Rand Pea407-1
Rand Pea407-1
Perspective
EXPERT INSIGHTS ON A TIMELY POLICY ISSUE
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developing products that would be affordable in the world’s with Ebola and Zika outbreaks.11 However, it has done so
poorest countries.7 Similarly, in the United States AbbVie to a lesser scale than for COVID-19 and with contribu-
has waived intellectual property rights for an existing com- tions from fewer companies. Similarly, levels of activity in
bination product that is being tested for therapeutic poten- response to the threat of antimicrobial resistance are still
tial against COVID-19, which would support affordability low.12 There are important policy questions as to whether
and allow for a supply of generics.8,9 Johnson & Johnson – and how – industry could engage with such public health
has stated that its potential vaccine – which is expected threats to an even greater extent under improved innova-
to begin trials – will be available on a not-for-profit basis tion conditions.
during the pandemic.10 The COVID-19 pandemic is a game-changer among
Pharma is mobilising substantial efforts to rise to global public health threats. The risk to human life (both in
the COVID-19 challenge at hand. However, we need to terms of morbidity and quality of life), the economic risks,
consider how pharmaceutical innovation for responding to the epidemiology of the disease and speed of escalation have
emerging infectious diseases can best be enabled beyond led to a crisis-response by many governments around the
the current crisis. Many public health threats (including world. This has in turn influenced the immediate indus-
those associated with other infectious diseases, bioterror- try efforts. Many other infectious disease threats may not
ism agents and antimicrobial resistance) are urgently in manifest as crises in the short term and in the same way as
need of pharmaceutical innovation, even if their impacts COVID-19, but they could nevertheless escalate. They are
are not as visible to society as COVID-19 is in the imme- not considered to be crises from a short term perspective
diate term. The pharmaceutical industry has responded to because they are contained to specific regions and affect
previous public health emergencies associated with infec- fewer people at present – or are re-emerging (e.g. Ebola) – or
tious disease in recent times – for example those associated their impacts have not yet materialised at a scale that would
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what constitutes a pandemic phase does provide guidance
on national policy response options, but not specifically
The emerging threats raise as they relate to healthcare innovation activity.14 There are
and the pharmaceutical prevent future global calamities. A crisis and ‘emergency
mode’ response may be inevitable for some diseases, but
industry can work more can be done to mitigate against the need for such a
response – especially in cases where emerging threats and
together. their consequences can be foreseen and are known to be
a risk. We need to anticipate and act now in terms of how
we plan and incentivise better for the future, and how we
qualify as an immediate crisis (e.g. growing risks of antimi- distinguish between different types of infectious disease
crobial resistance to some infectious pathogens). However, threats and phases in framing incentives and regulation.
such diseases and issues are recognised as global threats that
could become crises in the future.13
The emerging threats raise important policy questions Innovative financial instruments must
about how government and the pharmaceutical industry be integral to any sustainable and
can work together to ensure that pharmaceutical industry scalable approach to incentivising
innovation is incentivised sustainably and at scale. This is
pharmaceutical innovation for
important to help mitigate against current and emerging
threats becoming crises further down the line. At present,
tackling emerging threats to public
there are no clear and specific criteria to determine when health from infectious diseases
a disease can trigger the types of healthcare-innovation-re- The pharmaceutical industry has a responsibility to both its
lated policy actions that have been deployed in response to shareholders and to society at large.
the COVID-19 crisis. For example, this applies to criteria Incentivising the pharmaceutical industry to innovate
for securing financial resources for innovation-related solely on the grounds of being a socially responsible sector
activities, reforming regulation to accelerate trials and is unlikely to lead to a sustainable and scalable approach
regulatory approval processes, and securing reimburse- for innovating in response to emerging infectious disease
ment mechanisms that help enable industry engagement threats. There are also potential challenges to the types of
and the search for rapid solutions. The WHO guidance on innovation (i.e. how radical or incremental) a reliance on
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challenges have been barriers to innovation in vaccine R&D
and in the antimicrobial space, for example. Developing
Various incentive vaccines can be a technically complex effort that influences
mechanisms for
success rates, and it can take a long time. The returns on
investment are not guaranteed for diverse reasons, such as
addressing the
unpredictable market size, the risk that by the time a product
is developed it may be obsolete (for example if medicines
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Innovative financial instruments have gained attention
in more recent times, including the subscription-based
‘Netflix model’ and the use of vaccine bonds.
