Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad (2012) / Chapter Skim
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3 Critical Issues
3 Critical Issues
Pages 79-146
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From page 79... ...
The committee found that regulators abroad face problems with: adhering to international standards, controlling supply chains, infrastructure, their laws, their workforce, institutional fragmentation, surveillance, communication, and political will. A detailed analysis of each of these gaps follows.
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From page 80... ...
Proponents of standards maintain that their use helps traceability through the supply chain, eliminates redundant audits, and when, harmonized across markets, decreases bureaucracy. Others see standards as little more than fines on poor countries because of the high costs of compliance (Marucheck et al., 2011)
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. ICMF Specifications for is not a standard setting organization.
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TABLE 3-1 Continued 82 Year Organization Established What they do What they set standards in • Food quality and safety Codex Alimentarius 1963 Codex is responsible for developing "food standards, Commission guidelines and related texts such as codes of practice • Codes of hygienic or technological practice under the Joint FAO/WHO Food Standards Program" • Pesticide and food additive evaluation (CAC, 2011)
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. European Directorate 1996 The EDQM "protects public health by enabling the • Quality and safety of medical products (EDQM, 2011)
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At the very least it requires a supplier to be able to trace products through the supply chain and show proof of adherence to best practices at all stages of production. This proof usually takes the form of a certificate of inspection, audit, or accreditation.
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Regulators in low- and middle-income countries depend on standards developed abroad; they often have minimal input into the standard setting process. Even more so than with agri-food standards, adhering to drug, biologics, and device standards demands sophisticated testing laboratories and control of complicated supply chains.
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From page 86... ...
Even when international standards are available to regulators and are appropriate, there are problems in adhering to quality standards if the medical regulatory authority has insufficient funding or trained staff or both. For example, one essential function of drug and biologic standards is to answer the questions, "Is this drug what is says it is, in the stated strength, and is it free of contaminants?
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From page 87... ...
Traceability requirements are less clear in medical products supply chains. During the 2008 heparin crisis neither the U.S.
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From page 88... ...
The Food Supply Chain Large multinational corporations such as Wal-Mart, Archer Daniels Midland, ConAgra, Nestle, Cargill, and Unilever control a great deal of the international food market. These companies have close relationships with their suppliers; they can trace their supply chains in developing countries, a considerable accomplishment considering that a granola bar contains ingredients from half a dozen different countries (Figure 3-1)
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From page 89... ...
. With the notable exception of one participant from Uruguay, the guests at the various site visits for this study explained that there are two supply chains in their countries: one for export and one for local consumption.
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From page 90... ...
The Indian agricultural cold chain business has an estimated net value of $2.6 billion, expected to more than quadruple by 2015 (Narula, 2011)
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From page 91... ...
Drying and juice making near the farm could preserve expensive fruits and vegetables, for example, provided there is equipment to pasteurize and package the food. The Medical Products Supply Chain A typical pharmaceutical supply chain consists of the primary manufacture of chemicals from their raw state; several steps of secondary manufacture from processed products; market warehouses and distribution centers; wholesalers; retailers; hospitals, clinics, or pharmacies; and, finally, patients (Yu et al., 2010)
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As in the food supply chain, some of the problems with medical products supply chains are related to infrastructure. There is a lack of hard data on where in the pharmaceutical supply chain bottlenecks exist (Oluka et al., 2010)
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From page 93... ...
. The revised definition defines substandard drugs as drugs that do not meet quality specifications, but that are produced by manufacturers authorized by a given national medical regulatory authority.
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From page 94... ...
. Box 3-2 describes the vaccine supply chain in developing countries.
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Measles, Polio Pentavalent Pnemococcal Introduced Introduced Introduced* DTP, BCG Rotavirus Introduced Introduced*
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Trained logisticians and supply chain managers will be invaluable to this effort, but they are hard to find in the places that need them most. There are two vaccine supply chains in developing countries: one that carries the vaccines from the factory to the developing country port of entry and one that carries the vaccines from the port of entry to the patient.
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Such redundancy hinders the development of integrated, efficient supply chains. SOURCE: Kauffmann et al., 2011 or whole seller.
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From page 98... ...
