Good Governance for Medicines
Ministry of Public Health
Lebanon

The Problem

The country experienced a long civil war that started in 1975 and weakened the government. The civil war ended in 1989, after which the Rebuilding of the devastated country started.
Since 2005, the country has been going through severe political instability, including heavy military aggressions in 2006, and assassinations creating additional turmoil. The government nonetheless faces serious challenges in the economic arena with a national debt reaching 50 billion dollars in 2009.
The health system was severely affected all through, resulting in a rapid growth in an unregulated manner of the private for profit high technology health sector and a weakened public sector. Progress was made towards improving the health system performance in general, and regaining the stewardship function of the ministry of health (MOH).
The pharmaceutical sector in Lebanon is complex and the high medicines bill could be due to many factors overlapping. This sector is mostly based on imported drugs and on patent brand names constituting more than 80% of the total market. Different stakeholders are involved in different stages of this sector. These include players from the public sector, private sector and others. Lebanon’s very large number of pharmacists and physicians, most of them working in the private sector contribute to escalating medicine costs. The absence of an independent national regulatory authority for medicines in addition to the lack of transparency at one or more levels of the pharmaceutical system could be the underlying causes of the high medicines bill.
Apart from the Health System Reform launched in 1998 restructuring of medicine policy emerged as a main concern for MOH, were efforts made to improve and reinforce the pharmaceutical sector. In order to ensure that essential medicines reach the people who need them, at a reasonable cost it was important more than ever for Lebanon to tackle the issues of regulation and transparency in medicines regulation and supply.
Another problem on a smaller scale that was facing the public seeking services from the ministry of health; is that their applications/documents were recorded/registered manually and there was no system in place to track documents within the ministry like in any other ministry in the country.

Solution and Key Benefits

 What is the initiative about? (the solution)
The issue of transparency was directly addressed through Good Governance for Medicines (GGM) programme that started in 2007. Since then, MPH has demonstrated high-level commitment to institutionalizing both the concepts of transparency and accountability in every aspect of medicine policy and management practice.
Main reasons why Lebanon wanted to implement GGM include: to add to the significant efforts made to regulate pharmaceutical sector, the presence of political commitment of the MPH to improve good governance and transparency as part of regaining its stewardship in health, and the credibility of main partner involved which is the World Health Organization (WHO).
Thus MOH in Lebanon, in collaboration with the WHO started its National Good Governance for Medicine program by conducting a National Transparency Assessment of the pharmaceutical sector. The aim was to provide a comprehensive picture of the level of transparency and vulnerability to corruption in six essential functions of the public pharmaceutical system: registration, promotion, inspection, selection, procurement and distribution of medicines. This assessment identified a number of gaps which in turn triggered some far-reaching changes.
Some of the progress that was made based on the assessment results include; development of written procedures and updating existing ones related to the pharmaceutical sectors. One of the Examples: updated Good Manufacturing Procedures (GMP), this document had not been updated since 1983. The revised GMP guidelines were officially adopted on 28 May 2009. This document give guidelines for how local manufactures of medicines should operate and for MOH inspectors how to evaluate these manufacturers. The update and the implementation of this document will ensure that medicines produced locally are of good standards, high quality and safe to be used by the public. Also, this will give a good reputation and empower the local manufacturers to export their products to international markets and will thus reflect on the economics of the country.
Another example is clear terms of reference for the new committee responsible for revision of National Essential Medicines List. An important achievement is the enforcement of a conflict of interest form as of 21 October 2010, to be filled by all members of ministry of health committees’ members dealing with pharmaceuticals, including the registration, pricing and GMP committees and inspectors. As part of being transparent; all relevant documents are now published on the ministry website: www.moph.gov.lb.
In the context of e-Government Plan, and to improve transparency in general, the MPH started a process of standardization and automation of all transactions forms used within the ministry and implemented the tracking of administrative papers of citizens through the website. The main objectives of this project are to unify & standardize the content as well as the layout of the application forms used for the administrative services and to automate these forms in order to ensure a better and fast service for the citizen.
These forms are published on the MPH website to ensure their availability and to reduce burden of administrative processes for citizens. Thus increasing transparency of ministry work and strengthening citizen confidence in public sector.

