[Ip-health] Health Policy Watch: Inside View with Fifa Rahman

Thiru Balasubramaniam thiru at keionline.org
Wed Aug 14 23:24:50 PDT 2019


https://www.healthpolicy-watch.org/how-to-fix-the-medical-rd-model/


How To Fix The Medical R&D Model
14/08/2019 by David Branigan



Fifa Rahman, Unitaid NGO Delegation board member and PhD Candidate at the
University of Leeds, moderated a panel at the recentIAS Conference on HIV
Science in Mexico entitled “How To Fix Our Medical R&D Model: A Spotlight
On TB Treatment.” The panel featured speakers from Médecins Sans
Frontières’ (MSF/Doctors Without Borders) Access Campaign, Drugs for
Neglected Diseases initiative, Treatment Action Campaign, Treatment Action
Group, The International Union Against Tuberculosis and Lung Disease (The
Union), and the Mexican National Institute of Health Sciences and Nutrition
(National Institute Salvador Zubirán). Here, Rahman shares highlights from
the panel on why the medical research and development (R&D) model needs to
be ‘fixed’, as well as ways to go about fixing it, including greater
transparency, new incentives for investment in R&D that are alternatives to
intellectual property, and increased NGO and community participation
throughout the research and development process.

Health Policy Watch: At the IAS Conference on HIV Science in July, you
moderated a panel on how to fix the medical R&D model, with a focus on
tuberculosis (TB). Can you describe some of the key themes discussed during
the panel regarding what needs to be ‘fixed’ about the medical R&D model?
What were some of the specific strategies or solutions presented to go
about doing this?

Fifa Rahman: The profit-driven medical R&D model means that so-called ‘poor
nation’ diseases like tuberculosis are underfunded. And while there are 7
antibiotics for TB in the R&D pipeline, this is insufficient to address the
sheer burden of the disease that we have today. In discussion of this
broken R&D model, several themes emerged – notably the need for details on
public funding into research of drugs to be made public and transparent;
that other forms of delinkage to separate R&D costs from product prices,
such as prizes for developing new antibiotics, be funded; and that
companies license their drugs, including to the Medicines Patent Pool (MPP).

Paula Fujiwara from The Union spoke about the Life Prize, which is aimed
towards delivering an affordable, short-course treatment regimen that is
effective against all forms of tuberculosis. How this would work is that
donors would put their monies into a prize fund, and this prize funding
(pegged at US$ 30 million) would be given to companies producing drugs that
enter clinical trials to develop a pan-TB regimen, and that also fulfil all
predefined criteria, such as addressing stewardship concerns and licensing
to ensure access. This plan is guided by principles of access and
affordability, and removes the drug development process out of the faulty
profit-driven system. It’s a brilliant idea – but needs political
commitment from donor countries.

Sharonann Lynch from MSF Access was supportive of the Life Prize idea, and
additionally spoke about the need to regulate the margin of income over the
cost of manufacturing, and that countries needed to commit to transparency
of the cost of R&D to make this work.

HPW: The need for public health-driven R&D has been a major theme this
year, with intense debate over how best to achieve this in multiple United
Nations fora, including the World Health Organization, the Human Rights
Counciland more recently the General Assembly in negotiating the political
declaration on universal health coverage (UHC). Do you see progress taking
place nationally and internationally in advancing public health-driven R&D,
and if so how? If not, why not?

FR: It’s hard to say. On one hand you’ve got developed and developing
nations, including Italy, Malaysia, Spain, Brazil, an entire African bloc
of nations, and the United States, endorsing a World Health Assembly (WHA)
resolution on drug pricing and research and development transparency, which
is clearly a major milestone. We’ve also got increased visibility on drug
pricing debates. High drug prices are no longer a developing country issue,
with buyers clubs being established on the cystic fibrosis drug Orkambi in
the UK, and people dying due to substitution of originator insulin in the
United States. We also have some of Switzerland’s top university hospitals
teaming up to tackle high CAR-T cancer therapy prices and offer them at a
third of the cost.

On the other hand you’ve got the United Kingdom intensely resisting drug
pricing transparency at the WHA, and uncertainty around Democratic
Presidential Candidates in the United States, and how the election will go
in 2020. Despite the diminishing global dominance of the U.S. for some time
now due to the rise of emerging market nations, and of course China, the
impact of United States’ regime-making capacity will be greatly dependent
on who wins in 2020. For example, a Joe Biden presidency would be vastly
different to an Elizabeth Warren presidency in terms of how the U.S. would
advance public health-driven R&D internationally.

HPW: Intellectual property (IP) and patents are widely seen to be core
drivers that incentivise R&D of new health products, and in this light are
viewed by a range of actors as essential for innovation in public health,
even while they can lead to monopolies that restrict affordable access to
health products. What is your perspective on the role of intellectual
property and patents in public health-driven R&D, and can you describe some
of the challenges they pose, particularly when negotiated as just one
aspect of much more comprehensive trade agreements?