approval mechanisms). These incentives seek to reduce the upfront investment is intended to incentivise innovation
risks associated with the costs of R&D and market risks.17 because the payment received by industry is independent
The pooling of intellectual property– a mechanism where of the future volume of sales and of prescribing behaviours,
two or more patent owners license one or more of their which de-risks R&D and trials for pharma.21
patents to each other or third parties – can also help enable For example, in the United Kingdom, the National
innovation (although they are not an incentive per se). IP Institute for Health and Care Excellence (NICE), NHS
pools can apply to both new and mature technologies and England and NHS Improvement government agencies are
help remove some of the barriers to further downstream testing a subscription-based model in which they intend to
innovation, as well as enable better access to new medi- pay pharmaceutical companies upfront for access to antibi-
cines, for example in developing countries.18–20 otics that meet their criteria (with payment depending on
Innovative financial instruments have gained attention the value of the antibiotics to the NHS)23. However, antimi-
in more recent times, including the subscription-based crobial resistance is not a UK challenge only, it is a global
‘Netflix model’ and the use of vaccine bonds. While these one – thus models such as this only make sense as an
hold promise in terms of facilitating timely innovation incentive if they are adopted globally. A further challenge
activity within industry, they require global-level engage- is that the model is more aligned with single-payer systems
ment and buy-in, ex-ante robust estimates on likely degree like the NHS, unless there is involvement and commitment
of need (i.e. volume) of specific products, and transparent from multiple payers in multiple-payer systems.21
resource allocation processes and criteria, in order to In the United States, this Netflix model has also been
realise their full potential as financial instruments. In the used to negotiate access to Hepatitis C antivirals, with
‘Netflix subscription model’, pharmaceutical companies some US states paying a fixed monthly cost for access to
are paid a monthly fee (usually by healthcare authorities) in direct-acting antivirals from pharmaceutical companies, as
exchange for health authorities securing access to specific opposed to paying on a volume-based prescription basis.24
innovations upfront.21,22 The effectiveness of this model Given the large cost that these subscriptions can impose
depends in part on securing sufficient monthly fees, which on government authorities, one of the challenges asso-
may require investments at an international scale. The ciated with the ‘Netflix model’ is to achieve as accurate
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as possible an estimate of the degree of need on which to
base subscription fees; another revolves around negotiat-
ing industry commitment to appropriate treatment rates.25 In considering innovative
financial incentives
Subscription-based models also raise questions about
how to ensure clear, open and transparent processes for
7
Decisions on who the appropriate investors should be – for
example, in order to achieve scale – are likely to influence
how various incentive mechanisms are structured and Access to large amounts
of linked healthcare data
governed.
8
data ecosystems.29,31 The experiences of the European
Medical Information Framework (EMIF), which sought
to enable secure and coordinated access to patient-level Ensuring timely access to
the requisite clinical trial
data for research purposes across a federated context, may
offer particularly fertile ground for practical and action-
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infrastructure within a particular geography. The avail-
ability of good trials infrastructure is an incentive for phar-
maceutical companies – not least in relation to the quest There is a need to
consider success criteria
for speed and efficiency. To this effect, and in the context
of COVID-19, in the United Kingdom the Department of
10
when resources are diverted to a pandemic, and to ensure
ethical practices when considering supply to populations
across the world, including in the world’s poorest coun- Industry and government
actors will also need to
tries.37 To tackle some of these issues, policymakers and
industry will also need to focus on securing appropriate
11
industry commitment and global collaboration across
sectors, professions and disciplines are unleashed. Building
Innovation in response to on this momentum to ensure sustainable and scalable
12
Notes: https://sloanreview.mit.edu/article/in-the-face-of-a-pandemic-can-
pharma-shift-gears/
1.
Baylor College of Medicine. 2020. ‘Emerging Infectious Diseases.’
As of 14 May 2020:
11.
Pharmaceutical Technology. 2020. ‘From coronavirus to ebola: the
https://www.bcm.edu/departments/molecular-virology-and- five recent global health emergencies.’ 23 March. As of 14 May 2020:
microbiology/emerging-infections-and-biodefense/emerging-infectious- https://www.pharmaceutical-technology.com/features/coronavirus-
diseases ebola-latest-global-health-emergencies-who/
2.
