[Ip-health] German Bundestag on IGWG
Oliver Moldenhauer
Oliver.Moldenhauer@berlin.msf.org
Sun Apr 27 10:42:01 2008
On Thursday the German Bundestag debated about IGWG. There, the
parliamentary factions of the governing coalition of social democrats and
conservatives submitted a motion about the IGWG process. In accorance with
the usual process, it was forwarded to the relevant committees. A final
decision is not expected before end May or sometime in June.
However, as these are the governing factions with more than 2/3 of the
seats, it is going pass with only minor modifications. The opposition
parties have been positive towards it.
The most interesting part of the text is towards the end.
Ciao,
Oliver
___________________________________________
Oliver Moldenhauer
Coordinator Access Campaign Germany
=C4rzte ohne Grenzen e.V. / M=E9decins Sans Fronti=E8res
Am Koellnischen Park 1 - 10179 Berlin - Deutschland
Tel. +49-30-22 33 77 90 (Fax - 88)
mailto:Oliver.Moldenhauer@berlin.msf.org
visit us http://www.aerzte-ohne-grenzen.de
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[Translation: MSF]
Deutscher Bundestag Document 16=
/8884
16th Legislative Period 23 April 20=
08
Germany=92s Global Responsibility in the Fight against Neglected Disea=
ses =96
Promoting Innovation and Ensuring Access to Medicine for All.
That the Bundestag determine:
I The German Bundestag states:
[=85 Here, a part of 4 paragraphs on the description of diseases is left
out to make the translation possible before the IGWG session=85]
Modern medical and pharmaceutical research, particularly in the
private sector, is concentrated substantively largely on product
development and therapy strategies for health problems in prosperous
countries. With increasing enhancement of the share of commercial
research =96 primarily in the pharmaceutical industry, but also in
publicly financed institutes which are increasingly dependent on
commercial uses =96 research and development of effective forms of
therapy are being oriented towards economically lucrative =93health
markets=94, while the diseases of poor countries and poor people are not
profitable for such health research and are therefore neglected.
This also applies to an even greater degree to remedies for disease
recognition (diagnostics) and prophylaxis (prevention), such as
vaccines.
Moreover, new, effective medicines and procedures are, due to the
TRIPS Agreement, subject to virtually a worldwide monopoly of the
patent holders so that they have no imitator competition for long
periods =96 the current patent terms are at least twenty years =96 and are
therefore economically prohibitively expensive for needy sick persons
and their dependants in many regions of this world, although they
could be available and life-saving, on the basis of their production
costs at a fraction of their current prices.
But the developing countries, too, bear a responsibility. Insufficient
research and development efforts and insufficiencies in public supply
are a frequent cause for the fact that access to important medicines
in remains limited in developing countries. A World Bank study has
pointed to the problems of publicly provided drugs in sub-Saharan
Africa. Of every $100 spent by the public sector on medicines, only
$12 worth of medicines actually reach the patient. Moreover,
corruption also has a negative effect on the supply of medicines in
developing countries.
For ethical reasons, too, it is necessary that research efforts and
the development of mediations by the pharmaceutical industry be
determined not only by considerations of prospective sales and market
opportunities, but primarily by the physical needs, especially of the
neediest segments of the world=92s population.
For every AIDS patient who can be provided with anti-retroviral
therapy, at least five new HIV infections are counted. Therefore it is
appropriate to concentrate publicly supported research programmes
primarily on the development of preventative measures and vaccines.
In the area of tuberculosis treatment, too, there are still great
deficits. The range of available tuberculosis medications has not been
expanded over the past twenty years, and is increasingly losing its
efficacy due to the development of resistances. Not only clinical
trials of known substances, but also basic research for new therapy
approaches urgently needs to be undertaken here.
In recent years, financially potent foundations, the joint efforts of
governments and international organisations, private companies and
organisations of civil society have given rise to numerous initiatives
in the area of neglected diseases, with the goal of easing the crisis
faced by those affected, and of finding and closing the gaps in global
health care.
Donation programmes sponsored by business have had a positive effect
on the provision of medicines for AIDS, malaria, tuberculosis and
tropical diseases. For example, the British Department for
International Development (DFID) has confirmed the uniformly positive
results of such donation programmes in the area of tropical poverty
diseases, specifically of programmes in Sri Lanka, Uganda and Zambia
for the control of leprosy, river blindness and sleeping sickness.
Product-development partnerships (PDPs) such as the Global Alliance
for Vaccines and Immunisation (GAVI), the Drugs for Neglected Diseases
Initiative (DNDI), the International Partnership for Microbicides
(IPM), the Medicines for Malaria Venture (MMV), the TB Alliance and
others are working to advance the development of new therapies
urgently needed in developing countries. They are helping to mediate
between the economic interests of individual pharmaceutical companies
and public health interests, and to develop regulatory functions. For
example, such cooperative efforts have pushed the therapy costs for a
complete malaria treatment with the new artemisin combination of
preparations to below one euro in many African countries.
At present, an intensive dialogue about such models of cooperation is
taking place in expert circles. At the same time however, we are also
experiencing intense conflicts regarding the concrete implementation
of the TRIPS Agreement and the exception regulations confirmed in Doha
for the protection of public health which are particularly important
for developing countries.
The WTO declaration adopted in Doha in 2001 on the Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS) and on
Public Health sent an important message that a compromise would have
to be sought between the protection of intellectual property on the
one hand and the needs of health care in developing countries on the
other.
