Monday's ruling from India's Supreme Court that Novartis could not claim patent protection for an expensive leukemia drug throws a spotlight on India's limited intellectual property (IP) protections and may constrain much needed innovation both in the health industry and the broader economy.
The court's verdict upholds language in India's 2005 patent law that says new forms of a known drug must be significantly more effective in order to win a new patent. The court's move represents a win for India's booming generic pharmaceutical industry, but it may prove a pyrrhic victory as it threatens to fundamentally limit the government's ability to improve Indian healthcare over the long term. Foreign corporations with any IP concerns will now be more careful about operating in India. The ruling could also have the unintended consequence of keeping domestic makers of generic pharmaceuticals at the lower end of the value chain.
The verdict is in fact the latest move by Indian authorities targeting international pharmaceutical firms' IP protections in order to help lower Indian healthcare costs. But, despite the government's hostility toward their business model, research and development-focused pharmaceutical firms such as Novartis are unlikely to exit India entirely. They will, however, proceed slowly and cautiously with the drugs they introduce and the patents they file.
The government's approach will also further box Indian pharmaceutical firms into their role as producers of low-cost, low-margin generic drugs. Over the long term, many Indian companies plan to invest substantially in research capabilities in an effort to develop new treatments and move up the value chain. These firms could become victims of their own lobbying and legal successes. Indian pharmaceutical companies will find it difficult to make the transition to higher value products if their IP protections are limited.
More broadly, the verdict could constrain innovation in other areas of the economy as well. Any firm that depends on IP may find the Indian market either unprofitable or unwelcoming (or both). A clear medium-term risk is that foreign investment in Indian research centers will also probably decline, threatening India's long-term growth. The Indian government can ill-afford to stifle the virtuous cycle of innovation if the country's economy is to provide adequate jobs, healthcare, and social opportunities for a largely disadvantaged population of 1.2 billion.
Sasha Riser-Kositsky is a researcher with Eurasia Group's Asia practice.
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By Emily Hoch
On Monday, as locals flock to successive showings of Contagion, the United Nations General Assembly will meet in New York for its second ever high-level meeting on health, on the comparably mundane topic of non-communicable diseases (NCDs): heart and chronic respiratory disease, diabetes, and cancer, among others. With all the high-drama causes out there, it might seem odd that the U.N. is focusing its attention on what are typically considered codas to the lives of the rich and the elderly. But NCDs have become a universal threat. They kill three in five people a year, and 80 percent of the victims in 2011 will live in developing countries. Roughly a third will be younger than 60. Even larger numbers of people are living disabled by these illnesses.
As such, low- and middle-income countries are facing what demographers call a double burden: Policymakers must balance prevention and treatment of diseases typical of the young and impoverished, such as diarrhea, pneumonia, and malaria, with stemming an NCD pandemic that the World Health Organization predicts will increase deaths by 15 percent by 2020. And despite the announcement today that Ely Lilly will donate $30 million to developing-country diabetes research, only 3 percent of all development assistance for health (worth a total of $22 billion) is dedicated to NCDs.
The only other U.N. General Assembly meeting on health was the 2001 session on HIV/AIDS, a turning point in the struggle to curtail that pandemic. Since 2001, billions of dollars have been spent on HIV/AIDS prevention and treatment, and almost every country includes an action plan for HIV/AIDS in their policy framework. The biggest achievement of the HIV meeting was the establishment of the Global Fund to Fight AIDS, Tuberculosis and Malaria, which has been lauded for reducing the human burden of these maladies while improving efficiency and country-level leadership.
A Declaration of Commitment on NCDs is likely this time around, too, and countries, activists, and corporations have found common ground on low-cost interventions. But real action is likely years away. While many in the global health community want to expand the Global Fund's mandate or to establish funds for other causes, neither of these options is likely. Experts have concurred that a new institution or funding pledge might distract cash-strapped governments from key tasks, such as strengthening overall health systems and regulating risk factors, including changes in the food and beverage industry. Instead, the United Nations will probably encourage member states to insert line-items for NCDs in their health budgets, develop national NCD plans, and take a strong stand on prevention.
Even there, the challenges will be considerable. In nearly every country, the sale and distribution of tobacco, alcohol, and unhealthy foods -- key risk factors for NCDs -- is big business. Governments dependent on tax revenue from the sale of these products may be hesitant to compel their citizens to change their lifestyles. China recently passed its first smoking ban, for example, but the state-owned China National Tobacco company generated $76 billion in taxes and profit for the country in 2010. Russia, the number three beer-consuming nation (after China and the United States), delayed any attempts at improving behavior by only recently classifying beer as alcoholic. And in Brazil, where 40 percent of the population is overweight and 10 percent is obese, the government has been accused of welcoming Nestle plants and micro-distribution networks that specialize in fatty and salty foods. So while the U.N. meeting next week is a significant step forward, as with losing weight, these changes will take years (if not decades) to implement.
