[Ip-health] IP-Watch - The True Believer: An Interview With New IFPMA Director General Thomas Cueni

Thiru Balasubramaniam thiru at keionline.org
Wed May 10 03:05:50 PDT 2017


https://www.ip-watch.org/2017/05/08/true-believer-interview-
new-ifpma-director-general-thomas-cueni/


The True Believer: An Interview With New IFPMA Director General Thomas Cueni

08/05/2017 BY CATHERINE SAEZ AND WILLIAM NEW, INTELLECTUAL PROPERTY WATCH
LEAVE A COMMENT

The International Federation of Pharmaceutical Manufacturers and
Associations (IFPMA) has long been at the centre of global public health
policy in Geneva, representing industry from around the world. Now at a
critical moment of change in global policymaking, a new leader, Thomas
Cueni of Switzerland, has taken over, starting in February 2017.
Intellectual Property Watch recently sat down with him to discuss his views
and vision going forward, and discovered his thoughtful pragmatism and
diverse background which promise to open an ambitious new era for the
association and global health policy.

Intellectual Property Watch (IPW): Congratulations on your new post. Why
did you decide to come to IFPMA, what in your background led you to this
position, and what do you hope to accomplish?

Thomas Cueni: This is an exciting time to be asked to take on the
leadership of the organization representing the international
biopharmaceutical industry because we are in an era of change. What
prepared me to come to Geneva? I have not only argued for the value
proposition of the industry in Switzerland for more than 25 years, but I
have been involved throughout all those years in shaping the industry’s
policy approach at both European and global levels. When called to assume
leadership of IFPMA, with a mandate to strengthen the voice of the
research-based biopharmaceutical industry in Geneva, I felt it was the
right time — going back to my roots as a Swiss diplomat, I had always been
engaged in multilateral diplomacy.

The industry needs a strong voice of the industry, since we are called upon
to justify the innovative pharma business model. We are being challenged to
show the value medicines and vaccines bring to society. Let’s not forget,
10 years ago many people were talking about pharma pipelines not
delivering, threatening “patent cliffs” and predicting the end of the
blockbuster medicines. Fast forward to today, and we are looking at more
than 7000 medicines in development, many of which are the result of
breakthrough R&D. The innovative biopharmaceutical industry can boast not
just quantity of new medicines and vaccines, but also quality.

This current depth in quality of innovation is important. In the past, I
would not quarrel with certain criticisms of too many “me too” medicines. I
agree that in some areas, there have been drugs developed that did not
differentiate sufficiently. The current return to breakthrough innovation
shows that the market has adjusted and is rewarding real innovation for
unmet medical needs. Today, if you are too late and you come in to market
at 7th, 8th, or 9th, let alone 15th or 16th, it does not pay. In contrast,
if you can demonstrate significant added therapeutic value – whether
enhanced efficacy, better safety, or improved quality of life, you are
likely to obtain a premium price. Whatever it is designed to treat, new
medicines must have clear distinction: the 25th beta-blocker obviously does
not have that. But talk that the biopharmaceutical industry does not have a
strong pipeline, and is not coming up with innovative research, is outdated.

Talk that the biopharmaceutical industry does not have a strong pipeline,
and is not coming up with innovative research, is outdated. – Thomas Cueni

Examples of industry delivering on its pipeline are the recent great
advances in oncology treatment or rheumatoid arthritis. HIV/AIDS has been
turned from a deadly into a chronic disease, and there is today a rich
expansion of treatments for rare diseases. Twenty years ago, if you were
diagnosed with an ultra-rare disease, it was just bad luck. Nowadays, many
drugs can treat these rare diseases. Advances in science and incentives
like the ones contained in the Orphan Drug Act have worked.

The biopharmaceutical industry is still extremely competitive, but today
there is a much more collaborative approach to research. In some areas, for
example, the development of immuno-oncology combinations, you have
cross-company cooperation. In other areas, we are seeing many more
public-private partnerships, in particular in areas where the typical
business model is not working. I strongly believe in the competition-driven
business model based on strong protection of intellectual property, but in
areas like neglected tropical diseases or anti-microbial resistance, we
must think out of the box and be open to new kinds of partnerships. The
Innovative Medicines Initiative (IMI) of the European Union, collaborations
such as the GAVI Alliance, the collaboration in Geneva on Neglected
Tropical Diseases (as celebrated at the recent NTD Summit), the Medicines
for Malaria Venture (MMV), the World Intellectual Property Organization
Re:Search, are all examples of successful collaborations. The
biopharmaceutical industry has really opened up to new ways of working
together with the academic community and public sector – that is not only
exciting, but also good for global public health.

