Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 255
7
An International Code of Practice for Falsified and
Substandard Medicines
Ensuring a safe, reliable drug supply is ultimately a matter for individual countries. To
this end, every nation has four main responsibilities: regulating the responsible manufacture of
safe and effective medicines; preventing falsified and substandard drugs from entering the
market; detecting them when they do; and punishing those who knowingly manufacture and
trade them. Executing these responsibilities requires strong national systems for drug regulation,
surveillance, and law enforcement. Governments must work with key stakeholders in industry,
professional associations, and civil society to protect the drug supply.
However, no country acting alone can protect its citizens from falsified and substandard
medicines. The problem, as seen throughout this report, is international, fuelled by international
trade and telecommunications. Crime and easy money are powerful forces driving the
illegitimate medicines business. Its perpetrators gravitate to countries where surveillance,
regulation, and law enforcement are the weakest. They take advantage of international
manufacturing and trade to produce and sell their products in the global market.
The interconnectedness of modern manufacturing systems makes the “quality and safety
of goods… that travel in international commerce” a public health concern around the world
(Gostin and Taylor, 2008, 54). A coherent system of global governance founded on diplomacy
and international cooperation can improve product safety and protect health around the world
(Gostin and Taylor, 2008). This will require cooperation among countries, among agencies
within governments, and among consumers, manufacturers, professional associations, and civil
society groups.
This chapter discusses the global governance tools available to fight the public health
problem of falsified and substandard drugs. An emphasis on the public health risks of
illegitimate drugs is central to framing this problem; protecting drug companies’ proprietary
interests is not. In the past, disagreements about the overlap between public health protection and
intellectual property guarantees have crippled international discussion on drug safety. Any global
governance process will need to focus on public health, a goal all parties can support and come
to consensus around.
Global governance includes hard law, such as treaties, and soft law, such as resolutions,
declarations, memorandum of understanding, and codes of practice (Gostin, 2013). The
committee does not believe that the time is ripe for hard law solutions. If countries or regions
wish to negotiate a treaty on falsified and substandard drugs, then they should do so, but
international soft law may be a more practical short-term solution to the problem. A soft law
solution could encourage international momentum for drug regulation, surveillance, and law
enforcement. It would also build trust among stakeholders and pave the way for a future hard law
solution if necessary.
Two treaty processes already underway relate to the problem of substandard and falsified
medicines. The Council of Europe’s Medicrime Convention (officially, “the Convention on the
255
PREPUBLICATION COPY: UNCORRECTED PROOFS
OCR for page 256
COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS
counterfeiting1 of medical products2 and similar crimes involving threats to public health”) is a
multilateral treaty intended to prevent the public health threats of illegitimate medicines (Council
of Europe, 2011). The convention makes aims to make crimes of drug adulteration and of the
intentional manufacture, supply, or trade in illegitimate medicines or ingredients, and their
accessories (Council of Europe, 2011). Other criminal offenses under Medicrime include:
tampering with the drug pedigree or making false drug documents; putting an unauthorized drug
on the market; and intentionally aiding or abetting a criminal in one of the named offenses
(Council of Europe, 2011). Medicrime also gives terms for protecting victims, including victim’s
rights to compensation from perpetrators, and for international cooperation in investigation,
extradition, and mutual legal assistance (Council of Europe, 2011). By December 2012, twenty-
two countries had signed the convention, but only Ukraine had ratified it (Council of Europe,
2012). Medicrime will not come into force until five countries ratify it, including three Council
of Europe members (Council of Europe, 2011).
Critics of the convention see in Medicrime an attempt to treat routine quality control
errors as crimes (Attaran and Bate, 2010). And, though Susanne Keitel, the director of the
European Directorate for the Quality of Medicines, explained to the committee in March that the
Medicrime Convention does not cover infringement of intellectual property rights, some see
hostility to generics companies in the treaty (Attaran and Bate, 2010). This impression is fueled
by the recent memory of European Union (EU) customs officials seizing as counterfeit generic
drug shipments produced in India and bound for Africa or Latin America (EUbusiness, 2010;
Reuters, 2011).
