TACKLING DRUG-RESISTANT INFECTIONS GLOBALLY FINAL REPORT AND RECOMMENDATIONS

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Market Entry Rewards are not a one size fits all model
Market entry rewards should not be taken as a ‘one size fits
all’ model. The ‘de-linkage’ model may be the best way of
stimulating the market and supporting good stewardship for
certain types of products, particularly broad-spectrum antibiotics
that can be used in many situations. However, there may be
certain types of products developed where patient populations
are smaller and stewardship is less of a concern – particularly
narrow-spectrum antibiotics. It is possible that these drugs can
be purchased and made to be commercially attractive based on
a different pricing model. This type of pricing model will become
more realistic when there are rapid diagnostics that can quickly
establish the need for a patient to use a more tailored and higher
priced product, which is not the case yet. Work in the industry
is on-going already to consider such new models, whereby new
narrow-spectrum antibiotics would be reimbursed at a higher
price only if they are confirmed to have been required and have
been effective against a resistant pathogen.
Depending on the anticipated volume of patients expected to
need these products and on their price, this model may work
to both reward the developer commercially and ensure good
stewardship of new drugs. However, the question of access to
these medicines in health systems outside the richest countries
will need to be considered.
The funding and administration of market entry rewards needs
to be done at a supra-national level, with a sufficient critical
mass of countries signing up to the funding structure and to a
stewardship framework for the new drugs. Operating on this
scale will mean that individual governments do not feel they are
paying far in excess of their ‘fair share’, or that others use the
new drugs excessively with no regard to conserving them for the
future. A political agreement within the G20 group of countries
would be an ideal forum in terms of countries represented
and authority.
The market entry rewards system at the supra-national level will
Putting affordability and access at the heart of a solution
Across all parts of the world – but most frequently in low
and middle-income countries, gaps in universal health
coverage mean that affordability remains a pervasive barrier
to patients receiving the medicines and care that they need.
Antibiotics are no exception to this, and for many the lack of
drugs for treatable infections will pose a more direct threat
to their health than drug resistance. In India, for instance,
more children die from a lack of antibiotics than from
antibiotic‐resistant bacterial infections97.
has proven successful in working with patent-holders to lower
barriers to access to life-saving drugs for conditions such as
HIV/AIDS. Of course, efforts to improve access by such routes
need to have improved antimicrobial stewardship at their
core – something that, in low and middle-income settings,
will require substantial assistance from multilateral bodies like
the WHO, and global NGOs like MSF, as well as commitments
from pharmaceutical companies themselves (including
manufacturers of generic products.)
It is therefore crucial that any package of action to address
drug resistance and stimulate the development of antibiotics
at a global level has considerations of access and affordability
at its heart. This applies to existing antibiotics as much as
to new ones: access needs to be improved whilst reducing
excessive use.
The system of market entry rewards that we propose has
clear potential to support improved affordable access to new
antibiotics. Within reason, conditions can be applied to the
payment of the reward – which could include the product
developer making commitments to ensure supply of the
product to low and middle-income countries at affordable
prices. This might be via direct provision, or through licensing
arrangements such as the Medicines Patent Pool (MPP), which
The Davos Declaration98 included firm commitments from its
signatory companies to improved, affordable global access to
antibiotics. However, delivery against these commitments, and
wider goals established as part of the development of a system
of market entry rewards, will be complex and multifaceted,
and would benefit from neutral and objective assessment. We
note that the work of the Access to Medicines Foundation,
and its Access to Medicines Index (ATMI) has been effective
and widely-influential in shaping how global pharmaceutical
companies approach questions of ‘access’ in low and
middle-income settings. We believe that that there would
be significant value in establishing an iteration of the ATMI
specifically for antibiotics, to allow an objective assessment of
progress and achievement against these important goals.
97 Laxminarayan R, Matsoso P, Pant S, Brower C, Barter D, Klugman K, et al. Access to
effective antimicrobials: a worldwide challenge, Lancet, 2015, 387, 168–175.
98 Industry Declaration, 2016, [Online], Available at: www.amr-review.org/industrydeclaration