Medicines Promotion: Assessing The Nature, Extent and Impact of Regulation

Medicines Promotion: Assessing the Nature,

Extent and Impact of Regulation

Report and Preliminary Methodology for Pilot-‐testing

Contents

Introduction ..................................................................................................................................... 3
Acknowledgements. ......................................................................................................................... 3
Project report .................................................................................................................................. 4
Rational Use of Medicines, Medicines Promotion and regulation ................................................. 4
Project .............................................................................................................................................. 6
Looking ahead .................................................................................................................................. 9
Final preliminary methodology for pilot testing ............................................................................ 11
Document check list ......................................................................................................................... 12
Data compilation .............................................................................................................................. 15
Interview Schedule: Key Informant from Drug Regulatory Authorities ........................................... 23
Interview Schedule: Healthcare Professional Informant ................................................................. 27
Interview Schedule: Key Informant from Civil Society Organisation
or Patient Group or WHO country office ......................................................................................... 31
Interview Schedule for the Pharmaceutical Industry, the Insurers, and the Media ........................ 35
Page 2 of 38

Introduction
This report, which precedes the assessment tool itself, outlines the premise and context which has led to
the development of a methodology to investigate the regulatory framework of medicines promotion in
the context of national settings. The project has developed a methodology to gather information on any
given FRXQWULHV¶Uegulatory practice that is aimed at controlling the extent and influence of
pharmaceutical promotion. As a tool to gather data on regulation, it complements the World Health
2UJDQL]DWLRQ¶V(WHO) Ethical Criteria for Medicinal Drug Promotion1. The project has been conducted
by Health Action International (HAI) Global and co-funded by the Medicines Transparency Alliance
(MeTA) and the HAI global Programme, under the guidance of an advisory group of international
experts.
Acknowledgements
Project editors and report authors
Carole Piriou and Elizabeth Hayes, HAI Global
Project supervisor at MeTA

Wilbert Bannenberg, Technical Director
The list below includes members of the Advisory Group (denoted with a *) as well as individuals who
provided input during the development of the methodology.
Elodie Brandamir, MeTA

Guitelle Baghdadi-Sabeti, WHO-Geneva*
Wilbert Bannenberg, MeTA*
Christa Cepuch, HAI Africa*
Marieke Devillé, MeTA
Andy Gray, University of KwaZulu-Natal, South Africa*
Jinani Jayasekera, HAI Asia-Pacific*
Denis Kibira, HEPS Uganda/HAI Africa
Richard Laing, WHO-Geneva*
Joel Lexchin, York University, Canada*
Roberto López-Linares, HAI-Latin America and the Caribbean (AIS-LAC)*
Benoit Marchand, HAI-Nicaragua (AIS-LAC)*
Barbara Mintzes, University of British Columbia, Canada*
Mohammed Ramzy, WHO-EMRO*
Tim Reed, HAI Global
Fatima Serhan, WHO-Geneva
Lilia Ziganshina, Kazan State Medical Academy, Russian Federation
We would also like to acknowledge the contribution of the respondents in Peru, Uganda and Kyrgyzstan
who commented on a first version of the methodology.

1
Ethical criteria for Medicinal Drug Promotion WHO 1988
Page 3 of 38

Rational Use of Medicines and Medicines Promotion

When medicines are used rationally, patients receive appropriate treatment, in doses that meet their
individual requirements, for an adequate period of time. We can add to this that rational use of
appropriate medicines reflects the lowest cost both to the patient and/or their community2. However, it is
estimated that globally ³half of all medicines are prescribed, dispensed or sold inappropriately, and half
of all patients fail to take them correctly. Overuse, underuse or misuse of medicines results in wastage of
VFDUFHUHVRXUFHVDQGZLGHVSUHDGKHDOWKKD]DUGV´3 Since medicines can account for between one quarter
to two thirds of national health spending in developing countries, the potential for poor health outcomes
and resource wastage is acute.4 For example, in developing countries, out-of-pocket spending on
medicines can be an enormous burden on households, the majority of which may already be struggling
to meet basic needs5. Add to this the problem of anti-microbial resistance, whereby antibiotics are no
longer effective for treating the infections for which they were originally developed. Irrational
overprescribing has made a significant contribution to this devastating global problem6.
A crucial component to promote the appropriate use of medicine is accurate information on medicines to
healthcare professionals and consumers. While the pharmaceutical industry plays a central role in
developing and producing medicines, there can be a WHQVLRQEHWZHHQLQGXVWU\¶VQHHGWRH[SDQGSURGXFW
sales through the promotion of its products and the public health priority of rational use. In fact, the
:RUOG+HDOWK2UJDQL]DWLRQ:+2KDVFDOOHGLW³DQLQKerent conflict of interest between the legitimate
business goals of manufacturers and the social, medical and economic needs of providers and the public
WRVHOHFWDQGXVHGUXJVLQWKHPRVWUDWLRQDOZD\´7
To document this, findings based on the systematic review of research on the impact of medicines
SURPRWLRQRQKHDOWKSURIHVVLRQDOV¶EHKDYLRXUNQRZOHGJHDQGDWWLWXGHVFRQVLVWHQWO\VKRZVWKDW
prescribers who rely on promotion as their main source of information tend to prescribe less
appropriately, prescribe more often and adopt new medicines faster.8 Another review concluded that the
link between greater exposure to and reliance on promotion on one hand, and less appropriate
prescribing on the other, met epidemiological criteria for causation.9
In many developing countries, lack of resources results in promotional activities by the industry being
the main or sole source of information about medicines for health professionals and consumers.
Moreover throughout the world, the sheer volume and variety of persuasive medicines promotion, such
as the commercial interest in the sponsorship of continuing medical education, article ghost writing,
clinical research, patient group funding and influence, and so on, make promotional messages almost
unavoidable.

