Unpacking access to medicines:
a snapshot of the multilateral trade system rational medicines selection fair and sustainable financing
for health care systems reliable health and
supply systems affordable prices
health care providers
at the border:
'trade related'factors affecting prices:
behind the border:
intellectual property settings A glance at tariffs LDCs tend to import medicines (HS3004) free of any duty.
Many LDCs have reduced or eliminated tariffs on imported medicines in past years.
Several maintain higher average rates, up to 14% WHO recommendation on national drug policy:
no tariffs on essential medicines two themes:
what data can 'the system' offer us?
what's going on out in the field? 75 WTO Members in categories 3 and 4 surveyed (of 84 in all):
Low tariff rates on medicines ready for retail sale
Lower on averages than for medicines broadly defined (ingredients, etc.). non-LDC national average tariff rates for medicaments (HS3004) fairly low, i.e. below 10%.
a few with rates up to 12% But low sectoral averages conceal frequent tariff peaks, especially in developing countries with a domestic pharmaceutical industry.
some tariff peaks from 14% up to 35%
1) Pharma sectoral initiative:
negotiated during the Uruguay Round, full liberalisation of over 6,500 pharmaceutical products and inputs covering an estimated 79% of global trade of these products.
11 WTO Members have liberalised their pharmaceutical sector under that initiative (or as part of accession commitments): Albania, Armenia,, Canada, EU-27, Japan, Kyrgyz Republic, Macao China, Moldova, Norway, Oman, Switzerland and the United States.
committed to regular review of coverage for additional pharmaceutical products for tariff elimination. Now entering 3rd review.
2) NAMA Tariff reduction modalities:
could result in a significant drop in pharmaceutical tariffs.
developed countries already bound most tariffs in this sector at zero, few remaining peaks would be reduced
Major developing country markets would also have to reduce pharmaceutical tariffs assuming that they do not choose to apply flexibilities on these tariff lines.
3) NAMA Sectoral initiative for Open Access to Enhanced Healthcare:
initiative for tariff elimination and reduction in pharmaceutical and medical products proposed by Singapore; Switzerland; Chinese Taipei; and the United States (2006 and 2007 ).
Reduce cost of healthcare through the substantial elimination or reduction of tariffs and specific NTBs affecting the trade in medicines, medical devices and "innovative medical technology products".
Built around the critical mass concept to include the key consumers and producers of these products.
Negotiations on reduction/elimination of
tariffs and non-tariff barriers Agreement on Technical Barriers to Trade (TBT)
recognizes protection of human health as a legitimate objective
notification of proposed or modified technical regulations
46% of notified regulations aim at protecting health
relatively few concern pharamaceutical products per se
TBT Information Managment System: 16 Members have notified 115 technical regulations specifically concerning pharmaceuticals
Discussions on specific trade concerns have included certification and recognition of Good Manufacturing Practice and the maintenance of quality standards Agreement on the Application of
Sanitary and Phytosanitary Measures (SPS)
covers measures designed to protect human life from food borne risks and plant/animal carried diseases
little connection with essential medicines and primary pharamceutical products for human health
considerable information on medicinal food products such as tea or herbs (177 notifications) and functional foods with nutritional additives Trade in health services
General Agreement on Trade in Services (GATS)
high flexibility in defining obligations undertaken in a given service sector, whether or not to open market to foreign suppliers at all, scope and conditions; whether to bind such opening in GATS specific commitments.
maintain the ability to regulate service quality and accommodate other domestic policy concerns.
emphasizes the need for government regulations to protect the interests of its citizens.
impact of GATS on trade in health services remains insignificant
low level of commitments in this sector
mostly only bind existing levels of market access.
GATS commitments in health services not an end in itself, one consideration in health policy-making.
If appropriate regulatory environment is in place, possibility of foreign investment and know-how, wider choice of available services, increase transparency and predictability.
in some cases, private health facilities are subject to "universal service" obligations with a view to improving access of the poor.
Assessing risks and opportunities of undertaking GATS commitments requires the involvement of all stakeholders concerned.
Agreement on Government Procurement principles of openness, transparency and non-discrimination when public money is spent on goods and services
cost benefits of open and competitive tendering for public expenditure
only applies to scheduled entities
many parties have commititted cover public health authorities
pharmaceutical products are covered unless otherwise specified (only one party excludes a limited list of some medical products, but not medicines as such)
Working Group on the Interaction
between Trade and Competition Policy
from 1997-2003 extensive material on competition and intellectual property
reports of national experiences
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)
2001 Doha Declaration on the TRIPS Agreement and Public Health
2003 Decision on waiver for new flexibility on access to medicines
2005 Protocol amending the TRIPS Agreement
Hong Kong, China
United StatesSee the full transcript