As the World Health Organization has raised its pandemic alert for swine flu to “phase 5” the second highest level, meaning that it believes a global outbreak of the disease is imminent, the relationship between patent rights and access to essential medicines has elicited again. As per WHO the phase 5 alert means there is sustained human to human spread in at least two countries. It also signals that efforts to produce a vaccine will be ramped up.
As it turns out that there is no vaccine available as yet and Tamiflu (Oseltamivir), a drug patented by Gilead and exclusively licensed to Roche is considered as one of the best drugs available today to cater to this kind of flu. Even at the time of the bird flu, it was known that Tamiflu was not the optimal drug to cater to such viruses– but only that of all the possible alternatives, it was the best.
In India, Deputy Controller of Patents, in a decision on the 23rd of March 2009, struck down Gilead’s patent application covering Oseltamavir compositions on the grounds of lack of inventive step, failure to comply with section 3(d) and failure to sufficiently disclose the invention claimed.
Since Gilead hasn’t patented this drug in all countries and has recently lost the Indian patent battle over “Tamiflu” just about a month back, these governments may turn to generic manufacturers for a cheaper priced alternative. And even if a patent exists , if Roche can’t meet the demands in terms of quantity and price some of these governments may decide to override the patent and grant compulsory licenses (treating it a case of national emergency) to enable cheaper alternatives.
It is interesting to note that the US does not have any compulsory licensing clauses within its patent regime that can be invoked. But there is a possible alternative that the situations can be worked into the ‘takings clause’ in 28 USC §1498 and perhaps the fifth amendment to the US constitution that contains ‘eminent domain’ principle. Under these principles, the government could use the patent without the permission of the patentee, subject only to payment of some reasonable compensation. The US had threatened to do something similar with Bayer’s patent during the Anthrax crisis.
But the bigger issue that was pointed out by Dr. Anatole Krattiger in a recent discussion with me is that “Back then, with Bayer’s Cipro, the US back-peddaled quickly so as not to undermine private patent rights. And now, most Western governments have stockpiled Tamiflu. But who will supply Tamiflu now to the low-income countries that have not had the currency reserves to stockpile Tamiflu?”
Further Reading:
Shamnad Basheer and Tahir Amin,Taming of the Flu: Working through the Tamiflu Patents in India , Journal of Intellectual Property Rights, Vol. 2, p. 113, March 2006
A recent article details Ug99, a stem rust of wheat, one of the most significant threats to global food security at present. Ug99 is a new variety of wheat rust fungus that has potential to spread throughout the major wheat growing regions of the world. Currently it is making its way east from Kenya through Ethiopia and Yemen after damaging crops in Kenya and Ethiopia. Once the fungus attaches to the above-ground wheat plant 50-100% crop loss can occur resulting in a substantial financial hit for farmers as well as decreased global wheat supplies, which in turn leads to increased costs for the consumer. Additionally, famines could occur if supplies are reduced in particular regions such as north Africa, as well as west and central Asia.
First discovered in Uganda in 1999, Ug99 is likely to infect wheat fields to catastrophic proportions, especially in some developing countries where wheat is a staple crop. According to Rick Ward of Cornell University, wheat rust “will translate into widespread food insecurity and civil unrest.” Some fields in east Africa, Kenya particularly, have experienced up to 80% losses.
In a normal setting, scientists’ ability to counter widespread plant diseases including fungi could be achieved by use of pesticides, by traditional plant breeding, and by genetic engineering. Unfortunately, however, Ug99 is highly infectious and thus has the ability to spread quickly through the movement of seeds and by normal weather (primarily wind) and thus remains difficult to contain; the use of fungicides, besides having limited effectiveness, is too expensive for most developing countries; also, traditional breeding takes many years of crossing and selecting; and genetic engineering requires the availability of effective resistance genes and of effective biosafety regulations. But there is hope because plant resistances have been found to be somewhat effective against Ug99 and have already been successfully bred into certain wheat varieties for certain regions. These varieties are currently acceptable to farmers in some regions, but they are not resistant to all rust strains, and some are still susceptible to Ug99 under certain local climatic conditions.
