Global Health: A Look Ahead at Trends in Seven Key Areas - Washington, D.C. + singapore
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Washington, D.C. + singapore
Global Health: A Look Ahead at Trends in Seven Key Areas
2022
CONTENTS 8 Oncology/Cervical Cancer
■ COVID-19 disruptions will result in additional
cancer deaths
2 Vaccines
■ New approaches to awareness and detection
will emerge
■ Consistent messaging will drive vaccination
■ Cervical cancer will pave the way for other
rates—and more
specific campaigns
■ Public-private partnerships will speed change
■ New vaccines will emerge—and not just for
COVID-19 10 Women’s Health
■ COVID-19 will move from pandemic to ■ Sexual and reproductive health efforts will
endemic in future years be renewed
■ Many countries will focus on low fertility rates
4 Health Financing ■ Cervical cancer will be targeted for elimination
■ Private-sector engagement will rise
■ New sources of financing will address global 12 Rare Diseases
pandemics ■ Science is advancing
■ More countries will adopt universal health ■ Global attention is rising
coverage ■ Regulators are adjusting
■ Data will help fight rare—and not-so-rare— ■ Payors are paying attention
diseases
14 Artificial Intelligence/
6 Antimicrobial Resistance Digital Health
■ Governments will increase their focus on ■ Virtual care will be increasingly important in
innovative incentives healthcare delivery
■ Countries are set to renew AMR efforts ■ More rules will be applied to data usage
■ Private-sector efforts will increase ■ AI guidance will come into sharper focus
LEVERAGE MEDIA LLC
EDITORIAL DIRECTOR MIKE WINKLEMAN
DESIGN DIRECTOR DEAN ABATEMARCO
C&M INTERNATIONAL
WRITERS PETER HAAPANIEMI, GORDON SCHONFELD,
PRESIDENT & CEO JENNIFER TAYLOR
AMBASSADOR ROBERT HOLLEYMAN COPYEDITOR SUE KHODARAHMI
MANAGING DIRECTOR PATRICIA WU PROJECT MANAGER ANDREA OLSTEIN
MANAGING DIRECTOR, ASIA CLARK JENNINGS
GLOBAL HEALTH GROUP LEADER NICHOLAS DIAMOND
PROJECT MANAGER CANDACE SPENCER
© 2022 CROWELL & MORING INTERNATIONAL. ALL RIGHTS RESERVED.
Global Health: A Look Ahead at Trends in Seven Key Areas
M
ore than ever, and regulatory issues. Our work
health is top of mind affords us a unique perspec-
around the world. tive on trends we believe will
In its 2021 report, positively transform and im-
“Global Expenditures on Health,” prove health for people around
the World Health Organization the world. With a clear-eyed
noted that between 2000 and view of present and potential
2019, the 192 countries that roadblocks, we work to help
WHO surveyed doubled their policymakers, regulators, and
total expenditures on health and industry partners visualize ways
increased the average percent- around them.
age of GDP targeted to health With this knowledge and
from 8.5% to 9.8%. these insights in mind, we cast
Not surprisingly, since the an eye in these reports on
emergence of COVID-19, WHO important developments we
reports an even more substan- believe will take place in sev-
tial rise. This growth is evident in en key areas: vaccines, health
the work of scientists, industry, financing, antimicrobial resis-
governments, regulators, the tance, oncology/cervical cancer,
health workforce, NGOs, and women’s health, rare diseases,
educators, united in their efforts and artificial intelligence/digital
to address global health issues health.
and scale innovative solutions. We hope you find the analy-
And that, we believe, makes the sis presented in these reports
information we are releasing in helpful, and we look forward to
this new series of global health sharing additional perspectives
reports particularly compelling. with you going forward.
Crowell & Moring Interna-
tional (CMI) serves clients at Best wishes,
the intersection of the public,
private, and nonprofit sectors Ambassador Robert Holleyman
on a wide range of critical global President & CEO
health policy, market access, Crowell & Moring International
Global Health: What’s Ahead 1
Vaccines
Pushing the Pace of Change
Despite challenges, innovation will continue in immunization
research, development, and infrastructure.
N
The development of othing in recent years has focused the world’s
consistent messaging attention on the development, use, and efficacy of
vaccines more than COVID-19. Through efficient
on the value of
public-private partnerships, global R&D platforms
vaccination generated several highly effective COVID-19 vaccines and
across the life governments around the world rallied to approve and ad-
course remains a minister them within their populations.
priority for all But there were bumps in the road. Supply CONSISTENT MESSAGING WILL DRIVE
chain problems tied to delivery, trade bar-
stakeholders. VACCINATION RATES—AND MORE
riers, and cold chain issues slowed down
distribution. Vaccine hesitancy—borne not Though the situation varies among coun-
only from misinformation but also from tries, the development of consistent yet
limited access and understanding of the tailored messaging regarding the value of
value of vaccination—put downward pres- vaccines has become especially import-
sure on vaccination rates globally. By the ant. For routine vaccinations, the focus
end of 2021, nearly a year after multiple will remain on developing consistent
vaccines were approved, less than half the messaging for both providers and pa-
world had been vaccinated and significant tients, especially around adult immuniza-
differences persisted in vaccination rates tions, supported by policymaking aimed
between countries. at increasing access for all communities.
