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Recommends The Government To Proceed To The Adoption Of A Framework Law Of Chronic Disease By Setting A Proper Scheme For Access To Medicine, As Well As The Systematization Of All Legislation Applied To The Reimbursement Of Medicines

Original Language Title: Recomenda ao Governo que proceda à aprovação de uma Lei-quadro da Doença Crónica, definindo um regime próprio para o acesso ao medicamento, bem como a sistematização de toda a legislação aplicada à comparticipação dos medicamentos

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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.


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


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


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;


d) Regimes that require the prescription to be made by doctor

specialist, and others in which it can be carried out by any


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


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


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


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


-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


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.


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


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


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.


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



-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


-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