Due to the relatively rapid pace at which the fungus is spreading throughout the world, short-term solutions must be implemented until the time when durable resistance genes can be successfully transferred to wheat and distributed to farmers. Long-term solutions are irrelevant if Ug99 spreads quicker than anticipated, as suggested by Dr. Norman Borlaug of the Borlaug Global Rust Initiative (“BGRI”). Unfortunately, once disease-resistance is bred into modern wheat varieties, it will take years to grow enough seed and subsequently distribute it to farmers in need. And Dr. Borlaug, winner of the Nobel Prize for his wheat breeding work since the late 1940s in Mexico that ultimately led to the Green Revolution, should know. It was Dr. Borlaug who was instrumental in raising alarm some 7-8 years ago, not least of all because his early success in wheat breeding focused on rust resistance. His work and that of many colleagues at CIMMYT and Indian and Pakistani breeders, among others, led to a 50 year period during which stem rust was a minor problem.
There appear to be very few short-term solutions to this problem despite scientists’ confidence that long-term solutions can be had. Whether rust-resistant seeds will arrive soon enough remains but a hope, but given the severity of Ug99 that prospect seems unlikely. In the short term, expensive fungicides are one option for farmers who can afford to purchase them, who are equipped to apply them safely, and who are farming in a relatively well developed area with well trained agricultural extension systems. Many farmers in developing countries, especially in the poorer areas which are on the likely Ug99 path are unlikely to be capable of purchasing and using the fungicides effectively, so funding agencies should consider allocating increased funds for this purpose; concurrently, agricultural chemical companies should consider more targeted tiered pricing of fungicides, thus significantly reducing the cost to lower income countries.
Although fungicides represent a mere temporary solution as part of a more comprehensive approach to a lasting problem, they have potential to increase marketable yields quickly thus increasing farmers’ incomes and keeping food supplies steady. If wheat farmers continue to experience low yields they will be less capable of turning a profit and sustaining their farms into the future thus rendering efforts to engineer rust-resistant seeds an increasingly futile effort if there will be fewer farms left to supply. Farmers experiencing severe crop damage would surely be willing to try fungicides if money were granted for its purchase in developing countries.
If fungicides can be provided to farmers in developing countries some level of education may be necessary. Farmers must be aware of the optimal times to spray upon consideration of the particular variety of wheat they grow. Optimal wheat yields can be achieved by ensuring fungicides are utilized early before Ug99 or other rusts have an opportunity to infiltrate farmers’ fields. Improper application of fungicides in the past has led to yield losses and health risks for farmers, so education is key. This can be accomplished by routine field inspections by qualified individuals and by ensuring farmers’ access to necessary information.
Of course fungicides are merely one component of a short-term solution to threats posed by wheat rust, but if funding agencies realize the seriousness of Ug99 they may be on board with allocating emergency funds for certain regions that have been hit hardest. Currently billions of fungus spores continue to blow east which threatens global food supplies as well as the livelihoods of wheat farmers. Something must be done now to prevent the aforementioned problems until successful Ug99-resistant wheat varieties can be deployed and marketed to farmers throughout the world.
BGRI and its partners are currently attempting to transfer resistance genes from rice to wheat, but this component of the project will take 10 years or more, even if government regulations for the field testing of genetically modified wheat (biosafety regulations) become more science-based and permissible. One presumed reason why the BGRI is not focusing on genetically modified wheat, which could lead to the faster development of Ug99 resistant wheat, is due to the tremendous regulatory roadblocks and resistance to adopt genetically modified crops in general and wheat in particular. Onerous biosafety regulations already increase the development cost of genetically modified crops by millions of dollars and delay the delivery of many crops, including that of Golden Rice by 5 years or more. More efficient, science-based regulations are therefore necessary to combat Ug99 as quickly as possible.
Of far greater relevance, both the criticism and the attempted response (such as this patent pool) may be based on the faulty assumption that patents are the primary barrier to access to essential medicines. A study published in 2004 suggests that poverty, rather than patent policies, inhibits access to essential medicines in developing countries. The study examined sixty-five low- and middle-income countries and found that patenting was rare (1.4%) for the 319 products on the World Health Organization’s Model List of Essential Medicines (WHO-EML). The author argued that “[p]atents cannot cause essential medicines to be inaccessible in ‘many’ developing countries because they do not exist 98.6 percent of the time; similarly, patents cannot be a ‘global’ necessity of pharmaceutical business because companies forgo them 69 percent of the time.”
