[Ip-health] IP-Watch: Do We Need A Global Body To Set Priorities For Diseases And Research?

Thiru Balasubramaniam thiru at keionline.org
Wed Feb 14 08:08:58 PST 2018


https://www.ip-watch.org/2018/02/14/need-global-body-set-priorities-diseases-research/

Do We Need A Global Body To Set Priorities For Diseases And Research?

14/02/2018 BY WILLIAM NEW AND CATHERINE SAEZ, INTELLECTUAL PROPERTY WATCH



A recent panel of health experts gathered at the hallowed Swiss
Intellectual Property Institute in Bern (which counts Albert Einstein among
its alumni) tackled some of the toughest questions facing global health
policymakers with an eye toward actually solving them and not just
restating polarised positions. One of the ideas discussed at the event was
how priorities for diseases and research can be handled at the global level.

The event, entitled, “Stakeholder Discussions on Innovation: availability
and affordability of medical products. Can we achieve it all?” took place
on 1 February. It included representatives from across Swiss government, as
well as leading thinkers from different sides of the issues – industry,
health advocates, international organisations, and academia, all speaking
in their own capacities.

With high prices and availability of medicines a key topic of debate,
Paris-based Ecole des Mines Professor Margaret Kyle suggested that a global
body is needed to rank priorities, highlighting the most important areas
where a global commitment and global financing are needed.

But, she asked, “Do you trust that global body not to be captured by one
country or another, or one political party or another. As an example, she
referenced the United States congressional debate over the budget for the
National Institutes of Health (NIH), which is responsible for about $30
billion of investment per year. “Do you now trust Congress to be deciding
on what the NIH priorities should be?” she asked, adding that some would
have a lot of doubts.

A key question in creating these kinds of structures is to ask if we trust
the governance to work well, and what do we put in place to check those
kinds of potential problems, she said.

And finally, she touched on the system of using prices as an incentive for
innovation.

A lot of national pricing systems are “out of whack,” she said, where “we
are paying too much for drugs that don’t do too much,” leaving no budget
for the really important breakthroughs when they do come along.

That is going to distort incentives, said Kyle. If it is less expensive to
develop a marginal kind of product, a marginal innovation, than it is to
develop a big breakthrough, but the price is the same, companies will go
after products with minor breakthroughs.

This issue of pricing in national system needs to be discussed at the
country level as well as across countries at the international level, she
said, and that means accepting that rich countries contribute more, and
that there will be price differences across countries and across treatments.

It is easier to work on the pricing and reimbursement than tinker with the
patent system. “We have much more information about the value of a product
at the time it is brought to market than at the time the patent application
is filed,” she said.

[Note: a follow-on story will look more deeply into the discussion of
pricing]

Panel moderator Alexander Schulze, co-head of the Division Global Programme
Health at the Swiss Agency for Development and Cooperation, summarised that
speakers talked about how to direct R&D funding to highest priorities more
directly. He noted Beyer’s mention of AMR, and raised a question of whether
national priorities would be enough to create the needed incentives, and
what to do about countries without sufficient resources.

On the global body, Schulze asked if it is acceptable for countries to
identify priorities, then invest together. He highlighted efforts at the
WHO, with the R&D Observatory, and priority lists for areas like GARD-P,
but noted that these are by disease category, so still have the problem of
not necessarily priority-setting across diseases. He asked how these plans
can be developed with recognition of national reimbursement schemes.

Peter Beyer, senior advisor in the Department of Essential Medicines and
Health Products at the WHO, replied: “Easy. We have this global body. It’s
WHO. We can do priority-setting. Certainly it’s a bad idea to have
parliaments do priority-setting,” because they lack the knowledge, and are
not driven by scientific evidence.

He seconded Schulze’s point, saying WHO has done this for priority
pathogens. It does the priority-setting for TB and drives investment for
antimicrobial resistance (AMR). It works fantastically well with the
priority pathogens list, which is used by many mechanisms. CARB-X is the US
mechanism for example, and they use the WHO priority pathogens list to see
in which research projects they invest, he said. It takes a “really small”
amount of money, perhaps $300,000 from the German government, and “the
impact is huge,” he said.

Beyer said he does not think it would work to prioritise diseases against
each other, for instance it doesn’t make sense to prioritise diabetes and
Ebola. Rather, prioritisation should happen within groups. He gave the
example that it has to be at the international level because if it is at
the national level, for instance for Latin America they would identify
Chagas disease, while the rest of the world would say, “we don’t care” and
would leave them alone. And Africa has many neglected diseases, and others
would say, “we don’t care.”

