Drug Quality &Pharmacovigilence &Private Sector &Treatment Bill Brieger | 14 Jan 2010
Counterfeit
BBC’s Focus on Africa has identified Africa as the dumping ground for counterfeit goods. Some are cheap knock-offs of branded luxury goods that consumers know are not the real deal. Electronics are another area where the customer should beware. Others camouflage as the original product with packaging that is indistinguishable from the authentic item.
Toothpaste is a good example where the fake, which retailers call ‘Chinese’ contains a poison known as diethylene glycol which is used in anti-freeze. The retailers sell both products for about the same price, but the incentive for pushing the fakes is profit.
On the genuine product he has made a 13% mark-up, on the counterfeit an impressive 50%. Fair play to him, some might say – after all it is only toothpaste.
But one cannot say ‘it is only medicine’ when drugs are fake. BBC notes that, “According to the World Health Organization (WHO), 30% of medicines sold in developing countries are fakes, and a major problem is that high numbers of government-owned drugs are being illegally obtained and then sold on for profit in the private sector.” BBC worries that …
… with the rising number of direct trade routes between Africa and China, together with porous border controls, outdated legislation and weak enforcement mechanisms, the continent has become fair game for counterfeiters – and the recession has made it worse.
Furthermore, “A UN report published in July 2009 reveals that revenues gained from 45 million counterfeit anti-malarial medicines were worth $438m – more than the annual gross domestic product of Guinea-Bissau.”
SafeMedicines.org keeps an update of fake medicine reports. For example in Ghana, “A citizen brought suspect antimalarial medication to a sentinel site set up by the U.S. Agency for International Development (USAID)’s Drug Quality Information Program (DQI).” This was reported July 22, 2009, and involved a fake of Novartis Pharmaceuticals’ malaria product Coartem.
Researchers at Georgia Tech University shared information on the magnitude of the problem. “The percentage of over-the-counter counterfeit artesunate tablets containing no artesunate apparently increased from 38 to 53 percent in southeast Asia between 1999 and 2004.”
Fake drugs kill directly with dangerous ingredients or indirectly when inadequate or no active ingredients are present. They also may drive legitimate manufacturers out of business. The threat is real and widespread in its impact.
The new funding program, Affordable Medicines Facility malaria (AMFm) aims to enable countries to place quality low-cost antimalarials into the private sector at prices that will supposedly compete favorably with inappropriate and fake medicines. Careful monitoring will be needed to see if this really happens.
Considering the profit margins mentioned above, the fake drugs may still out-compete the subsidized ones. In short, nothing can replace a vigorous drug regulatory system and donors need to strengthen technical assistance to countries to regulatory capabilities actually work.
Coordination &ITNs &Private Sector Bill Brieger | 25 Dec 2009
Keeping up with nets
With the big push to achieve universal coverage of long lasting insecticide-treated nets (LLINs) by the end of 2010, most countries are relying on procurement from a few big companies, most not located in endemic regions. As the Roll Back Malaria Partnership explains:
Rapidly scaling up to universal coverage for populations at risk is critical to achieve the targets of 50% mortality and morbidity reduction by 2010 and a 75% reduction in morbidity and near zero mortality by 2015. The principle of scale-up has been promoted since 2005 by the RBM Partnership. This commitment has been reaffirmed by the UN Secretary-General’s call on World Malaria Day in April 2008 to “put a stop to malaria deaths by ensuring universal coverage by the end of 2010†through the use of vector control and case management tools and strengthening of community-level efforts.
Because most country coverage figures show a major gap in net ownership AND use, the term ‘catch up‘ has been used to describe this massive scale up. For example, the recently released 2008 Nigeria Demographic and Health Survey shows
- 17% of households have any kind of bed net, treated or not
- 12% of children under 5 years of age slept under any net
- 11% of these children slept under an ITN
- 12% of pregnant women also slept under any net
Kenya’s newly launched national malaria strategy documents that in 2007 40% of pregnant women slept under an ITN, as did 50% of children under 5 year old.
