[Ip-health] WIPO Magazine: Perspectives on access to medicines and IP rights

Thiru Balasubramaniam thiru at keionline.org
Mon Dec 18 04:56:39 PST 2017


Perspectives on access to medicines and IP rights

December 2017

By John Zarocostas, freelance journalist

On average, people around the world are living significantly longer than
their grandparents. In part, this is thanks to innovation in vaccines and
to medicines reaching increasing numbers of patients. But as people live
longer and new medical breakthroughs create even greater opportunities for
new treatments, many governments find their limited resources spread ever
wider. Against this backdrop, the issues of access to medicines and
intellectual property (IP) have become hotly contested topics.  Two leading
experts give their views on these issues.


Thomas B. Cueni (right), Director General at the International Federation
of Pharmaceutical Manufacturers & Associations (IFPMA), offers an industry
perspective on the hurdles to access and the challenges that lie ahead in
the search for innovative healthcare solutions.

The high cost of medicines is straining health budgets in all countries.
What is the way forward?

Thomas Cueni: I understand concerns surrounding the cost of individual
drugs and that companies have to justify the value they bring, but I
believe the price debate is overblown. On aggregate there is no sign that
drug costs are out of control. The latest OECD data, for example, show that
between 2009 and 2015, there was a 0.5 percent annual reduction in per
capita expenditure for pharmaceuticals. More importantly, expenditures on
health should be seen as an investment towards increased welfare,
productivity and economic growth. They should not be seen exclusively as a
fiscal cost at a given point in time.  The research-based biopharmaceutical
industry is delivering breakthrough medicines for patients. Over the last
10 years, we have seen dramatic improvements in treatments for HIV, HCV
(hepatitis C), oncology and many rare diseases that have transformed the
lives of patients. The wider developments driving healthcare spending, and
the systemic challenges that limit access to high-quality, safe and
effective medicines around the world, need to be considered.

It is now widely acknowledged that the biopharmaceutical industry has made
tremendous progress in addressing public health needs and the cost of
drugs. One among many examples is the use of tiered-pricing for treatment
of HIV/AIDS, malaria and vaccines, and more recently in treating
multi-drug-resistant tuberculosis (MDR-TB). Johnson & Johnson’s new drug
(bedaquiline), for example, both brings an effective therapy for MDR-TB to
the table and introduces a very innovative and clearly structured,
tiered-pricing approach.

“It is now widely acknowledged that the biopharmaceutical industry has made
tremendous progress in addressing public health needs and the cost of
drugs,” says IFPMA’s Thomas Cueni (photo: FotografiaBasica / E+ / Getty

Are there opportunities for more public and private partnerships?

Thomas Cueni: Basically, all of the therapeutic progress that has been made
comes out of the labs of private industry. But now many more public-private
partnerships are emerging and there is greater openness to collaboration
and open innovation. There are, in fact, currently over 300 active health
partnerships listed in our directory. There is a strong sense that we have
to tackle healthcare issues together. This is most evident in tackling
neglected tropical diseases (NTDs). The pharmaceutical industry together
with the Gates Foundation, the United Nations (UN) and the World Health
Organization (WHO) have made great progress in meeting targets set out in
the 2012 London Declaration on NTDs. With this Declaration, pharmaceutical
companies, donors, endemic countries and civil society groups pledged to
work to control, eliminate or eradicate 10 NTDs by 2020. The work of the
Medicines for Malaria Venture (MMV) and GAVI, the vaccine alliance, are two
important examples of progress in terms of research and access. But there
is clearly scope to do much more.

The UN High-Level Panel on Access to Medicines and the Lancet Commission on
Essential Medicines have called for R&D to be de-linked from drug prices.
What are your views on this?

Thomas Cueni: De-linkage as called for by the UN High-Level Panel is a dead
end. Companies should be paid for the therapeutic value of their drugs to
society and patients rather than the cost of research and development or
manufacturing. You want to pay for outcomes rather than input. In my view,
the delinkage debate focuses too narrowly on intellectual property and
fails to address the multi-faceted and complex issues that prevent so many
people from accessing the medicines they need.

