a) All approved projects for Gf be prioritised accross all sectors to ensure that they form part of a single proposal document. In addition, funding should be targeted accross all sectors to ensure that competing sectoral demend are harmonised and their resources are equitably allocated;

 

b) These organisations should identify their sectoral interests that will be used as a guide in targeting their support;

 

c) A standard format for documenting all funding pledged should be developed and applied by all partners;

 

d) All Pledges must be categorised and specific(Not pledged, Partially pledged and Fully pledged) and request for funding should be developed, harmonised and standardised and provision should be inbuilt for linking activities to the funding work such that discrepancies be easily detected and remedial cure undertaken immediately without delay;

 

e) All contributions(financial and other resources) provided by these organisations be costed and consolidated into GF funding totals;

 

f) Negotiation be initiated with organisations enforcing stringent procedures which affect project implementation planning. Arrangements which suit Gf should be negotiated as fas as is feasible;

 

g) The key objective of Gf information systems should be developed to support planning and control of operations at every stage of each GF project's life cycle from inception through to completion. MIS which is required to achieve this should be timely, accurate, meaningful and relevant. The information needs of these organisations are clearly varied and have different purposes. However, the common goal of all participiants is to be able to plan, coordinate and control an array of prospective and live projects for monitoring them. Within this framework, each user's specific information needs should be identified and systems developed to achieve these requirements. GF information requirements be driven by a sectoral activity which can be carried out in any of the organisations. By standard caterorisation of each element of information which is required to plan, co-ordinate and control GF activities, information could be held across all GF projects within a standard database coding structures which would provide ease of consolidation and analysis of performance and hence improved management control and accountability;

 

h) Partner contributions should not be linked to their core business i.e a company that specialised in manifucturing of drugs for HIV should not contribute towards auxilliary activities such as supply of vehicles.

 

i) Salaries, drug trials and experimentations should not be funded under the partner contributions; and

 

j) Professional and consulting services of fees should not be paid to partners contribution in order to overcome tendency leading towards conflict of interest.

From my long  experience  working in vaccine regulatory authority within drug regulatory authority , I would recommend that Global Fund procured Medicinal Drug Products against HIV/AIDS, T.B and Malaria should follow the same procedures used in UNICEF procured Vaccines donated to countries  to  be of assured quality, safety and efficacy from WHO Prequalified Manufacturers (public or private) that are manufactured under cGMP conditions and to be tested by independent competent regulatory authority in order to avoid all forms of conflict of interest.  GF should avoid donated pharmaceutical products that might not conform to international standards as public health concerns are of paramount importance as well as to avoid other donations from organizations that pursue specific religious , cultural or political causes that would question GF impartiality and might be considered as a form of propaganda to such entity that would have negative impact on the programme as a whole .

The same principle should be applied for clinical trials, GF should not participate in clinical trials utilizing medicinal pharmaceutical products as treatment  may succeed or   may not succeed.  Depending on the etiology and  specific disease prevalence  within a specific country; clinical trials are  performed by either  Industry- sponsored , Institutional- sponsored , Government- sponsored or Investigator-initiated clinical research. Guidance on various aspect of clinical research are available from WHO, ICH, CIOSM EMEA, FDA that should be implemented. International Ethics Guidelines should be followed , research is to be  described in protocol, risk identification , benefit risk assessment, review by independent Ethics Committee/IRB,  protocol compliance, informed consent, continued review/ongoing risk benefit assessment , Investigator qualification , records , confidentiality ,privacy , GMP , QS . Data on recruitment, eligibility, informed consent, safety management and reporting should be available. Selection of team members should be based on properly qualified, trained and experienced investigators and study personnel provided that forms of conflict of interest should be avoided..that  the existence of a well functioning pharmacovigilance  system that can monitor adverse events effectively.

In spite of extensive efforts and money are directed towards treatment still there is a rising numbers of more infected people each year, countries should set targets for prevention programmes . In light of the concept that ' Prevention is better than cure ' ; Stopping the spread of malaria requires a combination of effective treatment , through use of effective drugs of assured quality, safety and efficacy as well as spraying households and the use of insecticide- impregnated nets to kill the carrier mosquitoes. As tuberculosis spreads through insanitary and crowded living conditions and through poor nutrition, thus its prevention is linked more closely to improving the socioeconomic conditions, whereas , preventing HIV/AIDS and other STIs is a more related matter to changing the life styles of those affected group of people with unsound relations and prohibit  the use of contaminated needles by intravenous drug  users or prevent  the use of unsafe blood from remunerated donors. Private sector can successfully participate in increasing  public awareness  especially among the youth and to  prevent unsanitary habits of smoking shisha  which might aid in spread of TB that could be a real problem if not properly handled, , training of  medical and paramedical staff ,  perform subsidized testing and counseling which require collaborative efforts from all parties i.e Governmental , Public  & Private sectors , NGOs as well as Religious people  among others..

There is a long list of in-kind-donations. I think GF should restrict the donations within a limited list. By that GF can deal properly with type of donation. GF is financing organasation and disburses funds according to approved action plans. If we want to approve in-kind donations, this means that the GF should change the strategies and methods of work. Receiving funds from nongovernmental organizations should be planned in a way to avoid conflict of interest. Private sector can have an important role in increasing the support to GF. I think this the matter of importance on which the GF should put more emphasis.

Ali As'ad MD,MPH

To,

e-Forun 2008

In preceding discusion,I have detailed standard of conduct for
private companies & potential donors,GF could interact with potential
donor's various form of foundation,campaign,corporate,national govt,
constitutionally formed organisation.
Potential donors should also support international monetary system,
understanding of international liquidity with contribution to GF,
provide exchange arrangement in settlement of international transactions .
In fund raised &spent,finance instrument ,GF should consider
international payment mechanism including suitable instrument of
payments,forreign exchange instrument, convertible monetary units
prevalent in countries& fund recipient country.
GF innovative finance should also understand international liquidity,
international capital movement for fulfill recipient & sub recipient
medium of payment mechanism.
In above process ,ODA(official development assistance & IFT)could
give additional capacity development support to GF specific inter-
national funding mechanism for donors,GF & partners.
GF secretariat could frame specific standard of conduct for restriction of financial contribution,creation of suitable reserves
by using international capital movement,&correct maladjustment in
accessibility between private(pharma,corporate) companies& affected population,public sector inclusion for procurement of products&
goods.GF framework document in general principles has detailed
structure including finance instrument,financial resources,
proposals,& innovative financing.
These structures could consider specific standards of conduct for
international acceptability of GF principles,financing measures,
international business opportunity& elimination of foreign exchange
restriction prevalent in less GNP countries.

Thank you
ASHISH SRIVASAVA
ex-International Marketing
CCM(SEAR-INDIA)81237