Legal aspects of medicines consumption

Abstract

In this paper is presented a study of juridical aspects of medicines consumption through the lens of consumer protection rights, the sources of law regulations concerning le-gal liability for causing health damages to medicines consumer who is the final recipient and the main subject of social relations in the healthcare field through pharmaceutical activity. Health damages to medicines consumer can be brought in a purely pharmaceutical way through drugs that are counterfeit, falsified or nonconforming. It can be concluded that in Republic of Moldova drugs consumer protection does not have a standing legal support and needs adjusting to European standards for this purpose.

 

Table of Contents

1. Purpose of this paper

2. Materials and methods

3. Results

4. Conclusions

 

1. Purpose of this paper

To analyse legislation in Republic of Moldova which concerns legal liability to damages that can cause health or life damages to medicines consumer in order to propose legislative changes and initiatives.

 

2. Materials and methods

Constitution of the Republic of Moldova and the subordinate legislation. Main methods used are: synthesis, logical legal deduction, content analysis and comparative analysis.

 

3. Results

Legal relations which were a subject to examination, show that different sources of law represent a system of different determined external forms, which include norms that gene-rally regulate social relations that are important to the whole society, concerning citezens’ health protection and its main link – legislation concerning medical assistance through pharmaceutical activity.

Traditionally one of the main forms (sources) for law expression are the laws that can be special or general, normative acts, where the key position is occupied by The Supreme Law which is The Constitution. Other law sources might be generally recogni-zed principles of international law and international treaties (title I, article 8, Constitution of Republic of Moldova), international law norms [1] and the subordinate legislative acts (nor-mative acts of central public administrations (APC), local administrations (APL), at district or municipal level, within the limits of their competence).

Analysing the specific features of these legal regulation legislative acts of social relations in the healthcare field through phar- maceutical activity, can be noticed the lack of medicines consumer term and legal liability norms in cases of patient’s health or life damage. This happens at a stage when the society is set to have the best quality service and assistance across all branches of this system (public health protection).

 

Constitution of the Republic of Moldova. One of the fundamental rights of a Republic of Moldova citezen is the right to health protection.

Art.1 par. (3) of the Constitution states that Republic of Moldova is a democratic State in which the dignity of people, their rights and freedoms, the free development of human personality, justice and political pluralism represent supreme values that shall be guaranteed. In the Constitution of Republic of Moldova art.16 par.(1) and art. 36 guarantee these rights, respect and protection of a person constitute the foremost duty of the State.

Art. 36 from RM Constitution states that:

1) The right to health protection is guaranteed,

2) The minimum health insurance provided by the State shall be free of charge,

3) The structure of the national health security system and the means aimed at protecting the physical and mental health of the individual shall be provided for by organic law. As it is generally known human health depends on numerous factors. In RM Constitution there are listed the factors and the means specific to health protection as well as citizen categories with specific guaranteed rights.

Art. 37 states “every individual has the right to live in an ecologically safe and healthy environment, to consume healthy food and to use harmless household appliances”; also, “Private individuals and legal entities are liable for the damages caused to a person’s health and property due to ecological infringements.”

Art. 47 states “The State shall be bound to take actions in order that every person has a decent standard of living that would ensure him/her and his/her family members health protection and welfare including food, clothing, shelter, medical care, as well as necessary social services. All citizens have the right to be insured in case of: unemployment, disease, disability, widowhood, old age or other situations where, due to causes beyond one’s control, one loses the source or means of obtaining the necessities of life”.

Art. 50 states “The mother and the child shall enjoy special assistance and protection; children and young people shall enjoy a special form of assistance in the pursuit of their rights, etc.”.

