Council of Ministers

Center for Prevention and Countering
Corruption and Organized Crime

Concept for a central body

CONCEPT FOR A CENTRAL BODY FOR THE AWARD OF 

PUBLIC PROCUREMENT CONTRACTS IN THE HEALTHCARE SECTOR

1. INTRODUCTION
The present concept has been created on the basis of the analyses that have been carried out, the summary of findings of weak spots and the measures and complex decisions proposed by the Center for prevention and countering corruption and organized crime (CPCCOC) for prevention of the opportunity to be developed corrupt practices presented in the reports "Solution model in the area of Public Procurement" and "Analysis of the pharmaceutical policy in the Republic of Bulgaria".
In summarizing the conclusions and measures of the two projects, CPCCOC has performed additional analyses, too, such as analysis of the present Bulgarian legislation in the Healthcare sector, financial-economic analysis, case studies of media publications and of audit reports of the Public Financial Inspection Agency (PFIA) in the sector; it has made a survey, an overview and an analysis of Directive 2014/24/EU on public contracts of the European Parliament (EP) and the Council of 26.02.2014 and of the repeal of Directive 2004/18, the transposing of which into Bulgarian legislation was running, comparative analysis of best practices in the framework of the European Union (UK, Denmark, Greece, Cyprus), overview of the awarding of contracts in Norway, Slovenia, Sweden, Canada, Romania and more; it has performed check-up on active or passive gold-plating in order to simplify the legal regulations of PPA, RIPPA and has made proposals for amendments in the relevant laws in the Healthcare sector in conformity with the proposals that were made on a Central Body for the Award of Public Procurement Contracts in the sector.
The main and most important conclusion is that the measures proposed by us on the prevention of corruption through the realization of a Central Body for the Award of Public Procurement Contracts in the Healthcare sector with an electronic procurement platform are in full compliance and in harmony with the requirements of the European legislation: Directive 2014/24/EU and the main principles and norms of PPA and RIPPA. The measures comply with the goals and measures of the already adopted Government Program for Sustainable Development of the Republic of Bulgaria (2014-2018), item 6 (legislative changes in the sphere of public procurements), the National Strategy for development of the sector of public procurements 2014-2020, adopted by DCM № 498 of 11.07.2014 and the Concept for better healthcare.

2. SUMMARY
2.1. DESCRIPTION OF THE PROJECT
Creation and development of a body for centralized award of public procurement contracts in the Healthcare sector which will hold the procedures for public procurement tendering in order to conclude framework procurementcontracts on behalf of and on account of the budget of contracting authorities in the sector and will identify contractors through a specially designed integrated information system: online electronic commerce platform (electronic tendering and electronic catalogue).
The minister of healthcare should be the Central body for the award of public procurement contracts in the Healthcare sector (CBAPPCHS). In the implementation of his awarding powers, he may be assisted by a Central Contracts and Administering Unit Directorate at the Ministry of Healthcare.
The unit should have specially trained personnel who will carry out public procurement tendering pursuant to the Public Procurement Act (PPA) for the needs of the target groups indicated below and by observing bylaws on its implementation as well as the applicable legislation of the European Union in this area and will administer the electronic platform.
The electronic platform should integrate, in a common information system,the already existing electronic registers such as the register of in-patient healthcare establishments which have been permitted to perform medical activities and are on the list of the Ministry of Healthcare (MH) pursuant to Art.49, Par.1, item 1 of the Healthcare Establishments Act (HEA), the register of wholesalers who have received permission for wholesale trade in medicinal products kept at the Bulgarian Drug Agency pursuant to Art. 19, Par.1, Item 4 of the Medicinal Products in Human Medicine Act (MPHMA) and nomenclature lists (Appendix 1, 2, 3 and 4) of 3463 medicinal products on the Positive Drug List published on the website of MH.

