Key Benefits:
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DRAFT RESOLUTION NO. 64 /XI/1ª
It is recommended to the Government to proceed to approval of a framework Act of the
Chronic disease, defining a regime of its own for access to
medication, as well as the systematization of all applied legislation
to the comparticipation of the medicinal products.
Exhibition of Motives
In Portugal, the system for the comparticipation of medicines, is based
at various scales, defined on the basis of essentiality criteria
therapeutics and socio-economic conditions of the patient.
The Decree-Law No. 118/92 of June 25 establishes the regime of
state turnout in the price of medications, predicting the
possibility of comparticipation through a general regime and a
special scheme, which applies to specific situations covering
certain pathologies or groups of patients.
This diploma, through the Decree-Law No. 129/2009 of May 29, recorded
their eleventh amendment, particularly changes to the level of the
scales of comparticipation.
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In the general arrangements for the envisaged comparticipation of the Decree-Law No. 118/92, of
June 25, the determination of the escalations of comparticipation had
underlying criteria of essentiality and social justice, in which the
State pays a percentage of the price of medicines, depending on
its pharmacotherapeutic classification provided for in the Portaria No. 1474/2004,
of December 21, and in accordance with Despacho No 21844/2004, of 26
of October 2004.
In this dispatch the pharmacotherapeutic groups and subgroups find
if organized as a function of the graduation of the state's comparticipation in the
cost of medications, taking into account the therapeutic indications of the
medication, its use, as well as the entities that prescribe it
and still the increased consumption for certain types of patients.
The state's comparticipation in the price of medicines used in the
treatment of certain pathologies or by special groups of
patients are the subject of special arrangements to regulate in legislation
own and differently graded in function of the entities that the
prescribing or dispensing.
Arising from the current legal framework of this matter and to
respond to the needs of specific social groups or interests and
without there being concern for equity and social justice in the system,
resulted in a myriad of diplomas and dispatches, referring to regimes
special, to special pathologies, to groups of medicines, to quality
of the prescriber, and others, which substantiate more than one hundred of
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normative instruments to be taken into account, either by the doctor who prescribes it,
either by the pharmacy that dispensing the medicine, or by the entity
administrative responsible for the conference of invoices.
But more relevant, it is the injustices that a legislative system with
these characteristics potency, creating discrimination for diverse
pathologies, positive for those who have their medicines
comparticipates, negative for others who are forgotten in this
case-by-case legislative activity.
These measures have made the system vulnerable to the extension of regimes
special to other population groups (with legitimacy, or not) that
considered or consider that their characteristics should
allow.
In this context it results in a set of such disparate situations, such as:
a) Patologies for which patients are entitled to all the
medications are comprised at 100% and others in which
only a few are;
b) The percentages of comparticipation vary from pathology to
pathology, without justification for such differentiation;
c) Houses in which the special comparticipation is by fable groups-
therapeutics, others by the medicine;
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d) Regimes that require the prescription to be made by doctor
specialist, and others in which it can be carried out by any
medical;
e) Situations in which access is restricted to the hospital and others in which the
medications are accessible in workshop pharmacy;
f) And, still, situations in which the cost of medications dispensed
by the hospital pharmacy constitutes financial responsibility of the
ARS and others in which it is from the hospital itself.
By way of example, the costs of the necessary medicines to the
treatment of chronic insufficient renal patients and transplanted
renals (Despacho n. 10/96, 16/05; Despacho n. 9825/98, 13/05,
changed by Despacho n. 6370/2002, from 07/03, Despacho n. para.
22569/2008, of 22/08 and Despacho n. 29793/2008, of 11/11.), patients
with amyotrophic lateral sclerosis (Despacho 8599/2009), patients with
lupus, hemophilia or hemoglobinopathies (Despacho 11387-A/2003),
patients with familial amyloidoptic polyneuropathy (Despacho 4521/2001),
are comprised at 100% by the State.
Already the costs of medicines necessary for the treatment of patients
affected by Alzheimer's disease are comprised of the C-level
37% (Despacho # 4250/2007, from 29/01, changed by Despacho n. para.
9217/2007, from 27/04, Despacho n. 19733/2008, from 15/07, Despacho n. para.
22188/2008, from 19/08, Despacho n. 25938/2008, from 07/10, Despacho
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no 694/2009 of 12/23/2008, Despacho n. 10676/2009, 17/04,
Order No. 12806/2009, of 21/05 and Despacho No 18629/2009, of
04/08).
In addition to the situations of inequality that this multiplicity of
origine regimes, the system becomes complex in terms of conference
of prescriptuary, not allowing, in an appropriate way, to validate the
specifics adopted for each regime thus instituted.
Result of this normative framework is the existence of a system of
comstake based on differentiated rates for various diseases
chronicles, which covers specific drugs, or not, and restricts the
place and conditions in which these can be obtained.
It is clear that, in general, the definition of these special schemes
carries valuations, often subjective, nursing,
consequently of equity issues in access.
Such a diversity of situations evidences the importance in defining which ones are
the chronic and debilitating diseases that would pass the benefit of the
special comparticipation, in simplified and uniform terms.
As early as 2005, the " Study of the Medication Comment System and
its Adequacy to the Reformation of Health ", of the responsibility of the Government
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PSD/CDS, pointed out various measures in the direction of reforming the system of
comparticipation of medicines, taking into account improvement criteria
of access, equity and economic efficiency.