However, several objections have been directed against this study, including the fact that limiting the analysis too only “essential medicines” as defined by those medicines on the WHO-EML is overly narrow and imprecise (the reader is referred to the Attaran article for a more detailed discussion). Additionally, it has been argued that new drugs (as opposed to the older drugs on the WHO-EML) will not be available if pharmaceutical companies cannot gain returns for their investments. In such cases, patent pools may very well increase access in developing countries by reducing the transaction costs necessary to obtain a license and presumably also the licensing fee. This is not to suggest that patent pools are “the answer.” However, reading the above study to mean that patent policies are irrelevant – and I am not suggesting that that was the author’s intent – is likely an overstatement of the reality of the situation. While GSK’s gesture is not without merit (to GSK’s credit the patent pool is not the only avenue GSK is exploring), poverty is also clearly a factor that must be considered when addressing this issue. Ultimately, the precise interplay between poverty and patent barriers will determine the utility of these types of patent pools.
My post of 14 March entitled “Shortsighted Sustainability Efforts in Africa,” below, may have been a bit shortsighted itself in light of new information brought to my attention. The primary critique in that post was that despite significant funding from the Gates Foundation which purported to connect increased funding of agriculture markets in developing countries and increasing educational opportunities (thus lifting them out of poverty) failed to recognize the substantial amount of time it would take to benefit education systems directly. However, a recent report by the International Food Policy Research Institute (IFPRI) indicates that the connection between increased funding and benefits to education are not quite so tenuous, and indeed, direct benefits to education are quick once agriculture markets are stimulated. The relationship of agriculture markets to increases in education is an important one that must be furthered because of the future benefits education provides. According to IFPRI, increases in a developing country’s agriculture market leads directly to increased educational opportunities because the world’s poor are very likely to invest in their children’s education when they have disposable income.
On a related matter, a March 26 article in Business Daily Africa indicates that agribusiness leaders in Kenya are beginning to back a number of technologies (including nanotechnologies, oddly) which could stimulate growth of agriculture markets in Kenya. However, the article fails to define the true scope of the benefits which could result because it focuses on food production as the sole benefit and ignores offshoot benefits. As above, education can be stimulated by increases in the strength of a country’s agriculture market. Of course having an ample stock of food is important, but Kenya’s Biosafety Bill 2008 will arguably provide many benefits in additional areas. In order for Kenya to achieve its full potential, the Biosafety Bill must be utilized to the greatest extent possible.
As a result of the Biosafety Bill, there is hope that many semi-arid areas (which includes half or more of Kenya’s total land mass) can soon host genetically modified crops under development; more specifically, the Biosafety Bill allows for such technologies and crops to finally be tested in Kenya. The ability to grow where very little water exists, and in times of drought, is increasingly important (especially in Kenya) now that global warming has begun to alter rain patterns. William Ruto, Kenya’s Minister for Agriculture, believes there is “no excuse to ignore the technology that can increase our food output.” An important element of the Bill may be that it does not require farmers to label their crops as products of genetic engineering. This will allow for an acceptance of the benefits of GM by default, because consumers will purchase these products and realize that they are safe.
In addition to the potential benefits to food production and education (which would lead to great economic advances far into the future), an increased focus on GM agriculture in Kenya’s struggling economy may foster an increase in scientific activity in Kenya. Once scientists in Kenya recognize that their efforts in genetic engineering of crops will be welcome (at least by government), the likelihood of their desire to develop strains specifically suited to Kenya’s needs may increase. A growing biotechnology industry could therefore emerge in Africa as a result of the Biosafety Bill. All areas of biotechnology would benefit – everything from medicine to genetics research, as well as pharmaceuticals and generics.
Predictably, detractors still exist thus casting the Biosafety Bill under a wave of dissent from civil society groups. An open letter to Kenyan president Mwai Kibaki and Prime Minister Raila Odinga, signed by 53 different organizations, cautions that the nation’s precautionary principles have been compromised. Specifically, the letter cites a number of perceived risks such as contamination of non-GM crops and greater risks of toxicity, allergenicity, and cancer in humans. Relevant scientific data indicates that the likelihood of these concerns coming to fruition are unsupported by fact. Also, the letter indicates that “Kenya has the opportunity not to repeat the mistakes made by the US and South Africa,” which again indicates an unfounded fear. The US did experience some setbacks in the initial development of GMOs, but they were necessary parts of the scientific process.
In sum, Kenya’s Biosafety Bill will prove to be an important part of the country’s development throughout the 21st century. However, the Bill should be utilized to its greatest potential. Increases in education could potentially result from increases in agriculture yields because when farmers have more expendable income they are likely to provide educational opportunities for their children. Children who receive increased educational opportunities have the potential to become leaders in their communities and add to the economic development of their nation. This cycle of beneficial growth must be perpetuated throughout the developing world if we are to fare well amidst increased populations and diminishing natural resources.