Health is one of the priorities of the Sustainable Development Goals
(SDGs). What can be achieved between now and 2030?

Thomas Cueni: Clearly, any progress in delivering on the SDGs will require
partnerships and joint action by governments, civil society and the private
sector. In terms of non-communicable diseases (NCDs), most of the essential
medicines to treat cardiovascular disease are off-patent, but still
patients do not have access to them. This is a clear indication that
patents are not a barrier to access. If we are to improve access, we need
stronger health systems, more professional health workers, and we need to
empower women in health care and to address the lifestyle factors that
cause poor health. We need to make sure that treatments for diseases like
diabetes, cardiovascular disease and cancer reach patients. Coalitions of
partners across the health delivery spectrum are critically important.
That’s why IFPMA recently joined a multi-stakeholder coalition led by PATH,
a global non-profit health organization, to support initiatives like their
No Empty Shelves project, which is looking at why essential medicines and
technologies to treat diabetes are not reaching patients in low-resource

The nexus between innovation and patents has been politically contentious
since TRIPS took effect in 1995. Does it need to be revisited?

Thomas Cueni: Revisited? No. The TRIPS Agreement acknowledges that IP is a
driver of innovation. The pharmaceutical industry has learned since the
South African lawsuit in 2001, where it was seen as getting in the way of
people being properly treated. That was perhaps the dumbest thing the
industry ever did. But now, least developed countries (LDCs) enjoy a waiver
of TRIPS provisions relating to patenting of pharmaceutical products up to
2033. And with the Doha Declaration, LDCs can import the drugs they need
from manufacturers in third countries. These adjustments certainly help to
meet public health needs. But all parties have to work together and the
industry has to make sure that patients in less developed countries have
access to innovative drugs. That is one of the reasons why 23 of our
companies joined ranks with the World Bank and the Union for International
Cancer Control (UICC) in January 2017 to launch the Access Accelerated
partnership to tackle access barriers to NCD medicines in low and lower
middle-income countries.

“Many more publicprivate partnerships are emerging… There is a strong sense
that we have to tackle healthcare issues together,” says Thomas Cueni
(photo: SolStock / E+ / Getty Images).

Could multilateral agencies like WIPO be more creative in addressing
patents and medicines?

Thomas Cueni: On October 1, in partnership with WIPO, IFPMA signed an
agreement establishing the Patent Information Initiative for Medicines, or
Pat-INFORMED. The initiative will clearly link public patent information to
registered medicines in a new online gateway. The purpose is to help health
agencies responsible for procuring medicines assess the patent status of
medicines in different countries. Under the partnership, 21 leading
research-based pharmaceutical companies represented by IFPMA have committed
to make available their patent data on small molecules via a data bank to
be hosted by WIPO. We expect to launch the platform in early 2018. The
objective is to make the management of patent issues in medicines
procurement less time- and resource-intensive and to help ease access to
patent information for public health authorities and help them establish
smarter procurement strategies.

Pat-INFORMED is a major step forward and shows the sort of practical action
that can be taken to help reduce the complexity surrounding patent
information. Then, of course, there is WIPO Re:Search, established back in
2011 by WIPO with the active participation of leading industry players and
others to catalyze the development of medical products to treat neglected
tropical diseases, malaria and tuberculosis. The industry also has a number
of other well-established partnerships with, for example, the Medicines
Patent Pool (MPP), the Drugs for Neglected Diseases initiative (DNDi) and
its joint initiative with the WHO, the Global Antibiotic Research
Development Partnership (GARDP). I envisage and certainly hope we will see
more partnerships like these in the future.

Do you agree that there is a need for greater transparency in the pricing
of medicines and vaccines?

Thomas Cueni: Clearly, governments and companies need to show value for
money, but pharmaceutical companies also need to be able to argue for the
value of the products they bring to the market. The flaw in the
transparency debate is that it tends to look at the costs of drugs that
make it to market and to overlook how much is spent on those that don’t.
Calls for cost-plus pricing are a recipe for creative accounting, not for
driving efficient outcomes. Companies should be paid for outcomes (value)
and not for input (costs). Successful innovation should be rewarded because
it’s good for patients and society. This approach, rewarding true
innovation, has effectively dealt with the debate about “me-too” drugs.
Today, the focus is on significant, often transformative innovation, and on
“follow-on” drugs that add value by providing a useful alternative or
enhanced therapeutic options and introducing price competition.  Rewarding
true innovation has led to a focus of biopharmaceutical research on areas
of high medical need where significant innovation is rewarded by the market.


