[Ip-health] Charles Clift on behalf of Ruth Dreifuss address to the IGWG

[Ellen T HOEN]

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Presentation to IGWG =E2=80=93 Charles Clift on behalf of Ruth Dreifuss=E2=
=80=93 4 December=0D
2006=0D
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1.      It is my honour to be asked to present to the Intergovernmental=0D
Working Group the report of the Commission on Intellectual Property Rights,=
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Innovation and Public Health.  Before I begin I should point out that the=
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resolution which set up the working group was a negotiated amalgamation of=
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two draft resolutions - one proposed by the WHO secretariat based on the=0D
CIPIH recommendations and the other proposed by Kenya and Brazil. So this=
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group needs to consider the recommendations of the CIPIH alongside the=0D
proposals contained in the Kenya/Brazil resolution.=0D
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2.      It is also a somewhat daunting task.  The Commission=E2=80=99s repo=
rt is=0D
both long and difficult to absorb without considerable effort.  It is not=
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therefore a simple task to convey all its messages in a short presentation.=
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3.      It is also no secret that it was difficult to get a complete=0D
consensus both on the analysis contained in the report and on its=0D
recommendations.  As Secretary of the Commission I can tell you this was=0D
not for want of trying!  At one point, a member of the Commission referred=
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to our task in seeking consensus as the labour of Sisyphus =E2=80=93 the fi=
gure in=0D
Greek mythology who was condemned by the gods to roll a huge rock up to the=
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top of a hill only to see it fall back down again and to repeat this over=
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and over again =E2=80=93 a symbol of fruitless and never-ending labour.=0D
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4.      However =E2=80=93 the labour in this case did end =E2=80=93 at abou=
t the tenth trip=0D
up the hill.  And it was not fruitless.  In spite of the diversity of views=
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and perspectives amongst its members, the Commission, in the words of its=
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Chair Ruth Dreifuss, accepted the =E2=80=9Creport as a solid contribution t=
owards=0D
continued international dialogue, and progress towards the objectives for=
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which the Commission was established=E2=80=9D.  The fact that WHO member st=
ates=0D
decided to set up this Group at the World Health Assembly this year is one=
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testimony to this.  As Ruth Dreifuss also said in her preface to the=0D
report, the experience of the Commission reflects the reality of the wider=
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world:=0D
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=E2=80=9Cfinding a way forward depends on overcoming differences in the roa=
d to=0D
take. Even so, I am persuaded that the time for action is now favourable,=
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and the need urgent.  Never before have the same possibilities existed to=
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address the problems of public health of the developing countries, and more=
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particularly of their poor populations: heightened international=0D
consciousness, the possibility of additional financing for development, new=
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scientific advances and new institutional forms, such as public=E2=80=93pri=
vate=0D
partnerships.  Each one of these four elements is essential, and=0D
interdependent.  If one of them suddenly weakens, the current momentum,=0D
still insufficient, could be lost.  It is in the hope of contributing to=0D
this synergy that we submit our report to the World Health Organization,=0D
which we hope will carry this beacon forward.=E2=80=9D=0D
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5.      Because of the complexity of the innovation process, the Commission=
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thought it necessary to look at the bigger picture.  Even if its mandate=0D
referred principally to intellectual property rights, it felt it had to=0D
examine also the many other factors that contribute to innovation for the=
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improvement of public health in developing countries.  It sought reasons=0D
why, in spite of a greater effort in recent years, R&D has not yet produced=
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the results hoped for, or even expected, for poor people in developing=0D
countries.  It therefore placed this issue in a broader perspective,=0D
including for example regulation and the determinants of access to new as=
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well as existing medicines, as well as the importance of political=0D
commitment, in both developed and developing countries, in promoting=0D
innovation and access.=0D
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6.      Its terms of reference made it clear that the focus of its enquiry=
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should be the development of new diagnostics, vaccines and medicines to=0D
treat diseases which disproportionately affect developing countries.  It=0D
quickly concluded, however, that innovation was pointless in the absence of=
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favourable conditions for poor people in developing countries to access=0D
existing, as well as new, products.=0D
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7.      For too many conditions either adequate products for treatment or=
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prevention of diseases do not exist or, if they do, they are not accessible=
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to poor people.  The price of medicines is an important factor in=0D
determining access, whether the purchasers are poor people themselves as in=
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so many developing countries, or indeed where the purchaser is the=0D
government.  This is true even in developed countries.  But medicines or=0D
vaccines have also to be available and acceptable to people who need them.=