These figures are well below the 2010 RBM coverage target of 80%. As the UN concedes, “Nigeria and Kenya (are) two nations which together account for one third of the estimated 1 million deaths worldwide from the deadly disease.” While Nigeria alone is in the process of distributing more than 60 million LLINs by the end of 2010, this feat aby itself will not guarantee achieving the MDGs. As RBM explains …
Even if parasite prevalence falls to low levels, malaria control will not eliminate the mosquito vector, the parasite, or the favorable environmental conditions for transmission in many locations. To keep malaria at bay, countries need to maintain high levels of coverage even in the absence of a large number of cases. Relaxation of control—whether because of the decline in political will, decrease in funding, or some other reason—could lead to resurgence in transmission and to epidemics.
The maintenance phase of intervention is known also as ‘keep up.’ This means replacing LLINs that are damaged or lose their insecticide strength or to provide nets to new members of a population.
RBM has estimated a 4-5 year life-span for LLINs. As Stephen Smith from CDC reminds us, “Long-lasting nets don’t last forever.” Smith cites data from Laos and Ghana that show in field conditions nets may be effective for only 1-3 years. This in part stems from the fact that manufacturers do not guarantee the strength of the insecticide beyond 20 washings. Behavior change to prevent frequent washings has not been easy. Nets are also damaged with holes and tears, and while this does not affect the insecticide potency, it may expose the sleeping person to mosquito bites.
So where are the continuous net supplies coming from to keep up? The New Times of Kigali provides one answer. “Rwanda’s manufacturing giant, Utexrwa has entered into a partnership with German chemical and pharmaceutical giant, Bayer to produce over 70, 000 anti-malaria bed nets.”
This brings another partner to the continent to join A to Z Textile Mills in Tanzania who through and agreement with Sumitomo Chemical have been producing long lasting nets since about 2003. Local production has so far not been able to meet the bulk of the scale up needs for malaria control.
Hopefully local production will be positioned to address the keep up/maintenance needs for nets. This will require coordination between manufacturers, national malaria control programs and the private commercial sector to guarantee a market for nets. This also assumes that WHO’s pesticide evaluation processes is scaled.
Local production is often made synonymous with capacity building. Without a realistic business plan and collaboration among malaria partners, local production may become a disappointment.
Funding &Integrated Vector Management &Private Sector Bill Brieger | 18 Dec 2009
Ghana’s private sector support against malaria
Last week we highlighted the global role of the private sector in malaria control. Today we share some specific country level examples from Ghana.
For the past few years AngloGold Ashanti has been operating a successful pilot indoor residual spray (IRS) program in Obuasi District. The project reported downward trends in hospital attendance and admission due to malaria which were attributed to the twice yearly spraying efforts. Some pilot larviciding was also included.
Based on these efforts US President’s Malaria Initiative working with the National Malaria Control Program and partners began planning to initiate IRS in five northern districts. “PMI expanded IRS from five to six districts, protecting over 708,000 residents,” and is now planning collaboration with Ghana’s Global Fund grant recipients to expand further.
Now Now AngloGold Ashanti is ready “to extend its anti-malaria control to 40 districts in the Upper East and West, Ashanti, Western and Northern regions of Ghana, come January 2010,” as a recipient of Global Fund support from Ghana’s Round 8 Malaria Grant.
Another private partner in Ghana is the Zoomlion Waste Management Company. The Ghanaian Chronicle reports that, “The Volta Region office of Zoomlion Waste Management Company Limited has intensified its efforts to spray gutters, toilets and refuse disposal sites in the districts, as a step to destroying the breeding grounds and resting places of mosquitoes, to curb the menace of malaria.”
While such spraying may be more likely to kill culex species of malaria more than the malaria-bearing anopheles, the effort does show how the private sector can play a direct role.
Another mining company, Newmont, while not providing direct services, does offer health education to “help all those in affected areas prevent the spread of this terrible yet preventable disease,” on its website.
