TWN
Info Service on WTO and Trade Issues (Nov16/12)
14 November 2016
Third World Network
Strong support for UN panel's recommendations on access to drugs
Published in SUNS #8354 dated 14 November 2016
Geneva, 11 Nov (Kanaga Raja) -- A meeting of the WTO TRIPS Council
on 8-9 November discussed a recent report of the UN Secretary-General's
high-level panel on access to medicines with many developing countries
expressing strong support for the panel's recommendations which advocates
amongst others the full use of TRIPS flexibilities.
The item on the UN Secretary-General's high-level panel report on
access to medicines was placed on the agenda of the TRIPS Council
meeting by Brazil, China, India and South Africa.
The high-level panel was convened in November 2015 by Secretary-General
Ban Ki-moon and its final report was released on 14 September 2016.
Amongst its recommendations are that WTO members must make full use
of the TRIPS Agreement flexibilities as confirmed by the Doha Declaration
to promote access to health technologies when necessary. Governments
were also called upon to adopt and implement legislation that facilitates
the issuance of compulsory licenses for legitimate public health needs
and particularly with regards to essential medicines, and that public-funded
research in the pharmaceutical sector must ensure that knowledge generated
from such research must be made freely available (see SUNS #8313 dated
16 September 2016 for details of the panel's recommendations).
During the discussions on this agenda item at the TRIPS Council meeting,
many developing countries including Egypt, Indonesia, Bangladesh and
Bolivia, welcomed the discussions on the report in the TRIPS Council
and voiced their support for the high-level panel's recommendations.
The US, the EU, Japan and Switzerland, supported by Korea differed
from developing countries, while some other developed countries said
they needed more time to study the panel's recommendations.
In its statement, India, one of the co-sponsors of the agenda item,
noted that in November 2015, United Nations Secretary-General, Mr.
Ban Ki-moon, had convened a High-Level Panel (HLP) on Access to Medicines
with an objective "to review and assess proposals and recommend
solutions for remedying the policy incoherence between the justifiable
rights of inventors, international human rights law, trade rules and
public health in the context of health technologies."
The High-Level Panel was co-chaired by Ms. Ruth Dreifuss, former President
of Switzerland and Mr. Festus Gontebanye Mogae, former President of
Botswana, and was comprised of 15 eminent individuals with an understanding
of a broad range of legal, commercial, trade, public health and human
rights issues central to promoting innovation and access to technologies.
Their work was supported by a 25-member Expert Advisory Group constituted
from academia, the private sector, civil society and relevant United
Nations and international organizations, such as the World Trade Organization
(WTO).
On 14 September 2016, the UN Secretary-General's High-Level Panel
on Access to Medicines released its Final Report.
According to India, the HLP, inter alia, made recommendations on Intellectual
Property laws and access to health technologies, especially on (i)
TRIPS flexibilities and TRIPS-plus provisions, and (ii) Publicly-funded
research.
India underlined that the TRIPS Agreement established minimum standards
of protection that each government has to give to the Intellectual
Property of fellow WTO members. The TRIPS Agreement tried to strike
an appropriate balance between the interests of rights holders and
users.
Article 7 of the TRIPS Agreement entitled "Objectives" recognizes
that the protection of intellectual property should contribute to
the promotion of technological innovation and to the transfer and
dissemination of technology, to the mutual advantage of users and
producers of technological knowledge and in a manner conducive to
social and economic welfare and to a balance of rights and obligations.
The search for a balance between the need to protect IPRs to provide
incentives for R&D on the one hand and, on the other hand, to
address concerns about the potential impact of such protection on
the health sector - in particular its effect on prices - has been
an important consideration in the WTO's work, said India.
According to India, the TRIPS Agreement also recognizes that the principles
of IP protection are based on underlying public policy objectives.
Article 8 of TRIPS Agreement entitled "Principles" states
that WTO Members may, in formulating or amending their laws and regulations,
adopt measures necessary to protect public health and nutrition, and
to promote the public interest in sectors of vital importance to their
socio-economic and technological development, provided that such measures
are consistent with the provisions of this Agreement.
