OR WAIT null SECS
Eduardo Pisani, director general of the International Federation of Pharmaceutical Manufacturers & Associations, discusses the global health initiatives and related activities of the association.
The complexity of global health concerns requires the engagement of national and regional governments, the private sector, nongovernmental organizations, and other civil-society organizations. For the pharmaceutical industry, this involvement can be through individual companies and collective industry actions. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) is an important instrument of collective participation on global health concerns. IFPMA represents 26 multinational research-based pharmaceutical companies and 45 national industry associations in North America, Western Europe, Japan, Australia, Central and South America, Asia, and Africa. Eduardo Pisani, IFPMA’s director general, recently spoke with Pharmaceutical Technology to discuss the association’s policy objectives and action plans in global health, including influenza pandemic preparedness, noncommunicable diseases, counterfeit medicines, and neglected tropical diseases.
IFPMA’s framework of action
IFPMA occupies an important position at the table of stakeholders involved in global health policy and action. “The mission of the IFPMA is to engage with international organizations to build mutual understanding and to find effective and sustainable solutions to major global health issues with a focus on medicine quality, innovation, and access,” says Pisani. To that end, IFPMA, based in Geneva, has formal consultative status with the United Nations (UN), UN’s specialized bodies, including the World Health Organization (WHO), and with other international organizations, such as the World Intellectual Property Organization, the World Bank, and the World Trade Organization. Consultative status with the UN Economic and Social Council is granted to qualified nongovernmental, nonprofit, or voluntary organizations to enable these organizations to contribute to the work programs and goals of the UN by serving as technical experts, advisers, and consultants to governments and the UN Secretariat. Organizations with consultative status are invited to participate in UN conferences, General Assembly special sessions, and other meetings called by other intergovernmental bodies. In its consultative status with the UN, IFPMA is engaged in the ongoing dialogue on the major global health concerns and is a participant in the solutions that emerge from that dialogue.
Pisani outlines IFPMA’s focus in drug quality, innovation, and access. “In the area of quality, IFPMA’s role is to advocate for policies and regulations aimed at ensuring that quality standards of medicines and vaccines are consistently implemented in all countries,” he explains, “and to provide expertise and capacity-building support so that patients’ health is not comprised by substandard or counterfeit medicines, particularly in developing countries.” In the area of innovation, Pisani says IFPMA’s aim is “to help create a global policy environment that is conducive to biopharmaceutical innovation for the benefit of all patients.” With regard to access to medicines, he emphasizes that the association “advocates policies and seeks partnerships that facilitate substantial access to medicines around the world. This involves working to ensure that medicines are available to patients worldwide but also underscores the need to upgrade healthcare infrastructure so that they are capable of absorbing new therapeutic options.”
These three core areas of quality, innovation, and access serve as the framework for the specific work of IFPMA in global health, which increasingly requires partnerships between the private and public sector. “Nowadays, most of the work accomplished in the global public health arena is collaborative in nature, so multistakeholder partnerships are encouraged,” says Pisani, pointing to partnerships in research and development (R&D), capacity-building, training, or technology transfer.
He points to the collaborative focus inherent in the UN Millennium Development Goals (MDGs), a set of eight time-bound targets for addressing extreme poverty, hunger and disease (i.e., maternal and children's health and specific diseases, such as HIV/AIDs, malaria, and tuberculosis), gender equality, education, and environmental sustainability, particularly MDG Goal 8, which emphasizes global partnerships. “MDG Goal 8 specifically mentions the need for cooperation with pharmaceutical companies in the development of a global partnership to provide access to affordable, essential drugs in developing countries,” says Pisani. To illustrate IFPMA’s role in the MDGs, Pisani noted that IFPMA member companies have approximately 210 projects in place, worth an estimated $9.2 billion that address the health-related MDGs. By 2015, the date set for the MDGs to be realized, if the present trend is maintained, the value of these projects is expected to increase to $20 billion (excluding companies’ expenditures on R&D for diseases of the developing world), he adds.