Some governments and companies For COVID-19, key steps will remain coun-
responded by requiring vaccination and tering misinformation while developing
implementing other restrictions designed culturally competent messaging to be
to encourage vaccine uptake. At the used with diverse global populations.
same time, rates for non-COVID child, Tailoring these messages to a rapidly
adolescent, and adult vaccinations fell as changing environment will be especially
the pandemic reduced routine provid- important as new variants emerge and
er visits. Despite these challenges, key the science advances. The audience for
developments in vaccine research and these messages will go beyond those
commitment to improved healthcare to whom the vaccine is administered,
by a range of stakeholders foreshadow extending to all stakeholders—including
continued innovation and public health government—focused on immunization
impact, highlighted by the following. financing and policy interventions to sup-
2 C&M iinternational
Vaccines
port innovation in both vaccine develop- es. This will build on existing innovation VARYING RATES OF COVID-19
ment and delivery. in the vaccine pipeline that predates the VACCINE COVERAGE
COVID-19 pandemic.
Percentage of population
This spirit of innovation will go be-
PUBLIC-PRIVATE PARTNERSHIPS that had received at least
yond the COVID-19 vaccine platform to
WILL SPEED CHANGE place much-needed global emphasis on
one dose of a COVID-19
vaccine by January 14,
Developing and fostering partnerships adolescent and adult vaccination, which 2022, by region
between the public and private sectors, will be critical as people begin to travel
WORLDWIDE
along with collaboration among local and again and are exposed to other infec-
61.2%
international NGOs and other nongov- tious, but preventable, diseases. There
ernmental entities, will be a key driver will also be an emphasis on innovation in
of both local and global efforts to shape the delivery of immunizations, including
core messaging. Public-private partner- to address supply chain and distribution
ships have had and will continue to have a challenges, such as cold chain for rural 76 72 72
66
critical role in pandemic response, not just communities, to support broad public 51
in communication, but also in building the health impact.
infrastructure necessary to streamline de- 14
livery by identifying and solving challenges COVID-19 WILL MOVE FROM PANDEMIC
U.S./CANADA
LATIN AMERICA
ASIA-PACIFIC
EUROPE
MIDDLE EAST
AFRICA
related to health system capacity. TO ENDEMIC IN FUTURE YEARS
A common theme across countries will
continue to be increased focus by gov- The ultimate goal of the COVID-19
ernments on sustainable immunization vaccine is to reduce the impact this
infrastructure, particularly financing, deadly, highly contagious virus has on
through cooperation among government the health and well-being of the world 72% of these shots were
health regulators, trade officials, and by stemming transmission, improving administered in high- and
health outcomes following infection, and upper-middle-income
customs officials. Now and in the future,
preventing hospitalization and death. countries. Only 1% were
the lessons learned and infrastructure administered in low-
developed through the response to Emerging variants have hindered prog-
income countries.
COVID-19 can be leveraged for all vacci- ress in pandemic response, as have such
Source: Our World in Data,
nation programs across the life course. forces as supply chain issues and vac-
University of Oxford, published
cine hesitancy. by The New York Times
While many believe that 2022 will see a
NEW VACCINES WILL EMERGE—AND
continuation of COVID-19 as a pandem-
NOT JUST FOR COVID-19 ic, the effects of global progress in the
What helped drive the rapid develop- forecasts above is likely to bend the arc
ment of the COVID-19 vaccines was not of COVID-19 in future years. As COVID-19
just the prior R&D investments in exist- transitions to the endemic phase in
ing vaccine and therapeutic platforms, future years, continued emphasis on sus-
but also reduced administrative barri- tainable immunization financing, building
ers, increased funding, and streamlined global health systems capacity, develop-
regulatory approval processes. Inspired ing consistent messaging on the value of
by this, there will be an expansion of vaccination, and public-private partner-
the use of innovative vaccine technology ship in policymaking will remain critical
platforms for other novel indications, for responding to public health needs
such as HIV and other infectious diseas- across the immunization life course.
Global Health: What’s Ahead 3
Health Financing
innovative approaches driving outcomes
Although public financing hasn’t kept pace with need, countries now
understand the importance of boosting investment.
I
While public financ- t’s fair to say that the current state of health financing
ing for healthcare is mixed. On the one hand, outside of pandemic-related
funding, public financing hasn’t kept pace with the in-
remains essential,
creasing need for healthcare, due to rapidly aging pop-
the private sector is ulations and the rising incidence of noncommunicable dis-
using new, innovative eases. In addition, there is more emphasis on responding to
financing techniques health problems than on preventing them, and political will
to complement to take important funding measures is in short supply.
public funding and On the other hand, country-level appre- ceptable return for investors.
ciation of the need to boost investment in One of the best-known examples is
close gaps in access. healthcare is rising; there is positive move- Maternal Outcomes Matter (known as
ment in private-sector solutions; and the MOMs), which aims to improve maternal
pandemic has helped foster recognition health in sub-Saharan Africa and South
that a well-financed healthcare system can Asia, where women are dying at high
strengthen economic health. rates from complications of pregnancy
The following are four key trends that and childbirth. Launched in 2019 with a
we see in health financing during 2022. commitment of $50 million in debt and
grant financing, MOMs is a collaboration
PRIVATE-SECTOR ENGAGEMENT of the U.S. International Development
WILL RISE Finance Corporation, MSD for Mothers,
Credit Suisse, and the U.S. Agency for
Private-sector efforts are growing, and International Development.
increasingly, they are taking the form Health impact bonds are a form of
of innovative partnerships. Prominent blended capital that combines elements
among these efforts are blended capital of impact investing, private-sector part-
and health impact bonds. nerships, and results-based contracting.