Article 8 (2) further states that appropriate measures may be needed
to prevent the abuse of IPRs by right holders, or to resort to practices
which unreasonably restrain trade or adversely affect the international
transfer of technology.
India pointed out that in furtherance of the objectives and Principles
of TRIPS enshrined in Articles 7 & 8, a number of safeguards or
flexibilities have become an integral part of the TRIPS framework.
"These flexibilities can be used to pursue public health objectives.
However, to implement these flexibilities, action is needed at the
domestic level by incorporating them into national IP regime keeping
in mind each country's individual needs and policy objectives."
Key TRIPS flexibilities include transition periods for LDCs (extended
by the WTO last year until 01 January 2033), differing IP exhaustion
regimes (international exhaustion allows parallel importation of patented
products from other countries where they are the cheapest), refining
the criteria for grant of a patent ( patentability criteria), pre-grant
and post-grant opposition procedures, as well as exceptions and limitations
to patent rights once granted, including regulatory review exception
("Bolar" exception) to facilitate market entry of generics,
compulsory licences, including through para 6 mechanism and government
use.
For pharmaceutical patents, these flexibilities have been clarified
and enhanced by the 2001 Doha Declaration on TRIPS and Public Health
that WTO members have the flexibility to interpret and implement the
TRIPS provisions in a manner supportive of their right to protect
public health.
Although the TRIPS Agreement provides substantial degree of flexibility
to WTO members, the full utilization of these flexibilities is in
the hands of relevant member States.
However, many developing countries are constrained by limited technical
capacity to make full utilization of the TRIPS flexibilities and therefore
they need appropriate technical assistance from relevant multilateral
organizations in order to fully utilize the TRIPS flexibilities from
the perspective of specific sectors of their economies such as agriculture,
manufacturing, public health, environment, etc.
Moreover, even where some developing countries have used the flexibilities
available to them under the TRIPS Agreement to address public interest
objectives through measures which are fully consistent with the TRIPS
Agreement, these attempts have been challenged legally as well as
politically.
"A slew of regional trade agreements containing TRIPS-plus standards
of IP protection and enforcement have the potential to significantly
undermine the effective and full use of the TRIPS flexibilities. Investor-State
disputes under regional or bilateral investment protection agreements
are also emerging as a major challenge to the use of TRIPS flexibilities
in the public interest," said India.
Against this background, said India, the recommendations of the HLP,
especially on (i) TRIPS flexibilities and TRIPS-plus provisions and
(ii) Publicly-funded research are very important with regard to access
to health technologies:
"4.2. TRIPS flexibilities and TRIPS-plus provisions
World Trade Organization (WTO) Members should commit themselves, at
the highest political levels, to respect the letter and spirit of
the Doha Declaration on TRIPS and Public Health, refraining from any
action that will limit their implementation and use in order to promote
access to health technologies. More specifically:
(a) WTO Members should make full use of the policy space available
in Article 27 of the TRIPS Agreement by adopting and applying rigorous
definitions of invention and patentability that curtail the evergreening
(of patents) to ensure that patents are awarded when genuine innovation
has occurred.
(i) The United Nations Conference on Trade and Development (UNCTAD),
the United Nations Development Programme (UNDP), the World Health
Organization (WHO), the World Intellectual Property Organization (WIPO)
and the World Trade Organization (WTO) should cooperate with one another
and with other relevant bodies with the requisite expertise to support
governments to apply public health-sensitive patentability criteria.
(ii) These multilateral organizations should strengthen the capacity
of patent examiners at both national and regional levels to apply
rigorous public health-sensitive standards of patentability taking
into account public health needs.
(b) Governments should adopt and implement legislation that facilitates
the issuance of compulsory licenses. Such legislation must be designed
to effectuate quick, fair, predictable and implementable compulsory
licenses for legitimate public health needs, and particularly with
regards to essential medicines. The use of compulsory licensing must
be based on the provisions found in the Doha Declaration and the grounds
for the issuance of compulsory licenses left to the discretion of
governments.
(c) WTO Members should revise the paragraph 6 decision in order to
find a solution that enables a swift and expedient export of pharmaceutical
products produced under compulsory license. WTO Members should, as
necessary, adopt a waiver and permanent revision of the TRIPS Agreement
to enable this reform.