2.2. TARGET GROUPS:
Contracting authorities: Part of the contracting authorities pursuant to Art.7, Item 3 and Item 4 of PPA in the Healthcare sector and namely the in-patient healthcare establishments pursuant to Art.9 of MIA in their capacity as public legal entities as defined in PPA and the associations of legal entities pursuant to Item 3 of PPA.
A register of healthcare establishments which have received permission for medical activities is kept at MH, pursuant to Art.49, Par.1 of HEA.
The healthcare establishments in the Healthcare sector are 12 924, and from them the in-patient healthcare establishments are 318.
Potential contractors: all the sellers who have received permission for wholesale trade in medicinal products on the territory of the country.
Pursuant to Art.19, Par.1, Item 4 of MPHMA, a register of the sellers who have been permitted to do wholesale trade with medicinal products is kept at the Bulgarian Drug Agency.
According to the register, the number of the wholesalers with medicinal products is 287.

2.3. PARTICIPATING RESPONSIBLE DEPARTMENTS
The Minister of Healthcare as the Central body for the award of public procurements in the Healthcare sector (CBAPPHS);
The Ministry of Healthcare.
2.4. OBJECT OF THE PUBLIC PROCUREMENTS
Procurement of medicinal products from the Positive Drug List (PDL) for the needs of the in-patient healthcare institutions
Pursuant to Art.262 of MPHMA, the Positive Drug List (PDL) includes medicinal products classified in pharmacological groups, according to the codesof the Anatomical Therapeutic Chemical Classification, with the respective international non-proprietary names which are divided in 4 nomenclature lists (Appendix 1, 2, 3 and 4) and include the following 4 groups of medicinal products, listed in a public electronic register:
• Medicinal products designed to cure diseases which are paid pursuant to the Healthcare Insurance Act: 1203 in number;
• Medicinal products paid from the budget of the healthcare establishments pursuant to Art.5 of the Healthcare Establishments Act and from the budget of the healthcare establishments with state and/or municipal participation pursuant to Art.9 and 10 of the Healthcare Establishments Act: 1809 in number;
• Medicinal products designed to cure AIDS, infectious diseases, diseases not covered by the Healthcare Insurance Act paid pursuant to Art.82, Par.1, Item 8 of the Healthcare Act as well as vaccines for compulsory immunizations and re-immunizations, vaccines at special indications and in exceptional circumstances, specific serums, immunoglobulins: 369 in number;
• Medicinal products pursuant to Art.261a, Par.4 with indicated marginal prices by elements: 82 in number.
Total number of the medicinal products in PDL: 3463.
It has been found from the analysis of cases indicated in PFIA reports that the in-patient healthcare establishments acting as contracting authorities most often award public procurement contracts with object:
1. Delivery of medicinal products from PDL, delivery by virtue of sale/purchase, renting or leasing of medicinal products, incl. medical consumables, instruments, equipment, consumables for different kinds of laboratories (for example, microbiological), specific devices such as a system for cranial and spinal navigation; delivery of hospital food and food vouchers; delivery of ambulances;
2. Providing services - different kinds, pursuant to Appendix 2 and 3 to Art.5 of PPA;
3. Construction, incl. installation and repair works, pursuant to Appendix №1 of Art.3 of PPA.
It has been found from the performed statistical analysis of PFIA reports that hospitals have made the following expenditures arranged by the size of their relative share:
1. For the delivery of medicinal products, the total expenses of 10 of the biggest healthcare establishments, in the previous year, was 14 140 812.68 BGN without VAT. (It refers to Multi-profile Hospital for Active Treatment (MHAT) "Tokuda"- Sofia, MHAT "St. Mina"EOOD (Sole owner Limited liability company) - Plovdiv, MHAT - Pazardzhik JSC, MHAT "Deva Maria" EOOD - Burgas, Specialized Hospital for Active Treatment in Cardiology (SHATC) "Cardio Centre Pontica" Ltd, MHAT "Dr. Stefan Cherkezov" AD (JSC) - Veliko Tarnovo, MHAT "Dr. Dobri Berov" EOOD, MHAT "St. Anna" AD - Varna, Specialized Hospital for Active Treatment of Cancer "Dr. Marko Markov" EOOD - Varna, SHATC EAD (sole owner JSC) and others.)
2. For the delivery of different kinds of medicinal products, incl. medical consumables, medical instruments and medical devices, the total expenses of the above-mentioned hospitals is 12 659 710.63 without VAT.
In view of the above, the present conception envisages:
1. As a pilot project, CBAPPCHS should at first start and carry out tendering procedures for the award of public procurement contracts for delivery of medicinal products only on behalf of and on the account of the in-patient healthcare establishments listed in Art.9 of the Healthcare Establishments Act.
2. In the second stage, to extend the number of entities which use the services of CBAPPCHS by including other healthcare establishments in the system, too, which can be contracting authorities pursuant to Art.8 and 10 of PPA.
3. In the third stage, to extend the number of goods in the electronic catalogue; having created a national electronic register of the medicinal products covered by public funds, it will be integrated in the electronic platform, and the goods will be included in the online platform.
4. At discretion and if necessary, CBAPPCHS may be assigned to hold tendering procedures for the award of public procurement contracts on behalf of and on the account of the contracting authorities with object providing services (standard services).
FUNCTIONS of the Central body for the award of public procurement contracts in the Healthcare sector:
1. Holding of procedures for the concluding of framework agreements after identifying the needs of the contracting authorities (Target groups in item 2.2) in the Healthcare sector.
2. Defining of the selection criteria and drawing up of documentation for participation in the framework agreements, incl. of contract forms for the framework agreements.
3. Announcing, publication of the necessary documents in the "buyer's profile" and sending of information to PPA as well as feedback to EU.
4. If necessary, holding of procedures for the award of public procurements on behalf of and on the account of a particular contracting authority.
5. Concluding of framework agreements with wholesalers who have received permission for wholesale trade and are listed in the public register and with all in-patient healthcare establishments.
6. Control over the implementation of the framework agreements with regard to observing the conditions of those contracts: prices, quantities, deadlines for implementation and more.
7. Collection of the necessary data in a database for monitoring, statistical analyses and forecasts and/or market research with relation to the awarded contracts of medicinal products that are an object of a framework agreement.
8. If necessary, conducting of mini procedures under the concluded framework agreements through the use of the electronic platform for buying of medicines.

