Advanced Search

Recommends To The Government The Adoption Of Measures For Generic Consumption Expansion And Reducing The Waste Of Prescription Drugs And Diagnostic And Therapeutic Guidelines

Original Language Title: Recomenda ao Governo a adopção de medidas de expansão do consumo de genéricos e de redução do desperdício de medicamentos prescritos e de orientações em diagnóstico e terapêutica

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.

1

DRAFT RESOLUTION NO. 127 /X/

" Recommends the Government to adopt measures to expand the consumption of generics

and reduction of the waste of prescription drugs and guidelines in

diagnostic and therapeutic ".

Health, regarded as the good and essential right of citizens, has in the medicine a

fundamental pillar for the improvement of the quality of life levels, which constitutes yet,

a modern vector of scientific progress and economic development.

In health, national indicators highlight a noticeable progression of the

our Country, in recent decades, specifically in terms of average life expectancy,

putting us well close to the European average, which has to be credited to the Service

National Health, and still the whole health system, notably its organisation,

to professionals, the pharmaceutical industry and the network of pharmacies, with outposts

distributed by the national whole.

The special nature of the good that is health, benefiting from the contribution of extraordinary

scientific progress and technological advancements of medicine, there has long been determining

an impairment demand for new care, both at the level of equipment, and

treatments, as well as of new pharmacare.

This process has, of course, as a reflection, a fortissimo boost at the level of the

investment in research, with evident and important after-effects in the

industrial production and trade in the countries.

Governments have been recognizing and taking on the strategic character of research and

national pharmaceutical production, approving measures for promotion of the sector, supporting the

research, and the strategies of conquest of size, specifically through the

2

international cooperation.

But, the progressive increase in spending in the area of health, specifically with the

medications, there has long determined measures of rationality and balance, even in the

more developed countries of the European Union.

In Portugal, total expenditure on health accounts for about 9.6% of GDP,

superior percentage to be verified in many countries of the Union, not letting up

illustrative, by way of example, the fact that in 1970, in our Country, the actual spending with the

health, in% of GDP, are significantly lower than those in Spain and the United Kingdom,

Whereas in the last few years, this relationship has inverted in a well-highlighted manner, in

injury to our Country; or still the case of Sweden, which 15 years ago spent, in% of GDP,

well more than Portugal with their health expenditure, to, in the topicality, present

indicators of total expenditure lower than our Country.

One other data, referenced to 2001, and related to the national consumption of

medications in ambulatory, per capita , indicated that this superava in absolute value the

spent per capita of the United Kingdom, country that integrates the group of the most developed countries

of the European Union.

In the meantime, a recent study reveals that 49.7% percent of prescription drugs are

wasted, that is, almost half of the medicinal prescriptions are not used, the

which confirms a reality long perceived by the health professionals, but until then

never quantified.

For this situation they will contribute, according to the study, to the suspension of medication by the

patients and the gap between the size of packaging and the duration of treatment.

As the authors of the study refer, and it seems clear, this situation connates large

public health risks, by the non-completion of the therapeutics, by the risk of

creation of resistances, but also by the possibility of later self-medication,

eventually with fable out of time and, by consequence, potentially toxic.

One such reality demonstrates, at satiety, in an absolutely dramatic way, which is a

colossal squandment of economic resources.

If we are still present that about half of the medicines consumed are

mattered, we will be able to assess the repercussion in the national economy of the negative effects of the

lack of rationality in this area of health.

3

The reshaping of the packaging has been the subject of some attention by the

responsible authorities, in various governments, but the practical consequence, in the various

pharmacist groups, was of continuous and persistent disadjustment.

There is also to be taken into account the unquestionable data published by the " Observatory

Portuguese of Health Systems " in its Spring 2004 and 2005 reports, and

still a comprehensive study to 26 countries in Europe, published in the journal "Lancet" in 2005,

that come by confirming worrying indicators about the Portuguese consumption profile of

pharmaceuticals, from some therapeutic groups, such as antibiotics for example, in clear

divergence with the scientific recommendations of international organizations of

reference in the area of medicine, with economic and public health consequences

gravosas for our country.

From highlighting still the fact that, despite the interesting and continuous growth of the market of

generics since some time to this part, these represent approximately 14%

of the total sales value of medicines in our country, in euros, while the volume of

units sold relatively to the total market if cipher only in the 10%.

This sets some de-virtues of the principles guiding the function of the generics in the

market, and requires taking of measures that position the generics in their importance

relative value / volume, in line with most of the countries that with all success

deployed in the market.

