[Ip-health] Battle for Access to Medicines and Vaccines Takes Centre Stage at WHO

Kim Treanor kim.treanor at keionline.org
Mon Feb 5 08:54:04 PST 2018


Battle for Access to Medicines and Vaccines Takes Centre Stage at WHO
Priti Patnaik in The Wire on 2 February 2018

As the business of global health expands, inevitably the gatekeepers of
international trade and investment have become important at World Health
Organization (WHO) – the axis on which public health policy rests. Of the
many policies that get formulated at WHO, discussions on the access to
medicines including cost of drugs, transparency in research and
development, transfer of technology have been contentious for years. In
parallel, how the UN’s only norms-setting body engages with non-state
actors while dealing with policies that have implications for giant
businesses, has also drawn attention.

At this decisive stage in his tenure at WHO, Director General Dr Tedros
Adhanom Ghebreyesus sits down to decide who gets a seat on the table and
how he would preside over seemingly irreconcilable positions among member
states on matters such as access to affordable drugs. Luckily for Tedros,
his team and a constellation of invested member states will guide his
decision-making on such crucial matters that are central to his aim of
providing Universal Health Coverage to a billion people more among his
other priorities.

At the conclusion of the 142nd Executive Board meeting last week, it is
unclear the direction or the force with which the Tedros administration
will align on such issues. But this period is crucial.

“Early in the tenure, leaders tend to get locked into positions that become
very difficult to get out of. Inertia in policy-making sets in. So Tedros
will have to be careful about the position he takes,” James Love of
Knowledge Ecology International told The Wire.

>From prohibitive cancer drugs that make it harder to fight the rising
burden of non-communicable diseases; making resources available to fight
microbial drug resistance; investments for neglected tropical diseases , or
getting access to timely diagnostics – access issues are a cornerstone for
equitable health systems worldwide even as overall health systems
strengthening driven by countries is important.

While a significant part of the global disease burdens manifest in the
developing world, the rewards for fighting these health conditions accrue
to global pharmaceutical companies often located it developed markets. But
what has changed over the years that have come to affect such facile
calculations is the high cost of drugs that affect rich countries as well,
eating into their health budgets and denying medicines to those in need. In
addition, the benefits accruing to generic producers of cheap drugs in
alliance with pharmaceutical giants have also changed the dynamics.

All these factors come to influence discussions at WHO during events such
as the executive board meeting last week. While these issues have festered
in Geneva for a long time, it is interesting to note the underlying change
in politics that has come to govern the discussions on access to medicines.

This story will describe how discussions on two separate decisions related
to access to medicines unfolded at the meeting and what they mean for the

In the first such contested debate on medicines under Team Tedros, the EB
encapsulated how tense the fight is likely to be in the coming months and

As mentioned earlier, the meeting saw the United States and it allies on
these issues (Switzerland, Japan, the United Kingdom) not unchallenged by
emerging coalitions of member states. Brazil led the way, while India
pushed for behind-the-scenes manoeuvres, not unlike others countries
including Colombia. Among European Union countries, Malta, The Netherlands,
Greece, Portugal and others played their part in guiding the discussions
along their interests. (Official statements made by some of the member
states can be read here).

The roadmap for access to medicines

At the meeting, member states discussed a report submitted to the Board on
addressing the global shortage of, and access to, medicines and vaccines.
After many deliberations before and during the board meeting, countries
managed to get the Board to approve this decision that essentially asks
Tedros to consult with countries and work on “a roadmap to improve access
to medicines and vaccines, including activities, actions and deliverables
for the period 2019−2023”.

The Executive Board has now recommended that this decision be adopted by
the World Health Assembly in May this year. Further, such a roadmap will be
considered in 2019 at WHO meetings.

Some countries have informally called this document and the decision as
“the access to medicines agenda” with an overarching framework that will
govern all these issues collectively at WHO.

“This effectively and firmly pins the access agenda in the WHO framework
for the coming five years,” a delegate from one of the developed countries
told The Wire.

As previously reported, getting some contentious issues formally placed at
WHO meetings have not been straight forward, so a few countries are
counting this as a strategic win.

The issue of shortage of, and access to medicines and vaccines, has
repeatedly featured at key WHO meetings over the last few years. What was
contentious this time was the explicit mention of the recommendations of
the UN High Level Panel (UNHLP) on Access to Medicines which had divided
countries and the mapping of these by WHO in the official document.

At the meeting Brazil, India and others commended WHO for referencing the
UNHLP recommendations and appealed that these should be discussed and taken
forward within the organisation. “It is politically symbolic that the UNHLP
recommendations featured in a document that was finally approved by the
Board,” one country delegate said.

