Country work

Albania

2019

Self-assessment benchmarking of the national regulatory authority (NRA).
Direct technical assistance based on an institutional development plan (IDP) for the NRA.
WHO workshop on implementation of European Union (EU) guidelines on good distribution practice (GDP).

2016

Supporting the development of an outpatient medical devices reimbursement scheme in Albania.

Armenia

2019

Phase III pilot of Smart Safety Surveillance (3S) Project (pharmacovigilance for tuberculosis (TB) medicines) completed.
Development of mobile phone application for reporting adverse drug events.
Direct technical assistance based on the IDP for the NRA.
Peer learning site visit to the Norwegian Medicines Agency.
First visit to agree next steps on NRA benchmarking.
Advanced GDP training for the national pharmaceutical inspectorate.

2018

Introduction of the Smart Safety Surveillance Project, supporting collaboration between the pharmacovigilance programme and TB programme of the national regulatory authority (NRA) in monitoring adverse events relating to the use of new TB medicines (such as bedaquiline).

Azerbaijan

2019

Advanced good manufacturing practice (GMP) training completed (three modules).
Registration for the WHO collaborative registration procedure (CRP) commenced.
Advanced GDP training for national pharmaceutical inspectorate.

2018

Organization of the Commonwealth of Independent States (CIS) subregional meeting of the Pharmaceutical Pricing and Reimbursement Information (PPRI) Network.
Consultation and sharing experiences with the Kyrgyz authorities about the introduction of medicines price regulation.
Training in good manufacturing practices (GMP) inspection.

Belarus

2019

Registration for the CRP commenced.
Peer learning site visit to Amgros, the Danish procurement agency.
Advanced GDP training for national pharmaceutical inspectorate.

2018

Technical input to and collaboration with partners on the Second Regional Consultation on Expanding Access to Affordable and Quality Assured Medicines and Diagnostic Technologies in Eastern Europe and Central Asia in Minsk.
Technical guidance and consultation related to monitoring of antimicrobial consumption and follow-up action linked to a national action plan on AMR.

Bosnia and Herzegovina

2019

Self-assessment benchmarking of the NRA.
Direct technical assistance based on the IDP for the NRA.
WHO workshop on implementation of EU guidelines on GDP.

Cyprus

2015

Assistance in analysing the pharmaceutical sector in Cyprus:

Following a request from the Government of Cyprus, WHO/Europe assisted in analysing the country’s pharmaceutical sector in the context of the 2013 memorandum of understanding with creditors from the European Commission, European Central Bank and International Monetary Fund. The memorandum called for, among other changes, the introduction of a national health system finance reform by mid-2016 to allow free choice of provider, social equality and solidarity, financial sustainability and universal coverage of a minimum benefit basket.

Estonia

2016

Assistance to increase the availability of medicines in Estonia:

WHO/Europe supported a study to identify possible barriers to increasing the availability of medicines in Estonia and to suggest options to overcome them. The analysis included a review of relevant national and European Union (EU) legislation regulating the marketing of pharmaceuticals, as well as local practices related to pricing, reimbursement and procurement. WHO/Europe and Estonia also continued their work on the development of the clinical guideline process, which has been a priority in WHO’s collaboration with Estonia for more than 5 years.

Georgia

2019

Peer learning site visit to the Norwegian Medicines Agency.
Direct technical assistance based on the IDP for the NRA.
Registration for the CRP commenced.
Advanced GDP training for national pharmaceutical inspectorate.

2018

Technical guidance in shaping the national regulatory inspection function and competency-based training of five pharmaceutical inspectors.
Review and technical advice in relation to the government’s revision of medicines legislation
Development of a quality management system for the NRA.
Basic training to strengthen national pharmacovigilance monitoring and analysis.

Greece

2018

Technical guidance to the Ministry of Health on the introduction of health technology assessment (HTA) as part of the decision-making process for inclusion of new medicines for reimbursement.
Technical guidance to the Ministry of Health in drafting an action plan for implementation of the legislation on HTA.

2016

Providing technical assistance for the development of health technology assessment (HTA) capacity in Greece, including a study visit to Portugal for Greek policy-makers on 6–8 July 2016 to provide an overview of a well-established HTA agency in a European country of comparable size and with similar economic, social and cultural conditions.

