Langkawi, Malaysia March 2008

Transcription

1 SOUTH ASIA AND SEAP REGIONAL WORKSHOP PHASING-OUT CFC-BASED METERED DOSE INHALER (MDI) Langkawi, Malaysia March 2008 Jointly Organised by United Nations Development Programme (UNDP) United Nations Industrial Development Organization (UNIDO) UNEP DTIE OzonAction Programme The World Bank and Department of Environment, Ministry of Natural Resources and Environment Government of Malaysia With funding assistance from Multilateral Fund Secretariat

2 TABLE OF CONTENTS PAGE 1. BACKGROUND 4 2. OBJECTIVES 5 3. SUMMARY OF DISCUSSIONS IN DAY SUMMARY OF DISCUSSIONS IN DAY SUMMARY OF DISCUSSIONS IN DAY OTHERS LANGKAWI DECLARATION ON PUBLIC-PRIVATE PARTNERSHIP ECOM PAPER ON THE NEED FOR MDI TRANSITION STRATEGY CFC REQUIREMENT AND STORAGE OPTIONS 27 ANNE 1 CONCLUSIONS AND RECOMMENDATIONS 29 ANNE 2 LANGKAWI DECLARATION ON PUBLIC-PRIVATE PARTNERSHIP 41 ANNE 3 ECOM PAPER ON THE NEED FOR CFC MDI TRANSITION STRATEGY 45 ANNE 4 PHARMACEUTICAL CFC STORAGE OPTIONS 51 ANNE 5 SUMMARY OF HANDBOOK ON EUN (2005) 67 ANNE 6 COUNTRY BY COUNTRY ACTON PLAN 70 ANNE 7 FOLLOW-UP ACTIONS 98 ANNE 8 AGENDA 101 ANNE 9 CONCEPT NOTE 109 ANNE 10 LIST OF PARTICIPANTS 118 ANNE 11 GUIDANCE NOTE FOR GROUP DISCUSSION 139 Page 2 of 142

3 MAIN REPORT Page 3 of 142

4 1. Background The growth in CFC Metered Dose Inhaler (MDI) usage particularly in Article 5 countries has been of concern to the Montreal Protocol community. During the 17 th Meeting of Parties to the Montreal Protocol, the Meeting of Parties (MOP) requested the Executive Committee to suggest options for phasing out dependence on CFC MDIs including conducting awareness activities to reduce prescription of CFC MDIs. Further, it was also recommended that in 18 th Meeting of Parties, a possible decision, which would address the difficulties that some parties operating under paragraph 1 of Article 5, may face in relation to MDIs. During the 26 th Open Ended Working Group (OEWG), the matter was discussed further and in the 18 th Meeting of Parties, a decision addressing difficulties faced by some Article 5 Parties manufacturing MDI, which use CFCs, was taken. Following the guidance from the 18 th Meeting of Parties, UNEP organized the MDI Thematic Meeting for South Asian Ozone & Health Officers in Colombo in December 2006 to discuss critical outcomes in Decision VIII/16. The main focus at the MDI Thematic Meeting was that the National Ozone Unit should take the responsibilities for preparation of National Transition Strategy for CFC-free alternatives to CFC MDIs in consultation with Ministry of Health and other key stakeholders. Due to the reduction schedule under the Montreal Protocol and potential uncertainty of supplies of pharmaceutical-grade CFCs in the future, there is an urgent need for MDI manufacturing countries to accelerate their transition strategy, which will inevitably affect MDI importing countries due to the eventual withdrawal of CFC MDI. In order for the countries to implement their CFC MDI transition strategy in an effective and smooth manner, it is essential that some potential barriers to CFC MDI phase-out be addressed and eliminated. As a mean to strengthen capacity of the countries to develop their transition strategies, the Executive Committee of the Multilateral Fund at its 52 nd Meeting in July 2007 approved a global project for UNEP to organize a series of regional workshops around the world to promote the transition to CFC-free alternatives. The South Asia and SEAP Regional Workshop on Phasing-out CFC-based MDI is the first workshop organized as part of this global project. UNEP, in cooperation with other Implementing Agencies of the Multilateral Fund, have brought together government officers from National Ozone Unit and Public Health department, industries, asthma/copd associations, NGOs, and resource persons to share their valuable experiences and perspective during the workshop. During the workshop, the main challenges and barriers were discussed. Key elements which are essential for the preparation and implementation of CFC MDI transition strategy were discussed and identified. The workshop also addressed the uncertainty in the supply of pharmaceutical grade CFC and management strategy for pharmaceutical-grade CFC during and beyond. Final conclusions and recommendations of the workshop, agenda of the workshop, concept note for the workshop and list of participants in the workshop are presented in Annex 1, Annex 8, Annex 9 and Annex 10 to this report respectively. Page 4 of 142

5 2. Objectives The main objectives of this workshop are to discuss approaches and actions, primarily relating to (i) investment projects for countries with CFC MDI manufacturing facilities, (ii) non-investment activities through education, awareness building and required regulation on CFC MDI phase-out and adoption of CFC-free alternatives. The workshop also focuses on national information collection and monitoring system and elements of transition strategy for both MDI manufacturing countries and MDI import-reliant countries for achieving transition. The coverage if the workshop to address the objectives included the following. Investment Activities o Plans of CFC MDI manufacturing countries in achieving CFC MDI phase-out; o Linkages with pharmaceutical-grade CFC supply to cater to CFC MDI manufacturing needs for the period and beyond; o Regulations to manage stockpiles and CFC consumption in MDI and RAC sector; o Strategic options / learning from implementation experiences in other Article 5 countries; o Impact on import-reliant Article 5 countries, particularly low volume consuming countries (LVCs); Non-Investment Activities o Education and awareness building on CFC MDI phase-out and adoption of alternatives to CFC MDIs; o Regulations required for phasing-out CFC MDIs and adoption of alternatives to CFC MDIs; o National information collection and monitoring systems for achieving CFC MDI phase-out in line with guidance given under decision 51/34; o Elements of CFC MDI transition strategy for LVCs for achieving transition; Page 5 of 142