2
Promoting rational use of medicines: core components 2002. WHO Policy Perspectives on Medicines No.5, Geneva, World
Health Organization, 2002.
3
The rational use of drugs. Report of the Conference of Experts. Geneva, World Health Organization, 1985.
4
WHO | 10 facts on essential medicines 2009
http://www.who.int/features/factfiles/essential_medicines/essential_medicines_facts/en/index1.html
5
Prescription for healthy development: increasing access to medicines. Millennium Project Task Force 2005
6
WHO Global Strategy for Containment of Antimicrobial Resistance 2001 WHO/CDS/CSR/DRS/2001/2/EN
7
World Health Organization. Clinical Pharmacological Evaluation of Drug Control. WHO, 1993
8
Drug promotion, what we know, what we have yet to learn WHO and HAI 2005
9
Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 2000; 283: 373-‐380
Page 4 of 38

The question then is what can be done to control the unethical nature of pharmaceutical promotion that
so distorts the use of medicines that individual health outcomes are poorer, there is a worldwide growth
in anti-microbial resistance, and a misuse of scarce health resources.
Regulation of Medicines Promotion

In 1988, the WHO took a landmark step and published the Ethical Criteria for Medicinal Drug
Promotion10 in an effort to help countries safeguard public health by offering guidelines on what might
constitute an ethical way of promoting medicines. This document is not only the gold standard against
which promotional activities might be judged, but remains a blueprint for international, national and
regional efforts to regulate promotion, ranging in type from government legislation to pharmaceutical
industry self-regulatory codes of practice.
In an attempt to prompt action from member states, a resolution on the rational use of medicines
(WHA60.16) was adopted at the 60th World Health Assembly in 2007. The resolution urged Member
States:
µ«to enact new, or enforce existing, legislation to ban inaccurate, misleading or

unethical promotion of medicines, to monitor drug promotion, and to develop and
implement programmes that will provide independent, non-promotional
information on medicines¶11
The WHO does not make regulations, and does not insist member states adopt legislation, so the WHO
Ethical Criteria do not include any kind of advice on sanctions for breaches of ethical promotion, and
they lack any advice on how the recommendations should be implemented, rather it is left to the
member state.
7RGDWHIHZHUWKDQKDOIRIWKHZRUOG¶VFRXQWULHVKDYHLQWURGXFHGDOHJLVODWLYHIUDPHZRUNWR

regulate the promotional activities of the pharmaceutical industry12. Results from a WHO study13 show
that regulatory frameworks vary widely regarding content, implementation and enforcement. In
developing countries especially, overstretched health systems may have difficulties allocating sufficient
resources to support robust regulation. Indeed, many regulatory bodies fail to provide the tools, such as
guidelines and standards, needed to support effective regulation. Regulatory gaps also occur where laws
have been enacted but the regulatory agency fails, for various reasons, to implement its mandate.
When legal framework does not exist, the control of promotional activities is often left to the
pharmaceutical industry itself, through self- regulation with the International Federation of
Pharmaceutical Manufacturers and Associations (IFPMA) code of practice14 or national industry codes.
Although voluntary codes of practice have been criticized for shortcomings in their coverage, for being
poorly enforced and lacking deterrent sanctions, they are nevertheless often the only mechanism for
restraint.15

10
http://apps.who.int/medicinedocs/documents/whozip08e/whozip08e.pdf
11 th
Resolution 60.16 on Rational Use of Medicines. 60 World Health Assembly, 2007
12
World Medicines Situation WHO 2004
13
Ratanwijitrasin S, Wondemagegnehu E. Effective drug regulation: a multicountry study. Geneva, World Health Organization
2002
14
IFPMA Code of Pharmaceutical Marketing Practices 2007
Page 5 of 38

Few attempts have been made to map and comprehensively explore the regulatory situation in countries
regarding medicines promotion control. This is a crucial first step to determine the current barriers and
best approaches to the control of promotion, in order that an effective promotion framework, which
enshrines the rational use of medicines and protects public health, might be constructed.
As mentioned above, there has been little research on the impact of regulatory structures concerning
medicines promotion, but the WHO has published two methodologies which informed this project.
7KH:+2¶V Good Governance for Medicines16 indicators are explicitly designed to assess countriHV¶
vulnerability to corruption. The program has so far revealed that in most countries where it has been
applied, the area of medicines promotion is often poorly appreciated by regulatory officials, in spite of
misleading promotion being of µworrying proportions¶17.
³(IIHFWLYH'UXJ5HJXODWLRQ$0XOWL-country Study´18 is also of key relevance to this project and

involves a similar literature review and key informant interviews methodology, but as its authors
acknowledge, it falls short of providing an investigation of outcomes. It focuses on the organisational
structure of regulatory authorities and the regulatory tools available for implementation and
enforcement.
These two methodologies and the WHO Ethical Criteria provided crucial background information for
+$,¶VPHWKRGology development.
Project
For all these reasons, HAI Global in collaboration with MeTA, has developed a methodology
(accompanying this report) to help countries gain an overview of the national regulatory framework and
DVVHVVNH\VWDNHKROGHUV¶SHUFHSWLRQV of the regulatory situation regarding medicines promotion.
Although unethical promotional practices and irrational use of medicines are global issues, regulatory
practices are usually local (national or regional), and depend on many factors, including the social,
political and economic context of regions, countries, and populations. Because of this context-specific
nature of regulation, policy recommendations cannot be provided without an extensive understanding of
WKHFRXQWU\¶VVSHFLILFVLWXDWLRQ It is hence necessary to investigate what the regulatory texts stipulate,
but also to map the structure of the drug regulatory authority and related bodies, and to gather
testimonies and opinions of the different stakeholders involved in or affected by medicines promotion.
Objectives
The methodology aims to determine:
x The scope of regulation on pharmaceutical promotion in country settings