Hungary

2015

Support for improving budget control for outpatient medical devices in Hungary:

The Hungarian Ministry of Health requested WHO/Europe’s assistance with its pricing and reimbursement system for outpatient medical devices. Expenses related to outpatient medical devices increased significantly compared to predictions during the past 5 years in Hungary; though the overall amount spent remained fairly stable during 2011, 2012 and 2013, it is estimated to have increased by about 9% in 2014. The Government of Hungary is looking for solutions to improve budget control in this area.

Kazakhstan

2019

Advanced GMP training completed (three modules).
Direct technical assistance based on the IDP for the NRA.
Registration for the CRP commenced.
Advanced GDP training for national pharmaceutical inspectorate.

2018

Technical guidance and facilitation of several workshops to improve efficiency in regulating Pharmaceuticals.
Benchmarking of the NRA functions; technical guidance and training related to implementation of the NRA institutional development plan.
Technical guidance and consultation related to monitoring of antimicrobial consumption and follow-up action linked to a national action plan on AMR.
Training in GMP inspection.

Kyrgyzstan

2020

Conducted a series of online capacity-building activities for staff of the NRA staff.
Peer-learning training provided by the Swiss regulatory agency, SwissMedic, on performance effectiveness, quality, reliability and regulatory agency accountability.
Supported training on the Common Technical documents and regulation of medicines and medical devices within the Eurasian Economic Union (EEU).
Work undertaken on the implementation of the institutional development plan developed in accordance with the WHO Benchmarking tool for regulatory agencies.
Provided technical assistance on piloting of a new government decree on price controls for medicines included in the health insurance package.
Supported the local procurement of PPE and medical equipment for Covid response.

2019

A new mechanism on pricing regulation for medicines reimbursed at the primary health care level developed and approved.
Revision of clinical guidelines for respiratory tract infection and urinary tract infection ongoing.
Regulations for medicines and medical devices revised; bylaws developed and adopted.
NRA self-benchmarking completed and IDP implemented, with the introduction of quality management system (QMS) and establishment of a GDP/GMP inspectorate.
Analysis of procurement of medicines by hospitals.
Advanced GMP training completed (three modules).
In-country GMP/GDP sensitization workshop, with two days of roundtable discussion with manufacturers, distributors and GMP/GDP inspectorate and two days dedicated to the implementation process of QMS for the GMP/GDP inspectorate.
Advanced GDP training for national pharmaceutical inspectorate.

2018

Technical guidance to the Ministry of Health and related government bodies and institutions to improve access to quality medicines and medical devices, including:

Technical guidance on the drafting of new pharmaceutical bylaws and their adoption
Workshops and policy dialogues on efficiency in regulation of quality and safety, as well as pricing policies for national actors and stakeholders
Technical guidance linked to the introduction of regulation of medical devices
Support to the task force responsible for development of medicines price regulation
ATC DDD course participation at the Norwegian Institute of Public Health (WHO Collaborating Centre for Drug Statistics Methodology), Norway
Introduction of a Unitaid project supporting collaboration between the NRA pharmacovigilance programme and TB programme in monitoring adverse events relating to the use of new TB medicines (such as bedaquiline)
Follow-up on antimicrobial consumption monitoring activities and work on adoption of a national action plan on AMR, anti-infective treatment guidance development and responsible use of medicines, in collaboration with Control of Antimicrobial Resistance Unit, WHO Regional Office for Europe
Training in GMP inspection for NRA staff

2017

Promoting good governance in Kyrgyzstan’s pharmaceutical system:

WHO continued to support Kyrgyzstan on the reform and regulation of the national pharmaceutical sector. A study tour to Estonia for Kyrgyzstan’s Members of Parliament and other government officials took place to help understand better how efficiency in medical product regulation can be achieved and to enrich the collaboration between representatives from different governing institutions.

Training in benchmarking for the National Medicines Regulatory Authority:

WHO trained 25 staff of the National Medicines Regulatory Authority in benchmarking medicines and medical products against WHO norms and standards, to ensure that health products are regulated consistently and to eliminate substandard and falsified medicines. The workshop guided participants on computerized benchmarking tools and established a roadmap for the process in the country.