6 DAY 1: 13 MARCH 2008 SESSION 1: OPENING SESSION INAUGURAL SESSION The opening session of the meeting was held on 13 March 2008 between a.m. The opening session was conducted by Mr. Thanavat Junchaya, Regional Network Coordinator of SEAP Network, UNEP, warmly welcomed participants of the South Asia and SEAP Regional Workshop on Phasing-out CFC MDI in Langkawi, Malaysia. In his inaugural speech, he mentioned that the Montreal Protocol is one of the most successful Multilateral Environmental Agreements as it has successfully phase-out consumption and production of CFCs by over 95%. Despite this success, it was found that CFC-based Metered Dose Inhaler (MDI) is one sector that the developing countries have not yet adequately addressed. He emphasized that, starting from 1 January 2010, consumption and production of CFCs will be ceased. There is an urgent need for MDI manufacturing countries to accelerate their transition strategy, which will inevitably affect MDI importing countries. This workshop is the first one organized as part of a global project to organize a series of regional workshops, which was approved by the Executive Committee at its 52 nd Meeting in July He further mentioned that key elements for transition strategy, main challenges and barriers, and strategy to address uncertainty in the supply of pharmaceutical-grade CFC will be important aspects that need to be covered during this workshop. Dr. Helen Tope, co-chair of Medical Technical Options Committee (MTOC), expressed her thanks to UNEP and other implementing agencies for giving her an opportunity to attend this workshop. She mentioned that CFC MDI transition to CFC-free alternatives is almost completed in developed countries, while CFC MDI manufacturing transition is just beginning in many developing countries with increasing CFC consumption. Although essential uses nomination is allowable under the Montreal Protocol after the mandated phase-out date, she emphasized that the best option for developing countries is to complete CFC MDI transition as quickly as possible to avoid significant risks associated with stockpiling pharmaceutical-grade CFCs. She highlighted that there is an urgent need to accelerate the current rate of transition to CFC-free alternatives to avoid potential difficulties for patients in developing countries. Transition strategies need to establish clear goals and manageable steps to achieve the goals and the key to a smooth transition will be consultation and partnerships between key stakeholders. She also mentioned that some measures such as removal of any tariffs on import CFC-free alternatives may be considered or cost parity and affordability of the new drugs through government subsidies may be encouraged. Ms. Saleha Md. Ewan, National Pharmaceutical Control Bureau, Government of Malaysia, welcomed all participants to Malaysia. She expressed her appreciation to the donor countries, Multilateral Fund Secretariat, all implementing agencies for their continued support in the implementation of various phase-out activities in Malaysia. She further mentioned that, for CFC MDI transition, the National Pharmaceutical Control Bureau (NPCB) has been acted as secretariat of the Technical Working Group on MDIs, Page 6 of 142

7 which is responsible for development of Malaysia Transition Strategy. In 2004, Malaysia Transition Strategy was accepted in principle through consensus agreement among the members. As a result of its Transition Strategy, there are only 11 CFC MDIs registered with the Drug Control Authority and some have not been imported since For CFCfree alternatives, 33 non-cfc MDIs and 27 dry powder inhalers (DPI) already registered with the Drug Control Authority. She emphasized that this workshop would be an excellent forum for the exchange of ideas and experiences among the network countries to enhance implementation of the Montreal Protocol including CFC MDI transition strategy and hope that the world community will continue to assist Article 5 countries to facilitate the transition. With these words, she declared the South Asia and SEAP Regional Workshop on Phasing-out CFC MDI officially open. OBJECTIVES OF THE WORKSHOP The first presentation of the workshop on objectives of the workshop was presented by Mr. Atul Bagai, Regional Network Coordinator for South Asia Network, UNEP. He provided background and objectives of the workshop, which includes both investment and non-investment activities. He mentioned that, in addition to the Ministry of Health and pharmaceutical industries, it is very critical for each country to identify and establish the connection with asthma and chronic obstructive pulmonary disease (COPD) associations in the country. He also highlighted that countries from South Asia Network can learn from the experience regarding developing and implementing CFC MDI transition strategy executed by countries in SEAP Network, which was conducted as part of their National CFC Phase-out Plan. He also emphasized that it is essential for Ministry of Health and pharmaceutical industries to collect statistics of CFC MDIs and CFC-free alternatives in order to develop CFC MDI transition strategy and to monitor implementation progress of CFC MDI transition. DAY 1: 13 MARCH 2008 SESSION 2: NEED FOR CFC MDI TRANSITION STRATEGY NEED FOR CFC MDI TRANSITION STRATEGY Ms. Kristine Whorlow, MTOC, made a detailed presentation covering prevalence of asthma and COPD and issues related to transition strategy. She mentioned that, in Asia Pacific Region, prevalence of asthma and other respiratory diseases is rising significantly and inhaler use is increasing across the region. She emphasized that transition to CFC-free alternative must be seamless without any intermediate disruptions in supply or usage issues. Patients and doctors must be informed well about CFC free alternative product usage and storage requirements. She further mentioned that the transition to CFC free alternatives should actively involve medical associations, patient groups, industry, pharmacists, the pharmaceutical industry, pricing and regulatory bodies, government and media. Page 7 of 142