The Anti-Counterfeiting Trade Agreement (ACTA) is the other treaty relevant to falsified
medicines. ACTA sets international standards for intellectual property protection and creates a
regime outside of the World Trade Organization (WTO) and the World Intellectual Property
Organization (WIPO) to protect intellectual property (Ilias, 2012). Eight countries3 signed
ACTA in October 2011, but Japan is the only country that has formally ratified the treaty
(MOFA of Japan, 2012; USTR, 2011). ACTA will only come into force once six countries ratify
it (USTR, 2011).
As Chapter 1 explains, this report is not concerned with intellectual property rights; the
committee believes that the real or perceived mixing of public health and intellectual property
concerns only holds back action on the problem of falsified and substandard drugs.
THE ROLE OF THE WHO
Protecting public health is the goal of the proposed code of practice on falsified and
substandard drugs. Therefore, the World Health Organization (WHO) is the natural home for the
negotiation, development, and adoption of the code. Article 2 of the WHO Constitution
authorizes the organization, “to act as the directing and coordinating authority on international
1
The Medicrime Convention defines a counterfeit as a false representation as or identity or source (Council of
Europe, 2011).
2
The Medicrime Convention defines a medical product as human and veterinary medicines and medical devices
(Council of Europe, 2011).
3
Australia, Canada, Japan, Morocco, New Zealand, Singapore, South Korea, and the United States have signed
ACTA (USTR, 2011).
256
PREPUBLICATION COPY: UNCORRECTED PROOFS
OCR for page 257
AN INTERNATIONAL CODE OF PRACTICE FOR FALSIFIED AND SUBSTANDARD
DRUGS
health work.”4 To this end, the WHO Constitution also grants extensive normative powers to
World Health Assembly (WHA), the governing body of the WHO. The WHA’s jobs include
determining the organization’s policies and budget, appointing the Director-General, directing
the Executive Board on areas for study or action, inviting other organizations to participate in
WHO activities, and maintaining agreements with the United Nations.5 The World Health
Assembly also has the authority to recommend actions to members, and to require members to
give yearly reports on action taken to comply with recommendations.6
Key Findings and Conclusions
The political climate is not conducive to a hard-law solution, such as a multilateral treaty,
against falsified and substandard drugs.
A code of practice is a soft-law solution that would and give member states clear,
consistent guidelines and benchmarks for their work against falsified and substandard
drugs.
The WHO should lead in the development of a code of practice on falsified and
substandard drugs, in consultation with the WCO, UNODC, and other stakeholders.
This report makes clear that substandard and falsified medicines are an international
problem. There is a precedent for WHO establishing international codes on problems of global
public health consequence. Concern about the marketing of infant formula to new mothers led to
the 1981 WHO and Unicef International Code of Marketing of Breast-Milk Substitutes (WHO,
1981). In 2010, the WHO responded to the problem of international health worker migration
with The Global Code of Practice on the International Recruitment of Health Personnel (WHO,
2010). The codes were possible because of WHO leadership and an open, consultative,
deliberation process. The committee believes that a similar process, lead by WHO, will be
essential to international action against illegitimate drugs.
The WHO is also the international leader in the current discussion about substandard and
falsified drugs. In November 2012, WHO member states met in Argentina as part of a new effort
to collaborate on illegitimate medical products (WHO, 2012b). In her opening remarks, Director-
General Margaret Chan reiterated the organization’s commitment to working against harmful
products in the drug supply and promoting the availability of good quality medicines around the
world (Chan, 2012).
Engaging Stakeholders
In developing the proposed code of practice, the WHO should engage all major
stakeholders; the inclusion of scientific experts and civil society groups is essential. The WHO
Essential Medicines division can bring great technical depth to the discussion, especially the
public health aspects of the problem. Because the problem has legal dimensions, it will also be
4
World Health Organization, Basic Documents, Constitution of the World Health Organization, 45 ed., Supplement,
October 2006. Chapter II, Article 2(a).
5
World Health Organization, Basic Documents, Constitution of the World Health Organization, 45 ed., Supplement,
October 2006. Chapter V, Article 18(a), (c), (d), (f), (h), (j).
