Abstract
Paneuropean development of patients’ rights represent a relatively recent concern, the legislative norms of which aim at granting to patients real-time access to all sorts of medical services. To this end, the European Union imple-mented a unitary normative professional and juridical background: Directive 2011/24/U.E. on the rights of patients to international treatments.
Consequently, the patients are free to choose them-selves the suppliers of medical services which do not include hospitalization, without a previous authorisation (country, doctor and medical institution) while, in the case of long-term treatments, a principial authorisation will be necessary. In both cases, the carrier of the therapeutic ser-vice receives the payment for his actions at the level of those established at national level, the difference being usually payed by the patient.
Keywords:the right to health, international medical assis-tance, national information centers, reference networks, man-agement of rare diseases, unitary communication system.
1. PREMISES FOR A UNITARY CONTINENTAL PLATFORM
Opening of the international access to health evi-dences new criteria and exigency. Practically, a new regime of services’ monitorization is devel-oped for increasing the quality and safety of the therapies applied, while patients’ free circula-tion is expected to generate a honest competicircula-tion among the medical systems and institutions of the member states.
Synthetic objectives, namely diversification, multiplication and improvement of therapies’ quality, a system in which each (national/medi-cal) unit shoud be concentrated on the practical advantages acquired. Structurally, the directive aims at creating centers of national contact, con-nected to the European reference network,
cooperation and procedural harmonization among all EU member states.
Analytical objectives, permitting institutional specialization of rare diseases’ therapy, manage-ment of the relatd networks, of the data bases and, consequently, of the registered patients. The new system prevents, to a considerably extent, dissipation of the existing resources by staff’s specialization inside the network, avoidance of parallel investments in equipments, research and control [1,2].
Creation of a common EU medical network will facilitate communication among the expert cent-ers and the therapy units based on a unitary communication system permitting the real, uni-tary conversion of the medical information avail-able at European level. Each member state is obliged to create at least one national center of information on the international medical services available (costs, diagnosis, structure or content of the therapies etc.).
Manifestations outside the objectives: potentially, they evidence the possible activation of factors stimulating medical tourism, in negative agree-ment with the absence of financial sustainability and competitivy of the national health systems.
2. MAIN SOCIO – JURIDICAL – MEDICAL MOTIVATIONS
Nowadays, the whole Europe is facing known or still new challenges related to the modifi-cations of the continental forces, including, too, areas of common or strategic interests (the new geopolitical trend), such as globalization of
PRESENT AND FUTURE PERSPECTIVES IN INTERNATIONAL
MEDICAL ASSISTANCE
M. Luchian1, Carmen Stadoleanu2, Cornelia Ursu3, V. Busuioc1,
S. Leica3, Georgeta Sinitchi2
1. Lecturer, Dr. , Dept. General Medicine, Faculty of Dental Medicine ”Apollonia” University of Iaşi 2. Univ. Prof., Dr., Dept. Dental Medicine, Faculty of Dental Medicine ”Apollonia” University of Iaşi 3. Assistant Prof., Dr., Dept. General Medicine, Faculty of Dental Medicine ”Apollonia” University of Iaşi
economy, under conditions of severe economic decline, fluctuations of the unique coin, a con-stantly negative demographic evolution, the right to a healthy life for each of us, in parallels with the higher costs of such sectors and, last but not least, the need for sustained energetic resources.
Theoretically, the concept of “civic welfare” of the old continent has had a rapid semantic evolu-tion, coming to represent one of the fundamental concepts of the European Union (fig. 1), inclu-sively as a manifest opportunity of the Treatise of Lisboa, according to which:
• the general unitary background for the implementation of a continental law has been created;
• gradual improvement of health policies is attempted at;
• health protection of the patients of the union is viewed as a national responsi-bility;
• quantificable procedures and measures may be applied, such as: requesting and granting patients’ rights to specific types of care, minimal standards and excep-tional care services, size and profile of the pharmaceutical component;
• the parameters of the therapeutical act are generically designed;
• medical logistics is established (necessary specialized staff, equipments, medication, structure and duration of therapies);
• the effects of high-risk drugs, smoking and alcohol abuse may be controlled;
• international threatenings (the potential of reaction at different types of risks, included) are quantified.
Such a collective approach establishes the problems and, mainly, the expectations of the EU countries of being treated on the territory of other states. Juridically, economically and medi-cally, the problem became especially important in the last decade, being viewed as an objective necessity of the present and, mainly, of the imme-diate future, understood and recognised by the Council of Europe [3.4].
The Treatise of Lisboa, followed by Directive 2011/24/E.U. on patients’right to international treat-ment, adopted on January 19, 2011 by the
Parliament of Europe, is a normative act with communitary impact, as:
• it recognizes the major role of medical assistance in developing social and regional cohesion for each citzen of the member countries;
• reflects the concerns of the citizens, which require a collective effort;
• adopts common standards of social and medical assistance, explicitly requiring “cooperation… for improving the complemen-tarity of health services in international regions”;
• assures high-quality, reliable and efficient health care services.