The telecoms giant, “MTN Ghana, a leading telecom company in Ghana, has announced that since its entrance into the Ghanaian telecom market, the company has invested about $2 million in socio-economic development projects in the areas of health and education.” More specifically, as part of its malaria fund and awareness raising efforts leading up to the Football World Cup of 2010, MTN is including Ghana in its target countries.
These examples are not meant to be exhaustive, but to show the different roles the private sector can play at the country level ranging from direct control activities to raising awareness and educating people to protect themselves. For long term benefit, all such efforts need to be coordinated, like the IRS project, with the National Malaria Control Program and its RBM Partners.
Private Sector Bill Brieger | 07 Dec 2009
Private Sector and Health Aid
The BBC reports that, “The UN’s aid chief has said there needs to be a more effective partnership between humanitarian organisations and the private sector.” Sir John Holmes pointed to some examples of private sector response, like after the tsunami in Banda Aceh, he commented that, “We have not yet found ways to engage together systematically and productively. This is inward looking and short-sighted,” especially in some of the ongoing crises like Darfur.
If humanitarian needs are short of responses from the private sector, what of ongoing health and development programs?
For several months from early 2008 the Global Fund featured what they termed “Corporate Champions” on the front page of their website. During the intervening months only Chevron was featured as a champion. Chevron made a commitment of US$ 30 million to the Global Fund at the World Economic Forum in Davos that January.
Product Red was another corporate effort to raise funds through a portion of sales by companies that designated and packaged special red items ranging from shoes to laptops to greeting cards. This effort, launched in 2006, has apparently generated $130 million for HIV/AIDS efforts of the Global Fund.
American Idol is another private source of support. “The Global Fund has been receiving support from ‘Idol Gives Back‘ since 2007. To date, the contribution from the initiative totals US$ 16.6 million.”
The malaria program of GFATM was designated for support from another television program. “Comic Relief in the UK announced that it will contribute £2 million over a two year period to the Global Fund, with funds being directed to support the fight against malaria in Zambia,” in April of this year.
On a continental basis the “MTN Group signed a memorandum of understanding (MoU) in March this year with the Malaria Community, a network of advocacy groups. The MoU gives expression to the commitment the telecoms operator made earlier in the year to combat malaria. Malaria Group consists of Malaria No More, the John Hopkins University VOICES Project and PATH MACEPA Project.”
MTN, while also being a sponsor of the 2010 Foorball World Cup, is involved in the “United Against Malaria” campaign involving national football associations from Ghana, Ethiopia, Ivory Coast, Mali, Tanzania, Uganda and Zambia. Bell, a former Cameroon International goal keeper who is supporting the effort describes his experiences with malaria: “I know a lot about malaria. I could have died before age five. I missed school, I missed practice, and I missed matches because of malaria.”
ExxonMobil’s Africa Health Initiative has been focused clearly on malaria targets and is an active RBM Private Sector Partner. “Since the inception of the Africa Health Initiative in 2000, we have committed over $50 million to support efforts to fight malaria through disease prevention, control and treatment programs.”
RBM’s private sector constituency has been mobilized because it “possesses a breadth of expertise and implementation skills – including delivering products and programmes in the developing world. These skills include innovation, production and distribution at global and country levels. Additionally, many enterprises within the private sector have global reach.
The RBM Private Sector Constituency has included A-Z Textile Mills [Arusha], BASF, Bayer, ENI, ExxonMobil, GlaxoSmithKline, H.D. Hudson Manufacturing Company, Novartis, Procter & Gamble, Sanofi Aventis, Sumitomo Chemical, Syngenta, Vestergaard Frandsen, Medecins Sans Frontiers, the World Economic Forum, Development Finance International (DFI), Phoenix Consulting, Premier Medical Corporation, Rio Tinto, Shell International, Sigma Tau SpA, and TropMed Pharma Consulting.
The Private Sector Delegation (PSD) of RBM provides technical assistance. “The Affordable Medicines Facility for malaria (AMFm) which is hosted by the Global Fund has also been drawing on the vast experience of the PSD to inform its deliberations on co-financing mechanisms and effective delivery of the essential medicines to the target populations.” Members also contribute in cash and kind – supporting malaria efforts where they work, sponsoring innovative demonstration programs, and prividing the malaria commodities that they produce.
