The NOAH Code of Practice for the
Promotion of Animal Medicines: A Short Guide
Introduction and History
The NOAH Code of Practice for the Promotion of Animal
Medicines has its origins in the Veterinary Code established in June l974 by
the Animal Health Register of the Association of the British Pharmaceutical
Industry (ABPI). In September 1978 that was replaced by the ABPI’s Code of
Practice for the Promotion of Animal Medicines.
NOAH was formed in 1986 and in 1987 became independent
from the ABPI, and adopted its own Code of Practice for the Promotion of
Animal Medicines in October 1987. As technologies, strategies and
expectations in the marketing world continue to evolve, so too have the
Rules of the Code, which has been amended regularly. The latest edition of the Code
can always be found on the NOAH website.
The Code also incorporates the provisions of the European
Code of Practice for the Animal Health Industry, adopted by IFAH-Europe. The
European Code, together with the Introduction to the NOAH Code are deemed
part of the Provisions of the Code and its Rules of Procedure.
As with any industry, marketing animal health products is
a key factor in spreading information about the benefits of their use, as
well as promoting sales. All advertising is subject to the rules of the
Advertising Standards Authority, but – as with human pharmaceuticals –
promotion of animal medicines is regulated. There are special requirements
in the law, in addition to which this industry Code of Practice is
obligatory on all NOAH members and has also been endorsed by several
non-member companies.
Why Promote?
Many animal medicines owe their existence to research
carried out by their manufacturers or to the development by them of results
of academic research. Before an animal medicine is placed on the market the
company will have accumulated considerable toxicological, pharmacological
and clinical evidence and will have met all the statutory requirements for
the testing, manufacture, and marketing of that product, including
compliance with the prevailing international requirements of ‘Good
Manufacturing Practice’ and ‘Good Laboratory Practice’.
With the full co-operation of the industry, comprehensive
national and European Community legislation has been introduced to safeguard
the public by ensuring that all medicines marketed meet standards of purity,
effectiveness and safety which are acceptable in the state of present
knowledge and experience.
It is necessary, however, for the company, operating as
it does in a keenly competitive industry and providing a range of products
in respect of which freedom of choice is essential, to draw attention to the
existence and nature of a particular product; for example, by appropriate
promotional measures and the dissemination of further knowledge and
experience gained in widespread use.
Self Regulation
While it is possible to legislate satisfactorily for the
testing, manufacture and control of animal medicines, NOAH believes
appropriate standards of marketing conduct cannot readily be defined by the
same means. For this reason responsible companies have agreed to be part of
and abide by the Code of Practice.
The Code emphasises the importance in the public interest
of providing accurate, fair and objective information on animal medicines so
that rational decisions for prescribing and use can be made. Moreover, the
Code accepts the principle that such information should be presented in a
form and by ways and means which conform not only to legal requirements but
also to ethical standards and canons of good taste.
The Code, therefore, represents an act of self-discipline
and participants are encouraged to resolve differences between themselves.
Acceptance and observance of its provisions are a condition of membership of
NOAH. Member companies also acknowledge that the Code itself is to be
applied in the spirit, as well as in the letter. Animal medicine companies
outside NOAH are invited to accept and observe the Code because it is
considered that ethical standards should be followed throughout the whole
industry if it is to maintain the confidence of all the interests which it
serves. Everyone who participates in the NOAH Compendium of Data Sheets for
Animal Medicines, for example, has to agree to abide by the Code.
NOAH member companies recognise that for the Code to
operate effectively, they must accept and abide by the decisions of the
Committee without delay.
The Committee
The Code is administered by a Committee set up by the
Board of Management of NOAH. The Committee consists of:
-
an independent legally qualified Chairman from
outside the industry, currently a barrister
-
seven further independent members not engaged in the
industry including four veterinarians and two livestock farmers
-
and eight members who are drawn from the senior
management of member companies of NOAH including at least four
veterinarians
The Chairman has general authority to obtain expert
assistance in any field, and has an original and a casting vote.
The Committee will meet to deal with complaints, to
secure compliance with the Code, and to make such recommendations as it
deems fit for the amendment of the provisions of the Code.
The Code
The term “promotion” means those marketing activities
under a company’s control which do or may encourage the prescribing, supply
or use of its products. This includes, for example, various aspects of sales
promotion such as journal and direct mail advertising including ‘teaser’
campaigns; the use of films and other audio-visual material and exhibitions;
the provision of samples, gifts and hospitality; and responses to technical
enquiries if such responses do or may encourage the prescribing supply or
use of the company’s products.
Dependent on the form of promotion, certain basic data
must be included, such as: the brand name; a list of the active ingredients;
indications for use; the possible side effects, precautions and
contra-indications; the legal category; the name and address of the
producer; and, when promoting POM-V or POM-VPS to people other than those
legally allowed to prescribe them, the promotion should include the clear
instructions that advice on the use of this or alternative medicines must be
sought from the medicines prescriber.
Promotions for POM-V medicines aimed at people other than
those legally allowed to prescribe them must include a focus on education
and/or disease information. By law, POM-V medicines may not be advertised to
the general public.
Perhaps the most important doctrine of the code is that “The
methods of promotion must never be such as to bring discredit upon, or
reduce confidence in, the industry”. There are sections of the code
detailing how promotion should be carried out and what may or may not be
permitted. These are:
-
Nature and Availability of Information
-
Claims and Comparisons
-
Disparaging References
-
Printed Promotional Material
-
References to Official Bodies
-
Distribution of Printed Promotional Material
-
Reprints, Abstracts and Quotations
-
Audio-Visual Material
-
Material Reproduced on Television Apparatus, Visual Display
Units and the like
-
Radio and Television Promotion
-
Sales Representatives
-
Samples
-
Market Research
-
Relations with the General Public and the Communication Media
-
Sponsorship, gifts, hospitality
In all these sections the fundamental advertising principles
“legal, decent, honest and truthful” apply.
How it works
Before the case
A complaint about an animal health product promotion can be
made by anyone, the complainant. The Code encourages complainants to try and
settle their differences directly. Only when such private contacts fail should a
case be passed to the committee. The complaint must be formally presented in
writing and sent to the Code of Practice Secretary. Once the complaint has been
received, a formal letter is sent to the company responsible for the promotion,
the respondent. After a reply has been received from the respondent the case
papers are circulated to the committee. Both parties are informed, and the
respondent and complainant are invited to appear at the meeting.
During the case
If a member of the committee is from either of the parties
involved in the case they are asked to leave the hearing, so there can be no
accusations of biased decisions. After reviewing the case papers, the committee invites the
complainant and respondent to make a statement and answer questions. Once the committee has heard from the parties they must deliberate on whether or
not the Code of Practice has been breached.
After the case
After the decision has been made, if any breach has been
found, a short press release is issued, summarising the committee’s findings.
Any party found in breach is required to give an appropriate undertaking not to
repeat the activity.
The minutes, giving the full background and reasons for
the decision, follow as soon as possible thereafter. A précis of each case
is produced: this is put on the NOAH website and sent to all companies that
are subject to the code.
Fees and Penalties
Over and above the costs involved in losing a case, the real
'teeth' of the code result from the ruling of the committee - a company can be
required to immediately withdraw an advertisement or leaflet and must sign an
undertaking not to repeat the practice. As the results of all cases are made
public, the publicity itself acts as an effective deterrent.
Finally any company refusing to comply with a ruling may be
suspended or expelled from NOAH. |
