Global Health Policy
January 03, 2008
WSJ Columnist's Tepid Endorsement of Vaccine AMC Repeats Some Tired Canards
Posted by Ruth Levine at 11:10 AM
Monday's Wall Street Journal (subscription required) ran a column by Nick Timiraos about the "big obstacles" facing application of the advance market commitment (AMC) - a novel approach in which donors promise in advance to buy a not-yet-licensed product for the developing world, if and when one is created that meets pre-established specifications. (Readers of this blog will know that a couple of years ago I co-chaired a CGD working group which set out the potential merits and practical implementation of an AMC in Making Markets for Vaccines: Ideas to Action and helped to launch the current international experiment.)
Nick concludes with a tepid endorsement of AMCs: "These questions don't mean the experiment is without merit. If it works, it could produce huge societal and economic benefits." But readers might be forgiven for infering that it's hardly worth a try after he first presents a mishmash of genuine obstacles to an AMC success and tired canards that have been addressed by the AMCs many enthusiastic backers. Given WSJ's role as cheerleader for market-driven solutions, it's puzzling and a little disappointing that Nick didn't offer his readers a more balanced picture.
The article starts with an irrefutable fact: getting the pharmaceutical industry to invest precious R&D resources in products for developing countries is hard. If it were easy, it would already be happening - and pharmaceutical executives would be devoting as much effort to filling up the pipeline with vaccines against malaria as they are to finding the next treatment for erectile dysfunction. It's definitely not easy, and every approach that has been tried or is being proposed - from AMCs to pooled patents to public-private research partnership - has to jump over major hurdles.
The article then repeats some oft-heard concerns about AMCs, all of which merit a response:
For one thing, drug companies may not be willing to bet their development budgets on these commitments. Before a deal can be reached, drug makers, donors and recipient countries have to agree on a price and specifications for the vaccine. "Pharmaceutical companies will always be concerned about how reliable those [advance market commitments] really are, whether the plug could be pulled out at the 11th hour," says Peter J. Hotez, a tropical-disease specialist at George Washington University.
Dr. Hotez, one of the greats of international public health, has a good point, but AMCs are not like the vague and often illusory promises we are used to in global health. The commitments have to be legally binding, with an enforceable contract to back them up and a rock solid financing arrangement. These will be drawn up and made public, making it virtually impossible for funders to withdraw support. It's crucial to make the commitments credible, but the chances of a last minute withdrawal from the deal by the funders is close to nil.
Moreover, though advance market commitments were first conceived as a way to spur research and development of vaccines still at an early stage - those for HIV, tuberculosis and malaria, for example, which remain years or even decades away from completion - they may not be well suited for that. Science, not money, presents the biggest hurdles for those diseases, says Adel Mahmoud, the former head of vaccines at Merck. That suggests advance commitments may be better suited to vaccines in the late stages of development, where funding is the biggest obstacle.
There is a role for AMCs at all stages of R&D. Arguably, the earlier commitments are made, demonstrating a potential market for a given product, the more potential they have to affect whatever decisions firms are making about the resources to devote to one project versus another. The scientific pathway is indeed important, as Dr. Mahmoud has repeatedly said, but there must be some relationship, albeit not a proportional one, between the amount of resources devoted to a particular scientific problem and the pace of progress. If this were not the case, why would anyone bother to lobby for more money for research on one diseases or another? I imagine that when he led the vaccine division at Merck, Dr. Mahmoud often heard his colleagues advocate for a particular project, making a compelling case that the firm's investments in more intensive discovery work would pay off in revenues over the long term. Money alone cannot overcome scientific barriers like those faced in development of an AIDS vaccine, but without money the cause surely is hopeless.
Skeptics contend that the pilot project [for a pneumococcal AMC] won't prove that advance market commitments can deliver big scientific breakthroughs because the initiative is targeting a mostly developed vaccine. Such commitments aim for low-hanging fruit, they say, rather than delivering true scientific innovation.
It's absolutely true that no single AMC pilot will "prove" the applicability of the concept for other types of research and financing problems. What the pneumo AMC does have the potential to demonstrate is that donors can make binding commitments, and that firms will agree to a relatively high price up front in exchange for providing a product at a predictable lower price over the long term.
Oxford economist Andrew Farlow argues that the opportunity costs of an advance market commitment are too high. Even if such arrangements save some lives, he says, they will peel away money and energy that could instead go to less-costly treatments for people already afflicted: "You may get your success story, but it's what you'll lose in the process that you might have had." He and others say that more people would be helped by paying for things like measles immunizations, improved water quality and sanitation or mosquito nets in malarial regions.
Dr. Farlow repeats here one of several critiques he has voiced before. The basic idea of the AMC is that a contract would bind the donors, but would not require that they put money on the table at the start of the process. Given the peculiarities of public budgeting in at least some countries (such as the UK) obligations of this type do not "score" against current-year budgets. This means that there is, in fact, no real-world trade-off between spending today and spending tomorrow (or, as the case may be, in 10-15 years). This may be an affront to those who know there is no free lunch, but the reality is that there can be a deeply discounted lunch. Today's funding can and should be used for interventions that save lives today - but there is great value in making a commitment to accelerate progress to innovations that will save lives tomorrow. There may be some opportunity cost associated with the commitment, and in the case of the pilot pneumo AMC some donors may put money into the "pot" early in the process. So the analytic work to figure out whether the AMC is cost-effective has to take that into account - and will. But a sweeping statement about the harmful trade-offs just obfuscates. (For those who are interested, my former colleague Owen Barder has previously posted a more detailed critique of Dr. Farlow's views.)
And while the "pull" funding of the commitments isn't meant to replace research grants and other "push" funding, some politicians have hailed commitments as a silver bullet. That has critics worrying that other policy approaches could be shortchanged.
Politicians have not hailed commitments as a silver bullet. As for whether AMCs will crowd out other approaches: Even the most ardent advocates of AMCs recognize that they will not work in all cases, and there is little question that the search for other creative solutions must and will continue. For example, there has been very rapid and enthusiastic policy endorsement of the idea of providing FDA priority review vouchers to companies that successfully obtain approval for a drug or vaccine against neglected diseases, which was proposed at about the same time as an AMC. Similarly, there is much momentum behind greater funding for public-private partnerships and innovations related to patent regimes. All of this is for the good. As the Wall Street Journal says, "creative thinking will be needed to overcome the world's most daunting health problems."
October 22, 2007
Unusual Business At The WB-IMF Annual Meetings: Investing In AIDS Vaccines R & D
Posted by Nandini Oomman at 02:00 PM
It wouldn't be fall in downtown Washington, D.C. without the sudden swell of black suits emerging from shiny black limousines, road blockades and heightened security that herald the arrival of finance ministers and their entourages from 185 member countries off the World Bank Group and International Monetary Fund (IMF). It's the usual business of "Annual Meetings" to discuss a range of issues related to poverty reduction, international economic development and finance, but what's unusual is the discussion that took place on Friday about financing the R & D of AIDS vaccines:
At the Annual Meeting of the International Monetary Fund (IMF) and the World Bank today, Finance Ministers from India, the United Kingdom and South Africa, gathered in an unprecedented satellite meeting to express their support for an intensified search for new vaccines to prevent AIDS and other major infectious diseases. The ministers agreed that more needs to be done to expand financing for vaccine research & development (R&D). They proposed forming a working group of government representatives and technical experts to explore the optimal mix of financing mechanisms. The working group is to report back to the ministers as early as possible.
