ATMI and Medicines Use: an Index Country-based NGO view Christa Cepuch BSc Phm

1. ATMI and Medicines Use: an Index Country-based NGO view Christa CepuchBScPhm Health Action International Africa ICIUM Antalya, Turkey 17 November 2011

2. 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

3. RUM and Price: practices http://www.theeastafrican.co.ke/news/-/2558/848390/-/pwbuvlz/-/index.htmlYou 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

4. 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?

5. RUM and Price: data www.economist.com/research/articlesBySubject/displaystory.cfm?subjectid=7933596&story_id=15320793

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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. Methodology and sampling • Journals: 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 Number of advertisements collected

14. 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 Promotional material analysis WHO’s Ethical Criteria compliance: British National Formulary 56th edition (September 2008) used as a reference to determine adherence to the technically-based criteria

15. Promotion to health workers: Results Compliance with the assessed WHO Ethical Criteria < 70% generic name • None of the advertisements studied meet all the criteria assessed • Less than 50% of the medicines promoted were on WHO EML < 60% approved indication < 33% precautions contraindications warnings, side effects and interactions

16. V 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 indication Advertisement for an antibiotic, Kenya, 2008

17. V Promotion to the public: Results Major precautions, contra indications, warnings In all countries (but Madagascar), less than 40% of the material mention those  In most of the cases: complete absence Advertisement for an antibacterial, Zambia, 2008

18. V Promotion to the public: Results 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? Advertisement for an antibiotic, East African Medical Journal, 2008

19. 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

20. ATMI and RUM Factors affecting RUM ATMI 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?

21. 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)

22. 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...

23. Acknowledgements and References References Drug 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-SystPharm 2004 Leading regional medical journals -Pharmaceutical Journal of Kenya -East African Medical Journal -East and Central African Journal of Pharmaceutical Sciences Acknowledgements HAI Africa network members on the ground Carole Pirou, HAI Africa intern 2008 / 09 Patrick Mubangizi, (ex) HAI Africa Regional Coordinator DGIS funding through HAI Global