Ellen  F.M. 't  Hoen (right), researcher at the Global Health Unit of the
University Medical Centre Groningen, Director, Medicines Law and Policy and
former Executive Director of the Medicines Patent Pool (MPP) offers her
perspective on ways to improve access and to increase innovation in areas
of unmet medical need.

The high cost of medicines is straining health budgets in all countries.
What is the way forward?

Ellen ’t Hoen: There are measures that countries can take immediately. Ten
years ago access to medicine was an issue exclusively for developing
countries but that is no longer the case. Today, many high-income countries
can’t afford the medicines they need and are even rationing certain
medicines on the World Health Organization’s Essential Medicines List.
Clearly something needs to be done. We can draw lessons from the way
countries dealt with the HIV drug pricing challenges, for example, by
making use of flexibilities in the Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS) to purchase lower-cost generics.

We are now also seeing people in some European countries and the United
States calling for the use of compulsory licensing. The Irish Medical
Association, for example, has asked the Irish government to make use of
compulsory licensing to ensure that everyone in Ireland who needs hepatitis
C treatment can get it. Similar calls have been made in France. And in
Italy and Switzerland individuals are explicitly allowed to import generic
medicines to treat hepatitis C. These examples show that governments can
access lower-priced generic medicines even when patents exist. That’s one
part of the answer. The bigger question is how to finance the development
of these products in such a way that new medicines remain affordable.
That’s where the real problem lies. The current mechanism for financing
pharmaceutical innovation is predominantly based on granting market
monopolies, which inevitably means high drug prices.

Are there opportunities for more public and private partnerships?

Ellen ’t Hoen: An important mechanism for such collaboration of course is
the Medicines Patent Pool (MPP), which is now expanding beyond HIV into
other diseases such as hepatitis C. They are also exploring a potential
role in non-communicable diseases (NCDs) such as cancer. It is important to
acknowledge that companies are increasingly willing to engage with the MPP.
GSK, for example, has publicly committed to license its oncology portfolio
to the MPP. But we also need to ensure that more public money is available
to fund research into new treatments. We cannot exclusively rely on
charitable institutions like the Wellcome Trust or the Gates Foundation.
When it comes to public funding, we need to make sure that the financing
mechanisms in place don’t mean that patients pay twice, first through taxes
and then through high drug prices. If you look at the U.S. National
Institutes of Health (NIH), or the European Commission’s Horizon 2020
program, both important funders of pharmaceutical research, the conditions
placed on entities that apply for research funding are very weak.
Commercial companies acquire IP rights over government-funded innovations
which they can then sell at a high price. Luckily, there is an ongoing
debate about the need to tackle this, including in academia, which is
exploring equitable licensing policies.

The UN High-Level Panel on Access to Medicines and the Lancet Commission on
Essential Medicines have called for R&D to be de-linked from drug prices.
What are your views on this?

Ellen ’t Hoen: The High-Level Panel actually calls for international
negotiations to conclude a medical R&D treaty to regulate the sharing of
both the costs and the benefits of R&D based on de-linkage principles. You
need to have a mechanism at the international level to deal with
free-riders. The Lancet Commission also recommends progressive de-linking
for a set of priority products – the so called missing essential medicines.
Take, for example, anti-microbial resistance (AMR) and the pressing need to
develop new antibiotics. The pharmaceutical industry is being honest when
it says those products will not be developed under the current model
because it makes no business sense for them to do so. This is an area where
you see greater acceptance by companies of de-linking R&D and drug prices.
But de-linkage models of innovation can also be applied for other diseases.
The Drugs for Neglected Diseases initiative (DNDi) has shown how this can
be done successfully. If the cost of R&D is financed directly, there is no
need for market exclusivity and high prices. We have to find a way to
finance the development of these products that does not depend on the
ability to sell them at a high price.