15
Putzeist M. Self-‐regulation of drug promotion. A cross-‐sectional analysis of the practical codes and WHO ethical criteria on
the promotion of medicines. Unpublished report. 2009
16
http://www.who.int/medicines/ggm/en/
17
ReMed conference, oral communications on GGM progression in Benin and Cameroon, Nov 2009, Paris
18
2002
Page 6 of 38

x The impact and effectiveness of the regulatory framework on promotional practice
For this purpose, HAI developed a methodology to help countries identify:
x National legal provisions on promotion as well as existing mechanisms to implement and

enforce them. This includes assessing the extent of self- regulation by the pharmaceutical
companies where relevant.
x Examples of existing forms of unethical promotion occurring in the country and how they
breach legislation or codes of practice
x Any gaps in the regulatory framework that need to be addressed
Methods
A draft methodology was developed by HAI Global and reviewed by an international advisory group
comprising public health, pharmaco-epidemiological, pharmaceutical policy and methodological experts
(see acknowledgements). The draft tool aimed to assess the impact of promotion regulation using a
semi-structured questionnaire and an interview guide, targeting key informants from a wide range of
VWDNHKROGHUV7KHWRROZDVILUVWVXEPLWWHGWRWKHSURMHFW¶Vadvisory group for comments and was
subsequently reviewed by key informants in three countries where MeTA is active: Kyrgyzstan, Peru
and Uganda. Both parts of the draft tool were updated in terms of length and content following the
review.
The methodology comprises a literature review section and semi-structured interview questionnaires for
key informants to scope the extent and effectiveness of national regulatory policies on promotion and
related perceptions. It provides information on the national situation by looking at the literature
available, the structures in place for implementation and enforcement, and the perceptions of
stakeholders (gathered through key informants). Regulatory policies are defined here to include: direct
government regulation, self-regulation by pharmaceutical and advertising industries, and any relevant
policies affecting industry, the media, professional and patient organisations.
+$,¶VUHVHDUFKWRROFRPELQHVGHVNUHVHDUFKDQGin-country key informant interviews and includes:
x An analysis of relevant laws, guidelines or codes related to the promotion of medicines
x An assessment of existing mechanisms for implementation and enforcement
x Key informant interviews for in-depth analysis of the actual situation
The literature review comprises D³GRFXPHQWFKHFNOLVW´DQGD³GDWDFRPSLODWLRQ´WRRO. This part of the

scoping exercise is to be carried out by a local researcher, preferably someone with background
NQRZOHGJHRIKLVKHUFRXQWU\¶VUHJXODWRU\IUDPHZRUN7UDLQLQJVHVVLRQVWDUJHWHGWRWKHORFDOUHVHDUFKHUV
should be held to familiarise them with the project, and a practical guide should be developed to assist
third parties to carry out the scoping exercise by themselves (see below, ³ORRNLQJDKHDG´
The literature review is a backbone of the scoping project as it assesses the type, depth and breadth of
any given regulatory structure and the legislative landscape and context in which it is enshrined.
Page 7 of 38

However, whilst the existence of regulation of promotion can be an almost quantitative exercise, a more
qualitative empirical question resides in their interpretation and systematic enforcement. Hence, semi-
structured interviews of the stakeholders involved in or affected by promotion are needed to obtain
further information. These key informants include regulators, pharmaceutical industry representatives,
payers and/or insurers, health professionals and consumer associations, health service administrators,
patient groups, and regional WHO pharmaceutical advisors depending on country context.
It is important to keep in mind that the key informant interview schedules provided with this report are
templates that are made to be updated upon completion of the literature review, so as to contextualise
them to the country social, political, economic and regulatory environment.
Ethically, it is the suggestion here that it is necessary that the consent of the Ministry of Health is
obtained before research takes place, and it is highly recommended that its cooperation is sought, as
political will is a key factor driving policy changes.
/LWHUDWXUHUHYLHZ³'RFXPHQW&hecklLVW´DQG³'DWD&RPSLODWLRQ´WRRO
The ³'ocument CKHFNOLVW´LVLQWHQGHGWRJXLGHWKHUHVHDUFKHUVWKURXJKWKHFollection of relevant

GRFXPHQWVZKLFKDUHWKHQXVHGWRILOOWKH³'DWD&RPSLODWLRQ´WRRO. This checklist is not exhaustive as
to which type of regulatory documents might exist, but rather enables the researcher to prospect in
different directions in order to find relevant documents where they exist. It allows the compilation of
texts in relevant area and provides hints as to what kind of documents could be found. For example, the
field test of the methodology underscored that legislation relevant to the promotion of medicines can be
IRXQGLQWUDGHRUFRQVXPHU¶VSURWHFWLRQUHODWHGOHJLVODWLRQ or adherence to self-regulatory codes may be
available from the pharmaceutical industry association.
The available documents are to be collected and catalogued and the process detailed, as accessibility of
regulatory documents is an important factor affecting transparency.
The regulatory documents available then answer questions in the data compilation tool on the regulatory
structure and the provisions concerning medicines promotion, using original excerpts where possible to
minimise bias.
Those questions include the scope of regulation (e.g. which forms of promotion are covered), the
mechanisms in place for monitoring and enforcement and the existence and nature of provisions
concerning violations. The description of the bodies responsible for issuing regulation, monitoring its
effects and enforcing it is then sought.
Key Informants interviews: 4 interview schedules templates
The key informant interviews are crucial to discuss the actual regulatory situation, issues of political
commitment, human and financial resources, whether the codes or laws are enforced etc. with all the
stakeholders. The interviews schedules provided here are templates, and need to be adapted in each
FRXQWU\DIWHUWKHOLWHUDWXUHUHYLHZKDVEHHQFDUULHGRXWVRWKDWWKH\DUHUHILQHGWRLQYHVWLJDWHDFRXQWU\¶V
specific context.
.H\LQIRUPDQW¶s interviews (approximately 10 per country) explore current practice, models of

