Whilst the pharmaceutical industry plays a key role in developing and producing medicines, there is a tension between industry’s need to expand product.

Slides:



Advertisements
Similar presentations
Child Rights Toolkit Comprehensive Toolkit To Address Children's Rights In Development & Humanitarian Cooperation And Government Programming.
Advertisements

A study of advertisements in five African countries
Regulation of Pharmaceutical Promotion: assessment, analysis & advocacy Lilia Ziganshina 20 May 2009 WHA.
Technical cooperation with countries Technical Cooperation for essential drugs and traditional medicines September 2005.
Management of Drug Formulary Dimitry Gotlinsky Western University Managed Care Clerkship ProPharma Pharmaceutical Consultants, Inc. 06/16/06.
Group 3 Irrational use of Medicine and medical technology.
World Health Organization
Lucila Beato UNMIL/HRPS
Sakthivel Selvaraj, Habib Hasan, Preeti Kumar, Maulik Chokshi Public Health Foundation of India, India 1.
Progress Toward Impact Overall Performance Study of the GEF Aaron Zazueta GEF Evaluation Office Hanoi, March 10, 2010.
Evaluation at The Prince’s Trust Fire Service Prince's Trust Association meeting 18 th February 2010 Subtitle.
Project Advisory Committee Meeting 26th June 2012, New Delhi Vikash Batham CUTS International Exploring the Interplay between Business Regulation and Corporate.
First Evaluation of Good Governance for Medicines Programme Brief Summary of Findings.
Kellie Wilson and Dave Burrows. Issues One key area of improvement required for GF proposals include the provision of: stronger more comprehensive situation.
Development of a tool for assessing site-readiness for the provision of vaginal microbicides and oral PrEP in South Africa.
TRAINING FOR ANTIMICROBIAL STEWARDSHIP PROGRAMMES IN HOSPITALS JUNE 2014.
Eurasian Corporate Governance Roundtable
Access to Medicine Index 3 rd International Conference for Improving the Use of Medicines Poster 599 Tuesday 15 th November 2011.
EDM STRATEGY FOR WORKING WITH COUNTRIES-TANZANIA Rose Shija EDM NPO TANZANIA.
Critical Appraisal of Clinical Practice Guidelines
3rd Baltic Conference on Medicines Economic Evaluation, Reimbursement and Rational Use of Pharmaceuticals Pricing and Reimbursement of Pharmaceuticals.
National Medicine Policy
A Common Immigration Policy for Europe Principles, actions and tools June 2008.
Regulations Relating to Foodstuffs for Infants and Young Children (Foodstuffs, Cosmetics and Disinfectants Act, 1972) Briefing to the Portfolio Committee.
MeTA Jordan Executive Summary Baseline data is an important source for policy makers to diagnose the pharmaceutical and health sector situation in order.
Medicines Transparency Alliance05/09/2015 Medicine Promotion Robert Louie P. So, MD Program Manager DOH - National Center for Pharmaceutical Access and.
Stakeholders In Clinical Research Government and Regulatory Bodies Professor Phil Warner.
Asia-Pacific High-level Meeting on HIV and AIDS The Asia-Pacific High-level Intergovernmental Meeting on the Assessment of Progress against Commitments.
INTRODUCTION TO RA.
Evaluation methods and tools (Focus on delivery mechanism) Jela Tvrdonova, 2014.
Medicines Transparency Alliance01/10/2015 Availability of Medicines Anita Wagner Harvard Medical School & WHO Collaborating Center in Pharmaceutical Policy.
Good Participatory Practice UNAIDS & AVAC Document Pauline Irungu Global Campaign for Microbicides.
Introduction to MAST Kristian Kidholm Odense University Hospital, Denmark.
1 Webinar: Challenges in Clinical Training Ben Wallace, Executive Director, Clinical Training Reform Health Workforce Australia.
Summary of ICIUM Chronic Care Track Prepared by: Ricardo Perez-Cuevas Veronika Wirtz David Beran.
Summary from the Economics Track With thanks to all track participants, presenters, rapporteurs, moderators and organizers.
Rasha Hamra, PharmD, MPH Ministry of Health, Lebanon Antalya, November 17, 2011 Transparency Monitoring Study: A Rapid Assessment of Transparency in Key.
EVALUATION APPROACHES Heather Aquilina 24 March 2015.
Medicines Transparency Alliance14/10/ Medicines promotion: innovative tools to promote rational use Carole Piriou Project officer Rational use of.
4 th - 18 November 2011 ICIUM 2011 Conference Antalya, Turkey 16/10/2015.
Policy track summary ICIUM 2011 – 18 Nov Policy track topics 1.The pharmaceutical policy process 2.Quality and safety of medicines in LMIC 3.Policy.
BASELINE SURVEYS AND MONITORING OF PHARMACEUTICAL SITUATION IN COUNTRIES. Joseph Serutoke NPO/EDM WHO Uganda November 2002.
Promoting Drug and Therapeutics Committees in the Developing World
Presenter name:Noel Juban, M.D, MsC Affiliation: Department of Clinical Epidemiology U.P. College of Medicine November 2011MeTA Process and Lessons from.
Objective the aim of this project was directly addressing a major health problem for Jordan by producing a guideline as a pilot in which the strengths.
WHO-Technical Briefing Seminar | October-November 2012 Dr Cécile Macé 1 |1 | Good Governance for Medicines Programme Dr Cécile Macé EMP/MPC.
BREASTFEEDING CONSULTATIVE MEETING FEEDBACK - TRACK 4 23 AUGUST 2011.
Medicines Transparency Alliance Presented by Gilles Forte Department of Essential Medicines and Health Products, WHO On behalf of WHO and HAI Technical.
Understanding and responding to pharmaceutical promotion: A practical guide  Americas  Europe  Western Pacific  Eastern Mediterranean  Africa  South-East.
Reduction of Mercury in Products Action Plans. 2 Action Plan  describes the activities to be carried out and the related implementation strategies for.
Medicines Transparency Alliance16/12/ MeTA Uganda: Promotion Nazeem Mohamed MeTA Council Co-Chair.
Some reasons for unnecessary procedures
Portfolio Committee for Health Medicines and Related Substances Amendment Bill (06/08/08) IMSA represents Research Based Pharmaceutical Companies.
MONITORING THE PHARMACEUTICAL SECTOR IN A DEVELOPING COUNTRY - THE GHANA EXAMPLE Gyansa-Lutterodt M. 1,7, Andrews E 2, Arhinful D 3,7, Addo-Atuah J 4,7,
DOES DRUG USE EVALUATION (DUE) REQUIRED BY NATIONAL POLICY IMPROVE USE OF MEDICINES?
Does Drug Use Evaluation Required by National Policy Improve Use of Medicines? Akaleephan C*, Muenpa R**, Sittitanyakit B***, Treesak C #, Cheawchanwattana.
Strategic Objective 4 To promote the exchange of experiences and regulatory knowledge between NRAs inside and outside PANDRH“ Lessons learned from international.
1 CHALLENGES IN REGULATING QUALITY AND RATIONAL USE OF ANTIBIOTICS ALLIANCE FOR THE PRUDENT USE OF ANTIBIOTICS: INAGURAL MEETING COURTYARD.
The First Conference for Medicines Regulatory Authorities In Sudan and Neighboring Countries Khartoum December 2014 Alain PRAT, Technical Officer,
Steps for the Integration of Traditional Medicine in the National Health Care Delivery System 18 TH ICASA Special Session on Traditional Medicine 1 st.
5. Presentación general de la iniciativa REDD+ SES 5. Presentation of the REDD+ SES Initiative.
Prepared by: Imon Rahman Lecturer Department of Pharmacy BRAC University.
A look at progress in the development of eHealth in the European Region Results and recommendations from the 2016 report “From Innovation to Implementation:
Project: EaP countries cooperation for promoting quality assurance in higher education Maria Stratan European Institute for Political Studies of Moldova.
Implementing the guideline
Logez S, Hutin Y, Somda P, Thualt J, Holloway K
Regulation of Medical Products & Patient Safety- A Narrative Review
Health Technology Assessment for Universal Health Coverage
National Medicines Policies
National Medicines Policies
Presentation transcript:

