Author: Igor Şeremet, Lawyer, university lecturer, at the Department of International Law and European of the USM Faculty of Law, Doctor in Law
Although, the special legislative basis regarding the regulation of the management of production and household waste for the purpose of their reduction and their maximum reintroduction into the economic circuit, as well as, for the purpose of preventing environmental pollution, was fixed by Law no. 1347-XIII of 09.10.1997 [1 ], the first normative approaches regarding waste from medical activity were observed in The waste management strategy in the Republic of Moldova for the years 2013-2027, approved according to Government Decision no. 248 of 10.04.2013 .
Thus, according to the existing evaluation and analysis regarding waste management in the Republic of Moldova, in particular, medical waste, according to the Strategy, the following was found:
1. Medical institutions produce various waste consisting of food scraps, drug waste (pills, powders, reagents), antigen-laboratory tests, disinfectants, detergents, biological waste (culture media, biochemical, immunological materials, biological substrates, blood, sera, organic tissues), medical devices and radioactive materials, household waste. All these wastes are defined as the flow of medical waste originating from medical assistance centers.
2. About 75-90% of medical waste are similar to household waste, being made of paper, plastic, etc. who were not in contact with patients. However, approx 10-25% from medical waste is hazardous waste which require special treatment. Medical waste presents an increased risk for both human health and the environment. Due to the lack of special ovens, this waste accumulates together with household waste or is stored in medical institutions.
3. According to the publication "Health without any harm" (www.noharm.org), made by the European company "Health Care Without Harm", the annual generation of medical waste is 15.7 thousand tons, of which 2.75 thousand tons are infectious waste and 314 tons constitute hazardous waste. These calculations do not include medical waste generated in other medical institutions, such as pharmacies, medical offices, which need to be taken into account in the Medical Waste Management Plan.
The World Health Organization has established a webpage focused on medical waste management (www.healthcare.org), which could serve as a very good starting point for elaboration Medical waste management plan. In addition to the basic information, this page contains data on the cost and technologies available in this field.
4. Another problem faced by hospital institutions is the lack of a centralized collection network for used syringes. This problem must be solved by creating the capacities to process and reuse this waste.
Treating infectious and hazardous waste is very expensive, and in order to reduce investments and operational expenses it is important to limit the amount of hazardous infectious waste. In this context, the selective collection of these waste streams are important steps that must be taken.
Starting from 23.12.2017, Law no. 1347/1997 on production and household waste was repealed by the new Law no. 209 of 29.07.2016 on waste, which in turn, in addition to the novelties taken from the community instruments, brings some special regulations regarding waste from medical activity .
Respectively, art. 55 paragraph (1) of Law no. 209/2016 lays the foundation for the specific mechanism for managing waste resulting from medical activity, which is considered waste resulting from medical assistance activities for humans and animals and/or from related research , classified into hazardous and non-hazardous waste in accordance with item 18 of the Waste List.
The list of waste, classified and identified by types and categories, to which the noted legal norm refers, can be found in Chapter III of Government Decision no. 99 of 30.01.2018 , and respectively, in the Annex to the Sanitary Regulation on the management of resulting waste from the medical activity approved by Government Decision no. 696 of 11.07.2018 , according to which, Position 18 includes – Waste from medical or veterinary care activities and/or from related research (except waste from food preparation in kitchens or restaurants, which does not come directly from medical care activities).
It is important that, art. 7 para. (4) of Law no. 209/2016 states the obligation Waste producers and owners, legal entities, regardless of the type of activity, type of property and legal form of organization, source of financing, including public authorities for defense, public order and national security, to classify each type of waste generated from its own activity in the codes of the Waste List according to the normative acts approved by the Government (HG no. 99/2018, HG no. 696/2018, etc.).
The imposed classification is to be carried out based on the classification of waste according to its properties in: dangerous and non-dangerous, the main rule that emerges from the legislation is - "Waste that does not have hazardous properties is classified as non-hazardous".