Never before has a gathering of finance ministers focused on the subject of R&D for new vaccines. The meeting, called on the initiative of Indian Finance Minister Palaniappan Chidambaram, is a significant milestone. The involvement of finance ministers in the AIDS crisis in the late 1990s was partly responsible for the rapid increase in funding in the early years of this decade, which led to the expansion of new antiretroviral therapies and their availability at affordable prices in low-income nations.
It's unusual for this topic to get attention at such a forum, but it isn't a surprise that the Indian Finance Minister P. Chidambram initiated this gathering. As my colleague Ruth Levine pointed out in a blog post about a whole new world of vaccines, it is not only big, western pharma that is turning its attention toward the growing demand for vaccines, but also emerging pharmaceutical companies in--you guessed correctly!--countries like India. Profit motives aside, the Indian Finance Minister made a reasonable case for increasing investments in the R & D of AIDS vaccines:
Although US$800 million is spent annually on research, AIDS vaccine funding still remains inadequate. The International AIDS Vaccine Initiative (IAVI) and the Global HIV Vaccine Enterprise estimate that about US$1.2 billion is needed per year. "This gap is not going to be filled," said Mr. Chidambaram, "without innovative financing mechanisms, without drastic interventions from our governments and without either committing more public money to vaccine R&D or creating incentives for greater private investments." Among the proposals Mr. Chidambaram raised were greater funding for public-private product development partnerships, such as IAVI, and extending tax credits and fiscal incentives for those investing in AIDS vaccines.
The meeting's outcome: the assembled ministers offered support for the establishment of a working group that will more closely examine the creation of better incentives for vaccine research. With CGD's impressive effort to launch the idea of the Advance Market Commitment many of us will be watching this working group with great interest. For now though, loud claps are in order for the UK for its continued investments in vaccine research (the U.S was notably absent!). Even louder applause for the finance ministers of India and South Africa who have looked carefully at their development needs and have even billed themselves for part of the cost of developing an AIDS vaccine. With the realization that the cost of treatment will continue to grow exponentially, or that sexual behavior is hard to change, finance ministers of two of the most heavily affected countries (in terms of absolute numbers of HIV positive individuals) are stepping in with the strong message from Mr. Chidambram that "health issues such as HIV/AIDS are global problems, and true global collaboration will be needed to get us to the goal of an effective AIDS vaccine."
September 28, 2007
A Whole New World of Vaccines
Posted by Ruth Levine at 06:02 PM
In the "olden days" before the turn of the 21st century, immunization was not exactly headline-grabbing. Fascinating science, yes. One of the fundamental ways to keep children healthy, yes. But the object of intense business strategy-making, a key part of the fight against sexually-transmitted disease, and the focus of glamorous gatherings of the philanthropic elite - not so much. A few recent news items suggest that it's a whole new world. For example:
- In August, the New York Times described the extent to which pharmaceutical companies are banking on profits from their vaccine businesses, rather than from their therapeutic sides. This is a dramatic turnabout, given that the vaccine industry used to be the poor stepsister to the drug business. (We blogged about this phenomenon earlier.) Could it be that Big Pharma doesn't see many blockbuster drugs on the horizon and, after the Vioxx debacle, sees fewer and fewer products that will sell in such large volumes? Perhaps vaccines are among the only remaining products for the masses.
- The October 1st issue of Newsweek features an article on the science and financing of vaccines, with a helpful focus on the often-overlooked challenge of conducting large clinical trials, which are more difficult for vaccines than for most other products. (If you're injecting healthy people with biologically active material, you've got to pay extra-special attention to safety. And in looking for evidence about effectiveness in protecting against infectious disease in a population, the sample size typically has to be much larger than if you're measuring effectiveness of a product to treat people who have already been identified as being sick.) The pilot advance market commitment (AMC) for pneumo vaccine makes a cameo appearance in the article.
- At the Clinton Global Initiative this week, a high-profile panel explored vaccine development, with particular attention to how to expand coverage while at the same time providing incentives for R&D. Of particular note: Suresh Jadhav of the Serum Institute of India was on the panel and brought a powerful message to the assembled members of the global health gang: its not just the multinationals who see the promise of vaccines both for health and for the bottom line - emerging manufacturers are seeing a bright future in this growing market, too. (You can access the full webcast via the Kaiser Family Foundation.)
- In a remarkable display of (mostly) "girl-power," luminaries (including at least two princesses) gathered in Brussels this week to talk about cervical cancer and HPV, with attention to when, where and how to introduce the new vaccine; the HPV vaccine could prevent the deaths of something like 200,000 women in developing countries each year. It's pretty clear that the roll-out of the Merck and/or GSK products will depend on serious commitments from governments and donors, combined with - you guessed it - good demand forecasting. PATH already has a major project underway looking at precisely these issues, and at the CGI Merck just committed to contributing 3 million doses of their vaccine, Gardasil, to developing countries over the next five years.
All this is some combination of well choreographed public relations (of course) and something quite real: To achieve the broadly shared ambitions of better health in low-income countries, there's a growing recognition among donors and developing country governments of the potential of immunization. At the same time, the commercial interests are intensifying, both among Big Pharma and emerging suppliers - and they are carefully watching for potential opportunities to reach both rich and not-so-rich markets. Meaning that maybe there's a chance for genuine win-win solutions (the AMCs and more) to be developed.
September 24, 2007
A Reflection on the AIDS Vaccine Trial: What's the Real Failure?
Posted by Ruth Levine at 04:16 PM
"Disappointing" is the only word to describe the news that sponsors of the STEP study, testing Merck's AIDS vaccine candidate, have discontinued the Phase IIb trial. Interim analyses showed that the product doesn't prevent infection or reduce the presence of HIV in the blood once someone is infected, calling a halt to tests of the most promising candidate in the field. This is clearly a setback in the search for an effective AIDS vaccine, and - like the microbicide trial failure in January - a painful reminder that the virus that causes AIDS is the medical equivalent of Osama bin Laden: an ever-present threat that is diabolically difficult to counter.
This turn of events may add fuel to the argument that an AIDS vaccine is simply impossible to develop. Almost precisely three years ago, Richard Horton, editor of The Lancet, said as much in The New York Review of Books:
Contrary to the predictions and promises of most AIDS experts, the signs are that a vaccine to prevent HIV infection will not be found for, at the very least, several decades to come - if at all. Those responsible for carrying on the global fight against AIDS do not accept this grim outlook, at least publicly. Yet it is a conclusion, based on all the evidence gathered so far, which increasingly defies rebuttal. Until the gravity of this scientific failure is openly acknowledged, a serious debate about how to end HIV's lethal grip on some of the poorest and most vulnerable human populations in the world cannot take place.