8 MOP DECISIONS DAY 1: 13 MARCH 2008 SESSION 3: CFC MDI RELATED DECISIONS Dr. W.L. Sumathipala, NOO - Sri Lanka, presented MOP Decisions related to MDIs. The presentation included Decision VIII/10, VIII/11, and VIII/12 regarding transition to CFC-free alternatives in Parties not operating under Article 5. The presentation also covered a request to the Parties to submit available information of MDIs as per Decision IV/5 to the Ozone Secretariat and annual update. For Parties operating under Article 5, related MOP Decisions included Decision II/2 encouraging Article 5 Parties to develop transition strategy based on economically and technically feasible alternatives and Decision VII/14 and Decision VIII/16 regarding difficulties faced by some Article 5 Parties in manufacturing CFC MDIs. In conclusion, he emphasized that the government authority should encourage multinational companies to switch to non-cfc alternatives as soon as is practical, consistent with the needs of patients and appropriate education efforts. Dr. Purkayastha, Ozone Cell Bangladesh, expressed that, in continuity with the MOP Decision VIII/16, MDI manufacturing countries should inform the Implementation Committee, the Executive Committee, and the Ozone Secretariat on the situation that additional consumption for meeting demands for MDI and RAC sectors may be needed. In view of this, Mr. Atul Bagai, UNEP, suggested that MDI manufacturing countries should urgently look at their current consumption to fulfill 2010 phase-out commitment. An analysis of consumption in MDI and RAC sectors should be conducted and submitted to the Implementation Committee for their consideration. ECOM DECISIONS Ms. Kusmulyani Sugiarto, NOU Indonesia, made a presentation on ExCom Decisions related to MDI issues. During her presentation, she elaborated that relevant ExCom Decisions on MDIs could be categorized into 3 topics i.e. (i) MDI production (Decision 35/4(c) and Decision 36/9(e)), (ii) draft guidelines for MDI projects (Decision 37/61), and (iii) difficulties faced by some Article 5 Parties with respect to CFCs used in the manufacture of MDIs addressing both MDI manufacturing countries and MDI importreliant countries (Decision 48/36(c), Decision 49/33 and Decision 51/34). She mentioned that Decision 49/33, which is specific for Bangladesh and Egypt, would be elaborately discussed in the afternoon session on Day 1. She also highlighted Decision 45/54 that the ExCom would consider up to US $30,000 for the preparation of a transitional strategy for CFC MDIs in LVCs, when requirements under Decision 51/34 had been fulfilled. One issue raised during her presentation was ability of the LVCs to fulfill requirements to submit MDI baseline information for the previous three years. Page 8 of 142

9 DAY 1: 13 MARCH 2008 SESSION 4: MTOC REPORT GLOBAL AND REGIONAL PERSPECTIVE GLOBAL SUPPLY OF CFC MDIs AND CFC-FREE ALTERNATIVES Dr. Paul Atkins, MTOC, made a presentation on global supply of CFC MDIs and CFCfree alternatives by Article 2 and Article 5 countries. He mentioned that MDI is a complex device and it was impossible to drop-in a new propellant to replace CFC propellants so that new formulation must be developed. He also highlighted that HFA MDIs and dry powder inhalers (DPI) are now widely available and the trends in global CFC essential use by Article 2 countries have significantly dropped when compared to the past (with current annual use at tonnes). He further gave an overview of different approach of CFC MDI transition between USA and Japan. In conclusion, he emphasized that CFC MDIs can technically be phase-out by and patients will not be negatively impacted as a range of CFC-free alternatives are widely available and new HFA MDIs and DPIs will continue to be developed. SUPPPLY OF PHARMACEUTICAL-GRADE CFCs Dr. Tim Noakes, INEOS Fluor, presented supply of pharmaceutical-grade CFCs. He provided information that there are only a few manufacturing facilities in Spain (key source), USA, India and China, which still produced pharmaceutical-grade CFCs. He provided an overview of pharmaceutical-grade CFC specification. He highlighted that there are no dedicated pharmaceutical-grade CFC plants left and there are only a few multi-product refrigerant gas plants that can be swung to make pharmaceutical grade CFCs. He also mentioned that MDI importing countries should facilitate fast track registration to avoid shortage of CFC MDIs given the fact that price of pharmaceutical-grade CFCs are steadily rising and the main producers may remain production of pharmaceutical-grade CFCs until late With regard to supply of pharmaceutical-grade CFCs beyond 2009, he emphasized that manufacturer(s) would need firm commitment and plenty of notice to maintain availability on the plant. He also presented options to deal with Out of Specification CFCs and destruction costs are likely to get incorporated in the total cost of manufacturing. While it may not practical to produce pharmaceutical-grade CFCs post 2010, he also presented the stockpiling option, which can be a useful tool, but detailed planning is critical and must be carefully considered. Mr. Atual Bagai, UNEP, mentioned that supply of pharmaceutical-grade CFCs in and after 2010 is the most critical issue as this links to compliance issue of MDI manufacturing countries. He also proposed the MTOC, health and ozone officers, CFC and MDI industries to discuss the supply of pharmaceutical-grade in the next 2 years and beyond 2009 and to come up with the public-private partnership. Page 9 of 142

