Slide1: Access to ARVs in EMR: Findings of the Survey EDB / ASD 5-7 April, 2005, Cairo Inter-country Meeting on Antiretroviral Drugs Pricing, Procurement and Supply Management


About the survey : About the survey A quick attempt to get information about the ARVs supply situation in the EMR countries. A questionnaire was sent to pharmaceutical authorities in all the countries. 12 out of 22 countries responded. The data was analyzed and being presented in this presentation.


Responses received from : Responses received from Afghanistan Bahrain Djibouti Egypt Iran Iraq Jordan Kuwait Lebanon Libya Morocco Oman Pakistan Palestine Qatar Saudi Arabia Somalia Sudan Syria Tunisia UAE Yemen


What we asked for ? 1 : What we asked for ? 1 Is there a National Medicines Policy approved by the government? Is there a national EDL? If yes, does the NEDL include ARVs? Does the public medicine procurement and supply agency procure and supply ARVs? - if yes, what is the procurement policy? - If not, then please specify the ARV procurement and supply system in your country? On which treatment guidelines is the procurement list of ARVs based? - National guidelines - WHO guidelines - Others (please specify)?


Slide5: 6. Are ARVs locally produced? - if yes, list the ARVs which are locally procured? - If no, then please specify the sources of ARV procurement and provide a breakdown of ARVs procured per year (estimates if exact figures are not available)? - Brand name ARVs: …% - Generic ARVs …% Please list the 10 ARVs that are most commonly procured and used in your country (in order of priority)? Briefly explain what obstacles are experienced in procurement and supply of ARVs Does the public medicines procurement and supply agency also procure and supply diagnostic kits? What we asked for ? 2


Slide6: Are there regulations which allow fast track registration of generics and/or medicines included in national EDL? Is your country a WTO member? If yes, does the law in your country allow to utilize TRIPS provisions? In case your country is not a WTO member: does your current patent legislation have safeguards which allow to use generics? What we asked for ? 3


Slide7: 14. Have you ever used list of WHO prequalified ARVs for registration or procurement purposes? What we asked for ? 4


Is there a National Medicines Policy approved by the government ?: Is there a National Medicines Policy approved by the government ? 11 out of 12 countries have NMP? Afghanistan Egypt Iran Jordan Lebanon Oman Palestine Sudan Syria Tunisia UAE Yemen


2. Is there a national EDL?: 2. Is there a national EDL? 11 out of 12 countries have NEDL? Afghanistan Egypt Iran Jordan Lebanon Oman Palestine Sudan Syria Tunisia UAE Yemen


3. Does the NEDL include ARVs?: 3. Does the NEDL include ARVs? 11 out of 12 countries include ARVs in their NEDL? Afghanistan Egypt Iran Jordan Lebanon Oman Palestine Sudan Syria Tunisia UAE Yemen


4.a Does the public medicine procurement and supply agency procure and supply ARVs? : 4.a Does the public medicine procurement and supply agency procure and supply ARVs? In 10 out of 12 countries public sector procure and supply ARVs Afghanistan Egypt Iran Jordan Lebanon Oman Palestine Sudan Syria Tunisia UAE Yemen


4.b - If yes, what is the procurement policy?: 4.b - If yes, what is the procurement policy?


5. On which treatment guidelines is the procurement list of ARVs based? : 5. On which treatment guidelines is the procurement list of ARVs based?


5. Are ARVs locally produced?: 5. Are ARVs locally produced?


6. List of ARVs produced locally: 6. List of ARVs produced locally


6. Availability of ARVs with brand names and generic names in EMR countries: 6. Availability of ARVs with brand names and generic names in EMR countries


7. 10 Most commonly used ARVs in reporting EMR countries: 7. 10 Most commonly used ARVs in reporting EMR countries


8. Obstacles are experienced in procurement and supply of ARVs: 8. Obstacles are experienced in procurement and supply of ARVs


9. Public Procurement & Supply of diagnostic kits?: 9. Public Procurement & Supply of diagnostic kits? All the countries which procure ARVs through medicine supply agencies also procure diagnostic kits. Afghanistan Egypt Iran Jordan Lebanon Oman Palestine Sudan Syria Tunisia UAE Yemen


10. Are there regulations which allow fast track registration of essential drugs?: 10. Are there regulations which allow fast track registration of essential drugs?


11. WTO membership?: 11. WTO membership?


12. If yes, does the law in your country allow to utilize TRIPS flexibilities / safeguards?: 12. If yes, does the law in your country allow to utilize TRIPS flexibilities / safeguards?


13. In case your country is not a WTO member: does your current patent legislation have safeguards which allow to use generics?: 13. In case your country is not a WTO member: does your current patent legislation have safeguards which allow to use generics?


14.Have you ever used list of WHO pre-qualified ARVs for registration or procurement purposes?: 14.Have you ever used list of WHO pre-qualified ARVs for registration or procurement purposes? 6 out of 12 countries have used it Afghanistan Egypt Iran Jordan Lebanon Oman Palestine Sudan Syria Tunisia UAE Yemen


Conclusions : Conclusions Responses received from 12 out of 22 countries. 10 out of 12 countries have NMPs. 11 out of 12 countries have NEDLs. Big majority have included ARVs in their NEDLs. Almost all countries procure ARVs through public sector supply system. All the countries either have National treatment guidelines or they use WHO guidelines. Only Iran and Egypt are manufacturing ARVs in the region. There is a mixed situation about the use of branded and generic ARVs in the reporting countries. High prices and delay in supply are the most common obstacles mentioned in access to ARVs.


Conclusions : Conclusions All the countries also procure diagnostic kits through the same systems. Majority of the countries (9/12) have regulations for fast-track registration of essential drugs. 5 countries are WTO members and 7 are not. WTO members have important flexibilities and safeguards in their patent laws. Non-WTO members also have enabling patent laws for generic use. Half of the countries have used pre-qualification information in their procurement work.