Kearney developed solutions that relieved the pressure of health care budgets, reduced the cost of medicine, and improved the efficiency of the drug supply chain (A.T. Kearney, 2004b)
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. INFRASTRUCTURE It is difficult to separate problems controlling supply chains from problems with infrastructure.
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In South Africa, the drug regulatory authority contracts universities to do quality control testing for biologics and drugs (Essack et al., 2011)
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Their efforts are improving reference laboratories and supporting pharmacists in good clinical practice and good pharmacy practice. The Southeast Asia Infectious Disease Clinical Research Network (SEAICRN)
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From page 102... ...
. Local manufacture and sale of processed foods is part of life around the world, but the manufacture of medical products is more controversial.
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From page 103... ...
Recalls depend as much on transportation and communication infrastructure as they do on product tracing. Farmers in poor countries are usually obliged to sell their crops at harvest, when the market is glutted and prices are lowest, because the spoilage process starts quickly, as mentioned above in the discussion of supply chains.
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. The laws governing food and medical products invariably reflect a country's political, economic, and cultural
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Some developing countries have no laws governing food or drug safety; others have a surfeit of confusing and contradictory ones (Vapnek and Spreij, 2005; WHO, 2005)
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In these countries, as in many other emerging economies, regulatory authorities face more problems enforcing their laws than creating them. It is difficult to strengthen law enforcement in the face of poor staffing, inadequate infrastructure, and lack of political will (Bollyky, 2009)
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Civil Liability Appendix B, "A Review of Tort Liability's Role in Food and Medical Product Regulation," describes the role of product liability in regulatory systems and provides an overview of the different systems in place in South Africa, Brazil, China, and India. WORKFORCE During the public meetings for this study the committee repeatedly heard that regulatory authorities in developing countries have too few staff, insufficient technical training for staff, and an inability to retain staff.
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. A 2002 comparative analysis of 10 different drug regulatory authorities found the shortage of qualified staff to be the main problem facing medicines regulatory authorities around the world (Ratanawijitrasin and Wondemagegnehu, 2002)
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From page 109... ...
. Similarly, the non-profit organization Engineering and World Health identified lack of trained staff as a serious barrier to the use of hightech medical devices in the poorest countries, explaining, "In countries where the literacy rate can be 50 percent, eligible workers can be difficult to find" (Malkin, 2007, p.
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More junior implementing staff are harder to reach. Reaching and training the proper staff for a variety of jobs in the food and drug regulatory authority are of special concern to this report.
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From page 111... ...
Problems Retaining Staff Government jobs in food and medical product regulation do not pay as well as positions of comparable seniority and scientific expertise in the private sector. This is true in rich countries as well, although in 2007 Congress authorized incentive pay for government scientists in an effort to close this pay gap (Bridges, 2007)
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The government understood that a stable, independent regulatory authority was important to economic development: investors are reluctant to fund industry if the regulations governing it change with every election. The National Health Surveillance Agency (Anvisa)
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From page 113... ...
Fragmentation is even more serious a problem in the poorest countries. In its analysis of medicines regulatory authorities in Sub-Saharan Africa, the WHO found that an organizational chart was missing in four countries; nine had unclear or missing job descriptions for key positions (WHO, 2010a)
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In both China and India, every regulatory authority has offices at multiple levels of government. That is, the national drug regulatory authority has provincial and municipal levels as well.
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. In the era of global supply chains, anti-microbial resistance, and international epidemics, "all countries .
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surveillance is still part of the regulatory system. It is difficult to trace back through a supply chain that includes many anonymous transactions (Todd and Narrod, 2006)
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Nowadays, when food is contaminated at or near the farm or in processing, the global food supply chain can quickly spread the pathogen. Modern outbreaks can be far removed from their triggers in time and place.
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Drug and Device Surveillance Medical products go through safety and efficacy evaluations before they come to market. Even large-scale trials, however, cannot identify rare or latent problems with the product, nor do trials have the power to assess product safety in small sub-populations.
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. The poorest countries generally do not have drug regulatory authorities with sufficient pharmacovigilance systems to become full members of Uppsala.