It becomes so clear, that the state, citizens, or both, spend on medications more

of what is reasonable and consenting to the level of average health care required in a

modern society, with the level of development and the possibilities of the Country.

It is still felt by professionals, at the level of diagnosis and therapy, some deficiency of

up-to-date and systematized information in accordance with the standards of DG Health and good

practices, which contributes to some dispersion in the criteria used in the clinical exercise,

potentially detrimental to the defence of professionals in the face of possible litigation with

the users of the system.

All of this has been contributing to a health system with some elements of expenditure

and dysfunctionality, incorporating unnecessary tensions for reasons that have nothing to do with

with the progress of the system, diminishing the trust of citizens, and feeding the idea of the

predominance of corporate interests over the interests of citizens.

4

Recalling and highlighting the important national developments in health care, and

recognized to the main agents the fair's merits of that evolution, it is absolutely

evident, imperious and inadible, the need for rationality and balance in this area.

The framework described can change in the best sense. The change is within reach of the

same agents and entities that contributed to a very positive evolution of the Country to the

long of the last decades, pores:

1 There are among the most developed countries of the European Union consumption shares of

generic drugs in the order of 40-50%. And such medications may be

obtained 35% cheaper than the originals. Portugal is far from this reality and

it is desirable for the state to quickly create conditions to reverse the current state

of things, safeguarding that generic medicines are actually

cheaper than the branded.

2 According to specialists in the sector, about half of the active substances

existing in the Portuguese market no longer have patent rights and can convert-

whether in generics. The domestic industry may have in the strengthening of the national market of the

generics a means of their own dynamisation and the search for competences and

competitive capacity in the international market, specifically through the

cooperation.

3 Studies reveal that in the last two years, 46.7% of prescribed medications

could have been replaced by generics, on the part of the doctors. It is indispensable

that the state mobilize and interest the health professionals for this dismay

national that everyone can benefit from.

4 The recent Protocol concluded between the Ministry of Health and Industry

Pharmaceuticals may come to constitute a new opportunity for rationalization of the

pharmaceutical market as well as the development of scientific research in

new molecules and in new internationalization projects based on innovation

technological.

5 State, health professionals, industry and pharmacies, can ensure the prescription,

the supply and dispensation of medications at appropriate doses to each therapeutic,

avoiding the colossal squandment that today occurs.

6 A The country's external economy will be highly benefited by a policy of

5

medication that promotes the increase in the consumption of generics and a decrease

of the wastage of the prescribed medications, whether generic or branded.

Attentive to this matter, interpreting and defending the interest of citizens, and surpassing

differences of ideological and partisan nature, the Assembly of the Republic may appoint a

way through a clear message of confidence in the possibility of creation of a

framework of solutions that should be of course requirement for each agent, but

simultaneously take into consideration their fair and balanced expectations,

integrated into a streamlined Portuguese market, without creating them constraints on

terms of sustainability.

Such a framework to be developed by the Government, must secure the agreement and a broad

participation of the sector actors, but it will not be able to be blocked by the resistance of

corporate interests, contrary to the greater interest of the Portuguese.

In the face of the recitals, the Assembly of the Republic resolves, in the terms of the provisions of the

(b) of Article 156º of the Constitution of the Portuguese Republic, to recommend to the Government

the following:

I-That develops a program that ensures the growth of the market of

generics, equiparable to the verified in the most developed countries in this area, and still

mechanisms leading to the respective prices to be effectively lower than those of

brand.

II-That promotes the consolidation of the business and competitiveness of the industry

pharmaceutical, in particular in the segment of the generics.

III-That develops studies in order to create unidosis in the dispensation and

marketing of the medications throughout the ambulatory.

IV-That encourages the functional units of the S.N.S. (Family Health Units,

Health Centres, Urgency Services, Hospitalar External Consultation Services, etc.) à

prescription of generic drugs, depending on the national targets.

V-Which adopt, in collaboration with the professional organisations of the sector

(specialty colleges of the order of doctors, medical associations, foundations,

medical societies, order of pharmacists), a " Manual or Guide to Good Practices in

6

Diagnostic and Therapeutic Examinations ", advisor and facilitator of professional practice, de

how to make converge the clinical performance in diagnosis and therapy according to the

good clinical practice of international consensuses and the current state of the art.

Palace of S. bento, May 11, 2006

The Deputies of the Socialist Party