Proposition 51K2125

Projet de loi modifiant l'arrêté royal n° 78 du 10 novembre 1967 relatif à l'exercice des professions des soins de santé.

General information ¶

Submitted by

PS | SP MR Open Vld Vooruit Purple Ⅰ

Submission date

Nov. 29, 2005

Official page

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Status

Adopted

Requirement

Simple

Subjects

pharmacist health care profession paramedical profession

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Discussion ¶

March 8, 2006 | Plenary session (Chamber of representatives)

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Mr. Speaker, Mr. Minister, dear colleagues, our committee examined this bill at its meetings of 10 January, 7 and 14 February 2006. by

In his introductory presentation, the Minister of Social Affairs and Public Health recalls that the bill under consideration intends to concrete the results of a reflection on the role of the pharmacist, initiated in 2004 and concretized in the Framework Agreement concluded with the representatives of pharmacists and ratified by the Council of Ministers of 20 and 21 March 2004. by

The role of the pharmacist as a health professional and specialist in medicines is affirmed here. This framework agreement aims in particular to modify the method of remuneration of pharmaceutical practitioners so that it takes into account the added value of the pharmacist’s intervention in the context of patient care.

The role of the pharmacist is to provide the patient with quality pharmaceutical medicines and services at the most appropriate cost and with the greatest transparency. The pharmacist must work together with other health professionals, in particular with the treating physician in the patient’s interest. Effective pharmaceutical monitoring should be systematically implemented in order to prevent and limit adverse effects and accidents resulting from both the effects of medicinal products and the circumstances of their use. by

The pharmacist’s advice on loyalty to treatment, prevention, detection and problem-solving is an essential part of the pharmacist’s role. The pharmacist also ensures the distribution of the medicines and thus guarantees their accessibility. by

The bill defines the concept of pharmaceutical care and provides for the possibility for several pharmacists to associate to operate the same pharmacy without resulting in an increase in the administrative burden. by

The draft includes provisions for administrative simplification, in particular as regards the conditions and procedure to which the transfer or temporary closure of a pharmaceutical office is subject.

In the general discussion, Mr. Luc Goutry supports the bill to be examined in so far as it facilitates the provision of medicines for compassionate use and ensures administrative simplification. Ms. Tilmans welcomes the options adopted by the bill as well as the consultation that preceded its elaboration. Ms Avontroodt appreciates the consultation that preceded the drafting of the bill under discussion. A distinction should be made between the proprietary pharmacist, made responsible by the draft law for the pharmaceutical acts and the management of the pharmaceutical office, and the holder of the authorisation that is not covered by the project.

by Mr. Drèze notes that the bill extends the duties of the pharmacist, but specifies that he must exercise them in close consultation with the doctor.

As regards the sanction for the breaches committed by the holder of the authorization, the Minister refers to the bill that constitutes a sufficient basis: the holder of the authorization must provide the holder of the office with the means, equipment and autonomy necessary for the exercise of the profession.

Ms. Detiège notes that the pharmacist who works for a company must also know that he has a responsibility. When he is interpelled by the Order for a particular problem, it is also his responsibility to justify himself. by

Mrs Avontroodt, however, recalls that the licensed pharmacist is often in a subordinate relationship with the authorisation holder.

Now to the discussion of articles and votes.

In article 1bis, Ms Avontroodt et consorts submit an amendment aimed at inserting a new article 1bis. Referring to her intervention during the general discussion, Mrs Avontroodt indicates that the words "pharmaceutical art" should be replaced in the title of chapter 1 of Royal Decree 78 with the words "pharmaceutical care". This amendment will be reposted for each article where these words will appear.

The Minister considers that the terminology issue raised by Ms Avontroodt seems reasonable in so far as the terminology used in the bill is adapted. However, it should be noted that in French, the adaptation of terminology can pose problems: replacing the words "pharmaceutical art" with the words "pharmaceutical care" gives the impression of a regression, the exercise of an art may seem more noble than the simple dispensation of pharmaceutical care. by

Before proceeding to vote on the articles, the committee decided to submit Amendments No. 1 to 13 of Mrs. Avontroodt and accompanied to the opinion of the Belgian Pharmaceutical Association (APB) and of the Office des pharmacies coopératives de Belgique (OPHACO). The Committee took note of the opinions requested at its meeting of 14 February 2006. The Minister of Social Affairs and Public Health stressed that both the APB and the OPHACO were unfavorable to amendments no. 1 to 13. These organisations, in fact, consider that the approach to replace the terminology used in Royal Decree 78 is premature; it must, on the contrary, be subject to thorough consideration. Therefore, at the Minister’s invitation, Ms. Avontroodt withdraws its amendments while considering that the reflection should be continued in order to adapt the terminology to the current reality of the pharmaceutical profession. Amendments 1 to 13 were therefore withdrawn. Articles 1 to 6 are successively adopted unanimously. The entire draft law is adopted unanimously.

Mr. Speaker, you’ll apologize, I’m leaving the Public Health Committee and I’m trying to get my breath back.

He arrives, he is questioned by television. by

Mr. Speaker, Mr. Minister, Mr. Colleagues, in the preamble, I am delighted that the various provisions have been the subject of broad consultation to lead to an agreement with the pharmacists. This agreement was ratified by the government at the Council of Ministers of Ostende in March 2004.

As for this bill, it defines the concept of pharmaceutical care and empowers the King to define the principles and guidelines of good pharmaceutical practice. These provisions are excessively important since, by doing so, we rehabilitate the role of the pharmacist in the framework of proximity medicine. by

In fact, the pharmacist is also a first line provider. From preparer of medicines, he also becomes a dispenser but above all, he is the counselor in the field of medicine. Pharmaceutical care, in collaboration and in consultation with the treating physician, now addresses all types of problems related to medicines and includes the detection and resolution of problems related to the use of medicines. They also include pharmaceutical accompaniment in the form of information or advice to patients, during and after the delivery of the medicinal product for optimal, effective and safe use. With this in mind, we demand the establishment of a delivery fee to enhance the active role of the pharmacist in the healthcare system.

Finally, this bill promotes the provision of medicines for compassionate use, as doctors and dental practitioners will also be able to provide these medicines in addition to emergency medicines and samples. I will here recall what the notion of compassionate use medication covers. It is the provision, for compassionate reasons, of a medicinal product to a group of patients suffering from an invalidating, chronic or severe disease or a disease considered to put the life of the patient in danger. These patients cannot therefore be treated satisfactorily by an authorised medicinal product. The medicinal product concerned must be the subject of an application for a marketing authorisation or be the subject of clinical trials. In general, the access of Belgian patients to innovative medicines is the subject of our full attention. The provision of medicines for compassionate use is a positive measure, but it cannot, of course, serve as a pretext for the authority not to authorize, within a prompt time, the placing on the market of this type of medicines.

Strict compliance with the deadlines for the authorisation of innovative medicines is obviously imperative. At the same time, an appropriate budget must be released, otherwise these innovative drugs will remain inaccessible.

Here, Mr. Speaker, Mr. Minister, dear colleagues, are the various remarks I wanted to make to this debate.