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Pharmaceutical Manufacturing Industry Assessment Study Request for Proposals (Re-Posted) Capacity Building and Access to Medicines (CBAM) Afghanistan A. Introduction Health Partners International of Canada (HPIC) is a humanitarian not-for-profit relief and development organization dedicated to improving access to medicine and enhancing health in the developing world. HPIC contributes to well-being by providing donations of essential medicines, supplies and vaccines, building national health sector capacities, and responding to emergencies and health threats. We partner with a network of ministries of health, non-governmental organizations (NGOs) healthcare professionals, healthcare product companies, and with Canadian government departments; and counts on the financial support of individual donors, foundations and corporations. CURRENTLY HPIC IS CONDUCTING A PROJECT TO BUILD NATIONAL HEALTH SECTOR CAPACITIES IN AFGHANISTAN AND IS SEEKING A CONSULTANT TO SUBMIT A FULL PROPOSAL TO CONDUCT AN ASSESSMENT OF THE PHARMACEUTICAL MANUFACTURING INDUSTRY OF AGHANISTAN TO BE PART OF THE CAPACITY BUILDING AND ACCESS TO MEDICINE (CBAM) PROJECT. Details follow: The goal of the Capacity Building and Access to Medicines (CBAM) project is to support the Ministry of Public Health (MoPH) in Afghanistan to effectively ensure greater and more equitable access to priority pharmaceuticals and medical supplies for all Afghans with a specific emphasis on women and children. The pharmaceutical manufacturing and production industry plays a significant role in Afghanistan’s ability to provide effective, quality medicines to the population and therefore this assessment study is an integral part to the success of the CBAM Project. The CBAM project is dedicated to conducting an assessment study of the current pharmaceutical manufacturing industry. The pharmaceutical manufacturing industry is a complex system that has many key players, in its basic concept it consists of facilities that manufacture medicines and medical supplies, as well as businesses that supply raw materials, pack finished products and locations that sell the final products. These can be private or publically, locally or internationally owned. Further, there are governments that regulate the industry for quality assurance. The objectives of the assessment are to identify manufacturing interests and operations that currently exist in Afghanistan, identify opportunities for pharmaceutical manufacturing industry development in Afghanistan and identify past successes and failures to guide future recommendations and strategies. Overall, the assessment will strengthen understanding of the needs and opportunities currently existing within the industry and identify possibilities for the future of local pharmaceutical manufacturing operations within Afghanistan. This study will explore various aspects of the pharmaceutical manufacturing industry and will include, but is not limited to: - The role of the Government of Afghanistan (GoA), including laws, regulations and control of the industry, as well as human and physical resources - Current international initiatives, laws, regulations and standards, as they apply to Afghanistan - Private and public investments - Distribution mechanisms - The three phases of pharmaceutical production: Primary production (manufacturing active pharmaceutical ingredients and intermediates), secondary production (finishing dosage forms from excipient (non-active ingredients) and active substances), tertiary production (packaging finished products or repackaging bulk finished products)[1] - Herbal and alternative medicine production - Regional development in pharmaceutical production and manufacturing HPIC has committed to conducting this assessment study of the pharmaceutical manufacturing industry and providing recommendations for future possibilities for the industry. The assessment study will lead to a stakeholders meeting to share the results of the study with government, industry and other stakeholders as part of a process to determine recommendations for the development of the manufacturing industry. The ultimate goal of the consultant is to deliver a report on the state of the pharmaceutical manufacturing industry in Afghanistan, including recommendations for future development and enhancement of the industry. B. Qualifications of Consultant
Education: Master’s Degree or higher C. Deliverables The outputs of the assignment shall include: a. Assessment framework and tools b. Stakeholder presentation c. Final assessment report with recommendations
D. Deadlines Due dates for various activity components: a. PROPOSAL MUST BE SUBMITTED TO HPIC BY SEPTEMBER 1, 2010 BY 5:00PM EST at knicholson@hpicafghanistan.ca. b. Only complete proposals based on this RFP will be evaluated. c. Preparation to be completed by September 30, 2010 d. Information gathering to be completed by November 30, 2010 e. Meeting to present assessment results to be held by January 31, 2011 f. Final assessment report with recommendations completed by March 31, 2011
E. Timeframes The length of time to complete each task: a. Gathering information for the assessment study will begin in September 2010 and will be completed by November 2010. Initial findings to be prepared before by end of December 2010. The stakeholders meeting to present the findings will be held in January 2011 and the final report must be submitted by March 31, 2011.