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Poverty and the lack of infrastructure for delivering health care to poor=
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people are obviously of critical importance in this context.=0D
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8.      The framework for the Commission=E2=80=99s report was the innovatio=
n=0D
process which it categorized sequentially as discovery, development and=0D
delivery.  It then considered specifically how to foster innovation in=0D
developing countries and how one might move towards a plan to promote=0D
sustainable innovation and access for products required to prevent,=0D
diagnose and treat diseases which disproportionately affect developing=0D
countries.=0D
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9.      The detailed recommendations are many, and are listed in the report=
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and in the document A/PHI/IGWG/1/2.  Like the report, the recommendations=
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are wide-ranging and directed at different stakeholders including=0D
governments, industry, the WHO and other organisations.  It would be=0D
inappropriate here to consider here in any detail these recommendations =E2=
=80=93=0D
rather they should form, as the report proposes, a menu for consideration=
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by governmental and non-governmental stakeholders.  It is important to note=
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that although the member states of WHO have established an=0D
intergovernmental working group, the Commission was quite clear that=0D
progress depends on involving major non-governmental stakeholders whose=0D
role may be almost as important as that played by governments.  One thinks=
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particularly of the role played by charitable foundations, by industry, by=
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NGOs, by product development partnerships and by a range of international=
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organisations (in setting standards, or as providers of finance).   As the=
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IGWG seeks to develop a global strategy and plan of action, the active=0D
involvement of these stakeholders will be crucial to success.=0D
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10.     Rather than describing the detailed recommendations in the body of=
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the report, it is appropriate to concentrate on the central findings of the=
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Commission, and what it considered might constitute components of a plan of=
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action.=0D
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11.     The Commission found that in industrialized countries there is an=
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innovation cycle in biomedical R&D that is, to a large extent,=0D
self-sustaining.  The incentive for R&D in the private sector is the=0D
existence of a large market for health-care products supported by both=0D
public and private demand, and underpinned by protection of intellectual=0D
property which allows companies to capture financial rewards from=0D
innovation.  The market-driven R&D process in the private sector =E2=80=93 =
in=0D
pharmaceutical and biotechnology companies =E2=80=93 is supported by a subs=
tantial=0D
upstream research effort, funded principally by the public sector, in=0D
universities and public-sector research organizations.  The innovation=0D
cycle is thus completed because there is a feedback mechanism which through=
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a market process links the needs of patients to the incentives for R&D in=
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the private sector.  Of course, there is much debate about how effectively=
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this feedback mechanism works within developed countries, and this debate=
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was reflected in the Commission (for instance, in relation to the issue of=
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incremental innovation).=0D
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12.     However, this conjunction of positive conditions is generally not=
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present in low-income countries.  The innovation cycle is not=0D
self-sustaining.  Upstream research capacity is generally weak or=0D
non-existent, except in a few mainly large technologically advanced=0D
countries.  Many do not have sufficient resources to invest in public=0D
sector research, or a private sector with innovative capacity. Markets for=
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products are usually small and health services underfunded.  In those=0D
circumstances, the incentive effect of intellectual property rights lacks=
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efficacy.  Developing countries are therefore largely dependent on the=0D
products of innovation designed principally to meet the health-care needs=
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of developed countries.  In some cases these products meet their needs if=
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funding is available (for instance, in the case of vaccines against=0D
universal childhood illnesses, or antibiotics) but in others, no treatments=
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are available for prevalent diseases or are not adapted to the special=0D
conditions relating to delivery and compliance in developing countries.=0D
Also existing medicines, whether patented or not, are often too costly in=
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the poorest settings for patients paying out of pocket, or for governments=
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purchasing for public health programmes.  Thus, current government policies=
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and company strategies including incentive and funding mechanisms, both in=
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developed and developing countries, have not generated sufficient=0D
biomedical innovation relevant to the needs of most developing countries.=
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New, and even existing, treatments remain unavailable and unaffordable to=
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those who need them.=0D
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13.     In this context, the Commission quoted Bill Gates who told the=0D
World Health Assembly in 2005:=0D
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    =E2=80=9CPolitical systems in rich countries work well to fuel research=