6
World Health Organization, Basic Documents, Constitution of the World Health Organization, 45 ed., Supplement,
October 2006. Chapter V, Article 20, Article 23.
257
PREPUBLICATION COPY: UNCORRECTED PROOFS
OCR for page 258
COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS
crucial to include experts in law enforcement, criminal justice, and customs. In order to assure
the proper range of expertise in the drafting of the proposed code of practice, the committee
recommends the WHO work with the United Nations Office on Drugs and Crime (UNODC) and
the World Customs Organization (WCO).
The UNODC helps member states fight organized crime, trafficking, corruption, and
terrorism (UNODC, 2012a). Its previous work has described the trade in illegitimate medicines
as the business of terrorist organizations and criminal cartels (UNODC, 2009, 2011, 2012b). The
agency’s 2012-2015 strategy emphasizes that responding to transnational, organized crime is a
priority, and it highlights their work against new kinds of drug trafficking (UN, 2012).
Contributing to the law enforcement and criminal justice sections of an international code on
falsified and substandard medicines would draw on the agency’s strengths and complement the
goals set out in its 3-year strategy.
The WCO, the only international organization dedicated to policing flows of goods into
and out of countries, is the other stakeholder organization that should contribute to the proposed
code. The WCO works on supply chain security and on the harmonization of simplified customs
procedures (WCO, 2012a). National customs offices are under pressure to facilitate international
trade and to monitor the safety of products entering the country; they have a unique
understanding of the circumstances through which illegitimate medicines enter commerce. The
inclusion of the WCO in the development of an international code on falsified and substandard
drugs could help ensure the code’s validity to stakeholders in customs.
The committee recognizes that some stakeholders might object to the inclusion of the
WCO in this process, given the organization’s professed commitment to protecting intellectual
property rights (WCO, 2012b). Monitoring the trade in illegitimate medicines and enforcing laws
against them depend on customs bureaus, however. Failing to include them in the development
of the code would risk the product being unacceptable or impractical for customs officers, one of
the main groups that would need to adhere to it. While some stakeholders might not approve of
the WCO, the committee sees no value in excluding them from the discussion.
Global governance for health increasingly requires health organizations such as the WHO
to work with other international agencies. There is precedent for WHO forming partnerships in
the development of a code of practice. The WHO and Unicef collaborated on the International
Code of Marketing of Breast-milk Substitutes, and, since its release in 1981, 84 countries have
enacted legislation implementing all or many of its provisions (Unicef, 2012; WHO, 1981).
Unicef continues to work with legislators and lawyers to implement maternity protection laws in
more countries (Unicef, 2012). Given the clear relationship between maternal and child health
and Unicef’s mission, it was only appropriate for WHO to engage this organization. Similarly, a
partnership with the UNODC and WCO would benefit the development and implementation of
the proposed code of practice.
Recommendation 7-1: The World Health Assembly, in partnership with the United
Nations Office on Drugs and Crime and the World Customs Organization, and in
consultation with major stakeholders, should institute an inclusive, transparent
process for developing a code of practice on the global problem of falsified and
substandard medicines. The code should include guidelines on surveillance,
regulation, and law enforcement, empowering states and the international
community to prevent and respond to drug quality problems.
258
PREPUBLICATION COPY: UNCORRECTED PROOFS
OCR for page 259
AN INTERNATIONAL CODE OF PRACTICE FOR FALSIFIED AND SUBSTANDARD
DRUGS
CONTENT OF THE CODE
The code will not be credible unless it is developed through a fair and inclusive process;
such processes take time. At a minimum, however, the committee recommends the process give
some attention to international surveillance, drug regulation, and law enforcement as main areas in
which to give guidance.
Key Findings and Conclusions
The international surveillance component of the code of practice should provide
guidelines on how to develop a surveillance system for falsified and substandard drugs
and how to link it to routine pharmacovigilance.
The code should recommend guidelines, minimum standards, and benchmarks for
medicines regulation.
The code of practice should provide guidance on how to investigate and punish
pharmaceutical crimes; suggest standard minimum punishments for different crimes;
and establish common definitions for various criminal acts.
