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PROPOSED LAW NO. 204 /X

Exhibition of Motives

In the use of the legislative authorization granted by Law No. 8/2001 of May 21, the Government

has approved, by the Decree-Law No. 288/2001 of December 10, the Statute of the Order of the

Pharmaceuticals, in whose Article 77 defines the content of the pharmaceutical act, which

integrates, both in relation to the medicine of human use and the medicine

veterinarian, a set of activities that Article 76 of the appointed diploma reserves, in

exclusivity, the competence and responsibility of the pharmacist.

They are concerned, specifically, the registration, manufacture, control, storage,

conservation, wholesale and retail distribution, information, consultation, follow-up,

monitoring and control of the distribution, dispensation and use, of both the drug of use

human as the veterinary medicine, which are thus, indistinctly, subject to the

same uniqueness situation.

In what it touches, however, to the veterinary medicine, they are lacking today, by virtue of evolution

registered, arguments that support that exclusivity. In addition, having the exercise of the

pharmaceutical activity, as an essential objective, the person of the patient, as

significantly if achieved in Article 72 of the said Statute, reason none of

principle imposes the maintenance of that reserve of activity, as far as the

veterinary medicine, in the exclusive sphere of the pharmacist.

In effect, the differentiation of the status of the human-use medicinal product in relation to the

veterinary medicine, has been steadily asserting itself: so, for example, the

Decree-Law No. 72/91 of February 8, which defined the status of the drug of use

human, included, in the concept of the constant medicine of the point a) of your article 2, " all

the substance or composition that presented curative or preventive properties of the

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diseases and their symptoms, of man or of the animal ". This status of the medicine of

human use came, as early as 2006, to be replaced by the Decree-Law No. 176/2006, of 30 of

August, the which in the definition of medicine, constant of the point ee) of paragraph 1 of your article

3., limited it to " the whole substance presented as possessing curative properties or

preventive of diseases in human beings ".

In the same logic of differentiation of the human-use medicine regime in relation

to the veterinary medicinal product, came, following the Restructuring Programme of the

Central State Administration (PRACE), the supervision over the veterinary medicine

to be integrated into the mission of the Directorate General of Veterinary Veterinarian, under the terms of the h) from the

article 14 of the Decree-Law No. 209/2006 of October 27, while the

corresponding tasks of INFARMED, in respect of medicinal products, were

circumscribed to the medicinal product of human use, as a result of the point a) of the Article 2 (2)

17. of the Decree-Law No. 212/2006 of October 27. As a result of this development,

also the respective marketing fee, which was initially subject to the

same collection regime as the human-use medicinal product, by imposition of the

Decree-Law No. 282/95 of October 26 came to be of this highlight, by the effect of the recent

publication of the Decree-Law No. 253/2007 of July 9, which it awards to the Directorate General of

Veterinarian competence for its collection, as far as the veterinary medicine is concerned,

both immunological and pharmacological, and targeted the respective product, exclusively,

to the financial support of actions related to the quality assurance of the

veterinary medicinal products, from the National System of Pharmacovigilance and Toxicology

Veterinarian for veterinary medicinal products and the National Plan for Control of

Use of Medicinal Products Intended for Exploitation Animals, and still for actions

related to training and information of animal health professionals.

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On the other hand, Community legislation, collected and systematized, in two Directives

various, the status of the medicinal product of human use and the status of the medicinal product

veterinarian, respectively, Directive No 2001 /83/CE, of the European Parliament, and of the

Council, of November 6, and Directive No 2001 /82/CE of the European Parliament and

of the Council, of November 6.

Thus, the differentiation of the status of the veterinary medicinal product, should stay

definitely established, in internal planning, by the necessary transposition of the

Directive No 2001 /82/CE of November 6, of the European Parliament and of the Council,

amended by Directive No 2004 /28/CE of March 31, of the European Parliament and of the

Council, which institutes a real code of the veterinary medicine.

With this transposition occurs to occur to check that, the universe of professions that, nowadays,

have adequate knowledge of the correct and safe handling of the medicine

veterinarian, is not restricted to the pharmacist, as is apparent from the legislation itself

community, in which, in particular, the "qualified person" to be designated by the holder of the

authorization of veterinary medicinal products, is defined as the holder of a diploma

certified by a university training cycle in the disciplines of pharmacy, medicine,

veterinary medicine, chemistry, chemistry and pharmaceutical technologies and biology, in the terms

of Article 53 (2) of Directive No 2001 /82/CE of November 6, of the Parliament

European and the Council, as amended by Directive No 2004 /28/CE of March 31.

It will therefore be timely, with a view to the eminent transposition of the said Directive, to avoid

that all activity related to the veterinary medicinal product, stay acantoned, without

any justification, in the content of the pharmaceutical act, and consequently, under the

exclusive competence of the pharmacist. It is thus necessary to make changes to the

Status, in which this condicion, in relation to the veterinary medicinal product, the

competition and the free exercise of provision of services in this field.

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Of further mention, as stated in the recommendation No. 1/2006 of the Authority of the

Competition, issued following the European Council of Lisbon in March 2000,

where an economic reform programme was adopted, where it was emphasised to

importance of competition within the scope of services provided by the professions,

with the development of initiatives by the Commission, in the sense of motivating the authorities

of the Member States to undertake reforms with a view to removing the restrictions

regulations not objectively justified or replace them with less restrictive rules,

in such a way as to create greater conditions of competition in those professions.

The self-governing bodies of the Autonomous Regions and the Order of the

Pharmacists.

Thus:

Under the terms of the paragraph d) of Article 197 (1) of the Constitution, the Government presents to the

Assembly of the Republic the following proposal for a law:

Single article

Amendment to Decree-Law No 288/2001 of November 10

Article 76 of the Statute of the Order of Pharmacists, approved by the Decree-Law

n ° 288/2001 of November 10, it is replaced by the following:

" Article 76.

[...]

1. The pharmaceutical act shall be the sole competence and responsibility of the

pharmacists.

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2. The provisions of the preceding paragraph shall not apply to the drug of use

vet. "

Seen and approved in Council of Ministers of April 17, 2008

The Prime Minister

The Minister of the Presidency

The Minister of Parliamentary Affairs