10 Mr. Maqsood Akhtar, Ozone Cell Pakistan, expressed his thanks to implementing agencies in organizing this workshop and to the speakers for their exemplary presentations. He stated that HFA MDIs and DPIs are much more expensive than CFC MDIs. This would affect patients in this region who have limited income to access DPIs. It was clarified that, to date, a unit dose DPI is available for a range of the products. The patients can purchase unit dose capsules for DPI instead of purchasing 1 canister of 200 doses in a propellant inhaler. Mr. Rabbur Reza, Beximco Bangladesh, mentioned that price of CFC MDIs in Bangladesh has increased during the past 1-2 years. With regard to HFA MDs, the cost for HFA MDI is now approximately 10% more expensive than CFC MDIs. He also mentioned that, if CFC MDI products are discontinued, cost of HFA MDIs would be 7-8% (not more than 10%) higher. Mr. Viktar Shatrauka, UNIDO, mentioned that when manufacturers of CFC MDIs cease production of CFC MDI, the MDI import-reliant countries would have to phase-out use of CFC MDIs. In this regard, he asked whether there is the need to have a CFC MDI transition strategy in MDI import-reliant countries. Dr. Paul Atkins, MTOC, clarified that it is essential for countries to have their CFC MDI transition strategy. Discussion with pharmaceutical companies is needed in order to determine situation of CFC MDI transition in the countries and to develop the plan. Ms. Kristine Whorlow, MTOC, confirmed that MDI import-reliant countries do need to have a transition strategy because all stakeholders need to be educated on CFC MDI transition. Mr. Mohammad Rafiqul Islam, ACME Bangladesh, mentioned that comments from developed countries on CFC MDI transition may not be the same in the least developed countries. Attention and help should be provided to these countries. In developing countries, the number of HFA MDI products approved by the drug control authority is quite a few. He also asked whether the price of propellants, which keeps increasing, could be reduced in order to assist patients in these countries to keep the cost of MDIs low. Mr. Atul Bagai, UNEP, suggested that the MDI companies and Dr. Tim Noakes form a contact group to discuss concerns about the supply-demand of pharmaceutical-grade CFCs in order to draw up conclusions and recommendations on this. Mr. Muhammad Hanif, GlaxoSmithKline Pakistan, supported comments made by the representative of ACME. He also stated that Pakistan needs support from MLF in order to implement its CFC MDI transition stratagy aiming to help poor asthma patients in the country, which accounts for 10% of the total population, to provide access to low price inhalers. It was clarified that Dr. Helen Tope will make a presentation on the promotion of affordable MDIs in developing countries. This could be one of the options to assist countries in the region to get access to low-cost MDIs. Page 10 of 142

11 DAY 1: 13 MARCH 2008 SESSION 5: EPERIENCES IN MDI TRANSITION STRATEGIES IMPLEMENTATION OF CFC MDI CONVERSION PROJECT Mr. Anil Sookdeo, UNDP, made a presentation on the implementation of the CFC MDI conversion project Bangladesh and Cuba experiences. He gave an overview of project implementation in Bangladesh and Cuba. He mentioned that technology transfer and technical assistance are critical components of the MDI conversion project, which must be closely examined and monitored during project implementation. Unlike Cuba that has only 2 formulations, a phased approach is being adopted for implementation of the conversion project for 10 products in Bangladesh. Salbutamol and Beclomethasone will be re-formulated first followed by the rest. IMPORTANCE OF AWARENESS AND NETWORKING WITH ASTHMA ASSOCIATION Professor Javaid Khan, MTOC, made a presentation on the importance of awareness and networking with asthma association on CFC MDI phase-out. He mentioned that, in Article 5 countries, in particular the least developed countries, priority is not given to phase-out of ozone depleting substances due to other urgent matters i.e. traffic problems, riot situation, population growth etc, which need immediate action. He highlighted that awareness of CFC MDI phase-out in developing countries is very limited. People are not aware of the propellant used in MDI as long as the inhaler can cure their asthma and COPD. This knowledge must be strengthened to ensure the smooth implementation of the transition strategy. He emphasized that professional societies/asthma organizations can pressure the Ministry of Health and pharmaceutical companies to ensure availability of MDIs at affordable price. Dr. Purkayastha, Ozone Cell Bangladesh, asked a question regarding supply of HFA MDIs in the Pakistan market. It was clarified that Pakistan does not have any manufacturing facilities for HFA MDIs. All HFA MDI products available in Pakistan are imported from other countries. In addition to GlaxoSmithKline Pakistan, there is another local manufacturer of CFC MDIs in Pakistan. Mr. Maqsood Akhtar, Ozone Cell Pakistan, further clarified that Pakistan has already requested UNDP and UNEP to work with a project proposal for CFC MDI transition strategy. DAY 1: 13 MARCH 2008 SESSION 6: MANAGEMENT STRATEGIES FOR CFCs USED IN MDI MANAGEMENT STRATEGY FOR CFCs Dr. Helen Tope, MTOC, presented on management strategies for pharmaceutical-grade CFCs. She gave an overview of feasible options to access pharmaceutical-grade CFCs beyond 2009 i.e. continuing annual production beyond 2009 (limited feasibility), final Page 11 of 142

12 campaign production, and stockpile. Key considerations for these options were also elaborated. She also highlighted that final campaign production in 2009 and the compliance issues would need to be addressed and a MOP Decision may need to be considered due to CFCs exceeding the Montreal Protocol allowance. For final campaign in 2010 and beyond, there is need for Essential Use Nomination under Decision IV/25. She further mentioned that the deadline for Essential Use Nomination in 2008 has passed and the next deadline is on 31 st January Essential Use Nominations need justification to demonstrate the need, which must take into account technically or economically feasible alternatives. She emphasized that the best management strategy for pharmaceutical-grade CFCs is to complete CFC MDI transition as soon as possible rather than rely on pharmaceutical-grade CFCs that might not be available in the future. A summary of the UNEP Handbook on Essential Use Nominations (2005), which is provided in Annex 5, was prepared and distributed to five MDI manufacturing countries in the region. Mr. Sidi Menad Si Ahmed, UNIDO, asked, if MDI manufacturing countries that have received financial support from the MLF are not be able to completely phase-out CFCs by December 2009, will these countries be allowed to apply for Essential Use Nomination? He also proposed that the question should be submitted to the ExCom for consideration. Dr. Purkayastha, Ozone Cell Bangladesh, mentioned that the MOP Decision clearly stated that the Essential Use Nomination would be allowed beyond 2009 given that an alternative is neither available nor feasible for production. He also emphasized that developing countries should prepare projects and submit to the ExCom for consideration. Need for pharmaceutical-grade CFCs beyond 2009 should be submitted as part of Essential Use Nomination. Dr. A. Duraisamy, Ozone Cell India, mentioned that India fully supports Bangladesh. In addition, according to ExCom Decision 51/34, the ExCom suggested Article 5 countries consider the need for Essential Use Nomination beyond January Subsequently, India has raised in the OEWG Meeting in 2007 that the Essential Use Nomination should be continued beyond 2009 as it is not technically feasible to have all alternatives to CFC MDIs available before Therefore, India fully supports that the ExCom should consider recommending the Essential Use Nomination beyond 2009 for all developing countries. Mr. Atul Bagai, UNEP, mentioned that these issues should be brought to the consideration of the MOP through the MTOC report. In addition, he highlighted that all MDI manufacturing countries need to discuss how to move the CFC MDI phase-out strategy beyond He emphasized that although Essential Use Nomination is a very new process for Article 5 countries, the countries should collect information as requested, and submit information to MTOC by the deadline on 31 st January 2009 to avail themselves of Essential Use Exemptions beyond Implementing agencies are willing to assist the countries to prepare information and reports for the Essential Use Nominations. Page 12 of 142