Rees, V. 2020. ‘Open letter calls for UK government to stop pharma Access to Medicine Foundation. 2020. ‘2020 Antimicrobial
12.
profiting from COVID-19.’ European Pharmaceutical Review, 17 April. Resistance Benchmark.’ 21 January. As of 14 May 2020:
As of 14 May 2020: https://accesstomedicinefoundation.org/publications/2020-
https://www.europeanpharmaceuticalreview.com/news/116990/open- antimicrobial-resistance-benchmark
letter-calls-for-uk-government-to-stop-pharma-profiting-from-covid-19 Bloom, D.E. & Cadarette, D. 2019. ‘Infectious Disease Threats in the
13.
3.
EFPIA. 2020. ‘European pharmaceutical industry response to Twenty-First Century: Strengthening the Global Response.’ Frontiers in
COVID-19.’ As of 14 May 2020: Immunology, 28 March, 10: 549.
https://www.efpia.eu/covid-19/member-updates/ WHO. 2020. ‘Guidance for pandemic preparedness.’ As of 14 May
14.
4.
Hanney, S., Wooding, S., Sussex, J. & Grant, J. 2020. ‘From COVID- 2020:
19 research to vaccine application: why might it take 17 months not http://www.euro.who.int/en/health-topics/communicable-diseases/
17 years, and what are the wider lessons?’ Health Research Policy and influenza/pandemic-influenza/pandemic-preparedness/guidance-for-
Systems, 2020. Accepted for publication. pandemic-preparedness
5.
Moll, N. 2020. ‘Partnership and collaboration: The new normal in the
15.
Azimi, T., Conway, M., Heller, J., Sabow, A. & Tolub G. 2019.
fight against COVID-19.’ 16 April. As of 14 May 2020: ‘Refueling the innovation engine in vaccines.’ 8 May. As of 14 May
https://www.efpia.eu/news-events/the-efpia-view/blog-articles/ 2020:
partnership-and-collaboration-the-new-normal-in-the-fight-against- https://www.mckinsey.com/industries/pharmaceuticals-and-medical-
covid-19/ products/our-insights/refueling-the-innovation-engine-in-vaccines
6.
Innovative Medicines Initiative (homepage). 2020. As of 14 May Pronker, E.S., Weenen, T.C., Commandeur, H., Claassen, E.H.J.H.M.
16.
2020: https://www.imi.europa.eu/ & Osterhaus, A.D.M.E. 2013. ‘Risk in Vaccine Research and
Development Quantified.’ PloS ONE, 20 March. 8(3).
7.
GSK. 2020. ‘GSK actions to support the global response to COVID-
19.’ As of 14 May 2020: World Economic Forum. 2018. ‘Antimicrobial Resistance: Tackling
17.
https://www.gsk.com/en-gb/media/resource-centre/our-contribution-to- the Gap in R&D Resources with Pull Incentives.’ As if 14 May 2020:
the-fight-against-2019-ncov/ https://www.weforum.org/reports/antimicrobial-resistance-tackling-
the-gap-in-r-d-resources-with-pull-incentives-in-collaboration-with-
8.
Financial Times. 2020. ‘AbbVie drops patent rights for Kaletra wellcome-trust
antiviral treatment.’ As of 14 May 2020:
https://www.ft.com/content/5a7a9658-6d1f-11ea-89df-41bea055720b WIPO. 2014. ‘Patent Pools and Antitrust – A Comparative Analysis.’
18.
N., Martei, Y.M., Gorea, C. & Kieny, M.P. 2019. ‘Patent pooling to
Smith, N.C. & Scholz, M. 2020. ‘In the Face of a Pandemic, Can
10.
increase access to essential medicines.’ Bulletin of the World Health
Pharma Shift Gears?’ 16 April. As of 14 May 2020: Organization. 575–577.
13
Lampe, R. & Moser, P. 2016. ‘Patent Pools, Competition, and
20.
Marjanovic, S., Ghiga, I., Yang, M. and Knack, A. 2017.
31.
Innovation—Evidence from 20 US Industries under the New Deal.’ The ‘Understanding value in health data ecosystems: A review of current
Journal of Law, Economics, and Organization. 32(1): 1–36. evidence and ways forward.’ European Federation of Pharmaceutical
Industry Associations (EFPIA).
