Medicines Transparency Alliance18/09/ MeTA Kyrgyzstan Country Overview Public Sector Civil Society

Medicines Transparency Alliance18/09/ Country overview Mariam Djankorozova MeTA Country coordinator

Medicines Transparency Alliance18/09/20153 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

Medicines Transparency Alliance 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 18/09/20154

Medicines Transparency Alliance 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 18/09/20155

Medicines Transparency Alliance 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 18/09/20156

Medicines Transparency Alliance18/09/20157 Thank you Mariam Djankorozova MeTA Country coordinator Mobile number: Skype: mariamdjan1 Website:

Medicines Transparency Alliance Djusupova Djanyl Deputy director of NDRA of KG Public Sector Expertise of current Legislation 18/09/2015 8

Medicines Transparency Alliance 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 18/09/20159

Medicines Transparency Alliance 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 18/09/201510

Medicines Transparency Alliance 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 18/09/201511

Medicines Transparency Alliance 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 Contradictions in certain normative documents including differences in terminology It is necessary to improve the regulatory framework (conflict of interests of NDRA and exclusion of obsolete rules) Medicines included in the scope of the Law "On the basis of technical regulation in the Kyrgyz Republic” New rules of establishment of regulation status may lead to the fact that regulations of the drug provision will cease to be binding Inadequacy of certain legislation (complication of pharmaceutical inspection, law enforcement pressure on pharmacies) 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) - 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 - 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 18/09/201517

Medicines Transparency Alliance Thank you Djusupova Djanyl Deputy director of NDRA of KG Mobile number: Skype: Website: 18/09/201518

Medicines Transparency Alliance18/09/ MeTA Kyrgyzstan Burul Makenbaeva CSO Coordinator, Kyrgyzstan

Medicines Transparency Alliance18/09/ 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!

Medicines Transparency Alliance 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 18/09/201521

Medicines Transparency Alliance 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 18/09/201522

Medicines Transparency Alliance 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 18/09/201523

Medicines Transparency Alliance 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 18/09/201524

Medicines Transparency Alliance 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. 18/09/201525

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