13 Mr. Yong Wang, SEPA China, mentioned that China has already submitted an MDI sector plan for the consideration of the ExCom. However, based on the plan, China cannot completely phase-out consumption of CFCs in MDIs before China, therefore, also needs Essential Use Exemption of CFCs for MDI sector after In this regard, China supported the comments of Bangladesh and India. He also asked that, if Essential Use Nomination is approved after 2009, where would the pharmaceutical-grade CFCs come from? Mr. Sidi Menad Si Ahmed, UNIDO, mentioned that there is no issue for the countries that have already received financial assistance and need to apply for essential use nomination in He, however, highlighted the problem with countries that do not receive funding and need to apply for Essential Use Nomination after He emphasized that this is an important issue that need to be put forward for the consideration of the ExCom. Mr. Atul Bagai, UNEP, clarified that there are 5 countries in the region that need industry conversion projects. While Iran and Bangladesh has already received financial assistance from the MLF, project proposal of the other 3 countries i.e. India, Pakistan and China is expected for approval at the 55 th ExCom Meeting at the latest. In response to a question asked by China, he mentioned that this is a very critical issue to access to pharmaceutical CFCs beyond It was clarified that China has been granted exemption by the ExCom for manufacturing 550 MT of CFCs for MDI use per year during Stockpile of the unused amount could be used for production of CFC MDI beyond India, which produces CFC domestically, should explore this possibility and address the issue. For Bangladesh, Iran and Pakistan, it is suggested that the countries discuss the way to move forward with access to pharmaceutical-grade CFCs beyond Dr. Paul Atkins, MTOC, mentioned that it is essential that each CFC MDI manufacturing country sets their phase-out target and quantify how much pharmaceutical-grade CFCs they need annually. In this regard, Mr. Atul Bagai, UNEP, suggested that the ozone officer, health officer, and industry in each country discuss and set an estimated figure of pharmaceutical-grade CFCs needed in 2008, 2009 and beyond 2009 considering their CFC MDI phase-out plan. BALANCING OF CFC CONSUMPTION IN MDI AND RAC SECTOR Mr. Atul Bagai, UNEP, made a presentation on balancing CFC consumption in MDI and RAC sector during covering (i) the ExCom Decision 49/33 and (ii) accelerating implementation of the National CFC Phase-out Plan in MDI manufacturing countries. Given that some MDI manufacturing countries in the region are facing a similar situation in which aggregated consumption in MDI and RAC sector may exceed allowable consumption, he mentioned that these countries should examine opportunities for reducing CFC consumption in RAC sector and use this quantity for MDI sector. He gave an overview of Decision 49/33, which is specifically for Bangladesh and Egypt, to reduce consumption in RAC sector through introduction of drop-in alternatives, cost-effective retrofits, and use of recycled CFCs. He also mentioned that accelerating implementation of National CFC Phase-out Plan would reduce consumption in RAC sector faster than original plan, but good management is essential to achieve this. Page 13 of 142

14 Mr. Sidi Menad Si Ahmed, UNIDO, said that it is known that all CFC MDI manufacturing countries will be in a difficult position to comply with phase-out obligations in He mentioned that recommendations to assist Article 5 countries to meet the compliance on CFC MDI phase-out should be forwarded for consideration during the OEWG and ExCom meeting, in particular; how these Article 5 countries could access funding to phase-out CFC MDI. He also mentioned the need to balance the ExCom commitment to approve additional funding for CFC MDI transition strategy. It was clarified that the issues of compliance that MDI manufacturing countries are facing would be discussed during this workshop. MDI workshops in the other regions would be held during the next two months and issues confronting them would also be addressed during these regional workshops. It was also requested that ExCom members attending this workshop should raise the issues faced by Article 5 countries during the meeting in Montreal in April Some countries mentioned that compliance with CFC MDI phase-out in manufacturing countries will also affect MDI import-reliant countries. The CFC MDI phase-out plan in MDI manufacturing countries should involve pharmaceutical companies, patients and doctors. Dr. Purkayastha, Ozone Cell Bangladesh, mentioned that consumption in MDI and RAC sector should be considered separately. According to the ExCom Decision 49/33, it was found that drop-in alternatives could not be a possible option to reduce CFC consumption in RAC sector. In addition, retrofitting of existing CFC system can reduce consumption of CFC in servicing sector i.e MT a little. Page 14 of 142