Actors and Stakeholders

 Who proposed the solution, who implemented it and who were the stakeholders?
The WHO launched and designed the GGM program in 2004 and it is currently implemented by 26 countries in the world. The GGM program leads the WHO’s efforts to reduce corruption in the health sector. The goal behind this program is to contribute to health system strengthening and to prevent corruption by promoting good governance. The GGM aims to complement broader anti-corruption efforts by focusing on the pharmaceutical sector. The WHO approached the Lebanese ministry of health in 2007 to join the program. The program is designed to follow 3 phases. Currently Lebanon is at the beginning of phase III. The program is being implemented by the ministry of health; a task force was nominated and consists of staff from the Ministry of Public Health and experts in the field of pharmacy and academics. In addition, a steering committee was officially nominated by a ministerial decree no. 812/1 in 2009 included high level officials and all key stakeholders.
This national committee is headed by the Minister of Public Health. The Committee also includes representatives from the Order of Physicians, the Order of Pharmacists, the Syndicate of drug importers, the Syndicate of drugs manufacturers, the Central Inspection, the Council of Civil Service - Department of Research and Guidance, the World Health Organization, the Ministry of Administrative Development Affairs, the Consumer Protection Association and a Media Consultant. Main task for the steering committee is to supervise the work done in the GGM by the task force. The WHO provided technical support when needed.
As for the Transaction Forms Standardization & Automation project, it was first proposed by the Office of the Minister of State for Administrative Reform in Lebanon (OMSAR), where they provided guidance and technical support and the project was totally implemented by the MPH staff.

(a) Strategies

 Describe how and when the initiative was implemented by answering these questions
 a.      What were the strategies used to implement the initiative? In no more than 500 words, provide a summary of the main objectives and strategies of the initiative, how they were established and by whom.
The goal that was behind joining the WHO GGM initiative was to reduce corruption in the pharmaceutical sector systems by applying transparent and accountable administrative procedures, while promoting ethical practices among civil servants involved in the public pharmaceutical sector.
Combating corruption and promoting good governance in the pharmaceutical sector requires a long term strategy for action, while structural and procedural changes are an important step and this was the focus of work of the ministry in this program. To achieve these changes the ministry of health initiated a national consultation process to define components of national framework within GGM this was done with all relevant key actors and stakeholders of the pharmaceutical sector. Thus, the strategies used were consensus building strategy with bottom-up approach to gain ownership from all partners and discipline based strategy based on existing laws and regulations that can be applicable to the public pharmaceutical sector. It included all legislations, laws and administrative procedures related to good governance, sanctions, and mechanisms to promote transparency that are enforced in Lebanon.
As for the tracking of documents project; it included a comprehensive review strategy and assessment of all administrative services offered in MOH to identify information needed to create the application form related to each service. The MOH adopted the unification and standardization method for the format, layout and content of all applications forms and the creation of an electronic copy for publication at the MOH official website to ensure public accessibility at anytime. All this will result increase efficiency and flexibility of services in addition to transparency.

(b) Implementation

 b.      What were the key development and implementation steps and the chronology? No more than 500 words
Transparency assessment was conducted as a self-assessment by MOH between October and December 2007 as phase I of GGM program. Findings have enabled ministry to identify weaknesses in system and move on to phase II to develop strategies to address them. First national GGM workshop was done in December 2008; it was attended by high level officials and stakeholders involved in the pharmaceutical sector. Overview of assessment was given and consensus was obtained to proceed. During conference the topic of development of national Framework for Good Governance in public pharmaceutical sector was introduced.
The next step was working on developing a national GGM framework for Lebanon based on model designed by WHO for phase II. The focus of work was on discipline based strategy. This part was developed based on existing laws and regulations that are applicable to public pharmaceutical sector. It included legislations, laws and administrative procedures related to good governance, sanctions, and mechanisms to promote transparency that are enforced.
A code of conduct was included. This code covered practices permissible and prohibited on public sector employees, in addition to rights, duties and responsibilities of civil servants in general that are applicable to employees working in public pharmaceutical sector. This code of conduct is obligatory by law. Workshops and trainings will be conducted in Phase III on this code.
GGM document defined corruption and categorized its relevant forms and possibility of its occurrence in public administration, its impact and implications on the pharmaceutical sector with a view on how to control, diagnose and treat its forms if taking place.
Moreover, document covered mechanisms for reporting breaches, suggested cooperation with other initiatives of good governance, and encouraged collaboration with institutions that fight corruption via administrative, judicial, social, and media means.
A discipline based component was added, since it is believed that there is a need for ethical conduct in the administrative work and commitment of employees in the public sector within a sound moral behavior during the performance of their public duties that can lead to preventing unethical practices and to decrease corruption
This document was officially adopted and cleared by the national steering committee. Then a final version of document was disseminated during a national conference that took place in June 2009. This conference again was attended by relevant stakeholders where the process and different components of GGM framework were presented and discussed.
Implementations of recommendations of assessment are part of Phase III that will ensure that concrete actions are developed and implemented and anti-corruption efforts are sustainable.
As for key developments done in automation of MOH services and to move forward in the e-government plan, the following was accomplished over the past years: reviews of all administrative services offered by MOH departments and identify information needed to create application form related to this service, unify and standardize the format of all application forms and create an electronic copy, publish these forms on MOH official website and other public sector portals and create an Electronic Manual for Administrative Services.