The monetary value of private sector support to the global malaria effort may not approach that of large donor programs like the Global Fund, the US President’s Malaria Initiative or the World Bank booster program, but the variety of contributions can provide important lessons that can be adopted by national and donor program efforts.
ITNs &Private Sector Bill Brieger | 02 Jul 2009
Net Channels – are we losing the private sector?
The New Vision reports that, “ALL Ugandans will be given free insecticide-treated mosquito nets, the health ministry has said, adding that their distribution will start in September,” according to government officials. The is is keeping with the United Nations drive to achieve universal net coverage by 2010. Could this approach have any downsides?
Karen Grepin has observed that after free net distribution in Ethiopia, “the private distribution channels that existed before this distribution programs suffered major set backs. No one needed to buy a net anymore, so no one did. Importers stopped importing nets, distributors stopped distributing nets, and retailers stopped selling nets. Selling bed nets was no longer good business.”
Karen is not suggesting that nets should not be provided free, she does feel that, “donor funds (could have) been used to purchase some of the nets from local distributors, using local channels, than the networks might have been saved – even rewarded for their efforts.” Without these local sources, Karen asks how people will buy additional and replacement nets.
This problem gets at the heart of the challenge of undertaking both catch-up and keep-up net distribution strategies. Without alternative sources of net supplies, we may not be able to keep up with need in case donor program money does not flow continuously.
Up until recently net delivery strategies in Africa are categorised as public, private or mixed. Voucher schemes that include a public sector subsidy and private sector distribution are a good example of the mixed. Voucher schemes have never been touted as a solution to universal coverage, but now they are being made redundant by mass or universal distribution.
Campaigns are needed, especially if they can guarantee that people actually use the insecticide-treated nets they receive, but if they kill local business as well as mosquitoes, we have cause to worry. Malaria itself created economic burdens, and we don’t want malaria control to add to the burden. Local net production can benefit from campaigns if governments buy and distribute these local ITNs. Keeping local net production and sales alive can benefit the keep-up strategies, especially in these days of unxcertain economic and donor vitality.
Health Systems &Private Sector Bill Brieger | 02 Feb 2009
Infrastructure, the market and health in Nigeria – any solution for malaria?
“Nigeria (is) one of the emerging countries that is being penciled down by leading global economists and market observers as the most dynamic market driven economies on the African continent,” according to Eze Nwagbaraji reporting in the Vanguard Newspaper. Certainly much of health care in Nigeria is market based.
On the other hand, Salisu Suleiman in the Daily Trust stresses a government role. “… government uses resources at its disposal to provide a number of goods and services, particularly those that may not be efficiently provided and equitably distributed through the market system. They include public goods, and services like education, health, water and power supplies, postal service, police protection, defense etc.”
What really happens? Nwagbaraji describes Enyiogugu, a large city in Imo State, and in particular points out that, “The community health center is a parasite – ill equipped and almost non-functional.” No wonder people look to the private sector for health care. Nwagbaraji suggested infrastructure bonds as a source of financing as well as the possibility of the private sector undertaking the upgrades and managing the results. This may be the way to go since the public sector appears incapable of maintaining infrastructure improvements in places like Enyiogugu to date.
In the short term, where do people get help? Recognizing that the private sector accounts for a very large proportion of malaria treatment, Nigeria’s Global Fund recipients reformulated its Phase Two plan for the Round 4 Malaria Grant to involve patent medicine vendors (PMDs) in selling subsidized anti-malarials. Informally, the Principle Recipient thinks that approximately 20% of PMVs in the 18 target states are participating in the plan.
This PMV approach is a good start. Since we estimate that 50-80% of the people get their malaria treatment from PMVs, this effort may serve as a pilot scheme. Is wider application possible?
Recently the Future Health Systems Consortium held a conference on the role of innovators and entrepreneurs in improving the performance of private providers of healthcare in Abuja, Nigeria. Actual social entrepreneurs presented innovations ranging from training PMVs to appropriate technology for district hospitals, health maintenance organizations for the poor and community involvement to improve health service quality in both public and private sectors.