Art. 51 states “Persons with special needs (disabilities) shall enjoy special protection from the whole of society, the state shall ensure normal conditions for medical treatment and rehabilitation, education, training and social integration for them. No one can be subject to forced medical treatment unless for the cases set by the law.” [3]

 

The Civil Code of the Republic of Moldova no. 1107 of June 06.2002 (31 modifications) includes legal norms about obligations, general notion of contracts by the means of gradual transition from a centralized national health system to a different system based on a contract with The National Health Insurance Company while medical services can be provided by private medical organizations with entrepreneur status. The most relevant for this study are the following parts: chapter XI “Entrepreneurship and Offer of Services”, the third section “Offer of Services”, art. 970-979; Chapter XXVI “Insurance” art. 1301-1330; Chapter XXXIV “Obligations born from causing damages” art.1398-1431. [2]

 

Republic of Moldova law of May 25, 1993 No. 1456 - XII, “regarding pharmaceutical activity” republished in Official Monitor of Republic of Moldova no. 59-61/200 of 15.04.2005 defines for the first time basic legal terms related to pharmaceutical field “pharmaceutical activity, authorization, expertise, approval, registration, unauthorized drug, producer price, purchase price, delivery price from the local manufacturer”; as well as “authorization methods of pharmaceutical activity, medicines and medical items quality control, guaranteed medicines provision to population, demographic norms for opening a pharmacy (a pharmacy can be opened at a population density of 3000-4000 people), etc.”.

Through article no. 18, par. (4) modified in law no. 63 of 06.04.17, MO155-161/19.05.17 art. 257 states that Medicines and Medical Devices Agency in Republic of Moldova suspends or interdicts the manufacturing, import and marketing of medicines, drugs and para-pharmaceu-tical products that do not meet the requirements in Pharmacopoeia or any other normative and technical documentation approved by Ministry of Health, Labor and Social Protection as well as in cases when there were established harmful effects on human health. [6]

 

Republic of Moldova law no. 411-XIII of March 28, 1995 No. 411-XIII “About health protection” appeared in the first few years after the independence proclamation and contains pioneer law principles in the healthcare field such as:

a) decentralized administration of preventive, curative, sanitary prophylactic and anti-epidemic units also pharmaceutical units or units of any other nature;

b) the responsibility carried by central and local public administration authorities, economic entities and decision making factors in national policy promotion ensuring population health;

c) responsibility of medical and sanitary organizations and units for the whole volume of accessible, opportune, high quality sanitary and medical services, also in terms of the quality of professional training and improving the qualification of medical and pharmaceutical staff;

d) the usage of modern medical practice including modern technologies and scientific achievements in the medical activity of these units;

e) defence of employee rights and control over the exercise of professional obligations;

f) prophylactic orientation in ensuring health to the whole population in all spheres of vital activity;

g) the diversity of medical assistance (provided by the state, by insurance or in a private manner);

h) free and accessible medical assistance in national medical institutions, transition to provision of these services by general practitioners, according to a national program in set volume and limits;

i) a patient’s freedom to choose their current practitioner and curative unit (with the suggestion for this to be completed with pharmacist and pharmacy). In relation to the research topic the only liability for damages caused to a citizen's (consumer’s, patient’s) health, there is only one specification j) the responsibility of each person for his or her own health. [9]

 

National Health Policy approved by Governmental Decision no. 886 of August 6, 2007 states that “population health represents an objective of primary importance in national policy of every State; health represents the most treasured value and an indispensable component ofs social development and prosperity and establishes as a priority in efforts made by the Government and by civil society in order to continue to strengthen each person’s health throughout their lives especially during the most risky periods of life health-wise, such as: beginning of life, adolescence and old age as well as rectification of economic and social situation in the country.” National Health Policy have as a purpose adjusting the legal framework to European Union rigors and standards as well as elaboration of new normative acts for the implementation of National Health Policy and of an Action Plan for Republic of Moldova and European Union. Researched legislative acts highlight the emphasis put by the state on declaring guarantees to citizens and some facilities offered do special (separate) categories of citizens in the healthcare field. There can be attested some decentralization elements of national medical assistance by public and local authorities and municipal entities. It’s specific to this time and to this document that mentioned state guarantees are not going to be seen as concrete and tangible tasks for involved subjects but as recognized legitimate citizen rights. [11]