But is it necessary to abandon the search for an AIDS vaccine to support the implementation of intensified and expanded HIV preventions programs today? The clear answer is no. We quite obviously need to do better on prevention now and the global community has a disgraceful track record so far; this latest development is just a reminder that we cannot afford to be missing current opportunities. But at the same time we need to continue to encourage scientists to pursue a range of potential vaccine strategies and candidates - striving for biomedical progress in this area as we do in many others where the timeline is long, the risks are great and the potential rewards are very high. The vaccine trial results represent a set-back, but one that is intrinsic to the scientific enterprise.
The real problem is not that too much money is being spent on AIDS vaccine research, but rather that far too little is being devoted to prevention programs at all. There's just no question about the wrong-headedness of under-investing in HIV prevention, and still it persists. Last year, something like 4 million people in poor countries acquired the virus that causes AIDS - more than in 2004. While treatment programs are scaling up at a remarkable rate, with 2 million people now on ARVs, no one seriously believes we can treat our way out of this problem. Despite this, the resources for prevention programs is very low - and shrinking, as a share of total spending. As explained by the HIV Prevention Working Group:
The nature of HIV prevention makes it challenging for prevention programs to attract sufficient funding. HIV prevention is complex and involves multiple interventions that can be difficult to evaluate; the timeframe for HIV prevention is beyond the terms of most political leaders; and prevention success is defined by the absence of an undesirable result, often less compelling than treatment and care programs, which provide demonstrable help to individuals and households to enable them to transition from sickness and vulnerability to good health and security. As monitoring of national HIV resource flows indicates, HIV prevention efforts are consuming a progressively smaller share of HIV expenditures in developing countries.
The disconnect between what ought to be done and what is done is manifested in the US PEPFAR program, which now provides by far the largest share of external support in most of the worst affected countries in sub Saharan Africa. Oddly, PEPFAR is constrained by currently legislation to spend a mere 20% of total resources on prevention - despite the fact that, according to last year's Kaiser Family Foundation Survey of Americans on HIV/AIDS, more than half of the respondents said HIV prevention should be the top priority for US spending. The lack of attention to prevention at the international level simply defies logic.
So when we hear the disappointing news that an AIDS vaccine candidate didn't live up to expectations, to me this seems less like failure than like a speed bump on the road that might, in the end, lead to life-saving new technologies. The real failure is that many of those engaged in the fight against AIDS are not directing more money, skills and political pressure toward developing and expanding the implementation a broad range of HIV prevention strategies today.
July 06, 2007
A Global Call for Informed Decisionmaking on HPV Vaccines
Posted by Jessica Pickett at 10:58 AM
HPV vaccines are the first of several new preventive technologies aimed at adolescent girls - an entirely new market that poses a series of unique policy and finance challenges to developing country governments and donors. As a result, decisions about HPV introduction have been so closely linked to the eventual availability of AIDS vaccines and microbicides that the conversation has largely shifted away from talk of cost-effectiveness and public health benefits (e.g. herd immunity) that are the traditional hallmarks of the global vaccine discourse and assumed the "health as a human right" rhetoric more often associated with the AIDS debate. Thus, within global health circles the discussion is generally couched as a question of how - not whether, when or under what circumstances - to introduce, finance, and deliver HPV vaccines throughout the developing world.
Now, a new coalition is formally adopting this charge. The Global Call to Stop Cervical Cancer, which was launched at the World YWCA International Women's Summit in Nairobi earlier today, "urges governments to prioritize cervical cancer in national development and health budgets, calls on multilateral agencies to ensure accelerated regulatory processes, appeals to international donors to ensure new vaccines and diagnostics are widely available, and calls upon industry to provide adequate supplies of new technologies at radically tiered prices." (See the press release for more details.) By launching the Global Call at a conference focused on HIV and AIDS, the organizers hope to encourage HIV activists and cervical cancer activists to learn from one another and share strategies to expand access to prevention and treatment.
The availability of this impressively effective vaccine seems to have magically brought down the walls of global health silos, but ultimately the adoption and uptake questions should be based on an assessment of the vaccine's own particular benefits (and costs) as an intervention in a given context, and not solely as a preparatory step for future products. One of the biggest hurdles - and current unknowns - is the price of the vaccines (set at $360 per course in the U.S.) and the costs and feasibility of programs to reach adolescents in developing countries. A recent study in the New England Journal of Medicine found that "for countries with a gross domestic product of less than $1,000 per capita, the per-dose cost may need to be as low as $1 to $2 to make vaccination both cost-effective and affordable." With that in mind, then, we need to be careful that we don't put the cart before the horse - or in this case, the advocacy bandwagon before the cost-effectiveness analyses, impact evaluations and other operational research activities that can best inform policymakers as they weigh this important decision. So I propose that the Global Call call for one more thing, too: the systematic generation of practical, credible knowledge that should inform country-by-country decisionmaking about whether introducing HPV vaccines makes sense.
Via Christine Gorman
July 02, 2007
IAVI Looks Ahead at India's Role in the Development and Use of an AIDS Vaccine
Posted by Ruth Levine at 10:10 AM
You can't understand immunization in the developing world if you don't understand what's happening in India. On the demand side, you've got a population of more than one billion and a vaccine market of more than $300 million sales each year. With its significant economic growth and continued population growth, the potential market will only grow. On the supply side, India is home to the Serum Institute, the fifth largest vaccine manufacturer in the world, with sales revenues that are now growing at 35 percent per year; it produces most of the vaccines used in the developing world, including nearly all the measles vaccine used in Africa. Increasingly, India's pharmaceutical industry is undertaking product development as well as large scale manufacture. In short, India's role in the future of immunization will be even greater than it is today.
So, the International AIDS Vaccine Initiative has made a wise choice to focus some recent forward-looking analytic work on AIDS vaccine policy issues in India. Three publications were just released including:
- Accelerating AIDS Vaccine R&D in India: An Assessment of Obstacles and Possible Solutions, which identifies possible ways to enhance the role and efficiency of the public and private sectors in vaccine development.
- Forecasting Demand for Preventive HIV Vaccines in India, assessing the demand for a first-generation HIV vaccine.
- The Introduction of New Health Technologies in India, which takes a close look at what it would take to adopt and implement AIDS vaccines in India.
Interesting reading for all those who are thinking about future health technologies.
June 29, 2007
Insuring the Flu: Vaccines for All?
Posted by Ruth Levine at 01:17 PM
* This post is co-authored by Jessica Pickett
Reuters recently reported that the global health community is beginning to explore potential insurance mechanisms and risk management products to finance pandemic flu vaccines for developing countries, in addition to a new vaccine stockpile supported by GSK and other manufacturers:
The World Health Organization made a unique proposition [at the Pacific Health Summit on June 13, 2007] - what if big donors pooled resources to take out private insurance to pay for vaccines in the case of a bird flu pandemic?