2016

Support for the regulation of pricing and reimbursement of outpatient medicines in Kyrgyzstan:

WHO/Europe has been working with the Ministry of Health of Kyrgyzstan on the reform and regulation of their national pharmaceutical sector. A country analysis, commissioned by WHO/Europe in 2016, examined the causes of high out-of-pocket payments for prescription medicines in Kyrgyzstan and presented options to address the problem through policy reform. Recommendations to control and reduce high out-of-pocket payments included putting in place price regulation for medicines publicly reimbursed by the Kyrgyz health insurance fund, regulating retail sector margins, updating legislation on the criteria and processes for adding or removing medicines from the list of reimbursed medicines, and improving data collection on reimbursement prices.

Support for reviewing Kyrgyzstan’s National Essential Medicines List:

WHO/Europe provided technical assistance to the Ministry of Health of Kyrgyzstan for updating the National Essential Medicines List (NEML) and worked with members of the national expert group appointed to conduct this review. The expert group reviewed discrepancies between the 2015 WHO Model List of Essential Medicines and Kyrgyzstan’s 2012 NEML, and suggested revisions for consideration by the Minister of Health.

2015

Conducted a series of online capacity-building activities for staff of the NRA staff.
Peer-learning training provided by the Swiss regulatory agency, SwissMedic, on performance effectiveness, quality, reliability and regulatory agency accountability.
Supported training on the Common Technical documents and regulation of medicines and medical devices within the Eurasian Economic Union (EEU).
Work undertaken on the implementation of the institutional development plan developed in accordance with the WHO Benchmarking tool for regulatory agencies.
Provided technical assistance on piloting of a new government decree on price controls for medicines included in the health insurance package.
Supported the local procurement of PPE and medical equipment for Covid response.

Lithuania

2018

Participation, along with several EU Member States, in a Ministry of Health-organized consultation on the regulation of pharmacy practice, linked to pharmaceutical sector reform activities in the country.
Leading up to this consultation, carrying out a review of regulation of pharmacy practice in the Region (a WHO report will be published in 2019) to gather evidence for sharing during the national consultation.

Montenegro

2019

Self-benchmarking assessment of the NRA.
Legal support for drafting a law on operations of retail pharmacy outlets.
WHO workshop on implementation of EU guidelines on GDP.

2018

Technical guidance to the Ministry of Health in developing a law governing the activities of the retail pharmacy sector and participation in a national consultation on the topic * Technical guidance on the selection and use of medicines, including monitoring of antimicrobial consumption and follow-up action linked to a national action plan on AMR.

North Macedonia

2019

Self-assessment benchmarking of the NRA.
Direct technical assistance based on the IDP for the NRA.

2018

Support to strengthen the pharmaceutical system, focusing on regulatory issues as part of the EU accession process.
Revision of legal documents reforming the selection and pricing of medicines.

Poland

2018

Review and technical guidance to the Ministry of Health on development of the national pharmaceutical policy.

Portugal

2018

Co-organization of the Infarmed conference “Facing the Challenges: Equity, Sustainability and Access”.

Republic of Moldova

2020

Organized the rapid assessment of national procurement and supply management system for essential medicine, according to the UNICEF Maturity Model.
Contributed to New National Health 2030 Strategy and to the development of new draft of Law on Pharmacy.
Organized the review of National Essential Medicines List and new methodology for inclusion/exclusion based on WHO EML.
Facilitated a series of capacity building activities for the NRA and the development of Emergency Use Approval for Covid-19 vaccines.
Prepared the national survey on antimicrobials supplied in community pharmacies in Republic of Moldova following the COVID-19 pandemic to be implemented in 2021.
Designed the national availability, price and affordability survey of essential medicines in the community pharmacies to be implemented in 2021.

2019

Medicines availability and pricing survey conducted using the WHO MedMon tool.
Advanced GMP training completed.
Advanced GDP training for national pharmaceutical inspectorate.

