I do respectfully appreciate your narrative style of writing to us to  make highlighting the points of GF implementation Plan of Action. I do  agree with you the characteristics of the youth leadership to be identified and classified categories. I am deeply concerned to have the pleasure to acknowledge your explanation by using UN English standard without entering into jargon languages. Once, again I and my team are willing to respect the e-forum and appreciate inviting us to participate. However, The moderating of the  e-forum has not been clearly understood.  Anyhow, The HIV/AIDS, TB and Malaria are the three disease affecting our socio-economic developments of the developing countries or LDCs mainly, Africa and Asia and Latin America, We must have action plan oriented to combat the diseases.

As of here, the youth organizations have been activity acting to work with the local and UN, INGOs and faith organization, Grassroots, women association to fight against the HIV/AIDS, TB and Malaria which greater number of lives has been threatened as result of these diseases. We have to state that Implementation plan should be done at regional within geographical areas. to consider how best to make country level CCMs to organize workshops aiming to brainstorming how best to play in away which reflects into applicable methodologies at communal levels then country level through, that to regional and global level. this will reflect respecting of cultural diversity of global society and context of every and each social groups.

PEPFAR meeting in Kampala, Uganda in 3 - 7 June, 2008 outcomes and involvement of Global Fund should be intervention points. however, I do suggest hereof making and establishing of regional data base health centers will be very important. Since we divide the stages into two main principles:-

1. awareness and prevention of HIV/AIDS
2. curing and medication bills for HIV/AIDS affects personswe have to act more appropriately.

 Looking forward hearing your responses.

Prof. Jama Abdullahi Sh. Jama

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Dear members of the forum, e- forum facilitators,

-For successful implementation I strongly recommend  independent  body that oversight activities of the of the entire chain using highly qualified staff as was addressed by Fenna  that investigate risk management issues including funding channels , awarding of contracts  , look at QA process , TQM ,UM ...etc , review appropriate fund utilization  . Also, it is important to analyze the places where programs are going to be implemented ans ensure that rural communities benefit from Global Fund Grants for TB, Malaria and HIV that can be used to strengthen and improve Infrastructure. It is important that Global Fund responsible people to perform sight visits and oversight the whole process and ensure participation of wide range of organizations, NGOs and monitoring to be at all levels.

-Strong political commitment is mandatory with  community sensitization  and  orientation at  all levels  eg : national, district ,sub-country  community  levels and NGOs to work in collaboration with community involvement , health system strengthening. Also, to  develop a mechanism of responsibility /Accountability between  CCM and Global fund.

-I support Dr Fareed , Dr. Cleaconscience that strong technical support systems should be established to help countries/organizations that does not  have satisfactory achievements and to educate people how to maximize the the use of their skills and prioritize their efforts.

- As I have a long experience ( 10 years) of regulation of Biological products  and  vaccines within a Drug Regulatory Authority I highly support  implementation of quality aspects at all levels of Global Fund activities to ensure that manufacturers stick to cGMP issues all through the production process  for medicinal product procurement . WHO, FDA, EU  , Swissmedic certification the is deffently important and is  supportive of the selection process  but still need to prove that medicinal product e.g anti-malarial medicinal product is of the required Quality, safety and efficacy, however , I disagree with D. meppiel  as regards the importance of bioequivalence studies.

Data on bioequivalence provide a bridge between two or more pharmaceutical equivalents when safety and efficacy data are available for one of the products, but not for the other. For multisource (generic) products bioequivalence studies are necessary to ensure therapeutic equivalence and interchangeability of the products. Bioequivalence can also be demonstrated by comparative clinical studies, pharmacokinetic studies or appropriate in vitro studies.

WHO Prequalification of anti-malaria drugs is important for International Procurement e.g UNISEF and for help in accelerated registration within local authorities . Prequalification is performed according to unified standards based on acceptable quality , safety and efficacy. Comprehensive evaluation of the quality, safety and efficacy of medicinal product are  based on information submitted by manufacturers and inspection of the corresponding manufacturing and clinical site. It would be advisable to  speed the process especially for serious diseases to prevent an African child is dying due to malaria.