UHJXODWLRQXQGHUFRQVLGHUDWLRQEDUULHUVWRHIIHFWLYHUHJXODWLRQDQGµEHVWSUDFWLFH¶7KH\LQIRUPD
variety of issues, ranging from political commitment to rational use and regulating promotion, to the
actual practices at the primary care level. For further recommendations, the context in which the
Page 8 of 38

policies were developed, how transparent the regulatory process is, and who is involved in the decision-
making process are investigated.
Depending on their background, and the context analysis, informants are asked their opinions, advice,
and information about barriers to enforcing legislation and how to overcome them.
7KLVQHHGWRDGDSWWKHTXHVWLRQWRWKHNH\LQIRUPDQWV¶EDFNJURXQGLVWKHUDWLRQDOHfor having four

different interview schedules depending whether the informant comes from:
x Regulatory authorities
x Healthcare professions
x Civil society, patient organisations and WHO country offices
x The pharmaceutical industry, payers/insurers, and the media
This allows using the most of the areas of expertise in each category, while keeping the interviews
concise enough to be carried out during a single session.
Research Outcomes
The research tool provides DGHWDLOHGRYHUYLHZRIDFRXQWU\¶VFXUUHQWSURILOHconcerning promotion. This
will include:
x The strengths and weaknesses of any regulatory framework
x Issues related to the implementation and enforcement of the existing regulation
x $QXQGHUVWDQGLQJRIWKHSROLWLFDOFRQWH[WDQGVWDNHKROGHUV¶SRVLWLRQVUHJDUGLQg regulation
By highlighting the strengths and weaknesses of any national system, be it constitutional, legislative or
self-regulatory, the methodology enables researchers to locate gaps in the regulatory framework and
highlight best practices in various areas. Advocacy options will emerge from cross country comparisons.
Looking ahead
The country profiles obtained through this assessment should, in turn, help inform country-specific
policy recommendations to control promotion more efficiently and promote rational use. The findings
will shed light on the efficacy of pharmaceutical promotion regulation, highlight the areas in which
regulation needs strengthening and provide the basis for recommendations to improve national policies
on promotion. National surveys carried out using this tool should provide an evidence base upon which
countries can make policy choices to improve the rational use of medicines. Successful examples from
other countries can be used to provide recommendations and strengthen the interpretation of the law.
The discussion on the methodology led to the development of a new component that would assess the
³RQWKHJURXQG¶VLWXDWLRQE\ORRNLQJDWSURPRWLRQLVVXHVDWWKHhealth facility and patient levels. This
Page 9 of 38

need for field data is also strHVVHGLQWKH:+2³(IIHFWLYHDrug 5HJXODWLRQ´ report19. Members of the
Advisory Group mentioned the importance of analysing promotional material found in health facilities
or conducting VXUYH\VRIVDOHVUHSUHVHQWDWLYHV¶EHKDYLRXU. This would inform the actual levels of
enforcement of the law, regulation, guideline or code.
The Advisory Group agreed that a second research component should be developed to enable HAI to
gather data at the facility and patient levels. It was thought that this addition to the present methodology
would make it more robust and better ensure that it gathered information that would inform countries
DERXWLPSRUWDQWDVSHFWVRIWKHLUUHJXODWRU\V\VWHP¶VHIIHFWLYHQHVVLQFRQWUROOLQJSDUWLFXODUPHGLFLQH
promotion practices and encouraging rational use. It will also enable the monitoring of the impact of any
policy change in a given country.
It is anticipated that the methodology will be run as a pilot in countries representing global and regional
diversity, GDP and regulatory context. The advisory committee determined that an important output
would be a practical guide to assess regulation practices and examples of best practices that would result
from the scoping exercise. Moreover, it is recommended that guidelines be developed to train the
researchers carrying out the literature review and the key informant interviews in an effort to enhance
comparability of the data. HAI will continue to discuss this with the Advisory Group and will work to
have a draft ready for use during the pilot testing phase. The revised manual and the full methodology
will then be shared as an open access resource.
Conclusion
Controlling the promotion of medicines is a crucial step in encouraging the rational use of medicines.
Very little is known about existing regulatory frameworks governing medicines promotion, apart from
the fact that few countries possess efficient ones, and that regulatory provisions and structure vary
considerably across the world. The methodology accompanying this report addresses the need for
information on various frameworks for medicines promotion by providing a means by which extensive
data on regulatory structures can be gathered. It allows an analysis at different levels, by assessing the
situation from a theoretical/technical point of view (laws, decrees, codes etc.) and the qualitative opinion
of key stakeholders.
The research outcomes will help increase transparency in regulatory activities and provide a picture of
the strengths and weaknesses of national systems. This will in turn lead to policy recommendations that
promote good practice, SXEOLFKHDOWKDQGFRQVXPHU¶VSURWHFWLRQ

19
2002
Page 10 of 38

Final preliminary methodology for pilot testing

Part I p. 12-‐22
Literature review: Document check-‐list and data compilation tool
Part II p. 23-‐38
Key informant interview schedules
Page 11 of 38