Accordingly, Law no. 209/2018 establishes the procedure for evaluating the hazardous properties of waste according to which a range of rules are established:
1. The list of waste (provided by HG no. 99/2018 and HG no. 696/2018) is mandatory to determine if a waste should be considered hazardous waste;
2. A substance or an object is considered to be waste only when the holder throws it away or has the intention or obligation to throw it away;
3. In the case of a type of waste that falls, according to the Waste List, under two different codes, depending on the possible presence of some dangerous characteristics (the codes marked with an asterisk), the classification as non-hazardous waste is carried out by the producers and holders of such of waste only on the basis of an analysis of the origin, tests, analysis bulletins and other relevant documents;
4. Only the reference laboratories, established by the Ministry of Agriculture, Regional Development and Environment, analyze cases of uncertainty regarding the characterization and classification of waste;
5. Producers and owners of waste, legal entities, are obliged to perform and possess a characterization of the hazardous waste generated from their own activity and of the waste that can be considered hazardous due to its origin or composition in order to determine the possibilities of mixing, treatment methods and their elimination;
6. Based on an analysis of the origin, tests, analysis reports and other relevant documents provided by waste producers and holders, the Environment Agency considers that a waste is hazardous, even if it is not on the List of wastes, when it presents one or more of the properties specified in Annex no. 3 of Law no. 209/2016.
7. If the Ministry of Agriculture, Regional Development and Environment finds, based on laboratory analyzes or feasibility studies, that a waste that is classified in the waste list as hazardous does not have any of the properties specified in Annex no. 3 of Law no. 209/2016, it is considered to be harmless;
8. It is prohibited to reclassify hazardous waste as non-hazardous waste by diluting or mixing it in order to reduce the initial concentrations of hazardous substances to a level lower than the level required for a waste to be defined as hazardous.
At the same time, in addition to the rules specific to the procedure for evaluating the hazardous properties of waste, GD no. 99/2018 on the approval of the list of waste establishes the duty of producers or holders of waste to comply with the following rules:
1. Any waste from the Waste List marked as hazardous - the codes marked with an asterisk, is considered hazardous waste;
2. Hazardous waste is considered waste that presents one or more of the hazardous properties specified in Annex no. 3 of Law no. 209/2016.
That is, for the assessment of the hazardous properties of waste, the criteria established in Annex no. 3 to Law no. 209/2016 are applied, including those that refer to:
a) the presence of hazardous substances due to which the respective waste exhibits one or more hazardous properties;
b) limit values related to each substance. If a substance is present in waste below its limit value, the substance is not included in the calculation of any threshold;
c) concentrations of substances in the respective waste and other criteria;
3. the assessment of the hazardous properties of a waste and its classification as hazardous can be carried out, as appropriate, using the provisions of the national legislation regarding the classification, labeling and packaging of substances and mixtures mentioned in Law no. 209/2016;
4. If the hazardous property of a waste was evaluated based on a test, carried out using the applicable test methods, and by using the concentrations of dangerous substances according to the indications in Annex no. 3 to Law no. 209/2016, the results the test takes place.
Annex no. 3 to Law no. 209/2016, provides the guiding conditions for the evaluation of the hazardous properties of a waste and its classification as hazardous according to the types and categories provided for in HG no. 99/2018, and respectively, in HG no. 696/2018 .
In order to categorize a waste individually, especially that resulting from medical activity, the producers or their owners have the obligation to code them with 6 digits, in accordance with the List of waste approved by Government Decision no. 99 of January 30, 2018, and respectively, which is annexed to HG no. 696/2018, respecting the following procedure:
- the waste-generating activity from Chapter 18 is identified, i.e., Waste from medical or veterinary care activities and/or from related research (except waste from food preparation in kitchens or restaurants, which does not come directly from medical care activities);
- identify the sub-chapter in which the waste falls, which concerns the first 4 digits;
- identify, within the subchapter, the waste individually, according to the corresponding code, consisting of 6 digits, excluding the codes ending with 99;
- if the waste is not identified in Chapter 18, Chapters 13, 14 and 15 are examined to identify the waste;
- if the waste is not identified in Chapters 13, 14 and 15 either, Chapter 16 is examined;
- if the waste is not identified in Chapter 16 either, then the codes with the ending 99 – other waste, corresponding to the activity from which the waste originates, are examined for identification.