At least one prominent EU science advisor is looking to a rather unusual source for inspiration regarding the future of global science and health policy: President Obama’s newly appointed panel of science advisors. Professor John Beddington, science advisor to Prime Minister Gordon Brown, urges EU member states to look to the U.S. as an example of how science policy should be made. Changes in policy-making are necessary, Beddington argues, because a global food, water, and energy shortage will culminate by 2030. Recognition of the benefits of GM crops and other sustainable technologies by top UK policy-makers is an important step in the right direction because this recognition within a historically resistant nation indicates a potential for a shift in policy away from prior restraints on growing and selling useful GM foods. If UK officials are beginning to speak out against inappropriate prior restraints on science and technology, all EU member states have similar potential. Currently, the UK and Ireland are the only EU member states with a designated science advisor.
Acceptance of GM crops (both in government and public spheres) as a viable, safe technology is essential to the survival of millions because demand for food, feed and fiber is predicted to increase by 50% by 2030, at which time the world population will exceed 8.3 billion. As previously discussed on this website and elsewhere, we will face a serious global crisis if food and water shortages are not remedied quickly and efficiently. Many countries are doing their part to alleviate the problems posed by vast increases in global population and shortages of many vital natural resources by utilizing sustainable technologies and increasing agricultural yields. Although the EU has failed to take advantage of certain technologies (e.g., biotech crops) capable of alleviating, at least in part, the food shortages, (see below: “Rethinking the Precautionary Principle at Upcoming Biotech Conferences” by J. Kasting & V. Lancaster) there are respected EU scientists, such as Professor Beddington, who recognize the benefits of implementing such technologies. However, in order for sustainable technologies to take hold in the EU, a greater majority of senior government officials and legislative bodies must be willing to adopt such technologies.
Food shortages must be prevented because when supply becomes scarce prices will begin to increase throughout the world. Having top scientists advise policy-makers will lead to relatively quick increases in acceptance of GM crops which could eliminate the risk of dwindling food supplies. Food prices are currently low, but we must not forget that they will rise someday soon resulting in various ancillary problems (such as a decrease in access to education in developing countries). Although the food, water, and energy shortage is not expected to culminate until the distant future, the time is now to stimulate a debate that can lead to real change. The world’s fresh water supply is dwindling, and now more crops are lost to drought than ever before. Acceptance of GM crops in the EU will aid the food crisis, so we must act fast.
Promoting scientists like Professor Beddington to top advisory positions will be one important means of countering the negative effects of the precautionary principle in the EU. Member states can and should provide policy-makers with the same high quality scientific advice President Obama receives. To do so increases the potential to reshape the global regulatory landscape thus facilitating increased food supplies and delaying or eliminating a global crisis. A significant step that can be taken to remedy a future global crisis is to install informed advisors in top government posts throughout the EU because this will facilitate an informed debate among citizens and their government leaders. Also, for the sake of argument, any country (not just the EU) currently lacking a prominent science advisor would do well to have one as science and technology continue to impact the global economy now more than ever.
In 2004 the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) released a report entitled, “Case study on estimating HIV infection in a concentrated epidemic: Lessons from Indonesia”. The report described a study done over a three week period in May of 2001 in Indonesia. The study used “second generation surveillance” which focuses on the populations most at risk of contracting HIV from those persons already infected. The study also took a “de-centralized” approach to gathering this information by using field reports from suburban and rural areas as well as statistics gathered from major urban populations. WHO and UNAIDS emphasized the report’s ability to produce a more concise number of the individuals and their specific behaviors that are most likely to contribute to the further spread of HIV in Indonesia. This information armed advocates lobbying for HIV resources with national government generated data as opposed to estimates using limited data produced at the headquarters of international organizations. This does not seem to be the best use of our resources however as we already know what drives the spread of HIV. Rather resources should be put into prevention and treatment programs as opposed to studies that produce numbers.
The WHO/UNAIDS report has some value in the immediacy of the information it provides about the HIV/AIDS epidemic at the time of the study as applied to Indonesia and in the aforementioned advantage given to advocates lobbying for resources. However, the study came to the same conclusion as that of previous studies done in other countries including the United States. Namely that high risk groups comprised of sex trade workers, IV drug users and men who have sex with men (MSM) are the main population sources for the potential spread of HIV/AIDS.