Among the UN panel’s most significant recommendations is that “governments
and the private sector must refrain from explicit or implicit threats,
tactics or strategies that undermine the right of the WTO Members to use
TRIPS [the agreement on Trade Related Intellectual Property Rights]
flexibilities”. The panel said that undue political or commercial pressure,
including punitive measures against offending members, should be reported
to the WTO secretariat and its members. (This, among other recommendations
has been deemed problematic by the US).

In a statement at the meeting India said, “…Equitable access to medicines
is denied due to market distortions and price barriers to procurement which
may include IP provisions, extremely tight regulatory standards and
monopolies.” In addition, the country also requested a detailed discussion
on the recommendations of the UNSG’s HLP Report on access to medicines,
particularly with respect to the use of TRIPS flexibilities.

India also drew attention to the 1st World Conference on Access to Medical
products and International Laws for Trade and Health, held in November 2017
in New Delhi. A report on the conference was submitted to WHO. It makes
specific recommendations for governments and other international

Public health, IP and innovation – the drama

The session that saw the most fireworks last week was when the overall
programme review of the global strategy and plan of action on public
health, innovation and intellectual property (GSPoA) – a report that was
commissioned by member states – was taken up.

The comprehensive review of the strategy charts the negotiations at WHO,
the landmark report of the Consultative Expert Working Group on Research
and Development (CEWG), discusses the developments in IP and innovation,
documents the varied and diverse efforts to improve access to medicines
including issuances of compulsory licenses for drugs, and other emerging
challenges spread over the last decade until now.

The strategy failed on implementation and the review streamlines the
previous work on the strategy and distilled 33 recommendations with a
budget estimate of a little more than US $30 million to implement it
effectively over the next five years. The review also listed 17
high-priority actions to meet hasten implementation of the strategy.

Among others, the recommendations pushed for national laws to reflect TRIPS
flexibilities and improve transparency in R&D costs in addition to asking
countries to commit spending at least 0.01% of their gross domestic product
to basic and applied research relevant to the health needs of developing
countries. The decision on this matter was the heart of the conflict on
access to medicines at the EB.

The US and Switzerland, followed by Japan held a position that they were
unable to support the decision. The US said that there was not enough
consensus on the goals of the recommendations suggested by the overall
review of the strategy. (Some of the recommendations were not a part of the
original strategy and were not negotiated, it was pointed out.) This
effectively blocked the decision from being approved even as member states
pushed for consideration of the recommendations, fuelled by sustained
efforts of more than 10 years on the matter.

The US made it clear that it was unhappy with WHO’s advocacy role on
matters including on intellectual property – an area the US considered, as
being outside the institution’s mandated expertise. It feared that
potential long-term consequences to global innovation would be devastating.
In addition, it effectively dictated what WHO can and cannot do. “The
United States maintains it’s inappropriate for WHO to intervene on matters
in the domain of the World Trade Organization, particularly with respect to
interpreting member states’ legally binding TRIPS obligations.” (This also
follows the stringent opposition of the US to the UNHLP panel and the
strategy that pushes for WHO’s role in supporting the implementation of
TRIPS flexibilities.)

The US, which is not a member of the Executive Board, called for a drafting
group to revise the text of the decision related to the recommendations.
Japan, a board member seconded the need for a drafting group.

Brazil led a blistering defence on the importance of not delaying the
implementation of the recommendations. Brazil assured countries that the
GSPoA is not against protection of intellectual property and that the
recommendations do not threaten any industry. “We cannot reopen the TRIPS
agreement here”, the representative from Brazil declared. The goal was to
implement TRIPS and its flexibilities to meet public health needs.

Soon other countries including Iraq, Sri Lanka, Pakistan, Colombia,
Thailand, The Netherlands among others coalesced around the position of
Brazil. France, Germany, Sweden aligned with Canada to create a drafting
group to revise the text of the decision.

Brazil maintained its position and tried to forge a way forward by stating
that any revision will be limited to one or two changes in recommendations.

The consultations between countries outside of the EB proceedings continued
over the course of the day without any agreement until the following

Sources alleged that US, UK, Japan and Switzerland blocked elements of the
recommendations on transparency on costs of research and development,
delinking prices of drugs and costs of R&D and TRIPS flexibilities during
the consultations of the working group.

It was only the next morning when the members reached an agreement on the
text of the decision that turned out to be a watered down version of the
originally proposed decision. The board now recommended this decision to be
adopted by the assembly in May.

