ATMI and Medicines Use:

an Index Country-basedNGO view

Christa Cepuch BSc PhmHealth Action International Africa

ICIUMAntalya, Turkey

17 November 2011

Factors affecting RUM

Availability and price of medicines Education and practice of health workers Policies of health insurance companies Strategies and priorities of governments Structure and function of health systems Practices of the public Tactics of pharmaceutical companies

ATMI key indicators are directly and / or indirectly related to these factors

RUM and Price: practices

http://www.theeastafrican.co.ke/news/-/2558/848390/-/pwbuvlz/-/index.html

You will now pay less for original antibioticsBy PHILIP NGUNJIRI Posted Sunday, January 24 2010

Pharmaceutical firm GlaxoSmithKline has announced a price reduction on two of its key antibiotics, across East Africa. Augmentin and Zinnat will get a price slash of 40 per cent and 30 per cent respectively….

generic medicines form the backbone of Kenya’s health systems amoxicillin/clavulanic acid (“Augmentin”): on WHO EML and may at times be

found in Kenya’s public health facilities (often sourced as a non-GSK generic) cefuroxime (“Zinnat”): not on EML and any price reduction associated with it, is

hence of limited significance to the health of the majority of Kenyans

RUM and Price: battles

Legal and trade battles against emerging markets governments over patent protection

Novartis in India Pfizer in the Philippines Abbott in Thailand Sanofi-Aventis in Thailand

What do these “policies” mean for AEM for people?

5www.economist.com/research/articlesBySubject/displaystory.cfm?subjectid=7933596&story_id=15320793

RUM and Price: data

RUM and Price: data

Median prices of AL 20/120mg (pack size 6x4) by country: non-AMFm (OB and LPG)

FO

RM

AL

INF

OR

MA

L

FO

RM

AL

INF

OR

MA

L

FO

RM

AL

INF

OR

MA

L

FO

RM

AL

INF

OR

MA

L

FO

RM

AL

INF

OR

MA

L

FO

RM

AL

INF

OR

MA

L

GHANA KENYA NIGERIA TANZANIA MADAGASCAR UGANDA

0.00

2.00

4.00

6.00

8.00

10.00

12.00

14.00

7.87

11.59

6.96

5.836.88

10.25

8.96 8.96

3.05 3.28 3.222.68

3.89 3.56

12.42

2.242.87

Non-AMFm(OB) Non-AMFm(LPG)

Pri

ce (

US

D $

)

ATMI Methodology on Promotion-related Indicators

Self reported by industry… but this has not been shown to be effective (WHO HAI 2005)

Media scans (note BMS, GSK, AZ – recent and enormous settlements reported in the media)

Credible sources… but in Africa: industry is a powerful presence and a significant source of

“information” (Health Horizons 1992) few studies about promotion (WHO HAI 2005) poor compliance with existing regulation (Chirac et al 1993,

Sibanda et al 2004)

Policy based evaluation... but what is the reality

WHO Ethical Criteria

Constitute general principles for ethical standards

Apply to POM, OTC medicines, TMs and any other product promoted as a medicine

No legal obligation: for governments and industry to adapt / adopt

WHO EC: Required information for print advertisements - 1

To health professionals• name(s) of the active ingredient(s) using either international

nonproprietary names (INN) or the approved generic name of the drug

• brand name• content of active ingredient(s) per dosage form or regimen• name of other ingredients known to cause problems• approved therapeutic uses• dosage form or regimen• side-effects and major adverse drug reactions• precautions, contra-indications and warnings• major interactions• name and address of manufacturer or distributor• reference to scientific literature as appropriate

WHO EC: Required information for print advertisements - 2

To the general public• name(s) of the active ingredient(s) using

either international nonproprietary names (INN) or the approved generic name of the drug

• brand name• major indication(s) for use• major precautions contraindications warnings• name and address of manufacturer or

distributor

The IFPMA Code of Pharmaceutical Marketing Practices

Required information for print advertisement to health professionals

• name of the product (normally the brand name)• active ingredients, using approved names where they

exist• name and address of the pharmaceutical company or

its agent responsible for marketing the product• date of production of the advertisement• “abbreviated prescribing information” which should

include an approved indication or indications for use together with the dosage and method of use; and a succinct statement of the contraindications precautions and side effects

A methodology to evaluate ethical promotion

2008 study: Kenya, Madagascar, Malawi, Uganda, Zambia,Zimbabwe

1. To assess the compliance of promotional materials with the WHO Ethical Criteria on Medicinal Drug Promotion

2. To establish the status of national policy and regulations on medicines promotion

Methodology and samplingJournals: Advertisement in 2008 issues of the 3 leading regional medical journals were compiled (Pharmaceutical Journal of Kenya , East African Medical Journal, East and Central African Journal of Pharmaceutical Sciences)