For the managers of the health system, these norms permit elucidation of the decisions adopted, referring to the care services available for patients abroad, concomitantly with permit-ting to the national systems to maintain a strict control on the right of the patients, including solicitations from the communitary network. At the same time, the suppliers have certain advan-tages for earning more money by offering their services to EU patients, at acceptable quality standards [5,6].
At present, Europa does not possess all neces-sary instruments for such projects. As a matter of fact, the created system should be permanently updated, adopting reliable mechanisms for a coherent development, capable of fulfilling the expectations of the Europeans, alongwith the consolidation of the democratic character and of the fundamental values of the Union, in agree-ment with the basic-doctrinary objectives on which its creation has been based.
Analysis of treatise’s structure permit to identy the main elements: the cooperation and application directions, made functional by the control of the Permanent Council of Physcians of Europa (fig. 2).
The cooperation direction aims at:
• settling of unitary norms for the continen-tal health domain;
• harmonizing the adopted procedures (functional and morally-correct solutions);
• assuring the complementarity of medical services (explicit criteria of performance and costs);
The application directive aims at implementing some universally-valid principles:
• recognizes that the systems of medical assistance represent a national component;
• adopts common standards of medical assistance at continental, national and regional level;
• aims at fluidizing the international medi-cal assistance;
• facilitates the access to reliable, high- quality international medical assistance.
The application directive has limited competences or it cannot be effectively applied in the case of:
• long-term specialty services;
• allotment of organs and access to the bank of organs for transplant interventions;
• national inoculation programs of the population against infectious diseases, including specific measures of national planning and implementation;
• national demographic interests, preven-tion and napreven-tional security programs etc.
The Permanent Council of Physicians of Europe has been given direct competences for imple-menting the procedures and for promoting uni-tary standards of medical training and practice. The main practical obstacles identified in the application of this directive may be classified as:
• frequently, patient’s access is delayed;
• no performant/optimum therapeutic solu-tions are provided;
• a too high, sometimes unacceptable level of costs;
• delayed repayment of the costs involved by the medical services.
The states having signed the treatise are obliged to make operational the above-men-tioned norms, as well as of the administrative documents, until October 25, 2013.
3. COOPERATION IN THE FIELD OF INTERNATIONAL ASSISTANCE AND MEDICAL TECHNOLOGY
This aspect involves an extremely large and complex domain, mainly of structural-functional nature: medico-therapeutical, technico-medical, juridical and economico-financial. Each member state agreed to assure the necessary credits, as part of the general budget.
Reciprocal assistance and cooperation for grant-ing public health has its specific standards on the quality, safety and exchange of information among the national contact units. The norms assumed permit the realization of agreements at regional and local level, including medical assis-tance specific to border zones.
Recognition of the prescriptions recommended in another member state. Practically, each restric-tion is forbidden, with the exceprestric-tion of the cases based on reasonable doubts on their authenticity, content or transparency. The aspects liable to developments or detailing refer to a:
• full understanding of the treatment;
• correct identification of the prescribed drugs or medical devices;
• development of e-prescriptions intreoper-ability;
• specific aspects related to patient’s safety in case of their substitution (common denomination, active substance and cor-responding dose);
• assuring treatment’s continuity.
The structural technological cooperation aims at:
• providing, in due time, of all necessary medical information;
• general compatibility (reliable, transparent, comparable and transferrable informa-tion);
• analysis of the nature and type of data with which an exchange of information may be initiated etc.
According to the quantity and quality of the obtained data, the European institutions involved in the project may rapidly intervene for:
• sustaining financing of technical and administrative assistance;
• reciprocal communication of the evalua-tion methodologies of the medical tech-nologies;
• supplying of transferable scientific infor-mation etc.
4. RESPONSIBILITIES OF THE MEMBER STATES
International medical assistance is assured according to the legislation, standards and qual-ity criteria in force, on observing the norms adopted by the state in which the treatment is made [5,6].
National contact centers. In each state of the union, one or several national contact centres – necessary for assuring international medical assistance – may be created. These structures are announced to the Permanent Commission of the Physicians, which make them public, their objec-tive being of collaborating in the specific net-work, of analitically developing the obtained data and of having consultations with:
• the organizations of patients;
• the medical services suppliers;
• the legal representatives of the national health systems (insurers) for the problems under discussion (fig. 3).
Previous authorisation may be refused by the member state in the following situations:
• the patient may be exposed to an useless, major, unacceptable risk;
• the case does not represent a medical urgency;
• the optimum therapy cannot be appled within a reasonable time, comparatively with the real situation and probable evolution of the disease from which the patient suffers etc.