IPW: What is the incentive for a company to take the initiative to
collaborate and participate in these initiatives that are needed to address
diseases that fall on the side of profitability? Can the private sector be
the one to drive those kinds of initiatives?

CUENI: I believe strongly in a competitive research model where innovation
is supported by strong protection of intellectual property. Successes are
rewarded and not failures. This business model based on IP rights and
competitive markets has delivered great medical breakthroughs for patients
and society. But, there are areas, and the NTDs are one example, where
there is no functioning competitive market, where we all need to think out
of the box, where you need to think beyond the classic business model. And
there are areas, such as orphan drugs or AMR, where you can create
market-based incentives to make it attractive.

IFPMA doesn’t need to be loved, it wants to be respected.

What is special about the biopharmaceutical industry? Companies are very
much aware of societal expectations. Corporate social responsibility is not
just a buzzword. To a significant extent pharmaceutical companies derive
their license to operate from delivering value to society at large.
Clearly, they have to be profitable to invest in R&D for innovative
treatments, but they are also expected to act in socially responsible ways.
As a trade association leader, I always felt that I had a dual job: on the
one hand, I have to stand up and defend the value proposition of our
industry, on the other I have to build bridges and demonstrate that the
biopharmaceutical industry is part of the solution and not the problem in
improving the health of the people in developed and developing countries
alike.

When you look at what is hindering access to medicines, what are the
barriers, a lot of them are systemic. For example, a couple of years ago
there has been a great deal of soul-searching around the Ebola epidemic.
But let us not forget that neither the 2003 report on Priority Medicines
for Europe and the World, commissioned by the World Health Organization and
the Dutch Government, nor its 2013 sequel mentioned Ebola as a priority
disease since most experts considered that an outbreak – in contrast to a
major influenza pandemic – could be easily contained by classic public
health measures such as isolation of patients. Things did not unfold in
that way because of health systems failure in affected countries. The
interesting thing is how fast a vaccine was produced — through
public-private collaboration and the involvement of regulatory agencies —
once the crisis was fully realized. If there had not been some vaccines in
the pipeline, this result could never have been accomplished in a manner of
months.

Today, the Coalition for Epidemic Preparedness Innovations (CEPI)
initiative, the WHO PIP Framework (Pandemic Influenza Preparedness
Framework for the sharing of influenza viruses and access to vaccines and
other benefits) show that the biopharmaceutical industry continues to
contribute to novel solutions.

IPW: You are bringing a message to say industry is not a problem, being
part of the solution, you are not coming in with an idea to change the
existing business model for the private sector, and research and
development, and accessibility and affordability?

CUENI: No, the existing business model works. There is no better incentive
for coming up with innovative treatments than competitive research, strong
intellectual property protection, and the reward for the successful
innovator. But in tackling the health care challenges of the developing
world we need to leave our own “comfort zone” and collaborate with others,
be it in engaging on health systems reform or in partnerships to bring
medicines to people in resource-constrained settings. For example, IFPMA is
now hosting the secretariat of an initiative called Access Accelerated,
launched earlier this year.

Access Accelerated brings together 23 global biopharmaceutical companies,
teaming up with the World Bank, the Union of International Cancer Control
(UICC), and Boston University in an effort to demonstrate that you can
really make significant progress in addressing the NCD epidemic through
cooperative action. Access Accelerated has several components: pilot
country systems development in the area of non-communicable diseases
(NCDs), a multi-stakeholder best practice exchange platform with the World
Bank, regulatory harmonization in Africa, a World Bank project in
partnership with the Bill & Melinda Gates Foundation (BMFG), the
partnership with the C/Can 2025 Initiative of the Union for International
Cancer Control (UICC) in five pilot cities in developing countries,
multiple access initiatives of the 23 participating companies, and,
finally, the willingness to submit the industry’s efforts to the scrutiny
of Boston University, which has been tasked with establishing a metrics
framework for measuring progress in a transparent way.

