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

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now

Read the untranslated law here:

DRAFT RESOLUTION ‡ is ƒ the n⺠64/XI/1st Recommends to the Government that the DRAFT RESOLUTION ‡ 1 is ƒ the n⺠64/XI/1st Recommends the Government to proceed is approval of a framework law of Chronic Disease ³ nica, defining a scheme next ³ prio for access to medicine, as well as the sistematizaà of all legislation applied is comparticipaà of medicines.

Display statement In Portugal, the comparticipaà system of medicine, is based on several µ s scalable, defined on the basis of criteria of therapeutic and essentiality condition µ es socio. ³ micas Decree-Law No. 118/92., June 25 establishes the comparticipaà scheme of the State in the price of medicines, providing for the possibility of comparticipaà through a general scheme and a special scheme, which applies to situation µ s especà you're covering certain pathologies or patient groups. This diploma, through Decree-Law nº 129/2009, of 29 may, registered his tenth top first change, particularly changes µ s to the level of µ s comparticipaà scalable.

2 in the general scheme of comparticipaà of the provisions of Decree-Law nº 118/92, of 25 June, the calculation of µ s scalable comparticipaà had the underlying criteria essentiality and of social justice, in which the State pays a percentage of the price of medicines, depending on their classification farmacoterapà ª utica provided for in Decree No. 1474/2004. , of 21 December, and in accordance with the Decree n. º 21844/2004 Â, of 26 October 2004. In this order the groups and subgroups farmacoterapà th uticos are organised in function of the graduaà of the comparticipaà of the State at the cost of medicinal products, taking into account the indication µ s therapeutic companies of medicine, their utilization, as well as the entities that prescribe the increased consumption for certain types of patients. The comparticipaà of the State in the price of medicines used in the treatment of certain pathologies or for special groups of patients is the subject of special arrangements to regulate legislation own ³ pria and unlike graduated in function of the entities that prescribe or dispense. The current framework jurà doctor of this matter and to respond to the needs of social groups or graphics especà and interests without concern for equity and social justice in the system, a mirà ade of diplomas and dispatches concerning the special arrangements, the special pathologies, the groups of medicinal products, quality of prescriber, and others, which are more than a hundred 3 regulatory instruments to be taken into account the physician who prescribes the pharmacy that dispenses the medicine by the administrative entity responsible for Conference of invoices. But, most important, are the injustices that a legislative system with these features power, creating discrimination µ s to various pathologies, positive for those who have their reimbursed medicines, negative for others that are forgotten in this legislative activity feature casuÃ.

These measures have made the system vulnerable to is extension of special schemes for the other population groups (legitimate or not) who regarded or consider that their features should allow.

In this context results in a set of µ s situation so give spares, as: a) Pathologies for which patients have the right to have all the medicines are reimbursed to 100% and others in which only a few are; b) the percentages of the comparticipaà range of pathology for pathology, no justificaà for this differentiation; c) cases in which the special comparticipaà is by easy groups rmaco-uticos therapeutic, others by medicine;

4 d) Regimes that require that the master recipe is made by medical specialist, and others in which can be carried out by any physician; and) µ s situation in which access is restricted to the hospital and others in which the drugs are accessories available in pharmacy of workshop; f) and µ s situation in that the cost of the medicines dispensed by the hospital pharmacy is the ARS and other financial responsibility in that is the hospital itself ³.

The title for example, the costs of the medicines needed for treatment of chronic renal insufficient patients ³ and renal transplant (dispatch No. ° 10/96, 16/05; Order No. 98, paragraph 9825/13/05, amended by order No.  º 6370/2002, 07/03, dispatch No.  º 22569/2008, of 22/08 and dispatch No.  º 29793/2008 of 11/11), patients with amiotrà lateral sclerosis is ³ (8599 Dispatch/2009), patients with hemophilia, paragraph wool puss, or Hemoglobinopathies (11387-Dispatching A/2003), amiloidà polyneuropathy patients ³ family practice (order 4521/2001) , are reimbursed 100% for the State.

Already the costs for medicines needed for treatment of patients affected by Alzheimer's disease are reimbursed by the scalable C â € “ 37% (order Nr 4250/2007, 29/01, amended by order No. Â º 9217/2007, of 27/04, dispatch No. Â º 19733/2008, 15/07, dispatch No. Â º 22188/2008 of 19/08 , Dispatch No. Â º 25938/2008, 07/10, Order 5 n. º 694/2009, 12/23/2008, dispatch No. Â º 10676/2009, of 17/04, dispatch No. Â º 12806/2009, 21/05 and dispatch No. Â º 18629/2009, 04/08).

Apart from the situation of inequality µ that this multiplicity of regimes stems, the system becomes complex in terms of Conference of receituÃ, not allowing, in an appropriate manner, validate the specificities taken to each scheme so instituÃ.

A result of this regulatory framework is the existence of a comparticipaà system is based on differentiated rates for various chronic diseases ³ nicas, covering medicines especÃ, or not, and restricts the location and µ s condition in which these can be obtained.

‰ is clear that, generally speaking, the definition of these special regimes entails valoraà µ s is often subjective, fell sick, as a result of equity issues in access.

Such diversity of µ s situation highlights the importance in defining what are the chronic diseases ³ nicas and debilitating that would benefit from the special comparticipaÃ, in simplified terms and uniforms.

Already in 2005, â € œ Comparticipaà System Study of Drugs and their Fitness is health reform of € , the responsibility of Government 6 PSD/CDS, pointed out a number of measures to reform the system of comparticipaà of medicinal products, taking into account criteria of improving access, equity and economic efficiency ³ mica.