 

National Medicines Policy approved by Governmental Decision no. 1352 of October 3, 2002 presents the development of the health system in Republic of Moldova which implies providing healthcare to all citizens basing on the principle of equality. A medicine is an important element in prophylaxis, diagnosis and treatment of various diseases. Coordinated development of the pharmaceutical sector, especially in cases related to social importance which is one of the most prioritized problems in healthcare. This policy was intended to serve as a base for elaborating new development programs in pharmaceutical field in Republic of Moldova (development, testing, authorization, manufacturing, distribution and rational use of medicines) as well as new legislation in the in the domain of medicines and the pharmaceutical field. National Medicines Policy is a huge component of national health policy but does not acknowledge the legal liability for causing health or life damages to medicines consumer. [12]

 

Republic of Moldova Law No.105-XV of March 13, 2003 “on Consumer Protection” Includes basic terms which are directly related to healthcare – consumer, manufacturer, provider, fake product (counterfeit), quality, validity, safety of products, services and works. Articles 7, 8, 9, 16 of the Law mentioned above determines the obligations of the manufacturer, executor and seller while article no.6 establishes specific stipulations which concern protection of consumer’s life, health, heredity and security and through this process guarantee the right to safety of the mentioned goods, products, services and works.

This Law regulates in detail complete, accurate and precise information provided to a consumer, both about the manufacturer (executor or seller) as well as about goods, products, provided services and works. Taking in consideration the presumption that the consumer lacks special knowledge, article no. 21 of this Law requires a specific training for the consumer, that should be provided through establishing consumers’ information systems concerning their rights by implementing necessary measures for protecting their rights such as organizing seminars, publishing special editorials on the particular topics and by other undertaken measures by bodies responsible for the consumers protection, and by non-governmental organisations, as well as by the means of mass media and other interested organizations. [4]

 

Republic  of  Moldova  law  No.  263-XVI  of  October  27,  2005  “on  patients’  rights  and responsibilities” includes an article dedicated to the liabilities in case of violation of patient rights.

According to article 18 of this law “(1) The liability for the violation of a patient’s right to health care is carried by public central and local administrations and authorities of healthcare system at all levels and in case of violation of individual rights stipulated in the following law the liability is carried by the providers of the health services. (2) Those responsible for violation of a patient’s rights stated in this law are liable in accordance with the law.” On one hand this article refers to the in-force legislation which refers to the compensation for the damage caused (including the CCRM). On the other hand, it proclaims the principle of responsibility for damaging actions (inactions). Also, it is very important that in this law, there is no mention the possibility of unfavorable results or risks such as: damages caused to a citizen’s health and especially as a result of medicines consumption or even worse, the death of a person. [5]

 

Republic  of  Moldova  Law  No.  1585-XIII  of  27  February  1998  “on  compulsory  medical insurance” sets legal, economic and organizational grounds for compulsory medical insurance provided to Republic of Moldova citizens. The main objective is to intensify the interest and responsibility of the citizens, state, companies, institutions and organizations on healthcare field in new economic conditions. The law guarantees their constitutional right to medical care. According to the terms of the law insured persons (by medical and sanitary institutions which have a contract with The National Health Insurance Company) have the right for medical care corresponding to the volume (different types of medical care) and to the quality stipulated in the insurance contract and the list of medical services established by the Single program of compulsory medical insurance approved by Order of the Government of the Republic of Moldova No. 1387 of December 10, 2007 “about approval of the single program of compulsory medical insurance”. Realizing the importance, complexity and the up to date goals linked to healthcare protection, the Government established starting  with  2013  a  top  priority  activity  program  entitled  “European  integration:  Freedom, Democracy, Welfare” – “increasing the performance of all the providers of medical services by application of the minimum quality standards”, the main goal being the service quality improving.