WHO Director-General Dr. Margaret Chan said the organization had been given more preparation time than it could have hoped for ahead of an influenza pandemic [and that] the WHO was using that time to study various financing options to allow poor developing nations to receive vaccines and prevent a pandemic catastrophe that could kill millions of people.
"I am sure the insurance industry can underwrite a policy for that," said Chan, speaking during a panel discussion at the Pacific Health Summit in Seattle. Taking donations to buy vaccines before an outbreak may not please cost-conscious donors, said Chan, but it may make more sense to have organizations donate money to pay for an insurance policy premium.
"Is the world prepared to buy an insurance for an event which is low probability and extremely high risk?" said Chan. "I am not sure it will work, but clearly we need to think outside the box."
Out-of-the-box thinking is certainly what we need, and it's very likely that we are not using possible risk-management methods to their best advantage, but it's not clear that the idea now being floated makes much sense. Aside from the fact that it must seem odd to potential insurers to hear that pandemic flu is a "low probability" from the head of an agency predicting public health doom, there are a few devilish details to think through. For example:
- If such an insurance mechanism were put into place, would we create a situation in which heavy demands would be placed on insurers if and when bird flu emerges, just at the time when a global economic downturn would be inevitable? Ideally, the risk management instrument would be structured so that the global wins and losses would balance; for instance, if donors are unwilling or unable to guarantee purchase of a certain number of units of vaccine, maybe an insurance instrument could be developed for manufacturers that would be provide a pay-out in the event that the demand is lower than anticipated. This would give manufacturers greater ability to invest in scale-up of manufacturing, and only kick-in in the happy eventuality that the vaccines are not required.
- Would we unintentionally undermine the much needed preparatory actions by creating a false sense of security that "we have insurance, it's taken care of"? The problem of moral hazard is a real one, and can act in subtle ways on decisionmaking at both global and national levels. We need to make sure that in redistributing risks we are strengthening the signals to do the right thing, not diluting a sense of responsibility.
- Is the core problem really about how to buy the vaccines, or about how to ensure that a portion of the (limited) manufacturing capacity is set aside for developing country needs, or about whether it's even possible to organize a mass vaccination program for adults in developing countries? The implementation issue is really quite critical because there is currently limited ability to detect early emergence of a problem, and weak infrastructure for vaccine delivery in the places where new strains are likely to emerge. The debates about how to scrape together the money to buy vaccines shouldn't distract from the bigger, more important and more costly challenges about how to build up delivery capacity.
If we're being asked to think "out of the box," maybe the box we should think out of is the "health box." As I wrote in "A Cure for the Asian Flu," we have to look for fundamentally new ways to think about the level and type of resources required to tackle global infectious disease outbreaks. We could think about pandemic flu as a natural disasters, for instance: predictable in that it will happen; unpredictable in that we don't know when or how severely; and when it happens the affected countries will be vulnerable to very bad consequences in part because of the wide ranging economic effects. If we start to think about funding the preparation for and mitigation of pandemic flu in the "disaster box," then we could get together with others who have been exploring revolving funds, insurance instruments and other ways to mobilize resources and distribute risks over time and between those at greater and lesser risk today.
See also: Owen Barder previously blogged about disaster insurance and failure of the public sector here.
June 14, 2007
USG Funding for AIDS Research is No Laughing Matter
Posted by Jessica Pickett at 05:10 PM
Last week's Onion analyzed the breakdown of President Bush's request to double PEPFAR funding to $30 billion:
Unfortunately, the satirical newspaper actually overestimated the amount of PEPFAR funds that would go towards an AIDS vaccine. The current grand total? $0. In fact, a recent recommendation from the outgoing Director of Foreign Assistance would reportedly cut USAID support for the International AIDS Vaccine Initiative entirely - down from $29m in FY07 - as well as for many other critical research efforts to develop vaccines, drugs and microbicides for developing country diseases. Now that's no laughing matter.
- $10 billion: Programs to get people off AIDS and back to work
- $30 million: Equipping future Black Hawks with crates of pamphlets and condoms, so next time won't be a total loss
- $1.5 billion: Installing particularly vicious anti-AIDS dictator in Uganda
- $17 million: Global campaign to promote dry humping
- $1,137.62: AIDS-vaccine research
- $8.2 billion: Guns to shoot AIDS with
- $15 billion: Faith-based initiatives
- $.41: Strongly worded letter to AIDS
- $14.80: Nameplate for AIDS czar
March 30, 2007
GSK's New Mening Vaccine Prepares for a Hurdle Jump
Posted by Ruth Levine at 09:23 AM
We're seeing an interesting and positive development on the regulatory front today, as GlaxoSmithKline submits a regulatory file to European Medicines Agency (EMEA) under Article 58 for the combination vaccine candidate Globorix (diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and meningitis serogroups A and C). EMEA's Article 58 provides for the agency to offer a scientific opinion on the the efficacy, quality and safety of medicinal products intended for use exclusively outside the European Union - in this case, in Africa and Asia.
In a press release issued today, Jean Stephenne, President of GlaxoSmithKline Biologicals, says:
Using the innovative Article 58 mechanism will expedite the availability of Globorix to those in greatest need while ensuring it meets the world's most stringent standards for safety and efficacy. This vaccine candidate could be available as early as 2008 and has the potential to break the cycle of meningitis epidemics in Africa. It will provide babies with protection against 7 diseases in a combination vaccine and, administered in the classical Expanded Programme on Immunisation, it will help to simplify logistics and costs.
Good as it is to see the technical resources of EMEA being made available to focus on evaluating products for the developing world, Article 58 addresses only one of a panoply of regulatory and post-regulatory obstacles to greater access to drugs, diagnostics and vaccines. The list includes, among other issues, bottlenecks in the international processes for pre-qualification of products and establishing recommendations for use; and confusing and slow in-country procedures for licensure and registration.
One cheer for Article 58 today. Three cheers when the new vaccine, which looks like it might contribute significantly to reduce the impact of epidemic meningitis, actually makes it into the EPI programs in countries that need it.
March 15, 2007
Immunization in the News
Posted by Jessica Pickett at 03:45 PM
There have been several interesting articles on the vaccine front recently:
- The U.S. State Department has devoted an entire issue of eJournalUSA to the subject of life-saving vaccines.
- The Banker shares an analysis of the International Finance Facility for Immunization from the perspective of the financial and investment community.
- The latest issue of The Economist examines the game theory behind immunization choices; the article focuses on influenza in particular, but has implications for other vaccines as well.