Blended capital is funding contributed The Utkrisht impact bond, for instance,
by multiple sources that may include gov- has raised around $50 million to support
ernments, international organizations, private healthcare facilities in Rajasthan,
and private-sector entities. A blended India, to help reduce maternal and new-
instrument is structured to address two born mortality. The Brookings Institution
primary objectives: achieving a specific reports that there are 32 active health
health outcome and generating an ac- impact bonds worldwide.
4 C&M iinternational
health financing
NEW SOURCES OF FINANCING WILL The United Nations has adopted 2030 Despite the Need,
as its target date for global UHC and will Government Healthcare
ADDRESS GLOBAL PANDEMICS
host a meeting in 2023 to review the Spending Has Remained
The global fight to control the coronavi- progress that has been made so far. But Relatively Stagnant
rus and prepare for future pandemics achieving the 2030 goal isn’t assured,
got a potentially big boost from the G20 and diverse financing approaches will be Median government health
nations in 2021. In October, G20 health needed. We see the biggest obstacles as spending (% of total
insufficient funding and the political cal- government spending)
and finance ministers announced the
formation of a Joint Finance-Health Task culus in many governments that getting
Force to forge greater cooperation and to UHC simply isn’t feasible. 15
High income
support sustainable financing by mem- Our hope is that in 2022, the combination
ber states. of momentum at the UN and the massive Upper-middle income
We’re optimistic the task force can be a damage wrought by COVID-19 can push 10
catalyst for meaningful action by the G20 more countries toward their UHC goals. Lower-middle income
and the world. More specifically, we are Low income
5
looking for five developments in 2022: DATA WILL HELP FIGHT RARE—AND
NOT-SO-RARE—DISEASES
n Creation of a new financing facility with
0
the flexibility to complement Historically, the diseases whose treatments
multilateral development banks 2010 2015 2019
have gotten the most financial attention
n Establishment of a financial are the Big Three: HIV/AIDS, malaria, and Note: Median values are present-
intermediary fund, along with a tuberculosis. Funding is much lower for ed to minimize the influence of
common understanding about how its rare diseases (extremely debilitating ill- extreme values.
funds will be managed nesses that affect a relatively small number
Source: WHO Global Health Expen-
diture Database, 2021.
n Commitment by member states to of people). While treatments for rare dis-
provide a level of funding eases are expensive to develop and bring
commensurate with the scale of need to market, their effectiveness could have
n Recognition that governments must lasting gains for society in terms of mortali-
mobilize increased domestic resources ty and economic productivity.
on a sustained basis Data is playing an increasingly import-
n Efforts to leverage the capabilities of the ant role in fighting rare diseases. New
private and philanthropic sectors tools to analyze disparate and complex
data sets are accelerating efforts to
MORE COUNTRIES WILL ADOPT diagnose and treat rare diseases. Big
UNIVERSAL HEALTH COVERAGE data analytics is also being used for more
common diseases. Pharmaceutical giant
Universal health coverage (UHC) isn’t Roche, for example, is using its data on
universal: Some nations offer healthcare the costs and usage of innovative can-
to their citizens at little or no cost, but cer treatments to help improve insur-
others don’t. While there is growing inter- ance coverage for cancer therapies and
est in attaining UHC, doing so will require diagnostics in China. We expect this data
sufficient, sustained, equitable, and cre- sweet spot—at the intersection of health-
ative funding together with an openness care and insurance—to attract more
to developing new partnerships. interest going forward.
Global Health: What’s Ahead 5
Antimicrobial Resistance
FIXING A BROKEN SYSTEM
As more antibiotics are rendered ineffective, there is a recognition that
the problem—and the solution—is market-driven, not scientific.
A
The search for ntimicrobial resistance (AMR), which is making a
lasting solutions growing range of antibiotics ineffective, is an
increasingly critical problem. Driven largely by
to the broken AMR
the improper use of antibiotics, AMR causes more
market is leading than 1.2 million deaths every year. As this resistance grows,
to actions such as it is eroding the power of a cornerstone of modern
paying for antibiotics medicine. And if nothing is done, that figure is expected
based on their value to reach 10 million deaths a year by 2050.
to healthcare, The problem is not new, and many in key to finding lasting solutions to the
healthcare and government have been broken AMR market. This is leading to
rather than usage. sounding the alarm for some time. Nev- actions such as a pilot program that
ertheless, there has been little progress pays for antibiotics based on their value
in producing new classes of antimicro- to healthcare, rather than usage, and
bials. This is largely a market problem, proposals to allow governments to
rather than a scientific challenge. Antibi- compensate companies that create
otics are ideally taken for short periods new antimicrobials by granting fast-
of time, which makes them less lucrative approval status to their other, more
than drugs intended for extended use. lucrative drugs.