Flash forward to a February 2, 2009 BBC article entitled “Tackling Indonesia’s HIV Spread” or a March 11, 2009 YOUANDAIDS (UNAIDS) article entitled ‘HIV and Indonesia: Nation sits on a volcano”. Both articles state that the highest rates of infection and the main sources for the potential spread of HIV are concentrated in the marginalized groups of IV drug users, sex trade workers and MSM. A noted irony here is that the Indonesian government endorsed the 2004 WHO/UNAIDS report but the BBC article states that “Those groups have not always been well-targeted in the past. In fact, most people here - even in government - would prefer not to see or talk about them.” (Emphasis added.) The arguably poor choice of placing limited resources into funding studies rather than creating prevention and treatment programs is made tragically worse when the very government endorsing the study refuses to acknowledge the results!
Given the world-wide economic woes, it will be more difficult for developing countries to attract HIV/AIDS resources from the developed world. Indonesia is fortunate that it is an emerging young democracy, it occupies a position as an important ally in the “war on terror” and it straddles the Strait of Malacca, a thoroughfare for oil and natural gas pipelines. All these facts have attracted the attention of countries with the resources to assist in the fight to stem the spread of HIV/AIDS. Indonesia was one of the first stops for newly appointed US Secretary of State Hillary Clinton. The Australian government and the Clinton Foundation are combining monetary forces to “increase the availability of affordable HIV treatment and diagnostic testing in Indonesia”. Unfortunately, there are other developing nations that are not in this same fortunate political and economic position.
The Center for Disease Control and Prevention (CDC) guidelines state that early treatment of HIV infection “may reduce HIV transmission.” Although not the only factor to be considered, when deciding how to allocate resources organizations need to balance the costs and benefits of a given course of action against the goal (namely to reduce the transmission of HIV). To do otherwise during the current global economic crisis could have dire consequences on those whose lives are affected by these decisions.
“I see a system failing. It is doing something, but it is not solving the problem.” These were the words uttered by Purnima Menon, a public health researcher with the International Food Policy Research Institute and reported in a New York Times article on March 13, 2009. She was referring to the rampant malnutrition evident among children in India. Almost half of all children under three years of age are underweight or severely underweight and malnutrition among children accounts for more than one-fifth of the total disease burden. Surprisingly, this staggering rate of malnutrition is occurring in a country that has one of the fastest growing economies in the world and has shown substantial economic growth for over a decade.
Certainly prioritizing funding to this area is part of the problem both at the national (Amartya Sen, a Nobel prize-winning economist, noted that hunger was not enough of a political priority in India) and international levels (Ruth Levine noted in her blog that malnourishment is well known to be severely under-funded internationally). Yet, insufficient funding alone does not tell the whole story. India runs the largest child feeding program in the world and has a $1.3 billion Integrated Child Development Services program to combat malnutrition via financing a network of soup kitchens in slums and villages. Despite this substantial investment, the program has been, for the most part, unsuccessful largely due to the fact that the program is not well designed and does not adequately target the groups most in need of their services (i.e., children). For instance, the New York Times article noted above described one center in which there were no children; instead the food was being given to the few adults who showed up. It has been argued that this problem, which is reflected at the international level, is due to a lack of leadership and governance (see Source 3).
Many believe that the solution is greater governmental intervention. The author of a Lancet article addressing this issue back in January 2008 wrote, “The compelling logic of this scientific evidence is that governments need national plans to scale-up nutrition interventions, systems to monitor and evaluate those plans, and laws and policies to enhance the rights and status of women and children.” Likewise, a blog published on March 13, 2009 (Hanging in the Balance: Who Will Deal with Child Malnutrition?) argued for increased governmental (both at the local and international level) attention and action.
Given the demonstrated success of PDPs in the area of drug development for neglected diseases in developing countries, it is somewhat baffling why a similar approach has not been more aggressively pursued in this area. The hurdles preventing programs from successfully managing malnutrition seem to be similar to those present in developing drugs for neglected diseases. As has been noted, the primary impediment in India (and arguably in other developing countries) has been a lack of implementation and efficient use of resources. These are the very areas that the private sector excels at addressing. It has been frequently observed in the areas of vaccine distribution and health care innovations that the strength of the private sector is reaching markets and dealing with regulatory challenges (see Sources 4 & 5) while the public sector brings to the table a thorough knowledge of the needs of the country (i.e., areas that are most effected by child malnutrition).
There are some who might argue that the lack of short-term commercial returns would deter private sector involvement. We find this argument to be both unpersuasive and unsupported by the data. Regarding the funding of neglected disease projects, Mary Moran reported that commercial incentives were largely irrelevant to large companies. Rather long-term business considerations such as “positioning themselves in emerging developing country markets, or building access to low-cost, high-skilled developing country researchers” were the primary motivators.
