[e-drug] R&D Appeal calls governments to boost innovation for neglected diseases

e-drug
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E-DRUG: R&D Appeal calls governments to boost innovation for neglected diseases
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Sign up NOW to urge governments to support R&D for neglected diseases
on www.researchappeal.org

DNDi and its Founding Partners*, have launched a call to governments to boost innovation for neglected diseases, in association with Oxfam GB, and the BIOS Initiative Australia. (Text of the appeal below). Government leadership is urgently needed to set global public health priorities, fund the R&D gaps, and stimulate R&D for neglected diseases.

Too many people die from lack of drugs for diseases such as AIDS, malaria, TB, as well as the most neglected diseases like sleeping sickness, Chagas disease and kala azar. They die needlessly. The profit-driven model cannot or will not develop new, improved drugs for them. Who will? Scientific knowledge exists to develop new treatments, but the political will does not. How long can we rely on generous philanthropic efforts to support R&D projects? DNDi urges governments to act now.

The R&D appeal marks the start of a year long campaign to collect signatures to present to member states at the WHA in 2006. Eighteen Nobel laureates and numerous scientists, physicians and policy makers have already put their name to the appeal.

We urge you to sign up at www.researchappeal.org and please forward to others to sign.

Your support is critical to the lives of millions suffering from neglected diseases.

APPEAL TEXT:

<BOOSTING INNOVATION FOR NEGLECTED DISEASES>

Call to governments to provide significant and sustained support to bring essential new drugs, vaccines, and diagnostics to people suffering and dying from neglected diseases
* Every day over 35,000 people die from infectious diseases such as AIDS, malaria, tuberculosis, and most neglected diseases such as leishmaniasis, Chagas disease and sleeping sickness.

* These diseases affect hundreds of millions, yet we lack safe, affordable, effective, field-adapted vaccines, diagnostics, and drugs to tackle them.

* Between 1986 and 2001, global funding for health research rose from $30 billion to US$106 billion, but progress towards new health tools for the poor remains insignificant.

* Of 1,393 new medicines approved between 1975 and 1999, only 1% was developed for tropical diseases and tuberculosis.

* Basic science about infectious diseases exists and biomedicine is developing extremely fast, but without political determination this progress cannot be used to develop essential products.

* The profit-driven model of drug development is not suited to developing essential health tools for neglected diseases.

* Current regulatory practices are poorly adapted to assessing the therapeutic advances of new drugs, vaccines and diagnostics for neglected diseases.

* Higher levels of intellectual property protection have not resulted in increased drug R&D for global health needs.

In the last few years, this health challenge has spurred global awareness and some commitment from the international community. A number of developing countries have been strengthening their capacity for new health technologies, and their role will be increasingly critical. Not-for-profit entities have been established to accelerate innovation for neglected diseases. They are beginning to build a pipeline of projects in response to the real needs of neglected patients. These product development partnerships act as "virtual" laboratories, working collaboratively with public research institutes, universities, and pharmaceutical and biotechnology industries. However, the majority of these entities are mainly funded by philanthropic organisations and individual donors. The response remains insufficient with only marginal involvement by wealthier governments.

There is an urgent need to correct the fatal imbalance of the current drug development model. Governments must take responsibility for global public health.

New models and financial mechanisms must be pursued. Determined policy action is needed to direct health-needs driven R&D and harness collaborative R&D initiatives. This will ensure that initial progress is translated into improved, affordable and field-adapted drugs and diagnostics that can reach patients most in need.

We urge governments to provide

* Political leadership - Make global health and medicines a strategic sector and set R&D priorities according to the needs of patients. Only then can the world achieve the Millennium Development Goals that envision - among other things - significant progress in combating HIV/AIDS, tuberculosis, malaria and other neglected diseases.

* Sustained financial support - Governments rich and poor, as well as inter-governmental organisations should provide, on a sustainable basis, US$ 3 billion a year needed to reach an appropriate level of health research for diseases of the poor. To secure long term success new funding mechanisms should be designed.

* New rules to stimulate essential health R&D - Redirecting today's knowledge and scientific expertise to neglected needs will mean a substantial shift in the way essential health products are valued, financed and made available. A new enabling framework should include access to knowledge, chemical compounds, and research tools protected by intellectual property rights. Technology transfer and research capacity strengthening in disease-endemic countries should be at the heart of the endeavour. In addition, regulatory approval processes must be streamlined in order to rapidly deliver essential medicines to patients. The risks and benefits of each drug or vaccine must be assessed in relation to the needs of patients, the severity of the disease, and available treatments and vaccines.

