1. Ministry of Health of the Kyrgyz Republic The progress in the implementation of the Drug Circulation Program for 2014-2020 ( The Decree of the Government of the KR №376 from July 8, 20 15) Ms. Moldoisaeva Chief Specialist on Drug Policy The Ministry of Health of the KR Bishkek, 2015 1

2. The Program has 3 main areas of implementation: 1. ENSURING DRUG AFFORDABILITY 2. DRUG CIRCULATION SYSTEM 3. IMPROVEMENT OF DRUG CIRCULATION MANAGEMENT 2

3. 1. What has been done in 2015? 2. Priorities for 2016 3. Barriers 4. Proposals for the procurement plan 3

4. What has been achieved? – the improvement of the legislation (1) The new draft Law on medicines has been developed – a large number of changes were made to it in accordance with: 1. The Law on Normative and Legal Acts; 2. The Law on Licensing System; 3. The elimination of reasons leading to political and system-based corruption in governmental bodies 4. The unification of the terminology in EEU. 5. The separation of medical products, medical equipment and veterinary products from the law on medicines 6. The new structure of the law, which is based on drug circulation stages. 4

5. What has been done? – the draft law on medicines Novelty What has been done? – the draft law on medicines Novelty: The new version of the Law on medicines enlists 17 methods of the state regulation The authorities of the Government to define the EDL pricing policy are introduced Biologically active supplements are excluded from the draft law on medicines ( BAS will be regulated by EEU’s technical regulations on BAS) Article 10 is added – Drug Circulation 5

6. What has been done? – the draft law on medicines (3) Novelty What has been done? – the draft law on medicines (3) Novelty : Article 14. State Register of Medicinal Remedies of the Kyrgyz Republic: State Register of medicines of the Kyrgyz Republic is an unified informational system; The maintenance of the Register is implemented by the Ministry of Health; The Register saves the personified history of changes made to registry records, indicating the date and time when the records were made, changed and removed. It is not allowed to delete data from the unified Register. The data, contained in the Register, is open for the public. 6

7. What has been done? – the draft law on medicines (4) What has been done? – the draft law on medicines (4) Novelty : Prohibition of clinical tests on pregnant women and children Compassionate use - programs to provide experimental drugs for a potential life saving of patients, which suffer from a disease, which has no authorized satisfactory treatment and/or who can not take part in a clinical trial; For the first time a clear formulation is provided on prohibition to sell prescription medications: Article 53, retail sales of prescription and non-prescription medications (a new article is added). 7

8. What has been done? – the improvement of the Law on Patents (5) Amendments are made to the Law on Patents (April 10, 2015, № 76), based on the principles of protection of health care and state interests, as well as the fact that the country is obliged to implement only the minimum requirements of the TRIPS Agreement, which will allow to eliminate an additional 5-year barrier established by the national legislation, thus, allowing the registration and importation of more affordable generic drugs to be started 5 years earlier in accordance with the quality requirements set for such drugs. 8

9. What has been done? – the improvement of the Law on Medical Products (5) A new draft law on medical products is developed, which takes into account the complex specifics of the market of medical products and equipment The draft law on medical products is in compliance with the norms of EEU on regulation of circulation of medical products 9

10. What has been done? – the improvement of the legislation - Amendments/additions are proposed to be made to : What has been done? – the improvement of the legislation - Amendments/additions are proposed to be made to : The Law of the Kyrgyz Republic on the Protection of Health of Citizens of the Kyrgyz Republic The definitions of «rare diseases» and «orphan drugs» are provided in accordance with international norms The duty to develop the list of socially significant diseases 10

11. What has been done? – the improvement of the legislation - Amendments/additions are proposed to be made to : What has been done? – the improvement of the legislation - Amendments/additions are proposed to be made to : Criminal Code of the Kyrgyz Republic; The Code of the Kyrgyz Republic on Administrative Liability Strengthening responsibility for violating drug circulation rules, counterfeiting of drugs and sale of drugs with expired shelf life Liability of officials (heads) of the markets for selling drugs in unauthorized places Increased penalties 11

