Transcript What have been done on improvement of management of medicine

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
11
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
Development of SMP 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
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-ofpocket 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 procurement
2. 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 sale
3. 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 Management
of Drugs Circulation Area via achievement of
Removing contradictions and gaps in
the legal framework of medicine circulation
Introduction of concept of “medicine" as a special type of commodity
Establishment mandatory GPR compliance in the area of medicine
circulation
Stipulation 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 !