Brochures: Data collectors from the 6 countries were trained in Kenya to collect advertisements

• in health facilities from public, private and mission sectors• from different regions within each country

Journals 79

Kenya 313

Zambia 79

Malawi 21

Madagascar 73

Uganda 57

Zimbabwe excluded

Number of advertisements collected

Promotional material analysisWHO’s Ethical Criteria compliance:

Promotion to health professionals

• Name of active ingredient • Brand name• Content of active ingredient• Approved indications • Dosage form or regimen• Side effects, adverse drug

reactions • Precautions, contraindications,

warnings • Interactions• Name and address of

manufacturer

Promotion to the general public• Name of active ingredient• Brand name• Major approved indications• Major precautions,

contraindications, warnings• Name and address of

manufacturer• No use of the word safe without qualifications

British National Formulary 56th edition (September 2008) used as a reference to determine adherence to the technically-based criteria

• None of the advertisements studied meet all the criteria assessed

• Less than 50% of the medicines promoted were on WHO EML

< 70% generic name

active ingredient

brand name

approved indicationdosage form

interactions

name and physical address

precautions CIs warningsside effects

strength

0

10

20

30

40

50

60

70

80

90

100

%

Compliance with the assessed WHO Ethical Criteria

< 60% approved indication

< 33% precautions contraindications warnings, side effects and interactions

Promotion to health workers: Results

V

0

10

20

30

40

50

60

70

80

90

100

Kenya Zambia Malawi Madagascar Uganda

%

Promotion to the public: Results

Promotion of approved therapeutic uses

Less than 50% of the material promote only approved indications

Extension of the indications

Promotion of unlicensed indicationAdvertisement for an antibiotic, Kenya, 2008

V

0

10

20

30

40

50

60

70

80

90

100

Kenya Zambia Malawi Madagascar Uganda

%

Major precautions, contra indications, warnings

Promotion to the public: Results

In all countries (but Madagascar), less than 40% of the material mention those

In most of the cases: complete absenceAdvertisement for an antibacterial, Zambia, 2008

V

16% of the promotional materials meet all the criteria

Name of active ingredient Brand name Major approved indications Major precautions,

contraindications, warnings Name and address of

manufacturer Use of the word safe only if

qualified

DTCA only allowed in US and NZ?

Promotion to the public: Results

Advertisement for an antibiotic, East African Medical Journal, 2008

Interventions to counter promotion

• Self-regulatory systems do not provide effective control

• Review by journal editors do not provide effective control

• Regulations that should control promotion are ineffective

• Education about promotion appears to change attitudes and can improve skills

• Publications of deceptive promotion lead manufacturers to improve promotional practices

ATMI and RUM

Factors affecting RUMATMI methodology and strategy?

Availability and price of medicines

Education and practice of health workers

Policies of health insurance companies

Strategies and priorities of governments

Structure and function of health systems

Practices of the public Tactics of pharmaceutical

companies

Evaluate availability and price on the ground in IC countries

Base on known interventions to counter promotion

What do industry policies and practices mean to the people struggling to get access to medicines?

Ideas for ATMI Methodology

Increase focus on MIC Implement questionnaires on the ground in IC’s IC partnerships with treatment activists, public health

advocates, organizations working on medicines access

Quantitative and qualitative approaches In-depth case studies ensuring anonymity of

responders (transparency)

General views as time allows…

ATMI helping to define a set of tools and benchmarks for good practice

Important for investors / shareholders when (if??) assessing companies and holding them to account

Is there a clear understanding of some of the ATMI indicators (Big Pharma policies) on AEM?

Is there a way to validate the methodology vis a vis findings (ratings)? And with respect to the reality of peoples’ struggles to access essential medicines?

Language and the images it evokes can shape and influence attitudes and expectations …

ATMI? or ATMBI? or IEATM? or IPPBAATM? etc...

Acknowledgements and ReferencesReferencesDrug promotion what we know, what we have yet to learn. WHO and HAI, 2005

Africa survey shows pharma information valued. Health Horizons 1992

Drug marketing in French-speaking African countries. Chirac and al. Social Science and Medicine 1993

Pharmaceutical manufacturers’ compliance with drug advertisement regulations in Zimbabwe. Sibanda et al. Am J Health-Syst Pharm 2004

Leading regional medical journals-Pharmaceutical Journal of Kenya -East African Medical Journal-East and Central African Journal of Pharmaceutical Sciences

AcknowledgementsHAI Africa network members on the groundCarole Pirou, HAI Africa intern 2008 / 09Patrick Mubangizi, (ex) HAI Africa Regional CoordinatorDGIS funding through HAI Global