Document check list

This checklist is indicative and aims at helping the researcher in his work by giving him indications as to which documents might be relevant to medicines
promotion control. Many countries might have only few of these documents available. The material found shall be used as support to answer the questions
in the data compilation part.
Document Exist/does not exist Name of the document and Source (if available on the Reason ,if not provided
date Internet, please include URL)
Legislative documents
Medicines regulation law/ act
National Medicines Policy
If relevant, provisions pertaining to

medicines promotion in:
Supranational/regional agreements
Sub national policies/laws
Advertisement law
Commerce law
Consumer protection law

Other (guidelines, codes)
Self regulation
Pharmaceutical industry code(s)
Related procedures for enforcement
Other relevant documents
Procedures for:
-‐obtaining pre-‐approval of

advertisements for medicines
-‐complaining about medicines

promotion
-‐sanctions and enforcement
Annual reports/descriptive material on

the work of regulatory authorities on
promotion
List of institutions or departments

involved in promotion regulation and
the areas they cover (organigram)
Number of staff involved in

promotion regulation and their
positions (organigram)
Page 13 of 38

Description of activities the bodies

involved in promotion regulation
Conflicts of interests policies of the

bodies involved in promotion
regulation
Published research on promotion in

the country (GGM/MeTA/other)
Other relevant policies/regulation

from:
Professional associations
Medical schools
Hospitals
Scientific offices
Page 14 of 38

Data compilation

dŚĞĨŽůůŽǁŝŶŐĨŽƌŵŝƐƚŽďĞĨŝůůĞĚĂƐŵƵĐŚƉŽƐƐŝďůĞǁŝƚŚĞǆĐĞƌƉƚƐĨƌŽŵĚŽĐƵŵĞŶƚƐĐŽůůĞĐƚĞĚǁŝƚŚƚŚĞŚĞůƉŽĨƚŚĞ͚ĚŽĐƵŵĞŶƚĐŚĞĐŬůŝƐƚ͛͘
dŚĞƉĂƌƚ͚ƐĐŽƉĞŽĨƚŚĞƌĞŐƵůĂƚŝŽŶ͛ƉĂƌƚŝƐƚŽďĞĨŝůůĞĚĨŽƌĞĂĐŚƌĞůĞǀĂŶƚůĂw, code or guideline collected. The following parts request details on the body (or
bodies) in charge of issuing, monitoring and enforcing those documents. In certain countries all those functions are undertaken by the medicines regulatory
authorities. In others, the task of monitoring and enforcing the law is delegated to the private sector.
Scope of the regulation

1. tŚĂƚŝƐĚĞĨŝŶĞĚĂƐ͚ĂĚǀĞƌƚŝƐĞŵĞŶƚ͍͛
2. What is defined as ͚ƉƌŽŵŽƚŝŽŶ͍͛
3. What are the provisions concerning medicines promotion/

advertisement?
4. Does it cover traditional medicines, complementary medicines?
How?
Page 15 of 38

5. Do advertisements have to comply with approved product

information/label?
6. Are certain categories of medicines banned from advertising?
Which ones (unregistered medicines, narcotics...)?
7. Is advertising to the general public authorised? For which

substances? Through which media?
8. For which medicines is advertising to health professionals
authorised?
Through which media? (E.g. medical journals only?)
9. What information has to be included in an advertisement?

Specify by media type.
10. Are requirements for advertising identical for exported and/or

imported medicines and/or locally produced medicines?
11. Are there minimal qualifications listed as necessary to be a
pharmaceutical sales representative?
What are they?
Forms of promotion covered: what is written about...
12. Gifts/payments to doctors or other health professionals
13. Pharmaceutical sales representatives͛ŝŶƚĞƌĂĐƚŝŽŶƐǁŝƚŚŚĞĂůƚŚĐĂƌĞ

professionals
14. Discounts and rebates on medicines
15. Distribution of free medicine samples
16. Sponsorship of Continuing Medical or Pharmacy Education
Page 16 of 38

17. Sponsorship of scientific meetings
18. Information to patients (package inserts contents)
19. Packaging and labelling
20. Internet and related social networking media
21. Post-‐marketing studies
22. Clinical trials and promotion
23. Promotion of off-‐label indications
24. Other
Page 17 of 38

Issuing regulation/codes/guidelines
1. Which body (ies) issue(s) regulations on medicines promotion?
2. What is its stated mission?
3. How is the body governed?
4. Number of full-‐time equivalent staff for medicines promotion

regulation?
5. Budget for medicines promotion regulation in USD and as
percentage of total budget for pharmaceuticals
6. What are its other activities?
7. Funding mechanisms (fees, fines and/or public funds?)
8. How is information about regulation disseminated/made

public? Through official publications, newsletters, websites?
9. Can staff of the regulatory body also work in/be funded by the
pharmaceutical industry? Sit on boards?
10. To whom is the body responsible for issuing regulations
accountable?