At the same time, the national legislation provides contradictory regulations that create difficulties in identifying subjects/entities that meet the qualities/conditions of producers of waste resulting from medical activity, as follows:
1. According to Law no. 209/2016 on waste:
– waste producer is any person whose activities generate waste (initial producer of waste) or any person who carries out pretreatment, mixing or other operations that lead to the modification of the nature or composition of this waste;
– waste holder is the producer of the waste or the natural or legal person who is in possession of it.
2. According to HG no. 696/2018, in the category Waste producers natural/legal persons are attributed, regardless of the type of property and legal form of organization that generate waste resulting from medical activity, i.e. – Medical-sanitary institutions and related activities/research.
According to Law no. 411 of 28.03.1995 on health protection, medical and sanitary institutions can be public as well as private, providing medical services, whose list and nomenclature are approved by the Ministry of Health, Labor and Social Protection .
3. GD no. 637 of 27.05.2003 regarding the control of the transboundary transport of waste and its disposal, Waste producer, is any person, who contributes through his activity to the formation of waste and/or who performs processing, treatment, mixing or other operations that generate a change in the nature or composition of this waste (if this person is not known, the waste producer is considered the person who owns this waste) .
4. GD no. 248 of 10.04.2013 regarding the approval of the Waste Management Strategy in the Republic of Moldova for the years 2013-2027, promotes, among other main objectives, the promotion and implementation of the principle "Extended producer responsibility", including hazardous ones (medical waste, etc.).
Pursuant to Law no. 209/2016 on waste (art. 12), "Extended producer responsibility" represents the totality of obligations imposed on producers, either individually or collectively, for the recovery and valorization or recycling of end-of-life products, which concern: natural or legal persons (the product manufacturer) who, at a professional level, design, produce, process, treat, sell and/or imports the products mentioned in this law.
Unfortunately, the objective indicated above according to GD no. 248/2013 was not found in the list of products, the management of the waste generated by them being the responsibility not only of the natural/legal persons who use them in their activity, but especially to those who sell and/or import them.
The activities for the application of the extended responsibility of the producer aim at the acceptance measures of the returned products and the waste that remains after the use of the respective products, as well as the subsequent management of the waste and the financial assurance for these activities.
Respectively, according to art. 12 paragraph (14) of Law no. 209/2016 on waste, in order to promote the extended responsibility of the producer, only the following products will be subject to these regulations as a priority:
a) batteries and accumulators;
b) electrical and electronic equipment;
5. Decision of the Ministry of Health no. 05-00 of 14.12.2001 regarding the approval and implementation of the Regulation on the management of medical waste , which, surprisingly, was not repealed by the approval of GD no. 696 of 11.07.2018 for the approval The sanitary regulation regarding the management of waste resulting from medical activity.
Respectively, in the sense of point 21 of the Regulation of 14.12.2001, "producer of waste from medical activities" is any natural or legal person whose activity produces waste that falls into the categories listed in points 5-7, which make a delimitation into large, medium and small producers (expressly indicating the list of public/private medical units), among which, to for example: pharmaceutical units, medical optics centers, pharmaceutical warehouses, private medicine units, etc.
Thus, the identification according to the legal provisions described above of the producer of waste resulting from medical activity, and respectively, the appropriate application of the rules regarding the classification of waste according to the types and categories standardized at the international level, generates the opposability of a series of obligations towards medical and sanitary institutions and its leaders, whose failure to honor or improper execution forms grounds for civil liability (disciplinary in employment relations), administrative, and respectively, in some cases, even criminal (Chapter IX of Law no. 209/2016 and Chapter XIII of HG no. .696/2018).
However, even starting from the conditions of art. 55 paragraph (7) of Law no. 209/2016, According to, "Producers of waste resulting from medical activity are obliged to:
a) to collect waste separately at the source, ensuring their sorting by waste categories, in order to facilitate the treatment and elimination specific to each category of waste;
The mechanism for the separate collection and packaging of waste resulting from medical activity is exhaustively provided for in Chapter III of HG no. 696/2018, which also involves the mandatory opposition of the head of the medical and sanitary institution as well as the persons designated responsible according to the job description.
