Transcript Title of presentation - Medicines Transparency

MeTA Kyrgyzstan
Country Overview
Public Sector
Civil Society
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Medicines Transparency Alliance
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Country overview
Mariam Djankorozova
MeTA Country coordinator
22/07/2015
Medicines Transparency Alliance
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Multi-stakeholder process

Situation analysis of multi-stakeholders in the Country

Organization of MeTA Council in Kyrgyzstan

Regular meetings engaging multi-stakeholders

Formation of MeTA CSOs Coalition

Private sector from remote regions of KG more interested in
MeTA than central regions

CSOs was active in dialogues with private and government
sectors

Procurement and availability of medicines is the main issues for
CS and private sectors:
–
–
Implementation of CS observers in tenders (Gov bodies are inviting)
Private sector suggested to implement E-procurement system in
hospitals
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Major achievements and successes

Common forum for discussion on pharmaceutical issues

Availed platform for Problem solving on significant issues in the
sector, including WEB-site (has launched, content in the process of
filling)

Conduct inter sectoral collaboration via design of activities
allowing data gathering and information

Improved communication and awareness of different sectors

MoH KG

Private sector initiated to organise small active group on
Legislation issues and regular meetings.

Capacity building of the CSO Coalition is considered as the
major success in Kyrgyzstan
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Overall challenges

Current political situation with constrained government
management (poor transparency and accountability)

Private sector involvement limited due to inadequate information
on how to engage in MeTA process

How to show the benefit of MeTA to every sector

Poor leadership of MeTA Council due to conflict of interest
(Director of DRA is chairman of MeTA Council)

Overcoming conflict of Interest and engagement between sectors
(better understanding of each other & role of each sector in the
country)

Active promotion of MeTA was not possible because of political
situation
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Lessons Learned

Different background of MeTA Council Member complicate the
dialogue

Development of Criteria for management of MeTA Council
requires wider consideration than sectoral interest

Engagement of Multi stakeholder is a Process and takes time

Requires skills to engage and manage the different sectors
(particularly to listen to the other sector and increase awareness)

MSP requires good facilitation and these skills need to be
development and learnt

Power in numbers… (when we are many we are stronger)

Benefit is important: Private sector wants to be involved more
active in Legislation issues.

Media strategy for promoting MeTA it must be at the beginning
of process
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Thank you

Mariam Djankorozova

MeTA Country coordinator

Email: [email protected]

Mobile number: +996 555 92 94 12

Skype: mariamdjan1

Website: www.metakg.org
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Public Sector
Expertise of current
Legislation
Djusupova Djanyl
Deputy director of NDRA of KG
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Summary Analysis at start of MeTA



Since gaining independence of KG when the
pharmaceutical sector privatized the legal framework
corresponding new function requirements in drug provision
has been established
NDRA KG has been established
However, regulatory tools lacked to ensure transparency
and accountability in the pharmaceutical sector if basic
legislation was available
Survey objective:
Analysis of legislation, with emphasis on mechanisms of transparency
and accountability, including an assessment of the law in practice and
existing contradictions
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Summary Analysis at start of MeTA
The new policy reforms aimed at improving the business environment by
removing administrative barriers to business and investment has led to:
-
A reduction of 30% of licenses and permissions for business activities.
Changing the system of control and inspection of business.
Reduction to 30% of the bodies monitoring business.
A significant impact on regulation of pharmaceutical sector:
According to advisory group of BEI project medicines were considered as an ordinary product
without regard to their characteristics. The adoption of some recommendations could lead to
deregulation in pharmaceutical sector:
- Activities of wholesalers and manufacturers of medicines and pharmacies (except
pharmacies produced medicines extempore) is no longer licensed
- MoH standards would be voluntary implemented in pharmaceutical sector
- the declaration of compliance with medicines is introducing instead of mandatory
certification of medicines
- Unilateral recognition of medicine registration
Pharmaceutical Inspection has no rights to have unexpected visit , even
there are public complaints
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Major milestones

META initiated a dialogue with the USAID BEI project involving
private sector, NGOs, government and WHO to prevent an
imbalance in the regulation of the pharmaceutical sector under an
authoritarian approach and non-transparency of the policy

Expert group on legislation analysis conducted meetings with
representatives of different sectors:
-
- Public sector: MoH, MoF, NDRA
-
- CSOs sector

- Private sector

Identified issues and contraventions in legislation were discussed at the
Round Table by all parties participated

E- group involving all stakeholders was created to discuss legislation
issues
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Areas of survey

1. The main normative documents governing the drug provision in KG:
1.1. Effectiveness of legal documents to ensure transparency of drug
provision in KG
1.2. Legal and regulatory shortcomings and contradictions

2.
The patient’s rights on the drug provision and their protection
2.1. Information public support on medicine issues
2.2. Services on the drug provision
2.3. The possibility of appeal by patients of their rights on the drug
provision

3.
State regulation
3.1. Regulation of licensing issues concerning the drug provision
3.2. Bodies authorized to control the drug provision
3.3. The system of state control efficiency and drug safety