2018

Technical guidance to the Ministry of Health and related government bodies and institutions to improve access to quality medicines and medical devices, including:

Consultations on access to medicines with the government’s health committee and stakeholders
Technical guidance on the selection and use of medicines, including monitoring of antimicrobial consumption and follow-up action linked to a national action plan on AMR
Initiation of a medicines price survey
Initiation of high-level policy dialogue on the revised draft law on medicines
Gap analysis of the pharmacovigilance system and creation of a follow-up plan
Introductory workshop on systematic reviews and use of HTA methods
Training in GMP inspection

2016

Support for strengthening the legal framework of the pharmaceutical sector in the Republic of Moldova:

At the request of the Ministry of Health of the Republic of Moldova, WHO/Europe is supporting the country’s move to align its pharmaceutical legislation and practice with respective EU acquis communautaire, or obligations of membership. The Government of the Republic of Moldova has expressed a strong political desire to achieve EU membership, which necessitates this alignment process. WHO/Europe organized a series of 3 seminars on key aspects of pharmaceutical regulation in the EU, aimed at increasing the capacity of staff of the Ministry of Health, the Agency for Medicines and Medical Devices, the National Health Insurance Company and the State Medical and Pharmaceutical University to support the necessary legislative changes.

Help with increasing access to hepatitis C medicines in the Republic of Moldova:

WHO/Europe also supported the Republic of Moldova in increasing access to new hepatitis C medicines. In collaboration with WHO headquarters in Geneva, Switzerland, the health technologies and pharmaceuticals programme conducted a rapid assessment of the patent status for hepatitis C medicines in the country, and concluded that the patent rules allow for the import and use of generic versions of these medicines. The programme also facilitated contact with a manufacturer of generic medicines for hepatitis C to foster their import to the Republic of Moldova.

2015

Organized the rapid assessment of national procurement and supply management system for essential medicine, according to the UNICEF Maturity Model.
Contributed to New National Health 2030 Strategy and to the development of new draft of Law on Pharmacy.
Organized the review of National Essential Medicines List and new methodology for inclusion/exclusion based on WHO EML.
Facilitated a series of capacity building activities for the NRA and the development of Emergency Use Approval for Covid-19 vaccines.
Prepared the national survey on antimicrobials supplied in community pharmacies in Republic of Moldova following the COVID-19 pandemic to be implemented in 2021.
Designed the national availability, price and affordability survey of essential medicines in the community pharmacies to be implemented in 2021.

Romania

2019

Support for access to TB medicines.

Russian Federation

2019

WHO NRA follow-up visit.

2016

Supporting national regulatory agency assessment in the Russian Federation.

Serbia and Kosovo

2019

Benchmarking of the NRA finalized.
In area technical assistance and trainingKosovo¹:
Revisions to the national essential medicines list completed.
WHO Access, Watch and Reserve (AWaRe) categorization of antibiotics adopted.
Self-assessment benchmarking of the NRA.
Direct technical assistance based on the IDP for the NRA.
WHO workshop on implementation of EU guidelines on GDP.

₁ All references to “Kosovo” should be understood as “Kosovo (in accordance with Security Council resolution 1244 (1999))”.

2018

Technical support, including workshops, to improve efficiency in regulation of pharmaceuticals.
Benchmarking of the NRA functions with a focus on vaccines, technical guidance and training related to implementation of the NRA institutional development plan.
Technical guidance and consultation on the monitoring of antimicrobial consumption and follow-up action linked to a national action plan on AMR.
In area technical assistance and trainingKosovo1:
Technical guidance to the public health authorities to improve access to essential medicines linked to the planned introduction of a Kosovo health insurance fund, including guidance on revision of the Kosovo essential medicines list and processes for evidence-based selection of medicines for the list and the health insurance fund.
Technical revision of the administrative instruction for creating a pharmaceutical pricing committee.
Technical guidance and consultation on monitoring antimicrobial consumption and follow-up action linked to a Kosovo action plan on AMR.

·₁ All references to “Kosovo” should be understood as “Kosovo (in accordance with Security Council resolution 1244 (1999))”.

Tajikistan

2019

Implementation of regulations on export of medicines.
Revising and updating pharmaceutical legislation.
Advanced GDP training for national pharmaceutical inspectorate.

2018

Technical guidance and consultation on monitoring antimicrobial consumption and follow-up action linked to a national action plan on AMR, including training of a new national focal point.
Training in GMP inspection.

2016

Providing technical assistance to national medicine regulatory authorities on the implementation of the WHO certification scheme on the quality of pharmaceutical products in Tajikistan.

Turkey

2019

National action plan for AMR developed.
NRA self-assessment benchmarking completed, and IDP prepared.
Technical support for transition process to the WHO Global Benchmarking Tool Revision VI.

2018

Technical workshop for the NRA on self-assessment of the national regulatory functions for medicines.

Turkmenistan

2019

National action plan for AMR developed.
Advanced GDP training for national pharmaceutical inspectorate.