- creating an electronic clearinghouse for information on vaccine supply and demand
- improving forecasting and pre-booking, capturing local information about health conditions and demand
- establishing systems for redistribution from areas of surplus to areas of shortage
- reducing lead times through technological innovation in production and transportation
March 09, 2007
Beating the Market
Posted by Ruth Levine at 11:29 AM
The vaccine industry is looking healthier and happier than it has in years, according to The Economist, thanks to the combination of new science, new money and new recognition of the value of prevention. The advances in adjuvants - ingredients in vaccines that make the antigens go further and work better - and new ways to deliver vaccines without needles, such as nasal sprays mean that genuine innovations are hitting the market. And it appears to be a market ready to place a value on products that can prevent disease and associated treatment costs. Health care payers in both developed and developing countries are willing to pay for higher-priced vaccines than before, making the vaccine business substantially more attractive than in the past. Interestingly, The Economist cites the importance of GAVI's vaccine purchases, and new financing approaches like Advance Market Commitments, as contributors to the rosier picture.
What The Economist doesn't mention is that the vaccine industry looks particularly good in comparison to the drug side of the pharmaceutical business, which has few true innovations in the pipeline and has developed a business model largely predicated on minor tweaks of old products - the "me too" generation - and expanding the list of approved uses for existing on-patent medicines. Take, for example, the news from Pfizer that their cholesterol-reducing big seller, Lipitor, is now OK'd for five additional therapeutic uses; this is decidedly good news, at least in the short run, for a firm that faces the patent expiration of its major money-makers, and has an anemic pipeline of new products. In the medium term, the weak pipeline has to mean trouble, and it's a problem across the industry.
In a world where prevention and public health have long been the poor cousins of high-tech curative care, it's refreshing to think that vaccines are giving the drug business a run for its money.
March 02, 2007
Fighting Paralysis in the Polio Program
Posted by Ruth Levine at 10:31 AM
In the end, will the world-wide eradication of polio go down in the "grand success" or "dismal failure" side of the global health ledger book? That was the basic question faced by World Health Organization Director-General Margaret Chan and a host of polio experts at a conference held this week to review the international polio program's progress and problems. As reported by the Associated Press, "some leading experts asked a grim question: Is it time to abandon the goal of eradication and focus instead on containing the disease? The answer, for most, was no - even though many had doubts." Those doubts seemed to touch on a range of concerns: How can additional spending on polio eradication be justified in the face of problems that are larger (in terms of the burden of illness)? Do the countries where polio is still endemic, Nigeria, India, Pakistan and Afghanistan, have the political will and institutional capacity to push back against the disease? Do we really have the technology to do the job, or do we need to move away from the inexpensive, easy-to-administer oral vaccine to an injectable version that has less risk of generating new cases?
From the outside, the polio eradication program has always seemed like an effort that had some blindspots: It's been heavily promoted by true believers, who haven't always seemed open to questions about strategy. Targets and timetables used for advocacy and fundraising have become dissociated from the ground realities. And in many countries that program has been implemented largely through specialized personnel, reporting and logistics systems in a way that seemed at times to compete with routine immunization and other health system priorities. But the achievements are indisputable, and it just might be that what's called for now is redoubled effort (with some modifications) rather than abandoned hope. Since the program started in 1988, the incidence of polio has declined by 99 percent, and many countries have been polio-free for years. Paradoxically, one of the reasons polio doesn't look like a major priority is because it's already been largely tamed. The remaining cases, something like 2,000 per year, are coming from some of the most challenging places on the planet, so it is little surprise that the ambitious target dates set for eradication come and go.
The way forward might be inspired by the bumper sticker phrase: Think global, act local. Any progress in the countries where polio continues to be found depends on the engagement of local leaders, both in the health sector and in the broader community. These are leaders who, frankly, may not care very much about globally-set polio eradication targets, but who do care about something - maybe the refurbishing of their health infrastructure, or the creation of surveillance systems for infectious diseases that they are worried about, or better transportation to higher-level health facilities. With a bit of creativity, surely the international funders and technical agencies that see the benefits of finishing the job of polio eradication can find ways to respond to the local priorities in ways that reinforce progress on the polio front.
February 21, 2007
Senator Lugar Leads U.S. Push for Advance Market Commitments for Vaccines
Posted by Sarah Jane Staats at 05:11 PM
Supporters of the Advance Market Commitment (AMC) for vaccines had much to toast this month as five countries--Britain, Canada, Italy, Norway and Russia--put forward $1.5 billion to support the first AMC for pneumococcal disease, the leading cause of childhood pneumonia deaths, and the second leading cause of childhood meningitis deaths worldwide. Notably absent from the AMC launch in Rome, was the U.S. (See CGD President Nancy Birdsall's blog arguing it isn’t too late for U.S. leadership on AMCs.) But now, a glass can also be raised to Senator Lugar (R-IN), ranking member of the Senate Foreign Relations Committee, for leading the charge for U.S. support of AMCs.
Last week, Senator Lugar introduced the "Vaccines for the Future Act of 2007" (pdf), a bill to accelerate the development of vaccines for HIV/AIDS, tuberculosis, malaria and other infectious diseases that disproportionately affect populations in developing countries. In an op-ed in today's Philadelphia Inquirer, Lugar argues that key ingredients in the success of public health victories like smallpox and polio eradication were vaccines, global partnership, and U.S. leadership:
But, disappointingly, the United States has not yet joined in funding the first vaccine under this groundbreaking plan, even though the Bush administration worked with other countries to develop the Advance Market Commitment idea and made an earlier commitment to support it.That's why I have introduced the "Vaccines for the Future Act" to authorize the United States to contribute to the Advance Market Commitment for pneumococcal vaccines. Equally important, it will require the administration to develop a comprehensive strategy and commit to speed development, testing and distribution of life-saving vaccines through innovative financial incentives like the AMC.
The pneumococcal vaccine is a good choice for the first AMC because these diseases kill an estimated 1.6 million people each year, up to one million of them children. Most of these deaths occur in developing countries; Africa is particularly hard hit.
Lugar urges the Bush administration and Congress to support the AMCs through the "Vaccines for the Future Act" and in doing so, solve a "humanitarian problem that lends itself to a market-based solution."
Cheers too to U.S. Rep. Pete Visclosky (D-IN), who plans to introduce the companion legislation to Lugar's "Vaccines for the Future Act of 2007" in the House of Representatives.
February 16, 2007
Advance Market Commitments for Vaccines: Not too Late for U.S. Leadership
Posted by Nancy Birdsall at 10:18 AM
Proponents of the Advance Market Commitment (AMC) were pleased to see the Washington Post editorial supporting U.S. involvement earlier this week. It is not too late for the U.S. to be a major force in making AMCs work. A U.S. financial commitment would ensure continuing analytic and policy engagement with an initiative shaped by optimism about the potential to make markets work for people. There is much to be done to ensure this pilot for a pneumococcal vaccine works, and to put that learning to work for a comparable initiative for malaria and other killer diseases.
The ideas and the policy work behind this initiative, after all, came originally and primarily from the U.S. research and policy community over many years. I am personally pleased by the role that CGD has played in translating the concept of a market guarantee for a future vaccine into implementation, first worked out in detail by Michael Kremer (before he joined CGD as a non-resident fellow). In doing this, we collaborated with Michael in building on many earlier efforts to refine the idea and bring it to the attention of the policy community -- see for example a Financial Times Op-ed by Michael with CGD Honorary Board member Jeffrey Sachs in 1999.