3. MOTIVES
3.1. ECONOMIC MOTIVES
3.1.1. It has been found from the performed review and analysis of the documents published in the Public Procurements Register (PPR) as well as from the in-depth analysis of the drug policy in RB that the contracting authorities in the Healthcare sector and the in-patient healthcare establishments in particular are one of the weakest links allowing for the biggest number of violations and abuses by the award of public procurement contracts pursuant to PPA. Just to give some information, only in 2012 statements were drawn up of violations for huge sums against: "St. Mina" - Plovdiv for 4.3 mil. BGN, Specialized hospital for active treatment of hematological diseases for 395 000 BGN, ‘St. Sofia" hospital for over 875 000 BGN, "St. Ivan Rilski 2003" - Dupnitsa for over 866 000 BGN. In 2013, the biggest number of violations in the hospitals checked were found in the Complex Oncological Centre - Plovdiv (112 000), in MHAT - Pazardzhik (89 000); MHAT "St. Nikolay Chudotvorets"- Lom is the third. The hospitals in Karnobat, Svoge, the one for pneumo-phtysiatric diseases in Troyan, the cardiological in Veliko Tarnovo, the oncologigal and "St. Anna" in Varna and others.
3.1.2. It has been found that the public procurements for the delivery of medicinal products and medical devices for the healthcare establishments are one of the weakest links in the healthcare system through which a huge number of violations and abuses are made. The main violations consist, most often, in an intentional division of contracts in view to prevent appeals and, at the same time, providing the hospitals with the products, violations by the examination of the tenders, lack of transparency and publicity (withholding of information according to the requirements of PPA and the Rules of Implementation of PPA), incorrectly defined methodology. The most frequent violation turns out to be non-holding of procedures. This is so since private hospitals do not accept the obligation, assigned to them by PPA, to hold public tenders for the supply of medicines which are covered by the Healthcare Insurance Fund. The cases of non-held procedures or of violations/omissions found with them were 174 for over 115 mil BGN. Damages were identified for over 162 000 BGN, the data of PFIA indicate. According to the data of PFIA, the value of the unjustified held public procurement tenders in the above-mentioned hospitals was c. 59 mil BGN.
3.1.3. The historical review of the legislation has shown that up to 2011 the MH performed centralized supply of medicines for the hospitals which allowed the negotiation of lower prices because of the large quantities. After the decentralization of tenders, the hospitals have awarded public procurement contracts for the supply of medicinal products themselves. As can be seen from the data disclosed in different publications, this has lead to buying of medicines at higher prices not only because of the smaller quantities but also because of the fact that this way allows the very producers of medicines to impose higher prices. The risk increases if there is a closing of the cycle of production, distribution and retail trade since it contains prerequisites for cartel agreements and dumping prices which would prevent the participation of all registered wholesalers on the market.

