Promotion/information

Control of promotion information APMA + TGA co-regulation y Drug Council/ Pharm. Services Div. SAM Pharm. Services Dept. KOAG DPM NDA INH MCAZ... 

Except in the United States of America and New Zealand, where direct to consumer (DTC) advertising of prescription medicines is allowed, companies are not allowed to communicate directly with patients. The Association of the Pharmaceutical Industry (ABPl) Code of Practice has been relaxed a little in this area in recent years and companies can now communicate in a very limited fashion with the general public. Clause 20.2 of the Code allows the provision of non-promotional information either in response to a direct enquiry from an individual or via press conferences, press announcements, lectures and media reports, public relations activities and the like. 

At the time this information is required, the medicines concerned (or the changes to them) will not be the subject of marketing authorizations (though applications will often have been made) and it would thus be contrary to the code for them to be promoted. Information may, however, be provided on the following basis ... 

A CTSA does not recommend alternatives. Instead, the goal is to promote informed decisions that integrate risk, performance, and cost concerns by providing businesses with easily accessible information. 

In 1982, the European Union s Council Directive 82/501/EEC on the major-accident hazards of certain industrial activities, also known as the Seveso Directive, was adopted. The Directive was mostly designed to promote information flow and created the requirement that each Member State (i.e., each country belonging to the European Union) appoint a Competent Authority to oversee safety issues. The Seveso Directive was amended twice, following major accidents at the Union Carbide chemical factory in Bhopal, India in 1984 (a leak of methyl isocyanate caused thousands of deaths), and at the Sandoz chemical warehouse in Basel, Switzerland in 1986 (fire-fighting water contaminated with mercury, organophosphate pesticides and other chemicals caused massive pollution of the Rhine River and the death of hundreds of thousands of fish). Both amendments, broadened the scope of the Directive, in particular to include the storage of dangerous substances. 

Promotional information should be clear, legible, accurate, balanced, fair, objective and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the pharmaceutical product concerned. Promotional information should be based on an up-to-date evaluation of all relevant evidence and reflect that evidence clearly. It should not mislead by distortion, exaggeration, undue emphasis or omission, or in any other way. Every effort should be made to avoid ambiguity. Absolute or all-embracing claims should be used with caution and only with adequate qualification and substantiation. 

Promotional information should not imitate the devices, copy, slogans or general layout adopted by other manufacturers in a way that is likely to mislead or confuse. 

Promotional information should not imitate the devices, copy, slogans or general layout adopted by other manufacturers in a way that is likely to mislead or confuse. Promotional information must not infringe or be able to infringe intellectual property rights, trademarks, patents or similar rights of other person or entity. 

Promotional information that appears on exhibition stands or is distributed to participants at international scientific congresses and symposia may refer to pharmaceutical products that are not registered in the country where the event takes place, or registered under different conditions, provided that the following conditions are observed ... 

Promotional information should be clear, legible, accurate, balanced, fair, objective and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the pharmaceutical product concerned. 

Promotional information should be based on an up-to-date evaluation of all relevant evidence and reflect that evidence clearly. It should not mislead by distortion, exaggeration, undue emphasis, omission, or in any other way. Every effort should be made to avoid ambiguity. 

Non-promotional information for patients and the general public Subject to any applicable national laws and regulations, websites may include non-promotional information for patients and the general public on products distributed by the company (including information on their indications, side effects, interactions with other medicines, proper use, reports of clinical research, etc.), provided that such information is balanced, accurate and consistent with the approved summary of product characteristics (SPC). For each product that is discussed, the website must contain full, unedited copies of the current SPC and patient leaflet. These documents should be posted in conjunction with other information about the products or be connected with that discussion by a prominent link advising the reader to consult them. In addition, the website may provide a link to the full, unedited copy of any public assessment report issued by the Committee for Medicinal Products for Human Use or a relevant national competent authority. Brand names should be accompanied by recommended international non-proprietary names (rINNs). 

Promotion of a website that contains promotional information by non-web-based mechanisms, e.g. sales representatives, direct mail, journal ads, would require prior PAAB clearance review of the website content. 

It provides practical knowledge and advice that is independent of government and acts as a balance to promotional information provided by the pharmaceutical industry. 

Decision no. 645/96/CEE of the European Parliament and Council, of 29 March 1996, for adopting a Community programme for promotion, information, education and training in health matters within the framework of action in the public health sphere (1996-2000). 

In light of current policies that are unevenly evoked to ensure safety and efficacy, reliance on promotional information, no matter how skillfully executed, this is folly unless authoritative scientific evaluations are well known to back up any claims of worth and parameters of use. There is little meaning in the belief that natural is safe, any more than one can expect the same for a pharmaceutically derived product. The following guidelines for rational herb use follow many recommendations already outlined by Murphy (1999) and Drew and Myers (1997) (Table IX). 

All information supplied through a pharmaceutical company marketing department will be regarded as promotional in nature. After all, the information would not be disseminated unless it was designed to increase the consumption of the medicinal product in question. Information can only be regarded as non-promotional if its dissemination is supervised by the medical department and is clearly scientific and factual in nature. Even then it should be clearly understood that information sent out by the medical department can be subject to and considered under the Code of Practice. The concept of promotional information can be readily controlled and be acceptable to prescribers as unbiased information when it has been seen to be subject to medical department review and approval in the same way that promotional material is reviewed and approved. Indeed, one would advise that when scientific information is to be used on a promotional basis, for example a scientific article or medical report, it should be clear that the piece is being used with the support of the medical department review process. 

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