February 12, 2007
Incentives for Better Health around the World
Posted by Ruth Levine at 04:54 PM
*This post is co-authored by Michael Kremer and Ruth Levine co-chairs of a CGD working group on Advance Market Commitments that wrote the 2005 report, Making Markets for Vaccines: Ideas to Action
There were no fireworks when several wealthy countries announced Friday in Rome that they were making an advance market commitment to help pay for a life-saving vaccine for children in poor countries. But there should have been. These countries - including Italy, Canada, Norway, Russia and the United Kingdom - are breaking new ground by committing in advance to help finance the purchase of vaccines against pneumococcal disease (pneumonia, meningitis, and other killers), which annually claims the lives of up to one million children a year.
By promising in advance to pay for life-saving vaccines once they are produced, these countries are creating incentives for biotechnology and pharmaceutical companies to produce vaccines appropriate for use in poor countries, and to sell them at affordable prices. Estimates from the World Bank and the Global Alliance for Vaccines and Immunizations (GAVI), who have worked closely with donor governments to hammer out the design of the innovative financing program, suggest this pneumococcal commitment could prevent an estimated 5.4 million childhood deaths by 2030.
Why is an advance market commitment needed? An effective vaccine is currently available in the U.S. (under the Prevnar brandname), but at around $60 for each of the three doses required, it is too expensive for the poorest countries, and it needs to be adapted to prevent the strains of disease that are common in developing countries but not the industrialized world. Normally it takes 10 to 15 years for a vaccine introduced in the U.S. to become widely available in the developing world. While maximizing the benefits of the funding commitments depends on important contractual details, the "pay for results" approach can shorten this lag and help to ensure that the vaccine will be adapted to suit the patterns of disease and health care systems of poor countries.
Just as the U.S. market provided incentive for pharmaceutical companies to develop a vaccine to cover the disease strains most common in North America, an advance commitment strengthens incentives for firms to finish the work necessary to adapt the vaccine for global use, and to make large numbers of doses of the vaccine available to poor countries at lower prices. By linking a defined payment to a final product, advance commitments encourage investors to provide researchers with support to do whatever they can to ensure that the final vaccine is a usable product. In addition, because funding is open to all comers, firms feel the heat of potential competition - spurring them to develop the best possible vaccine in the shortest period of time.
We recently co-chaired a Working Group - convened by the Center for Global Development and supported by a grant from the Bill & Melinda Gates Foundation - which brought together a group of public health professionals, economists, top pharmaceutical lawyers, and individuals with in-depth knowledge of the vaccine industry. The Working Group concluded that an advance commitment could effectively stimulate greater private sector investment in the development of new vaccines appropriate for use in poor countries, and accelerate their adoption.
Putting in place this type of commitment for a pneumococcal vaccine is a vital step forward - and is a pathbreaker for the use of advance commitments to encourage R&D on more distant and technologically challenging vaccines, such as for malaria and HIV. The goal of an advance commitment for a vaccine at an earlier stage would be different and more ambitious, and because the scientific and regulatory hurdles are more substantial the appropriate total value of a commitment would be larger.
Advance market commitments for vaccines are a smart way to save millions of lives. We congratulate the donors who are supporting the pneumococcal disease vaccine advance market pilot for having the courage and conviction to try something new, for asking themselves "why not?" and then proceeding to give it a try. And we hope that the international community will be encouraged by this example to undertake advance market commitments for other urgently needed vaccines, and indeed for other health products for which there are compelling human needs but no commercially viable market.
February 09, 2007
Launch of AMCs in Rome
Posted by Owen Barder at 10:06 AM
Greetings from Rome, where Italy, Canada, Russia, Norway and the UK, with the World Bank, GAVI and the Gates Foundation, have launched the first Advance Markets Commitment. The first AMC will target pneumococcal disease, costing about $1.5 billion and expected to prevent more than 5 millions deaths by 2030. Governments will create an incentive for private sector investment in the development and production of life-saving vaccines, by guaranteeing to pay for a suitable vaccine, meeting international standards, when it is developed. The agreement includes long run sustainability by ensuring that the vaccine will be available to developing countries at low prices once the Advance Market Commitment is exhausted.
This proposal, originally made by Michael Kremer, was developed by a Working Group convened by CGD. That group coined the term Advance Market Commitment, and set out the main elements of the policy that has now been announced.
This is a remarkable tale of how an idea developed by a brilliant academic has entered into the highest levels of policy, leading to discussion at G7 Finance Ministers meetings and culminating in today's announcement. There can be few examples of academic research translating into practical policies in such a short time.
For more details about the launch and the background, see below.
The following commitments were made today:
* Britain - $485 million (£249 million at current exchange rate)
* Italy - $635 million
* Canada - $200 million
* Russia - $80 million
* Norway - $50 million
* Gates Foundation - $50 million
Pneumonia is the leading infectious cause of child mortality worldwide, causing an estimated 1.9 million child deaths each year, almost 20% of all child deaths. Pneumococcal disease is the leading cause of these child pneumonia deaths, as well as the second leading cause of childhood meningitis deaths. It kills more than 1.6 million people including nearly 1 million children under age 5 every year. HIV/AIDS is increasing the rate of infections, with HIV-infected children 20 to 40 times more likely to get pneumococcal diseases.
The idea of an AMC has been discussed at length on this blog, and elsewhere. The main point is the legally binding commitment that donors will make to pay for vaccines that meet a suitable standard and which are demanded by developing countries.
There is an enormous amount to do to translate this commitment in principle on the part of donors into a specific agreement, with legal contracts, technical specifications and a suitable institutional architecture. GAVI and the World Bank will lead this technical work, which will continue to involve the developing countries, the public health experts, the industry, and donors.
The launch in the grand surroundings of the Italian Treasury was opened by the Italian Health Minister, Tommaso Padoa-Schioppa. He explained the AMC mechanism, and showed a short film that had many of us crying. (You can see it by pressing "video" on the PneumoAdip site). Then speeches from each of the guests, including ministers from Ghana and Malawi, Her Majesty Queen Rania Al-Abdullah of Jordan, the President of the World Bank, and representatives of donor governments.
I was sitting in the corner of the room with some of the people who have worked so hard for so many years to make this happen - Michael Kremer, Amie Batson, Orin Levine, Andrew Jones, James Droop, Rudi Daems and many others, not all of whom could be there (such as Wendy Taylor and John Hurvitz). I was a poor substitute for colleagues from CGD who should have been there too, notably Ruth Levine. We are all going out to celebrate tonight in Rome. On Monday begins the hard work of tying down the details.