(d) Governments and the private sector must refrain from explicit
or implicit threats, tactics or strategies that undermine the right
of WTO Members to use TRIPS flexibilities. Instances of undue political
and commercial pressure should be formally reported to the WTO Secretariat
during the Trade Policy Reviews of Members. WTO Members must register
complaints against undue political and economic pressure, and take
punitive measures against offending Members.
(e) Governments engaged in bilateral and regional trade and investment
treaties should ensure that these agreements do not include provisions
that interfere with their obligations to fulfill the right to health.
As a first step, they must undertake public health impact assessments.
These impact assessments should verify that the increased trade and
economic benefits are not endangering or impeding the human rights
and public health obligations of the nation and its people before
entering into commitments. Such assessments should inform negotiations,
be conducted transparently and made publicly available.
4.3. Publicly-funded research
(a) Public funders of research must require that knowledge generated
from such research be made freely and widely available through publication
in peer-reviewed literature and seek broad, online public access to
such research.
(b) Universities and research institutions that receive public funding
must prioritize public health objectives over financial returns in
their patenting and licensing practices. Such practices may include
publication, non-exclusive licensing, donations of intellectual property
and participation in public sector patent pools, among others. Sufficient
incentives must be in place in these practices to make it attractive
for developers to underwrite the cost of bringing a product to market
at affordable prices that ensure broad availability.
(c) Universities and research institutions that receive public funding
should adopt policies and approaches that catalyse innovation and
create flexible models of collaboration that advance biomedical research
and generate knowledge for the benefit of the public."
India encouraged Members to share their views on the recommendations
of the HLP at this session of the TRIPS Council. At the subsequent
sessions of the TRIPS Council, it encouraged Members to share their
experiences in using the TRIPS flexibilities to address public policy
priorities, in particular, related to public health.
In its statement, Brazil noted that among the high-level panel report's
recommendations, some are directly related to the TRIPS Agreement.
One of these calls for WTO members to commit, at the highest political
levels, to respect the letter and the spirit of the Doha Declaration
on TRIPS and Public Health, refraining from any action that will limit
their implementation and use in order to promote access to health
technologies.
More specifically, it recommends:
1. WTO Members should make full use of the policy space available
in Article 27 of the TRIPS Agreement by adopting and applying rigorous
definitions of invention and patentability that curtail the evergreening
(of patents) to ensure that patents are only awarded when genuine
innovation has occurred.
2. Enhanced cooperation among the United Nations Conference on Trade
and Development (UNCTAD), the United Nations Development Programme
(UNDP), the World Health Organization (WHO), the World Intellectual
Property Organization (WIPO) and the World Trade Organization (WTO)
and with other relevant bodies with the requisite expertise to support
governments to apply public health-sensitive patentability criteria.
3. It also recommends these multilateral organizations to strengthen
the capacity of patent examiners at both national and regional levels
to apply rigorous public health sensitive standards of patentability
taking into account public health needs.
4. Governments should adopt and implement legislation that facilitates
the issuance of compulsory licenses. Such legislation must be designed
to effectuate quick, fair, predictable and implementable compulsory
licenses for legitimate public health needs, and particularly with
regards to essential medicines. The use of compulsory licensing must
be based on the provisions found in the Doha Declaration and the grounds
for the issuance of compulsory licenses left to the discretion of
governments.
5. Governments and the private sector must refrain from explicit or
implicit threats, tactics or strategies that undermine the right of
WTO Members to use TRIPS flexibilities.
Brazil said it has "a strong commitment to the improvement of
public health in our country and in our region."
To increase the bargaining power of governments in the acquisition
of essential medicines, Brazil and other countries have established,
in 2015, a regional system of procurement for these life-saving goods.
This arrangement, with the participation of most South American countries,
is one sort of innovative mechanism aimed at helping countries to
cope with high prices of pharmaceuticals.
According to Brazil, engaging in the discussion of recommendations
by the High Level Panel might allow members to consider different
aspects of the relationship between access to medicines and the Patent
System.
Brazil said it is convinced that a balanced and effective IP system
would go a long way toward facilitating access to essential medicines
without in any way infringing on market principles.