These innovations must not only be encouraged but taken to scale if the market can truly help Nigerian in need of health care, including malaria treatment.
Private Sector &Treatment Bill Brieger | 19 Sep 2008
Involving the private sector in Uganda, Nigeria
The New Vision online (Uganda) reports that “The Government is to provide Coartem, an anti-malaria drug, to private health units at a subsidised price, the Ministry of Health announced yesterday.” These will be sold at ‘affordable prices‘ according to the ministry.
“Primary health care state minister Emmanuel Otaala said the ministry, in conjunction with donors, would provide the drugs at sh200 per dose for children and sh800 for adults.” Normally Coartem costs “between sh12,000 and sh18,000 in private clinics.” In approximate dollar terms this is a difference between a subsidized rate of US $0.12- 0.48 compared to $7.25 – 10.87.
For implementation the devil will be in the details in terms of procurement and supply chain management (PSM) (public vs private) as well as positioning of the subsidized drugs where existing products may offer the shop owners a greater profit margin.
Nigeria is reframing its Round 4 Global Fund Malaria Grant to include the private sector and provides some lessons about the challenges of dual districution channels for ACTs. The August 2008 grant progress report outlines these issues.
“There was a delay in the approval of the PSM plan because the PR wished to repackage their ACTs in a manner that would differentiate them from those given out by YGC (Yakubu Gowon Center – PR Public Sector), the other malaria PR. That is because SFH (Society for Family Health – PR private sector) is distributing ACT through the private sector with cost recovery and YGC distributes through the public sector for free. As there were no compliant factories in Nigeria, SFH had to change suppliers to one that could package the drugs according to their needs. This delayed the approval of the PSM plan which was finally approved on March 8th 2008. Procurement is now underway andimplementation can begin fully in the next quarter.”
Private sector involvement is crucial for achieving coverage for a number of reasons, least of which are the fact that in Nigeria it was estimated that a monitory of people with malaria get their treatment in medicine shops. One could never
achieve 80% prompt treatment with ACTs only in the public sector. So while the effort is commendable, it is not something that can be embarked upon quickly.
Well thought out logistics and monitoring plans are needed to ensure the subsidized ACTs actually reach their intended population.
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Please note that the World Malaria Report 2008 is now available to download from WHO’s Global Malaria Program.
Funding &Private Sector Bill Brieger | 10 Jun 2008
Awards and Gaps
The Global Business Coalition on HIV/AIDS, Tuberculosis and Malaria has made its 2008 awards to some of the world’s largest corporations. “The HIV/AIDS winners include Viacom (leadership); Standard Bank (workplace); Telkom, (testing and counseling); Intesa Sanpaolo (community philanthropy); BBC World Service Trust (core competence); Xstrata Coal South Africa (community initiative); Johnson & Johnson (women & girls). BD (Becton, Dickinson and Company) receives the tuberculosis award and Exxon Mobil Corporation receives the malaria award.” DHL and Novartis have also received commendations for their malaria work. According to the Kaiser Network, “The coalition is a group of 220 companies worldwide that aim to address HIV, TB and malaria in the workplace.”
In its press release GBC President and CEO emphasized that, “‘The prospects for winning the fight against global epidemics are stronger now than ever before, and these nine companies have shown the world what is possible for business to achieve. Business action is making a critical difference. If we get it right – and our partners are depending on us to do just that – business has the power to reach millions of people in a way that no other organization can. It possesses the skills, resources and influence to achieve otherwise inconceivable outcomes. We need many, many more to make their own contribution.” Contributions range from worker health promotion, to community programs to advocacy efforts to stimulate policy and funding of disease control programs.
Ironically, at about the same time, the biggest coordinated source of finance for the three diseases has decried funding gaps on the horizon. Reuters reported that, “The Global Fund to Fight AIDS, Tuberculosis and Malaria requires another $7 billion to $8 billion to reach its funding goals for 2008, the fund’s executive director, Michel Kazatchkine, said on Monday. ‘The estimated gap, again, this year is around $7 to $8 billion. It is going to increase to $10 to $12 billion in the next two to three years,’ Kazatchkine told reporters at a briefing.”