3.2. LEGAL
3.2.1. The current Public Procurement Act (PPA), Art.8a, Par.1, provides the opportunity for the contracting authorities to acquire supplies or services from or through a central body of public procurements which may have the rights of a contracting authority regarding the holding of procedures and the concluding and implementation of contracts or framework agreements for the needs of other contracting authorities. On the basis of Art.8a, Par.4 of PPA, the Council of Ministers may set up a central body for public procurement orders for the needs of the executive government bodies, upon a proposal of the Minister of Economics, while the rules of organization of its work and the fulfillment of its functions may be set up by the act of its establishment. In view of the above, it is obvious that notwithstanding the existence of CBPPO established by DCM №112/2010, there is no legal obstacle for the creation of Central Body for Public Procurement Orders in the Health Sector. This conclusion is drawn in view of the specifics of the activities as well as the control exercised by MH on the work of the hospitals, the work of the wholesalers in medicinal products and the medicinal products entered in PDL. Article 16c of PPA allows the use of electronic tenders for identifying contractors on condition that the technical specifications of the public procurements are precisely defined for an open or restricted procedure, a procedure of negotiation with notice in the cases under Art.84, item 1 as well as in the cases of framework agreements with more than one contractor when not all the conditions have been defined (Art. 93b, Par.3) and in the cases of a dynamic purchasing system. The conditions are met for the application of Art.16c of PPA regarding the electronic catalogue since the object of the orders, in this case, is the supply of goods which are standardized or for which it is possible to issue or approve internal standards.
3.2.2. Public electronic registers are created and exist of all the healthcare establishments, incl. for the in-patient healthcare establishments under the special law: HEA. They represent a large number of contracting authorities with relatively uniform needs related to the fulfillment of their functions. There is also complete publicity of the wholesalers with pharmaceutical trading license whose list is kept up-to-date in another public electronic register pursuant to MPHMA. There are nomenclature lists of medicinal products with prices given for each product that are updated every two weeks by the National Council on Prices and Reimbursement of Medicinal Products (NCPRMP) and the same are entered in a public register on the websites of MH and NCPRMP.
3.2.3. The establishment of a CBAPPCHS and the use of an electronic platform is also in line with the goals and measures envisaged by the National Strategy for the development of the public procurement sector for the period 2014-2020 adopted by a DCM №498/11.07.2014, the Concept for better healthcare and the Government Program for Sustainable Development of the Republic of Bulgaria 2014-2018, item 6 (legislative changes in the sphere of public procurements).
3.2.4. The proposed measures for the establishment of CBAPPCHS with an electronic platform for online commerce are in full compliance with the rules and policies of Directive 2014/24/EU of EP and of the Council of 26.02.2014. The Directive allows concentration of the purchases by central purchasing bodies in order to achieve economies, lower prices and transaction costs and better and more professional management. In relation to the aforementioned, the Directive requires provisions to be envisaged at EU level to define the central purchasing bodies. According to recital 70, contracting authorities should be allowed to award a public service contract for the provision of centralised purchasing activities to a central purchasing body without applying the procedures provided for in this Directive. It should also be permitted for such public service contracts to include the provision of ancillary purchasing activities. Recitals 72 indicates that electronic means of communication are particularly well suited to support centralised purchasing practices and tools because of the possibility they offer to re-use and automatically process data and to minimise information and transaction costs. The use of such electronic means of communication should therefore, as a first step, be rendered compulsory for central purchasing bodies, while also facilitating converging practices across the Union. The opportunity is envisaged for the contracting authorities to be able to require electronic catalogues