[Ip-health] BBC: Call for $2bn global antibiotic research fund

Outterson, Kevin mko at bu.edu
Fri May 15 05:50:40 PDT 2015


Public domain treatment might not be in the public interest for antibiotic patents after a full buy out, as that might drive resistance. Under the full delinkage model, the IP rights would be held by a global body such as the Medicines Patent Pool, who would be in charge of all sublicenses for low-cost production globally.  This entity must be transparent, trustworthy and focused on global public health.

The “hybrid” delinkage model pays less up front, with the companies retaining IP and selling the antibiotics, with contractual commitments on price, access and conservation.  These contractual commitments must be realistic and enforceable, again with an overriding focus on global public health.

The Chatham House report that will issue around June 18 will give much more discussion on new business models for antibiotics, particularly delinkage.  There is a significant and growing academic literature. For an early, short treatment, see Jamie’s article from 2008 http://www.scidev.net/global/health/opinion/prizes-not-prices-to-stimulate-antibiotic-r-d-.html and my longer law review article from 2005 http://papers.ssrn.com/sol3/papers.cfm?abstract_id=873401.

Kevin
___________________
Professor of Law & N. Neal Pike Scholar in Health and Disability Law - Boston University
Associate Fellow, Chatham House
Editor in Chief, Journal of Law, Medicine & Ethics<http://www.aslme.org/>
Blogging health law at The Incidental Economist<http://www.theincidentaleconomist.com/>
Research papers at SSRN<http://ssrn.com/author=340746> & Google Scholar<http://scholar.google.com/citations?user=m4to2LMAAAAJ&hl=en>
@koutterson | 617 935 6517

On May 15, 2015, at 5:32 AM, Dean Baker <Dean.Baker1 at verizon.net<mailto:Dean.Baker1 at verizon.net>> wrote:

how about the patents just be placed in the public domain subject to copyleft type rules (anyone can use the patents, but if they
have a patent that relies in some way on the prior patent, it must either also be in the public domain or they must negotiate
terms for the use)

On 5/15/2015 2:56 AM, Charles Clift wrote:
Or a rights would be given to a 'a global body'. "The most radical means of implementing de-linkage would be
for a designated global body, with a broad base of buy-in from nation states, to establish a mechanism to purchase the global
sales rights to new antibiotics, and to subsequently manage their supply internationally." See also my comment: http://www.chathamhouse.org/expert/comment/17659
Charles

-----Original Message-----
From: Ip-health [mailto:ip-health-bounces at lists.keionline.org] On Behalf Of Danny Edwards
Sent: 14 May 2015 22:26
To: Gaelle Krikorian
Cc: ip-health at lists.keionline.org<mailto:ip-health at lists.keionline.org>
Subject: Re: [Ip-health] BBC: Call for $2bn global antibiotic research fund


Link to full report here:

http://amr-review.org/sites/default/files/SECURING%20NEW%20DRUGS%20FOR%20FUTURE%20GENERATIONS%20FINAL%20WEB_0.pdf

The lump sum places some requirements on the company:

'Under this system we would expect the lump sum payment to come with a variety of conditions linked to stewardship and global access goals. For instance, the global body awarding the payment could impose conditions on the provision of drugs at an affordable price in low and middle income countries'

But I don't see mention of giving up exclusivity, even through licensing. Maybe I've missed it - seems the company is compensated up front and retains the right to make profits from sales.

Maybe I missed something - would be interested in other views.

Sent from my iPhone

On 14 May 2015, at 6:37 pm, Gaelle Krikorian <gaelle.krikorian at gmail.com> wrote:

The article says nothing about the IP status of the drugs that would be developed thanks to this fund.

It says:
In order to incentivise drug development, the review team says, there
should be lump-sum payments to companies that create proven new antibiotics.
`
The project would be very exciting if it was a lump-sum but no exclusive rights. If it is the addition of the two then it’s rather preoccupying. Taxe payers could end up paying billions before development and billions after commercialization of the drugs.
(Also, if it is clear that securing a captive market through patents is not an effective incentive to get companies to develop new antibiotics:
Many large companies have pulled out of antibiotic research.
The report says this is partly due to the uncertain commercial returns
for new antibiotics.
Then what is the rational behind giving exclusive rights?)

Does anybody have more info about the recommandations made by this review team?

Best

Gaelle



Le 14 mai 2015 à 15:57, Thiru Balasubramaniam <thiru at keionline.org> a écrit :

http://www.bbc.com/news/health-32701896

Call for $2bn global antibiotic research fund

Fergus Walsh
<http://www.bbc.com/news/correspondents/ferguswalsh>Medical
correspondent

The global pharmaceutical industry is being called on to pay for a
$2bn
(£1.3bn) innovation fund to revitalise research into antibiotics.

