everyone for joining,
1:03:38 uh,
1:03:38 the,
1:03:39 the WDR seminar series.
1:03:41 The papers,
1:03:42 uh,
1:03:42 Gavin and Asundu,
1:03:43 they presented will be on the,
1:03:45 uh,
1:03:46 the WDR 22025 website,
1:03:48 so you can,
1:03:49 uh,
1:03:49 you can actually reach out and if you want to read the whole report.
1:03:52 Uh,
1:03:52 and thank you all for,
1:03:53 for joining the,
1:03:54 the series.
1:03:55 Uh,
1:03:55 we look forward to seeing,
1:03:56 seeing you again in the next seminar.
1:03:59 Thanks for the opportunity.
1:04:01 Thank you.
1:04:01 Thank you.
1:04:02 Thank you very much,
1:04:03 everyone.
1:04:03 Bye.
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