E-drug: European Parliament on poverty and access to medicines
-------------------------------------------------------------------------
[Following yesterday's long message from on the European
Commission's "Draft Declaration on TRIPs and access to affordable
medicines", I think many E-druggers would also want to see the
resolution the European Parliament adopted on poverty reduction
and access to medicines (edition 4.10.01). To keep the size
somewhat manageable, I left out the initial wording in which the
stage is set. Copied from the Healthgap list. Thanks colleagues! HH]
European Parliament
Texts Adopted by Parliament
Provisional Edition : 04/10/2001
Poverty reduction
A5-0263/2001
European Parliament resolution on the Commission communication
to the Council and the European Parliament on accelerated action
targeted at major communicable diseases within the context of
poverty reduction (COM(2000) 585 - C5-0014/2001 -
2001/2006(COS)) and on the Commission communication to the
Council and the European Parliament on a Programme for Action:
accelerated action on HIV/AIDS, malaria and tuberculosis in the
context of poverty reduction (COM(2001) 96 - C5-0112/2001 -
2001/2006(COS))
The European Parliament,
- having regard to the Commission communication (COM(2000)
585 - C5-0014/2001),
(from here the introductory wording, which is interesting, but I'll
save you the time. If anyone really needs it, I can send the full text.
HH)
1. Welcomes the Commission's innovative and comprehensive
policy framework and the EU Programme for Action on accelerated
action on HIV/AIDS, malaria and tuberculosis as they constitute
coherent initiatives that extend beyond traditional strategies in
addressing health and development in the context of poverty
reduction in the developing countries; calls on the Commission to
put in place a mechanism to ensure effective coordination across
the Directorates-General participating in the Programme for Action;
2. Considers that, in order to efficiently implement the Community
Programme for Action, funds have to be increased (notably
Community aid, including EDF funding) and used, as a priority, for
reinforcing healthcare services and structures (including building
and improving medical centres, providing equipment and training
medical staff) in developing countries; stresses that this not only
requires more investment in basic health services, but also the
transfer of know-how and technologies in order to develop national
capacity and increase the level of self-sufficiency in developing
countries; calls on the Commission therefore to give priority to a
continuous financial aid in this field, since well-functioning health
care systems are essential components in the prevention and
treatment of HIV/AIDS, tuberculosis and malaria;
3. Stresses that EU actions should be based around the principles
of sustainability and ownership by developing countries, and that
finding sustainable solutions will require substantial political
commitment from both developing countries and developed
countries;
4. Points out that effective and coherent action against
communicable diseases must simultaneously combine:
- prevention, through information and education campaigns,
immunisation programmes and action to promote better living
conditions, as good housing, employment, nutrition etc, provide the
best possible prevention;
- treatment, which implies access to drugs as well as the
availability of health care structures and staff;
- research into more effective vaccines and drugs which are better
suited to populations in developing countries;
5. Calls on the European Union to adopt directives to untie
development aid for tenders on healthcare related products and
services and calls on the EU to play a leading role in providing
sufficient funding and in establishing appropriate guidelines and
support capacity building for more efficient untied procurement,
local manufacturing and a tiered pricing mechanism with clear
standards to ensure access to affordable pharmaceuticals at
marginal costs for prevention and care for these communicable
diseases; considers that this mechanism should be transparent and
should not be limited in time or place so that all developing
countries can benefit from it; considers also that rules on
intellectual property concerning the production, use and transport of
affordable generic drugs should take account of the need to arrive
at equitable prices;
6. Notes that one third of the world's population is under the age
of 20, and that half of all new HIV infections occur in the 15-24
age group; calls on the Commission therefore to give particular
attention to preventing HIV infection in this age group by providing
them with the information, education and services necessary to
reduce their vulnerability to HIV infection, and promoting the use of
condoms; considers that parents, primary and secondary school
teachers, health workers, politicians, religious leaders etc. in the
communities must be trained along these lines, and that these
campaigns must take place in local schools and communities, taking
account of local cultures;
7. Supports the Commission's intention to contribute significantly
to improved budgeting, financial management, planning, quality
assurance, procurement through tendering, distribution, and optimal
use of pharmaceuticals in developing countries;
8. Points out that satisfactory responses to the issue of access to
drugs and treatment can be found only as part of an increased
effort on the part of industrialised countries in the field of
development aid in general and support for health systems in
developing countries in particular;
9. Calls for the European Union, to support measures for
preventing as well as treating HIV/AIDS, malaria and tuberculosis,
and in this regard, to devote 10% of its development aid spending
