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Pharmaceutical Legislation and Regulation 7 Pharmaceutical Production Policy 8 Pharmaceutical Supply Strategies Financing and Sustainability

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Pharmaceutical Legislation and Regulation 7 Pharmaceutical Production Policy 8 Pharmaceutical Supply Strategies Financing and Sustainability Part I: Policy and economic issues Part II: Pharmaceutical management Part III: Management support systems Policy and legal framework 1 Toward sustainable access to medicines 2 Historical and institutional perspectives 3 Intellectual property and access to medicines 4 National medicine policy 5 Traditional and complementary medicine policy 6 Pharmaceutical legislation and regulation 7 Pharmaceutical production policy 8 Pharmaceutical supply strategies Financing and sustainability chapter 6 Pharmaceutical legislation and regulation Summary 6.2 illustrations 6.1 The role of pharmaceutical legislation and Figure 6-1 Resources for medicine registration in twenty-six regulation 6.2 African countries 6.13 Why pharmaceutical laws and regulations are Figure 6-2 Reports of counterfeit medicines by therapeutic necessary • Differences between pharmaceutical laws, class received in 2007 6.15 regulations, and guidelines • Evolution of policy and Table 6-1 Resources required for effective administrative law • Globalization and harmonization • Drafting and control 6.17 revising pharmaceutical legislation and regulations country studies 6.2 Basic elements of national pharmaceutical legislation 6.7 CS 6-1 The evolution of pharmaceutical legislation 6.4 CS 6-2 Harmonization efforts in the Americas 6.5 6.3 Key provisions of national pharmaceutical CS 6-3 Revising registration procedures in legislation 6.7 Namibia 6.12 Defining the roles of various parties • Licensing, inspection, CS 6-4 Regulatory interventions in Lao P.D.R. 6.14 and quality control • Pharmacovigilance • Advertising and promotion • Sanctions boxes 6.4 Medicine registration, licensing, and marketing Box 6-1 Elements of a comprehensive drug law 6.7 authorization 6.10 Box 6-2 Adverse drug reaction monitoring 6.9 Classifying pharmaceuticals for dispensing • Regulating Box 6-3 Stages in the evolution of a medicine registration traditional and herbal medicines system 6.11 Box 6-4 Interchangeability 6.12 6.5 Controlling alternative and informal distribution Box 6-5 Regulatory hurdles in the development of channels 6.13 microbicides for HIV/AIDS 6.16 6.6 Substandard and counterfeit medicines 6.14 6.7 Establishing effective administrative control 6.15 Required resources • Financing • Guiding principles for small national drug regulatory authorities 6.8 Evaluating the effectiveness of pharmaceutical legislation 6.18 References and further readings 6.19 Assessment guide 6.20 copyright © management sciences for health 2012 6.2 POlicY AND LEGAL frameWORK SUMMARY Realistic and effective laws and regulations are needed • Inventory the laws and regulations already in force for the pharmaceutical sector because— • Determine what type of legislative instrument is required • Pharmaceuticals concern the whole population • Involve both legal and health experts • Many parties are involved: patients, health provid- • Keep all interested parties informed ers, manufacturers, and salespeople • Serious consequences, including injury and death, National drug legislation generally includes provisions can result from the lack or misuse of medications relating to the manufacturing, importing, distribution, • The consumer has no way to determine product marketing, prescribing, labeling (including language), quality dispensing, and sometimes pricing of pharmaceutical • Informal controls are insufficient products, as well as the licensing, inspection, and control of personnel and facilities. A regulatory authority is usu- Countries may choose to develop new legislation or to ally established for administrative control. Medicine revise existing laws. When starting afresh, it is useful to registration is often a major element in legislation, to prepare a general law. Models exist, and expert assistance ensure that individual products meet the criteria of effi- is readily available. After the law is passed, regulations cacy, safety, and quality. made under it can bring its various provisions into oper- ation, one by one, as the necessary resources and experi- Countries that need to introduce comprehensive legisla- ence are acquired. tion can seek guidance from the experiences of others and from WHO (2001a) guidelines. In drafting or revising legislation, a country should— 6.1 The role of pharmaceutical legislation language that enables the government to issue regulations and regulation based on the law. Passing new laws may require a lengthy process, with the country’s legislative branch giving final The role of pharmaceuticals has become more prominent approval. Regulations can be passed more rapidly and sim- on international agendas as