1. Procurement and Supply Management in Moldova Laurentiu IONESII

2. Introduction Main objective of the presentation is to show that Moldova has a procurement system in line with international standards and guarantee access to safe, effective and good quality medicines and commodities. Procurement of medicines needs a more wide approach than procurement of other commodities because:  Medicines save lives  Medicines are costly  Medicines are different from other consumer products That is why we have to put the procurement in the PSM Cycle that includes: Selection – Procurement- Distribution – Use. All this rests on the Policy and Legal Framework and Institutional Capacity.

3. Policy and Legal Framework Main elements are: National Health Policy and the implementation plan 2008-2017 National Medicines Policy. Among other topics it includes: – Affordability; – Medicines financing; – Medicines regulation; – Rational use; – Research; – Selection of essential medicines. Medicines act is formed of two laws 1) Law on pharmaceutical activity 2) Law concerning medicines. Both these laws provide for : Establishment of a National Medicines Regulatory Authority; Inspection and market surveillance; Quality control laboratory; Pharmacovigilance; Medicines pricing. Public Procurement Act is – The Law on Public Procurement.

4. Institutional Capacity Medicines Agency. Is subordinated to the Ministry of Health.The Medicines Agency (M.A.) is the main institution with responsibility for pharmaceutical policy implementation. It was recently restructured. Its functions are detailed below and correspond more or less to the standard spectrum of M.A. responsibilities. The M.A. is adequately staffed with technical people, including pharmacists, doctors and chemists. The main functions of the MA are:  Development of pharmaceutical management-related policies and regulations;  Regulate the public sector procurement and distribution system of essential medicines;  Elaborate or contribute to the elaboration of the Essential Medicines List;  Regulate or participate in the regulation of medicines pricing in the public and private sector;  Elaborate or contribute to the elaboration of Standard Treatment Guidelines;  Supervise pharmaceutical services of the public and private sector.

5. Institutional capacity Agency for public procurement. Is subordinated to the Ministry of Finance. APP implements the state policy in the field of public procurements and ensures regulation, supervision, control and inter-ministerial coordination of public procurements. It has the following functions: – Implementation of the laws in public procurement – Ensuring of transparency and ethics of PP – Ensuring competition and fighting against unfair competition – Monitoring and Evaluation of the performance and adherence of the Contract Authorities to the procedures To be able to implement it’s functions the APP has the following attributes: – Develops the standard documentation; provides to the local authorities methodological support; issues the Public Procurement Bulletin; examines bidding documents and evaluation reports; registers contracts concluded by the CA; examines and solves complaints and litigations; reports to the Government.

6. Procurement planning Procurements from public resources is done in accordance with the Law on Public Procurements. Principal recipients UCIMP and PAS do the procurements in accordance with their own Procurement Manuals. Because prior to the implementation of the GF grants these recipients implemented World Bank projects the Procurement Manuals are based on the World Bank procurement Guidelines for Goods and for Consulting Services. Procurement planning. The law provides for the CA to develop and publish in the Public Procurement Bulletin the procurement plans for one year. The procurement of medicines for the National Programs is done by the Medicine Agency. In accordance with the regulation on the Procurement of Medicines and other medical products for necessities of medical services by the 1 st of July each year the managers of the health institutions determine the necessities of medicines for the next year based on the list presented by the MOH. By the 1 of August each year the principal specialist of the MoH will determine the necessity of medicines to be procured centralized for the national programs.

7. Product selection. Development of specifications Product selection and specifications are developed by a multidisciplinary committee from various institutions. In accordance with the law the following rules apply to the development of specifications: – The characteristics of the goods to be procured will represent an exact and complete description so that every criterion required will be performed; – The characteristics of the goods must correspond to the requirement of the CA regarding the quality, efficiency, testing, dimensions, packing, manufacturing processes etc; – The technical requirements will not make reference to trademarks, to a certain economic agent, will not indicate an origin, a certain manufacturer; – The specifications will be based on National and international standards. The selection of medicines is done by the working group of the clinical service in accordance with the National Treatment Protocols and National Medical Essential List The National Medical Essential List is a major component of the National Medicines Policy and the selection of items is based on available resources, disease patterns etc. Modova has STG for AIDS treatment that is updated each year and STG for the treatment of OI.

8. Procurement methods

9. Procurement methods PR Goods International Competitive Bidding will be used for contracts equivalent or above 200 000USD. Shopping procedure will be used for readily available off-shelf goods of standard specifications. This procedure will require quotation from at least 3 suppliers. Direct contracting. Will be used for upgrade or proprietary items. Procurement form International non-profit agencies. Whenever feasible and particularly in cases of medicines. GDF, GTZ, IDA, WHO supply division, UNICEF. Most of ARV’s were procured from international agencies. Consulting Services: Quality and Cost Based Selection. Selection based on Consultancy qualification, up to 100 000 USD. Selection of Individual Consultants. At least three CV.s are required.

10. Procurement process A Government Decision of 29 May 2008 appointed a Committee on Public Procurement to supervise the process of public procurement. APP reports to this Committee on public procurement issues. The Committee have to report to Government every 6 months on public procurement. The Committee are required to approve Contract Awards for Goods > MDL 5,000,000 and for Works > MDL 20,000,000 The APP acts as independent commission to review procurement protests against Contracting Authorities. The Law specifies how and where contract awards are to be published and tender opportunities are published on the APP website tender.gov.md Law states that foreign suppliers’ rights to participate in the public procurement are similar to the rights of Moldovan suppliers. There is no a requirement for association witj local firms. There is a domestic preference of no more then 15%. Article 44 requires the Contracting Authority to evaluate bids only against criteria described in the tender documentation. Article 45 defines the decision criteria described as “the most advantageous in economic terms.

11. Distribution Medical institutions act as independent contracting authorities procure and use decentralized the medicines. For national programs selection, forecasting, procurement and monitoring is centralized but there is no a central store. The medicines are delivered from the stores of economic agents to the destination. Except for TB program that has a centralized store and ARV’s ( the store is being refurbished now). For the TB there is an electronic system of logistics of medicines and supplies. For HIV/AIDS there is a paper system and in short time a software will be developed. The distribution system is Push and Pull. The inventory management is based on principle FEFO.

12. USE Ensuring rational use of medicines. The surveillance of the drug use, side effects, is one of the activities of the Medicines Agency the department “Clinical evaluation and pharmacological vigilance”. In the activity of the medical institutions the system of pharmaco therapeutical formulary will be applied. The side effect report form is the instrument for reporting side effects. This form is distributed to the public health institutions. All reports on adverse effects are analyzed at the centre. These cases are reported to the MA, which has the role of evaluating the quality of medicines. If the information presented has good evidence, the information is sent to the WHO regional side effects monitoring unit. Adherence. Implementing DOT treatment. Involvement of civil society. With the support of USAID most of the treatment guidelines were updated.