Influenza pandemic preparedness
Influenza pandemic preparedness, including access to vaccines for developing nations, is a crucial issue in global public health and was one of the topics addressed by the World Health Assembly, the decision-making body of WHO, which met in mid-May in Geneva. At the meeting, the World Health Assembly, which consists of the delegates from all WHO member states, agreed to the Pandemic Influenza Preparedness (PIP) framework. IFPMA contributed to the deliberations of the WHO Open-Ended Working Group (OEWG) of Member States on PIP, which was tasked with improving the global system for responding to future influenza pandemics. The OEWG adopted an agreement in April 2011 for a PIP Framework, which was endorsed by the World Health Assembly in May.
IFPMA supported the OEWG's plan, in particular for addressing key challenges, such as increasing the capacity of vaccine production and enabling access in developing countries. IFPMA also supports the WHO's financial parameters for the industry for the WHO Global Influenza Surveillance Network (GISN). GISN serves as a global alert mechanism for the emergence of influenza viruses with pandemic potential and is also the mechanism through which WHO recommends the content of the influenza vaccine for the subsequent influenza season.
The OEWG recommendation includes specific requirements for users of the GISN to ensure that vaccines and antivirals are made available to developing countries in the event of a future pandemic. During the most recent H1N1 pandemic, IFPMA vaccine manufacturers committed 166 million doses to meet the WHO target of 200 million vaccine doses for developing countries, according to IFPMA.
In commenting on the PIP framework, IFPMA recognized the importance of local production of vaccines and antivirals in pandemic preparedness and said it would continue to explore local production, pointing to investment made by member companies in several countries, including Mexico, Brazil, China, Indonesia, and Thailand. During the OEWG/PIP consultations, individual IFPMA members confirmed that they also were willing to voluntarily undertake a selection of actions in the event of a future pandemic, including production-capacity expansion and access to reverse-genetics technology, dependent upon skills, knowledge, financial management, public-health policy, and national regulation.
IFPMA supported the adoption of the OEWG/PIP recommendations by the World Health Assembly in May, but also pointed to the need to increase vaccine-production capacity. “It has reminded us that timely access to candidate vaccine viruses and reagents is vital; secondly, that rapid evaluation and approval mechanisms for vaccines must be in place along with effective distribution networks; and thirdly, that seasonal vaccination recommendations provide a means to reduce the burden of influenza whilst sustaining and increasing global vaccine production capacity,” said Pisani, in a May 24, 2011, IFPMA press release.
In an interview with Pharmaceutical Technology preceding the World Health Assembly meeting in May, Pisani noted the importance of participation of other stakeholders in global influenza pandemic preparedness. “We believe that national governments should play a crucial role in ensuring vaccines reach their population, including immunization policy of seasonal influenza as advised by WHO,” he said. “This would need to be accompanied by regulatory procedures, country surveillance, health-system surveillance, and rules for transfer of viruses to build on significant contributions to the global pandemic made by IFPMA members.”
Noncommunicable diseases, particularly cancer, cardiovascular disease, respiratory disease, and diabetes, are a growing health problem in the developing world. “Noncommunicable diseases present a gigantic challenge for the public health community over the coming years,” says Pisani. “Today, the poorest countries account for a very high burden of the global noncommunicable disease burden. As in the developed world, part of the problem arises from lifestyle choices that can contribute to certain diseases. Noncommunicable diseases have become a problem in certain countries as lifestyle choices, such as an unhealthy diet and tobacco use, accompany a rise in the overall standard of living for middle-income countries as the economies of these countries improve.
To address the problem, the UN will hold a first-ever UN General Assembly High-Level meeting on noncommunicable diseases in New York in September 2011. IFPMA will be responsible for conveying the research-based pharmaceutical position on chronic diseases. “We believe that the experience in the developed world demonstrates the crucial role of changing risky behaviors and prevention,” says Pisani. “We also will be advocating for the effective, multistakeholder strategies at the global, regional, and national levels that are fully integrated into healthcare systems.” In this multistakeholder framework, he says that governments, the research-based pharmaceutical industry, civil society organizations, and health professionals can play a role in increasing education and awareness, improving early detection and disease surveillance, and facilitating implementation of prevention programs.
