[Ip-health] IP-Watch: World Health Assembly Approves Plan To Strengthen Access To Essential Medicines

Thiru Balasubramaniam thiru at keionline.org
Sun May 25 22:44:13 PDT 2014


World Health Assembly Approves Plan To Strengthen Access To Essential
MedicinesPublished on 24 May 2014 @ 9:08 pm

By Joséphine De Ruyck <http://www.ip-watch.org/author/josephine-de-ruyck/> for
Intellectual Property Watch, Julia
Fraser<http://www.ip-watch.org/author/julia-fraser/> for
Intellectual Property Watch and William

World Health Organization members tonight approved a resolution aimed at
improving access to essential medicines. Agreement came after a compromise
on a proposed provision referencing other medicines that are not qualified
as essential medicines.

The 67th World Health
Assembly<http://who.int/mediacentre/events/2014/wha67/en/> took
place from 19-24 May.

The latest available version of the adopted resolution on access to
essential medicines, A67/B/CONF./6, is available

The Assembly had before it a draft resolution on access to medicines, as
well as a secretariat report, document

The resolution includes a number of actions for governments to take on
access to medicines, such as providing adequate resources for comprehensive
national medicine policies, governance of pharmaceutical systems, and
coordinate activities.

In committee today, there were a number of proposed amendments to the text.
The key change was in provision OP1.2, on national policies. India proposed
to add reference to “critical medicines,” so it would have stated:

“to improve national policies for selection of essential medicines, *including
critical medicines*, particularly by using transparent, rigorous,
evidence-based processes based on the methods of health technology
assessment in selecting medicines for inclusion in the national essential
medicines lists according to each country’s health needs and priorities.”

But the United States, Australia and Thailand opposed this proposal.
Sources said what was underlying the debate was whether there could be
recognition of other medicines not included on the WHO essential medicines

India said that many essential medicines do not include medicines which are
critical for people in need, so it wanted not only essential medicines, but
also other medicines which may be critical for countries, to be considered
for inclusion.

It then offered an alternative wording to say, “essential medicines
critical for public health needs.” The European Union, represented by
Greece, suggested a slight change to this, to say, “their” public health

But this proposal was also rejected by Thailand. After further
consultations, the following language was agreed for OP1.2:

“to improve national policies for selection of essential medicines “which
should include medicines critical to their priority public health needs….”

Also in the latest version of the draft decision, Oman came under pressure
from developed countries for a proposal for Article OP2.9 that would have
called for improved procedures to implement flexibilities within the World
Trade Organization Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS).

Several developed countries opposed it, leading Oman to withdraw it.

*Access a Hot Topic at WHA*

Member states in committee on 23 May discussed the original draft
resolution, which originated at the January Executive Board meeting as document
EB134.R16 <http://apps.who.int/gb/ebwha/pdf_files/EB134/B134_R16-en.pdf>

Access to essential medicines was a hot topic at this Assembly, following
recent outcry over unaffordable costs of new drugs against cancer and
hepatitis C.

Access to essential medicines is also important for global efforts to move
“towards universal health coverage and achieving the health-related
Millennium Development Goals,” says the resolution.

The resolution urges member states to develop and provide adequate
resources for “comprehensive national medicine policies, strengthened
pharmaceutical regulatory, procurement and distributions systems and
coordinated responses to address” the determinants of access to essential
medicines to “improve their availability, affordability, quality and
rational use.”

Member states are also urged to be transparent and use evidence-based
national processes for the selection of essential medicines as well as to
support research on the procurement, supply and rational use.

The resolution calls for sharing of best practices, the identification of
key barriers, monitoring of shortages and the adaptation of “national
legislation in order to make full use of the provisions contained in the
TRIPS agreement, including the flexibilities recognized by the Doha
Ministerial Declaration,” it says.

The director general is also asked to support national capacity building
and policy making “with regard to regulation, financing, selection,
procurement, distribution, pricing, reimbursement and use” of essential
medicines, including technical support to member states wishing to make
full use of TRIPs flexibilities.