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to lance Center 667 (in 2002) Yes Yes National From Mandatory No None Yes China State Food and Drug Center for 4,700 (in Administration Adverse Drug 1988–1999)
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to Drug Event more than Monitoring 500 (in 1999) Center Yes Yes N/A Yes None Yes Malaysia Drug Control Malaysian From 787 (in Authority Adverse Drug 2001)
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. The postmarket surveillance for medical products is complicated, and it is a wide gap in developing countries.
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From page 123... ...
They cannot respond without data collected from safety surveillance. The WHO's Developing Country Vaccine Regulator's Network is a useful forum for representatives of drug regulatory agencies of Brazil, China, Cuba, South Korea, India, Indonesia, South Africa, and Thailand to come together to share their knowledge and experience (Chocarro et al., 2011)
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. As exemplified by the surveillance of RotaShield, SANEVA's approach is improving vaccine safety monitoring in Latin America.
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The Indian HPV scandal is a reminder that even if developing country regulators improve their capacity for pharmacovigilance, it will be of little value without complementary improvements in communication. COMMUNICATION For food and medical product regulators, who are privy to trade secrets and confidential information on product development, trial results, and inspections, the balance between sharing information and building trust in confidentiality can be hard to strike.
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The communication problems developing country regulators face fall into four broad categories: communication within a regulatory authority and across government agencies that share regulatory responsibility; communication between regulatory authorities and those they regulate; communication to the public; and communication with counterpart regulatory agencies abroad. Communication Within a Regulatory Authority and Across Government Agencies That Share Regulatory Responsibility When multiple agencies within a country share oversight and responsibility for regulation, the need for communication among all the agencies is paramount.
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From page 127... ...
In developing countries, it is more complicated. Sometimes a culture of saving face prevents admission of problems; other times the regulatory authority may question the utility of taking public action, such as issuing a recall, if it lacks the muscle to implement it.
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There are international forums that bring regulators together, however. The WHO's International Food Safety Authorities Network and its International Conference of Drug Regulatory Authorities bring together regulators to strengthen international collaboration.
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. In some large developing countries food and medical product safety programs are the purview of the same agencies responsible for either promoting commerce or assuring drug availability through price controls.
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. The SFDA is in charge of "the administrative and technical supervision of the research, pro duction, distribution, and utilization of drugs, bulk chemicals, medical devices, medical dressings, and pharmaceutical packaging materials" (Zhen, 2004, p.
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From page 131... ...
Ministers of Health in these countries have many problems: malnutrition, child mortality, infectious disease, water shortages, health financing, and poor sanitation, to name a few. With so many demands on their attention, they do not always see food and medical product safety as a high priority.
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From page 132... ...
The 2008 Global Health Initiative Strategy Document describes the Obama administration's commitment to strengthening health systems, in particular the goal of "improved research and regulatory capacity to support clinical trials, bring new, high-quality innovations to partner country markets; and monitor the quality, safety, and efficacy of the supply chain" (GHI, 2012, p.
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From page 133... ...
It also hedges them out of lucrative export markets. International standards assume control of supply chains.
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More commonly, food and medical product safety slip through the many cracks in nascent health systems. Ironically, the past decade of donor support for health programming has encouraged governments to spend their money in other sectors.
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2004b. An imperative for public health care: Improving the medicine supply chain.
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2011. Consultation on interactions between national regulatory authorities and national immunization technical advisory groups.
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2011. Antibiotic supply chain and management in human health.
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2008. Procurement, supply chain management and service delivery of the Global Fund grants to the government of India.
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2010. Improving health systems in developing countries by reducing the complexity of drug supply chains.
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2010. From decentralised developmental state towards authoritarian regulatory state: A case study on drug safety regulation in China.
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2011. Product safety and security in the global supply chain: Issues, challenges and research opportunities.
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2012b. Rethinking the vaccine supply chain.
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2008. Unraveling the food supply chain: Strategic insights from China and the 2007 recalls.
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Critical issues in the fresh fruit and vegetable supply chain (update)
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2011. Supply chain management: Providing quality medicines for people living with and affected by HIV/AIDS.
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2010b. Counterfeit medical products: International medical products anti-counterfeiting task force: Report by the secretariat.
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