(c) Overcoming Obstacles

 c.      What were the main obstacles encountered? How were they overcome? No more than 500 words
One of the main obstacles encountered were the political instability and changing of the government that were overcome by readjusting the timing of the activities as frequently as it needed.
Other obstacles that were faced by the GGM program include the poor understanding of the culture of transparency and good governance, the fear of being evaluated, and resistance to change. These were overcome mainly by frequent in depth discussions with relevant stakeholders, as well as two plenary workshops that took place for all stakeholders to expose the GGM process and philosophy.
Access to legislation documents was not an easy task. That was handled by the selection of the task force to include MOPH members from different departments and not just from the pharmaceutical related ones, and other members from relevant scientific institutions (such order of pharmacy and academia,…)
The difficulty in integrating the project within the existing national structure due to bureaucracy was another obstacle. This issue was resolved by the formation of the task force to include staff from different departments at the ministry and high level commitment from within the ministry.
Finally, sometimes attention was not given to GGM due other urgent priorities at the ministry agenda especially in cases of emergencies and epidemics (e.g. H1N1).
As for the automation project, no real obstacles were observed.

(d) Use of Resources

 d.      What resources were used for the initiative and what were its key benefits? In no more than 500 words, specify what were the financial, technical and human resources’ costs associated with this initiative. Describe how resources were mobilized
All human resources involved with this program were staff within the ministry of health and experts from the private sector including academia who were working on voluntary basis. Technical and financial supports were provided when needed by WHO.
As for the automation project, all resources were used from within the ministry in terms of financial and human resources.

Sustainability and Transferability

  Is the initiative sustainable and transferable?
This initiative is sustainable at the financial level for at least 2 years, since the WHO will continue to finance it based on the country cooperation strategy agreement signed between the ministry of health and the WHO Lebanon office. GGM is institutionalized within the ministry of health since there is a GGM active team working on all aspects under the supervision of the general director of the ministry in addition to the steering committee headed by the minister of health.
As mentioned earlier, the GGM program is currently being implemented in 26 countries in the world. Lebanon is considered to be a success story among other countries; Lebanon case study was documented in 2 recent reports by WHO; first one entitled: “WHO Good Governance for Medicines Program: An innovative approach to prevent corruption in the pharmaceutical sector: compilation of country case studies and best practices, World Health Report (2010) Background Paper, 25” and the second one: “Good Governance for Medicine, Progress Report 2010”.
In December 2010, Lebanon was invited to present its work to promote good governance in the pharmaceutical system during the International anti-corruption day that took place in WHO-Headquarter office in Geneva in December 9. Also, Lebanon participated in a workshop that took place in WHO, EMRO office between December 13 and 15 in Cairo to share its experience with GGM with 5 new Eastern Mediterranean Countries that showed interest to start implementing the GGM program in their countries as of 2011. The automation project and tracking of documents can be applied in other governmental organizations as well as other ministries.

Lessons Learned

 What are the impact of your initiative and the lessons learned?
The main key success is the possibility of initiating such an intuitive project in a poorly conducive political and administrative environment. This may be due to the fact that Lebanon is a small country, public pharmaceutical control is done at the central level and high level commitment from within the ministry.
Another success is the involvement of both public and private sector since the beginning of the project in all its phases. And a third success is the introduction of the theme to stakeholders and their relative commitment to support the transparency and good governance efforts.
Another success perhaps is the creation of a dedicated and motivated nucleus of experts with diversity of expertise through the task force who worked on the project that can be very helpful for the actual implementation of initiatives for phase IIII.
The GGM project is perceived by the relevant stakeholders and at many levels of the ministry of health as a catalyst for change, and a gradual slow change is already seen in the achieved recommendations that were discussed. The high level political support and commitment from within the ministry is important but not enough. There was and still a need to give attention and work at the technical level as well.

Contact Information

Institution Name:   Ministry of Public Health
Institution Type:   Government Agency  
Contact Person:   Rasha Hamra
Title:   Director of Public Relations &  
Telephone/ Fax:   00961-1-615711
Institution's / Project's Website:   00961-1-615020
E-mail:   rashahamra@yahoo.com  
Address:   Ministry of Public Health in Lebanon-Museum Area
Postal Code:  
City:   Beirut
State/Province:   Beirut
Country:   Lebanon

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