In the autumn of 2007, the Intergovernmental Working Group on Public
Health Innovation and Intellectual Property (IGWG), founded in 2006,
began, under a mandate from the WHO World Health Conference, to
develop proposals for solutions which were to take up the results of a
WHO experts=92 commission on this issue. The continuation of these
negotiations is to be provided this spring; a draft resolution is to
be presented to the World Health Conference in Geneva in May 2008.
However, the efforts to rein in especially infectious diseases through
education, prevention, or vaccines available in quantities appropriate
to the need, are still far too modest! In view of the great power of
innovation of global business structures, it is now important to
provide incentives for development processes such that research into
diseases as well as preventative strategies and vaccines so far
neglected become a worthwhile project for science.
The Federal Republic of Germany has researchers and research
capacities at its disposal which are recognised worldwide and can
serve to help people all over the world and enhance the reputation of
the Federal Republic. The historical commitment of German researchers,
such as Robert Koch, Paul Ehrlich and others, for public health and
for the scientific reputation of our country, justify a special
international responsibility.
II. The German Bundestag welcomes
- The existing commitment of some pharmaceutical companies, which has
contributed to the development of a malaria preparation tailored to
the needs of tropical African countries, or which has, for the past
two years, used the transfer of technology programmes to share their
technical know-how with local companies in developing countries for
the production of a HIV medicines free of charge;
- The fact that the Federal Republic of Germany, through its
parliament and government, was able, during its EU presidency and as
the host of the G8 Summit, to demonstrate that it takes these pressing
challenges seriously. At the G8 Parliamentarians=92 Conference on the
Economic Rewards of Investing in HIV/AIDS Prevention and Health in May
2007, over a hundred MPs formulated firm demands on the governments of
the G8 countries. The Federal Republic has also provided important
financial aid for treatment and preventive programmes for the three
major diseases AIDS, TB and malaria, not least by means of its
contribution to the funding of the Global Fund to Fight AIDS,
Tuberculosis and Malaria, and by the expansion of relevant bilateral
commitments;
- The commitment of the Federal Government for the first European
measure under Article 169 of the EC Treaty, the European and
Developing Countries Clinical Trials Partnership (EDCTP), in which
member countries undertook to jointly promote the development and
evaluation of new vaccines, drugs and other measures for preventing
and combating HIV/AIDS, malaria and tuberculosis in close partnership
between Europe and Africa;
- The efforts of the Federal Government during the IGWG negotiations
in favour of a constructive solution and for the achievement of
progress for developing countries, jointly with our European partners.
III. The German Bundestag calls on the Federal Government
- To encourage pharmaceutical companies to develop alternative pricing
structures which take into account such criteria as large quantities
and lower profit margins, and improve access to drugs;
- To take measures to advance research, the expansion of capacities,
and regional procurement systems, and to help with registration, so as
to facilitate and promote the production of lifesaving drugs by
developing countries;
- To promote, in the context of the major developmental policy goal
=93Health=94, the application of the following measures:
+ a broad spectrum of platforms, including public-private
partnerships, which have the objective of research and
development in the area of poverty-related, tropical and
neglected diseases, and are prepared to cooperate with
corresponding public health initiatives,
+ a simpler and less expensive management of licence agreements
for companies which want to produce necessary medicines in
developing countries,
+ examination of new research incentives,
+ construction of international research instruments to be
maintained on a broad basis through intergovernmental
cooperation, and orientation of research and development of new
medicines against life-threatening diseases towards real needs;
here, the main emphases should be placed where medical research
is the most necessary, and development assistance in the area of
the medicinal supply can be structured more economically on a
permanent basis,
+ at WHO, promotion of the formulation of research priorities on
neglected diseases, along with others;
- To support, within the European Union, amplified funding of research
and development in the area of the neglected diseases in the research
framework programmes,
- To work within the European Union to ensure that EU financial aid in
the context of the existing funding be strengthened for those
public-private partnerships which are active in the research and
development of drugs which are particularly important for developing
countries;
- To work within the European Union and worldwide to ensure that free
access to publicly financed medical research results be secured for
people in the countries of medium and low income;
- To provide support, including political support, to developing
countries, as provided under the TRIPS Agreement, and to make use of
the so-called flexibilities confirmed in the Doha Declaration in the
interests of supply with affordable drugs for life-threatening
diseases. Here, the Federal Government should further ensure that the
Economic Partnership Agreements not result in any stricter application
of TRIPS in the least developed countries: the exception regulations
in the area of protection by pharmaceutical patents which were granted
to the least developed countries should be extended beyond 1 January
2016;
- To continue to constructively support the success of the IGWG
Process in the context of the regular negotiations at the World Health
Organisation, and to regularly inform the Bundestag about the progress
of these negotiations;
- The objective of the contribution of the Federal Government in this
regard should be:
+ to formulate and publicise clear responsibilities and
transparent support structures within the Federal Government for
the fields of work stated herein,
+ to promote such innovations in the area of health which are
relevant for people in the developing countries and have hitherto
been too little investigated,
+ to facilitate needs-oriented access to medicine for people in
developing countries,
+ to establish a priority for research into vaccines and
preventative medicines and non-medicinal strategies,
+ to examine and/or strengthen effective new instruments for
innovation support, along with the incentives provided by the
patent system,
+ to ensure that commitments which are as clear, effective and
binding as possible are made.
--
Dipl. Phys. Oliver Moldenhauer
Coordinator Access Campaign Germany
=C4rzte ohne Grenzen e.V. / M=E9decins Sans Fronti=E8res
Am Koellnischen Park 1 - 10179 Berlin - Deutschland
Tel. +49-30-22 33 77 90 (Fax - 88)
mailto:Oliver.Moldenhauer@berlin.msf.org
visit us http://www.aerzte-ohne-grenzen.de