So, he said, it has to be handled at the international level and then there
has to be solidarity for high income countries to do the R&D.

Schulze then asked, how do you reimburse these when it might be something
that is not a national priority.

Beyer said he thinks it works, because of the concern that, for instance,
Ebola might spread to Europe. He compared the Ebola vaccine to an insurance
model: “you want it there as insurance” in case the outbreak gets worse.
The reimbursement can be given for someone to make the stockpiles where
needed. Antibiotics is the same. You don’t want to use it very often. It’s
an insurance model, and for this insurance you have to pay a premium, which
is more difficult for some countries.

At another point in the conversation, Beyer told the story of the Ebola
crisis, where he said what “saved us” was that some research had already
been in the process, mainly from a military standpoint as Ebola was seen as
a possible risk. They were able to quickly conduct trials and developing
candidates. Many of his colleagues at the WHO went to get a shot during the
safety trials they ran in Lausanne at the time, he said. And companies also
came to offer drugs they had that they said would work for Ebola. So they
had to go through this list of drugs and candidates, many with very little
data, for Ebola in particular, to look at whether there was any chance to
use them.

They recognised that they needed to invest much more work in
priority-setting and looking at the pipeline. So they looked at these and
others with an eye toward the health priorities, and identified cases where
there are no vaccines, no diagnostics, no treatments. Then they looked at
the pipeline to see who is investing. For a particular disease they met
with all of the players and ask what are the priorities to use the limited
funds they had for the less attractive diseases and then use the limited
public funds they had for each of the viruses and pathogens to choose two
candidate treatments in phase two, two candidate vaccines in phase two, so
that when we have a big outbreak we are not confronted with having to do
safety trials.

Then a big group of vaccine companies said they were ready under a
no-profit, no-loss model to develop these vaccines. GSK said they could set
up a manufacturing facility in the US for $150 million and produce vaccine
candidates for these pathogens. The vaccine industry has the problem that
when there is an outbreak and they have to stop and focus on Ebola, they
don’t earn money. So a system needs to be set up for that.

Peter Braun, head of Global Access Strategy and Health Policy at Roche in
Switzerland, said there are successful examples of planning for a pandemic.
But he said it is “extremely difficult” because you need to have the
capacity in place to be able to ramp up manufacturing from maybe a million
or two doses to well over a billion or two or three billion, all within
weeks. How do you do that in a sustainable way? he asked. You have to have
the material stockpiled in countries. To prepare for a pandemic influenza
required a lot of coordination among manufacturers, pharma companies, WHO
and many governments, he said.

But even there, with WHO stating very clearly that governments need to put
aside a certain amount of material, many – in fact most – countries did not
do it, he said. It does require very significant accountability of all
parties to make this work.

For Ebola, and AMR, Braun said it has to be asked how to do that, and it
requires a lot of discussion and conversation. And he said he is happy to
say there is a “robust” discussion around AMR ongoing, noting, “We haven’t
figured it out yet though.”

Kyle responded that she is interested in learning more about the agreement
on AMR, and asked how much global agreement there is about how to do it,
who is willing to kick in to the prize fund, or to the research grants,
plus what arguments have been used that have been successful or not.

Beyer replied that for AMR, some of the biggest investors include the US,
UK, the Netherlands, Switzerland, South Africa, Germany, Luxembourg, and
others. He agreed that it is difficult, even to convince the minister of
health, as the minister has no money for R&D. And if you go to, say,
Switzerland, they have a plan and advanced universities, but they have no
free money that they can just give, he said. But he noted that they now
have a directorate in the Ministry of Education and Science for global
health R&D, which is well-funded and has some Chf 500 million for AMR. They
invest in CEPI (a WHO R&D initiative called the Coalition for Epidemic
Preparedness Innovations, meant to accelerate the development of pipeline
vaccines for these diseases through Phase II trials so that they can be
ready for use in the next outbreak), and the Global Innovation Hub.

“That’s what we want to see,” said Beyer, ministries of science and
technology investing directly in global health R&D, where the market is not
attractive enough. And then for manufacturing, capability can be
transferred to facilities in developing countries, because you can’t have a
facility doing nothing until there’s a pandemic, he said. The idea was that
they do vaccines because there’s a market, and then they can change to
pandemics. But then they will have to charge higher prices so you will have
to pay more for locally produced vaccines, so that’s not very attractive
either. So he said he completely agrees that it is not easy to have
pandemic production.

Note: this story is one of a series from the Swiss IPI event.



-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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