Recommendations to the applicants, who undertake bioequivalence studies and/or who wish to request a waiver of in vivo bioequivalence studies for immediate release solid oral dosage forms.  Guidance explains how the bioequivalence studies should be performed, and when biowaivers can be requested in the context of the WHO Prequalification of Medicines Programme.

 

Major deficiencies in the application Dossier could be related to one of the following : either no bioequivalence study performed and no adequate justification for not performing study, unacceptable reference product, inadequate validation of bioanalytical method. No verification that the test product used in bioequivalence study is identical to product intended for marketing . 90% confidence interval for pharmacokinetic parameters not present (or more generally no adequate statistical analysis). Minor deficiencies may be related  to absence of information on batch size of test product, certificate of analysis is not submitted , in-vitro dissolution profile not submitted for test product or reference or use of  reference of  different strengths of the same product.

 

] Guidelines related to bioequivalence studies , comparator products , Biowaivers implementation ,design of bioequivalence studies, choice of an innovator product for which quality , safety and efficacy are present.

 - I highly recommend coordination of efforts  and activities  between Global fund and World Health Organization to fight Malaria , TB and AIDS/ HIV to avoid unnecessary  duplication . The procurement of prequalified medicinal product would assist in Accelerated licensing  within the procuring country . GF/WHO could facilitate mutual recognition between  different regulatory authorities and tests may not need to be repeated on products provided that it is tested by an independent competent authority. 

 May Farag

Dear Konjit,

You name is a bit familiar with the names of our region; BTW, I’m from Bangladesh. Thanks very much for the kind wards you reiterate about my idea. I really appreciate your deep insight over the GF issues. I’m, indeed, glad to know your idea on institutionalize the GF-capacity building of the PR and SR and supporting the strengthening of civil society and the private sector to become the PR/SR.

I’m also pleased about your inspiration, thinking and reflection in your write up on setting indicator for civil society and private sector participation and bring more stakeholders and partners.

Well, I’ve no difference of opinion, however have you thought about these –

§        Who will do the institutionalize CB (capacity building); the PR or SR or GF? If the PR/SR has the ability of CB the concern would not arise at all, means they are either not willing or not able to. I, to a certain extent, believe that they are not willing to develop their overall capacity since there are certain benefits of the key people of not having the overall ability. Furthermore, living in ‘non-ability’, non competence environment for long time, it far beyond, even, for think of own capacity development by their own. What does all these means? It means we’ll need some agency to develop our capacity; if so, it is not institutionalize at all. Then what to do? Not thinking, no aspiration, no movements etc? No, not at all; we need agencies, as well as thinking ourselves on further development concentrating national efforts on basic developments – like education, media etc. How about a combination? Agency and media (to educate other on 3-disease issue, GF issues, our contextual issues etc) can be a better combination on the capacity building issues in shorter term version.

§        There are too many fallacies with setting the number of indicator. I, already, have concern and reservations on the existing GF indicators. I’ll be discussing in future, if I see interest and fruitfulness of our discussion. Let me concentrate on your point; we can include 10-20 private agencies as PR/SR; keep my share as major and fulfilling GF set indicator, if I wish. Hence, aging the capacity issue came back, capacity of the CCM. Where there is better CCM, better the program is there. What about if not a better CCM? How to judge a CCM is better functional or not? Counting the number of members? How many from different sector?

§        Last but not the least, how do you’ll institutionalize CB?

§        I already mentioned that LQAA has its own potential and the opposite as well. It is not THE perfect solution for solving ALL the concern and problems in the implementation and other issues related with GF; but to greater extent it can resolve many issues attempting the quality attainment.

§        Is it applicable for all? No, it is not. Yes, it is applicable for all. However, the magnitude of responsibility might differ and vary. The GF is thinking to put a shirt on everybody; is it possible? If not, what is feasible and logical? There are modalities, only we need to explore. I can, now, cite quite a few; what is the benefit? The major concern is that how much successful we want to be as GF? Does the GF want to be, at the medium-long run, like other large financing agency with renowned-defame? It is simply up to them. I, only, can put some thoughts, idea, concern, probable solution etc. Seems, I want a job in Geneva with GFATM at P5!! Ha, ha, haaaa……

§        There are many ways of posting the LQAA in the local country or regional context keeping it independent and bypassing the bureaucracy.