International Surveillance
As Chapter 3 explains, surveillance for substandard and falsified drugs is uncoordinated,
largely voluntary, and highly variable. The modern drug supply chain involves many countries;
therefore, drug surveillances should be a coordinated, global effort. International surveillance is
necessary to define the magnitude of the problem and to identify priority areas for action.
The sections of the code that discuss surveillance should give guidance on how to set up
routine drug quality surveillance and how to make strategic choices about which drugs to
monitor in the most vulnerable regions. Once routine surveillance systems are running, data
gleaned from them will inform some of these choices in an iterative process. It may be necessary
to use active surveillance methods for some high-risk drugs and passive surveillance for others.
The code might also recommend how to choose and manage key sentinel surveillance sites. The
guidelines should also explain how to tie monitoring for falsified and substandard drugs to
routine pharmacovigilance and how to link surveillance with response.
Drug surveillance also requires laboratories for quality testing. There are not sufficient
drug quality laboratories in most low-and middle-income countries to support the regulatory
agencies’ routine needs (IOM, 2012). And, as Chapter 6 explains, these assays are expensive;
running even minimal tests could quickly bankrupt a small county’s annual drug testing budget.
The code should suggest ways to accommodate the added burden that surveillance will place on
drug quality laboratories. There may be room for universities to take on more testing or for
donors to fund dedicated, regional drug surveillance laboratories. The use of minilabs and other
hand-held detection technologies could also alleviate the added strain surveillance testing will
place on drug quality laboratories.
Building surveillance also requires building a work force dedicated to data analysis and
the prompt dissemination of public alerts when necessary. Therefore, using surveillance data
259
PREPUBLICATION COPY: UNCORRECTED PROOFS
OCR for page 260
COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS
effectively requires a strong medicines regulatory system. Guidelines on surveillance for falsified
and substandard drugs will depend on commensurate guidelines for the regulation of medicines.
Medicines Regulation
The proposed code of practice should give guidelines on the quality, safety, and efficacy
of medicines that all countries can work towards. The code could suggest national minimum
standards for licensing of importers, distributors, and wholesalers, and guidelines on retail and
dispensing of medicines. The WHO has already collected most of this information; the
Medicines Regulatory Package will be a useful reference on how to organize regulatory
authorities and monitor their performance (WHO, 2011).
The code should direct countries to enact comprehensive medicines legislation that
provides for all the drug regulatory functions including: the licensing of manufactures and
distributors, the issuing of market authorization, the inspection and surveillance of the drug
distribution chain, and the monitoring of medicines on the market (Rägo and Santoso, 2008).
The code should also give guidance on harmonization and mutual recognition. Having
consistent requirements eases the regulatory burden on industry. Especially in small countries,
harmonization allows regulators to make efficient use of their limited labor. The code might
recommend opportunities for regulatory agencies in small countries to base their decisions on
internationally accepted criteria. The regulatory agencies of Switzerland, Singapore, Canada, and
New Zealand, for example, make more efficient use of their staff by accepting new chemical
entity data from larger regulatory agencies (ICDRA, 2010; Jessamine, 2010).
The code might support the work the Pharmaceutical Inspection Co-operation Scheme
has begun. The Pharmaceutical Inspection Convention and the Pharmaceutical Co-operation
Scheme, known jointly as PIC/S, work to advance mutual confidence, training, and information
exchange among 43 participating regulatory agencies (PIC/S, 2012b, 2013). PIC/S trains
inspectors from around the world in pharmaceutical inspections; its trainings and publications
promote harmonized understanding of good distribution and manufacturing practices (PIC/S,
2012c, 2012d).
Efficient staffing of the regulatory authority depends on sustainable financing. The code
could suggest methods for governments to ensure sustainable financing for their regulatory
authorities. Most regulatory authorities run off public money or market authorization fees; many
face an additional dilemma in soliciting user fees from the pharmaceutical industry (Abdul-
Rahman, 1996). The code might address this problem and give guidelines on an appropriate
financial relationship between the pharmaceutical industry and the drugs regulatory authority. A
frank public discussion of this question might have an added benefit of encouraging investment
in regulatory systems in developing countries. This includes investing in the training and
credentialing of the professional workforce needed to run a regulatory system.