Governments remain the largest contributors to international efforts like the Global Fund. The business world, as evidenced by the GBC awards, offers hope through innovation and example, but the question remains, can the business community offer more with its “skills, resources and influence” to help close these huge funding gaps?
ITNs &Private Sector Bill Brieger | 03 Jun 2008
Alternative ITN distribution strategies – achieving complementarity
Tanzania has three main ITN distribution mechanisms, the commercial market, a voucher system for subsidized net purchases and free nets distributed during campaigns. Khatib and colleagues found that, “All three delivery strategies enabled a poor rural community to achieve net coverage high enough to yield both personal and community level protection for the entire population. Each of them reached their relevant target group and free nets only temporarily suppressed the net market, illustrating that in this setting that these are complementary rather than mutually exclusive approaches.”
Different distribution strategies reached different groups: vouchers and free nets were more likely to be obtained for young children, while nets purchased at market price were more likely to be obtained for adults. In the study district, “Net use was 62.7% overall, 87.2% amongst infants (0 to1 year), 81.8% amongst young children (>1 to 5 years).” This process appears to have enabled achievement of RBM 2010 targets as early as 2006. Technically since LLINs were not introduced until after the study and some of the ITNs had not been treated in more than six months, the coverage results are not a perfect match for the RBM target, but they do indicate that products can actually be put in place for a large portion of the population.
Another important aspect of the complementarity of the strategies was, “Provision of nets at no cost through the public sector did not compromise the viability of either the voucher scheme or the commercial market.”
While the authors explain that a number of strategies are available to the National Malaria Control Program, it does not appear that the NMCP actually sat down with partners to plan how to achieve coverage using a multi-strategy approach. The results in a way appear to be that of a ‘natural experiment,’ i.e. that it just so happens that three different approaches were in place at the same time in the same district.
We discussed the involvement of the private sector yesterday, and this Tanzanian example reinforces the points made. The challenge is getting partners to sit down together and ensure that coordination happens – that one district does not get only free net distribution while another depends solely on vouchers. Planning is needed to ensure that each strategy reaches its appropriate audience depending in part on service utilization patterns and ability to pay.
Partnership &Performance &Private Sector Bill Brieger | 02 Jun 2008
1000 Days – everybody must buy in
RBM has interviewed the UN Special Envoy for malaria, Raymond Chambers and asked, “What needs to happen now so that Roll Back Malaria targets can be reached by 2010?” He responded, “That gives us a thousand days. We have to get all of our people working in the fields in cooperation with the local ministries of health; we’ve got to work with the manufacturers of the commodities for things like bed nets and medication and get them to have a schedule of delivery; we’ve got to accelerate some of the funding so that we can meet the requirements of the manufacturers of the commodities; and we’ve got to get everybody to buy into one plan. We’ve also got to ensure that plan is most effectively implemented and executed.”
As we have reported, countries like Ghana, Mali and Nigeria have a ways to go to achieve the 2005 targets of 60% coverage with ITNs, IPTp and appropriate case management with ACTs, let alone reach 80% or more. While all three countries have received Global Fund Grants, they have concentrated in large part on the public sector for service provision, and although they thereby reach their GFATM targets, they have problems achieving overall coverage goals.
Mr. Chambers is right, every partner – public, private and non-governmental, as well as the community – must come on board if 2010 targets are to be achieved. Often there is a reluctance on the part of the public sector, who often monopolize GFATM and other donor support, to ignore or look down on the private sector, especially the informal private sector such as medicine sellers. In rescuing its GFATM Round 4 grant, Nigeria came to the realization that the private sector is crucial and for Phase 2 selected an additional Principal Recipient to focus on this neglected component of malaria control.
Scale up to reach 2010 will be a challenge when we have yet to reach 2005 goals. We might have a chance if all sectors are involved in the partnership.