Because, in order to achieve the goal of facilitating the treatment and disposal of waste already collected separately and properly packed, through Chapter IV of GD no. 696/2018, management managers are offered the possibility of temporary storage in compliance with the restrictive conditions, as later, under the conditions of Chapter V, ensuring the transportation of waste resulting from hazardous medical activity on public roads to the place of treatment or disposal or their transfer for final disposal across the border (in accordance with art. 44 and 64 of Law no. 209/2018).
b) to ensure the treatment and/or disposal of waste, including hazardous waste, produced at enterprises or facilities authorized according to art. 25, as well as the rapid and complete elimination of potentially harmful factors for the environment and the health of the population;
c) to ensure the keeping of waste records and the transmission of information about the generated waste and its management in accordance with art. 32 and 33 from this law and with the normative acts approved by the Government.",
we identify a number of problematic aspects at the level of the existence of normative mechanisms regarding ensuring the execution of the obligations in question, namely:
1. In the sense of art. 25 of Law no. 209/2016, the completion of the environmental authorization regarding the management of waste by treating it is possible to the extent that the applicant (medical-sanitary institution/economic agent) proves that the treatment facility is in accordance with the National Program of waste management and with the regional programs of waste management.
The last National Program for the valorization of production and household waste approved by GD no. 606 of 28.06.2000, was repealed by GD no. 796 of 25.01.2012 (in force from 31.10.2012).
Since then, until now, despite the powers provided by art. 8 letter b) of Law no. 209/2016, the Government of the Republic of Moldova has not approved any National Waste Management Plan, including the one that concerns the waste resulting from the medical activity, a circumstance that stalls the process of authorizing the activity of waste management through treatment.
Despite the conditions described above, during this period a series of economic agents were authorized specifically with the activity of managing waste resulting from medical activity by treating it - http://www.mediu.gov.md/ro/node/111.
However, under the conditions of Law no. 209/2016, and respectively, HG no. 696/2018 (Chapter VI), the treatment of waste resulting from medical activity implies the use of different methods and processes, depending on the hazardous properties of the waste, the type or category according to the List of waste - Position 18, which cumulatively must not endanger public health and the environment and must comply with the following requirements:
1) does not pose a danger to water, air, soil, fauna or vegetation;
2) does not have a negative impact on the health of the population in the neighboring residential areas;
3) does not produce noise pollution and unpleasant smell;
4) does not affect landscapes or protected areas.
2. In the sense of Chapter VII of H.G. no. 696/2018, among the methods of final disposal of waste resulting from medical activity, which is identified according to the code assigned based on the List of waste, the following can be found:
- storage of non-hazardous waste at authorized municipal waste depots;
- incineration, only for the types of medical waste for which treatment by thermal decontamination at low temperatures is prohibited, pathological, chemical, cytotoxic and cytostatic drug waste, etc.;
- burying hazardous waste in special places intended for sedimentary residues from cleaning boilers, filters, channels and chimneys of incineration plants, being very dangerous;
- storage of hazardous waste and sharps in the authorized hazardous waste warehouse and, after mandatory treatment;
- burial of pathological waste in the cemetery, and in its absence, it can be composted in special pits. Composting in special pits will be applied until cremation facilities are created;
- composting of biodegradable waste.
Respectively, some of the ways listed above, at the moment, are not operable due to the following considerations:
a). Storage activities at non-hazardous, inert and especially hazardous waste depots are carried out in accordance with the provisions of Law no. 209/2016 (art. 16) and the Regulation on waste storage, approved by the Government, which has not yet been drafted/approved .
To the extent that, only the legal bases for a process are established, but the mechanism is not approved, until it can be implemented in a profitable format, especially in terms of the conditions for the storage of hazardous waste resulting from medical activity.
b). The conditions for the incineration and co-incineration of waste must correspond to the requirements provided by the environmental legislation, Law no. 209/2016 and the Regulation on waste incineration, which is also not yet developed/approved.