This idea of using PDPs is not novel despite the fact that it appears to be underutilized in the area of child malnutrition. Three years ago almost to the day (March 9, 2006) a document was released entitled Tackling Child Malnutrition Through Market/PPPs: An emerging trend. In this document the director of the UNICEF Nutrition Program in India observed that “solutions from a technical point of view are known, but the lack of collaboration between government, NGOs, and companies, together with obstacles inherent in existing structures, prevent real progress. In addition, the business community’s involvement is limited mostly to providing philanthropy, rather than developing and offering market-based solutions.” In light of this, and past demonstrated successes of PDPs, one has to wonder why a greater amount of attention and resources are not being put into developing PDPs.
3. Horton, R. (2008). Maternal and child undernutrition: an urgent opportunity, Lancet, 371, 179.
4. Mahoney, R.T., Krattiger, A., Clemens, J.D., and Curtiss, R. (2007). The introduction of new vaccines into developing countries IV: Global Access Strategies. Vaccine, 25, 4003-4011.
5. Mahoney, R.T. and Morel, C.M. (2006). A global health innovation system (GHIS). Innovation Strategy Today, 2, 1-12.
6. Moran, M. (2005). A Breakthrough in R&D for Neglected Diseases: New Ways to Get the Drugs We Need. PLoS Medicine, 2, e302.
A recent news post (03 March 2009) – based on the 2008 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on telemedicine for the benefits of patients, healthcare systems and society – discussed the benefits of telemedicine (delivery of medical care at a distance) to the lives of European citizens and their healthcare system.Specifically the post noted that telemedicine would be particularly useful in remote areas where medical support was not readily available or for medical specialties which are underrepresented in particular areas despite the need for them.Teleradiology and teleconsultation were offered as examples of medical services which could be used to “shorten waiting lists, optimise the use of resources and enable productivity gains” in regions lacking sufficient healthcare services whether due to access or a lack of expertise in a particular medical specialty.
It seems to me that poor access to health services and a lack of medical expertise are the very problems confronting developing countries, and in fact telemedicine arguably has the potential for greater good in developing countries compared to developed countries.Some have recognized this potential and are actively pursuing telemedicine in developing countries.The Bharatiya Janata Party in India increased R&D expenditures from 0.6% of GDP in 1999 to 1.1% of GDP in 2004 some of which was to be spent on the arrival of telemedicine in remote villages.The Telemedicine and Advanced Technology Research Center (TATRC), although a military organization focused on improving soldier healthcare, has also been involved in promoting medicine in developing countries such as the Balkans (Third Intensive Balkan Telemedicine and e-Health Seminar).
Still this is a far underutilized and largely unexplored technology given the potential benefits to developing countries’ healthcare.In 2001, Steven Edworthy published an article in the British Medical Journal in which he argues compellingly for the implementation of telemedicine in developing countries.His argument is predicated on several observations, including: (1) low bandwidth can reach very remote regions as evidenced by experiences in Cambodia, Kosova, and Uzbekistan; (2) telecommunications allow for greater flexibility in consultation which has the potential for greatly improved diagnostic accuracy; and (3) local physicians in developing countries will have greater access to medical literature.Although Edworthy acknowledges the hurdles involved in successfully implementing telemedicine in developing countries, he clearly believes it is worth the effort to explore the potential.A 2002 critique of the Edworthy article by Michael Rigby warned that significant strides in our understanding of the impact of telemedicine on developing countries’ health systems needed to be explored before such an endeavor could be safely implemented.Rigby concluded by observing that “[i]f telemedicine is to have any significant and safe impact in developing or other countries, global agencies such as the World Health Organization need to encourage and accumulate studies on its local impact, while also seeking a global framework to ensure its safety and ethics.”
Yet five years later it appears that very little progress has been made.An article published in 2007 in the Pacific Family Health Journal (Challenges of Telemedicine in Developing Countries) discussed many of the same issues discussed in 2001/2002 without any indication that progress had been made in addressing those issues.Still the tone of the article was positive and the author concludes that telemedicine has the potential to help solve the problems of healthcare access to remote regions.A 2009 article by Wootton et al. offered preliminary data indicating that low-cost telemedicine can be used to provide beneficial consultations in a low resource setting.In light of the generally positive outlook of telemedicine, and the potential for telemedicine to have a greater impact in developing countries compared to developed countries, it is baffling why such little progress has been made to implement such technology in developing countries.Apparently the technology itself is not a prohibitive hurdle since it is being actively explored in the European Union as evidenced by the article discussed above.I cannot help but wonder what it will take for a foundation such as the Gates Foundation to fund a project designed to seriously explore these issues.