§        Accountability of LQAA will only be to the GF and there are ways and means of collaboration with bilateral and multilateral donors that work in the country. Is it very necessary, especially collaboration with bilateral and multilateral donors? What is the uniqueness, then, with the LQAA other than mere an agency that mutually collaborate?

§        The cost benefit analysis of the LQAA is too simple; what matrix do you prefer to judge its cost benefit while I’ll putting the benefits and cost. If I set the weight, I’ll be doing in my way putting all the rationale even referring all the documents of the world! Cost benefit analysis is nothing but a game to win yourself and sale your idea. What I wanted to ventilate is that LQAA is simply simple, will have several immediate benefits, indeed. Nothing else I wanted to mean you all.

Have nice day. Wish you (all other readers) all the best.

The expectation is that Global fund monies are channeled into development programmes through a line of recipients and the results be measured in the standard way, but past experiences have shown that the ultimate goal is hardly appreciated in the target communities for a variety of reasons. It is therefore advised that Global Fund should exercise sufficient oversight of its projects through the establishment of Community or Local Government Area Offices through which the action, inaction and exuberances of grantees would be monitored. It is sad that this sort of close monitoring is still required in a civilized world but it might be worthwhile to set up these offices so that a more objective assessment of progress performance can be made. The cost of running these offices should not deter Global Fund from creating them as evidence abound in favour of a positive cost benefit ratio.This Community/Local Government Area office should be placed under the operational control of persons who are nationals or citizens of a completely different country. Alongside these monitors, the benefiting State and Local Governments should be empowered in the appropriate way to set up parallel ofices to also monitor and report back to Global Fund and the grantees.In the end the different reports should be weighed on the same scale to determine project performance.The Global Fund should restrict itself to the point to point enforcement of grantee proposal and should leave the aspect of community mobilization for service utilization and consumption to the respective Local Governments and District Authorities.

Dear Mariasururu, your comments on the GF to focus on programs that coordinate small projects in the rural areas desreves recognition. Allow me to add some experiences I have in this regard which may be helpful to address our communities in the rural areas. I was managing a project for civil society organization working in rural areas, it was a small scale local organization initiative project, and i can tell you how satisfied I was with the work, helping them to build their capacity, meeting the communities, seeing how they are benefiting. Within two years we have 100 community based organizations (PLWHIV, women, inschool and outof school youth, parents, research and other workds) were funded. Our maximum budget for each organization was USD 15000, and funded only once. All the funds were utilized and some of the income generating activities and the research that has been done was great. The organization now is in the process of documenting the best practices to share and disseminate. There are so many examples of youth associations, women PLWHIV assocations and faith based assocations who utilized the fund effectively and effciently with and for the community they targeted and were able to utilize all the fund. This is the kind of work that the GF should also target and reach. We have representative of the Government, civil society, donor, PLWHIV in the project appraisal committee which appraises the proposal and select for funding, working voluntarily. Believe me it was a great team, the volunteers and the donor and the organization which is implementing. We monitor and evaluate the projects. The external auditing and annual workplan and evaluation shows that 80% have successfully implemented and build their institutional capacity (recruiting project coordinator, computers, printers, faxes, office equipments, trainings) and were able to access other funds which otherwise they were not able, our fund opens their eyes (that is what they said) budild their self confidence. They have done excellent work, reached groups that were not reached before, implemented innovative interventions and are still going on and has mobilzed resources. They become visible and were reached by the Government and by other bilateral and multilateral funders. The GF fund as it has started including civil society as PR has to do more aggressively in supporting the networking organizations of civil society, fund local orgnizations who have the capactiy, assess the situations at the country level through the CCM. The CCM should be overhauled and be able to strategise to really represent civil society and the private secor. Fund and support bilateral organizations who work with civil society and also developming clear targets and indicators for the PR and SR of the number of civil soceity organizations they should support. The GF should have a technical expert that will focus on the inclusion of the civil society and the private sector. Mainstreaming (I am not sure if this is the right word) Gender and civil society withing the GF programs is important if we are going to be successful in fighting the three diseases and achieve the MDG.