FR: It’s no secret that there is a lot of patent abuse, over-patenting, and
evergreening, and as a result patients are deprived of access to medicines
which should now be off-patent. The system also encourages price gouging of
which we’ve seen numerous examples, but which is particularly visible with
stories like that of Tobeka Daki who died of breast cancer not having
access to Herceptin.

Trade-related IP binds IP to enforceable regimes, and requires countries to
increase intellectual property protection which enables price gouging and
evergreening as described. But there are signs of hope. You see,
trade-related IP responds to pharmaceutical markets, and as we move towards
more biologic medicines and personalised medicines, the IP regime will
respond accordingly. Over the past few years as we saw blockbuster drug
lists increasingly dominated by biologic drugs, we saw the United States
demanding specific intellectual property provisions for biologic drugs in
the Trans-Pacific Partnership (TPP) and the United States-Mexico-Canada
Agreement (USMCA). In the former, and as will be shown in upcoming research
in my PhD, despite economic interdependence on the United States, countries
including Australia, Malaysia and Chile formed strong coalitions based on
common ideation rejecting intellectual property maximisation on biologics.
So while trade-related IP responds to trends in the market, whether or not
countries accept them is dependent on other political economy factors –
including their economic interdependence on other large powers, the
visibility and emphasis of drug pricing debates in developed nations, and
the ability of developing nations to effectively utilise tools that can
increase their bargaining power in trade negotiations.

HPW: You’re currently serving as a board member of Unitaid on behalf of the
NGO delegation. Can you explain why Unitaid, a major global funder of
public health-driven R&D, includes an NGO representative as well as a
Community representative in its Executive Board? Do you think the medical
R&D system can do better at including NGOs and affected communities in its
R&D process, and if so how? Do you think this may also help to fix the
medical R&D model?

FR: The Unitaid NGO Delegation represents NGO entities and experts within
those entities, and the Communities Delegation represents communities
living with the diseases. Both of these delegations play a very important
role within the decision-making body of Unitaid because they bring unique
perspectives to grant approval and governance processes.

As the Board Member for the NGO Delegation I can speak on its behalf but
not the Communities, and I can say that the NGO Delegation draws upon
expert opinion from over 200 NGOs across the world, including input on
whether there are already suitable generics for a proposed investment;
whether there is proper waste disposal for plastic canisters from malaria
indoor spraying; whether the underinvestment in TB is best served by
projects on digital adherence technologies; or whether we would be better
placed investing in something like the Life Prize or investing in fixing
broken paediatric pharmaceutical procurement systems. We also frequently
engage with Unitaid grantees – which I think increases the robustness of
our feedback to the Board and Secretariat. Alongside the role of the
Communities and NGO Board Members, we always hope and expect that the other
Board Members, and especially the Secretariat, also find ways to consult
directly with NGOs and affected communities to sharpen their approach to
ensuring affordable medicines and diagnostics.

We as a Delegation think that NGOs should be consulted more upstream in the
R&D process, precisely because of our insight into access, affordability,
and equitability issues, as well as to ensure that new medicines and
diagnostics are designed in a manner that is best suited to use in
particular settings, or to ensure that such products are acceptable to the
people who must ultimately use them.

As to the question on ‘how?’ – there are a few approaches. One promising
avenue is to ensure prominent NGO and community participation at the WHO as
it continues to update and expand the Health Product Profile Directory,
which was launched by TDR, WHO’s Special Programme for Research and
Training in Tropical Diseases, earlier this year. It is also important that
major public funders of R&D, whether in the U.S., Europe or elsewhere, find
ways to consult and work directly with NGOs and communities – especially
since so many of the crucial inventions that are ultimately brought to the
market are brought forward by intramural or extramural research hosted by
these institutions. Finally, major philanthropic funders such as the
Wellcome Trust and the Gates Foundation, and many of their key recipients,
and in particular product development partnerships, can play a crucial role
in ensuring the participation of communities and NGOs both upstream and
also as products enter the market, where their contributions are equally
needed.

Such interventions can help to ensure that medical R&D, as far as initial
investments made in the public sector and philanthropies, are more attuned
to the needs of communities at the outset. Yet the breakdown of the R&D
model requires much deeper changes to how R&D is conducted, including a
need to search for incentives outside of intellectual property; the
importance of public health funders demanding a public return on public
investment; a need to promote transparency across the R&D process; and much
more substantial political will of governments to both balance the power of
pharmaceutical companies and to bring down prices of new medicines and
vaccines when these other interventions fail to ensure affordability of new
medicines.

Fifa Rahman is the Board Member for NGOs at Unitaid, working on good
governance, timeliness of investments, and procurement transparency, among
other things. She was formerly the head of policy at the Malaysian AIDS
Council, and worked on a HCV compulsory licence. She is now based in the
United Kingdom working on a PhD on trade negotiator tactics in intellectual
property negotiations at the University of Leeds.

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


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