February 07, 2007
Advance Market Commitment for Vaccines To Be Announced in Rome
Posted by Lawrence MacDonald at 10:43 PM
Reuters reported Wednesday that a group of wealthy countries including Italy, Britain, Canada and Norway will announce in Rome on Friday a $1.5 billion advance market commitment to purchase vaccines to prevent pneumococcus, which kills more than a than a million kids each year in the developing world, through illnesses such as pneumonia and meningitis. The report quoted the Italian economics ministry as saying that the program "aimed at saving millions of lives in the poorest countries and supporting their economic growth with new methods."
This is great news for the millions of kids who would otherwise contract this deadly disease. A pneumococcus vaccine is already available in the U.S., but at $60 per dose, and with three doses needed for immunization, the costs are prohibitive for poor countries. The advance market commitment will create incentives for private firms to adapt the vaccine for the strains of the disease that are common in developing countries, and to scale up production to meet the needs of the developing world.
I'm proud to say that CGD helped to lay the ground work for this path-breaking initiative. My colleague, senior fellow and director of programs Ruth Levine and non-resident fellow Michael Kremer convened and co-chaired a working group (along with the Vaccine Fund's Alice Albright) that investigated whether and how to make the concept of an advance market commitment a reality. In 2005 CGD published Making Markets for Vaccines: Ideas to Action which inspired the pilot that will be announced on Friday in Rome. The AMC for pneumo represents extraordinary efforts by a very large number of people and institutions, many of whom were first brought together to work on the AMC design in the CGD working group. For us it's a very gratifying example of using research to inform and affect policy.
This is a big deal for the development community, and for the millions of kids whose lives will be saved as a result. I'll be watching eagerly on Friday for the official announcement from Rome. And I'll be hoping that similar committments will soon be offered for vaccines to prevent other killer diseases, such as HIV, TB and malaria.
Update: For more details, see GAVI's new AMC website.
January 22, 2007
Hundreds of Thousands Saved: A Measles Success Story
Posted by Jessica Gottlieb at 06:28 PM
The numbers are in! The Measles Initiative, which set out to halve the global measles burden between 1999 and 2005, has surpassed its goal with a 60 percent reduction. A new Lancet study (subscription required) reports an estimated drop in measles deaths from 873,000 in 1999 to 345,000 in 2005 (based on a natural history model to evaluate mortality trends).
For related coverage, see The Economist, the Washington Post, the New York Times and elsewhere. But also be sure to check out CGD's Millions Saved for a detailed account of how measles was nearly eliminated in seven southern African countries in the late 1990s. The case study suggests some key ingredients for the intervention's success: the commitment of governments, the strengthening of surveillance systems, and the integration of measles vaccinations with other health services. Some of these reasons are echoed by WHO director Margaret Chan in an International Herald Tribune op-ed on the more recent Measles Initiative success. She said that "it took a new partnership - with commitment, caring and cash - to turn things around," and noted that the success in countries was aided by their ability to build on the strategies and infrastructure of existing health programs and services.
As usual in public health, this success implies more work to be done. In a good sign that past successes are being used to inform future aims, the Measles Initiative has already set a new goal of reducing measles mortality 90 percent by 2010. Margaret Chan is optimistic that the new measles target will be achieved; so am I.
January 04, 2007
Demand Forecasting Featured in Scientific American
Posted by Jessica Pickett at 11:03 AM
The Scientific American features a new article on the challenges of demand forecasting for global health products:
Unpredictable demand creates a three-way catch-22 problem [...] Poor countries have to know the price of a vaccine to see if they can afford it. Manufacturers, however, are hesitant to set a price unless they know how many doses will be bought. And aid donors cannot be sure they can subsidize a purchase without knowing the price and quantity of the sale.The author, J.R. Minkel, goes on on to highlight many of the ongoing efforts in this area, including CGD's own Global Health Forecasting Working Group.
January 03, 2007
Baltimore Sun Op-Ed Endorsing AMC Pilot
Posted by Jessica Pickett at 10:53 AM
Check out the Baltimore Sun op-ed by Orin Levine (Executive Director of PneumoADIP) and Michael Klag (Dean of the Johns Hopkins Bloomberg School of Public Health) endorsing a pilot advance market commitment for a pneumococcal vaccine. And for more information, see GAVI's new AMC fact sheet (.pdf).
Update: Leaders from the public and private sectors have also issued a letter (.pdf) urging President Bush to commit funding for an AMC.
December 18, 2006
Flu Vaccine Woes
Posted by Ruth Levine at 11:19 AM
Once again, volatile demand for flu vaccine is giving everyone a headache. A mere two years ago supply fell badly short of demand, turning US seniors into "immunization tourists" to Canada, and putting President Bush on the defensive during the 2004 campaign. This year, demand is way off, and suppliers can barely give the vaccine away; they face the prospect of wasting valuable doses because the vaccine is developed specifically for this year's strain. Paradoxically, despite the aggregate surplus some geographic areas are experiencing a shortage. As the New York Times reports, "The situation underscores the fragile nature of the nation's supply system for flu vaccine, a risky and volatile business, in which the federal government has a limited role."
The consequences, aside from the immediate financial losses to suppliers and doctors who purchased in bulk, may be a decrease in future production and, yes, more shortages. "I'm concerned that we'll throw away 20 million doses," said Dr. L. J. Tan, the co- chairman of the National Influenza Vaccine Summit, a group of 140 companies, nonprofit groups and public agencies. "If we keep on doing that, I can guarantee that the following seasons we won't have 115 million doses anymore."
The mismatch between supply and demand is as predictable as the flu season itself: we know it's going to happen, we just don't know how bad it's going to be. So what to do? Prashant Yadav, a supply chain expert at the MIT Center for Transportation and Logistics in Zaragoza, Spain (and a consultant to our Global Health Forecasting Working Group), thinks the reason policymakers haven't yet come up with a workable solution is because they haven't thought about the poor flow of information and product in the complex supply chain, which includes a host of players from patients to physicians, hospitals, transportation providers, insurers and manufacturers. The approach that he and co-investigator David Williams have arrived at in a recent study include:
The challenge of dealing with volatility in demand in a complex supply chain is familiar to those who are trying to get live-saving drugs, diagnostics and vaccines into wider use in developing countries. It's worth thinking about whether there are ways to apply some of these ideas to a broad range of products - one of the angles the Forecasting Working Group is looking at closely.
December 05, 2006
Finding Pneumo
Posted by Ruth Levine at 10:00 AM
Today's New York Times features efforts to introduce pneumococcal conjugate vaccine in developing countries, where it has the potential to combat life-threatening respiratory disease. Importantly, the article notes progress in putting together the pledges for a pilot application of the Advance Market Commitment to stimulate development and manufacture of pneumo vaccine that would be appropriate for use in African and Asian countries: $1 billion of the estimated $1.5 billion required, with the notable absence to date of pledges from the US and France.
December 04, 2006
GAVI Commits to Funding for Pneumococcal & Rotavirus Vaccines
Posted by Jessica Pickett at 02:08 PM
At its latest meeting, the GAVI Alliance board committed $200 million to support the introduction of new vaccines against rotavirus and pneumococcal disease in developing countries; the Washington Post subsequently ran an editorial in support of the decision.