Whilst the pharmaceutical industry plays a key role in developing and producing medicines, there is a tension between industry’s need to expand product sales and a country’s public health needs. “ There is an inherent conflict of interest between the legitimate business goals of manufacturers and the social, medical and economic needs of providers and the public to select and use drugs in the most rational way.” 1 Promotional material is often the main or only source of information about medicines for health professionals and consumers. The sheer volume of promotion al activities including industry involvement in continuing medical education, clinical research, patient groups and other areas, make persuasive promotional messages difficult to avoid. Medicines Promotion: Assessing the Nature, Extent and Impact of Regulation Irrational prescribing and use of medicines often results in inappropriate or harmful treatment, a waste of valuable health resources and increased drug resistance. The single most important stimulus behind irrational medicines use is the unethical promotional of medicines Many countries have introduced a legislative framework to regulate the promotional activities of the pharmaceutical industry; these vary widely regarding content, implementation and enforcement. Further information: Literature review Key Informants Interview Field analysis Methodology 1988 : WHO Ethical Criteria for Medicinal Drug Promotion. This document remains the gold standard against which promotional activities, and national and regional efforts to regulate promotion, are judged. The project aims to determine: The scope of regulation and/or restrictions on pharmaceutical promotion in countries The impact and effectiveness of regulatory frameworks and/or codes of practice aimed at restricting promotional activities This will help countries to identify: 1) National legal provisions on promotion as well as existing mechanisms to implement and enforce them 2) Existing forms of unethical promotion and best practice 3) Any gaps in the regulatory framework that need to be addressed This research will provide a detailed profile of how promotion is managed within a country’s, including Strengths and weaknesses of the regulatory framework Any outstanding enforcement issues A clearer picture of the political context and stakeholder positions on regulation The research findings will provide valuable insight into the efficacy of pharmaceutical promotion regulation; highlight areas that need strengthening; and inform recommendations to improve policies on medicines promotion. National surveys carried out using the HAI methodology will provide an evidence base, which countries can then use to make policy choices that contribute to the rational use of medicines. Rationale Background Regulation of Promotion: milestones Interview schedules for data collection from representatives from the drug regulatory authorities, WHO, health care professionals, civil society, pharmaceutical industry representatives, insurers and media. Qualitative analysis of insights into the current promotion situation, and observations on best practice. 2007: Resolution WHA on rational use of medicines urges Member States “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.” 2 Objectives Results Comprehensive tools for the systematic collection and analysis of relevant laws, guidelines or codes related to the promotion of medicines. Additional tools to assess existing mechanisms that implement and/or enforce restrictions on promotional activity. Monitoring specific promotion outcomes (such as direct- to-consumer advertisements, the impact of sales representatives and the uptake of generic medicines), thus allowing measurement of progress against legislative or code of practice intervention Next steps The methodology now needs to be pilot tested: by assessing a number of countries representing various levels of economic development; these countries will benefit from a comprehensive assessment and will be involved in the finalisation of the methodology. It will then be released as an open access tool. 1 World Health Organization. Clinical Pharmacological Evaluation of Drug Control. WHO, Resolution on Rational Use of Medicines. 60 th World Health Assembly, 2007