Unable to make this work commercially, In late 2021, the G7 finance ministers
many pharmaceutical companies essen- released a statement on antimicrobial
tially stopped developing new antimicro- resistance, saying “We are committed
bials years ago. In short, our approach to strengthen and intensify our action
to antimicrobial innovation is broken. across the G7” and “recognizing that
There are no simple solutions to AMR, this is a multiyear and multistakeholder
but in the coming year, growing aware- effort.” Such a statement from finance
ness of the problem may lead to action ministers—as opposed to health
in several key areas. ministers—underscores the growing
recognition of the need to address the
Governments will increase their economic side of the problem.
focus on innovative incentives In addition, the U.S. Congress is
considering the Pioneering Antimicro-
Governments understand that they are bial Subscriptions to End Upsurging
6 C&M iinternational
antimicrobial resistance
Resistance (PASTEUR) Act, which has a AMR solutions. For example, a few Room for Improvement
good chance of becoming law in 2022. years ago the International Federation
Despite more nations
This legislation would create a program of Pharmaceutical Manufacturers &
committing to taking action
in which companies that develop new Associations (IFPMA) launched the on AMR, only:
antimicrobials can offer their drugs Antimicrobial Resistance Industry
on a subscription basis that provides Alliance (AMRIA), which includes more
revenue without requiring high levels
of drug usage. Altogether, these efforts
than 90 member companies. The
group works on several fronts, such as
53%
have a standardized
send a clear signal that governments are promoting research into new drugs and national AMR surveillance
ramping up efforts to find new ways to stewardship to slow the emergence of system aligned with
incentivize antimicrobial development. AMR drugs. global standards
Looking forward, the alliance and its
Countries are set to renew members are likely to keep expanding
AMR efforts their efforts. This could include
improving the collection and sharing
20%
actively monitor the
When the 2015 WHO Global Action of AMR surveillance data, which a 2021 implementation of their
Plan on Antimicrobial Resistance called alliance report cited as an area for national plans
for countries to develop national AMR potential improvement. In addition, we
action plans, many countries—including are likely to see activity in the area of
a significant number of lower- and
middle-income nations—responded
responsible manufacturing and reducing
the “leakage” of antimicrobials into the
50%
have a functional AMR
with plans that typically run for three to environment. While members typically multisectoral
five years. Now, these plans are coming perform well on that front, the report coordination mechanism
to an end, and those nations are poised says, there is now an opportunity to
to renew them. Thus, 2022 will see extend those gains into their supply
increased activity in countries’ efforts
to assess the impact of their efforts,
chains.
Separately, the IFPMA formed an AMR
9%
have formally
incorporate the lessons learned into Action Fund in 2020—essentially, a incorporated AMR into
new plans, and spell out how they will venture capital fund that aims to invest healthcare worker
build response plans and surveillance $1 billion in startups, with the goal of training
capabilities and improve stewardship creating up to four new antimicrobial
to rein in the unnecessary use of drugs by the end of the decade. To Source: World Health
antibiotics. date, the fund has been working to Organization, 2021
Efforts to shape these new national organize and identify opportunities—
plans in the coming year will be critical and in the coming year, it is likely to
to the future of AMR, because they will start making investments to support
drive the on-the-ground work that is key clinical research, where there is often
to translating ideas into action. a funding gap. This type of action will
be important, but as the fund itself
Private sector efforts will notes, its main impact will be to buy
increase time for governments to implement the
innovative policies needed to address
The pharmaceutical industry has the fundamental market problems that
recently become more active in pursuing drive AMR.
Global Health: What’s Ahead 7
Oncology/Cervical Cancer
cancer returns to the forefront
Although many cancer-fighting efforts have been sidelined by
COVID-19, new approaches and initiatives will have an impact.
H
While the true toll istorically, the World Health Organization (WHO)
of COVID-19-related has led extraordinary efforts to eliminate, and even
eradicate, highly communicable diseases such as
disruptions in cancer
malaria and smallpox in low- and middle-income
care may only come countries. The UN-based agency, however, has increasingly
to light in 2022 and turned its focus to noncommunicable diseases, acknowledg-
beyond, awareness ing the burden that cancer, diabetes, and heart and respira-
campaigns, advanced tory diseases are placing on emerging economies.
technology, and new Cancer emerged as a key topic in 2017 COVID-19-Related Disruptions Will
when WHO member states unanimously
Result in Additional Cancer Deaths
planning efforts adopted a landmark resolution, com-
mitting to make cancer prevention and The COVID-19 pandemic has resulted in
have the potential control a global public health priority. major setbacks for cancer-fighting efforts
The following year, the International Can- around the globe. Not only are cancer
to mitigate the prob- cer Control Partnership—a consortium patients at higher risk from COVID-19,
lems this disruption of cancer control groups from around but 42% of countries reported disrup-
the world—announced its goal to reduce tions in cancer treatment because of the
has caused. deaths from noncommunicable diseases, pandemic’s strain on their healthcare
such as cancer, by one-third by 2030. systems, according to the International
In February 2020, the WHO released a Journal of Cancer.
180-page report outlining a plan to save Cancer screening programs were partic-
7 million lives from cancer over the next ularly affected. One study showed breast
decade by mobilizing stakeholders and cancer screening rates in Taiwan down by
strategically using limited resources in more than 20%. In the Netherlands, colo-
low- and middle-income countries. noscopies fell by 45%. Lung cancer scans
At the time, however, the attention of na- in the U.S. dropped by more than 70%.
tional health authorities shifted to the grow- The widespread impact will become
ing threat of the novel coronavirus disease more evident in 2022. UK researchers
(COVID-19) that had already been reported project significant increases in premature
in Asia, Australia, Europe, and the U.S. cancer deaths due to missed screenings
Just four weeks after the report was re- over the next five years, estimating as
leased, the WHO declared the COVID-19 many as 150,000 more deaths from col-
outbreak a global pandemic. orectal cancer, 95,000 from lung cancer,
8 C&M iinternationalOncology/Cervical cancer
65,000 from breast cancer. and 32,000 nosis, access to treatment and services, Emerging HDI Countries
from esophageal cancer in the UK alone. and evaluation, governance, and moni- Will Experience the
toring of implementation. It also requires Highest Increase in New
New Approaches to Awareness convening representatives from industry, Cases of Cancer
and Detection Will Emerge academia, and patient advocacy and pro-
vider groups, along with health ministry 2020 19.3M
With global health officials optimistic that officials, to identify the highest priorities 12
COVID-19 could begin to recede as a pub- and the most cost-effective responses.