Emily Hoch is an associate in Eurasia Group's global health practice.
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By Emily Hoch and Scott Rosenstein
In the shadow of Haiti's ongoing turmoil, infectious
disease tracker ProMed published a report
on Jan. 21 that polio
had may have been detected in Port de Paix and Port au Prince. Information remains scant. But if this report is only the tip of the
iceberg, this mostly forgotten scourge could regain a foothold in Haiti. This
is bad news for Haiti, the region, and a global polio eradication effort that
in the last few years has come tantalizingly close to success.
Polio is highly contagious and can become entrenched in communities, like Haiti, with weak water and sanitation systems. There is no cure, and few supportive therapies exist. Most cases do not cause significant illness but approximately 1 percent of all cases result in some form of paralysis and approximately 10 percent of these cases result in death.
Oral polio vaccine (OPV) is included in Haiti's routine child immunization program, but coverage remains poor at only 52 percent, well below the percentage necessary to provide herd immunity. Before the earthquake, 25 percent of children were malnourished (a significant risk factor for polio infection) and 40 percent did not have access to basic health services. Add to this equation mass displacement and nonexistent infrastructure and the prognosis becomes even more worrying.
The Americas were certified polio free in 1994. Since then, the only verified outbreak in the region was 21 cases in Haiti and the Dominican Republic in 2000-01. Surveillance in Haiti is difficult in the best of times and while there were no cases reported since 2001 some have speculated that failure to completely eliminate polio during this outbreak may have left the door open for its return.
Unless the Haitian Ministry of Public Health and the international community can act quickly and contain this outbreak, there is a considerable risk of it traveling to neighboring countries. Relations with the Dominican Republic, strained by decades of border disputes and the post-earthquake inflow of Haitian refugees, could worsen if polio, like cholera, makes its way into their country (on Friday the Dominican Republic reported its first cholera death). The Dominican Republic's polio immunization rate is considerably higher but still leaves them at the lower end of recommended levels. The United States has not had a polio case since 1993 and the vaccine coverage rate for 2009 was 93 percent, suggesting sufficient levels of herd immunity exist to prevent a significant outbreak. But coverage rates vary widely and growing vaccine skepticism in some communities has left large populations of children exposed to vaccine preventable diseases, making it impossible to rule out a limited return to the United States if there is a large uptick in cases within the Americas.
As we saw with H1N1 (swine flu) in Mexico, countries struggling to contain disease outbreaks in their own countries are quick to lay blame elsewhere. Regional spread of polio, if it occurs, will almost certainly see the majority of this blame placed on Haiti's shoulders. Travel restrictions and significant diplomatic disputes remain a very low likelihood scenario, but further demonization of Haitian communities can be expected if this outbreak is not contained.
After smallpox was eradicated in 1977, WHO pledged in 1988 that polio would be the next disease to be eliminated. 30 years later, endemic polio transmission is occurring in only four countries (Afghanistan, India, Pakistan, and Nigeria). However, politics and funding shortfalls threaten to thwart these efforts. A 2003 drive to eliminate polio in Nigeria collapsed after a combination of rumor, mistrust and poor communication convinced local leaders to boycott polio immunization, and subsequently led to outbreaks throughout Africa and as far away as Indonesia, which had been polio free for ten years. Vaccination drives in Afghanistan and Pakistan have been hampered by conflict, natural disasters, mobile populations, and religious refusals. Additionally, the Global Polio Eradication Initiative (GPEI) is perpetually struggling to meet its funding needs.
Details of this possible outbreak in Haiti will likely emerge in coming days and weeks. If cases persist, it will once again raise questions regarding the short-term trajectory of the polio eradication campaign, and it will be another in a laundry list of reconstruction challenges for this troubled Caribbean nation.
Emily Hoch and Scott Rosenstein are analysts in Eurasia Group's Global Health practice.
*This post has been edited since its initial publication to reflect that reports of polio in Haiti are currently suspected and unconfirmed.
THONY BELIZAIRE/AFP/Getty Images
By Scott Rosenstein
Last week, the World Health Organization (WHO) announced the end of the H1N1 pandemic (swine flu) and the beginning of the "post-pandemic phase." Upon hearing this momentous news, governments around the world did ... nothing.