F. Rationale for Assignment Like many industries in Afghanistan, the pharmaceutical manufacturing industry has been negatively impacted by decades of war. Afghanistan once had enough capacity to produce most medicines required in the country and was beginning to develop an export market of pharmaceuticals. However, the production of pharmaceuticals in Afghanistan has been drastically reduced from its high point in the 1970’s to today where very few pharmaceuticals are manufactured in country, approximately less than 5%, and most are in liquid or suspension form since technologies are lacking to produce tablets and more sophisticated methods of medicine production. In May 2009, HPIC visited the Avicenna Pharmaceutical Institute and met with stakeholders from the Ministry of Public Health to discuss the need for an assessment of the pharmaceutical manufacturing industry in Afghanistan. It was learned that Afghanistan is now reliant on other nations to supply almost all pharmaceuticals. Currently, most pharmaceuticals available and used in Afghanistan are imported, and there is a growing concern for the quality of these medicines.[2] The results of this study could contribute to the decisions that industry and government leaders will make in determining the future of the pharmaceutical production industry in Afghanistan. Furthermore, it is expected that with strengthened understanding of the industry and increased awareness of government and interested partners in the industry, Afghanistan can move forward in creating a local pharmaceutical industry that is realistic and responsive to the needs of the country. Thereby improving the availability of medicines within the country and improving access to medicines for the Afghan population. Before 1992, Afghanistan had developed a pharmaceutical production capacity through the state owned Avicenna Pharmaceutical Institute (API), and the Hoechst Pharma Company, which was a public/private venture, as well as with many smaller scale enterprises. After the Soviet collapse and during the civil conflict, most multi-national corporations pulled out of Afghanistan due to insecurity. With the fall of the Taliban regime in 2001, a few multi-national manufacturing corporations started to return along with bi-lateral and multi-lateral aid initiatives to redevelop and re-establish a pharmaceutical production industry in Afghanistan. Recent attempts include: - Hochpharma, previously called Hoechst Pharma, which is incorporated into Sanofi-Aventis, reportedly privatized in Afghanistan in approximately 2008 with 15% held by the Afghan government. They were to develop new products and adhere to European standards. Current status is unknown. - The American Afghan United Incorporated Pharmaceuticals began recently as a new enterprise and has a factory in Kabul. They are 100% foreign owned and were developing generic tablet medication capabilities (7 products to begin with) for sale in the local market as an alternative to imports. However, the future of this endeavour is now unclear as there appears to be a loss of interest and other challenges. - Baz International Pharmaceutical Company Ltd is an enterprise that was launched by the Swiss Business Humanitarian Forum, the European Generic Medicines Association and the UNDP Country Office in Kabul. They planned to produce urgently needed medicines for the local market. Current status is unknown - Khalid Irshad Pharmaceuticals achieved ISO (International Organization for Standardization) 9001:2000 accreditation in May, 2009. They are the first Afghan pharmaceutical company to achieve this level of international quality standards. This company manufactures around 25 pharmaceutical products including the water treatment solution and oral re-hydration salts as part of the COMPRI-A project - COMPRI-A is a five year and eight month project funded by USAID to build, among other objectives, capacity of the private sector to produce/procure and market affordable health and family planning products for low-income groups, including oral contraceptive pills, injectable contraceptives, condoms, water purification solution, oral re-hydration salts, zinc and iron folate tablets. Finally, there is the Avicenna Pharmaceutical Industry (API), which is owned by the GoA, specifically the Ministry of Finance and all profits are returned there. However, it is on a list of state owned enterprises that are to be privatized. Prior to the 1990’s API was producing approximately 120 generic medicines, but due to the wars and conflict it’s production capabilities have been seriously reduced. They reopened operations officially in 2007 and are only producing a limited number of products. There are also other small and privately owned pharmaceutical manufacturing enterprises that are beginning to emerge in Afghanistan (according to recent data there are approximately 12-14 