Info Service on WTO and Trade Issues (May15/12)
29 May 2015
Third World Network
CSOs urge support for LDC request on pharmaceuticals exemption
Published in SUNS #8027 dated 26 May 2015
Geneva, 22 May (Kanaga Raja) -- A number of civil society organisations
(CSOs) have urged support for a request by the Least Developed Countries
(LDCs) for an extension of the transitional period with regards to
the intellectual property protection of pharmaceutical products, which
is set to expire on 1 January 2016.
This call came on the sidelines of the World Health Organisation (WHO)'s
World Health Assembly, currently taking place here from 18-26 May.
It also comes ahead of a meeting of the WTO TRIPS Council in June
that is expected to hold a substantive discussion on the LDC request.
Bangladesh had introduced the LDC request under "other business"
at a meeting of the TRIPS Council on 24 February, with only a brief
discussion taking place on it.
Apart from being widely welcomed by health experts and activists,
support for the LDC request has also come from UN agencies such as
UNITAID, the UNDP and UNAIDS as well as members of the European Parliament
and generic drug suppliers such as the IDA Foundation, a non-profit
provider of generic drugs to low- and middle-income countries.
Back in February this year, Bangladesh, on behalf of the LDCs, had
submitted a duly-motivated request for an extension of the transitional
period "for as long as the WTO Member remains a least developed
The request for the extension of the transitional period also covers
test data protection under Article 30.3 of the TRIPS Agreement, as
well as seeks exemption from the "mailbox" (Article 70.8)
and exclusive marketing rights (Article 70.9) provisions of the TRIPS
Agreement (see SUNS #7970 dated 26 February 2015).
According to the LDC request (IP/C/W/605), in 2011, some 9.7 million
of the 34 million people living with HIV worldwide, live in LDCs.
Of the people living with HIV in LDCs, 4.6 million were eligible for
anti-retroviral (ARV) treatment in accordance with the 2010 World
Health Organization HIV treatment guidelines. However, only 2.5 million
were receiving it, it said.
While the ARV treatment situation may have somewhat improved since
the 2001 Doha Declaration on TRIPS and Public Health, the need remains
significantly great. There are particularly complex challenges for
LDCs with respect to second-line HIV treatment which is more than
double the price of the first-line regime, and third-line HIV treatment
which could be as much as 15 times the price of first-line treatment,
said the LDCs.
LDCs also bear increasing health burdens from non-communicable diseases.
For example, cancer incidence is expected to rise 82% from 2008 to
2030 in low-income countries (compared to 58% in upper-middle and
40% in high-income countries).
LDC Members of the WTO continue to face massive health challenges
from communicable and non- communicable diseases.
"In addition to the socioeconomic and financial constraints,
LDCs also lack adequate technological base and local pharmaceutical
manufacturing capacity. These special needs and circumstances of LDCs,
and the vulnerability of LDCs confirm the need for a renewed transition
period for as long as these constraints remain," said the LDC
At a media briefing by several CSOs on Thursday, Sangeeta Shashikant
of Third World Network provided some background surrounding the LDC
request for the extension of the transition period on pharmaceutical
At the TRIPS Council meeting in February this year, Bangladesh, on
behalf of the LDCs, had submitted a duly motivated request for an
extension of the transition period, which comes to an end on 1 January
2016, she said.
Apart from requesting the TRIPS Council to grant an extension of the
transition period for as long as the WTO Member remains an LDC, the
LDCs also requested that the TRIPS Council recommend that the General
Council adopt two waivers.
The first is a waiver from the "mailbox" obligation (under
the TRIPS Agreement), which is a facility for filing patent applications
for pharmaceutical products. The second waiver concerns the grant
of exclusive marketing rights, which is linked to the mailbox application,
where under certain conditions, exclusive marketing rights have to
be granted for a period of five years.
Shashikant said that the LDCs are home to some of the world's most
vulnerable people and they bear a considerable health burden. At the
end of 2013, an average of 10.7 million people living with HIV resided
in the LDCs and only 3.8 million had access to anti-retroviral (ARV)
There is also an expected increase in the non-communicable disease
burden in the coming years in the LDCs.
The percentage increase in cancer by 2030 compared to 2008 will be
much greater in lower- and middle-income countries than in other countries,
she said, adding that there is a huge public health crisis in the
In 2001, recognising the special circumstances of the LDCs, WTO members
granted a specific exemption for pharmaceutical products in paragraph
7 of the Doha Declaration on TRIPS Agreement and Public Health, which
was later adopted as a TRIPS Council decision in 2002.
This decision very specifically exempts LDCs with respect to pharmaceutical
products, where they do not have to implement patents and test data
protection, as well as not having to enforce existing patent rights
and test data obligations until 1 January 2016.
At the same time, the General Council granted a waiver for exclusive
marketing rights until 1 January 2016.
Shashikant explained that this is why the LDCs have submitted a request
for the extension of the 2002 decisions.