GF should pay special attention to programs that are mandated to coordinate small projects in the rural areas. It is important to put in place effective mechanism to supervise some of these programs because you find that most projects from the grassroots level are very much neglected which leads to some of them closing down or those who are more creative and care for the project try to find other means of fundraising to keep the project running. GF should therefore find ways and means of keeping the principal programs on their toes to avoid corruption at the expense of the small grassroots projects which depend on the principal program for their sustainability. It is amazing how some of the grassroots project do tremendous work in the community with very little resources. Therefore, there is indeed a need to supervise the principal programs because more often than not some of them don't live up to their promise of commitment to the project and instead end up channeling the funds to other things other than the original intended purpose. This is an oversight that GF needs to give special attention.

Dear Amzad Ali I found it an innovative strategy-which can be practical to check the quality of the GF programs among others in the national context through LQAA or LQCA. My quieries is regarding the LQAA, I agree that it should be independint body, can be a private sector and should not be representtive either of the Public-Goverhmnment, Private sector nor the civil socielty. The LQAA with the LFA and the CCM are then expected to improve the existing quality interventions as well as the bureacracy and reaching the people on the ground. My reflections and issues are how are the LQAA posted in the national (local) country, is this possible without agreement with the government machinery who will be recieving the GF and should open its account for the LQAA, its accountablity and collaboration with bilateral and multilateral donors that work in the country should also be thought of. In addtion we need to do a cost benefit analysis of the LQAA and whether such a mechansims can be adopted to the national contexts. Allow me to add to your ideas, with my limited experience and observation I really think that although the establishment of an indpendent body for the GF to assure quality of programs is one important area, the other priority I want to add on the sideline is the institutiaonalization of the GF-capacity building of the PR and SR and supporting the strengthening of civil society and the private sector to become the PR/SR-this I believe primiarily influence the input and output and then the outcome and impact of the programs. The GF should set an indicator, if possible a goal of the number of civil society and private sector that are recieving the fund. I reccomend a civil society/private sector rep at the GF level, to see that this sector is getting the GF. Here in Ethiopia, I am pleased in this round that the Network of People Living with HIV/AIDS is one of the PR for the GF, I feel this is great, but we arereally have to focus to bring more stakeholders and partners. Konjit Kefetew-Ethiopia

 

Dear Fenna and all,

Without any introduction let site few words about me although is not easy to say realistically about own self, it is often exaggerated, I would be careful enough! Be sure!

Now, I may like to respond you in relation with the model I’m proposing but will not in one day, dear Fenna. Of course it will require multi-disciplinary professional to develop. I can draft the skeleton, then request other to put flesh on it, that how I work.

Along with LAF, another independent inter-government agent (agency) to be in place to look into quality, assurance of quality, and independent assessment of project, etc for country implementation. We call Local Quality Audit Agent (LQAA). Let we now not discuss who the agent would be but there are reasons and rational for telling such agencies. Immunity, independency, lower overheads, flexible management that can be tailored as per country or regional situation (what UN usually cannot) looking after the interest of the government including the governance issues, partially if not the full.

Let we now concentrate model-1: how it can be??

This would be regionally placed looking after 3-5 countries. Why? Because there are geographical and socio-economic similarities among 3-5 neighboring countries hence there is lot of similarities of the 3-disease pattern, awareness level, practice, constraints, strengths etc. We talked about good practice sharing, civil society, participation, community mobilization (how do we understand this?---community cry and awareness to be translated into involvement  that might lead to participation, and after few more informal stages internalization may arise that would, hopefully, lead to community involvement ---some may call participation is mobilization! Kay, I don’t mind, but what ever the name we put into, do we really understand community participation or stakeholders’ involvement?---for the sake of our job what we do, often not correct and we cheat ourselves) {{after long bracket}} etc to be more streamlined for the FG issues in general starting from the project development up till implementation and attaining its impact, if not, at least outcome, the must. Do you think that the PR or SR or implementer is in the position to impart all these; or the CCM nor the LFA? My answer is NO. Before going to explaining, I rather request you all to participate why it is not (easily and usually) possible by the PR/SR/CCM/LFA? Or you may please mention and explain the rational that these are simply possible by the PR/SR/CCM/LFA. Let we have a healthy debate on Yes and No.</