Transcript What has been done? – the draft law on medicines

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, 2015)
Ms. Moldoisaeva
Chief Specialist on Drug Policy
The Ministry of Health of the KR
Bishkek, 2015
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The Program has 3 main areas of implementation:
1.
ENSURING DRUG AFFORDABILITY
2.
DRUG CIRCULATION SYSTEM
3.
IMPROVEMENT OF DRUG CIRCULATION MANAGEMENT
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1. What has been done in 2015?
2. Priorities for 2016
3. Barriers
4. Proposals for the procurement plan
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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:
The Law on Normative and Legal Acts;
The Law on Licensing System;
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.
1.
2.
3.
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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
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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.

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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).

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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.
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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
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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

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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
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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;
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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
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Eurasian Economic Union – common market of
medicines from 1st 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”.
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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 LS2. 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.
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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 20162020" is developed and currently is being under coordination
at the ministries and agencies.
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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).

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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)

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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.

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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
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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
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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
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Thank you for your attention!
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