Page 18 of 38

Monitoring medicines promotion

1. Is there a governmental system in place for monitoring of
medicines promotion? Any other monitoring system, such as
an industry self regulatory system or other body?
2. If so, is it active monitoring (collection of samples, watching
television advertisements, pre-‐approval) or passive monitoring
(complaint mechanisms by competing companies and/or
consumers)? Describe
3. Which body is responsible for monitoring?
6. Number of full-‐time equivalent staff for monitoring medicines

promotion?
7. Budget for monitoring medicines promotion in USD and as
percentage of total budget for pharmaceuticals
8. What are ƚŚĞďŽĚǇ͛Ɛ other activities?
9. Funding mechanisms (fees, fines and/or government?)
10. If pre-‐approval: Which material, on which media, for which

audience, for which substances?
11. What are the criteria/requirements for pre-‐approval? Are they
publicly available? If so where?
12. Who develops those criteria?
Page 19 of 38

13. Is there a fee for submitting promotional material for pre-‐

approval? How much is it in USD?
14. If there is a complaint mechanism, who can complain?
15. Are complaints published? Are the outcomes published?
16. What is the timeline for the complaint mechanism to be
completed from the time the complaint is filed?
17. How is information about monitoring activities disseminated/
made public?
18. Can staff of the monitoring body also work in/be funded by the
pharmaceutical industry? Sit on industry boards?
19. To whom is the body responsible for monitoring accountable?
Enforcing medicines promotion regulation

1. Which body enforces the law?
4. Number of full-‐time equivalent staff for enforcement of

medicine promotion regulation?
5. Budget for enforcing medicines promotion regulation in USD
and as percentage of total budget for pharmaceuticals
Page 20 of 38

6. What are its other activities?
7. Funding mechanisms (fees, fines and/or public funds?)
8. What are the sanctions: warning letters, issue of corrective

advertisement, prohibition of the advertisement, fines,
revocation of registration, jail, expulsion from association (for
industry self-‐regulation)?
9. What is the range of sanctions (for fines: in USD). List offences
and sanctions range.
10. Are the sanctions made public? How?
11. Is there an appeal mechanism?
12. Who can appeal? To whom?
13. What is the timeline for the appeal process from when the
appeal is launched until its completion?
14. Can staff of the enforcement body also work in/be funded by
the pharmaceutical industry? Sit on industry boards?
15. To whom is the body responsible for enforcement
accountable?
16. Are civil society and/or other stakeholders asked for
comments on pending decisions?
17. Are the reasons for the decisions published?
Page 21 of 38

Others
1. What are the relationships between the different
bodies/departments involved in medicines promotion
regulation (issuing regulations, monitoring and enforcement)
2. Do companies producing and/or selling medicines have to
disclose their budget for promotion and advertising? How and
where is this disclosure made? How much is that budget at a
national level for a given year?
11. How is generic substitution regulated? (E.g. substitution by
pharmacists)
12. How is prescribing regulated?
13. Is there a legal provision requiring the government to provide

independent information on medicines to health professionals
and/or consumers?

Page 22 of 38

Interview Schedule: Key Informant from Drug Regulatory

Authorities

COUNTRY:
DATE AND LOCATION:
RECORDING: YES NO

INTERVIEWEE

FULL NAME:

TITLE AND AFFILIATION:

E-‐MAIL:

ADRESS:

PHONE NUMBER:

INTERVIEWER

FULL NAME:

E-‐MAIL:

REMARKS:
Page 23 of 38

General introduction:
The purpose of this interview is to gather information on the regulatory system in your country
concerning medicines promotion. In many countries this is a grey area, there is little awareness about
the legislation, what is authorised and what is not. We want to learn more about the regulatory
framework, but we also want to know what are the promotional practices used in <COUNTRY> to
advertise medicines. The goal is to identify problems and best practices by gathering this information in
multiple countries. We review the legislation and interview key stakeholders, such as Drug Regulatory
Authorities, healthcare professionals, civil society, the pharmaceutical industry, etc. With this, we hope
to provide recommendations to strengthen regulatory systems to improve medicines use and public
health in general. After the assessment in your country will be carried out, we will get back to you with
the findings.
Did you see the fact sheet on the project? Do you have questions about it?
First of all, I would like you to introduce yourself and to talk to me briefly about the main areas you
focus on in your work.
Do you think you are the right person I should talk to in order to learn more about promotional
practices?
If not, could you let me know of other people you think might be able to provide valuable contribution?
Page 24 of 38

1. Does the government provide or support independent information on medicines to health care
professionals and/or consumers?
2. What do you think of the content of advertisements for medicines in general? Do you think that
information in advertisements is consistent with the actual product characteristics?
3. Are prescription-‐only medicines advertised to the public? In which ways? Are there disease
awareness campaigns in your country? Do they display brand names?
4. Are consumers exposed to advertisements from other countries? Which countries? Through
which media? Are they different from advertisements from your country? How?
5. Do doctors or pharmacists receive discounts, rebates or bonuses as an incentive to prescribe
and dispense more?
6. Are medicines prescribed by brand or generic name? Does it vary between sectors (public and
private)? How?
7. Is generic substitution allowed? Who is allowed to substitute? Is it done in actual practice?
What do patients think about it?
8. Who is involved in the processes by which medicines are selected to be supplied and/or
reimbursed? What is the influence of pharmaceutical companies?
9. Do patient organisations advocate for specific medicines to be registered or reimbursed in your
country? Who funds these organizations?
10. Are medicines sold informally on the (black) market, in kiosks? Are those activities monitored?
By whom?
Does the pharmaceutical industry have an official role in the regulation of drug promotion?
Which sort of role? If the industry self regulates its promotional activities, does the government
have an oversight on the mechanism? How? If not, do you think it has an informal role? How?

