Malta

[MT] Medicinal Products and Medical Treatments Consultation Document

IRIS 2007-10:1/28

Kevin Aquilina

Faculty of Laws, University of Malta

The Broadcasting Authority has launched a consultation process on the formulation of new Requirements as to standards and practice regulating programmes involving the participation of certain health care professionals in the broadcast media, and on advertisements, methods of advertising, and directions applicable to medicinal products and medical treatments. An Advisory Committee was set up by the Broadcasting Authority to draw up a consultation document, and is composed of one representative each of the Broadcasting Authority, the Consumer Affairs Council, the Medical Council, the Pharmacy Council, the Council for the Professions Complementary to Medicine, the Health Directorate General, and the Medicines Authority.

Briefly, the Requirements deal with the advertising of medicinal products, medicinal products and children, and medicinal claims. A definition of what constitutes a medicinal product and a medical treatment is afforded in the proposed Requirements. Various provisions are then made with regard to the detailed regulation of medicinal products and medical treatments, advertisements concerning female hygiene products, health promotion campaigns, and nutrition and health claims made with regard to food. Another aspect of the draft Requirements addresses the participation of certain health care professionals (that is, medical practitioners, dental surgeons, pharmacists, pharmacy technicians, nurses and midwives, but not including professions complementary to medicine as these are permitted to advertise in the broadcast media). The proposed rule here is that it should continue to be considered as contrary to the public interest, and discreditable, for certain health care professionals to advertise or canvass, directly or indirectly, for the purpose of obtaining patients or promoting his or her professional advantage. Indeed, careful consideration must be given to the ethical and legal implications of endorsements by certain health care professionals of a commercial product or service as is the case when new services are introduced about which patients are not well informed. Certain health care professionals must never overtly and publicly endorse advertisements for health-related services, such as nursing homes and private clinics.

On the other hand, certain health care professionals may participate in any programme on the broadcast media that discusses medical, semi-medical, dental or veterinary topics; listeners and viewers are entitled to be provided with information as to the professional academic qualifications of a practitioner who writes a book or article or gives a talk on radio and television; no information will, however, be provided that implies any unique or outstanding qualities or any greater experience in a particular field. Furthermore, all health care professionals are to refrain from discussing a medicinal product on the broadcast media. However, such professionals should, when discussing a therapeutic method, refer also to its side effects and when discussing a medical treatment refer to the need for the viewer or listener to contact a registered health care professional for advice, prior to receiving such treatment. The ill effects of such treatment should also be stated.

In so far as programmes involving medical matters are concerned, such programmes should not be of an advertising nature but of an informative and educational nature. These programmes will not be considered in breach of advertising regulations if several treatments provided by various hospitals and/or clinics are presented during the same series of the same programme. It is permitted to refer to a medical treatment provided that both its positive and negative aspects are mentioned, but it will not be acceptable to mention only the positive aspects of such treatments. The programme producer must also ensure that the programme is balanced when dealing with such positive and negative features. A member of staff of a hospital or clinic, which sponsors or advertises in that programme, will no longer be permitted to present themselves during the programme as the person who is administering a particular treatment.

Rules regulating sponsorship by undertakings involved in the manufacturing or sale of medicinal products and medical treatment and teleshopping of medicinal products and medical treatments, on the basis of the Television Without Frontiers Directive, are also referred to in the draft Requirements. Provision will also be made with regard to health warnings: all advertisements of medicinal products or medical treatments will have to contain wording to the effect that prior to purchasing the medicinal product or taking the medical treatment in question, the advice of a competent health care professional should be sought, as such medicine or treatment might have ill effects on one’s health and well-being. This health warning applies to all medicinal products, which do not need a prescription, and which may be bought over the counter, as well as to any type of medicinal treatment.

After the Advisory Committee discusses the feedback received, the Requirements will be revised accordingly and will be formally approved by the Broadcasting Authority. It is envisaged that these Requirements will become binding on 1 January 2008.