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Conference Agenda

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Session Overview
Session
5b. Policy: Consumers and Good Governance for Medicines
Time: Thursday, 17/Nov/2011: 10:15am - 11:15am
Session Moderator: Natalia Cebotarenco, CoRSUM - Coalition for Rational and Safe Use of Medicines, Moldova, Republic of
Session Moderator: Mohamed Ramzy Ismail, WHO-EMRO, Egypt
Session Rapporteur: Jing Sun, China National Health Development Research Center, MoH China, China, Peoples Republic of
Location: Jasper Auditorium

Presentations

Transparency Monitoring Study: A Rapid Assessment of Transparency in Key Functions of Pharmaceutical Services in 15 Countries

Rasha Saadi Hamra, Alessandra Ferrario, Maryam Bigdeli, Guitelle Baghdadi-Sabeti

World Health Organization/Alliance for Health Policy and Systems Research, Lebanon

Problem statement: WHO launched Good Governance for Medicine program with goal to contribute to health system strengthening and prevent corruption by promoting good governance: 26 countries joined since 2004. First step was to conduct a national assessment of level of transparency and potential vulnerability to corruption in pharmaceutical sector. A standardized instrument was designed to measure transparency in 8 functions of medicine chain: registration, licensing, inspection, promotion, clinical trials, selection, procurement and distribution. The assessment provides a baseline for countries to revise, adjust their laws, policies, administrative structures and processes. It measures vulnerability in systems at time of assessment and vulnerability scoring can be used to monitor progress over time.

Objectives: Analyze data on transparency for baseline and 2010 status; provide recommendations for improving GGM policies

Design: Comparative analysis between baseline transparency indicators with 2010 status. Indicators checklist was developed to collect data for 2010 based on the original Transparency Assessment Instrument indicators.

Setting: Public pharmaceutical sector.

Study population: All 26 countries that conducted Transparency assessment initially, were asked to participate on voluntary basis and were sent checklist to fill, but some choose not to participate in 2010 analysis for various reasons; not a priority, short time given to fill the checklist, change of focal points. Data were received from 15 countries: Benin, Bolivia, Cameroun, Costa Rica, Indonesia, Jordan, Lao, Lebanon Macedonia, Malaysia, Moldova, Mongolia, Philipine, Thailand, and Zambia.

Policies: Initial findings of assessments enabled ministries of health and national regulatory authorities to identify weaknesses and gaps in systems and develop strategies to address them. Current study will show which policies were addressed most and which were given least attention.

Outcome measures: Improvement in indicators across the 8 pharmaceutical functions and overall improvement in transparency and vulnerability to corruption of a given function.

Results: Improvement in pharmaceutical functions was most seen in selection, procurement and registration. Some improvement was seen in inspection and promotion as well. Improvement in licensing and control of clinical trials cannot be seen since we had complete data for baseline and status only for 3 countries to compare. Countries’ efforts to improve good governance consisted in making information publicly available, accountability of committee members, and participation of different stakeholders in various committees. Many pre-existing written documents, procedures and guidelines were made publicly available to increase transparency. Some countries worked on developing detailed terms of reference and guidelines for different committees.

Conclusions: Transparency assessment had power to initiate change at different levels and across various functions of the public pharmaceutical sector. Findings of this analysis gave a clear visualization of policy changes in different functions of pharmaceutical systems. The change introduced and documented will lead countries to further acknowledge importance of good governance. Results of this analysis and future ones will help in identifying agendas for policy change and setting realistic priorities for action in the pharmaceutical sector.

Funding source: AHPSR-WHO

711-Hamra-_a.pdf
711-Hamra-_b.ppt
711-Hamra-_c.pdf

Corruption and High Medicine Prices in Vietnam: A Qualitative Study

Tuan Anh Nguyen1,2, Rosemary Knight1, Andrea Mant1, Minh Quang Cao3, Husna Razee1

1School of Public Health and Community Medicine, University of New South Wales, Australia; 2Department of Pharmaco-economics and Pharmaceutical Management, Hanoi University of Pharmacy, Vietnam; 3Ministry of Health of Vietnam, Hanoi, Vietnam

Problem statement: Medicine prices in Vietnam were unreasonably high. Adjusted for Purchasing Power Parity in 2005, the prices to patients in the public sector were 46.58 and 11.41 times the international reference price for originators and lowest priced generic equivalents, respectively.