On the other hand, also the legislation that defines what is chronic disease,
relies on scattered diplomas and with fragmented approaches, of which
cite:
-Decree-Law No. 54/92 of April 11 regarding the moderating rates to
pay for users in the national Health Service, by forecasting in the art 2º,
points (l) and (n) the exemption of the respective payment to a reduced number
of chronic diseases;
-Portaria No. 349/96, of the Ministry of Health, of August 8, with the
following text: The list of chronic diseases is approved which, by criterion
doctor, require consultation, exams and frequent treatments and are
potential cause of early disability or significant reduction of
life expectancy, append to the present porterie, of which it is an integral part;
-Joint dispatching of the Ministries of Health, Social Security and the
Work, paragraph 407/98, of June 18, which provides for the following: Disease
chronicle-disease or sequels that arise from pathologies
cardiovascular, respiratory, genito-urinary, rheumatological,
endocrinological, digestive, neurological and psychiatric, as well as of
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other situations that are cause of early disability or significant
reduction of life expectancy.
-Joint dispatching of the Ministries of Health, Social Security and the
Work, paragraph 861/99, of September 10, considers: Chronic disease, the
long-lasting disease, with multidimensional aspects, with evolution
gradual of the symptoms and potentially crippling, which implies
gravity by the limitations in the possibilities of medical treatment and
acceptance by the patient whose clinical situation has to be considered in the
context of family, school and labour life, which manifests itself
particularly affected.
The comparticipation of chronic diseases should be studied in the framework
of a general review of the state's system of comparticipation, whose
need had already been identified in 2004, and / or go through the definition,
classification and regulation of the categories of chronic diseases of
how to eliminate the lack of equity generated by these special schemes ad
hoc , on the basis of also criteria for social justice and simplification
of the system itself. The study drawn up and presented in 2005 by the
INFARMED featured several proposals for changes to the System and
contemplated this problem of the special regimes, putting several
proposals for their resolution, framed in the General System.
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Also several countries in the European Union have adopted mechanisms
specific to chronic diseases. For example, in Finland, the
chronic diseases, were classified into categories of comparticipation
in accordance with clinical criteria based on the severity of the disease and the
need for the treatment with the medicine. According to the
defined clinical criteria were created categories of comparticipation
special for chronic diseases, for which the
medications necessary to the treatment or to maintain the health of the
sick. For each category the rate of comparticipation is different, in the
however, there is always a co-payment on the part of the patient.
In other countries such as Germany and the United Kingdom patients with
chronic diseases get an identification to prove in how
are chronically ill, which will enable them to make a co-payment
reduced of the medicinal product or even the total exemption of payment
(United Kingdom).
In Italy there is an official list of chronic diseases and patients with the
inclusion criteria in these diseases do not pay the medicines, whether
these comparticipates or not.
In Spain there is no official list, created by decree, of diseases
chronicles, but rather an official list of medicines that treat
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chronic pathologies, with the co-payment of the patient never exceeds
a relatively low value (2.64 € in 2008).
In France, chronic diseases or 'long-lasting diseases' have been
divided into 3 categories: a list of the 30 long-lasting diseases that
imply prolonged treatment and a cost-effective therapy
particularly high; the diseases not included in the previous list, but
that refer to serious diseases and behave a treatment
prolonged, with a foreseeable duration and more than 6 months and a
therapeutics at particularly high cost; the polypathologies that
includes the patient with a number of problems that provoke a state
disability pathological and necessitating care for a duration
higher than 6 months. Only the medicines that are in accordance with the
classification are comprised at 100%.
Every country in the EU has its pricing and comparticipation system, though
all of them are walking with the time to very systems
similar.
It is important to retain the relevance and concern given by the different
countries to equity in systems and in the classification of categories of
chronic diseases, or another way that ensures equality and justice in the
access to these patients.
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These issues of equity and social justice assume also particular
concern in other aspects linked to the comparticipation of the new
medications, particularly with regard to access to the
innovative drugs, intended for severe and debilitating pathologies.
The PSD understands to be urgent to create a legal framework that exceeds the current
constraints, be it at the level of the harmonisation of access to patients
cronic, be it at the level of systematization of normative instruments
existing for the purpose of the comparticipation of medicines.
On the other hand, it becomes necessary to review all the problematic inherent in the
Person with Chronic Disease, namely the Legal Status of the
Chronically ill and the definition of Chronic Disease, which are of fundamental
importance to minimise the effects and implications of diseases
chronicles in the individual and society.
The necessary measures require not only legislative changes, but
also the creation of conditions at the level of the services of the Ministry of
Health, taking into account the difficulties evidenced by INFARMED.
By the exposed, the Assembly of the Republic, pursuant to (b) of the article
156º of the Constitution of the Portuguese Republic, deliberating to the
Government:
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-The approval of a framework Law of Chronic Disease with a view to predict,
in an integrated manner, a set of supports specific to these patients,
particularly the medicines that are indispensable to the quality of
treatment and life of the chronically ill, defining a regime of its own
for access to the medicine;
-The review of all legislation applied to the comparticipation of the
medications, proceeding to the systematization of the instruments
existing normations and the rebalancing of the system itself of
comprised by the concurrent and compared application of criteria
goals to the entirety of the universe. The aim is to simplify
procedures and promote a fairer health policy and
equitable;
-The adoption of a comparticipation system that ensures, too, the
access to innovative medicines, targeted for serious pathologies and
debilitating, in conditions of equity and social justice, without
compromise the sustainability of the system.
Palace of Saint Benedict, January 27, 2010
The Deputies of the PSD
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