News Release
Poul Nielson
No. 155/04
October 29, 2004
EUROPEAN COMMISSION STEPS UP FIGHT AGAINST HIV/AIDS, MALARIA
AND TUBERCULOSIS
The European Commission has is stepping up the fight against HIV/AIDS,
Malaria and Tuberculosis (TB) by addressing these 3 killer diseases more broadly
as a human rights and security challenge while also increasing 4-fold to €1.1
billion the funds available for the period 2003-2006.
European Commissioner for Development
and Humanitarian Aid,
Poul Nielson,
stressed: “During the last five years this Commission has been busy attacking
HIV/AIDS, malaria and TB from all possible perspectives be it development, trade,
research or health. With the adoption of the new policy framework the Commission
is well placed to remain at the forefront of the fight against these three killer
diseases.”
More than 6 million people die every year from HIV/AIDS, malaria or tuberculosis.
A significant number of these people live on Europe’s doorstep. In 2003 alone,
almost 3 million people died of HIV/AIDS, rapidly becoming the worst infectious
disease catastrophe in recorded history. Malaria kills more than 1 million people
every year, including an African child every 30 seconds. TB kills about 2 million
people every year.
Building upon the lessons from an earlier Programme of Action launched in 2001,
the Commission’s new comprehensive approach covers:
• human rights, as there is a clear need to avoid further marginalisation
and stigmatisation of high risk groups;
• implications for human security, as HIV/AIDS in particular is decimating
communities and destroying social cohesion; and
• involving all EU external actions, and not just development policy, in
formulating a coherent response to the 3 diseases.
The new strategy also identifies a number of new areas where actions need
to be taken:
• increasing health-related capacity in national development plans;
• enhancing the regulatory capacity of third countries including the their
ability to approve clinical trials and grant market authorisations;
• promoting investment in the local production of pharmaceutical products
in third countries: for example for insecticide-treated bednets or combination
therapies for malaria;
• further reducing prices of pharmaceutical products by working further
on the issues of tiered pricing, price transparency and competition;
• and continuing work to support the research and development of new tools
and interventions such as vaccines and microbicides.
BACKGROUND
EU action against HIV/AIDS, tuberculosis and malaria 2000-2005
HIV/AIDS, malaria and TB collectively undermine global health, poverty reduction
and human security. In 2000, the EC accelerated its response to the global emergency
in a coherent and comprehensive framework for accelerated action targeted at major
communicable diseases [COM(2000)
585]. Based on this framework, the Commission in 2001 adopted its Programme
for Action (PfA) aimed at coherently addressing a range of development,
humanitarian aid, trade, research, enterprise, health and education issues. The
PfA focuses on 3 inter-related areas for action:
• to increase the impact of existing interventions;
• to increase the affordability of key pharmaceutical products;
• to encourage research and development.
There has been action at 2 levels, accelerating and increasing resource allocation
at country level, and advocating and adopting key policies and action at global
level.
EU Largest Contributor to Global Fund
The EU is the largest contributor to the Global Fund to fight HIV/AIDS, TB and
malaria, accounting for more than 55% of all pledges. The Commission’s pledge
of €340 million for 2003, in addition of €120 million allocated in 2002, puts
the Commission, with a total contribution of €460 million, in the forefront of
this effort as the second largest single contributor to the GFATM. The EC has
already honored over 70% of its pledges to the Global Fund. EU Member States and
the Commission combined have pledged a total of US$2.8 billion to the Global Fund
until 2007, accounting for more than 55% of all pledges made to the Global Fund.
Affordability of essential medicines
At the time of developing the Pfa, prices of some key pharmaceutical products
for the 3 diseases were unaffordable. In 2000 the price of patented Anti-Retro
Virals (ARV) was around US$10,000/person/year. Today, the lowest prices for first-line
ARV treatment are between US$100-US$350 per person/year. Various factors contributed
to the price decrease in some key pharmaceutical products and the EC has played
a leading role in issues such as the promotion of tiered pricing and issues relating
to intellectual property. Other factors were the result of the partnership with
civil society and developing countries and the increase in demand for ARVs due
to Global Fund funded projects in-country.