Or, in the sense of art. 17 of Law no. 209/2016, the Environment Agency of the Republic of Moldova can authorize the requesting units with the waste incineration activity in accordance with the conditions provided by this law (art. 25 para. (14) and Annex no. 2), and respectively, the mechanism established by the Regulation on waste incineration, approved by the Government.
3. According to Chapter VIII of GD no. 696/2018, the Producer of waste resulting from medical activity is obliged to keep a chronological record of the separate amount for each type of waste, of information regarding their management, including treatment methods, and other information, according to the provisions of Law no. 209/2016 and the normative acts approved pursuant to it.
The imperative mechanism is provided by the Instruction on keeping records and transmitting data and information about waste and its management approved by Government Decision no. 501 of 29.05.2018 .
However, keeping records and transmitting data and information about hazardous waste resulting from medical activity and especially their management is illusory for the following reasons:
- The generation, collection, transportation, storage and treatment of hazardous waste is carried out on the basis of the environmental authorization for waste management, in compliance with the conditions established in the authorization and ensuring the records and control of hazardous waste, ensuring traceability, starting with their production and up to the final destination, which due to the lack of a normative base regarding the storage of hazardous waste, and respectively, their incineration, at least these two recovery processes cannot be proven (art. 20 of Law no. 209/2016).
- The recording of data that represents the control of the production-transport cycle, treatment and/or final disposal by the manufacturer, is limited only to the stage of the production-transport cycle, the second being lacking until now of normative support for implementation/application.
At the same time, art. 55 paragraph (8) of Law no. 209/2016 imposes direct obligations on the leaders of medical assistance institutions for humans and animals and research institutions in this field, regardless of the type of property, namely:
a). To approve own plans for the management of waste resulting from medical activity and to ensure their implementation in accordance with the internal regulation and normative acts approved by the Government;
According to point 10 and point 11 of GD no. 696/2018, the Own Plan for the management of waste resulting from medical activity, in addition to the fact that it must contain a minimum spectrum of information, must also be coordinated with the territorial subdivisions of the National Agency of Public Health and of the administrative authorities for environmental protection, in order to be subsequently analyzed annually and updated as necessary (in the case of the implementation of new technologies, evaluation of monitoring results, risk assessment in case of calamities), but no less often than once a 5 years.
To the extent that the own Institutional Plan is approved, the head of the medical-sanitary institution ensures the purposes assigned to him by point 9 of GD no. 696/2018, and respectively, ensures at least the approval of an internal legal instrument that substantiates the implementation of the internal system of management of waste resulting from the activity of the public/private entity it manages.
The implementation of own plans for the management of waste resulting from medical activity is one of the monitoring processes by institutions of the system of managing waste resulting from medical activity, which also includes the following:
- the use of equipment for the treatment of waste resulting from medical activity;
– the quantities of infectious waste produced and treated in the institution;
– staff training activities;
- waste record activities resulting from medical activity and reporting to the competent authorities.
b). To nominate a person responsible for waste management activities resulting from medical activity;
In medical and sanitary institutions, the management of waste resulting from medical activity is part of the professional obligations and is entered in the job description of each employee.
Respectively, in order for these obligations to be entered in the job description, the managers of the institutions that produce waste resulting from medical activity and the personnel involved in their management must be trained.
Education and training in the field of waste management resulting from medical activity can be integrated into the training programs of general and higher education institutions of medical personnel at all stages of continuous training.
For the purpose of efficient and safe management of waste resulting from medical activity, all forms of training can be applied, including distance learning.
c). To ensure continuous professional training of employees in the field of waste management resulting from medical activity.
The medical and sanitary institution is obliged to ensure continuous professional education and training for employees involved in the management of waste resulting from medical activity, in the following situations:
1) upon employment;
2) when taking on a new job or moving to another position;
3) when introducing new equipment;
4) upon finding irregularities in the application of standard operating procedures;
5) periodically, but not less often than once every 12 months, regardless of whether or not there have been changes in the waste management system.
d). To foresee annually the expenses necessary for the implementation of the provisions of Law no. 209/2016.