12. What has been done? – the improvement of the legislation - Amendments/additions are proposed to be made to : What has been done? – the improvement of the legislation - Amendments/additions are proposed to be made to : The Law on Public Procurement (April 3, 2015, № 72) The first criteria for the procurement of drugs - maximum clinical safety and therapeutic efficacy for the patient, which is proven by the established manner, and the smallest risk of adverse reactions. The next most important criteria to select drugs is the lowest cost of the complete course of drug treatment; 12

13. What has been done? – the improvement of the legislation - Amendments/additions are proposed to be made to : The Law of the Kyrgyz Republic on Procedures to Inspect Business Entities Introduction of grounds to conduct unscheduled and unexpected inspections in emergency cases in order to identify violations and to take urgent measures to address revealed violations them 13

14. Eurasian Economic Union – common market of medicines from 1 st January 2016 The following laws are adopted: “On accession of the Kyrgyz Republic to the Treaty/Agreement on common principles and rules of circulation of drugs in the framework of the Eurasian Economic Union, signed on the 23 of December 2014 in Moscow”. “On accession of the Kyrgyz Republic to the Treaty/Agreement on common principles and rules for handling of medical devices (medical products and medical equipment) in the framework of the Eurasian Economic Union, signed on the 23 of December 2014 in Moscow”. 14

15. What has been done? – the improvement of the legislation– dispensing of prescription medications The Department developed the proposal "On making amendments and additions to the Decree of the Government of the KR dated January 5, 2011, № 2" On approval of the drug prescribing and dispensing rules in the Kyrgyz Republic "(the Decree of the Government of the KR dated April 22, 2015, № 232). There are approved new prescription forms - LS-1 and LS- 2. Prescription form LS-1 has detachable coupon to be filled in by doctors and pharmacists. When dispensing a drug a pharmacist leaves the coupon in a pharmacy. Detachable coupons can be used to monitor drugs prescribed by doctors and dispensed by pharmacists. After the drug is dispensed to the patient coupons are stored in the pharmacy for two years. 15

16. What has been done? – National database on drugs (1) 1. There was developed and approved the Concept on the development of an electronic database on drugs and medical products in the Kyrgyz Republic for the years 2016-2010 (The Decree of the Government of the KR № 743 from November 27, 2015). 2. Draft resolution of the Government of the Kyrgyz Republic "On approval of the Action Plan to implement the Concept on the development of an electronic database on drugs and medical products in the Kyrgyz Republic for 2016- 2020" is developed and currently is being under coordination at the ministries and agencies. 16

17. What has been done? – The selection of drugs (EDL and NDC) The Concept on the selection of essential drugs (EDL) A comprehensive system to select drugs in KR at all levels of the health care system Criteria for drug inclusion / exclusion Procedures to develop and update EDL in accordance with the recommendations of the WHO Expert Committee, taking into account the priorities of the health care system of the Kyrgyz Republic. There will be defined the roles and duties of all parties, taking part in the selection process to avoid potential conflict of interest (NDC). 17

18. What has been done ? – Public procurement of drugs The draft version of Standard Bidding Documents is developed for the procurement of drugs by hospitals, including technical specifications for drugs. The document is sent for approval to the Ministry of Finance of the Kyrgyz Republic, which is assigned to approve methodological documents on public procurement (The Decree of the Government of the KR dated September 15, 2014, № 530) 18

19. What has been done ? – Public procurement of drugs(4) What has been done ? – Public procurement of drugs(4) Drug Codifier is designed and piloted at the hospitals in Bishkek City, Osh City and Tokmok City Reporting forms are developed for hospitals to aggregate data on drug procurements The work is coordinated with the team of electronic portal for public procurement at the Ministry of Finance in order to integrate the codifier so that drug procurement is conducted by using the codifier. 19

20. Priorities for 2016 To promote the approval of draft laws at the Parliament and the Government of the KR To develop bylaws To develop the policy on the regulation of prices for drugs, included to EDL To install drug codifier to 1C accounting software in all health care organizations 20

21. Barriers Potential difficulties in the promotion of draft laws due to resistance of interest groups (for example, the issues of price regulation for drugs) Additional difficulties and work burden for the accounting group 1C related to integration of the drug codifier in HOs Closure of МеТА activities - the Alliance for transparency in the field of drug circulation 21

22. Proposals for procurement plan To support МеТА Secretariat To support development and promotion of bylaws (in accordance with the new law on medicines and medical products and new EEU regulations) To support the revision of EDL 22

23. Thank you for your attention! 23