In April 2011, the first global Ministerial Conference on Healthy Lifestyles and Noncommunicable Disease Control was held in Moscow. Presented at that meeting was a survey conducted by IFPMA and the Association of International Pharmaceutical Manufacturers (AIPM), which is the Russian national pharmaceutical trade association. The survey, Population Attitude to Personal Health: Perception of Health, Understanding of Risk Factors, Morbidity and Mortality, which was conducted in Russia from January 2011 to April 2011, showed a significant gap between what people think their state of health is and the negative impact of their behavior, such as smoking, abuse of alcohol, obesity, and lack of physical exercise, has on their health. “The Russian study illustrates the scale of the challenge to be tackled not only in Russia, but in other countries, such as China and India,” says Pisani. He cites estimates that projects that between 2005 and 2015, China, India, and Russia could lose $200 billion to $550 billion in national income due to the effects of noncommunicable diseases.
Counterfeit drugs in the developing world are a large public health concern and represent a key strategic focus for IFPMA. In 2010, 1735 incidents of fake medicines were reported by the Pharmaceutical Security Institute, a Washington, DC-based nonprofit organization, a nearly 10% increase compared with the prior two years. One third of these cases reached licensed wholesale distributors and/or pharmacies in 37 different countries. The Pharmaceutical Security Institute was established in 2002 in Washington DC with participation of the security officers of 14 pharmaceutical companies. It has since expanded to include representational offices in Hong Kong and London and membership of 25 pharmaceutical companies, which share information on counterfeit medicines and initiate enforcement actions through the appropriate authorities. In 2010, IFPMA partnered with its member association, PReMA, the national pharmaceutical industry association in Thailand, the International Association of Patients Organization, and the US Pharmacopeia to raise patient awareness about the health risks imposed by counterfeit medicines in Southeast Asia. IFPMA also chairs the working group on anticounterfeiting technologies of the International Medical Products Anti-Counterfeiting Task Force (IMPACT). IMPACT was established by WHO in 2006 as the organization’s drug anticounterfeiting group. It consists of multiple stakeholders, which include national pharmaceutical regulatory authorities, health professionals, patients, the generic-drug industry, the research-based pharmaceutical industry, and pharmaceutical distributors and wholesalers.
At its meeting in May, the World Health Assembly discussed the report from the working group of Member States on Substandard/Spurious/Falsely-Labeled/Falsified/Counterfeit Medical Products on improving access to quality and affordable medical products. The assembly approved the decision to extend the working group to resume its work and report to the next World Health Assembly. In commenting on the action, IFPMA stressed the importance of continuing and strengthening the efforts against anticounterfeit drugs. “The decisions taken on fake medicines provide a viable basis to build on existing work,” said IFPMA in a May 24, 2011, release. “It remains, however, in the longer term vital to establish a platform for international collaboration to protect patients from the dangers of fake medicines.”
Neglected tropical diseases
Approximately 1 billion people, or one person out of six people, are afflicted with a tropical disease, and WHO, along with IFPMA, recognize neglected tropical disease as a public health concern. In October 2010, WHO issued its first-ever report on neglected tropical disease, which typically have low visibility in the developed world as they tend to affect specific populations or areas in impoverished and developing nations. Of the world’s poorest 2.7 billion people (defined as those who live on less than $2.00 per day), more than 1 billion are affected by one or more neglected tropical diseases, according to WHO. The WHO report focuses of 17 tropical diseases: dengue fever, rabies, trachoma, Buruli ulcer, endemic treponematoses, leprosy, Chagas disease, sleeping sickness, leishmaniasis, cysticercosis, guinea-worm disease, echinococcosis, foodborne trematode infections, elephantiasis, river blindness, bilharziasis, and intestinal parasitic worms. Most of the diseases are parasitic diseases caused by various protozoan and helminth parasites.