registered companies) and will contribute to the growth of this industry. This study is set to examine and identify key players, gaps in products and services, potential room for expansion and provide recommendations to the industry. The assessment study, as part of the CBAM Project, will be conducted to strengthen understanding of the needs and opportunities existing within the industry and identify possibilities for the future of pharmaceutical manufacturing operations within Afghanistan. After the completion of the study, HPIC will disseminate the information from the developed report on the findings and work collaboratively with stakeholders to develop an action plan identifying next steps. Research conducted previously in Afghanistan suggests that, “(t)here is good justification (both for economic and public health reasons) for building local capacity in the production of essential generics, herbal / traditional medicines, infusion solutions and medicinal gases.”[3] This assessment study will be conducted and will either lend support to this argument or contribute to a better understanding of the direction the pharmaceutical manufacturing industry needs to take in Afghanistan. The information gathered and recommendations drafted will be shared with industry stakeholders to determine next steps based on the research. G. Goal and Objectives Goal: The goal of the assessment study is to determine the current capacities, strengths and weaknesses of the pharmaceutical manufacturing industry in Afghanistan. The assessment will review all sectors of the manufacturing industry in the country, including the private, public and non-profit sectors involved. Past successes and failures in the pharmaceutical manufacturing industry will also be explored to better understand the current situation and to learn from past experiences. In addition, the results of the study will be disseminated to participants and stakeholders to provide information and recommendations in drafting next-step strategies through a stakeholders meeting to be conducted upon the conclusion of the study. Objectives: 1. Conduct information review of any documents and sources of information pertaining to the Afghan pharmaceutical production industry, as well as relevant regional information, international guidelines and pertinent literature. 2. Conduct assessment study of the pharmaceutical manufacturing industry in Afghanistan, including the following (others to be identified throughout assessment study process): o Role of the Government of Afghanistan o Role of pharmaceutical associations in Afghanistan (such as Afghanistan Medicine Services Union) o Current international initiatives (such as COMPRI-A) o Private and public investments o Regulations and laws of the industry in Afghanistan such as production, land provision and patent laws o Licensing regulations o Import and export regulations o International laws, regulations and standards o Regional development in pharmaceutical production and manufacturing o The three phases of pharmaceutical production: § Primary production (manufacturing active pharmaceutical ingredients and intermediates) § Secondary production (finishing dosage forms from excipients (non-active ingredients) and active substances) § Tertiary production (packaging finished products or repackaging bulk finished products)[4] o Herbal and alternative medicine production o Pharmaceutical production logistics (storage of raw materials and completed products, transportation, etc.) o Distribution mechanisms o Quality control mechanisms o Controlling contraband pharmaceuticals o Human and physical resources o The market for pharmaceutical raw materials in Afghanistan o The research capacity of Pharmaceutical Enterprise (MoPH) and the Faculty of Pharmacy at Kabul University. o Opportunities and barriers 3. Compile data in a report, including recommendations for how industry, government and non-government players in the pharmaceutical production industry can move forward to increase access to pharmaceuticals for the people of Afghanistan. H. Approach and Methodology 1. Parties Involved: During the assignment, work and collaboration will occur between the following: a. Evaluation Team: HPIC anticipates requiring a core team of up to 2 international expert consultants along with 2 local expert consultants (given time and space constraints and considerations). The team should include individuals with expertise covering at least the following areas: i. Pharmaceutical manufacturing industry experience ii. Public sector pharmaceutical industry experience iii. Development experience in pharmaceutical sector b. Stakeholders Team: i. Ministry of Public Health of Afghanistan will have a participatory role and will be involved in providing insight, contacts and guidance for the assessment study, this can include but is not limited to the following