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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 CS 6-1 The evolution of pharmaceutical legislation 6.4
legislation 6.7 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
6.5 Controlling alternative and informal distribution Box 6-4 Interchangeability 6.12
channels 6.13 Box 6-5 Regulatory hurdles in the development of
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
• Pharmaceuticals concern the whole population required
• Many parties are involved: patients, health provid- • Involve both legal and health experts
ers, manufacturers, and salespeople • Keep all interested parties informed
• 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
Countries may choose to develop new legislation or to of personnel and facilities. A regulatory authority is usu-
revise existing laws. when starting afresh, it is useful to ally established for administrative control. Medicine
prepare a general law. Models exist, and expert assistance registration is often a major element in legislation, to
is readily available. After the law is passed, regulations ensure that individual products meet the criteria of effi-
made under it can bring its various provisions into oper- cacy, safety, and quality.
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
In drafting or revising legislation, a country should— and from wHo (2001a) guidelines.
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
tary laws, each introduced when the time is right. In some of pharmaceutical issues, which affects national legislation.
countries, certain aspects of the pharmaceutical sector are This globalization, exemplified through changes in inter-
governed by national laws, and other aspects, such as phar- national trade, patent protection, and pricing, has resulted
macy and medical practice, are governed by state or provin- in a number of initiatives that must be considered by coun-
cial laws. This chapter focuses on a single, comprehensive tries developing pharmaceutical regulations. Some exam-
drug law at the national level. Most of the issues discussed ples of these initiatives follow.
are also applicable in situations where legal responsibility TRIPS Agreement. The TRIPS Agreement (Agreement
is divided between national and state or provincial govern- on Trade-Related Aspects of Intellectual Property Rights)
ments. of the world Trade organization (wTo) has greatly
A law on medicines must, first and foremost, clearly affected international pharmaceutical regulation. TRIPS is
define what all the parties—manufacturers, doctors, an attempt to reduce gaps in the way intellectual property
pharmacists—are required to do, so that no serious mis- rights are protected around the world and to bring them
understanding is possible. Medicine registration laws and under common international rules; however, the impli-
regulations, for example, make clear what a manufacturer cations of the agreement’s provision on patents caused
needs to do to obtain a license to sell a product. They define concerns in developing countries. In response to those
how a registration agency should assess both the manufac- concerns, at the Doha Conference in 2001, wTo mem-
turer and the product to determine if they meet society’s bers adopted a special affirmation—known as the Doha
needs. Declaration—on issues related to TRIPS and public health.
A good law also creates administrative bodies to put The declaration affirms that the TRIPS Agreement should
rules into practice—for example, a national drug regulatory be implemented in ways that protect public health and
authority with broad competence, or separate organs to deal promote access to medicines. Chapter 3 on intellectual
with the various aspects of pharmaceutical regulation such property and access to medicines goes into more detail on
as practice of pharmacy, inspection of factories, and adver- these issues.
tising of medicines. Driven by the increase of global trade in pharmaceutical
Trying to achieve too much, too quickly, can be tempting. products and the subsequent complexity of technical regu-
It took more than a hundred years for pharmaceutical poli- lations related to medicine safety and quality, several initia-
cies and laws to evolve to current levels in the industrialized tives have been established to promote the harmonization
world. Sensible questions to ask are— of international pharmaceutical guidelines and regulations
6.4 PoLICy AND LEgAL FRAMEwoRK
by intergovernmental organizations at regional and inter- and provide a platform to develop international consensus
regional levels. on pharmaceutical regulation. The conferences are a unique
International Conference on Drug Regulatory forum that assemble all drug regulatory authorities, regard-
Authorities. organized by wHo, the International less of their organizations’ stage of development. The ICDRA
Conference on Drug Regulatory Authorities (ICDRA) pro- has been instrumental in guiding regulatory authorities on
vides officials from the drug regulatory authorities from all how the harmonization of regulation can improve the safety,
wHo member states with a forum to work on strength- efficacy, and quality of medicines.
ening cooperation and collaboration. Held since 1980, the International Conference on Harmonisation. The
annual conferences promote the exchange of information International Conference on Harmonisation of Technical
Country study 6-1
The evolution of pharmaceutical legislation
Venezuela’s first medicine-related law was issued in were also created by law, for example the Pharmacy
1883 as the ordinance of the Council of Physicians on and Medicines Directorate in 1981, the National
Secret Medicines and Patents. Pharmaceutical laws have Pharmacovigilance Center in 1984, and the National
been revised regularly; a significant number of phar- Medicines Control Laboratory in 1990.
maceutical laws were adopted over the course of the In the Netherlands, the legal basis for licensing of
twentieth century. The law that established the medicine pharmaceutical manufacturing and distribution was
registration system—the Law on the Exercise of the established in 1956. The Medicines Act of 1958 there-
Pharmacy—was passed in 1928, before the Ministry after regulated the admission of medicines to the Dutch
of Health was set up in 1936. The National Institute of market through the Medicines Evaluation Board. But the
Hygiene was established in 1938 to serve as the nation’s board started to operate only after 1963, triggered by the
national regulatory agency. over the years, new rules thalidomide disaster of 1961. European pharmaceutical
and organizations have been created to expand the scope regulation is now playing a growing role. In 1995, the
of regulation and to add capacity for executing the laws. European Medicines Evaluation Agency was founded to
The section on pharmacological advice, the Laboratory coordinate the tasks of the drug regulatory authorities
for Pharmacological Analysis, and the Center for of European Union member states. Certain aspects of
Pharmacological Surveillance were established in 1944, the Netherlands’ pharmaceutical regulation now follow
1946, and 1962, respectively. Rules for good manufactur- European Union rules. For example, gMP inspection is
ing practices (gMP) were drawn up in 1990. A pharma- based on the 1983 European Union guidelines for gMP.
ceutical law was approved in 2000 that addressed certain Since January 1, 1995, a European procedure for registra-
concepts for the first time, such as generic and essential tion has operated in the Netherlands. Now two types of
medicines. trade licenses exist: a European license and a national
Tunisia first introduced pharmaceutical regulation in license. Products with a European license may be sold
1942, in the form of a decree on medical and pharma- throughout the European Union, while the national
ceutical promotion and medicine control. All finished licenses are valid only for the country in which the
pharmaceutical products, whether manufactured in license was issued by means of the national registration
Tunisia or imported, must undergo a technical com- procedure.
mittee review and obtain a certificate of approval from Estonia’s drug regulatory framework began to take shape
the Ministry of Health before they may be placed on only over the two decades since the country gained inde-
the market. Registration is also required for homeo- pendence. However, the pace of regulatory development
pathic drugs, and some herbal medicines are registered has been rapid. The Licensing Board of Pharmaceutical
with the status of allopathic medicines. Key legislation Activities and the Center of Medicines were both created
includes the 1961 Law on Inspection of Pharmacies in 1991. Registration and licensing were introduced that
and Manufacturers, the 1969 Poisonous Drug Law, and year. In 1993, the State Agency of Medicines was created
the 1985 Law on Production of Drugs for Human Use. to become the Drug Regulatory Authority. The main leg-
Between 1985 and 1991, several legal texts were pro- islation—the Medicinal Products Act—came into force
mulgated concerning gMP, clinical trials, medical and in 1996.
scientific information, procedures to obtain licensing
of manufacturing and registration. New organizations Source: Ratanawijitrasin and wondemagegnehu 2002.
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