Implementation of State Program on development pf sphere of medicine circulation for 2014-2020 (ПП КР №376 от 8.07.15)

Saltanat Moldoisaeva. Senior Specialist on medicine policy

Ministry of Health МеТА Форум, 8 декабря 2015

Бишкек

Presentation structure

• Pharmaceutical sector specifics – Global aspects • Some data on pharmaceutical sector of Kyrgyz Republic from DRA• Stages of formulation of the state medicines policy• Features of state medicine policy for 2014-2020 (SMP): - development process - situation analysis and problems identification - setting the principles, goal of SMP - SMP structure and actions - progress with implantation in 2014-2015

Pharmaceutical sector specifics – Global aspects • Large volumes and a high rate of growth of the market- Enormous range of medicines and medical equipment• Large amount of advertising and other information to

promote the medicines that creates difficulty in finding objective information

• The powerful effects of drug manufacturers to physicians and consumers in order to promote their products and profit

• Irrational use and prescription of medicines • Nina Sautenkova, Flagship courses on health system strengthening, Barcelona,

21-25 November 2011

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Stages of medicines policy formation in the sphere of medicines circulation

• GoKR Decree 04.12.98, №794 «About the state medicine policy in KR». Implementation period 1998-2002

• GoKR Decree 15.10.02, №704 About the state medicine policy in KR». Implementation period 2002-2006

• GoKR Decree 12.01.07, №11 About the state medicine policy in KR for 2007-2010». Implementation period 2007-2010

• GoKR Decree 8.07.2014 № 376 «On approval of Government Program on development of sphere of medicines circulation». Implementation period 2014-2020

• Inter-sectoral working group (MoH, MoF, ME, STI, MoI, SADC, NGO) and expert group

• Through assessment of situation (desk study of all available researches, analysis and recommendations from WHO, HPAC, National stat. committee – KIHS)

• Wide discussion (focus group with representatives of public health organizations, private sector, Round Tables, posting the intermediate versions at the MoH, MeTA websites and AkiPress news agency)

• Комментарии от заинтересованных министерств, ведомств, профессиональных неправительственных организаций, международных донорских организаций (ВОЗ, ВБ, ПРООН), бизнес сектора

Development of SMP 2014-2020

Situation Assessment - Policy Research Document №67, Analysis of factors influencing on use of generic drugs, HPAC, 2009- Policy Research Document № 68 « Situational analysis on appropriateness of

hospitalization of children under 5 and pregnant women», HPAC, Bishkek, 2009‐ Policy Research Document № 76 «Access to healthcare services and out-of-

pocket payments in Kyrgyzstan: Household survey from 2001 to 2010», HPACV, Bishkek, 2011

‐ Policy Research Document № 77 «Evaluation of implementation and effectiveness of the State Drug Policy of the Kyrgyz Republic for 2007-2010», 2012 г., HPAC

- Quality of medicines within the public sector drug procurement system in the Republic of Kyrgyzstan, WHO, 2008 Report, Research Pharmaceutical Market of Kyrgyz Republic for the presence of counterfeit and substandard medicines using minilab, МеТА, 2010- Kyrgyz Integrated Households Survey, National Health Account, 2009, HPAC

Main groups of identified problems 1. Low affordability of medicines

• Deformed, overestimated demand, polypharmacy, unethical marketing• Deformed pricing Inefficient procurement2. Imperfect system of regulation and supply of drugs• Questionable therapeutic efficacy, safety and quality of generic drugs• Reduced availability of narcotic, psychotropic and other drugs• Illegal sale3. Weak system of management medicine circulation sphere • Contradictions and gaps in the legislation• Weak institutional capacity, poor inter-agency cooperation• Lack of transparency of regulatory processes

Principles • Continuity of health care reforms• Focus on ensuring equality in access to essential drugs, especially for vulnerable

populations• Declaration of drugs as special kind of products, affecting people’s health; quality

and efficacy of which can not be always assessed objectively either by doctor, prescribing drugs, or patient

• Further/continuous support of the Policy of generic drugs use• Focus of the SMP on Ethic norms• Ensuring of transparency at all the stages of drug circulation• Wide involvement of all stakeholders into the process of formation,

implementation, assessment of policy and feedback in the area of drug circulation area

The Program Goal

To ensure accessibility of essential, safe, effective and quality drugs for the citizens of the Kyrgyz Republic and their rational use.

SMP Structure

Ensuring Affordability of Drugs and Medical Devices

The System of Drugs Circulation

Improving Management of Drugs Circulation Area

What SMP suggests for improving the medicines

affordability (1)Strategic area 1. Ensuring affordability of medicines via achievement of Regulation of demand for medicines: - Introduction of efficient strategy for selecting essential medicines - Improving the demand for cheaper generics while ensuring equal

clinical efficacy- Rationalization of drugs consumption practice

What SMP suggests for improving the medicines

affordability (2)Strategic area 1. Ensuring affordability of medicines via achievement of Development of medicine price regulation policy:- To be determined by balancing of business and government interests

to avoid draining off the pharm. market- Revision and Optimization of State Medicine Benefit Program to use

its potential for influencing prices on EM from reimbursement lists - Improvement of public procurement of medicines

What SMP suggests for improving the medicines

affordability (3)Affect the formation of proposals drugs through the establishment of mechanisms of state influence on the formation of prices of medicines included in the EML program and beneficiary drug coverage:• Decrease markups in the wholesale cost of drugs through the

optimization of their number and reduce supply chain• Create mechanisms to regulate trade margins (wholesale and retail)• Implement a system of internal reference prices for reimbursable

drugs

What SMP suggests for improving system of medicines

circulation (1)‐ Simplification of procedure for registration of

medicines registered by the stringiest regulatory agencies (ICH,PIC/S)

‐ Gradual introduction of GXPs ‐ Organization of a comprehensive system of

surveillance over the market

What SMP suggests for improving management of sphere of medicines circulation (1)

Strategic Area III: Improving Managementof Drugs Circulation Area via achievement ofRemoving contradictions and gaps inthe legal framework of medicine circulationIntroduction of concept of “medicine" as a special type of commodityEstablishment mandatory GPR compliance in the area of medicine

circulationStipulation that pharm business needs close monitoring compared with

common business

What have been done for improvement of affordability (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.

What have been done for improvement of affordability (2) • 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).

What have been done for improvement of affordability (3) • 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)

What have been done for improvement of affordability (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.

What have been done for improvement of system medicine circulation (1)

• The new version of the Law on medicines enlists 17 methods of the state regulation

• 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

What have been done for improvement of system medicine circulation (2)

• 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.

What have been done on improvement of management of medicine circulation sphere (1)

• In Parliament the draft law on the removing the medicines out of scope of law on technical regulation

• Active work on the development and harmonization of legislation with the EEU

• Developed and submitted for approval by the Government of the draft law on medicines which eliminated all the contradictions and corruption risks

• Developed and submitted for approval by the Government a package of laws to support the provisions of the new law on drugs

What have been done on improvement of management of medicine circulation sphere (2)

• 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

• The draft law on medicines directed to the ministries and departments of the Kyrgyz Republic

What have been done on improvement of management of medicine circulation sphere (3)

• 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

• Criminal Code of the Kyrgyz Republic and 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 and Increased penalties

Thank you !