*Key Points from Delegations*

A strategy highlighted by member states is the promotion of local and
reasonable production of essential medicines.

“Local production wherever the economics of scale can be achieved may
contribute to bringing down the prices of medicines,” said India.
Therefore, “it is important to guide member states on this issue of
promoting local production of medicines.” Ethiopia also supported the idea
of strengthening capacity building and local production in developing

India also urged reviewing the selection criteria for the WHO essential
medicines list and promoting the right to benefit from science and
technology to include essential medicines with therapeutic advantage.

Thailand said support is needed for the monitoring of medicines supply to
identify causes of shortages. The delegate noted that there could be many
causes for shortages, including “limited production, neglected diseases,
and temporary stock-outs due to epidemics and changes in production lines.”
Monitoring would help develop necessary strategies for the mitigation of
problems caused by shortages, they said.

South Korea said it uses an integrated IT system to monitor supply of
medicines and collect statistical data to identify problematic areas of
drugs supply. Tanzania and Indonesia also said they have an electronic
monitoring system, which they said enhances efficiency and transparency of

The delegation of South Africa, on behalf of the African region,
highlighted that “the high price of medicines, particularly in the private
sector, is a key barrier to affordable essential medicines in developing
countries,” adding that it can be “a question of life and death.” Many
countries also identified unaffordable prices as one of the major barriers
to access.

South Africa suggested key strategies should be taken up by member states
including: control of purchase price from manufacturers; full use of TRIPS
flexibilities; systems to track availability; transparent regulatory
systems for generic production; and generic substitution policies.

South Africa recalled that “a range of policy options is available to
promote the use of generics.” Promoting competition is a key strategy for
increasing generic production and improving the affordability of medicine,
for example. In this context, patents have a dramatic impact on access to
medicines when they prevent competition, South Africa said.

Thailand also proposed strategies such as price negotiations, bulk
purchasing and the full use of TRIPS flexibilities. It further suggested
price control and promoting local production, generic production and
supporting technology transfer.

*TRIPS Flexibilities under Attack?*

Regarding the issue of intellectual property, Brazil said, “IP should not
be an obstacle to national policies on access to medicines. Countries
should therefore be able to use them in a way that is conducive to national

Malaysia said it fully supports the use of TRIPS flexibilities to increase
access. It added that in 2003, Malaysia used TRIPS flexibilities to obtain
antiretrovirals for HIV. It called upon the WHO to “render technical
assistance and strongly support member states” on the appropriate use of
TRIPS to manage practices and make medicines affordable.

Malaysia called for sharing practices on health technology assessment for
evidence-based selection of essential medicines, and new highly priced
innovative medicines, especially for treatment of cancer and rare diseases.

India said that “the full use of TRIPS flexibility has been under attack
through a variety of strategies such TRIPS-plus provisions, bilateral trade
agreements, investor state dispute settlements provisions, trade and
investment agreement, as well as lobbying by countries to adopt TRIPS-plus
provisions in their domestic laws.”

Bolivia expressed concern over the negative impact of bilateral agreements,
such as the Trans-Pacific Partnership (TPP) agreement currently under
negotiation, has on access to medicines.

India urged that “any attempt to hinder fully utilisation of TRIPS
flexibilities must be strongly countered by WHO and member states.”

The United States stressed that the “vast majority” of medicines on the
essential medicines list “are not under patent production.” They instead
encouraged countries to examine local barriers to access, and encouraged
the WHO to support countries in building systems to improve access and
rational use.

Norway said that the challenges to access often relate to market failures
due to low, unpredictable or fragmented demand. It expressed its support
for global initiatives that help shape markets to increase access, such as
the Medicines Patent Pool. Norway also reiterated its support for the Doha
Declaration on TRIPS and Public Health, and reminded states that many other
countries present here have also signed the declaration.

In the committee, India made its proposed amendment to add, after the word
“essential medicines” the phrase “including critical medicines,” which was
subsequently discussed and changed today.