Objective: To identify the main reasons for high medicine prices in Vietnam

Method: Semi-structured questionnaires were used to conduct 43 interviews with different stakeholders including pharmaceutical companies’ representatives, Ministry of Health officials, and prescribers in Vietnam from April 2008 to December 2009. The interviews were all recorded, transcribed, and coded using NVivo8 software. Ethics approval was obtained from the University of New South Wales.

Results: According to participants’ responses, originator medicines in Vietnam were too expensive due to a supplier monopoly. Prices of generic medicines were set at around 80%, sometime even higher than those of corresponding originator medicines due to informal payment to authorities, commissions for prescribers, and kickback to hospital pharmaceutical departments. Pressures for survival arising from an imperfectly competitive pharmaceutical market, among other reasons, were believed to force pharmaceutical companies to be inextricably linked to prescribers. Salary pressures and the perpetual corruption in the absence of penalties in Vietnam were given as the main motives for prescribers to collude with the pharmaceutical industry. The magnitude of reported corruption varied across geographic regions, sectors, and prescriber’s specialties. In addition, overreliance on the international market, poor market intelligence, failure to achieve economies of scale due to duplication in drug production and distribution, too many layers in the distribution network, and malfunctioning pricing policies were reported to be non-corruption related causes for the high medicine prices in Vietnam.

Conclusions: Corruption was reported as a main driver for high medicine prices in Vietnam. Although individual factors such as professional ethics and personal value influenced physician behaviours and their response to corruption, entrenched or intractable systemic issues including lack of transparency and accountability and poor legislation enforcement emerged as important factors perpetuating corruption. Addressing the widespread issue of corruption, both individual and systemic factors, is necessary in developing sound medicine pricing policies in Vietnam. Interventions to relieve dependencies for survival of health care services on the corrupt system are needed. Rationalization of the domestic drug production and distribution to achieve economies of scale and reduce wasteful uneconomic competition might be a solution that Vietnam needs to achieve soon.

Funding source(s): The Ministry of Education and Training, Government of Vietnam

193-Nguyen-_a.pdf
193-Nguyen-_b.ppt
193-Nguyen-_c.pdf

Active Enforcement to Code of Conduct and Conflict of Interest Policies Based on Transparency Assessment Study in Jordan

Sana Naffa, Adi Nseirat

World Health Organization, Jordan

Problem Statement: Transparency assessment survey showed that there are different levels of vulnerability to corruption, these levels are classified into; minimally vulnerable, marginal, , moderate, very and extremely vulnerable, in six key functions in the pharmaceutical sector.

Objectives: To assess the level of transparency and potential vulnerability to corruption of six essential functions in the pharmaceutical sector; and to develop a framework for improving the good governance in medicine practices within pharmaceutical sector.

Study Design: The assessment instrument contains three questionnaires, one for each function. Each questionnaire is used with key informants selected according to explicit criteria. Sixty-one key informants were selected.

Results: (1) Registration: 7.52—marginally; (2) promotion 1.88 —extremely; (3) inspection 5.79—moderately; (4) selection 7.71—marginally; (5) procurement 8.59—minimally; distribution 8.41—minimally. The total was 6.65—marginally.

Interventions: A national workshop was conducted. Two committees have been formed by ministerial decree—a task force to follow up on study findings and recommendations leading to developing a framework for implementing and socializing the framework; and a steering committee to approve and set policies for reform in the pharmaceutical sector. A national Framework for Good Governance in Medicine was developed to activate the integrity system, which includes a code of conduct, policies on conflict of interest, whistle blowing mechanisms, sanctions, and reprehensible acts. Information on the framework was distributed through a national workshop. The Code of Ethics and conduct was enforced in the civil servants practice. Conflict of interest policy and contest was enforced in all committees working at Jordan Food and Drug Administration. Guidelines regarding medicine promotion control have been issued. Other laws and guidelines are now under revision.

