[e-drug] R&D Appeal calls govts to boost innovation for neglected diseases(2)

["BONFACE FUNDAFUNDA" <bcfunda@hotmail.com>]

E-DRUG: R&D Appeal calls govts to boost innovation for neglected diseases(2)
------------------------------------------------------------------

   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 naïve.

   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>