The carrier state has to be sure that:
• the patients receive relevant information from the national contact center on the quality and safety standards, orientations, regulations on the control and evaluation of the suppliers of medical services, data on the accessibility, in hospitals, for hand-icapped persons, included. On request, the patient may receive a written notification with the maximum sum to be repaid, cal-culated transparently, (considering the clinical case and the necessary proce-dures), and with the decision of accepting or not mechanisms of financial compensa-tion (co-payment);
• the patients with rare pathologies are moni-tored for the establishment of the correct
diagnosis and treatment, being also informed (together with the medical staff and the financial representatives) on the steps performed. These patients are not obliged to obtain a previous authorization. Also, they are free to choose the institution in which they want to be treated, having the right of being wholly and directly financed by their own country (expected to pay all costs to the conutry supplying medical assistance to them) [7,8];
• the medical services suppliers provide to the patients all necessary information for mak-ing the most correct decision (data on the authorization/registration of the medical unit, competences and therapeutical options, costs, etc.);
• the legal protection systems are operative: assurance against malpraxis, security of the personal data, equal access to the best therapies, non-discrimination on national-istic criteria, language employed, corre-sponding medical monitorization etc. (fig. 4).
Each affiliated state grants that the adopted procedures are based on objective criteria, as fol-lows:
• necessary, proportional to the objective had in view and easily accessible;
• made public, for assuring an adequate information of the citizens;
• processed and disseminated at different levels, according to the pathological con-dition, urgency level and specific individ-ual requirements;
• estimation of the costs of assistance, moti-vated and periodically re-examined;
• the procedures may be attacked by legal means (according to the item discussing the temporary measures).
Directive nr. 24/2011/C. E. establishes the pro-fessional component of the medical services:
• eliminates all obstacles that might prevent international medical assistance, represent-ing risks for continental health protection;
• the suitable therapeutical act cannot be performed in the country of origin;
• states patients’ lawful rights to interna-tional medical assistance, according to the regulations sanctioned between the mem-ber states and the suppliers of medical assistance.
Repayment of the therapeutical costs follows a simple algorithm.
assured person is entitled. After having obtained the acceptance, the whole responsibility is held by the affiliated state, which establishes the con-crete therapeutical possibilities, the duration/ period, quality criteria, level and re-payment of costs.
Each state is obliged to elaborate and perma-nently update, in a most transparent manner, all elements for the calculation of international medical assistance costs.
The conditions, selection criteria and regle-mentation forms cannot be discriminatory. The-oretically, all these factors should not become an obstacle preventing the free circulation of patients and, implicitly, the medical services. However, the decision should be correlated to the real need for health, strictly oriented on its objective.
5. INTERNATIONAL MEDICAL ASSISTANCE:
PRESENT AND PERSPECTIVES
The whole body of regulations aims at a virtual development of assistance canals among the spe-cialized national contact center, medical services suppliers and expertise centers of the member states, by their voluntary contribution, according to the legislation of the reference state. Practi-cally, a new community is created online, for assuring the relation between patients and med-ical service suppliers, for the elucidation of cer-tain aspects of medical policy and practice settled by the European Directive.
The network will permit a complex connection, on specific problems and common interests in the domain of public health, in which managers, cli-nicians and the whole staff may work together, distribute primary information, exchange and discuss ideas, among them or/and also with the interested patients.
The network will be the central platform of the policy in the field of international medical assis-tance and will effectively support any future activity involving the practical application of the directive in the affiliated states.
The practical objectives aim at attaining a real standard of “welfare for the European citizens”, respectively consolidation of their health condi-tion, prolongation of their active life and of life expectancy, through:
• improvement of the cooperation stand-ards in problems of medical assistance;
• common utilization of the existing know-ledge for preventing citizens’ falling ill;
• improved diagnostication and high-qual-ity medical assistance at hand;
• lucrative utilization of the resources through their concentration in certain zones;
• amplification of the process of epidemio-logical research and monitorization;
• continuous formation of specialists in the deficitary domains;
• development, communication and dis-seminatin of information, knowledge and good practices;
• elaboration of quality, safety standards and application of the best suited proce-dures;
• support for the member states still lacking the necessary high technology or sufficient practice [9].
The member states are encouraged to develop such networks by:
• connecting of the medical services suppli-ers and of the expertise centsuppli-ers to these circuits;
• stimulation of an effective participation of the suppliers in the reference networks. E-health. The European poins and networks should support and facilitate cooperation within the whole EU territory in e-health problems through connections which will consider the aspects related to the electronic transferability of patients’ registration.
6. CONCLUSIONS
those from the border regions, from very small countries and for those affected with rare dis-eases.
For the Romanian patients, the main advan-tage will be the access to free information, pro-vided by the national contact center, on the rights and medical services they need, comparatively with the accessible ones. A statistical analysis of the extremely high differences between the costs of therapeutical services in West Europe and those of the national system of health assurance shows that the sums to be paid by the patients will be substantial.
Under such circumstances, the health condi-tion of the Romanian patients will further depend on the self-education for a rigurous life, and especially on the individual financial possibili-ties for full- or co-payment for optimum thera-pies. In Romania, reformation should start from inside, being strictly associated with a strong economic progress, implicitly with the general standard of life and protection of public health.
Consequently, international opening will still remain, for a relatively long period, only a theo-retical solution for numerous patients. Practi-cally, the symbolic message of the directive is towards a complex-structural integration in the European space, stress being laid in future on the common structure of the medical services.
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