Also, in this Law can be found actual monitoring, evaluation and quality control instruments and mechanisms for provided medical and pharmaceutical services quality (periodic estimation of recipients’ satisfaction rate about: the quality of the services, the prices, the way of according these services, waiting time and other aspects) are directed to diminish dissatisfaction degree and health or life damages reported to proposed goals though according to some authors there are attempts in this direction. [10]

 

Republic of Moldova Law No. 382-XIV, of 6 May 1999 “On the circulation of narcotic drugs, psychotropic substances and precursors” modified on 28.07.2016, states the following basic terms: drugs, psychotropic substances, precursors, circulation of narcotic drugs, psychotropic substances and precursors, analogues of narcotics and psychotropic substances (analog), ethnobotanical products, etc., determines the classification of psychotropic, narcotic substances and precursors which are subject to control on Republic of Moldova territory. The list (lists) and the ways they can be modified and completed can be determined and approved by the RM Government. This Law with its modifications and additions, determines the directions and principles of state policy in the field of narcotic and psychotropic substances trafficking and in fighting their illegal circulation. [8]

 

Republic of Moldova Law of December 17, 1997 No. 1409 “regarding drugs” sets the legal base for activities of those who takes part in medicines circulation, determines the state organizations that implement the practice of applying this law and the distribution of executive power in the medicines circulation field.

The Law regulates the relations that appear together with elaboration, preparation, manufacturing, preclinical and clinical studies of drugs, quality control, efficacy, safety, drug commercialization and other activities in the drug circulation field.

This Law describes the following terms: medicines (drugs products), drug substance (active substance), medicinal product, radioactive, preclinical drug studies, clinical trials of the drug, international common denomination (DCI), counterfeit drug, a drug’s registration certificate, official representative, manufacturers price registration, National catalogue of drugs manufacturer’s suggested retail price, original drug (innovative or new chemical entity), generic drug.

The law sets state regulatory methods which appeared in the drug circulation area. The most important for the science and medical practice are the norms of chapter III “Drug development”. For the first time there are set regulatory stipulations for drug development, preclinical and clinical trials for drugs. It was attempted to protect patient rights in a corresponding way for those who takes part in clinical trials for drugs (article 12). Even though this law is a part of “purely” pharmaceutical legislation, it does not contain any stipulations about fixing health or life damages that can occur after administrating drugs and also doesn’t refer to any other normative act. The practice of applying such a norm can help identify the strengths and weaknesses in regulating these legal relations. [7]

This way, after analyzing the in force legal norms concerning pharmaceutical activity as a part of healthcare, through the lens of legal liabilities for citizen’s (patient’s, medicines consu-mer’s) health or life damages presented in them, we can mention a total absence of the phar-maceutical and medical responsibility as a a specific legal liability because the mechanism of compensating the health or life damage of the citizens is first of all determined by Republic of Moldova administrative and civil legislation.

Besides that, the state mechanism is adjusted only to detect, investigate and solve cases related to violations and infringements assigned to the four types of legal liability: criminal, contraventional, civil and disciplinary, not diminishing but on the contrary, emphasizing once again the importance of ethical, moral responsibility, solemnly declared by swearing in Hippocrates’ Oath.

 

4. Conclusions

The study of legal aspects of medicines consumption, the sources of legal regulations concerning legal liability to damages that can cause health damages to medicines consumer, allows us to notice that in a short period of time, legal acts that concern health protection, pharmaceutical activity, the drug itself are set to become more specific, because as for now they lack the right definitions and concepts which lead in more difficult cases when there is need to protect the citizens’ legal rights and interests in different institutions including court.

Their indisputable value lays in determining the rights and obligations of all participants of social and legal relations in according of medical care (doctor-pharmacist-medicines consumer, etc.). It’s crucial to review pharmaceutical legislation in Republic of Moldova in order to reason and adopt new legal norms which would actually determine in a certain way the liabilities for provoking harm that appears following a medicine consumption and cause health damages. In our opinion time has come to raise the issue of drafting a new Code – the right template for the systematization of legislation which concerns this noble activity field, first of all in the light of citizen’s health protection.

 

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