to policies on combating the main communicable diseases, support
for health systems and population programmes;
10. Calls for use to be made of the existing general preventative
health programmes by increased efforts in the area of reproductive
health; notes that cases of HIV infection are increasing sharply
among women - in both rural and urban areas; notes the fact that
often women do not get access to health services;
11. Calls on the EU to ensure that the right of developing countries
to produce and market within those countries generic medicines
intended for the treatment of major epidemics is recognised at
international level, without costs arising from intellectual property
rights, by using the possibility offered by the TRIPS Agreement,
particularly compulsory licenses, but also by periodically evaluating
them and proposing any necessary amendments to that Agreement;
12. Calls on governments in the developing world to allocate an
appropriate level of national resources to health;
13. Calls for developing countries intending to make infrastructure
improvements not to cut expenditure on health and education
budgets, and calls on donors assessing aid on macroeconomic
conditions of developing countries to ensure that health and
education budgets receive priority;
14. Calls on developing countries to abolish tariffs and taxes on
import of essential drugs and equipment in order to make healthcare
more affordable;
15. Supports the recommendation contained in the Commission's
Plan for Action to support the WHO's efforts to revise the criteria
establishing the list of essential drugs in order to include costly
drugs such as anti-retrovirals;
16. Calls on the Commission to continue to develop close working
relationships with the WHO, UNAIDS, UNICEF and the World Bank
so that developing countries are encouraged to import only
country-specific essential medicines thereby ensuring best use of
national health budgets;
17. Is convinced that better cooperation and partnership between
NGOs, private and public sectors in healthcare delivery in
developing countries can minimise the cost of procurement,
distribution and delivery of medicines and treatment;
18. Stresses the need to improve links between NGOs, the private
sector and the public sector in the field of health care in the
developing countries; undertakes to contribute financially to this
objective, inter alia by targeting Community aid towards reinforcing
public healthcare services and granting funds to local, genuine and
well-established health-related NGOs to support their activities;
19. Stresses that all measures in this area must take account of
the cultural situation of each region and that priorities must be set
in cooperation with local communities and NGOs, including
patients" associations;
20. Emphasises the need for access to basic health care provision
in order effectively to combat the major infectious diseases in the
framework of reducing poverty; calls on the Commission, in
implementing the Programme for Action on HIV/AIDS, malaria and
tuberculosis, to take account of the targets set in the regional
estimates for 2001, in which a doubling of the budget for basic
healthcare is provided for; calls on the Commission also to increase
its 2001 budget for support measures in the areas of health care,
combating AIDS and population policy (HAP = HIV/AIDS
Prevention) by at least 2% over and above 2000 by spending at
least 10% of the appropriations on HAP measures;
21. Reaffirms that prevention policy must remain a central element
in the fight against the spread of communicable diseases, given that
prevention remains the most cost-effective way of combating the
spread of the diseases; urges the Commission therefore to develop
a prevention strategy especially targeted at the poorest and most
vulnerable groups, particularly women, young girls and adolescents
including information about preventing infection and educating the
public in making the right choices for maintaining good health and
welfare;
22. Stresses that promoting optimum living conditions is an
integral part of the overall strategy to combat communicable
diseases; considers therefore that all EU development policies and
programmes aimed at eradicating poverty and improving quality of
life in the developing countries should take account of health
issues, including communicable diseases;
23. Notes that, whilst welcoming the Commission's recognition of
the problem and its willingness to adopt short- and long-term
measures, there is a need for greater efforts by the Member States,
which are increasingly failing to fulfil the international commitment
they have given to provide 0.7% of GNP for development, to take
specific initiatives within the WHO to add to the essential drugs list
and to implement a plan to reduce the cost of drugs; stresses, in
this context, the responsibilities of the pharmaceuticals companies;
considers that this initiative could include a working group within
the WTO on access to medicines, working alongside with the WHO
and other international bodies to develop a global strategy;
24. Recognises that day-care health centres to test, diagnose, treat
and monitor progress of treatment of these diseases including
support for the DOTS (Directly Observed Treatment Short Course)
strategy for tuberculosis are essential in implementing the EU
Programme for Action;
25. Supports the creation of regional and sub-regional quality
control laboratory networks to ensure quality control of test
reagents and pharmaceuticals (including generics) being used for
treatment of these communicable diseases, according to
WHO-approved standards;
26. Supports the transfer of significant additional means to the
relevant development funds budget lines to enable in particular
capacity building in African research institutions so that scientific