IPW: You have a very rich background. What is your style – more an
analytical or an action-oriented person? How would you define your style?

CUENI: I am excited by the intellectual debate that is unfolding in Geneva.
I’ve always been interested in the brainstorming of an association job and
the challenge of bringing people with different backgrounds and thoughts
together. This is highly stimulating. However, the reason why I never
thought of becoming an academic myself is that I am very pragmatic and
solution-oriented. At the end of the day, while I love the intellectual
interaction, I am interested in actions and getting results.

IPW: Some see discouragement with a “Geneva syndrome” where they feel there
is a little too much consideration for anti-IP rights, too much impractical
thinking on how the world really works, and out of touch with the rest of
the world. What are your thoughts on this?

CUENI: As you may have noticed, I am quite willing to call a spade a spade.
It appears to me that there is not one but at least two Genevas. On the one
hand, you meet people of whom you think, ‘Oh God, are we back to the 1960s,
1970s?’ as if the world has not moved on, very much in a dogmatic trench
warfare. But then, you see an opening with institutions and organizations
like DNDi [Drugs for Neglected Diseases initiative], the Medicines Patent
Pool, the WIPO Re:Search, the Medicines for Malaria Venture, the London
Declaration on NTDs, the Bill and Melinda Gates Foundation, the multiple
public-private partnerships, including for product development, and there
is a sigh of relief. The world, including the industry, has moved on.

Personally, I consider it boring to talk just to the converted, and
industry has been quite good at talking among itself. My colleagues at
IFPMA have been reaching out and creating partnerships for quite a number
of years. We need to build on this and continue to stimulate debate and
also cross bridges. I am quite willing to stand up and argue the points I
make because I think one of the assets I bring to IFPMA is that I am a
believer. I believe in what I say. I am not a hired gun. However, we
probably need more conversations with people who are critical about parts
of what we do and we also need to be prepared to reflect on areas where we
may need to adapt and change.

I am quite willing to stand up and argue the points I make because I think
one of the assets I bring to IFPMA is that I am a believer. I believe in
what I say. I am not a hired gun.

IPW: There is a problem of high drugs prices affecting developing and
developed countries. Do you have a vision to address the problem? Do you
have a solution up your sleeve?

CUENI: I do believe in the value proposition of our industry. When we look
at how new medicines have transformed the treatment of many diseases over
the last 20 years, it is quite remarkable that spending on prescription
medicines in vast majority of OECD countries has been stable around 10-15%
of total health spending. Having said this, I am fully aware of the
concerns around the issues of pricing, in particular, of new medicines, and
we must be open to addressing the questions raised. However, the debate
should be fact-based and balanced. It is necessary to break down silos and
introduce whole system thinking, e.g. on waste in the system and efficiency
on health spending. In our sector, I do believe that discussions are
necessary on paying for outcomes, for performance, for example when you
look at the challenge of paying for combination products in the field of
immuno-oncology. The challenge is that health care systems work in silos:
doctors, nurses, medical devices, drugs, and that is static. These are all
fixed with annual budgets that are not dynamic.

I can understand why some prices are questioned, and that there are debates
about what is a fair price is. Obviously, we also can’t ignore the issue of
affordability for developing countries. However, I am apprehensive about
simple solutions. And we need to keep the debate in perspective. The fact
is, for example, that aggregate spending on all oncology drugs in
Switzerland represents just 1 cent out of every franc spent on health care.
In Switzerland, six times more is spent on tobacco (the leading cause of
lung cancer) than is spent on all oncology drugs together.

I can understand why some prices are questioned, and that there are debates
about what is a fair price is. Obviously, we also can’t ignore the issue of
affordability for developing countries. However, I am apprehensive about
simple solutions.

IPW: How would you measure your success at IFPMA on objectives that you
would like to be reached?

CUENI: I think it is clear: IFPMA doesn’t need to be loved, it wants to be
respected. Respected for helping develop new partnerships, respected for
helping our medicines reach millions more people in developing countries,
but also respected for standing up and firmly arguing the value proposition
of our industry.

IPW: Are any areas that you think need attention at IPFMA, as you inherited
the reins of IFPMA?