October 13, 2006
LA Times on the vaccine market
Posted by Jessica Pickett at 09:43 AM
This morning's Los Angeles Times ran an editorial on the state of the vaccine industry in light of Pfizer's acquisition of PowderMed:
Two years ago, the closure of one British vaccine plant wreaked havoc on the world's ability to respond to the flu. The investments by Pfizer and others show how market forces, in concert with the nonprofit and public sectors, can work in the public interest
October 11, 2006
Washington Post on New Vaccine Trials
Posted by Jessica Pickett at 08:19 AM
The Washington Post has recently run two feature articles on the development of new vaccines for malaria and hookworm.
September 06, 2006
NY Times Endorses Advance Market Commitments
Posted by Ruth Levine at 08:08 AM
In an editorial today entitled "Vaccine Futures," the New York Times encourages US support for a pilot Advance Market Commitment. The vote of confidence in the new approach to stimulate private vaccine R&D vaccine manufacture follows on the heels of the July G-8 summit, where leaders failed to reach full agreement about creating a pilot AMC for vaccines against pneumococcal disease, a major cause of child death in developing countries. Now, a broader coalition is being pulled together by the Governments of Italy, Canada, the UK and others that want to see real progress made toward committing public resources by year's end. Attention by the New York Times reminds us that the U.S. has another chance to turn its earlier backing of the idea into reality.
July 31, 2006
Beach reading: "Saving the World"
Posted by Jessica Pickett at 05:13 PM
It's not often that you come across novels about global immunization, but Julia Alvarez appears to have written one, aptly titled Saving the World:
Two women living two centuries apart each face "a crisis of the soul" when their fates are tied to idealistic men whose commitments to medical humanitarian missions end in disillusionment. Alma Heubner's husband, Richard, goes to the Dominican Republic to help eradicate AIDS, while Alma, a bestselling Latina writer, stays at home in Vermont to work on a story about a real, ill-fated 19th-century expedition chaperoned by Dona Isabel Sendales y Gomez, the spinster director of a Spanish orphanage who agrees to vaccinate 20 of her charges with cowpox and bring them from Spain to Central America to prevent future smallpox epidemics.
July 28, 2006
Another step towards realizing the IFFIm
Posted by Jessica Pickett at 05:17 PM
Reuters reports that the International Finance Facility for Immunization will issue bonds on the global capital markets later this year via Deutsche Bank and Goldman Sachs. (Also reprinted by the World Bank, citing additional commentary from Dow Jones.)
July 26, 2006
The importance of improving demand forecasting
Posted by Owen Barder at 07:07 PM
IAVIReportOnline.org reports on new efforts to improve demand forecasting
To help with the task of creating these forecasts, PPPs and NGOs are seeking the advice of economists, industry forecasters, and consulting groups. IAVI, the Accelerated Development and Introduction Plans (ADIPs) for pneumococcal and rotavirus vaccines (PneumoADIP and RotaADIP, respectively) coordinated by the Global Alliance for Vaccines and Immunization, and the Program for Appropriate Technology in Health's (PATH's) Malaria Vaccine Initiative are each currently developing (or have recently conducted) strategic demand assessment research. And the Center for Global Development (CGD) is in the process of holding a series of stakeholder workshops over the course of this year to gain consensus on how best to share data, techniques, and principles for demand assessments of vaccines and other medicines.These are crucial issues: we have reported here about the possibility of the UN having a role in demand forecasting, and here about the huge human costs of failure to forecast demand accurately.
The need (as distinct from demand) for vaccines and drugs for most infectious diseases is predictable - the burden of disease does not vary much from one year to another. So if demand is volatile, this is mainly a man-made problem: demand volatility must be largely due to erratic behaviour by donors and (probably to a lesser extent) regulators and developing country partners. The costs of this unpredictability are borne by suppliers and, ultimately, by the world's poor whose access to affordable and reliable supplies of essential medicines is jeopardized by this unpredictability.
There is a clear win for everyone if we can increase the predictability of demand. Suppliers will get the certainty they need to invest in large-scale production; donors will get more bang for their buck; and developing countries will get more stable and lower cost supplies of the medicines they need.
July 24, 2006
Health Technologies Require Policy Innovations
Posted by Ruth Levine at 09:00 AM
Health technologies have value if and only if they are used -- or, as we wrote in Millions Saved after reviewing 17 large-scale successes in global health, what's needed is "innovation within an effective delivery system, at a sustainable price." That simple observation bears repeating as a caravan of new drugs, diagnostic products and vaccines for diseases that predominantly affect poor countries move through the R&D pathway, and yet face speed bumps when it's time for scaled-up manufacture and delivery to those in need.
In Sunday's Washington Post, Mary Moran, author of a study describing the multiple products whose development in commercial or non-profit pharmaceutical firms is primarily being funded by the Bill & Melinda Gates Foundation, highlights a disconnect between product development and product deployment. While some of the R&D efforts are making headway -- Moran predicts that by 2010, we'll see six or seven major new drugs for malaria and tuberculosis -- she criticizes a narrow focus on technology: "That's the problem with a technology-led solution. There's a lot of medicines out there that aren't used."
Roger Glass and co-authors, in this week's Lancet (subscription required), similarly bring attention to the potential health benefits of two recently licensed vaccines, GSK's Rotarix and Merck's RotaTeq, and then go on to fret about the practicalities of buying and using the products. If these products are suitable for developing country conditions, and if they can be introduced and delivered broadly, these oral vaccines could prevent a large share of the estimated 600,000 child deaths due to diarrheal disease associated with rotavirus. But, as Glass and colleagues point out, the vaccines have not yet been subjected to efficacy testing in Asia and Africa, so the health benefits have not been confirmed. Beyond the science and the epidemiology lie the financial and organizational challenges of introducing and sustaining the use of these new products in poor countries: how will firms be convinced to produce them in large quantity, how will countries faced with multiple competing priorities decide which ones to use, what will be the role of the private distribution channels, and how will product purchase be financed over the medium-term?
In some ways, this is a set of problems we should be happy to have. Better to have the challenge of paying for drugs for major killer diseases than not to have the drugs ready to go. Better for countries to face lots of choices about which drugs and vaccines to use than to have no options at all. But surely there are still improvements to make on our way of doing business. One improvement might be to make sure that a strategy for purchasing the products at an affordable price over the long-term is part and parcel of way R&D is funded -- as, for instance, has been proposed with an Advance Market Commitment. Another would be a more rational means of determining which product or set of products donors subsidize, to avoid the near-chaos of the current advocacy-driven financing priorities. And still a third would be a set of actions to improve the ability of both developing countries and donors to provide credible demand estimates to pharmaceutical companies, so they can build and produce with confidence that products will be used (see the description of our Forecasting Working Group). Like drugs themselves, each of these policy innovations merits focused and accelerated R&D.