11. What proportion of the promotional material is approved when going through the pre approval
process (if applicable)?
Page 25 of 38

12. Are there concerns about promotional activities? Who is taking action? Consumers? Industry
competitors? Do you know of formal complaints being filed? What was the outcome? What do
you think of the complaint mechanism?
13. Are there penalties against offenders? How many penalties were applied in the last five years?
Can you give examples? Are they published? Do the sanctions deter future violations? If not,
why?
14. What do you think of the budget and staffing allocated to the regulation of drug promotion is
sufficient?
15. In your opinion what are the main strengths in the control of drug promotion in your country?
16. In your opinion what are its main weaknesses?
17. Have important developments affecting drug promotion regulation taken place during the past
few years? Are there important upcoming events which will likely influence medicine
promotion regulation in your country or region? Please describe them
18. What is the first thing you would do if you were in a position to change the regulatory situation
on medicine promotion?
Page 26 of 38

Interview Schedule: Healthcare Professional Informant

COUNTRY:
DATE AND LOCATION:
RECORDING: YES NO

INTERVIEWEE

FULL NAME:


E-‐MAIL:

ADRESS:

PHONE NUMBER:

INTERVIEWER

FULL NAME:

E-‐MAIL:

REMARKS:
Page 27 of 38

multiple countries. We review the legislation and interview key stakeholders, such as civil society, Drug
Regulatory Authorities, healthcare professionals, the pharmaceutical industry, etc. With this, we hope to
provide recommendations to strengthen regulatory systems to improve medicines use and public health
in general. After the assessment in your country will be carried out, we will get back to you with the
findings.
First of all, I would like you to introduce yourself and to talk to me briefly how you are interested in
promotion of medicines
practices?
Page 28 of 38

1. Where do healthcare professionals usually go for information on medicines? Are there sources
of independent information? Which sources do you use? How do you know about them?
3. Do healthcare professionals use treatment guidelines? Who is involved in their development?
On which basis?
4. Are medicines promoted for uses outside of approved indications? Which ones? Do you have
examples?
5. Do companies sponsor professional development such as scientific events or Continuing Medical
Education? Do sponsors have a role in choosing the speakers or setting the agenda?
6. What is the usual process to have a medicine added to a hospital formulary? Do you think
medicines promotion influences this process? In what way?
7. What information is given to patients when medicines are dispensed? (Package inserts and
labelling available?)
10. Do patients request for specific brands of medicines? How much influence does it have on
prescribing practices?
11. Are prescription medicines available over the counter? Is this a widespread phenomenon?
(What proportion of sales?)
By whom?
13. Are you exposed to advertisements from other countries? Which countries? Through which
media? Are they different from advertisements from your country? How?
Page 29 of 38

private)? How?
16. What is the relationship between health care professionals (doctors, pharmacists, others) and
pharmaceutical companies?
17. Do doctors or other health professionals receive gifts from medicines providers or producers?
What kinds of gifts are most common? What do you think of this practice?
18. Do doctors receive free samples of medicines? How many free samples of medicines do doctors
receive on average in a month? What do you think about this practice?
and dispense more?
20. Are there concerns about promotional activities? Who is taking action? Healthcare
professionals? Consumers? Industry competitors? Do you know of formal complaints being
filed? What was the outcome? What do you think of the complaint mechanism?
21. Are there penalties against offenders? Are they published? Do the sanctions deter future
violations? If not, why? Is corrective information given to healthcare professionals? Give
examples.
22. In your opinion what are the main strengths in the way medicines promotion is regulated in
your country?
few years? Are there important upcoming events which will likely influence medicine promotion
regulation in your country or region? Please describe them.

Page 30 of 38

Interview Schedule: Key Informant from Civil Society

Organisation or Patient Group or WHO country office

COUNTRY:
DATE AND LOCATION:
RECORDING: YES NO

INTERVIEWEE

FULL NAME:


E-‐MAIL:

ADRESS:

PHONE NUMBER:

INTERVIEWER

FULL NAME:

E-‐MAIL:

REMARKS:

Page 31 of 38

multiple countries. We review the legislation and interview key stakeholders, such as healthcare
professionals, Drug Regulatory Authorities, civil society, the pharmaceutical industry, etc. With this, we
hope to provide recommendations to strengthen regulatory systems to improve medicines use and
public health in general. After the assessment in your country will be carried out, we will get back to you
with the findings.
First of all, I would like you to introduce yourself and to talk to me briefly about the main areas you
focus on in your work.
practices?
Page 32 of 38

1. Where do consumers usually go for information on medicines? Are there sources of
independent information? Which sources do you use? How do you know about them?
3. Are consumers exposed to advertisements from other countries? Which countries? Through
which media? Are they different from advertisements from your country? How?
4. What is the relationship between health care professionals (doctors, pharmacists, others) and
pharmaceutical companies?
5. Do doctors or other health professionals receive gifts from medicines providers or producers?
What kinds of gifts are most common? What do you think of this practice?

6. Do doctors receive free samples of medicines? What do you think of this practice?
and dispense more?
By whom?
examples?
Page 33 of 38

private)? How?
17. Are there concerns about promotional activities? Who is taking action? Consumers? Industry
competitors? Do you know of formal complaints being filed? What was the outcome? What do
you think of the complaint mechanism?
18. Are there penalties against offenders? Are they published? Do the sanctions deter future
violations? If not, why?
19. Are consumers/ civil society organisations involved in regulating promotion? Does the
pharmaceutical industry have an official role in the regulation of drug promotion? Which sort of
role?
20. If the industry self regulates its promotional activities, does the government have an oversight
on the mechanism? How? If not, do you think it has an informal role? How?
your country?
regulation in your country or region? Please describe them.
Page 34 of 38

Interview Schedule for the Pharmaceutical Industry, the

Insurers, and the Media

COUNTRY:
DATE AND LOCATION:
RECORDING: YES NO

INTERVIEWEE

FULL NAME:


E-‐MAIL:

ADRESS:

PHONE NUMBER:

INTERVIEWER

FULL NAME:

E-‐MAIL:

REMARKS:
Page 35 of 38

multiple countries. We review the legislation and interview key stakeholders, such as civil society, Drug
Regulatory Authorities, healthcare professionals, the pharmaceutical industry, etc. With this, we hope to
provide recommendations to strengthen regulatory systems to improve medicines use and public health
in general. After the assessment in your country will be carried out, we will get back to you with the
findings.
First of all, I would like you to introduce yourself and to talk to me briefly how you are interested in
promotion of medicines
practices?