4.
Responsibility for the public health
Medicines Transparency Alliance
Challenges with legislative features
1.
1. Contradictions in certain normative documents including differences
in terminology
2.
2. It is necessary to improve the regulatory framework (conflict of
interests of NDRA and exclusion of obsolete rules)
3.
3. Medicines included in the scope of the Law "On the basis of
technical regulation in the Kyrgyz Republic”
4.
4. New rules of establishment of regulation status may lead to the fact
that regulations of the drug provision will cease to be binding
5.
5. Inadequacy of certain legislation (complication of pharmaceutical
inspection, law enforcement pressure on pharmacies)
6.
6. The lack of legislative mechanisms to ensure transparency and
accountability in the pharmaceutical sector
Medicines Transparency Alliance
Challenges with executive features
1. Procurement:
-
The inaccessibility of information on procurement of medicines, except for
procurement announcement
Violation of procurement procedures
2. Licensing system:
No transparency in issue of licenses
There is no public information on licensed pharmacies
Lack of information management system in the pharmaceutical sector
3. Disciplinary-executive:
•
- Competence of documentation requirement by certain control agencies
(prosecution or other fiscal bodies)
Medicines Transparency Alliance
Recommendations of Stakeholders (1)
-
Increasing the responsibility of officials (administrative, criminal,
disciplinary)
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Obligatory support information of patients including information on
ADR
-
To introduce standards for the number of pharmacies in a particular
area
To attract the local government to monitor the activities of
pharmacies
-
Promotion of ethic code of pharmacist
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To introduce bar code for medicines
-
To ensure timely review of list of medicines reimbursed
Medicines Transparency Alliance
Recommendations of Stakeholders (2)
Tender:
-
-
-
to implement e-procurement (legalize the flow of documents in
electronic format).
to introduce ethic standards for the members of tender commission
to introduce criteria for medicine procurement to procure quality
medicines (price should not be sole criterion)
Information:
Increasing public awareness
Information on the DRA website:
Licensed pharmacies ,
Certified products,
Registered medicines
To introduce provisional regulations on period of medicine
certification
Medicines Transparency Alliance
Lessons Learned

Working with different sectors revealed a significant lack of
information in the pharmaceutical sector (indicated by all parties)

Private sector and NGOs are ready to participate in development
and enhancement of legislation through:



Establishing working group involving all sectors to address specific laws
Establishing groups to lobby for promotion of certain laws
The system of regular meetings, newsletters, online forums

Involvement of all stakeholders enhances the process of
improving the legislation and its implementation

Activities META promote confidence-building between the sectors
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Thank you

Djusupova Djanyl

Deputy director of NDRA of KG

Email: [email protected]

Mobile number: +996 770 221 055

Skype:

Website: www.pharm.med.kg
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MeTA Kyrgyzstan
Burul Makenbaeva
CSO Coordinator, Kyrgyzstan
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Summary Analysis at start of MeTA
What were the needs and issues in your specific sector at the start
of MeTA?

Mission of Mental Health and Society is the return of people with
mental disorders into the community of closed psychiatric
institutions. Access to medicines in the community is a main
matter.

Since 2006 Drug Package of SGP for patients with mental
disorders has been implemented at the primary health care level
but patients were not informed

And a high level of mistrust between the sectors, the myths and
stereotypes from all parties

The lack of communication between NGOs and the public sector:
only letters - ineffective communication
Everything was a thick and gray clouds!
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Major milestones
What milestones have been achieved during the MeTA pilot phase?

Establishment of CSO Coalition, trainings and small grants
surveys

Studies have begun sowing clouds, the picture became more
clear, what works and how, and why if not working

The regular communication is created

Building trust and respect
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Successes
What were the successes for your sector during the MeTA pilot
phase?

NGOs participate in public procurement process at the national
level

The initiative of NGO inclusion comes from government

All Coalition members have full access to information

Building trust with the public media, local authorities, local
community
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Challenges
What challenges has your sector endured during the MeTA pilot
phase?

Lack of capacity and knowledge on drug circulation and lack
of legal capacity

The diversity of interests and different ideas of how to act in
coalition

Discussion took a long time and it was a risk to lose
interest

Change Leadership
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Lessons Learned
What are the lessons that your sector has learned from MeTA?

Identification of interests and motivations

Maintaining a balance of interests to develop a unified
strategy

Solidarity and broad cooperation including the International
MeTA

The necessity to react quickly to unforeseen difficulties

Flexibility

Full involvement of stakeholders from the beginning
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Lessons Learned
Topics:

Availability of psychotropic medicine under the State Guarantee Program in
Bishkek and Osh Cities. (PF Public Health in partnership with PF New View on
Mental Health).

Availability of medicine under the State Guarantee Program in rural areas
based on the example of Kochkor District, Naryn Province (PF Harmony Plus
in partnership with Village Health Committee (Kochkor District, Naryn
Province), PF Etiyat (Issyk-Kul Province) and NGO Door Eli (Bishkek).

Availability of vitally important medicines in children’s residential institutions
(League of Child Rights Defenders)

Study of State Procurement Practice at the National Cancer Center (PF
People Living with Chronic Myeloleukemia)

Rationality of medicine use at Bishkek hospitals based on the example of
Hospitals #1 and #6 (NGO For Safe and Rational Use of Medicine)

Availability of diabetes medicine in Chui Province.
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