“You can imagine what happened inside the room,” one exhausted delegate
told The Wire soon after the decision was approved by the board. Overall,
countries were satisfied that they were able to save the bulk of the
recommendations in the report. “It is better than nothing,” the delegate

Essentially, the contentious recommendations that bothered the U.S. and
others specifically on transparency around R&D costs were removed. In
addition, the recommendation that asked countries “to identify essential
medicines that are at risk of being in short supply and mechanisms to avoid
shortages, and disseminate related information accordingly,” was done away
with. So was the suggestion that countries commit spending on R&D.

The final text saw “national context” feature in the decision. This means
that countries can adopt the recommendations in line with their national
priorities. Sources said that most of the countries were not in favour of
committing to spending a designated part of their GDP on basic and applied
research relevant to the health needs of developing countries.

As a result, the revised decision makes the implementation of these
recommendations less effective and more vulnerable to vagaries of national
politics and interests. “In any case, WHO cannot tell countries what to
do,” one developing country delegate said.

At the same time, nothing stops countries to implement these
recommendations, with or without support from WHO, another country delegate
told The Wire.

The task for the WHO secretariat is cut out. The recommendations have
specific actions that WHO can implement including advocating for national
laws to reflect TRIPS flexibilities and for use these laws to enable
transfer of health technologies in countries.

“It appears the American industry was largely against many of the
recommendations of the overall review of the GSPoA strategy. What was
finally agreed lacks the venom of the original strong recommendations,” a
source said.

“The US opposition to transparency on costs related to research and
development is strategic. ‘We do not want to tell you how much it costs,
because then we cannot charge high prices for drugs and make profits’,
seems to be their position.’ It is unfortunate,” Love of KEI said.

One of the most important parts of the decision that was left out of the
final decision was committing to spending upwards of US $30 million to
implement the recommendations. (The annual budget of WHO is in the region
of US $2 billion.) While WHO will need resources to implement the strategy,
countries can also come together to find the budget necessary to implement

Citing an illustrative example on how countries can raise money, Ellen ‘t
Hoen, an expert on medicines law and policy explained to The Wire, “If
countries that pay the brand price for HepC medicines would switch to
purchasing generics those savings would royally pay for WHO’s work. The
list price of HepC treatment in the Netherlands is Euro 41,000. There are
an estimated 28,000 HepC positive people in the country. In the scenario
that everyone is treated, medicines would cost Euro 1,148,000,000. If the
Netherlands would purchase generics with a compulsory license it can access
the Euro 120 treatment offered by Pharco and the total medicines bill would
be Euro 3,360,000. Even a small part of those savings would pay for WHO’s
work on GSPoA and more.”

The DG has also been asked to come back with a report on the implementation
of the recommendations in 2020. “For now, countries have kicked the can
down the road and deferred immediate action,” a source said.

These efforts on the GSPoA are being seen as a subset of the overall access
to medicines agenda discussed earlier. A few member states are keen on
keeping the discussions on access to medicines active at WHO. “We will use
several parallel tracks to keep the access issue on the agenda. The wider
roadmap on the access to medicines, the specific recommendations of the
GSPoA strategy and simultaneously push for new resolutions where countries
will need to actually commit, such as the resolution on cancer prevention
and control that was adopted last year,” a country delegate said.

On his part, it is hard to read how Tedros will push ahead on the issue of
access. At the meeting he indicated a strong leadership of WHO on access to
medicines. “We have transformed a department on access into a cluster
(within WHO),” he said. In addition, member states and other stakeholder
welcomed the appointment of Dr Mariângela Batista Galvão Simão, WHO’s new
assistant director-general for drug access, vaccines, and pharmaceuticals.

He also seems to be of the view that there should be holistic discussions
on access to medicines, instead of only focusing on delinking prices of
drugs with costs of R&D.

Private sector engagement

In his many public statements on the matter of engagement with non-state
actors, Tedros has been bold in his articulation on the importance of
working with the private sector to deliver on the Sustainable Development
Goals. “We should not be shy about working with the private sector,” he
said during the EB meeting, adding that he had met with representatives
from the private sector twice. (Later this month, WTO, WHO and WIPO host
trilateral symposium on Sustainable Development Goals: Innovative
technologies to promote healthy lives and well-being)

In a significant statement, India like others called for a follow up of the
Framework of Engagement with Non-State Actors (FENSA) that was adopted two
years ago by WHO. “A comprehensive conflict of interest policy covering
both institutional and individual interests is yet to be developed.” India
also cautioned that any collaboration in R&D should be in line with the
FENSA framework.

The framework does not apply to countries and their engagement with
non-state actors, it only applies to the WHO secretariat – something the
new team must soon address.

Kim Treanor
Knowledge Ecology International
kim.treanor at keionline.org
tel.: +1.202.332.2670 <(202)%20332-2670>

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