3.Steven M. Edworthy. 2001. Telemedicine in developing countries. BMJ 323: 524-525.
4.Michael Rigby. 2002. Impact of telemedicine must be defined in developing countries. BMJ 324: 47.
5.Richard Wootton, John Menzies, & Paula Ferguson. 2009. Follow-up data for patients managed by store and forward telemedicine in developing countries. J Telemed Telecare 15: 83-88.
As discussed in “The Perfidy of the Precautionary Principle” (see blog by B. Harel and V. Lancaster), the EU’s adherence to the precautionary principle is stifling efforts to improve global sustainability in the realm of agriculture, thus inhibiting efforts to improve and expand health initiatives across the globe. Two upcoming conferences will afford members of the biotech community the opportunity to discuss the implications of current regulatory policy through the lens of the global financial crisis.
First, sponsored by Syngenta and the European Landowner’s Association (ELO), the 2nd annual Forum for the Future of Agriculture (FFA) will take place March 18 in Brussels. The goal of the conference is to address food and environmental security against the backdrop of the global economic crisis. Among Syngenta’s stated objectives is to determine Europe’s role in governing agricultural and environmental security (see Source 3). This objective suggests a growing unease with the de facto moratorium the EU has placed on the sale and production of GM crops, especially now that the global community must utilize biotechnology more than ever to aid developing countries.
Despite the global economic crisis, our global population continues to increase. GM crops and general applications of biotechnology can assist in abating problems stemming from inadequate food supplies due to overpopulation as well as insufficiently nourishing foods which can be altered to have more nutrients. No genuine data exists to suggest that GM crops are unfit for human consumption, however the EU has taken a “better safe than sorry” stance for far too long, and they continue to do so because aversion to all GMOs is deeply rooted in long-standing treaties and legislation. Perhaps extreme precaution would have been appropriate at the beginning of the agriculture biotechnology revolution when Monsanto released its first batch of Roundup-Ready seeds, or when the Flavr Savr tomato arrived because risks of GM crops were unknown, but now such risk-adversity is a detriment to efforts aimed at increasing sustainability in light of the complete lack of data suggesting GM is harmful. Of course ethical concerns (such as arguments that GM crops open the door to widespread use of GMOs in other disciplines) still come into play because they do not require scientific data to sound forceful.
The EU must rethink its risk-management strategy. There are other more effective methods of regulation, such as cost/benefit analysis and acceptable risk. The FFA conference, therefore, will be a tremendous step in the right direction because it will provide biotech scholars and policy makers the opportunity to discuss the merits of the precautionary principle in light of the current global crisis and compare it to the merits of other methods of regulation. Syngenta and ELO have invited representatives of the EU and US; because of this mixed group the precautionary principle should be discussed in the context of agriculture biotechnology in order to promote an international debate over whether the EU’s aversion is both appropriate and relevant. By doing so now and in the future, the precautionary principle will likely fade away gradually and be replaced by a regulatory scheme that will allow biotechnology to provide increased crop yields and sustainable practices for all.
Similar to the FFA conference, the Bio International Convention (BIC) will take place beginning on May 18, 2009, in Atlanta, Georgia. Whereas FFA will focus solely on agriculture, BIC will feature discussion of all facets of biotechnology – everything from health care to energy, as well as agriculture and fuel. According to Vertex Pharmaceuticals CEO Joshua Boger, the goal of the convention is for members of the biotech community to “pull up a seat and join the conversation” regarding the future of biotechnology, particularly in light of the global economic crisis.
The sheer scope of BIC will be important to help curb the negative effects of the precautionary principle by promoting roundtable discussions of other more appropriate regulatory models. As noted above, agriculture is not the only area being stifled, and indeed, the EU remains opposed to many other types of biotechnology – virtually anything involving GMOs. Those attending both conferences are likely to be cognizant of the global economic crisis, and they will be searching for sustainable solutions that can be achieved without increased funding, which has become increasingly scarce. By urging representatives from EU countries to part with anticipatory prior restraints on biotechnology, GM technologies can be furthered to benefit developing countries and promote food security.