On the other hand, also the legislation that defines what is chronic disease ³ nica, is based on diplomas scattered and fragmented approaches, that quote:-Decree-Law Nr 54/92 of 11 April for the charges to be paid by users in the national service of health, predicting the number, 2nd art neas l) and n) the isenà of the respective payment to a reduced number of chronic diseases ³ only;

-Portaria  º 349/96, the Ministry of health, August 8, with the following text: is ‰ approved the list of chronic diseases ³ nicas which in medical criterion, make consultations, examinations and frequent treatments and are the potential cause of early disability or significant reduction of the hope of life, attaches is this ministerial order , that is an integral part;

-Joint Decree of the Ministry of health, Social Security and labour, no ° 98/407, of 18 June, which provides the following: chronic disease ³ nica â € “ disease, or sequelae arising from cardiovascular diseases, respiratory, genito-urinary ³, reumatolÃ, endocrinolà ³ ³ gicas gicas, digestive, neurological ³ psiquià is beef and microbiological criteria, as well as 7 other situation µ s that are cause of premature disability or significant reduction of the hope of life.

-Joint Decree of the Ministry of health, Social Security and labour, no ° 861/99, of 10 September, considers: chronic disease ³ nica, long disease duration, with multidimensional aspects, with gradual evolution of symptoms and potentially crippling, which means gravity by limitation of µ s the possibilities of medical treatment and the acceptance by the patient whose situation the clan only has to be considered in the context of life school and family labor, which manifests itself particularly affected.

The comparticipaà of chronic diseases ³ only should be considered in the scope of a general review of the comparticipaà system of the State, which had already been identified in 2004, and/or pass by the definition, classification and the regulatory category of chronic diseases ³ only in order to eliminate the lack of equity generated by these special ad hoc schemes based also criteria of social justice and the simplificaà of the prio ³ system. The study prepared and submitted in 2005 by INFARMED presented several proposals to change the system and contemplated this problem special schemes, putting various proposals for their resolution, framed in the General System.


Also several paà ses of the European Union have adopted especà mechanisms for graphics the chronic diseases ³. For example, in Finland, the chronic diseases ³ nicas, were classified in categories of the comparticipaà according to criteria based on severity of nicos clan disease and in need of treatment with the drug. In accordance with the criteria defined categories were created only clan of special comparticipaà for the chronic diseases ³ Chronicles, for which they were identified the medicines needed to treat or to maintain the health of the sick. For each category the comparticipaà rate is different, however, there is always a co-pay on the part of the patient.

Other paà ses as Germany and United Kingdom patients with chronic diseases ³ only get an ID to prove in as are chronic patients ³, which will allow them to make a reduced copayment of medicine or even the isenà of the total payment (United Kingdom).

In Italy there is an official list of chronic diseases ³ nicas and patients with the criteria of inclusion in these diseases do not pay the medicines, whether compensated or not.

In Spain there is an official list, created by Decree of chronic diseases ³ only, but an official list of medications that treat chronic pathologies ³ 9 only, and the patient's copayment never exceed a relatively low value (2, ‚ € 64â in 2008).

In France, the chronic diseases ³ nicas or â € œ diseases of long duration oâ €  were divided into 3 categories: a list of 30 diseases of long duration which involve a prolonged treatment and a therapeutic with particularly high cost; the diseases include the not in the preceding list, but which refer to serious diseases and contain an extended treatment, with a duration greater than forecast and 6 months and a therapeutic with particularly high cost; the polypathology which includes the patient with a series of problems that cause malformations ³ State of disability and in need of care with a duration exceeding 6 months. Sà ³ the medicines that are in accordance with the classification are reimbursed to 100%.

Each paà s I has its price system and comparticipaÃ, although they all are walking with the time to very similar systems.

Is ‰ important retain relevà and concern given by different ses paà is equity in systems and in the classification of the categories of chronic diseases ³ nicas, or another way that ensures equality and justice in access to these patients.

10 These issues µ s of equity and social justice take also particular concern in other aspects is comparticipaà of new medicines, particularly as regards access to innovative medicines for serious and debilitating diseases.

The PSD considers it urgent to create a legal framework that goes beyond the current constraints, is to the level of harmonizaà the access to chronic patients ³, be to the level of sistematizaà of the existing normative instruments for the purposes of comparticipaà of the medicines.

On the other hand, it is necessary to review the entire problematic tica inherent is Person with Chronic Disease ³ nica, in particular the status of patient Chronic medical Jurà ³ and the definition of Chronic Disease ³ nica, which are of fundamental importance to minimize the effects and implications of µ s of chronic diseases ³ in indivà duo and in society.

Necessary measures require not just µ s legislative changes, but also the creation of µ s condition to the level of the services of the Ministry of health, taking into account the difficulties highlighted by INFARMED.

Therefore, the Assembly of the Republic, in accordance with in article b) nea 156 of the Constitution of the Portuguese Republic, decides to recommend to the Government: 11-the approval of a framework law of Chronic Disease ³ nica with a view to provide for, in an integrated manner, a set of especà the graphics support these patients, in particular those medicines available imprescindà is quality of life and treatment of chronic patients ³ nicos by setting a system next ³ prio for access to medicine;

-The revision of all legislation applied is comparticipaà of medicines and is sistematizaà of the existing normative instruments and reequilà the ³ panache prio comparticipaà system of µ s by applying the simultaneous nea and compared to objective criteria is the entire universe. The aim is to simplify procedures and promote a controversial health policy more fair and equitable;

-The adopting of a comparticipaà system that also ensures access to innovative medicines for serious and debilitating diseases in µ s condition of equity and social justice, without compromising the sustainability of the system.

Potala are Balaji, 27 January 2010 The members of PSD 12