CUENI: I am lucky that I can build on strong foundations. For example,
IFPMA has been pioneering work on ethics and business integrity. Compliance
with codes is something that is very important and will continue to evolve.

The recently launched Access Accelerated Initiative with UICC and the World
Bank is potentially a game changer as it is a really bold initiative.

I would like to see IFPMA be more visible and help our ideas gain more
exposure.

IPW: What do you see as key IP issues? At an event early in March you said
that transparency in prices was in fact not a good idea, could you
elaborate on this?

CUENI: There are in fact two issues on transparency, first about
transparency of costs and second, transparency of prices. I see in the
report of the UNHLP on Access to Medicines a call for cost-plus pricing.
You have the cost of R&D, you have the cost of manufacturing, the cost of
marketing, the cost of distribution, and then you add the margin and you
talk about what is a fair margin.

This approach is deeply flawed. History has shown that cost-plus pricing
has not led to breakthrough innovations. Instead, it incentivises less
risky, safe innovative paths where there is a high chance of success,
marginal differentiation, but a decent price and return on investment.
Instead, one should reward risk-taking and success, therapeutic added value
and not cost of input. This is why the US system which has always been much
more reward-driven, benefit-driven, with high reward for high innovation,
is very lucrative for the successful innovator, but also very tough for
those who fail to reinvent themselves every ten years. Frankly, this
applies equally to the biopharmaceutical industry as it does to other
innovative industries. As patients or consumers we want to pay for what we
get, and not for the potentially inefficient production costs. Cost-plus
pricing is fundamentally flawed in an industry, which relies so much on
true innovation.

I can see why Swiss hepatitis C patients denied reimbursement by their sick
funds may want to get cheap hepatitis C medicines from India. But if that
happened in a large scale, the system would break down in India.

My second point is about the flaws of full price transparency. It is worth
recalling the conclusions of a 2008 OECD study about pricing and
reimbursement of medicines, which raised the question whether there
shouldn’t be less, rather than more, price transparency. Indiscriminate
price transparency could go against efforts to make drugs more affordable
for those in need, because rich countries were unwilling to pay more than
poor countries if they had full access to prices paid by others. This was
at that time exemplified by the German Minister of Health, who publicly
argued that she was not willing to pay more than Portugal or Latvia,
because Germany is a big market, which is buying more and expects to pay
less. Looking at the North-South debate, the matter is even more critical.
Unless there is a “Social Contract” whereby rich countries accept to pay
more than poor countries, price transparency leads to less, rather than
more, solidarity. That is one of the challenges of the urge for
transparency. I can see why Swiss hepatitis C patients denied reimbursement
by their sick funds may want to get cheap hepatitis C medicines from India.
But if that happened in a large scale, the system would break down in India.

Unless there is a “Social Contract” whereby rich countries accept to pay
more than poor countries, price transparency leads to less, rather than
more, solidarity.

IPW: How do you see the interaction of IFPMA with other actors, such as the
WHO, in the context of the PIP Framework and the Framework for Engagement
with Non-State Actors, other international organisations, civil society,
patients’ organisations?

CUENI: We want to be respected for the strength of our arguments but also
be seen as constructive, solution-oriented and building bridges. Our
capacity to reach out is crucial. IFPMA has an observer status with the WHO
as well as the UN system. The private sector and civil society need to be
represented, and IFPMA is part of this broad network, operating within
clear rules of engagement to avoid conflicts of interests. I do see the
FENSA rules playing their part in creating transparency and preventing
conflict of interests. But at the end of the day, cooperation and
partnership of the UN system with the private sector is vital if you want
to get results and deliver more medicines and vaccines to the patients who
need them.

IPW: Do you think industry should have more elevated relationships with WHO
than civil society because they have to be at the table?

CUENI: We are part of the overall Geneva ecosystem. I do believe we have
some unique features in terms of our R&D skills, our knowledge of
developing new therapies addressing unmet medical need, and global
outreach, as demonstrated recently by the biopharmaceutical industry’s
ability to respond quickly to a crisis like Ebola but also living up to the
London Declaration on NTDs. I also believe that we have a unique role in
addressing the challenge of antimicrobial resistance. Therefore, I do
believe that we must have a seat at the table, along with civil society.

IPW: Thank you.



More information about the Ip-health mailing list