[Ip-health] Against 'Grave Challenge to Achievements of 20th Century' - UN Agrees Political Declaration On Antibiotic Resistance

Thiru Balasubramaniam thiru at keionline.org
Thu Sep 22 13:04:43 PDT 2016


Against ‘Grave Challenge To Achievements Of 20th Century’, UN Agrees
Political Declaration On Antibiotic Resistance


NEW YORK — The membership of the United Nations today agreed a political
declaration on antimicrobial resistance, elevating the global fight against
overuse and misuse of antibiotics – and lack of new antibiotics – to the
highest political level. The declaration struck by world leaders at the UN
General Assembly in New York includes mention of separating medicine prices
from the cost of research and development, and calls on the UN
secretary-general to create an interagency coordination group. Now – as
framed by many governments, intergovernmental organisations and
nongovernmental representatives – attention moves to implementation of
actions aimed at staving off this threat to humanity itself.


The AMR issue cuts across public health, agriculture, animal health, trade
and even security policy, and key element of the way forward involves
efforts to coordinate between various sectors. This was the fourth time a
health issue has been taken up by the UN General Assembly (following HIV,
noncommunicable diseases, and Ebola). The UN High Level Meeting on
Antimicrobial Resistance took place on 21 September.

“Antimicrobial resistance poses a fundamental threat to human health,
development, and security,” World Health Organization Director General
Margaret Chan said (see press release
from the event). “The commitments made today must now be translated into
swift, effective, lifesaving actions across the human, animal and
environmental health sectors. We are running out of time.”

“Common and life-threatening infections like pneumonia, gonorrhoea, and
post-operative infections, as well as HIV, tuberculosis and malaria are
increasingly becoming untreatable because of AMR,” the release stated.
“Left unchecked, AMR is predicted to have significant social, health
security, and economic repercussions that will seriously undermine the
development of countries.”

Among the many actions in the political declaration is reinforcement of the
principle of “delinkage” of research and development costs from the price
of resulting medicines.

It also called on the World Health Organization, the UN Food and
Agriculture Organization and the World Organization for Animal Health to
“finalize a global development and stewardship framework,” as requested by
the World Health Assembly.


R&D and Delinkage

On R&D and delinkage, the declaration under item 10 includes calls to:

“(b) Underline that basic and applied innovative research and development,
including in areas such as microbiology, epidemiology, traditional and
herbal medicine and social and behavioural sciences, as appropriate, are
needed in order to better understand antimicrobial resistance and to
support research and development on quality, safe, efficacious and
affordable antimicrobial medicines, especially new antibiotics and
alternative therapies, vaccines and diagnostics;

(c ) Underline also that all research and development efforts should be
needs-driven, evidence-based and guided by principles of affordability,
effectiveness and efficiency and equity, and should be considered as a
shared responsibility: in this regard, we acknowledge the importance of
delinking the cost of investment in research and development on
antimicrobial resistance from the price and volume of sales so as to
facilitate equitable and affordable access to new medicines, diagnostic
tools, vaccines and other results to be gained through research and
development, and welcome innovation and research and development models
that deliver effective solutions to the challenges presented by
antimicrobial resistance, including those promoting investment in research
and development; all relevant stakeholders, including Governments,
industry, non-governmental organizations and academics, should continue to
explore ways to support innovation models that address the unique set of
challenges presented by antimicrobial resistance, including the importance
of the appropriate and rational use of antimicrobial medicines, while
promoting access to affordable medicines;

(d) Underline that affordability and access to existing and new
antimicrobial medicines, vaccines and diagnostics should be a global
priority and should take into account the needs of all countries, in line
with the World Health Organization global strategy and plan of action on
public health, innovation and intellectual property [WHA62/2009/REC/1,
resolution 62.16], and taking into consideration its internationally agreed
follow-up processes;”

Some Government Views

In statements today, governments repeatedly emphasised their commitment and
detailed progress and challenges at the country level.

Germany said that fighting AMR will be a priority when Germany takes over
chair of G20 in December.

On R&D for new medicines, India mentioned the newly released report of the
UN Secretary General’s High Level Panel on Access to Medicines. “As
highlighted by the report, the existing imbalance between IPR and public
health is leaving people behind,” India said. “Therefore, we must
prioritise incentivizing investment in R&D for health technology

Zimbabwe also mentioned the report of the High-Level Panel, as well as
citing the importance of flexibilities to patents under the World Trade
Organization Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS).

Numerous governments mentioned the landmark “O’Neill” report from the UK
that sparked action with its alarming statistics and clear delineation of
the problem of AMR.

Australia mentioned a multi-million dollar fund. Another speaker mentioned
a new index for companies on AMR.


Two panels of experts were held during the daylong meeting, and highlights
of the panels will be captured in an *Intellectual Property Watch* story to

In one immediate reaction, Médecins Sans Frontières issued a response
the declaration, calling it “an important political step.”

“In addition to recognising that all countries must do much more to better
use existing antibiotics by strengthening health systems, human resources
for health and laboratory capacity, this declaration also highlights the
need to improve access to existing medical tools, including by reducing the
price of existing vaccines to prevent infections, as well as the need for
research and development of new products that are patient-focused,
affordable and appropriately available to all who need them,” MSF said.

The Drugs for Neglected Disease initiative (DNDi) issued a release
the declaration.

“Today’s UN declaration another encouraging sign that governments have
elevated the debate on biomedical innovation and access to medicines,
diagnostics and vaccines to the highest political levels,” it said.

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