In return, there would be guaranteed payments to companies which
produced vitally needed new antibiotics.

There are currently very few new antibiotics in development amid a
global spread of resistant bacteria.

The proposals are in a report by a UK government-appointed review team
headed by economist Jim O'Neill.

Mr O'Neill said: "We need to kick-start drug development to make sure
the world has the drugs it needs, to treat infections and to enable
modern medicine and surgery to continue as we know it."

He has previously warned that drug-resistant microbes could kill 10
million people a year worldwide by 2050 and cost $100 trillion in lost
economic output.

Resistant strains of bacteria are spreading globally, threatening to
make existing drugs ineffective.

A global innovation fund of $2bn over five years would be used to
boost funding for "blue-sky" research into drugs and diagnostics -
with much of the money going to universities and small biotech companies.

One promising area of research concerns so-called "resistance breakers".
These are compounds that work to boost the effectiveness of existing
antibiotics - a far less costly approach than attempting to discover
entirely new drugs.

Helperby Therapeutics, a spin-out company founded by Prof Anthony
Coates, St George's, University of London, has created a resistance
breaker that acts against the superbug MRSA.

The compound, known as HT61, will shortly go into clinical trials in
India, where it is being developed under licence by Cadila Pharmaceuticals India.

The review team said this kind of research could benefit from the
innovation fund and could be the key to making existing drugs last longer.

Mr O'Neill said the big pharmaceutical companies should pay for the
fund and look beyond short-term assessments of profit and loss.

Formerly chief economist with the investment bank Goldman Sachs, Mr
O'Neill drew parallels between the banking crisis and the looming
catastrophe of a world where antibiotics no longer worked.
Innovation funding

He said big pharma needed to act with "enlightened self-interest"
because "if it gets really bad, somebody is going to come gunning for
these guys just how people came gunning for finance".

Mr O'Neill was speaking to the BBC's Panorama programme, which has
spent six months following the work of the review team, filming in
India, the US and UK.

Mr O'Neill was appointed last year by Prime Minister David Cameron to
head the review into antimicrobial resistance - which already claims
an estimated 30,000 lives a year across Europe.

Many large companies have pulled out of antibiotic research.

The report says this is partly due to the uncertain commercial returns
for new antibiotics.

New drugs are often kept in reserve for years, to preserve their
potency, by which time they may be nearing the end of their patent.

After this expires, cheaper generic versions are available.

In order to incentivise drug development, the review team says, there
should be lump-sum payments to companies that create proven new antibiotics.

This would break the link between the profitability of a drug and its
volume of sales.

The review team predicts its proposals could lead to 15 new
antibiotics a decade, of which at least four should be "breakthrough
products" targeting the bacterial species of greatest concern.

It estimates the cost of guaranteed payments for these drugs would be
$16-37bn over a decade but says this is a small price to pay given
that antibiotics are essential to so many aspects of healthcare, from
common infections, to surgery and cancer treatment.
US breakthrough

It is nearly 30 years since a new class of antibiotics - meaning a
group of drugs with an entirely novel action - was introduced.

But this decades-long drought could be over as a result of a
breakthrough recently announced by US scientists.

A team at Northeastern University in Boston, Massachusetts, has
discovered
25 potential new antibiotics
<http://www.bbc.co.uk/news/health-30657486>,
all of them derived from soil microbes.

One of them, teixobactin, is effective against both tuberculosis and MRSA.

The drug is being developed by NovoBiotic Pharmaceuticals and should
go into patient trials within two years.

Prof Kim Lewis, of Northeastern University, who co-founded the
company, told Panorama: "We think there could be thousands more
antibiotics in the soil, yet to be discovered."

There are still many uncertainties.

Teixobactin has yet to undergo patient trials, and it is at this stage
that many promising drugs fail.

Nor is it effective against bacteria such as E.coli and Klebsiella,
which are responsible for a huge proportion of resistant infections.

But the Boston team's discoveries are the type of innovative research
many scientists believe essential to ensure we do not run out of
effective antibiotics.

Patrick Vallance, GlaxoSmithKline's president of pharmaceutical R&D
said that, as one of the few companies still conducting antibiotic
research they welcomed the report: "We are very encouraged by the
ideas it sets out to modernise the economic model to encourage
investment in research and ensure reasonable returns."

Prof Dame Sally Davies, chief medical adviser to the UK government, said:
"We have to respond to the challenge of antimicrobial resistance by
making sure we secure the necessary antibiotics for generations to
come, in order to save millions of lives and billions of pounds."
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