by all the existing procedures which involve the use of electronic means of communication since they contribute to increasing competition and the rationalization of purchases. Moreover, according to recital 50, the Directive indicates that a procurement procedure is not useful where supplies are purchased directly on a commodity market, including trading platforms for commodities such as agricultural products, raw materials and energy exchanges, where the regulated and supervised multilateral trading structure naturally guarantees market prices which is practically the case with the trade carried out in medicines. Connecting the electronic platform with the registers of hospitals and wholesalers and signing of a framework agreement between them allows the participation of all of them in conformity with the requirement of the directive to provide equal access of all economic operators and SME and to guarantee the observance of the general principles of non-discrimination and equality.
3.2.5. It has been found from the comparative analysis of the world experience that was carried out that practices are different. The supply with medicines is strictly centralized in Greece, Denmark, UK, Cyprus, Malta, and a relevant department is responsible in each of them. In other countries, such as Austria and Finland, there are, usually, several healthcare establishments which carry out joint assigning of medicines. The hospitals in Hungary, Slovenia and Finland are autonomous in awarding contracts in medicines. Tracking of statistics for the achieved economies in the individual countries has shown that economies are in the largest scale in those countries where there is centralized award of medicinal products through electronic commodity market: Greece, Denmark, UK which leads to the indisputable conclusion for the necessity of the existence of CBAPPCHS by the use of electronic means. The biggest successes have been achieved in Denmark and the United Kingdom. In Denmark, all the medicines for the in-patient healthcare establishments are purchased in a centralized manner by the public organization AMGROS established by regional authorities in 2007 in order to achieve economies. The statistics shows that about 1,6 billion Danish kroner are saved a year through the centralized assignment. On the basis of framework agreements, AMGROS organizes sealed-bid auctions (electronic commodity market) where it is the company with the lowest price which wins. When hospitals submit tenders for a given medicinal product, the message is sent to all the traders, and they announce their prices publicly. This is possible since they, too, have electronic registers of traders, of the prices of medicinal products and the in-patient healthcare establishments. In this way, the duration of a procedure is drastically reduced in view of the alleviations that are envisaged by the use of the electronic means. Because of the participation of all the traders in the tenders, the prices of the medicinal products have dropped. The pharmaceutical agency saves about 250 mil EUR of the local healthcare budget. In Greece, up to 2011, public procurement orders for medicinal products and pharmaceuticals of public hospitals were fulfilled mainly through defining reference prices and tenders based in hospitals. Invoices for the products were usually issued on the basis of patients, in the time of their use, which led to increased administration costs. Problems and weak spots were analogous to those in Bulgaria. That is why, a state Health Procurement Committee (EPY) was reestablished in 2011 through which the electronic supply of medicines through an electronic platform is carried out on the basis of combined requests of the hospitals. The mission of EPY is to reduce procurement costs, to improve payment time (currently more than three years on the average), to make uniform medical requests, to transfer redundant products from one hospital to another as well as to improve the management of expired products. EPY is responsible for the inclusion of the provisions of European directives. They conclude (but are not limited to): framework agreements, dynamic purchasing systems. In the framework of the new centralized purchasing system, an order (request) is entered by the lowest management level of the hospital (for example a medical department) and is then transferred to the respective regional healthcare system which will submit the requests of all the hospitals under its jurisdiction to EPY. At first, EPY had 40 employees while they are now about 26 and they administer the electronic platform for the supply of 18 222 medicinal products and medicinal devices.