Outcome Measures: Improve performance in transparency in six functional areas in the ph. sector. In medicine registration, the clear written criteria for selecting members of the committee scored 0.6 in the baseline assessment but was raised to 0.83; in the terms of reference for the committee was raised from 0.62 to 0.88. In inspection and market control, the baseline was 0.83 in 2007 and increased to 1.0 in 2010. In promotion control, the provision on medicine promotion and advertising included explicit mention of the different forms of promotion increased from 0.4 in 2007 to 0.9 in 2010 and the provision foresaw an enforcement mechanism stating sanctions, increased from 0.2 in 2007 to 1.0 in 2010. In selection of medicines, use of clear criteria for selection of members of the selection committee increased from 0.53 in 2007 to 0.86 in 2010.

Conclusions: The transparency assessment survey set the guidelines and a baseline for measuring six key functions in the pharmaceutical sector. Sector. Follow up on these measurable indicators in the assessment tool showed remarkable improvement in performance; setting the stage for new guidelines, policies, and reform.

Funding source: WHO

934-Naffa-_b.pptx
934-Naffa-_c.pdf

Tsunami Drug Donations in Sri Lanka: Have the WHO Guidelines on Drug Donations been Effective in Meeting Public Health Pharmaceutical Needs in Times of Disaster?

Rohini Fernandopulle1, Hemantha Beneragama2, Priyadarshini Gallappatthy1, Nilesh Fernandopulle2

1Faculty of Medicine, University of Colombo, Sri Lanka; 2Ministry of Health

Problem statement: Noncompliance with WHO good donation practices resulted in inappropriate donations

Objective: To determine compliance with WHO guideline for donations received by the Ministry of Health (MOH) following the tsunami in Sri Lanka in 2004

Design: Pharmaceutical policy analysis

Setting: State sector; private organizations were excluded.

Methodology: Data was collected using investigator administered questionnaires from March to July 2005. A product that had the same drug substance, in the same dosage form and in the same strength irrespective of their brand name and package size, was classified as a ‘unique drug product’ (UDP). The UDPs were then classified according to the 4 categories of the donation guideline (selection, quality assurance and shelf life, presentation packing and labelling, and information and mangement). Selection was determined on the Anatomical Therapeutic Chemical classification status in the WHO model list of essential drugs (2003), the MOH expressed list, the hospital formulary list (2004), the WHO/UNICEF emergency list , Sri Lanka registered medicines list and the British National Formulary (March 2005). Destroying costs were calculated using documents available.

Outcome measure(s): Percentage compliance with WHO guideline

Results: Of all the UDPs, 80% were unsolicited and arrived unannounced in unsorted boxes, 86% of which were under an individual’s name or donated to international focal points (~50%). The balance was donated by governments (8.4%) or national or multinational pharmaceutical firms (5.6%); 53% of UDPs belonged to the ‘non-list’ category; 38% of INNs were unregistered in the country; 50.5% (28 metric tons) did not have expiry dates. Among those with an expiry date, 6.5% had expired on arrival and only 67% complied with the guideline of a remaining shelf life of at least 1 year; 62% of UDPs were labelled in a non-understandable language, 81% were without package inserts, and 15% were without generic names. Medicines purchased after consulting with the MOH and over 90% of the donations sent directly by governments had the required shelf life of over 1 year and were 100% utilized. The value of 1 donation claimed by the donor was 50% of the public sector drug budget, but the budget for 2005 was reduced only by 4%. Cost of destruction of unwanted medicines was approximately SLR 2.5 million and was borne by Sri Lanka.

Conclusions: The WHO guidelines are comprehensive and would have prevented the burden of useless donations if adhered to, but total reliance on donor compliance resulted in inappropriate donations. The lack of a policy on acceptance of donations was a major contributory factor. Donors failed to comply with the guidelines on matters of selection, quality assurance and shelf-life, presentation, packaging, labelling, language, information and disposal.

Recommendations: MOH should have a written policy on drug donations based on the WHO drug donation guidelines and should strictly enforce adherence to the guidelines when donations are received.

Funding source(s): World Health Organization

773-Fernandopulle-_a.pdf
773-Fernandopulle-_b.pptx
773-Fernandopulle-_c.pdf