Without bold, new steps, disease will continue to ravage the developing world, with global consequences. Governments should act NOW.

Initial Signatories

Appeal Partners
* Nirmal K. Ganguly ( Indian Council of Medical Research, India);
* Rowan Gillies (President, Médecins Sans Frontières International);
* Richard Jefferson (Director, BIOS Initiative , Australia);
* Davy Koech (Director, Kenya Medical Research Institute , Kenya);
* Philippe Kourilsky (Director General, Institut Pasteur , France);
* Ismail Merican (Director General, Ministry of Health, Malaysia );
* Paulo Buss (President, Oswaldo Cruz Foundation , Brazil)
* Barbara Stocking (Director, Oxfam GB)

Nobel Laureates
* Pierre-Gilles de Gennes ( Physics 1991);
* Shirin Ebadi ( Peace 2003);
* Adolfo Perez Esquivel ( Peace 1980);
* Dario Fo ( Literature 1997);
* Nadine Gordimer ( Literature 1991);
* Roger Guillemin (Physiology or Medicine 1977);
* José Ramos Horta ( Peace 1996);
* Mairead Corrigan Maguire ( Peace 1976);
* Médecins sans Frontières ( Peace 1999);
* Rigoberta Menchú Tum ( Peace 1992);
* Sir Paul M. Nurse (Physiology or Medicine 2001);
* Sir John E. Sulston ( Physiology or Medicine 2002);
* Desmond Tutu ( Peace 1984);
* Betty Williams ( Peace 1976);
* Jody Williams ( Peace 1997)
* Gunter Grass (Literature 1999)
* Stanley B. Prusiner (Physiology or Medicine 1997)
* Prof. Rolf.M. Zinkernagel (Physiology or Medicine 1996)

Scientists and Physicians
* Kirana Bhatt (Department of Medicine, University of Nairobi, Kenya);
* Leigh Bissett (British Medical Association, UK);
* Pierre-Etienne Bost (Deputy Director, Institut Pasteur, France);
* Yves Champey (Chair, DNDi Board of Directors, France);
* Simon Croft (R&D Director, DNDi, Switzerland);
* Alan Fenwick OBE (Chair of Tropical Parasitology and Director Schistosomiasis Control Initiative, Imperial College London, UK);
* Peter Folb (Medical Research Council, South Africa);
* Silvio Garattini (Director, The Mario Negri Institute of Pharmacological Research, Italy);
* Lalit Kant (Deputy Director General, Indian Council of Medical Research, India);
* Helen Lee (Chief of the Diagnostic Development Unit, University of Cambridge, UK);
* Stephen Maurer (Goldman School of Public Policy, Berkeley University, USA - Tropical Disease Initiative);
* Carlos Morel ( Scientific Coordinator , Oswaldo Cruz Foundation, Brazil);
* Visweswaran Navaratnam (Clinical Pharmacologist, University of Science, Malaysia);
* James Orbinski (Munk Centre for International Studies, University of Toronto, Canada);
* Bernard Pécoul (Executive Director, DNDi, Switzerland);
* Bennett Shapiro (former EVP and Head of Research, Merck & Company, USA);
* Richard Smith (Board member, Public Library of Science and former editor BMJ, USA);
* C. P. Thakur (Former Union Minister, Ministry of Health and Family, India);
* Julio Urbina (IVIC - Venezuelan Institute for Scientific Research, Venezuela);
* Nick White (The Wellcome Trust Mahidol University Oxford Tropical Medicine Research Programme, Thailand);
* Dyann Wirth (Harvard School of Public Health, USA) ;
* Yongyuth Yuthavong (Senior Researcher, NSTDA-National Science & Technology Development Agency, Thailand)
* Nubia Boechat (Director of far Manguinhos, Brazil)
* Paul L Herrling (Head of Corporate Research, Novartis)