"We all know access to medicines is a challenge for most countries,
whether least developed, developing or developed. We present these
views in a spirit of dialogue, convinced that they are in the interest
of everyone, without exception, and encourage the whole Membership
to work constructively towards achieving the goal of universal access
to medicines," said Brazil.
According to trade officials, South Africa said that the panel report
calls upon WTO members to commit to and respect the Doha Declaration
on TRIPS and Public Health, and that countries should make full use
of the TRIPS flexibilities.
China said that it is pleased to be a co-sponsor of the agenda item,
adding that the high-level panel gave various recommendations and
provides valuable information to members.
Public health is one of the most important issues on the agenda, it
said, noting that leaders at the Hangzhou G20 summit also made a commitment
in this regard.
According to trade officials, the United States said that although
it is strongly committed to creating effective and affordable life-saving
medicines around the world, it was disappointed by the report which
it claimed "distracts from rather than benefits" the objective
of achieving universal health.
It maintained that intellectual property protections needed to be
in place to support new research and innovation.
"There can be no access to drugs that have not been developed;
support in innovation is essential," said the US.
The European Union maintained that the work conducted by the Panel
started from an assumption that there was a "policy incoherence
between the justifiable rights of inventors, international human rights
law, trade rules and public health".
"As the European Commission already indicated in its written
contribution to the Panel, it does not share this assumption,"
it said.
The Commission shares the Report's acknowledgement that there are
many reasons "why people do not get the healthcare they need,
ranging from: under-resourced health systems, a lack of sufficiently
qualified and skilled healthcare workers, inequalities between and
within countries, exclusion, stigma, discrimination and exclusive
marketing rights".
Another important problem are the global medicines shortages and stock-outs.
This is why in its written contribution to the Panel, the Commission
encouraged it to adopt a holistic approach to the problem of access
to medicines that could result in a valuable contribution to the wider
debate.
"However, due to its limited mandate, the High-Level Panel has
focused its proposals exclusively on addressing an alleged conflict
between a research and development model that (partially) relies on
intellectual property rights and the possibility of providing affordable
medicines."
The European Union said it is committed to increasing access to affordable
medicines and to find solutions to the world's pressing public health
challenges and inequities, adding that it pursues a rights-based approach
to health.
Strengthening all areas of a health system, including the availability
of qualified health workers, the provision of affordable medicines
and the adequate financing of the sector, is central to moving towards
universal health coverage with quality health services accessible
and affordable for all.
The quality and integrity of the pharmaceutical distribution chain
is also essential to improving public health.
"The challenge is to strike the right balance between the need
to promote and finance the research of new and better medicines for
all, ensuring that medicines are accessible and affordable to those
in need, while guaranteeing the sustainability of health systems.
We believe that these goals are not contradictory and must be pursued
jointly," it said.
The EU claimed that the current innovation model, including the role
of trade related to IP, has delivered consistent progress in global
public health, leading to key new and improved treatments as well
as much extended life expectancy, both in developed and least developed
countries.
It also said that the report under-plays the fact that the development
of new drugs requires significant investment and long-term research,
coupled with clinical trials and regulatory approval procedures.
The EU said that the exclusive right conferred by a patent is an important
incentive for innovator pharmaceutical companies to make the necessary
investments into that research and development.
Without incentivizing the innovator pharmaceutical companies to invest
in research, the sustainable development goal of ensuring healthy
lives and promoting well-being for all, including achieving universal
health coverage, would be severely undermined, it said.
According to trade officials, Switzerland, Japan and Korea expressed
similar concerns on the "narrow scope" of the report. They
argued that the use of compulsory licences must not discourage innovation.
A few countries, including Canada, Chile, Australia and Norway, said
that they needed more time to consider the wide array of recommendations
highlighted in the report.
The Holy See, an observer, echoed the concerns on access to medicines,
highlighting that health is a fundamental human right, and "millions
are left behind".
Ensuring success of the sustainable development goals included an
end to the epidemics, and it requires global solidarity and initiatives,
it said.
According to trade officials, the World Health Organisation (WHO),
the United Nations Conference on Trade and Development (UNCTAD), and
the Joint UN Programme on HIV/AIDS (UNAIDS) also highlighted the work
that they have undertaken in this area.