Nawrat, A. 2019. ‘Could Netflix-style subscription models work for
21.
medicines?’ Pharmaceutical Technology. As of 14 May 2020: Lovestone, S. 2019. ‘The European medical information framework:
32.
https://www.pharmaceutical-technology.com/features/subscription- A novel ecosystem for sharing healthcare data across Europe.’ Learning
payment-for-medicines/ Health Systems. 4:e10214.
Meier, G.A. 2019. ‘Using the Drug Pricing Netflix Model to Help
22.
European Commission. 2020. ‘Coronavirus: Commission launches
33.
States Tackle the Hep C Crisis.’ 16 August. As of 14 May 2020: data sharing platform for researchers.’ 20 April. As of 14 May 2020:
https://healthpolicy.usc.edu/article/using-the-drug-pricing-netflix- https://ec.europa.eu/commission/presscorner/detail/en/IP_20_680
model-to-help-states-tackle-the-hep-c-crisis/
Lobo, G. 2020. ‘European COVID-19 Data Platform.’ 6 May. As of 14
34.
24.
Ollove, M. 2019. ‘A Netflix Model for Hepatitis C: One Price, Lancet. 393(10189): 2382.
Unlimited Meds.’ As of 14 May 2020: 36.
AstraZeneca. 2020. ‘AstraZeneca joins UK Government’s ACCORD
https://www.pewtrusts.org/en/research-and-analysis/blogs/
trial platform.’ 28 April. As of 14 May 2020:
stateline/2019/02/25/a-netflix-model-for-hepatitis-c-one-price-
https://www.astrazeneca.com/media-centre/articles/2020/astrazeneca-
unlimited-meds
joins-uk-governments-accord-trial-platform.html
Trusheim, M.R., Cassidy, W.M. & Bach, P.B. 2018. ‘Alternative State-
25.
McBirney, S., Baxi, S., Kumar, K.B. & Richmond, T. 2020. ‘The
37.
Level Financing for Hepatitis C Treatment—The “Netflix Model”.’
unintended consequences of a proposed cure for COVID-19.’ As of 14
JAMA. 320(19): 1977–1978.
May 2020:
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GAVI. 2020. ‘International Finance Facility for Immunisation.’ As of
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About This Perspective About the Authors
In this Perspective, the authors discuss the need for more sustainable Sonja Marjanovic directs RAND Europe’s portfolio of research in the
and scalable ways of incentivising pharmaceutical industry innovation field of healthcare innovation, industry and policy. Her work provides
in response to infectious disease threats to public health. The authors decision makers with evidence and insights to support innovation in
consider incentives for innovation both in the current context of the healthcare systems, and to support the translation of innovation into
COVID-19 crisis, and in the context of preventing other emerging or societal benefits for healthcare services and population health. She
re-emerging infectious disease threats from becoming crises further has over fifteen years of experience working at the interface of policy
down the line. The paper discusses the potential for innovative financial challenges in healthcare innovation and healthcare service improve-
instruments, such as subscription-based models and bond-based ment, for public, private and third-sector decision makers. Sonja has
approaches, to act as incentives. The authors also highlight the need also worked for the UK Economic and Social Research Council’s
to tackle a range of critical success factors beyond financial consid- Centre for Business Research, and has both consulting and commercial
erations. This includes tackling issues related to data access and experience of business development and founding and managing a
the governance of data sharing, securing appropriate clinical trials start-up. She received a PhD from Judge Business School (University of
infrastructure, ensuring suitable approval processes and procurement Cambridge).
practices, and planning for manufacturing and supply chain capacity to
Carolina Feijao is an analyst working in the field of innovation, health
mitigate against unintended consequences in affordability and access.
and science policy at RAND Europe. She brings interdisciplinary and
Finally, the authors observe that the pharmaceutical industry will need
cross-sector perspectives to bear on healthcare innovation policy
to engage with society in ways that extend beyond producing a pill,
challenges, including from consulting engagements in other sectors
diagnostic test or vaccine, in order to deliver on commitments made in
(such as the agri-food sector). Previously, Carolina worked in scientific
response to any incentive systems that are put in place.
publishing. She holds a PhD from the Department of Biochemistry
(University of Cambridge) and an MSc in Quantitative Biology (Imperial
Funding College London).
This Perspective was made possible through internal funding provided
by RAND Europe. Acknowledgements
The authors would like to thank Jon Sussex, Kevin Dean and Tom
Saylor for their helpful comments and advice.
PE-A407-1