Others
* Giovanni Berlinguer (Member of the European Parliament -MEP-, Committee on Public Health);
* John Bowis (MEP, Rapporteur on neglected diseases);
* Dorette Corbey (MEP));
* Eduardo Galeano ( Uruguayan journalist, essayist and writer);
* Thomas Gebauer (Executive Director, Medico International);
* Paul Hunt (UN Special Rapporteur on the Right to the highest attainable standard of health );
* Glenys Kinnock (MEP);
* Stephen Lewis (UN Secretary General's Special Envoy for HIV/AIDS in Africa
* Ney Matogrosso ( Brazilian singer and songwriter);
* Luisa Morgantini (MEP, President of the Development Committee);
* Mary Robinson (former President of Ireland, former High Commissioner for Human Rights - Executive Director, The Ethical Globalisation Initiative ) ;
* Viviane Senna (President, Ayrton Senna Institute),
* Susannah Sirkin (Deputy Director, Physicians for Human Rights);
* Ismael Serageldin (President MURS International);
* Carl Schlyter (MEP, Co-chair of the Economic Committee of ACP-EU Parliamentary Assembly);
* Walter Veltroni ( Mayor of Rome and 2004 World Mayors finalist for Europe

*Kenya Medical Research Institute, Indian Council for Medical Research, Oswaldo Cruz Foundation Brazil, Malaysian Ministry of Health; Institut Pasteur; Médecins Sans Frontières.

Jaya Banerji
Communications Manager
Drugs for Neglected Diseases initiative
1 Place St Gervais
1201 Geneva, Switzerland

Tel: +41 22 906 9230/34 (direct)
Fax: +41 22 906 9231
jbanerji@dndi.org
www.dndi.org

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   Friends,
This call to support renewal of effort for neglected disease raises a few concerns:

Definition of neglected disease:

   What do we mean by neglected diseases? I would not refer to HIV/AIDS,
   malaria, TB, as a neglected diseases, given the publicity these areas
   enjoy worldwide. I would agree that sleeping sickness, Chagas diseas,
   Kala Azar, even cancer (especially in children) probably enjoy less
   profile than HIV/AIDS.

The nature of research and development:

   At the basis of this discussion is the assumption that R&D is easily
   possible for any disease area (neglected or otherwise). Secondly that
   governments (developed or not) can make a moral standard point that
   would compel R& D to focus on these diseases. My view is that govt can
   contribute to that process, but the driver remains potential for
   profit and recognition. Furthermore, we should not discount research
   process: Expect to take time, a very long time, as weve seen with the
   malaria vaccine. No one wants to present a product without complete
   confidence (think about liabilities, etc).

Political determination and spending on research:

   Governments have to demonstrate that they are attempting to address
   weak areas of health care like sleeping sickness. If governments do
   not make a demand on themselves to address these diseases, I do not
   believe donors, for all their good will, should be expected to make
   that judgement call. Once governments make their position and
   commitments clear, donors would be ready to support that commitment
   and to fund all areas of healthcare services, as long as governments
   take the responsibility and the leadership. The difficulty we have is
   that donor funds tend to be earmarked to specific programmes (eg, TB,
   HIV/AIDS, Malaria, Bed Nets). But donors are not blind to expressed
   need, and are expecting governments to demonstrate good judgement in
   deciding what problem areas to focus spending on.

   The report sites US$ 3 billion a year as required to be spent on
   research per year. I do not have information on hand to argue to argue
   for or against that budget, but Id imagine that even that sum of money
   may be a drop in the ocean.

Profit- Driven model for drug development:

   I believe it is stretching the point to suggest that this model for
   research is not suited to developing essential health tools for
   neglected diseases. All good and morally nice reasons that one might
   think of will not pay for what is one of the most demanding and
   resource- intense areas of pharmaceutical/ medical research. I
   recognise that research science will follow where the money is being
   spent. If government and donor funds are set aside to address the
   neglected diseases, science will be sufficiently challenged to focus
   on those diseases for drug development. Look at the interest in
   drawing up a vaccine against HIV.

   At the root of pharmaceutical/ medical research is the need to provide
   a treatment for illnesses that challenge humanity. That goal sits
   comfortably well with the (individualistic) prospect of recognition
   and profit, that one can expect from success for what is usually a
   private endeavour. To assume that removing the profit- element from
   research would result in the same level of interest specifically from
   the well- resourced research centres is, in my view, rather na�ve.

   Governments can do certain things: Create an enabling environment to
   support such research (including appropriate funding to universities
   and research institutes); focus resources (people and funds) on those
   diseases, and show that govt is adequately concerned about those
   areas; thirdly, ensure donor funds are raised and earmarked to support
   services for neglected diseases (eg, govt and professional advocates
   can bring these neglected disease areas to the same profile as
   Malaria, HIV/AIDS. Look at what LIVE AID has done as a contribution to
   the Debt Relief debate).