11
lic health emergency in 2022, countries
NUMBER OF NEW CASES (MILLIONS)
10
are urged to develop COVID-19 recovery Cervical Cancer Will Pave the Way 9
plans that address disruptions to health for Other Specific Campaigns 8
services in the short term, while also pro-
7
moting long-term policies to build more While efforts to fight all kinds of cancer will
resilient healthcare systems in prepara- get renewed attention, efforts to eliminate 6
tion for future pandemics. cervical cancer will be heightened in 2022. 5
Awareness and early detection will In 2018, the WHO called for the elimi- 4
continue to play a key role. Increased nation of cervical cancer by 2030 through 3 +64%
availability of telehealth services is a a combination of increased access to 2
much-needed health policy intervention to screenings and treatment as well as wide- 1 +95%
bolster awareness campaigns. They can be spread uptake of vaccination against the 0
aided by increased deployment of at-home human papillomavirus (HPV), which caus- HDI
LOW
MEDIUM
HIGH
VERY HIGH
screening tests for several cancers as well es the vast majority of cervical cancers.
as community- based programs for can- Though vaccination and screening cam-
cer screenings that cannot be performed paigns were hindered by the pandemic,
at home. The use of wearable devices to numerous organizations are poised to re- The rising burden of cancer
monitor patients undergoing cancer thera- double their efforts in the coming year. For will not affect all countries
py should become more common. example, in August 2021 the Asia-Pacific the same. While emerging
However, with government resources Economic Cooperation (APEC) forum, with markets, which rank lower
on the Human Develop-
and healthcare workforces depleted by 21 member economies, issued a road map
ment Index, currently have
COVID-19, government health ministries for forming multisectoral partnerships lower rates of cancer than
alone cannot launch a holistic post-pan- to defeat cervical cancer. The strategic countries that rank high-
demic response. A multistakeholder ap- objectives aim to support APEC economies er, they are likely to see a
proach that ensures the best use of limited in accelerating and scaling prevention of greater increase in cancer
resources, pools expertise, and considers cervical cancer through HPV vaccination of cases over the next two
decades due to demograph-
different perspectives will be needed. eligible populations and effective screening
ic and lifestyle changes,
The WHO’s February 2020 cancer and treatment of pre-cancerous lesions, increased life expectancy,
report specifically called on countries to expanding the application of health- and more reliable screening
adopt more effective National Cancer systems tools to improve the quality of and diagnosis. These shifts
Control Plans (NCCPs) by including pri- treatment and palliative care and im- will not only impact public
vate sector and nonprofit organizations proving health infrastructure to support health ecosystems, but
they will also have signif-
in their design and implementation. improvements in prevention and care.
icant economic impacts,,
A robust NCCP should tackle the range Look for the most successful strategies demanding innovative new
of cancer-related interventions: primary in this effort to be employed in other frameworks, partnerships,
prevention, screening and early diag- cancer-fighting campaigns in the future. and perspectives.
Source: GLOBOCAN 2020
Global Health: What’s Ahead 9Women’s Health
resuming progress as covid-19 recedes
In the pandemic’s wake, organizations, governments, and advocacy
groups are working to push women’s health initiatives forward.
N
While COVID-19 had o look ahead at women’s health issues in 2022
a negative impact on would be complete without a discussion of the
continuing impact of the COVID-19 pandemic.
women’s health and
COVID-19 death rates are significantly higher among
well-being worldwide men, but—for reasons experts are still trying to understand—
and stalled progress women are as much as four times as likely to suffer from “long
on a number of COVID,” with symptoms such as fatigue, insomnia, and cogni-
critical women’s tive dysfunction persisting after the infection has resolved.
Available evidence suggests that wom- sues to come to the forefront once again.
health initiatives,
en’s emotional well-being has also taken
global public health a bigger hit from COVID-19. In a survey Sexual and Reproductive Health
authorities are
by the international humanitarian orga- Efforts Will Be Renewed
nization CARE, 27% of women reported
pandemic-related mental health chal- The United Nations Population Fund
hopeful that several lenges such as anxiety, loss of appetite, estimated in April 2021 that a disrup-
issues will come to and inability to sleep, compared to 10% tion in contraceptive services due to the
of men. Women’s health advocates at- pandemic had resulted in 1.7 million
the forefront in 2022. tribute this to women’s outsized role as unintended pregnancies worldwide. One
unpaid caregivers for sick family mem- study revealed significant increases in
bers as well as children forced to stay maternal death, stillbirth, and maternal
home due to school closures. Women depression globally, citing limited access
also make up 70% of the frontline health- to maternal services and reduced health-
care workforce, which has consistently care-seeking behavior as major con-
reported highly elevated levels of stress tributing factors, especially in low- and
and burnout throughout the pandemic. middle-income countries.