4. GOALS AND MEASURES
GOAL № 1: Increasing the efficiency, quality and cost effectiveness of the award of public procurement contracts in the healthcare sector.
MEASURE № 1: Creation and development of CBAPPCHS.
The creation of CBAPPCHS for the centralized award of public procurement contracts through framework agreements for the supply of medicinal products for the in-patient healthcare establishments will lead to economies of time, administrative and financial resources for the hospitals as well as to reduction of the prices of the medicinal products because of the large volumes and quantities. The combination of CBAPPCHS with the electronic platform will provide the opportunity for a quicker and more qualitative response to the needs of the contracting authorities, sustainable agreements and easing the system responsible for procedure appeals. The exercised preliminary control pursuant to Art.19, Par.2, item 22 of PPA will provide the efficiency and quality of the orders.
MEASURE № 2: Making of sustainable and simplified legislation in full compliance with the new European directives.
The minimal changes in PPA proposed by us eliminate restrictive norms by which PPA regulates framework agreements in comparison to those allowed by the new European directives. Their adoption will contribute to a sustainable and simplified legislation which would be in full compliance with European norms.
MEASURE № 3: Building of sustainable administrative capacity and professionalism enhancing of the experts of CBAPPCHS.
In order for the measure to be independent and sustainable, it should be guaranteed that CBAPPCHS will perform its tasks without conflict of interest relationships. The appointment of employees, incl. of the unit director, should be performed according to their professional qualification, experience and personal qualities in the framework of a relevant job competition and in conformity with the applicable legislation. The competence of the employees of CBAPPCHS should be guaranteed through regular and goal-oriented and additional qualification according to international standards. Precise and suitable for the task materials and equipment should be provided as well as financial and personal resources necessary to perform the task.
MEASURE № 4: Market reviews for all the medicines and medicinal products should be prepared.
An important effect from the realization of this process would be the easier gathering of statistical information on the development trends of the market in medicines and the award of public procurement contracts which would support the overall functioning of the sector and the taking of correct management decisions.
GOAL № 2: Raising publicity and transparency by the award of public procurement contracts in the healthcare sector. Guaranteeing of opportunity for transnational award of contracts.
Conducting of the procedures in a public and transparent way is one of the main prerequisites for the elimination of the risk of some potential corrupt practices.
MEASURE № 1: The expanded use of electronic means and tools and the integration of the platform with the existing electronic registers created under the special healthcare acts will contribute to a large degree to the efficient countering and prevention of corruption in the area. The introduction of centralized supply of the medicinal products for the in-patient healthcare establishments through the online electronic platform (electronic tendering and electronic catalogue) will lead to cost reduction for the hospitals and the other healthcare establishments in the sector and realization of substantial economies of finances, time and administrative capacity while at the same time it will introduce common standards in the process of awarding of contracts. The dropping out of the conventional hard copy methods for contract tendering will contribute to the development of green economy which will provide effectiveness and swiftness of the business processes besides environmental protection.
MEASURE № 2: Increasing of the efficiency and quality of the current and subsequent control which will lead to increasing of society trust in the system.
GOAL № 3: Free and loyal competition
MEASURE: The introduction of electronic awarding of contracts will facilitate the participation of all wholesalers listed in the register of traders and will lead to increasing competition and to achieving more favorable conditions for the contracting authorities in the sector.
GOAL № 4: Prevention and countering corruption in the healthcare sector.
MEASURE: Only the complex application of the total set of measures indicated above will lead to the elimination or control of the weak spots identified by CPCCOC through our quality standard.