departments/divisions: a. Pharmaceutical Enterprise b. GDPA c. QC Lab d. APHI ii. Afghan private pharmaceutical industry leaders will be consulted and interviewed as part of the assessment; they will also provide further contacts to be consulted (Association of Pharmaceutical Manufacturing Companies, and others to be identified). iii. HPIC staff will be involved in the assessment process both in the Kabul office and the Canada office. HPIC staff will provide support, guidance and contacts for the assessment iv. Non-profit organizations that are involved in the pharmaceutical production industry or other health and business areas as deemed necessary v. Afghan pharmaceutical associations will need to be contacted, consulted and participate in the study. One organization is the Afghanistan Medicine Services Union, they can also provide information on other key informants vi. COMPRI-A has agreed to provide assistance in this assessment, it is a program dedicated to building the capacity of the private sector to produce affordable health and family planning products for low-income groups vii. Representatives from identified pharmacies, distributors and hospitals may be part of the stakeholders’ team, as well as officials from the Faculty of Pharmacy from Kabul University. They will need to be consulted when carrying out the assessment study and will have a vital role to play in providing information and further contacts.
2. Meetings: Before, during, and after the assessment, the following meetings, phone calls and contact between the commissioning organization are planned:
a. The assessment team will meet regularly, at minimum twice a month, to ensure all research and data collected is being shared in an appropriate manner. This will also ensure new contacts are shared and the assessment study is on time and on track to achieve the goals and outcomes. b. The assessment team will meet twice monthly with the HPIC staff to maintain open communication and to ensure all deadlines will be met and to ensure all data is being collected and collated in an appropriate manner. c. The stakeholders, MoPH, HPIC and assessment team will meet on an as needed basis to maintain open communication, to ensure all deadlines will be met and to share appropriate contact information. d. At the end of the assessment a meeting of all stakeholders will be held to discuss the outcomes of the assessment and to work together to identify the next steps in the process.
3. Methodology: a. An information literature review will be conducted to assess all research on the pharmaceutical industry in Afghanistan; it will look at both present and past research, as well as pertinent regional studies. A summary of this research will be produced.
b. Interviews and/or discussion groups will be conducted with the following: i. Key MoPH officials ii. Major donor representatives (EC, World Bank and USAID) iii. Private pharmaceutical production industry representatives iv. Regional and international pharmaceutical production industry representatives v. Local/regional pharmaceutical industry associations representatives vi. Local pharmacists (hospital pharmacists, community pharmacists, pharmacologist and clinical pharmacists), vii. Local/international distributors viii. Local and/or international non-governmental organizations ix. Kabul Medical University, Faculty of Pharmacy of Kabul University x. Other organizations as necessary.
c. Field visits will be conducted to pharmaceutical production sites in Afghanistan and/or regional manufacturing sites as necessary. Other field visits to various establishments may be necessary and will be included as required.
I. Specific Tasks and Deliverables 1. Tasks. a. Preparation i. Review existing information/documents for literature review ii. Develop assessment framework and tools iii. Harmonize and finalize assessment tools
b. Conducting the assessment i. Identify key informants and contacts ii. Key informant interviews and group discussions iii. Conduct facility visits
c. Post assessment i. Compile data ii. Analyze data iii. Prepare preliminary report and recommendations
d. Presentation and finalization i. Present to key stakeholders ii. Identify recommendations for next steps iii. Prepare final report and submit to HPIC
1 How to Develop and Implement a national drug policy, photocopied sheet [2]European Commission (Nov 2007-Jan 2008). “Afghanistan pharmaceutical sector identification mission report: Intervention scenarios for EC.” [3] European Commission (Nov 2007-Jan 2008). “Afghanistan pharmaceutical sector identification mission report: Intervention scenarios for EC.” 5 How to Develop and Implement a national drug policy, photocopied sheet
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Request for Proposals - Capacity Building and Access to Medicines (CBAM) Afghanistan
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