Noting that in 2013, the TRIPS Council had granted a general exemption
that applied to all aspects of the TRIPS Agreement, except for Articles
3, 4 and 5, she said that there is great value in the exemption on
pharmaceutical products because it is very specific to these products
and that it is clear, as well as giving a lot of certainty.
A number of LDCs have relied on this decision to enable the importation
of affordable pharmaceutical products in LDCs, and that it has been
a very effective mechanism to promote access to medicines in the LDCs.
Noting the concerns expressed that this extension will not be granted
or that it will be subjected to certain terms and conditions, she
expressed hope that the TRIPS Council, which will be hearing the LDC
request on 9-10 June, will actually consider and grant the LDCs' request.
James Love of Knowledge Ecology International (KEI) highlighted the
importance of the LDC request, saying that it is important going forward
that LDCs will have a different rule on patents, that they won't have
to patent pharmaceutical products, that they can legislate and remove
pharmaceuticals from their patent laws, that generic drug manufacturers
can anticipate the market, and that lawmakers can put in efforts to
change laws knowing that there will be more sustainable solutions.
The right thing to do is to make the LDC extension permanent, he said.
Rohit Malpani of Medecins Sans Frontieres (MSF)'s Access Campaign
said that MSF has been a strong supporter of the LDC extension request
since it was first introduced in 2002, and is also supportive of the
LDC request submitted in February. It is watching very closely to
see whether or not the request will be granted fully as Bangladesh
has set forward.
MSF is increasingly an organisation that exists in two realities,
he said. It is both in LDCs in which it is able to get access to the
lowest-cost generic medicines, vaccines and open platforms for diagnostics,
as well as in 35 middle-income countries in which the introduction
of intellectual property (IP) rules - and even stricter IP rules due
to Free Trade Agreements - makes it increasingly difficult to access
affordable medical tools.
"So in many ways we see situations in which we can get the lowest
cost tools to patients in the least developed countries and we cannot
do so in middle-income countries and that is why the LDC extension
is so important. This is because we want to be able to continue at
least being able to reach patients in LDCs with the best possible
medical care at the lowest possible cost," he said.
Another reason why the extension is important for MSF is that often
times it has a hard time encouraging generics companies in particular
to register drugs or to market drugs to the LDCs.
If the LDC extension is not granted in the way that it has been put
forward by Bangladesh, it reduces the certainty for these manufacturers
to sell their products in these markets, said Malpani, adding that
the certainty that the LDC extension provides plays an important enabling
role to ensure that we can get low-cost medical tools to these poorest
"MSF is concerned as it does think there is a history especially
by the US and the EU to put pressure on the LDCs to not introduce
these rules that have a strong public health impact," he added.
Meanwhile, in a press statement issued on Thursday, the United Nations
Development Programme (UNDP) and the Joint United Nations Programme
on HIV/AIDS (UNAIDS) called attention to the urgent and compelling
case for the international community to take all measures possible
to protect the health of people living in the LDCs.
"Millions of people rely on access to affordable, assured quality
generic medicines," said Michel Sidibe, Executive Director of
"WTO Members have before them a critical opportunity to help
least-developed countries to reach health and sustainable development
goals - failure to support them could put millions of lives at risk."
Access to adequate healthcare, including affordable medicines, remains
a key challenge in most LDCs affecting millions of lives. The flexible
intellectual property arrangements currently available to LDCs are
a crucial tool for improving health, said the UN agencies.
"While much progress has been made in scaling up access to HIV
treatment, much more will be required in the post-2015 era to achieve
the vision of a life of dignity for all, leaving no one behind,"
said Helen Clark, UNDP Administrator.
The percentage of people living with HIV who are not receiving antiretroviral
therapy has been reduced from 90% in 2006 to 63% in 2013. LDCs and
developing countries have effectively used transition periods to scale
up access to treatment for HIV and its co-infections by importing
or manufacturing lower-cost generic medicines.
According to the press statement, access to medicines such as sofosbuvir
used to treat chronic hepatitis C remains a grave challenge in LDCs
because of high prices. Sofosbuvir can cost as much as US$84,000 for
a 12- week course in developed country markets.
Lower prices via generic licenses are being offered by the patent-holder
in some developing countries, but that would still place a considerable
burden on health budgets.
A company in Bangladesh, making use of its LDC status, has launched
its own version for US$900 for the 12- week course.
"While this price is also out of reach of many patients in LDCs,
with the possibility of other manufacturers emerging in LDCs there
is potential for greater competition and further price reductions,"
said the UN agencies.
UNDP and UNAIDS noted that there is another transition period in place
which they have previously backed, that exempts LDCs from implementing
their WTO intellectual property obligations for all fields of technology
but this period expires in 2021.
"The proposed transition period on pharmaceutical products, for
as long as an LDC remains an LDC, is necessary on top of that general
transition period, for the longer-term security it would provide for
patients, manufacturers, donors and LDC governments alike."
UNDP and UNAIDS urged all WTO Members to support the LDC request for
a transition period on pharmaceutical-related patents and clinical
data for as long as a country remains an LDC. +