Private-sector support through R&D and direct financial contributions are part of the solution to addressing the problem of neglected tropical diseases. “IFPMA has supported WHO’s efforts to ensure that neglected tropical diseases receive greater attention,” says Pisani. In its 2010 report, WHO identified the contributions made by the pharmaceutical industry. Some specific company initiatives include:
• Novartis renewed its commitment to donate an unlimited supply of multidrug therapy and loose clofazimine for leprosy and its complications.
• GlaxoSmithKline announced a new five-year commitment to expand its donation of albendazole through WHO, in addition to its current donation for lymphatic filariasis to treat school-age children for soil-transmitted helminthiases in Africa. The commitment includes 400 million doses per year for this purpose.
• Sanofi agreed to renew its support for the WHO program to eliminate sleeping sickness and its support for treatments for Buruli ulcer, Chagas disease, and leishmaniasis for the next five years.
• Eisai committed to work toward the global elimination of lymphatic filariasis by providing free of charge to WHO up to 2.2 billion 100-mg tablets of the drug diethylcarbamazine.
• Johnson & Johnson announced it is expanding its donation of mebendazole to supply up to 200 million treatments per year for treatment of intestinal worms in children.
Aside from financial and product donations, Pisani points to collaborative R&D models that the industry is using to address neglected tropical diseases. He points to GlaxoSmithKline’s “open-innovation” strategy of sharing intellectual property in the area of neglected tropical disease. This approach was further advanced by the creation of a nonprofit organization, BIO Venture for Global Health, which provides scientists and their institutions with access to compounds, technologies, and expertise. Pfizer, along with the Drugs For Neglected Diseases initiative, have allowed affiliated institutes to screen approximately 150,000 compounds in Pfizer’s library for African sleeping sickness and Chagas disease. AstraZeneca partnered with the Medicines for Malaria Venture to permit 500,000 compounds in its library to be screened.
Capacity-building serves an important role in advancing global public health, and Pisani explains the role that IFPMA is playing. The association facilitated setting up a Clinical Research Career Development program, which is coordinated by the UN Children’s Fund (UNICEF)–UN Development Program (UNDP)–World Bank–WHO Special Program for Research and Training in Tropical Diseases. “The aim is provide practical clinical experience for promising researchers from low- and middle-income countries and encourage high-quality clinical R&D on medicines, vaccines, and diagnostics,” explains Pisani. After a 12-month fellowship with a research-based pharmaceutical company, the researchers will return to their home countries and institutes to become a resource for R&D for infectious diseases. In 2009, 12 fellows were placed in training programs with seven IFPMA member companies: Eisai, GlaxoSmithKline, Johnson & Johnson, Novartis, Pfizer, Roche, and Sanofi. This year, some of those companies are taking second fellows, and additional fellows are being placed with the IFPMA member companies of Astellas, Boehringer Ingelheim, Merck & Co., and Sigma-tau.
Using technology to improve healthcare delivery and access to medicines is another important component in global public health. Pisani points to the SMS for Life pilot, a public–private partnership initiated by Novartis with IBM, the mobile-telecommunications company Vodafone, and the Ministry of Health in Tanzania that uses mobile phones, short-message service (SMS) messages, and electronic-mapping technology to monitor stock levels of artemisinin-based combination therapies and quinine injectables at health facilities on a weekly basis as a way to eliminate medicine stockouts for these malaria treatments. The pilot was conducted during a five-month period in September 2009 and covered 226 villages and more than 1 million people in Tanzania with strong results. For example, during the first eight weeks, in one district, the number of health facilities with stock-outs was reduced by more than 75%.
IFPMA also is joining with other stakeholders to support plans to combat antimicrobial resistance, which was the theme of WHO’s World Health Day this year. “While recognizing the R&D-based pharmaceutical industry’s role in innovation, we called for viable approaches, including incentives, and support from other stakeholders in creating an environment that ensures new antibiotics continue to be developed.
Pisani emphasizes that the pharmaceutical industry’s participation in solving global health concerns is part of a larger collaborative, multistakeholder approach. In that effort, he says transparency, cooperation, and trust are key. “We have to walk the talk,” he concludes, underscoring not only the industry’s participation in the dialogue on global health concerns, but its specific involvement in solutions.