15 DAY 2: 14 MARCH 2008 SESSION 1: ANALYSIS OF COUNTRY DATA ON REGULATORY FRAMEWORK AND IMPORT DATA RELATED TO MDI COUNTRY WISE ANALYSIS IN SA AND SEAP Mr. Thanavat Junchaya, UNEP, made a presentation on country wise analysis in SA and SEAP region regulatory framework and import data. The analysis was based on questionnaires from 15 countries in SA and SEAP returned to UNEP. He mentioned that, out of these 15 countries, only 9 countries can provide import statistics by type of inhalers. The regulatory frameworks regarding (i) registration of asthma medication, (ii) classification of import statistic, (iii) prohibition of new registration of CFC MDI, (iv) prohibition of CFC MDI by active ingredients varies among the countries. Based on the analysis, he further mentioned that CFC MDIs are predominant in SA and SEAP region and are mostly supplied by Article 5 countries. In the case of Indonesia, he said there was manufacturing of CFC MDIs for 6 products during However, the company has already stopped manufacturing CFC MDI. He also emphasized that, in some countries, CFC MDIs were increasingly imported and this should be investigated by the countries and addressed to ensure smooth transition. Mr. Atul Bagai, UNEP, mentioned that the questionnaire UNEP sent to the network countries was developed in a simple form in close consultation with MTOC. However, it was found that a lot of information from returned questionnaires was incomplete. As MDI information is very critical for the development and implementation of the CFC MDI transition strategy, and the preliminary database has to be very strong, the countries (ozone officer, health officers and Customs Department) should discuss how to track and collect information on import data on the number of MDI units imported/exported including formulation of MDI products import/exported. In addition, he highlighted the need for regulations to prohibit new registrations of CFC MDIs. 11 of the 15 countries which replied do not have this regulation place. The countries should determine if they have enough time to establish regulations to prohibit new registration of CFC MDIs and to de-register existing CFC MDI products. Ms. Ratna Irawati, National Agency of Drug and Food Control Indonesia, provided information that 8 MDI products were locally manufactured in Indonesia. The local industry in Indonesia cannot produce CFC-free alternative as they do not have production technology for alternatives. She also emphasized that the price of CFC MDIs in Indonesia is cheaper than non-cfc MDI and DPI. Dr. Helen Tope, MTOC, provided her opinion on the ban on the import of CFC MDI. Salbutamol CFC MDIs are still widely consumed in a number of the countries although alternatives to CFC MDI are available. She suggested that the countries should initiate discussion to identify the reasons and determine if it is because of the cheaper price of Page 15 of 142

16 salbutamol CFC MDIs. Once the reason is understood, the countries can then explore the possibility of banning the import of CFC MDI. Mr. Rabbur Reza, Beximco Bangladesh, clarified that HFA MDIs were launched in Bangladesh since September Actually, Beximco exports CFC MDIs to 5-6 countries in the region i.e. Hong Kong, Singapore, Myanmar etc. The reason why CFC MDI products are still supplied in the region is not because of the price concern, but due to the long process for registration of CFC-free alternatives. It is essential that the Article 5 countries consider giving priority to the registration of CFC-free alternatives. Dr. Paul Atkins, MTOC, also mentioned that the countries should expedite approval of CFC-free alternatives to support implementation of the MDI transition strategy. ELEMENTS NEEDED FOR DEVELOPING MDI TRANSITION STRATEGY Mr. Thanavat Junchaya, UNEP, further presented elements needed for developing MDI transition strategy, which included: Industry conversion to CFC-free alternatives; Regulation to facilitate transition to CFC-free alternatives; Public awareness and interface with national stakeholders (including Bangladesh case study); Monitoring CFC MDI Phase-out. He emphasized that it is essential for countries to closely follow-up the phase-out schedule of CFC MDIs with pharmaceutical companies to verify timeliness and address potential risks that might cause negative impacts to patients. He also elaborated on the potential barriers to CFC MDI phase-out, which must be eliminated during the transition period. Countries should monitor and control the price of CFC-free alternatives and can learn from the experiences of other countries, where MDI transition has been fast. After this session, the participants were divided into two sub-groups MDI manufacturing countries and MDI import-reliant countries. DAY 2: 14 MARCH 2008 BREAKOUT SESSION (MANUFACTURING) SESSION 2.1: PROJECT IMPLEMENTATION ISSUES Mr. Viktar Shatrauka, UNIDO, made a presentation on the implementing agency perspective on project implementation issues. To implement the conversion project, there are a number of factors that need to be considered in MDI re-formulation technology transfer. He discussed thedifficulties of access to technology transfer from brand leaders and that the cost of technology transfer is higher than expected. He also highlighted that the incremental operating cost (IOC) is also important for successful transition and one year IOC is not sufficient to maintain the cost of HFA MDIs at the same level with CFC products. Page 16 of 142

17 For the industry perspective on project implementation issues, Mr. Rabbur Reza, Beximco Bangladesh, made a presentation covering (i) implementation planning, (ii) technology transfer and testing, (iii) acceptance of CFC free products, and (iv) production on a commercial scale. According to the conversion project in Bangladesh, the first product will be launched in June 2010 and patients will not have time to become familiar with HFA products. Possible solutions to address this problem were also elaborated. He further mentioned that technology transfer is critical to maintain the stability of new products. He also highlighted that education to patients, doctors, and chemist would be useful to stimulate acceptance of CFC-free product. Mr. Ameet Sule, Cipla India, presented transition of CFC to HFA MDI. Like Bangladesh, he mentioned that use of MDIs in India is growing. He emphasized that transition to HFA MDI is not easy due to formulation challenges, high capital investment and operating costs, long registration process to HFA MDIs, and patients and doctors accessibility to HFA MDIs. He emphasized that the company will require pharmaceuticalgrade CFCs until DAY 2: 14 MARCH 2008 BREAKOUT SESSION (IMPORTING-RELIANT) SESSION 2.2: AWARENESS AND INTERFACE WITH NATIONAL STAKEHOLDERS Ms. Kristine Whorlow, MTOC, made a presentation on strengthening awareness and collaboration among key national and regional stakeholders. Her presentation covered experiences in Australia with the National Asthma Council Australia, stakeholder collaboration, and the education and communication strategy with health professionals, patients and media. She emphasized that all stakeholders need to be involved in the MDI transition strategy and that consistent stakeholder coalition communication must be maintained. Dr. Norzila Mohamed Zainudin, Asthma Council Malaysia, presented on the roles of asthma and respiratory disease associations in MDI transition. She mentioned that the Asthma Council Malaysia was formed as the major national body for asthma in Malaysia and had played a key role in CFC MDI transition strategy as part of the technical working group and providing medical consultation regarding transition. She, however, mentioned that many health professionals were not aware that MDI propellants contained CFCs. Typically, it is the prescription from the doctor which determines the choice of MDIs for patients. Education and awareness programs need to be designed therefore. She also highlighted that the strength of asthma and respiratory disease associations in providing information to health care professionals through their medical conferences would facilitate the phase-out process. The website of the Asthma Council Malaysia, where patients and doctors can access information, was introduced to participants. Dr. Kirti Gunasekera, National Asthma Council, Sri Lanka, mentioned that the availability of inhaler in Sri Lanka is reliant on importation and it is difficult to convince the government to import higher price inhalers. He also mentioned that doctors won t know if MDIs are CFC-free unless the packaging indicates this. Page 17 of 142