 and=0D
    fund health care delivery, but only for their own citizens.  The market=
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    works well in driving the private sector to conduct research and=0D
    deliver interventions, but only for people who can pay.=0D
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    Unfortunately, the political and market conditions that drive high=0D
    quality health care in the developed world are almost entirely absent=
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    in the rest of the world. We have to make these forces work better for=
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    the world's poorest people.=E2=80=9D=0D
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14.     Thus the Commission believed that too few R&D resources are=0D
directed to the health needs of developing countries, in comparison to the=
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great need.  In the private sector, companies do not have the incentive to=
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devote adequate resources to develop products specifically adapted to the=
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needs of developing countries, because profitability is mainly to be found=
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in rich country markets.   The great majority of health research funded by=
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the public sector takes place in developed countries, and its priorities=0D
principally reflect their own disease burden, resource position and social=
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and economic circumstances.  The Commission noted an estimate that while=0D
R&D on malaria accounted for just 0.3% of global health-related R&D,=0D
malaria accounted for 3.1% of the global burden of disease.=0D
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15.     In reaching its conclusions on what might be included in a plan of=
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action, the Commission considered a number of examples from within the=0D
health sector and outside it.  For example it made reference to the Global=
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Plan of Action recently prepared by the Stop TB Partnership which provides=
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a costed ten year plan for meeting the objective of halving TB prevalence=
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and deaths by 2015, consistent with the Millennium Development Goal=0D
targets.  It also considered the example of the Consultative Group on=0D
International Agricultural Research, which provides over $400 million per=
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annum (funded mainly by governments and international organisations) to a=
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network of agricultural research institutes.  It should be noted that these=
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examples relate not just to resource mobilisation, but also include=0D
mechanisms for coordination, priority setting, monitoring and evaluation,=
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and advocacy.=0D
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16.     The Commission also provided an agenda of the key issues it thought=
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should be considered in developing a new approach:=0D
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=C2=B7 Identification of gaps in the current coverage of research for disea=
ses=0D
that disproportionately affect developing countries.=0D
=C2=B7 Actions that might contribute to increasing the overall R&D effort o=
n=0D
diseases that predominantly affect the developing world, and improved=0D
priority setting.  For example, recognizing the possible need for increased=
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support for those that currently receive less attention than HIV/AIDS, TB=
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and malaria.=0D
=C2=B7 Providing a sustainable source of funding for public=E2=80=93private=
 partnerships=0D
and other R&D institutions in the field.=0D
=C2=B7 Seeking ways to channel greater funding to research organizations in=
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developing countries in both the public and private sectors.=0D
=C2=B7 Whether common interests of product developers and producers in vari=
ous=0D
areas might be better addressed collectively in areas such as facilitating=
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clinical trials and product delivery.=0D
=C2=B7 Supporting product introduction in developing countries through impr=
oved=0D
regulation, at national, regional and international level.=0D
=C2=B7 Monitoring the impact of TRIPS and the Doha Declaration on innovatio=
n and=0D
access for medicines and other health-care products.=0D
=C2=B7 Measuring performance and progress towards objectives, and monitorin=
g and=0D
evaluation of programmes=0D
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17.     In the end, the Commission decided that it was not for it to set=0D
out a particular strategy, but it did emphasise the urgent need for action=
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to generate more and sustainable funding for R&D to address the health=0D
needs of developing countries, and to engage governments in this endeavour=
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more than has been the case to date.  That is why it called, inter alia,=0D
for a Global Plan of Action to be developed by the WHO.=0D
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 18.  With that introduction, I wish you success in your deliberations.  I=
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 hope they will not be like the labour of Sisyphus =E2=80=93 although there=
 is=0D
 bound to be an element of that.  On the other hand, Albert Camus, the=0D
 famous French writer, wrote in an essay about Sisyphus: =E2=80=9CThe strug=
gle=0D
 itself toward the heights is enough to fill a man's heart. One must=0D
 imagine Sisyphus happy.=E2=80=9D  The name Sisyphus also derives from the =
Greek=0D
 for =E2=80=9Cvery wise=E2=80=9D.  If we can be =E2=80=9Cvery wise=E2=80=9D=
 we will find a way to make a=0D
 real difference to the health of poor people in developing countries.=0D
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 _____________________________________=0D
=0D
 Ellen F.M. 't Hoen LL.M.=0D
 Director Policy Advocacy=0D
=0D
 Medecins sans Frontieres=0D
 Access to Essential Medicines Campaign=0D
 8, rue Saint - Sabin=0D
 75544 Paris cedex 11=0D
 France=0D
=0D
 tel: + 33 1 4021 2836=0D
 fax: + 33 1 40212960=0D
 e-mail: ellen.t.hoen@paris.msf.org=0D
 www.accessmed-msf.org