New rules to stimulate research and development:

   The report writer suggests that new rules should be set in motion to
   ease access to knowledge, chemical compounds and research tools
   protected by intellectual property rights. I do not believe it would
   work to force this process, which is easily handled through enterprise
   arrangements. There is sufficient evidence on record showing how
   poorly such state engineered ventures have faired globally. I would
   support an enabling environment that would encourage patent / product
   licence holders to enter into ventures with research institutes and
   companies that are based in developing countries, and over time
   leading to technology transfer over time.

Streamlined regulatory approval processes:

    My reading of this suggestion is that it would be of great benefit to
   all developing countries to have unified regulatory processes that
   would ensure and enable (new) drugs are subject to acceptable
   regulatory process at a central / regional location, leading to those
   drugs being simultaneously (rapidly) made available to the public in a
   number of affected countries. This idea has been discussed in this
   forum in respect to ARVs being subject to different national
   regulatory processes. In that debate (ARVs), my contribution was
   focused on stressing the purpose of drug regulation, which is to
   protect public health and safety in respect to clinical trial phase as
   well as post marketing phase.For that reason, national regulatory
   processes are necessarily different, being based upon national laws
   and regulations, directly linked to the purpose of protecting their
   citizens. This is a role one country, let alone an
   organisation, cannot assume for another. And that is why WHO Pre
   Qualification project is not a regulatory office, but plays an
   advisory, guidance role. What can be outsourced is the actual analysis
   of product quality. In many cases, I would imagine governments would
   want to interpret the results to ensure ownership. So, national
   frameworks for public safety need to be respected and strengthened.
   Some form of regional / global pre- qualification, quality control
   system can be agreed upon, but it would not and should not replace
   national responsibility over public safety.

   To apply a risk- benefit scenario to drug regulation is also rather
   simplistic. Governments, like industry, are liable for public safety,
   and need to be supported in ensuring that they do not release to the
   public products that may be harmful. Therefore, I would urge extreme
   caution, and advice against the suggestion or view that drugs,
   specially these new and complex molecules, can simply be released
   without national due process or diligence.

   In conclusion, I do support calls to focus on neglected diseases, and
   I think we have great opportunity to work with R&D industry, donors
   and indeed the governments. We have to clearly define what these
   neglected diseases are. We also need to accept that R& D. R&D industry
   is able and willing to work in this area, as long as funding is made
   available, and there is clear government and therefore donor
   investment. The mechanism for such collaboration may very much rely on
   governments taking the lead, and donors will follow that lead. In all
   of this, government / national ownership is primary, specifically in
   areas of pharmaceutical regulation, which require recognition and
   support. If these elements are missing, some of us may find it
   difficult to support this new call to support focus in neglected
   diseases, let alone sign the appeal.

   Regards,
Bonnie
Bonface Fundafunda PhD, MBA, B.Pharm(Hon)
Birkevej 32, Tranegilde Strand,
2635 Ishoj,
Denmark
"BONFACE FUNDAFUNDA" <bcfunda@hotmail.com>

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Dear Bonface Fundafunda:

I read with interest your contribution on neglected diseases and IP.
However, the comment: "I do not believe it would
work to force this process, which is easily handled through enterprise
arrangements" requires some consideration. It suggests that the market
is able to resolve the issue under discussion - the appropriate
allocation of R&D resources to neglected diseases. I maintain that the
market has failed and is therefore unable to resolve the distributional
inequalities of R&D resources. The problem is the failure of governments
in developing countries to intervene. I posit that the "enabling
environment" discussed below must be facilitated by a firm
government-led intervention in partnership with the local industry and
international players. Moreover, I do not believe that technology would
be transferred spontaneously without an incentive. Rather, well designed
contractual arrangements that remain sensitive to the economic
development needs of a country is what is needed.

Regards

João L. Carapinha

Director
Pharmaceutical Economics and Policy Program
Department of Pharmacy and Pharmacology
University of the Witwatersrand
Johannesburg, South Africa
www.wits.ac.za/pharmacy/practice

Tel: +27 (11) 7172269
Fax: +27 (11) 6424355
"Joao Carapinha" <carapinhaj@therapy.wits.ac.za>