“We need to encourage much greater diversity in the incentive mechanisms we
use to finance innovation,” says Ellen ‘t Hoen (photo: ZUMA Press, Inc. /
Alamy Stock Photo).

Health is one of the priorities of the Sustainable Development Goals
(SDGs). What can be achieved between now and 2030?

Ellen ’t Hoen: The SDGs are rooted in the principle of the human right to
health. That puts certain duties on governments to act. This includes
making sure that the innovations that are needed happen and are accessible
to those who need them. The SDGs strive for universal health coverage and
will help advance that goal, but that will require government action.

The nexus between innovation and patents has been politically contentious
since TRIPS took effect in 1995. Does it need to be revisited?

Ellen ’t Hoen: The TRIPS Agreement has enormous flexibility and allows
governments to do the things that need to happen. Problems arise when
legislation closes down those flexibilities. For example, new forms of IP
rights such as data exclusivity are being introduced which can be draconian
if the law does not provide a waiver to data exclusivity that can be used,
for example, in the case of a compulsory license. Such legislation
otherwise paralyzes a government’s ability to intervene when a compulsory
license is necessary. And when these arrangements are exported to other
countries through trade agreements, for example, they become a cause of
concern. We also need to move away from the notion – which tends to be
reinforced by the TRIPS Agreement – that patents are the only way to
stimulate and finance innovation. We need to encourage much greater
diversity in the incentive mechanisms we use to finance innovation. We need
to find a different way – one that is not primarily driven by commercial
interests – to set priorities in medical R&D. That does not require
rewriting the TRIPS Agreement, it requires governments to explore different

Could multilateral agencies like WIPO be more creative in addressing
patents and medicines?

Ellen ’t Hoen: WIPO remains focused on NTDs, where there is a strong
consensus that progress can be made. But WIPO could do more to help
countries operationalize TRIPS flexibilities, for example by providing
model legislation and more detailed practical advice on how to implement
legislation relating to patent law and public health. We have seen the
marvelous things that WIPO can achieve for the public good with the
Marrakesh Treaty to Facilitate Access to Published Works for Persons Who
Are Blind, Visually Impaired or Otherwise Print Disabled. The public
interest really is at the heart of that agreement. One could imagine
something similar in the area of patents and health and further exploration
of a variety of ways to support R&D such as open source innovation and
prize fund models – see, for example, Alternatives to the Patent System
that are used to support R&D Efforts (CDIP/14/INF/12).

WIPO is the UN agency dealing with IP, and yet discussions about IP and
some of the most complex issues from a public policy perspective often
happen outside the Organization. A more substantive and evidence-based
debate should be held at WIPO that moves away from ideological postures and
political positions. Only then can a sound policy debate take place.

Do you agree that there is a need for greater transparency in the pricing
of medicines and vaccines?

Ellen ’t Hoen: The argument that it is in the public interest to keep the
price of medicines secret makes no sense. Secret pricing is never a good
idea. We saw with antiretroviral medicines that as soon as prices were made
public and people could find them more easily, the market dynamics changed
completely. Another issue of concern is the fact that governments often
cannot make public the results of drug price negotiations with
pharmaceutical companies. This lack of transparency goes against the basic
principles of democracy and is not acceptable. Secret price negotiations
put enormous power into the hands of the pharmaceutical industry and
prevent countries from comparing the outcome of drug price negotiations. I
don’t believe this is in the public interest. We also need greater
transparency on the costs of R&D. Industry claims that the costs of drug
development are astronomical. We know drug development is costly but how
can we make important policy decisions on unsubstantiated claims?

Greater transparency would lead to a better-informed policy debate and
better public policies. Take, for example, supplementary protection
certificates granted in the EU to extend the basic patent of a registered
medicine to ensure the company can recoup its R&D investment. At present,
the company is not asked to demonstrate that extra market exclusivity is
indeed necessary. It would be sound public policy to ask companies to open
their books and show why their 20-year patent is not long enough before
additional public resources are spent on high-priced medicines. Today,
however, these decisions are made on assumptions, not real data.

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

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