The code of practice could also lead to the development of an accepted good regulatory
practices, and tools regulators can use to benchmark their performance. The WHO is the ideal
organization to lead the development of good regulatory practices, because of its technical depth
and experience in medicines regulation. The WHO has convening power to bring regulatory
agencies together; its International Conference of Drug Regulatory Authorities brings regulators
together to discuss common challenges and opportunities for collaboration (WHO, 2012a). The
development of good regulatory practices could also draw on the work the International
260
PREPUBLICATION COPY: UNCORRECTED PROOFS
OCR for page 261
AN INTERNATIONAL CODE OF PRACTICE FOR FALSIFIED AND SUBSTANDARD
DRUGS
Conference on Harmonization and the forum for Asia-Pacific Economic Cooperation have done
to the same end (Lourenco, 2008; Uyama, 2011).
Law Enforcement
Guidelines for surveillance and drug regulation will be central to a code of practice on
substandard and falsified drugs. This report makes clear, however, that the problem cannot be
solved without input from law enforcement, a broad category that includes disparate agencies
with limited budgets and competing priorities.
The nature of pharmaceutical crimes and the constraints on law enforcement agencies
pose challenges to prosecuting and punishing offenders. The illegitimate drug business is a
global industry that mirrors legitimate business in many ways: it sources materials from around
the world and bases manufacturing in countries with the cheapest labor and most favorable
regulatory regimes. Criminals and unscrupulous manufacturers use the internet to indentify
suppliers and customers. They may also sell drugs over the internet, on the black market, or even
through legitimate distribution channels. Thorough investigation and successful prosecution of
those responsible is difficult and expensive because of clandestine manufacturing and
distribution networks.
Pharmaceutical crime covers a spectrum of low-risk, high-reward offenses. Many
countries have not enacted laws making these acts crimes or set out terms for international
cooperation on investigations (Attaran et al., 2011). The code of practice on falsified and
substandard medicines could give guidelines on how to investigate and punish the illegitimate
medicines trade, as well standard minimum punishments for different crimes. The code could
also establish common definitions for different criminal acts such as the manufacture of an
illegitimate drug, the unauthorized re-use of packaging, tampering with any documents or
receipts necessary to recreate the chain of custody, and knowingly selling or distributing an
illegitimate product.
A code of practice would build momentum for international cooperation on the
investigation of pharmaceutical crimes. The national police agencies’ authority stops at the
border. Investigating transnational crimes sometimes requires mutual legal assistance treaties
(Attaran et al., 2011; Palmer, 2012). Pharmaceutical crimes are particularly time-consuming and
expensive to investigate. They put novel demands on the detectives and prosecutors who are
expected to work on homicides and other violent crimes. The code of practice could suggest
guidelines for police agencies on how to balance priorities. It could also give political cover to
police agencies looking to direct more staff time to investigating crimes against the drug supply.
The code would also establish guidelines for both choosing the venue to prosecute and the terms
for extradition.
Chapter 4 describes how police and customs officers may channel their work against
falsified drugs in brief, intense campaigns, and not in sustained, coordinated action. The law
enforcement guidelines in the proposed code of practice could explain how to integrate action
against falsified drugs into daily police work. They would also allow police and prosecutors to
make these crimes a priority.
At a minimum, the code should establish definitions for different crimes involving the
medicine supply, establish minimum penalties for these crimes, recommend protocols for
international cooperation on investigations and extradition, and clarify the role of customs and
261
PREPUBLICATION COPY: UNCORRECTED PROOFS
OCR for page 262
COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS
border police in investigating medicines trafficking. These actions could go a long way in
increasing awareness of the gravity of pharmaceutical crime.
Compliance by States and Stakeholders
A code of practice is a voluntary agreement. Countries have no formal, legal obligation to
conform. A code of practice can do much to raise awareness and promote harmonized actions
among countries. Some recent commentary has suggested that the WHO should exercise more
leadership on global health problems (Sridhar and Gostin, 2011). The organization is uniquely
poised to convene stakeholders and issue a soft law for addressing this problem. An open and
transparent convening process will lay the groundwork for future compliance with the code.