In the given chapter, we will address the current realities in relation to the obligation of the head of the medical-sanitary institution not only to foresee the necessary expenses but also to ensure their sufficiency.
Arising from the principle "polluter pays", each medical-sanitary unit must find financial resources for the proper management of the waste it generates. The implementation and continuous operation of the correct management system represents an important expense in the budget of the medical-sanitary unit.
Costs related to medical waste management are divided into internal costs and costs for contracting or so-called external costs.
Estimated internal costs include:
- separation at source;
- packaging of waste (especially hazardous, infectious, etc.);
- arrangement of temporary storage spaces;
- internal transport (equipment, mechanisms, etc.);
- neutralization treatment.
If the medical and sanitary institution has an incinerator, the following are added to the internal costs:
- costs related to the initial capital investment;
- incinerator operating costs;
- depreciation of incinerator and equipment;
- utility costs (fuel, electricity, water, etc.).
All these internal costs actually represent the salaries of those who carry out these operations as well as the costs related to the supply of the materials necessary for the good performance of waste management.
In turn, costs for contracts (external expenses) include:
- transportation of hazardous/non-hazardous waste to the final disposal site;
- final disposal for hazardous/non-hazardous waste in incinerator/neutralization station/waste depot;
The external costs consist in the payment of services provided by private economic agents authorized with waste management activities under the terms of Law no. 209/2016.
The expenses for the design, operation and maintenance of a correct management system of waste resulting from medical activity represent an important component in the total budget of the medical and sanitary institution and should be covered from a special fund created in the hospital budget.
However, in order to be able to talk about a pragmatic system for managing waste resulting from medical activity, we are going to analyze mainly the financing methods of medical assistance institutions for humans and animals and research institutions in this field, which largely respond to the realities existing regarding the honoring of the obligations of the leaders imposed by the legislation.
The budget of the medical-sanitary institution, in general, can be fed from several financial sources:
- The state budget;
- Health insurance budget;
- own income;
- Extrabudgetary revenues.
Accordingly, the budgeting of expenses can only be planned to the extent that, at an internal level, the own Plan for the management of waste resulting from medical activity is approved according to the conditions provided by Law no. 209/2016 and HG no. 696/2018.
More than that, point 14 of HG no. 696/2018 provides that the Managers of the medical and sanitary institutions are to identify and attract investments for the adequate management of the waste resulting from the medical activity, avoiding to expressly indicate the sources of financing as those from the state budget, the health insurance budget, etc.
At least, based on the mechanism provided by art. 7 of the Health Care Law no. 411 of 28.03.1995 regarding the financing of health care , and respectively, that provided by the Government Decision no. 1020 of 29.12.2011 regarding the tariffs for the medical and sanitary services , the respective sources are sufficient below the minimum necessary to ensure the current activity of the medical and sanitary institutions, without addressing the financing of the design, operation or maintenance of an internal system of waste management resulting from medical activity.
Conclusions and recommendations:
1. Despite the existing problems in the effective implementation of the waste management mechanism resulting from medical activity, until they are solved, DRIVERS healthcare institutions for humans and animals and research institutions in this field, regardless of the type of property, is to approve the Institutional Plans imposed by Law no. 209/2016, and respectively by HG no. 696/2018 to avoid sanction by the competent control bodies.
Respectively, according to Annex no. 2 to Order no. 1346 of 26.11.2018 regarding the approval of checklist no. 1.2/ANSP applied within the framework of state control over the activity of an entrepreneur regarding the management of waste resulting from medical activity , the Agency National for Public Health, will set the level of compliance by waste producers with the following normative acts:
– Sanitary regulation regarding hygiene conditions for medical service providers approved by Government Decision no. 663 of 23.07.2010, in particular, compliance with the conditions provided for in points 24-27;
– The sanitary regulation regarding the management of waste resulting from medical activity approved by Government Decision no. 696 of 11.07.2018, in particular, if the own Plan for the management of waste resulting from medical activity was approved and if they were coordinated and approved by the competent bodies, and respectively, the selective implementation of certain processes specific to waste management, etc.