COVID-19 has not only negatively The issue took center stage in mid-2021
impacted women’s health and well-being at the UN-organized Generation Equali-
worldwide, it has also stalled progress ty Forum, where participants pledged a
on a number of women’s health initia- cumulative $40 billion to accelerate gender
tives. However, with global public health equality efforts in the face of COVID-19
authorities hopeful that COVID-19 will at setbacks. That included $1.4 billion from
least partially recede as a global health the Gates Foundation, $1.2 billion from the
emergency in 2022, look for several is- government of Norway, and $83 million
10 C&M iinternationalwomen’s health
from the Ford Foundation to boost sexual place more emphasis on fertility issues Total Fertility Rate
and reproductive health efforts worldwide. in an attempt to bounce back from the by Region
The infusion is expected to jump-start pandemic baby bust. Given the parallel
Estimates and Projections,
Generation Equality’s efforts toward its efforts being made to increase access to
2000-2100
stated five-year goal of delivering quality education and contraception for women,
sexuality education to 50 million addi- however, developing the correct policy 7
PROJECTIONS
ESTIMATES
tional adolescents, providing access to responses to low fertility rates will be
contraceptive services to 50 million more complex as well as critical.
6
women, integrating comprehensive sex- Some countries have already begun
LIVE BIRTHS PER WOMAN
ual and reproductive health access into offering housing and childcare subsidies
5
health systems in 20 additional countries, to encourage births, along with requir-
and advancing legal and policy reforms to ing employers to offer paid maternity
4
support sexual and reproductive health leave and flexible work scheduling.
access in at least 10 additional countries. Several governments in Europe and Asia
Expect a progress report when many of have recently begun subsidizing fertility 3
the organizations at the Generation Equal- treatments such as in-vitro fertilization.
ity Forum gather in Kigali, Rwanda, for the China’s health commission has set a goal 2
Women Deliver conference in 2023. of having at least one institution offering
IVF for every 3 million people by 2025. 1
Many Countries Will Focus on
2000
2050
2100
Low Fertility Rates Cervical Cancer Will Be Targeted
for Elimination
At the same time, governments around Sub-Saharan Africa
the globe are raising the alarm about Increasingly, advocacy groups are touting Northern Africa and Western
Asia
dramatically declining fertility rates, women’s health initiatives as important
which are largely linked to increased for economic prosperity, enabling wom- Central and Southern Asia
educational attainment and access to en to participate fully in the workforce. Eastern and South-Eastern
Asia
contraception among women. The current global push to prevent and
According to demographers, the control cervical cancer could serve as a case Latin America and The
Caribbean
pandemic accelerated a drop in glob- study for that rationale. Most commonly
Australia and New Zealand
al fertility rates that had already been diagnosed between ages 35 and 44, cervical
occurring, and some believe that nearly cancer often strikes women in their prime Oceania excluding Australia
and New Zealand
every country could see shrinking popu- earning years, as well as during the time
Europe and North America
lations by the end of this century. More that they are most needed as caregivers to
important, populations are expected to children and elderly family members.
get significantly older, with more people Cervical cancer is also highly preventable Global fertility rates have
dropped significantly since
turning 80 than being born in 2100. through vaccination for the human papil-
1950, a trend that is pro-
Many governments worry that this lomavirus, screenings for early detection, jected to continue in most
could dramatically increase the burden and treatment of precancerous lesions. regions through the rest of
on the working-age population to sup- Though the pandemic sidelined vaccination this century.
port non-working, older adults, drive up and screening programs in many coun-
Source: United Nations Department
taxation rates, and foster political and tries, look for a comeback in 2022 as these
of Economic and Social Affairs,
social instability. countries aim to meet the UN’s targets for Population Division (2019a). World
In 2022, policymakers are expected to the elimination of cervical cancer by 2030. Population Prospects 2019.
Global Health: What’s Ahead 11Rare Diseases
the outlook brightens
Despite steps to incentivize development and accelerate treatment,
challenges remain. But barriers are beginning to fall.
R
The outlook for are diseases are considered rare because they affect
fighting rare relatively tiny numbers of people: up to 200,000 in the
U.S., for example, and less than one in 2,000 in the
diseases is bright-
European Union. While individually they are uncom-
ening as a result of mon, collectively they are not. More than 300 million people
scientific advances, live with one of about 7,000 identified rare diseases globally,
rising global aware- including 25-30 million in the U.S., according to EURORDIS-
ness, regulatory Rare Diseases Europe and National Institutes of Health.
momentum, and Historically, the combination of com- several years, unlocking the possibility of
plex genetic etiology, small patient curing some of the rare diseases caused
attention from populations, large development costs, by a defect in a single gene. While Fierce
and regulatory and reimbursement un- Pharma notes that the U.S. Food and
institutional payors.
certainty has limited the development of Drug Administration has approved only
treatments for rare diseases. Regulatory two gene therapies for rare diseases for
authorities in the United States, the EU, sale in the U.S., the American Society
and other developed markets have taken of Gene + Cell Therapy reports that 998
steps to incentivize development and ac- gene therapies for rare diseases are cur-
celerate approval of treatments for rare rently in the preclinical-to-preregistration
diseases, but challenges remain. Gene stages of development worldwide.
therapy, which could offer durable cures Clinical trials for more gene therapies
for many rare diseases, brings its own are reaching advanced stages. Many
mixture of promise and complication. are generating favorable data for safety
Overall, we believe that the outlook for and efficacy—an encouraging sign for
rare-disease treatments is brightening patients, caregivers, regulators, research-
and see several trends driving positive ers, and manufacturers alike.
momentum.