Page 36 of 38

2. Do patients request for specific brands of medicines? How much influence does it have on
prescribing practices?
and dispense more?
By whom?
7. Does the pharmaceutical industry have an official role in the regulation of drug promotion?
Which sort of role? If the industry self regulates its promotional activities, does the government
have an oversight on the mechanism? How? If not, do you think it has an informal role? How?
8. Do patient organizations advocate for specific medicines to be registered or reimbursed in your
country? Who funds these organisations?
private)? How?
Page 37 of 38

examples?
14. Are there concerns about promotional activities? Who is taking action? Healthcare
professionals? Consumers? Industry competitors? Do you know of formal complaints being
filed? What was the outcome? What do you think of the complaint mechanism?
your country?
regulation? Please describe them.
Page 38 of 38

Medicines Promotion: Assessing The Nature, Extent and Impact of Regulation

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Medicines Promotion: Assessing The Nature, Extent and Impact of Regulation

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Medicines Promotion: Assessing the Nature,

Report and Preliminary Methodology for Pilot-­‐testing

Project report .................................................................................................................................. 4

Rational Use of Medicines, Medicines Promotion and regulation ................................................. 4

Looking ahead .................................................................................................................................. 9

Final preliminary methodology for pilot testing ............................................................................ 11

Document check list ......................................................................................................................... 12

Data compilation .............................................................................................................................. 15

Interview Schedule: Healthcare Professional Informant ................................................................. 27

Interview Schedule: Key Informant from Civil Society Organisation

or Patient Group or WHO country office ......................................................................................... 31

Page 2 of 38

Project supervisor at MeTA

Elodie Brandamir, MeTA

Page 3 of 38

Rational Use of Medicines and Medicines Promotion

Regulation of Medicines Promotion

µ«to enact new, or enforce existing, legislation to ban inaccurate, misleading or

7RGDWHIHZHUWKDQKDOI  RIWKHZRUOG¶VFRXQWULHVKDYHLQWURGXFHGDOHJLVODWLYHIUDPHZRUNWR

³(IIHFWLYH'UXJ5HJXODWLRQ$0XOWL-country Study´18 is also of key relevance to this project and

x The scope of regulation on pharmaceutical promotion in country settings

x The impact and effectiveness of the regulatory framework on promotional practice

For this purpose, HAI developed a methodology to help countries identify:

x National legal provisions on promotion as well as existing mechanisms to implement and

x Any gaps in the regulatory framework that need to be addressed

+$,¶VUHVHDUFKWRROFRPELQHVGHVNUHVHDUFKDQGin-country key informant interviews and includes:

x An analysis of relevant laws, guidelines or codes related to the promotion of medicines

x An assessment of existing mechanisms for implementation and enforcement

x Key informant interviews for in-depth analysis of the actual situation

The literature review comprises D³GRFXPHQWFKHFNOLVW´DQGD³GDWDFRPSLODWLRQ´WRRO. This part of the

The ³'ocument CKHFNOLVW´LVLQWHQGHGWRJXLGHWKHUHVHDUFKHUVWKURXJKWKHFollection of relevant

Key Informants interviews: 4 interview schedules templates

.H\LQIRUPDQW¶s interviews (approximately 10 per country) explore current practice, models of

7KLVQHHGWRDGDSWWKHTXHVWLRQWRWKHNH\LQIRUPDQWV¶EDFNJURXQGLVWKHUDWLRQDOHfor having four

x Civil society, patient organisations and WHO country offices

x The pharmaceutical industry, payers/insurers, and the media

x The strengths and weaknesses of any regulatory framework

x Issues related to the implementation and enforcement of the existing regulation

Page 9 of 38

Page 10 of 38

Final preliminary methodology for pilot testing

Part I p. 12-­‐22

Literature review: Document check-­‐list and data compilation tool

Part II p. 23-­‐38

Key informant interview schedules

Page 11 of 38

Medicines regulation law/ act

National Medicines Policy

If relevant, provisions pertaining to

Sub national policies/laws

Consumer protection law

Other (guidelines, codes)

Pharmaceutical industry code(s)

Related procedures for enforcement

Other relevant documents

-­‐obtaining pre-­‐approval of

-­‐complaining about medicines

-­‐sanctions and enforcement

Annual reports/descriptive material on

Report and Preliminary Methodology for Pilot-‐testing

7RGDWHIHZHUWKDQKDOIRIWKHZRUOG¶VFRXQWULHVKDYHLQWURGXFHGDOHJLVODWLYHIUDPHZRUNWR

³(IIHFWLYH'UXJ5HJXODWLRQ$0XOWL-country Study´18 is also of key relevance to this project and

Part I p. 12-‐22

Literature review: Document check-‐list and data compilation tool

Part II p. 23-‐38

-‐obtaining pre-‐approval of

-‐complaining about medicines

-‐sanctions and enforcement

21. Post-‐marketing studies

23. Promotion of off-‐label indications

4. Number of full-‐time equivalent staff for medicines promotion

6. Number of full-‐time equivalent staff for monitoring medicines

10. If pre-‐approval: Which material, on which media, for which

13. Is there a fee for submitting promotional material for pre-‐

4. Number of full-‐time equivalent staff for enforcement of