INTERVENTION BY THE HOLY SEE
AT THE WORLD TRADE ORGANIZATION (WTO) - TRADE RELATED INTELLECTUAL PROPERTY
RIGHTS (TRIPs) COUNCIL
STATEMENT BY H.E.
ARCHBISHOP SILVANO M. TOMASI
PERMANENT OBSERVER OF THE HOLY SEE TO THE UNITED NATIONS
AND OTHER INTERNATIONAL ORGANIZATIONS IN GENEVA*
Wednesday, 10 June 2015
I join previous speakers to congratulate you on your election. The World
Health Organization (WHO) estimates that about one-third of the population lacks
regular access to essential medicines and vaccines. It believes that 10 million
lives could be saved annually if such resources were more readily available.
The Least Developed Countries (LDCs), as the poorest and weakest segment of
the international community, are most vulnerable. The classification of LDCs is
contingent on a number of key human development indicators, including levels of
poverty, literacy and infant mortality. At the beginning of the Millennium, the
Least Developed Countries enjoyed the strongest and longest growth rates since
the 1970s, benefiting from sustained global growth, surging commodity prices and
buoyant capital flows. Between 2000 and 2008, the average annual growth of this
Group’s real gross domestic product (GDP) exceeded 7 per cent, raising hopes
that some LDCs may be able to graduate from this category within the present
decade. However, with the global financial crisis in 2008 and the drastic change
in external conditions, LDCs have experienced a slowdown of economic activity.
As a result, their economic growth has been much weaker during the past five
years. It has been well below the target rate of 7 per cent annual growth
established in the Istanbul Programme of Action (IPoA) which is considered
necessary for attaining the Millennium Development Goals (MDGs).
With the recovery of the global economy remaining slow and uneven, the LDCs
faced a challenging international environment in 2013. This sluggish global
economic growth, which translated into weaker international demand for
commodities and a consequent decline in their prices, adversely affected the
economic growth and export performance of several LDCs. The outlook for the LDCs
in the short and medium term remains uncertain. While global output is expected
to strengthen moderately in the medium term, uncertainty about the pace and the
strength of the recovery persists. A fragile and uncertain global recovery could
hinder LDCs’ economic performance due to weak international demand and lower
commodity prices. Adjusting to a changing external environment has always been a
key challenge for these economies, but this is now exacerbated by a weak world
economy and prevailing uncertainties. The less favourable external environment,
coupled with LDCs’ weaker growth performance, suggests that achieving the MDGs,
or the SDGs that are planned to succeed them, will be difficult.
As underlined in the Istanbul Program of Action, LDCs are the most
“off-track” in the achievement of the internationally agreed development goals.
Their productive capacity is limited, and they have severe infrastructure
deficits1. In 2011, of the 34 million people living with HIV worldwide, some 9.7
million lived in LDCs. Of these, 4.6 million were in need of antiretroviral
treatment (ART); however only 2.5 million had received it2. Up to one-half of
those deprived of treatment were expected to die within 24 months3. In the 49
countries designated as LDCs by the United Nations, non-communicable diseases as
well are rising much faster than in higher income countries.
Some LDCs have used the transition period as a major selling point for
attracting investment in their local pharmaceutical industry4. However, some
LDCs have provided patent protection for medicines despite the availability of
the transition period or have signed free trade and investment agreements that
may contain IP provisions curtailing any benefits arising from the transition
period. In this context, the report observed that the transition period in
itself, though important, will not be sufficient to attract generic companies to
invest in local pharmaceutical production5. However, the transition period is
intended to provide LDCs with the necessary policy space to take measures that
would facilitate the growth of industrial capacity in desired sectors without
being impeded by the existence of patents, which could hinder the development of
the local industry.
Since 2000, there has been a noticeable decline in the number of new HIV
infections in LDCs since 2000, as in the developing world as a whole, reflecting
improvements in early diagnosis, access to treatment, nutrition, and responsible
behaviour change. However, despite such improvements, the goal of universal
access to anti-retroviral treatment is far from achieved and requires continuing
investment and both health and community system strengthening. Moreover, the
deficiencies of health systems in LDCs have been sharply highlighted during 2014
and 2015, in conjunction with the significant outbreak of the Ebola Virus
Disease in Coastal West Africa. Such health emergencies could jeopardize, or
even reverse, the achievements of several LDCs in terms of human and economic
We have before us a critical opportunity to help LDCs to reach health and
sustainable development goals and the failure to do so could put millions of
lives at risk. Access to adequate healthcare, including affordable medicines,
remains a key challenge in most LDCs. The current flexible intellectual property
arrangements for LDCs are a crucial tool for improving health. In fact, the
flexibility agreed in TRIPS Article 66.1 has been accepted in recognition of the
economic, financial, and administrative constraints preventing LDCs from
immediate observance of all the obligations set out in the TRIPS Agreement. The
general transition period may be useful in supporting the development of a
strong chemical industry that could gradually move toward to production of API
(Active Pharmaceutical Ingredient). Long-term sustainability of the local
pharmaceutical industry would require the development of the internal capacity
to manufacture generic formulations thus reducing dependency and the high import
costs for obtaining APIs. In particular, there is a need to develop a second
line HIV treatment which, a present, is more than double the price of the first
line regime. Moreover, the costs for a third line HIV treatment could be as much
as 15 times the price of first line treatment. Clearly, in this context, the
establishment of a pharmaceutical industry is particularly important.
As clearly stated by the TRIPs Agreement, a well-designed intellectual
property system “should contribute to the promotion of technological innovation
and to the transfer and dissemination of technology, to the mutual advantage of
producers and users of technological knowledge, in a manner conducive to social
and economic welfare, and to a balance of rights and obligations”6.
In conclusion, Mr. President, the Holy See Delegation hopes that a sense of
common responsibility, as shown in the decision adopted, will bring us all to
recommend to the General Council a waiver for LDCs from obligations under
Articles 70.8 and 70.9 of TRIPS for as long as they remain LDCs.
Thank you, Mr. President.
1) Istanbul Plan of Action (par.4) doc. A/CONF.219/3.
2) TRIPS transition period extensions for least-developed countries, UNDP and
UNAIDS Issues Brief,/13, February 2013.
3) Mr. Michel Sidibé, UNAIDS Executive Director, Report to 31st UNAIDS
Programme Coordinating Board, December 2012,
4) UNCTAD (2011), Investment in Pharmaceutical Production in the Least
Developed Countries: A Guide for Policymakers and Investment Promotion Agencies
(UNCTAD Secretariat, Geneva, New York), pp. 40-42, available at
http://unctad.org/en/Docs/diaepcb2011d5_en.pdf (last visited 3 June 2015)
6) Article 7 TRIPs Agreement.