health indicators have been ply than laws, sometimes requiring, for example, only the increasingly linked with a country’s successful development. approval of a single government minister on the advice of In addition, the legal and economic issues that surround experts. They can also be altered more easily. After approval, pharmaceuticals have become more complex and politi- a regulation has the same power as the law itself. Guidelines, cized because of the increase in global trade. which do not carry the force of law, can be more easily modi- fied and updated and offer informal information on what Why pharmaceutical laws and regulations are the government’s thinking is regarding the best way to necessary implement regulations. Following guidelines will help avoid misinterpretation of and facilitate compliance with laws and The use of ineffective, poor-quality, or harmful medicines regulations. can result in therapeutic failure, exacerbation of disease, Pharmaceuticals involve many parties, including patients, resistance to medicines, and sometimes death. It also under- doctors, other health workers, salespeople, and manufactur- mines confidence in health systems, health professionals, ers. The field also involves important risks: people can suf- pharmaceutical manufacturers, and distributors. To protect fer or die not only from a lack of medicines, but also from public health, governments need to approve comprehensive drugs that are impure, wrongly prescribed, or used incor- laws and regulations and to establish effective national regu- rectly. Thus, it is easy to see why laws and regulations are latory authorities to ensure that the manufacture, trade, and needed. However, some argue that medicines—like many use of medicines are regulated appropriately and that the other commodities—should be subject only to the control public has access to accurate information on medicines. of the ultimate user. But medicines are indeed different, as discussed in Chapter 1. Differences between pharmaceutical laws, Additionally, informal controls are insufficient: charla- regulations, and guidelines tanism or quackery (that is, the deliberate sale of remedies known to be worthless) is centuries old, and firm action Laws today are usually written in fairly general terms to may be needed to put a stop to it; however, as discussed meet present and possibly future needs. Laws usually have later in the chapter, the Internet presents new challenges in 6 / Pharmaceutical legislation and regulation 6.3 controlling deceitful drug promotion. Counterfeiting, also, • What are the most important goals to achieve within has been on the rise in developed and developing countries. five, ten, and fifteen years? U.S. customs officials, for example, report that pharmaceu- • What means are available to achieve them? ticals are one of the fastest-growing categories of counterfeit • In which order can they best be tackled? goods coming into the country illegally. Pharmaceuticals • What help is available? accounted for 10 percent of total seizures in 2008 to become the third-largest category, compared to 6 percent in 2007 The answers to these questions provide a good starting (Mui 2009). point in developing both policies and the laws needed to The approach to pharmaceutical regulation should not be support them. simply punitive: rules creating a positive situation tend to Laws and regulations are intended to be used together to be more effective. Finally, laws and regulations are effective achieve their objective. It is appropriate to begin with passing only to the extent that they meet society’s needs. a broad law, emphasizing the requirement that pharmaceu- tical products be safe and effective. The various provisions Evolution of policy and law of the law are then brought into operation through regula- tion, step by step, addressing the most important things first. There may be a long preparatory period before the sort of For instance, in resource-constrained countries, setting up consensus develops that can form the basis for a law. It is a new pharmaceutical distribution system may be urgently sometimes preferable to work for a while with informal necessary, but pharmaceutical registration can wait for sev- agreements among parties or with government guidelines, eral years, while procuring essential medicines in the mean- so that generally accepted rules of behavior can develop in time through reputable channels where product quality is practice; the law then serves to confirm and formalize them controlled. (see Country Study 6-1). Whether or not a national drug policy exists, countries Globalization and harmonization need effective, enforceable legislation and regulation. These legislative acts may take the form of a single national drug Laws and regulations evolve within countries over time, but law that deals with all the issues or a series of complemen- in recent years, the trend has been toward the globalization
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