networks can to carry out for themselves field testing of new drugs
and vaccines in coordination with European efforts; suggests, in
this respect, that the approach developed by the African Malaria
Vaccine Testing Network could be followed;
27. Urges the Commission to address as a matter of urgency the
increasing prevalence of mother-to-child transmission of HIV/AIDS,
through the provision of appropriate pre and post natal care for both
mothers and their children;
28. Calls on governments of the developing countries to facilitate
prompt local registration of pharmaceutical products approved by
the EU and other industrialised countries, so that they may be
available to their public without undue delay;
29. Considers that although major pharmaceutical manufacturers of
anti-retroviral and anti-malarial medicines have expressed the
intention to reduce substantially their prices in the framework of
special programmes of assistance to some governments of
developing countries, prices continue to be beyond the reach of
most people who are too poor to be able to afford them without
public funding at the national and or global levels;
30. Calls on all major manufacturers of essential life-saving
medicines to continue to collaborate with the EU and governments
of the developing countries to offer, as a first step, further
reductions (tiered pricing) in order to reach marginal costs, and as a
second step, to implement a global tiered pricing system;
31. Recognises the need for appropriate global measures, including
readily identifiable packaging to prevent re-importation to western
countries of tiered priced products destined for the poor; calls on
the Commission to also look at mechanisms at EU level to ensure
against product diversion and to explore ways under the TRIPS
Agreement of avoiding re-exportation of products destined for poor
countries to developed-country markets;
32. Recognises that in the short term a tiered pricing system is a
response to the problem of access to medicines for developing
country populations, but stresses that in the long term it is only part
of the solution to the problem of communicable diseases in the
developing countries;
33. Calls for greater research and development efforts to find more
sustainable ways of combating tropical diseases and to overcome
the stagnation in developing new vaccines against tuberculosis;
considers that the process of putting newly developed drugs to
combat communicable diseases into production and bringing them
into use in developing countries must be speeded up;
34. Calls on pharmaceutical manufacturers not to remove
live-saving, but unprofitable, drugs from the market, as they are
necessary for treating diseases in developing countries; stresses
that drugs which have been removed from the market for economic
reasons should be allowed to be produced by local manufacturers in
developing countries through voluntary licences;
35. Calls on the EU, the USA, Japan and other industrialised
countries to develop a range of initiatives, including appropriate
legislation that would offer financial incentives, for increasing
private-sector investment in research and development of vaccines
and cheaper medicines for treating communicable diseases that
mainly affect developing countries; considers that these incentives
should be structured in such a way as to ensure that products thus
developed are accessible for use in developing countries; considers
that a start could be made on adopting such measures in the course
of the next revision, in 2001, of EU medicine-licensing legislation;
36. Calls on the European Union and the industrialised countries to
encourage the transfer of technologies and knowledge in order to
establish or strengthen capacities for the local or regional
production of essential medicines in developing countries and
stresses the need to promote voluntary licensing, in particular as
regards intermediate countries;
37. Calls on the Commission and the Council to set up a joint
undertaking (research agency) under Article 171 of the EC Treaty in
close association with developing countries so as to organise and
monitor faster release of new vaccines and treatments and clinical
testing in the population most in need;
38. Stresses that a global strategy for confronting communicable
diseases can succeed only if appropriate and affordable vaccines
and medicines are developed for prevention and treatment;
considers that such a programme requires commitment to finance
the purchase and distribution of these products on a global basis
(as for polio vaccine); recommends that a global fund be established
to target the three major communicable diseases (FFID - Fund for
Infectious Diseases); considers that such an "outcome-driven"
fund, under the aegis of the WHO and UNAIDS, supported by the
EU, G8, the World Bank, the IMF and open to public and private
contributions (public private partnership with NGOs included), can
complement ongoing support to strengthen national health
infrastructures and promote access to medicines and treatment;
considers that allocation to a global fund should be additional to
existing aid efforts and be framed in the context of health as a
global public health good;
39. Acknowledges that there are safeguards within the TRIPS
Agreement to address the imbalance between the protection of
patents - essential for continued research and development of new
products including vaccines - and the right of everyone to access
affordable treatment; acknowledges that compulsory licensing is
already provided for under TRIPS in cases of health emergency and
calls on the Commission and the TRIPS Council to clarify where
Article 31 of TRIPS may be used and to provide a transparent
assessment of the impact the agreement has on access to essential
medicines; notes also that most developing countries are