The secretariat said it “will continue to support member states who have
chosen to invest in local production of health technology” as a key to
increasing access, including technology transfer.

*Response from Civil Society*

In its nongovernmental statement to the committee, the International
Pharmaceutical Federation (IPF) focused on the importance of using
medicines in a responsible manner. According to a recent survey, it said,
“500 billion dollars could be nearly saved if responsible medicine is

In this context, pharmacists appear to be key contributors to making these
savings happen, the group said, adding that access to medicine should be
“systematically combined with access to pharmaceutical expertise to ensure
responsible use.”

The Global Health Council (GHC) noted that “one population facing the
biggest challenges is children living with HIV,” and more attention should
be given to this category under the actions of the resolution.

In order to fulfil the gaps in access and R&D, International Pharmaceutical
Students Federation (IPSF) recommended that innovation to be driven “by
novel business models delinking the cost of R&D from price of medicines.”
There should be more open research initiatives and public-private
partnerships, it said.

Medicus Mundi International and People’s Health Movement said the draft of
the resolution “does not adequately address the issues of technology
transfer and local manufacturing capacity.”

Médecins Sans Frontières (MSF) said “medicinesaffordability is still a
critical problem,” and that “high prices keep medical tools out of the
reach of MSF patients and governments,” especially in middle-income

Affordability could be encouraged “through reform of patent laws and robust
use of TRIPS flexibilities and other measures to foster generic
competition,” MSF said.

MSF also proposed that the resolution could go further on three points: the
WHO Prequalification programme scope should be extended to include viral
hepatitis and non-communicable diseases; the WHO mandate should be
strengthen to promote a reform of the current R&D system; and WHO should
remain focused on the interventions best suited to achieve sustainable and
member state-driven strategies to ensure affordable access.

With regard to free trade agreements, such as the Transatlantic Trade and
Investment Partnership (TTIP), the International Federation of Medical
Students Association (IFMSA) and Universities Allied for Essential
Medicines (UAEM) argued that they threaten to limit access to essential

Governments must step out of their silos and take a proactive to integrate
global health priorities into the trade negotiations, they said, demanding,
“Do not let the world trade health for wealth.”

As an example, they pointed out that recently direct-acting treatments for
hepatitis C, which are strongly recommended by new hepatitis C Guidelines,
have been replaced in the Essential Medicines List by out-dated, less
effective active drugs “because their off-patent pricing rendered them
technically more cost effective.”

UAEM, Knowledge Ecology International (KEI), and the Young Professionals
Chronic Disease Network (YP-CDN) issued a briefing
on the subject.

“When the WHO considers measures to address the disparate needs of access
to new diagnostics and treatments for cancer, it should devote more
attention to the promising and logical proposals to delink R&D costs from
product prices, and to provide incentives for treatments that are
affordable and feasible in low resource settings,” they said.

“De-linkage proposals are designed to introduce new business models that
reconcile both innovation and access,” they added. “The failures of the
current business model to address equitable access to treatment in
developing countries, as well as current restrictions on access even in
high income countries, provide compelling rationales to move the de-linkage
debate forward.”

*Secretariat Report*

Member states also noted the related secretariat
A67/30. The report describes efforts, such as the WHO Model List of
Essential Medicines, aimed at promoting better “management of medicines,
more cost-effective use of resources and higher-quality health care, and
their effective implementation [which] will increase access to medicines,
avoid high out-of-pocket expenses, facilitate progress towards universal
health coverage and achievement of the health-related [UN] Millennium
Development goals, and ensure the effective treatment and care of
noncommunicable diseases.”

The report says that despite efforts, “problems with the low availability
and affordability of essential medicines in low and low-middle-income
countries remain.” It also discusses strategies related to generics,
pricing, reporting and data at the national level, and supplies, and lists
a range of activities being undertaken to promote access to essential
medicines. Examples are local innovation and universal health coverage.

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