The WHO can also give incentives for compliance and encourage cooperation among
nations. Countries that adopt the code should be able to report on their progress and share
strategies for overcoming obstacles. The WHO Director-General could then report to the World
Health Assembly on implementation and potential barriers to compliance. Nongovernmental
organizations could also have a useful role in monitoring compliance with the code, perhaps
issuing reports on which countries and stakeholder groups make good on their promises (Gostin,
2013).
One likely barrier to action is limited capacity for drug regulation, law enforcement, and
surveillance in low- and middle-income countries. The code might suggest incentives, such as
funding and technical assistance for implementation, as well guidance on how law enforcement
agencies can work together across jurisdictions.
Costs are another important barrier to widespread adaption of the code. The PIC/S funds
its activities through membership fees (PIC/S, 2012a). Attendance at conferences and trainings is
extra (PIC/S, 2012a). The expense can be a barrier for regulators from poor countries.
Furthermore, tracking countries’ progress to meeting the code and planning member state
activities will take staff time and administrative effort. It may be necessary to establish a WHO
secretariat dedicated to the code of practice on falsified and substandard drugs. In this case, the
WHA should direct the necessary funds to WHO for a formal secretariat to organize and
administer related activities.
Substandard and falsified drugs are a global problem. It is difficult to accurately measure
the burden of the problem, but illegitimate medicines appear in all countries, threatening health
and undermining confidence in the medical system. The proposed code of practice will
encourage coordinated international monitoring of medicine quality, strong regulatory systems,
and the appropriate investigation and punishment of crimes against the drug supply. Prominent
international action to protect the drug supply will advance public health around the world.
262
PREPUBLICATION COPY: UNCORRECTED PROOFS
OCR for page 263
AN INTERNATIONAL CODE OF PRACTICE FOR FALSIFIED AND SUBSTANDARD
DRUGS
REFERENCES
Abdul-Rahman, L. 1996. Financing of a drug regulatory authority and user fees. Paper read at
Proceedings of the Eight International Conference of Drug Regulatory Authorities
(ICDRA), Bahrain.
Attaran, A., and R. Bate. 2010. A counterfeit drug treaty: Great idea, wrong implementation. The
Lancet 376(July):1446-1448.
Attaran, A., R. Bate, and M. Kendall. 2011. Why and how to make an international crime of
medicine counterfeiting. Journal of International Criminal Justice 9(2):325-354.
Chan, M. 2012. Opening remarks at the first meeting of the member state mechanism on
substandard/ spurious/falsely-labelled/falsified/counterfeit medical products. Buenos
Aries, Argentina: The World Health Organization.
Council of Europe. 2011. Council of europe convention on the counterfeiting of medical
products and similar crimes involving threats to public health. Moscow.
———. 2012. Council of europe convention on the counterfeiting of medical products and
similar crimes involving threats to public health, cets no.: 211: Status as of 26/11/2012.
http://conventions.coe.int/Treaty/Commun/ChercheSig.asp?NT=211&CM=8&DF=&CL
=ENG (accessed November 26, 2012).
EUbusiness. 2010. WHO raps EU for seizing generic drug shipments from India.
http://www.eubusiness.com/news-eu/who-health-drugs.4u5 (accessed April 27, 2012).
Gostin, L. 2013. International law, global institutions, and world health. Cambridge, MA:
Harvard University Press.
Gostin, L. O., and A. L. Taylor. 2008. Global health law: A definition and grand challenges.
Public Health Ethics 1(1):53-63.
ICDRA. 2010 Novemer 30-December 3. 14 ICDRA recommendations. Paper presented at the
Fourteenth International Conference of Drug Regulatory Authorities, Singapore.
Ilias, S. 2012. The proposed Anti-Counterfeiting Trade Agreement: Background and key issues.
Congressional Research Service 7-5700(R41107).
IOM. 2012. Ensuring safe foods and medical products through stronger regulatory systems
abroad. Edited by J. E. Riviere and G. J. Buckley. Washington, DC: The National
Academies Press.
Jessamine, S. 2010. Field of dreams: The New Zealand experience with recognition of other
regulator's decisions. Paper presented at Pre-ICDRA Meeting, Singapore.