In some comments on the high-level panel report, the UNCTAD Secretariat
said that it recently recommended to Secretary-General Ban Ki-moon
to consider endorsement of the Report of the High Level Panel.
As a member of the Expert Advisory Group to the High Level Panel,
UNCTAD was involved in the expert discussions that fed into the High-Level
Panel's Report, and it also provided comments on the first draft of
the Report.
The Report makes recommendations in three separate, but inter-related
areas: (1) Intellectual property laws and access to health technologies;
(2) New incentives for research and development of health technologies;
and (3) Governance, accountability and transparency.
Within the context of its mandate, UNCTAD said its technical expertise
resides mainly within the first of these areas.
The bulk of UNCTAD's contributions during the technical discussions
with the Expert Advisory Group and the High Level Panel related to
intellectual property (IP) laws and access issues.
On intellectual property laws and access to health technologies, the
High Level Panel Report recommends the full use of flexibilities inherent
in the WTO TRIPS Agreement as reiterated in the WTO Doha Declaration
on the TRIPS Agreement and Public Health.
UNCTAD said its advisory and capacity-building work over the past
ten years shows that these flexibilities, such as the recourse to
strict patenting requirements, certain exceptions to patent rights
and the availability of compulsory licenses play an important role
in promoting generic competition and thus decreasing drug prices.
"According to our research many of those countries that now enjoy
a fully developed pharmaceutical sector in the past relied on many
of those flexibilities that the High Level Panel Report recommends
in order to strike a balance between inventors' rights and the realization
of certain development objectives."
According to UNCTAD, the High Level Panel's recommendations underline
the United Nations' commitment to the realization of Sustainable Development
Goal 3, which in its targets expressly refers to the goal of providing
"access to affordable essential medicines and vaccines, in accordance
with the Doha Declaration on the TRIPS Agreement and Public Health,
which affirms the right of developing countries to use to the full
the provisions in the Agreement on Trade Related Aspects of Intellectual
Property Rights regarding flexibilities to protect public health,
and, in particular, provide access to medicines for all".
On the new incentives for research and development of health technologies,
the High Level Panel Report recommends increased investment by governments
in health technology innovation to address unmet needs, such as neglected
tropical diseases and antimicrobial resistance.
The Report refers to various ongoing initiatives in this regard and
underlines the need to develop new and innovative sources of financing
public R&D, in line with the Addis Ababa Action Agenda on Financing
for Development, said UNCTAD.
The Report is not limited to public funding, but underlines the untapped
opportunities for increasing private sector funding. The recommendations
provide important support to efforts that seek to identify innovative
opportunities for both public and private sector funding of health
R&D.
UNCTAD said it is willing to contribute its vast experience in investment
policy making and technology issues in this regard.
Finally, on governance, accountability and transparency, the High
Level Panel Report calls for increased collaboration among UN agencies
to improve coherence in technical cooperation activities related to
public health as well as to monitor the implementation of the High
Level Panel's recommendations.
UNCTAD in the delivery of its technical cooperation activities on
investment and intellectual property rights as it relates to trade
and development already cooperates to a large extent with other agencies
such as UNAIDS, UNDP, WIPO, WHO and WTO.
UNCTAD welcomed the High Level Panel Report's recommendation to increase
inter-agency coordination.
In its statement, the WHO said that the report's conclusions are sobering.
"Millions of people continue to suffer and die from treatable
conditions," the report observes, "because of a lack of
access to health technologies."
Pharmaceutical research still focuses disproportionately on the treatment
of diseases that are common in the developed world, neglecting those
that primarily afflict the world's poor.
"The report thus echoes conclusions of previous reports done
under the auspices of the WHO, which draw attention to disparities
in the R&D system and lack of access to essential medicines,"
said the WHO.
The WHO then went on to go through the different recommendations in
the high level panel report, in particular those that are directly
addressed to WHO, and highlighted its relevant activities and future
plans in this area.
According to trade officials, members agreed to revert to the matter
at the next meeting of the TRIPS Council in February 2017.
(Full texts of some statements made during the discussion in the TRIPS
Council can be found on the website of Knowledge Ecology International:
www. keionline. org) +