A handful of media outlets carried the story. Some of the more ambitious blogs took the opportunity to update their big pharma conspiracy theories and hawk their own end of the world naturopathic remedies. But the most telling aspect of the announcement was in how little anybody cared. The alert system, which was set up to coordinate the global response to pandemic threats, failed to achieve that task and created a level of anger and cynicism that could obstruct coordination on future global health challenges for years to come.
As fear of swine flu swept across borders last year, many governments launched pandemic response plans that were linked to the WHO's alert system, a process developed over many years of tinkering that had never faced a real world test. As swine flu spread and the WHO moved to phase 4, these governments ramped up their surveillance activities and began mobilizing healthcare resources. When the system went to phase 5 -- sustained human-to-human transmission in at least two WHO regions -- emergency response plans were accelerated, and preparations for vaccination began. When the WHO chose to advance to phase 6 (the highest threat level) in June 2009, many countries had committed themselves to prepare for the worst, which included the acquisition and distribution of vaccines, antivirals, and other emergency goods. Many countries were ill-equipped to follow through on this costly plan.
But many people believed that, costly as they may be, emergency responses were absolutely necessary. The image of a modern day influenza pandemic included near or complete paralysis of the global supply chain in a world where most daily activities, including work and education, were significantly curtailed and human beings were living in near seclusion to limit the spread of the virus. That's not how it played out, of course. "Mild" pandemics happen, and by June 2009, it was becoming increasingly clear that that's what was happening in this case.
It was also clear that the world lacked a coherent definition of pandemic-not a trivial point when millions of lives and billions of dollars are at stake. Does a pandemic have to be a threat that humans have never before seen? How widespread must it be to qualify? Must it cause substantial human illness and death? If so, what constitutes substantial? Thousands of deaths worldwide? Millions? Is obesity a pandemic? The WHO made matters worse by presenting differing definitions on its website and within official preparedness documents.
In the months that followed, WHO officials continually tried and failed to communicate to the public that the various alert levels represented how easily the virus spread, not how deadly it was. The disconnect between the alert system and the public perception continued to widen as summer wore on, and many poorer nations began to reduce their preparedness efforts as wealthy countries squabbled over access to limited vaccines for populations that were becoming less and less interested in taking them. A growing perception that the WHO was ringing a false alarm fed anti-vaccine sentiment. As I wrote in this space six months ago, the WHO's communications failure became a catalyst for spurious claims that this institution's actions were carried out to serve the needs of pharmaceutical companies instead of global public health.
Flash forward to August 2010: The WHO announces the end of the pandemic, and virtually no one notices. European countries that responded to WHO alerts with heavy spending continue to face criticism. Countries like Poland that refused to purchase any pandemic H1N1 vaccine claim vindication, and there is real concern that growing skepticism could cripple plans to prepare for a future pandemic.
Like it or not, the need for an organization that can coordinate a global response to a transnational public health crisis remains. For now, there are no viable alternatives to the WHO. This institution's first challenge on the way to restoring its credibility is to help create a more unified definition of a pandemic. Considering some of the semantic vagaries currently surrounding this debate, this will not be an easy task. Next up will likely be an adjustment to their alert system to help health officials distinguish their mild and severe influenza response plans.
A successful effort on both fronts won't silence skeptics and critics. But perhaps the next time the WHO makes an announcement, a few more people will show up to listen. Presuming, of course, we are not all dead.
Scott Rosenstein is a global health analyst at Eurasia Group.
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By Scott Rosenstein
When the novel A(H1N1) virus ("swine flu") emerged in April 2009, many media outlets painted a picture of looming disaster, and the public looked for assurances that every precaution was being taken. The doomsday scenario appears to be off the table for now, and mainstream media interest in this issue now focuses primarily on criticizing the response. The World Health Organization (WHO) and many governments are now being taken to task for overreacting to a nonexistent threat that really only benefited pharmaceutical companies. This presents significant risks for institutions that now must defend themselves against a backlash that will likely reduce public engagement on this issue and reduce preparedness planning to emerging infectious disease threats of all kind.
In May 2009 we wrote about how the world was starting to get sick of swine flu. At that point, there were early signs that the virus might not produce the nightmare pandemic scenario that many public health experts were (and still are) worried about. The media was transitioning away from around-the-clock coverage as public interest began to wane. There were, however, lingering concerns about a more severe second wave of swine flu, and uncertainties about the quantity of and timeline for a vaccine.
Ten months later, those concerns are mostly gone. But the Council of Europe, a watchdog group, recently made headlines by claiming that the World Health Organization (WHO) hyped up a "false pandemic." Now the backlash is in full swing.
The Call, from Ian Bremmer, uses cutting-edge political science to predict the political future -- and how it will shape the global economy.