18 Ms. Peldon Tshering, NOU Bhutan, and Mr. Gyembo Dorji, Department of Public Health Bhutan, mentioned that Bhutan is a small country, which relies on importation of MDIs from other countries. Bhutan has limited technical capacity and needs to be advised of the awareness and educational materials for medical professionals, patients, and the media, and also of the availability of non-cfc products. It takes about 3-6 months to approve new products in Bhutan. Ms. Sonia R. Aqui, Bureau of Food and Drugs Philippines, shared the CFC MDI transition strategy in the Philippines. Public awareness materials and activities on the CFC MDI phase-out for health professionals, patients, and general public have been prepared to ensure a smooth transition. Seminars and consultative conferences with doctors, health professionals, pharmaceutical companies, and regional officers were organized. The Administrative Order has also been revised to expedite transition from CFC MDIs to CFCfree alternatives. From 2010, the Philippine would no longer import CFC containing MDIs. To motivate adoption of CFC free alternatives, the Philippines has set a priority lane to facilitate registration of CFC-free alternatives. Non-CFC MDI products in the Philippines have a CFC-free logo in the label. Dr. Helen Tope, MTOC, made a presentation on promotion of affordable MDIs in developing countries by the Asthma Drug Facility (ADF). She mentioned that the high cost of asthma drugs remains a major obstacle for patient access to treatment in developing countries. Because of this, the Asthma Drug Facility was established under the International Union Against Tuberculosis and Lung Disease (IUATLD) in 2005 to provide access for low- and middle-income countries to quality asthma treatment and affordable good quality CFC free medicines. Clients can purchase generics through ADF at low prices with reporting requirements that monitor asthma management provided to ADF (and also with minimum drug order requirements). Although there have been no orders to date, she mentioned progress towards an updated procurement system that should be completed mid-2008 and emphasized that ADF can be an agent for access to quality asthma treatment and smooth transition to CFC-free alternatives. It was suggested that Sri Lanka applies as a pilot program for low cost CFC-free MDI through the ADF. However, Dr. Kirti Gunasekera, National Asthma Council, Sri Lanka, mentioned that it is difficult for client countries to meet ADF requirement in monitoring and reporting as data collection and monitoring is complicated. Professor Javaid Khan, MTOC, asked what are the problems that the import-reliant countries anticipate in phasing-out CFC MDIs so that these areas could be focused on during the workshop. Mr. Bal Krishna Khakure, Ministry of Health Nepal, said that Nepal imports MDIs from India and Bangladesh. In addition, Nepal also has a free border with India and patients can buy from India. In this regard, the country needs good import data to monitor the CFC MDI phase-out. He also highlighted that the country should control the import licenses of CFC MDI rather than ban the import of CFC MDI. HFA MDIs are considered as new products there will be a long process to get approval. Page 18 of 142

19 Given that availability of inhalers in MDI import-reliant countries relies on supply of inhalers from MDI manufacturing countries, and it is one year and nine months to 2010, Professor Javaid Khan, MTOC, further asked what the problems are, if MDI importreliant countries only allow import of CFC-free inhalers.. Dr. Dammika Jayalath, Drug Regulatory Authority Sri Lanka, mentioned that Sri Lanka has given priority to non- CFC MDIs and there is no further registration of CFC MDI in Sri Lanka now. Dr. W.L. Sumathipala, NOO Sri Lanka, said that the country needs to have awareness and education in the first place. He also mentioned that banning the import of CFC MDIs may take a long period and the county should control import of CFC MDIs through import licenses. Ms. Mazuwin Zainal Abidin, National Pharmaceutical Control Bureau Malaysia, said Malaysia no longer accepted new application for registration of CFC MDIs since 1 st January 1999 through a Drug Control Authority Administrative Order. To date, some CFC MDI products registered before 1999 are still in the market. These CFC MDI products would be allowed on the market until 31 st December 2009 according to the phase-out date. If alternatives to the remaining products are available, Malaysia may de-register these CFC MDI products before the specific phase-out date. Mr. Moosa Ibrahim, NOU Maldives, mentioned that Maldives is an MDI import-reliant country. Maldives had conducted a workshop on the phasing-out of CFC MDIs and the survey has been done before the workshop. It was found that some of the inhalers are not labeled as CFC MDIs or CFC-free MDI. Ms. Sirinart Vasanavathana, Food and Drug Administration Thailand, mentioned that HFA MDIs should not be considered as new products. With regard to new registration of CFC MDIs, the Food and Drug Administration (FDA) would inform the pharmaceutical companies of its CFC MDI phase-out policy, and let the companies decide if they needed to import CFC MDIs. FDA also informed hospital and medical professionals to encourage them to use non-cfc MDIs. She also mentioned that the market mechanism would help to reduce the price of non-cfc MDIs when alternatives are widely available. It had been recommended that the Ministry of Health ensure that the price of HFA MDIs would not be much different from CFC MDIs. Ms. Peldon Tshering, NOU Bhutan, mentioned that Bhutan regulation for registration does not differentiate between CFC MDI and non-cfc MDI. If inhalers could be labeled clearly as CFC MDI or non-cfc MDI, this would help the country to expedite implementation of the CFC MDI transition strategy. Ms. Chuon Chantopheas, National Laboratory for Drug Quality Control - Cambodia, shared the same concern about how to find out whether the product is CFC-free or not. Ms. Kusmulyani Sugiarto, NOU Indonesia, mentioned that all CFC-free MDIs should have a special logo. This issue should be discussed with the Ministry of Health about how to put the CFC-free logo on to CFC-free MDI products. Page 19 of 142