experiencing huge difficulties in interpreting and making use of the
safeguards;
40. Recognises the role of patents in the development of essential
drugs, and supports the Commission in its view that there does not
necessarily have to be a contradiction between the protection of
intellectual property rights and accessible health care in developing
countries; emphasises, however, that unfortunately this may be the
case in practice;
41. Insists on the instrument of compulsory licensing but requests
the Commission to prepare and then submit to the European
Parliament and the Council, a well-argued proposal for a mandate to
be granted to the Commission which intends to examine and
propose ways and means seeking to review the relevant articles of
the TRIPS Agreement in order to:
(a) reduce the patent protection granted for 20 years and laid down
in the TRIPS Agreement in a number of patented medicines only in
the field of communicable diseases;
(b) specify the conditions under which the practice of
"ever-greening" - i.e. process of introducing "minor changes" to a
patented drug upon expiry - would be eligible;
42. Welcomes the positions recently adopted by all players in this
field on a pro-public health interpretation of the TRIPS Agreement
and emphasises the need to encourage a more equitable sharing of
the benefits of technological development in terms of health
between people in developed countries and people in developing
countries and to support the Commissioner responsible for such
issues in efforts to launch a debate in the WTO on reconciling
TRIPS with objectives regarding health protection in developing
countries;
43. Calls for the establishment of a technical and legal assistance
mechanism within the WTO in order to promote implementation of
the TRIPS Agreement which takes account of the specific public
health interests of the developing countries, and to prevent the
adoption of restrictive legislation in this field;
44. Considers that the setting-up of a WTO working group on
access to medicines, with WHO and UNAIDS participation, must
make it possible to respond to this concern;
45. Reiterates that the TRIPS Agreement allows local manufacture
of generic equivalents of patented medicines in cases of national
emergencies or other circumstances of extreme urgency or in cases
of public non-commercial use without authorisation of the right
holder through compulsory licensing; reiterates also that developing
countries should be encouraged to seek EC technical assistance to
collaborate with appropriate manufacturers to realise cheaper and
wider access to medication and treatment for those in need;
46. Recognises that the basic laws of demand and supply if applied
to countries characterised by limited purchasing power will not be
favourable to attracting the R&D effort of pharmaceutical
companies to develop drugs against communicable diseases;
proposes therefore that the Sixth Framework Programme devote
considerable funding to research into diseases of the poor, and that
cooperative projects with research or public institutes or
private-public partnerships intended to benefit poverty-stricken
countries, should be given priority;
47. Requests the Commission to take the initiative for a proposal
for neglected diseases (such as trypanosomiasis, filariasis, bilharzia
and ebola); considers that this proposal should provide incentive for
the development of drugs and vaccines destined to combat
poverty-related diseases for which there is a limited market;
48. Emphasises in particular the need to guarantee over the long
term increased and reliable financing for R&D relating to "forgotten
diseases" through a public commitment in the form of an
international treaty;
49. Regrets that countries that have made use of the safeguard
clause in the TRIPS Agreement have come under pressure to
withdraw their legislation in this area; considers, on the contrary,
that the Commission and the Member States should defend in the
appropriate fora the right of developing countries to use all the
safeguard clauses provided by TRIPS (compulsory licensing, parallel
importation, generic production of essential pharmaceutical
products, "Bolar" provisions) in the circumstances specified in the
agreement and, if necessary, to request adaptation of the TRIPS
rules in the WHO;
50. Stresses that an appropriate increase in human resources, with
expertise in social and human development, pharmaceutical policies
and procurement, health, education and gender, be made available
to the Commission, including the EC Delegations abroad, for the
Programme for Action to be properly implemented and monitored;
51. Calls on the EU to support the development of substantial,
sustained and efficient global financing mechanisms to enhance and
extend existing funding to improve health in developing countries;
considers that the EU should develop appropriate instruments to
allow substantial contributions to emerging global health financing
mechanisms and that allocations to a global fund should be
additional to existing aid efforts and be framed in the context of
health as a global public good;
52. Instructs its President to forward this resolution to the Council,
the Commission, the WTO, WHO, UNAIDS, the ACP-EU Joint
Parliamentary Assembly, the African Union, the European
Federation of Pharmaceutical Industries and Associations and
relevant NGOs (OXFAM, M�decins sans fronti�res).
------------------------------------------------------------------------
(1) 2304th Council (Development) - Press 421 No. 12929/00.
(2) OJ C 180 E 26.6.2001, p.156.
(3) Texts Adopted, Item 12.
(4) Texts Adopted, Item 13.
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Information and archive http://satellife.healthnet.org/programs/edrug.html
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.