GLOBAL ATTENTION IS RISING
SCIENCE IS ADVANCING
The fight against rare diseases is gain-
After decades of research, gene therapy ing attention worldwide from patients,
has taken a monumental leap from the medical providers, nongovernmental
lab bench to the bedside over the past organizations, and—most importantly—
12 C&M iinternationalrare diseases
regulators and institutional payors (e.g., rethink their methods and processes to RARE DISEASES: BY THE
health insurers and governments). adjust for potentially smaller trials, alter- NUMBERS
A major milestone occurred in Decem- native endpoints, and real-world data.
ber 2021, when the United Nations ad- Gene therapy adds further complexity.
opted its first-ever resolution recognizing
the more than 300 million people living
The good news is that regulators are
increasingly aware of the need to change.
7,000
Identified rare diseases
with rare diseases and their families. This is particularly true in the U.S., Eu- in the world
While the resolution was symbolic, its rope, Japan, and China, where most of
recognition of rare diseases’ seriousness the new treatments are in development
set a marker of sorts for others to join and regulators are already reviewing trial 300
million+
the fight and take concrete action. data. Regulatory agencies in emerging
Ultimately, each country must determine markets—notably Brazil, Chile, Indonesia,
its own approach to rare diseases, ideally Mexico, the Philippines, and Saudi Affected by rare diseases
with a formal national action plan. Few Arabia—are closely monitoring their
25 million+
such plans yet exist: Chile drafted one in larger-nation counterparts to see how
2021, and Malaysia and Peru are working they will need to adjust.
on their own. Several Latin American coun- Regulators in many smaller countries In the United States
tries (Argentina, Brazil, Chile, Colombia, face additional pressures to act both
200,000
Mexico, and Peru) have passed legislation from elsewhere and at home. On an
specific to rare diseases since 2010. external level, they see increasing access
The Asia-Pacific region is working on a to new treatments in larger nations and Or fewer Americans have
promising regional initiative. In 2018, the want the same for their own populations. a specific rare disease
Asia-Pacific Economic Cooperation forum Domestically, they face well-organized
1 in 2,000
(APEC) launched its Action Plan for Rare groups of patient advocates whose
Diseases to provide APEC’s 21 member increasingly vocal demands for new and
economies with a framework for policy improved medicines cannot be ignored. EU residents have a
action. The plan calls for members to specific rare disease
improve economic and social inclusion of PAYORS ARE PAYING ATTENTION
people with rare diseases and sets pre- Sources: EURORIDS-Rare Diseases
Europe; National Institutes of Health
cise targets for achievement by 2025. The economics underpinning the value
and cost of treatments for rare diseases
REGULATORS ARE ADJUSTING are unique and complicated, and they can
pose tough challenges for institutional pay-
Regulators represent one of the biggest ors as well as individuals covering out-of-
potential opportunities for the introduc- pocket costs. Payors will have to reassess
tion of new rare-disease treatments—and how they manage their reimbursement
not simply because their approval is re- risk when the number of potential patients
quired. Historically, regulators have made is low. Gene therapies pose especially big
approval decisions based on large-scale actuarial challenges for insurers.
participation in clinical trials that often last Fortunately, payors are beginning to
for years and generate huge volumes of explore, design, and pilot innovative
patient data. In order to most efficiently funding and financing mechanisms to
review new drug applications to treat accelerate access to rare-disease treat-
rare diseases, however, regulators must ments, including for gene therapies.
Global Health: What’s Ahead 13Artificial Intelligence/Digital Health
meeting the increased demand
Fueled by the pandemic, tools, policy, technology, and data are coming
together to produce opportunities for digital healthcare.
D
Advances in digital igital innovation continues to rapidly transform
health innovation, healthcare while, at the same time, raising several
policy challenges, including privacy, security, data
including AI-enabled
sharing and interoperability, transparency, safety
tools, allow public and effectiveness, and equity. These challenges are global,
and private sector requiring multistakeholder collaboration. The pandemic has
stakeholders to increased the demand for digital health and AI-enabled
use this technology tools and, correspondingly, the urgency in developing
policy solutions.
to improve health-
In the coming year, we expect to see infrastructure for adoption.
care delivery and continued emphasis by health sector Post-pandemic, policymakers are likely
outcomes and drive stakeholders worldwide on addressing to focus on evolving existing laws and
these challenges, with the goal of safely, regulations to support continued use and
supportive policy effectively, and equitably scaling health adoption by providers and patients. In
digitization. some countries, this will involve develop-
efforts. ing a new legal structure to support use
VIRTUAL CARE WILL BE INCREASINGLY of digital technologies, creating oppor-
IMPORTANT IN HEALTHCARE DELIVERY tunities to leverage best practices and
improve global regulatory harmonization.