Key Actions
EC Regulation on trade diversion: The concept of tiered pricing (that buyers
in developing countries should have access to medicines at considerably lower
prices than buyers in more well-off countries) is one that the EU has consistently
emphasised. Pharmaceutical producers in developed countries need security that
discounted products supplied in large volumes do actually reach the poor countries
they are meant for and are not diverted back into high price markets. In May 2003,
the EU adopted a Regulation
[Council Regulation (EC) No 953/2003] to avoid trade diversion into the European
Union of certain key medicines, aimed to encourage producers to increase supplies
of medicines significantly at tiered prices in developing countries, while maintaining
higher prices for the same products in the EU. Both patented and generic products
can be registered, as can donated products. In order to be added to the list,
medicines have to be made available either with a price cut of at least 75% off
the average "ex factory" price in OECD countries or at the cost of production
plus maximum 15%. The proposed system is simple and transparent, with products
on the list bearing a logo for identification purposes. To date, GlaxoSmithKline
(a leading manufacturer of ARVs, which has strongly supported the tiered pricing
policy from the beginning) has registered 7 HIV/AIDS products under the Regulation
to be protected against trade diversion. Two further applications from GlaxoSmithKline
are still pending and will be processed before the end of 2004.
Tariffs and taxes: The EU Commission also works to eliminate tariffs, taxes
and importation, distribution and local registration fees in importing countries
to enhance affordability of medicines. An EU Commission study on duties and taxes
on pharmaceutical products in 57 developing countries showed that there is still
scope for lowering tariffs and taxes in some countries. The range of duties and
taxes currently varies from 55% on most pharmaceutical products in India to 0%
in countries such as Gabon, Indonesia, Nicaragua and Uganda.
WTO agreement on trade-related aspects of intellectual property rights:
At the launch of the Doha
Development Agenda in Doha in November 2001, WTO members agreed to find a
solution giving developing countries with no manufacturing capacity the possibility
to import generics from third countries. A compromise was found in August 2003,
which received the support of all WTO members. The EC has proposed a Regulation
to allow manufacturers of generic pharmaceuticals to produce patented medicines
for export to “countries in need” without sufficient capacity to produce them,
implementing the WTO agreement.
Increased support for basic and strategic R&D with greater coordination
at European and international level: EC funding for R&D targeted at the 3
diseases has increased 4-fold from the 5th to the 6th FP (RTD) (from €109 million,
1998-2002, to more than €400 million, 2002-2006), being allocated to basic, pre-clinical
and clinical research in new interventions. Currently, a number of highly significant
research projects are under way and delivering results, funded by the 5th FP (RTD).
These include a multicentre trial of shortening TB treatment to 4 instead of 6
months, a series of early clinical tests for TB vaccination and various projects
dealing with new malaria drugs such as phosphidomycin. Another significant action
is the support to a pioneering effort of HIV/AIDS vaccine research in China, based
on the locally predominant C-strain of the HIV virus.
The EC also supports large research consortia, with strong partnerships
developed between European scientists, renowned African research institutions
and industry partners. It also supports for small-scale, high-risk and innovative
projects in the early discovery phase and incentives for participation by SMEs.
Participation in Global Partnerships: Policy and Political Dialogue
The EC has fostered a strengthened policy dialogue with partners in developing
countries; strengthened its partnership with WHO and other multilateral agencies,
the private sector and civil society; had a strong voice in international fora,
including the G8, the EU/African Union dialogue and the Global Fund to Fight HIV/AIDS,
TB and malaria; and developed a specific focus on the enhancement of capacity
for the local production of essential medicines in a number of developing countries.
Leadership in developing countries: Certain developing countries have demonstrated
strong leadership and successful strategies that have stopped or reversed infection
rates for HIV, malaria and TB over the past few years. Peru has attained effective
TB control nationwide through integrating TB control within the health system
throughout the country and maintaining high quality service, monitoring and management
of the system. Senegal saw early mobilisation of government and civil society.
There was also open government support for reproductive health, including sexually
transmitted disease and HIV prevention and HIV/AIDS treatment through ARVs. These
measures have kept the disease prevalence low. In Thailand, strong prevention
efforts promoting the use of condoms, production of generic pharmaceutical products
and testing and treatment have contributed to decreasing annual infection rates
in certain groups by a factor of 5 over the last decade. Thailand’s treatment
and care approaches have also been supported by the distribution of generic and
locally produced medicines. In Uganda, national prevalence of HIV/AIDS dropped
from 12% in the early 1990s to 4.1% in 2003. Iin the capital Kampala, this trend
was even more pronounced, with a prevalence of around 8% in 2002 as compared to
29% 10 years ago). This reduction was mostly due to education campaigns to mobilise
various leaders and condom promotion. In Vietnam, child mortality rates due to
malaria have declined over the last decade, primarily because of the use of insecticide-treated
bednets and community-based diagnosis and treatment.