Lourenco, C. 2008. Good regulatory practices: Presentation to APEC preliminary workshop on
review of drug development in clinical trials. Therapeutic Products Directorate, Health
Canada.
MOFA of Japan. 2012. Conclusion of the anit-counterfeiting trade agreement (ACTA) by japan.
http://www.mofa.go.jp/policy/economy/i_property/acta_conclusion_1210.html (accessed
December 18, 2012).
Palmer, E. 2012. Drugs for illegal internet pharmacy made in India, Mexico. FiercePharma
Manufacturing, October 2.
PIC/S. 2012a. Accession. http://www.picscheme.org/accession.php (accessed November 27,
2012).
———. 2012b. PIC/s. http://www.picscheme.org/pics.php (accessed November 27, 2012).
———. 2012c. Publications. http://www.picscheme.org/publication.php (accessed November
27, 2012).
263
PREPUBLICATION COPY: UNCORRECTED PROOFS
OCR for page 264
COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS
———. 2012d. Training. http://www.picscheme.org/training.php (accessed November 27,
2012).
———. 2013. Accession dates. http://www.picscheme.org/accession-dates.php (accessed
January 25, 2013).
Rägo, L., and B. Santoso. 2008. Drug regulation: History, present and future. In Drug benefits
and risks: International textbook of clinical pharmacolog. 2nd ed, edited by C. v. Boxtel,
B. Santoso and I. Edwards: IOS Press and Uppsala Monitoring Centre.
Reuters. 2011. Update 2- India, EU heal drugs seizures dispute with interim agreement. July 28.
Sridhar, D., and L. Gostin. 2011. Reforming the World Health Organization. JAMA: The Journal
of the American Medical Association 305(15):1585-1586.
UN. 2012. Resolution adopted by the Economic and Social Council: Strategy for the period
2012-2015 for the United Nations Office on Drugs and Crime. E/RES/2012/12.
Unicef. 2012. Nutrition: International code of marketing breast-milk substitutes.
http://www.unicef.org/nutrition/index_24805.html (accessed November 12, 2012).
UNODC. 2009. Transnational trafficking and the rule of law in west Africa: A threat
assessment.
———. 2011. Not what the doctor ordered: The growing linkages between fraudulent medicines
and organized crime. http://www.unodc.org/unodc/en/press/releases/2011/May/not-what-
the-doctor-ordered-the-growing-linkages-between-fraudulent-medicines-and-organized-
crime.html (accessed January 30, 2013).
———. 2012a. About UNODC. http://www.unodc.org/unodc/en/about-
unodc/index.html?ref=menutop (accessed November 26, 2012).
———. 2012b. Transnational organized crime: Counterfeit goods- a bargain or a costly
mistake? http://www.unodc.org/toc/en/crimes/counterfeit-goods.html (accessed January
30, 2013).
USTR. 2011. Anti-Counterfeiting Trade Agreement (ACTA). http://www.ustr.gov/acta (accessed
November 12, 2012).
Uyama, Y. 2011 April 26-28. Good regulatory practices: Do we have a common understanding?
Paper presented at Asia Regulatory Conference: Asia's Role in Global Drug
Development, Seoul, Republic of Korea.
WCO. 2012a. WCO goals. http://www.wcoomd.org/en/about-us/what-is-the-wco/goals.aspx
(accessed November 27, 2012).
———. 2012b. World customs organization: About us (accessed November 12, 2012).
WHO. 1981. International code of marketing breast-milk substitutes.
———. 2010. Managing health workforce migration- the Global Code of Practice.
http://www.who.int/hrh/migration/code/practice/en/ (accessed November 26, 2012).
———. 2011. Regulatory information and practical manuals: WHO medicines regulatory
package.
http://www.who.int/medicines/areas/quality_safety/regulation_legislation/regulatory_pac
kage/en/index.html (accessed November 26, 2012).
———. 2012a. International Conference of Drug Regulatory Authorities.
http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/
(accessed November 26, 2012).
———. 2012b. New global mechanism to combat substandard/spurious/falsely-
labelled/falsified/counterfeit medical products
264
PREPUBLICATION COPY: UNCORRECTED PROOFS