2018

Discussions with the Ministry of Health on registration of medicine products to advance the agenda on access to medicine.

2016

Providing technical assistance to national medicine regulatory authorities on the implementation of the WHO certification scheme on the quality of pharmaceutical products in Turkmenistan.

Ukraine

2020

Conducted a series of workshops for the Central Procurement Agency (CPA), focusing on WHO standards for procurement agencies and best procurement practices.
Facilitated PSM assessment of the CPA and development of an institutional development plan to ensure procurement of safe, quality-assured medicinal products.
Contributed to technical discussions on HTA and medicine selection procedures.
Facilitated analysis and preparation of a draft report of the results of an availability, price and affordability survey of essential medicines in the outpatient setting.
To enhance pandemic response supported CPA, MOH, and HTA department of State Expert Center of MOH with advice on procurement, clinical trials protocols and regulatory matters.
Support to local manufacturers for improvements of quality management systems.

2019

Report evaluating the Affordable Medicines Programme published.
Medicines availability and pricing survey conducted using the WHO MedMon tool.
Assessment of processes for development and revision of the national essential medicines list.
Advanced GDP training for national pharmaceutical inspectorate.

2018

Review and assessment of the outpatient reimbursement scheme – the Affordable Medicines Programme – after its first year and prior to expansion.
Participation in a Ministry of Health policy dialogue with stakeholders to present and discuss results and recommendations from the assessment.
Support in revising patent laws and regulation of intellectual property rights of medicines.
Technical guidance and consultation on monitoring antimicrobial consumption and follow-up action linked to a national action plan on AMR, including training of a new national focal point.
Introduction of a Unitaid project supporting collaboration between the NRA pharmacovigilance programme and TB programme in monitoring adverse events relating to the use of new TB medicines (such as bedaquiline).

2016

Support for the development of Ukraine’s national medicines policy:

In 2015 and 2016, WHO/Europe and partners consulted with the Ukrainian Ministry of Health on revising the processes and systems for the selection, financing, procurement and use of medicines in the country. In January 2016, the Ministry of Health circulated the terms of reference for 9 working groups that would contribute to developing the national medicines policy. Each group focuses on an aspect of the pharmaceutical sector, such as regulation, reimbursement, financing or responsible use. Through the health technologies and pharmaceuticals programme, WHO/Europe supported and advised the working groups during their discussions. The Ukrainian Government is continuing to develop a policy and strategy based on input from national stakeholders, and is expected to complete work in this area in 2017.

In 2016, other major activities included:

supporting the development of an outpatient medical devices reimbursement scheme in Albania;
providing technical assistance for the development of health technology assessment (HTA) capacity in Greece, including a study visit to Portugal for Greek policy-makers on 6–8 July 2016 to provide an overview of a well-established HTA agency in a European country of comparable size and with similar economic, social and cultural conditions;
supporting national regulatory agency assessment in the Russian Federation; and
providing technical assistance to national medicine regulatory authorities on the implementation of the WHO certification scheme on the quality of pharmaceutical products in Tajikistan and Turkmenistan.

2015

Conducted a series of workshops for the Central Procurement Agency (CPA), focusing on WHO standards for procurement agencies and best procurement practices.
Facilitated PSM assessment of the CPA and development of an institutional development plan to ensure procurement of safe, quality-assured medicinal products.
Contributed to technical discussions on HTA and medicine selection procedures.
Facilitated analysis and preparation of a draft report of the results of an availability, price and affordability survey of essential medicines in the outpatient setting.
To enhance pandemic response supported CPA, MOH, and HTA department of State Expert Center of MOH with advice on procurement, clinical trials protocols and regulatory matters.
Support to local manufacturers for improvements of quality management systems.

Uzbekistan

2019

Revising clinical guidelines for paediatric infections (pneumonia, otitis media).
Country consultation on moving to prescription-only status for antibiotics.
Advanced GMP training completed (three modules).
GMP/GDP sensitization workshop, advanced GDP training for national pharmaceutical inspectorate.

2018

Technical guidance and support to the Ministry of Health and related government bodies and institutions in relation to a major reform of the pharmaceutical regulation initiated by the president.
Training in GMP inspection.
Technical guidance and consultation on monitoring antimicrobial consumption and follow-up action linked to a national action plan on AMR.