2. The lack of a waste management Program at the national level, and respectively, to prevent the generation of waste produces a negative impact on the following aspects:
- analysis of the current situation of waste management resulting from medical activity throughout the country,
– taking the necessary measures to improve environmental conditions in the case of preparation for reuse, recycling, valorization and disposal of waste resulting from medical activity,
– the evaluation of the way in which the program will help to implement the objectives and provisions of Law no. 209/2016 on waste, and respectively, HG no. 696/2018 regarding the approval of the Sanitary Regulation on the management of waste resulting from medical activity,
– the approval by local public administrations of local waste management programs and programs to prevent the generation of waste resulting from medical activity,
– the development, approval and implementation of an integrated national and regional system for managing waste resulting from medical activity,
– the legal impossibility for the Environment Agency of the Republic of Moldova to issue environmental authorizations for the management of waste resulting from medical activity by treating them (even if the applicant is the public medical institution),
EVENT which require the central specialized bodies to expedite the process of elaboration and promotion for the approval of such an important normative act.
According to art. 25 paragraph (4) letter c) and paragraph (5) point 3) letter a of Law no. 209/2016 on waste, "In order to obtain the environmental authorization for waste management, the framework content of the technical memorandum is to be presented, the summary of which specifies the proof that the treatment plant is in accordance with the National Waste Management Program and the regional waste management programs".
3. The elaboration and approval of the Regulations on waste storage, and respectively, the one on waste incineration, by the Government of the Republic of Moldova, will at least create a normative clarity regarding:
– the conditions/requirements regarding the authorization of the waste management activity through their storage, and respectively, the responsibilities of the holder of the authorization at the post-closure/conservation stage of the waste deposit;
- the classification criteria for hazardous, non-hazardous and inert waste deposits, the mechanism for monitoring their activity both from those who manage them and from the competent control bodies;
– which types of waste are excluded for storage, and respectively, the responsibilities of those who monitor this mechanism;
- the requirements and the mechanism for placing waste incineration and co-incineration facilities on the territory of the Republic of Moldova and carrying out waste incineration and co-incineration operations, especially those resulting from medical activity;
- the conditions for the incineration and co-incineration of waste, including those resulting from medical activity;
- the procedure for authorizing the activity of operators specialized in waste incineration and co-incineration, and respectively, the obligations to be honored;
The objective in question is required to clarify the specific processes of waste management by the responsible entities given the fact that art.16 and art.17 in conjunction with art.24 and art.25 of Law no.209/2016 on waste make express references to the mechanism normative approved by the Government in the form of Regulations regarding the storage of waste and their incineration, which in turn can be elaborated by taking over some provisions from the following community acts:
– Directive no. 1999/31/EC of the Council of April 26, 1999 on landfills, as amended by Regulation (EC) no. 1882/2003;
– Directive no. 76/2000/CE of the European Parliament and the Council of December 4, 2000 on waste incineration.
Or, by Law no. 112 of 02.07.2014, the Parliament of the Republic of Moldova ratified the Association Agreement between the Republic of Moldova, on the one hand, and the European Union and the European Atomic Energy Community and their member states, on the other hand, according to which, our country, in addition to the multiple commitments provided for in the Preamble of the international act, assumed the commitment to progressively bring its legislation in the relevant sectors closer to that of the EU and to implement it effectively.
As a finality, the appearance in the legal system of the Republic of Moldova of the normative instruments mentioned above will create constructive premises (legal and financial) for the leaders of medical assistance institutions for humans and animals and research institutions in this field, regardless of the type of ownership, for the implementation of own Plans for the management of waste resulting from medical activity, ensuring the finality of all processes specific to an effective system for managing waste resulting from medical activity.
4. Based on the modest possibilities existing at the moment regarding the identification of sources of training and budgetary coverage of the expenses intended for the implementation by the public medical and sanitary institutions of The own waste management plans resulting from medical activity, in order to identify new ones, it is welcome to complete the entities that fall under "extended manufacturer's liability".