Conferences such as FFA and BIC represent a small step in a very lengthy process of reforming an established regulatory system. Unfortunately the damage has already been done because EU citizens have been told for many years that biotechnology is so egregious that it should be banned outright. Citizens may continue to be resistant appreciating the benefits of GM crops and sustainable technologies because their government officials have opposed them publicly for a long time. One promising solution is to urge proponents of the precautionary principle to slowly accept GMOs as a viable method of relieving some of the stresses of the current global crisis. The global population will not stop growing, and with increased populations comes increased need for sustainable solutions. The precautionary principle lacks a viable foundation so proponents of biotechnology must urge their EU colleagues to act for the benefit of the whole sooner rather than later.
Jason Kasting and Vanessa Lancaster
Sources:
Marchant, G.E. and Mossman, K. L. Arbitrary and Capricious: The Precautionary Principle in the European Union Courts. Washington, DC: The AEI Press; 2004.
The Gates Foundation (“TGF”) recently pledged $90 million to boost the incomes, training, and access opportunities of cocoa and cashew farmers in Africa. TGF is donating $48 million while private industry is granting $42 million in cash and in-kind contributions. The stated purpose of these grants is to assist farmers in building better lives for their families and communities by improving the quality and quanity of cocoa and cashews grown in Africa, and to improve their overall health. This will be accomplished by teaching farmers how to manage their farms, access alternate markets, improve business skills, provide new and improved seeds, and improve the quality and quantity of their crops thus leading to numerous benefits including increased incomes and therefore access to healthcare and purported educational opportunities. According to Bill Guyton of the World Cocoa Foundation, as many as 200,000 farmers will benefit from these grants because cocoa and cashews are mainstays in African markets.
Bill Gates argues that both global health and agricultural advancements will result from this and other funding diverted to Africa. In a speech excerpted on TGF’s website, Bill Gates focuses on the potential for increased educational opportunities resulting from the infusion of strategically allocated funds:
“Agricultural productivity is one of the most basic things that can help the poor move to a prosperous life…As a farmer is able to produce more they can have a buffer stock so if there is a bad year they still have enough to eat, and they can take some of the excess and sell it and buy books and send their kids to school.”
But will improved education actually result from this funding, even indirectly? Perhaps in two or three decades, but overall it seems unlikely.
It is entirely possible that the “buffer stock” of money Gates refers to could be used to improve agricultural markets as well as the health and prosperity of farmers and those living in rural African communities or villages, but Gates may be too optimistic if he believes there will be any significant impact on education in west African communities. “We can help 150 million people triple their income in a few decades,” Gates proclaims, arguing that this newfound income will allow parents to provide for the health and well-being of their children by providing money to send children to school or buy books and school supplies. The connection between a “buffer stock” of income resulting from increased yields of cocoa and cashews and education seems tenuous at best.
Despite Gates’ optimism, education seems decidedly detached from efforts concerning agricultural and economic improvements. Education (both of children and farmers) can be achieved relatively quickly without having to wait for the offshoot benefits Gates believes are likely to occur as a result of an influx of funding within agricultural communities. The grant money being distributed in Africa will be disbursed so widely across the continent that any benefits to education are unlikely to come to fruition for decades unless efforts are targeted specifically at education.
Global health initiatives like this one are admirable but leaders in funding such as TGF should be forthright about what is likely to occur as a result of their grants. The $90 million investment in Africa’s future will offer a tremendous boost to the productivity of that nation especially if the funds are invested in cocoa and cashews, two major crops in Africa, but to proffer educational gains throughout the continent as one of the main benefits of this grant is shortsighted in that it is unlikely to occur as a direct result of the grant. In a decade it is possible that, through the so-called “agricultural value chain,” enough economic prosperity will result from grants such as these that eventually education will be improved thereby allowing young African men and women to live prosperous lives. But if education is a goal for TGF, they should make that the focus of efforts concentrated more specifically on education and refrain from making false claims about educational benefits that are unlikely to result from grants aimed at agriculture.
Grants aimed at agriculture are important to help eradicate hunger and poverty because they provide jobs and skills necessary to grow crops and earn a living while feeding consumers. These are important facets of agriculture markets but unless on-the-ground efforts are taken to increase education across Africa’s population education will never be a significant enough focus to foster any true improvement in that area. Perhaps some of the $90 million at stake would best be allocated to improve education among Africa’s youth in order to improve health and prosperity one child at a time. By providing impoverished children a broad education from an early age, perhaps agriculture markets would be improved because smart young men and women would be capable of inheriting their family farms and running them smartly and efficiently.
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