Worldwide innovation in virtual care, in- We see virtual care being a critical tool
cluding remote patient monitoring tools for expanded access to care in remote
and telehealth platforms, will continue to areas worldwide.
augment patient care for an expanding
spectrum of clinical applications. More rules will be applied to
The pandemic has sharply increased data usage
this trend. In some countries, including
the United States, policymakers have Given the importance of health data to
made temporary or permanent changes patient care, governments and business-
to regulations that impact the use of es will continue to work to determine
such tools in order to expand access. how to simultaneously improve access to
These changes have been supported and protect health data.
by efforts to expand the enabling In many countries, patients have a
14 C&M iinternationalartificial intelligence/digital health
right to access their health data. In be “hardened” as new regulations are AI Adoption Rates Around
the United States, this long-standing implemented. the World
patient right has been strengthened For example, the European Commis-
by recent interoperability regulations, sion’s proposed Artificial Intelligence DEPLOYED AI
which strive to make it easier for Act (EU AI Act), which takes a risk-based
patients to access their health data approach, would have broad implications EXPLORING AI
electronically and for providers for AI-enabled health tools, especially if CHINA
to access and use such data to they are considered “high-risk.” Since the
optimize patient care. The expansion Act is novel, it may enjoy a “first-mover FRANCE
of individual data rights in many effect” akin to GDPR, in which other gov- GERMANY
countries, along with greater portability ernments pass similar regulations.
INDIA
of health data, will drive new waves of Key activities are occurring elsewhere
innovation that make use of that data. in the world. Effective March 1, China has ITALY
This will likely prompt regulators to implemented rules governing algorithms LATIN
increasingly scrutinize the use of health with key functions in the digital economy, AMERICA
data in consumer applications. including those that set prices and rec-
SINGAPORE
Meanwhile, there is increased atten- ommend and filter content. Singapore’s
tion to the value of using real-world data Infocomm Media Development Authori- SPAIN
(RWD) to support regulatory approvals. ty’s Model AI Governance Framework— UNITED
RWD is often leveraged in U.S. regulatory the first of its kind in Asia—provides KINGDOM
approval processes, and other actionable guidance to businesses on AI UNITED
governments, including in the Asia- ethics and governance issues across sec- STATES
Pacific region, have begun to explore tors, with the goal of promoting under-
0% 20% 40% 60% 80%
RWD policies. standing and trust.
The EU’s General Data Protection Reg- Governments have also begun to issue
ulation (GDPR) has formed a basis upon Almost one-third of IT
national strategies to develop their do-
professionals worldwide
which many governments have devel- mestic AI industries, which often include
say their firms are using AI
oped their own privacy rules. In the U.S., financial commitments, such as recent technology and almost half
most new privacy laws carve out health investments in Chile and India. These say their companies are
data subject to HIPAA, but also may cover developments provide potential opportu- exploring it.
health data in mobile apps that are not nities for industry to partner with govern-
covered by HIPAA. Policymakers are likely The top drivers of AI adop-
ments as they develop their economies’
tion in organizations are:
to focus on striking a balance between AI capabilities.
access to data and privacy and security Finally, strategies focused on AI and 1. Advances in AI that make
protection for the same data. healthcare are likely to receive further it more accessible (46%)
attention. For example, collaboration 2. Business needs (46%)
AI guidance will come into between regulators in the U.S., UK, and 3. Changing business needs
due to COVID-19 (44%)
sharper focus Canada on the guiding principles for the
use of AI and machine learning in med- Source: From Roadblock to Scale: The
Global Sprint Towards AI. IBM, 2021
Many stakeholders have developed ical devices is a key example of ongoing
high-level ethical principles for AI harmonization efforts. Potential future
systems. Many such initiatives center implementation activities relating to the
on accountability, bias, and transparen- GMLP principles will be important for
cy. This “soft law” approach is likely to stakeholders to monitor.
Global Health: What’s Ahead 15Crowell & Moring International
Washington, D.C. + singapore
Ambassador Andrew Blase Eric Obscherning
Robert Director Associate Director
Holleyman ablase@ eobscherning@
President & CEO crowell.com crowell.com
rholleyman@
crowell.com
Patricia Wu Nicholas Evan Yu
Vice President Diamond Associate Director
and Managing Director eyu@crowell.com
Director ndiamond@
pwu@crowell.com crowell.com
Clark Jennings Ryan Macfarlane Katherine
Managing Director Nunner
Director, Asia rmacfarlane@ Associate Director
cjennings@ crowell.com knunner@
crowell.com crowell.com
Kate Beale Mugant M Shelley Su
Director Associate Senior Consultant
kbeale@ Director, Asia ssu@crowell.com
crowell.com mugant@
crowell.com
16 C&M iinternationalGlobal Health
For more information about Crowell & Moring International and CMI’s Global
Health Group, visit www.cmintl.com. or contact Ambassador Robert Holleyman
at rholleyman@crowell.com or Candace Spencer at cspencer@crowell.com
Olivia Christian Roatta Jodi Daniel
Burzynska- Consultant Director
Hernandez croatta@ Jdaniel@
Senior Consultant crowell.com crowell.com
ohernandez@
crowell.com
Trey Flowers Akanksha Sinha David “DJ” Wolff
Senior Consultant Consultant, Asia Director
tflowers@ asinha@ djwolff@
crowell.com crowell.com crowell.com
Alexa Trost Christopher Terry Rea
Senior Consultant Gundermann Director
atrost@ Associate trea@crowell.com
crowell.com Consultant
cgundermann@
crowell.com
Maggie Henkin Myung Wang Candace Spencer
Consultant Manager, Global Assistant Director
mhenkin@ Operations cspencer@
crowell.com mwang@ crowell.com
crowell.com
Global Health: What’s Ahead 17Washington, D.C. + singapore
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