Or, in the sense of art. 12 paragraph (1) and paragraph (14), in order to strengthen the reuse and prevention, recycling and other types of waste recovery, natural or legal persons (the producer of the product) are subject to the regime of extended responsibility of the producer ) who, at a professional level, designs, produces, processes, treats, sells and/or imports the following products:
a) batteries and accumulators;
b) electrical and electronic equipment;
Respectively, the given nomenclature is to be completed with pharmaceutical/parapharmaceutical products/medical devices, etc., the producers of which will be obliged to subsequently manage the waste generated by users and/or the financial insurance for these activities.
5. We believe that for the operational launch of an integrated waste management system resulting from medical activity, it is not only sufficient to fulfill the recommendations provided above, but also to develop other instruments that will configure concrete steps to achieve the finality of implementation starting from the national level up to the institutional one, namely:
– National action plan regarding the management of waste resulting from medical activity, which will also include regional plans.
In a study carried out in January 2004, the Regional Office for Europe of the World Health Organization, within the Injection Safety Programme, empowered the AO Emergency to provide assistance to the Ministry of Health in the development of an integrated Plan for the management of medical activity waste for the Republic of Moldova.
In addition to the multiple recommendations, which as a finality have not acquired a distinct legal/normative form, there is the one regarding the development of three regional plans for the destruction of waste resulting from medical activity throughout the country, namely:
a. In North Region - a waste incineration chamber with a capacity of approximately 4 tons per day, installed in the municipality of Bălți, which will incinerate the waste resulting from the medical activity of specialized institutions in the territory of the districts/municipalities in the North of the country.
b. In Center Region - a waste incineration chamber with a capacity of approximately 5 tons per day, installed in the municipality of Chisinau (Republican Hospital), which will incinerate the waste resulting from the medical activity of specialized institutions on the territory of the districts/municipalities in the central area of the country.
c. In South Region – a waste incineration chamber with a capacity of approximately 2 tons per day, installed in the municipality of Cahul, which will incinerate the waste resulting from the medical activity of specialized institutions in the territory of the districts/municipalities in the southern part of the country;
– The national strategy for the implementation of the National Action Plan regarding the management of waste resulting from medical activity, including regional waste.
- Improving the legal framework regarding the formation of public-private partnerships in order to co-interest potential experienced investors in the field of waste management resulting from medical activity for the implementation of the above-mentioned plans, on the basis of a feasibility study recommended to be carried out in January 2004 through the Study on the development of the "Integrated Plan for the Management of Medical Activity Waste for the Republic of Moldova" by the World Health Organization.
- Published in the Official Gazette of the Republic of Moldova no. 16-17, art. 101 of 05.03.1998, repealed on 23.12.2017 by the entry into force of Law no. 209/2016;
- Published in the Official Gazette of the Republic of Moldova no. 82, art. 306 of 12.04.2013, in force from the moment of publication;
- Published in the Official Gazette of the Republic of Moldova no. 459-471, art. 916 from 23.12.2016, in force from 23.12.2017;
- Published in the Official Gazette of the Republic of Moldova no. 33-39, art. 115 of 02.02.2018, in force from the moment of publication;
- Published in the Official Gazette of the Republic of Moldova no. 295-308, art. 835 from 10.08.2018, in force from 10.02.2019;
- Published in the Official Gazette of the Republic of Moldova no. 34, art. 373 of 22.06.1995, in force since 22.06.1995;
- Published in the Official Gazette of the Republic of Moldova no. 99-103, art. 676 from 06.06.2003, in force from 06.06.2004;
- Published in the Official Gazette of the Republic of Moldova no. 13-15, art. 29 of 01.24.2002, in force since 01.24.2002;
- Published in the Official Gazette of the Republic of Moldova no. 176-180, art. 552 from 01.06.2018, in force from 01.09.2018;
- Published in the Official Gazette of the Republic of Moldova no. 34, art. 373 of 22.06.1995, in force since 22.06.1995;
- Published in the Official Gazette of the Republic of Moldova no. 7-12, art. 25 of 13.01.2012, in force from 13.01.2012.
- Published in the Official Gazette of the Republic of Moldova no. 513-525, art. 1846 from 28.12.2018, in force from 28.12.2018.