5. EXPECTED RESULTS AND BENEFITS
• Professional development, providing and maintenance of electronic procedures on the award of public procurement contracts in the healthcare sector;
• Sustainable and simplified legislation, in full compliance with the new European directives;
• Full publicity and transparency through the introduction of entirely electronic means and tools for the awarding;
• Higher efficiency and cost effectiveness by the award of public procurement contracts in the healthcare sector;
• Cost reduction of the in-patient healthcare establishments; Alleviation of the administrative burden;
• Improvement of the quality of public procurement orders, established lawful practice and reducing of the violations by the public procurement orders;
• Reducing of the corruption risk through active prevention;
• Observing of the good practices of the EU for central awarding of public procurement contracts;
• Preparation of market reviews for all the medicines and medicinal products'
• Standardization of the process of awarding; development, introduction and observing of standards for the electronic public procurement orders and products;
• Increasing competence of the experts in the area of public procurement orders;
• Building of sustainable administrative capacity and increasing of the efficiency of the current and subsequent control in the healthcare sector.

6. Plan (approach) to the realization of the Concept of a Central Body for the Award of public procurement contracts in the Healthcare sector:
1. A report on behalf of the minister of health to the prime minister of RB and the deputy prime minister for EU funds and economic policies in order to present the Concept and a proposal for the establishment of CBAPPCHS pursuant to Art.8a, Par.4 of PPA.
2. After a positive decision on item 1, MH takes action on the preparation of documentation for the award of a public procurement contract for the development and introduction of an electronic platform for purchasing medicines. The following requirements for carrying out the activity on the administration of the electronic platform for purchasing medicines should be taken into account by the preparation of the technical specification of the electronic platform:
- Ensuring of independence of the committed structure;
- Observing of the requirement of adaptation of the system to the existing solutions on the electronic award of contracts, incl. infrastructure, processes or software, incl. compatibility with the existing electronic registers of the traders, in-patient hospital establishments and pharmaceuticals.
- Providing of operational compatibility of the platform and conformity to the existing IT-solutions for the implementation of the E-governance development strategy;
- Providing of the necessary level of security and reliability of the electronic means of communication;
- Observing the requirement to assess elements, subject to an automatic assessment by electronic means without any involvement or assessment of the contracting authority;
- The opportunity should be provided to prove the processes performed electronically, respectively archiving pursuant to the requirements of PPA.
The Administration of the platform may be carried out by the Central body at the minister of healthcare or by another structure which could be tasked with performing this activity.
3. Creation of an organizational structure for the administration of the electronic platform for purchasing medicines:
3.1. Initiation of DCM for the establishment of CBAPPCHS. Setting up of a structural unit: Central Contracts and Administering Unit Directorate at the Ministry of Healthcare to support the activity of CBAPPCHS. Regulation on an obligation of the in-patient healthcare establishments to supply medicines through CBAPPCHS.

4. Initiation of changes in PPA and RIPPA:
4.1. Introduction of a simplified way of conducting mini procedures pursuant to Art. 93b of PPA (items 3 and 4) with an estimation of the applicability of Art.70 (by offers with more than 20% more favorable than those submitted by other participants) and Art.71, Par.5, item 1 (conducting of a public lot to designate a contractor among the first rated offers with the lowest price if it is offered in two or more offers) of PPA.
4.2. Regulation on a participation fee in the electronic platform due by potential contractors which should not surpass the real expenses for participation in the platform.

5. Initiation of changes in specialized laws
We propose a norm to be created in the Law on Medical Devices by which to regulate the creation of national register of medical devices paid by public funds with the aim to subsequently include the medical devices in the object of supply of CBAPPCHS.

ELEONORA NIKOLOVA
ACTING DIRECTOR OF CPCCOC