20 Mr. Onechanh Keosavanh, Hygiene and Prevention Department Lao PDR, mentioned that the health focus is not on the need to phase-out CFC MDIs, but more on immediate problems such as malaria, diarrhea etc. Healthcare providers are not aware of CFCs used in MDIs and would still be prescribing CFC MDI to asthma and COPD patients. As a number of countries expressed their concern about the lack of information on MDI packaging i.e.cfc MDIs or non-cfc MDIs, Ms. Kristine Whorlow, MTOC suggested that the MDI import-reliant countries should discuss with their Ministers of Health the use of an international CFC-free logo, which would assist health professionals and consumers to properly differentiate CFC MDIs from non-cfc MDIs. It was also recommended that this should be included as part of the public-private partnership proposed by UNEP. Mr. Atul Bagai, UNEP, suggested each country consider organizing a stakeholder workshop in the next 4-5 months to discuss forming a CFC MDI transition strategy. The respective Ministries of Health should identify the ways to facilitate adoption of CFC-free MDIs in the country. Each sub-group was then requested to make presentations on their discussion. The manufacturing country sub-group spokesperson was Dr. Surinder Singh, Ministry of Health & Family welfare. The import-reliant country sub-group spokesperson was Ms. Kristine Whorlow, MTOC. A summary of these presentations and the ensuing discussions is incorporated in the final conclusions and recommendations in Annex 1. DAY 2: 14 MARCH 2008 SESSION 3: REGULATORY FRAMEWORK FOR TRANSITION Ms. Sirinart Vasanavathana, Food and Drug Administration Thailand, presented on the role of the health authority for fast adoption of CFC-free alternatives. She gave an overview of a communication flowchart among key stakeholders for CFC MDI transition and the implementation steps toward CFC MDI transition as adopted in Thailand. She emphasized that the key to success includes good collaboration among key stakeholders, and education and awareness enhancing campaigns. In Thailand, there has been only one CFC MDI since 2007, it is possible that no CFC MDIs will be imported in Mr. Atul Bagai, UNEP, suggested that the MDI import-reliant countries should be looking at and adopting implementation steps as indicated in the presentation. These steps are necessary for the development and implementation of a CFC MDI transition strategy. Mr. Rahan Talalla, Glaxo SmithKline Malaysia, made a presentation on the industry perspective on regulations for transition to CFC-free alternatives. He stated that industry supports the Montreal Protocol and recognizes the negative impacts of ozone layer depletion. He mentioned activities the MDI industry has carried out. He also highlighted Glaxo SmithKline s position on phase-out CFC MDIs and advised that Glaxo SmithKline will eliminate the use of CFCs from its product portfolio and operations by the end of From the industry perspective, he said that importing HFA MDIs into the region may be Page 20 of 142

21 the most cost-effective option (due to significant investment cost) and import tax reduction could be an effective policy to facilitate fast adoption of CFC-free alternatives. Professor Javaid Khan, MTOC, asked that, what are Glaxo SmithKline s plans for its Pakistan operation for converting manufacturing from CFC MDI to CFC-free MDI. The major concern is that 50 percent of MDIs used in Pakistan are salbutamol. When the phase-out deadline comes, there will be a problem in if a CFC-free alternative is not available to patients. Mr. Atul Bagai, UNEP, also clarified that Glaxo SmithKline Pakistan is a joint venture with Glaxo SmithKline with approximately 20% local shareholding. Accordingly to the ExCom guidelines, Glaxo SmithKline Pakistan would be entitled to only 20% of eligible incremental cost and the rest of this must be borne by the enterprise itself. In view of this Glaxo SmithKline headquarters was asked to explore and identify supporting measures to assist GlaxoSmithKline Pakistan Limited to convert its CFC MDI facility to CFC-free alternative. DAY 2: 14 MARCH 2008 SESSION 4: MONITORING IMPORT/EPORT OF CFC-BASED MDI Dr. Paul Atkins, MTOC, made a presentation on monitoring the import/export of CFCbased MDI. He mentioned that it is very important for MDI manufacturing countries and MDI import-reliant countries to know where products have been manufactured and where products are distributed. For Essential Use Nomination, he highlighted that Essential Use Nominations in the past had set a high standard for the countries to provide a certain amount of information, which must be complete and consistent, for consideration and recommendation by MTOC. He introduced the database and website of the International Pharmaceutical Aerosol Consortium (IPAC), to find information about HFA MDIs and DPIs and where the products are manufactured around the world. The IPAC database also provides information on HFA MDIs and DPIs country by country. It was noted that the IPAC database does not include product information of the pharmaceutical companies that are not its members. He also highlighted the information required for Essential Use Nomination and a table of required information was presented to the participants. If CFC MDI manufacturing countries need to apply for Essential Use Nomination, they must provide information on the following: On a product basis, the amount of CFCs used for manufacturing of CFC MDIs to be supplied domestically and to be exported to each country (must be reported country by country); On a company basis, the amount of CFCs used for manufacturing of CFC MDIs to be supplied domestically and to be exported to other countries. The IPAC database of February 2008 and the table of information required for Essential Use Nomination were provided to participants. Page 21 of 142