The present guidelines are issued by the European Blind Union which represents
more than 10 million blind and partially sighted consumers in Europe, in
particular those residing in European Union countries.
In the recent amendment of the EU directive, 2001/83 EC as amended in directive
2004/27stEC, art 56 A, 2nd sentence:
"the marketing authorisation holder shall ensure that the package information
leaflet is made available on request from patients' organisations in formats
appropriate for blind and partially-sighted".
The article also includes a provision regarding Braille labelling on medicine
packages. This issue is dealt with in a separate set of guidelines provided by
the European Blind Union.
The provisions set out in the EU directive offer a way of meeting a
long-standing need to give visually impaired citizens in Europe the same access
to information about medicine as their sighted peers. The proportion of elderly
people in the visually impaired population is on the increase. They are a key
target group due to their special vulnerability. Their special needs should
therefore be considered in the guidelines which follow.
The European Commission, Directorate-General on Enterprise and
Industry, has issued a guidance note on this issue, amongst other things.
The type of print used in such material for partially sighted people in large
print is specified: sans serif typefaces, 16-20 point, contrast, black letters
on white paper, word spacing, alignment, line spacing, layout, paper quality.
As for persons with no residual sight ("blind people"), it is specified that the
text has to be provided in an appropriate format perceptible by hearing (CD-Rom,
audio cassette, etc.). In certain cases, it may be appropriate to have the PIL
available in Braille.
Choice of the appropriate medium should be made by the Market Authorisation
Holder (MAH) in consultation with representatives of organizations for the blind
and partially sighted. It is the responsibility of the MAH to provide the PIL on
request from patients' organizations in the appropriate format and to ensure
that the current version is supplied.
The EBU comprises organizations in 45 European countries including all EU
countries and EEA countries. The EBU thus speaks as the voice of all visually
impaired end-users and should be regarded as such by authorities and
entities/agencies dealing with pharmaceutical matters that have an impact on
visually impaired persons. At a national level, authorities and bodies
representing the pharmaceutical industry should as far as possible address the
acknowledged and authoritative organisation of the blind in the country in
question. In this way they will obtain the clearest indication of how visually
impaired people themselves regard solutions. To take advantage of the
representative character and expertise of the European Blind Union, we strongly
recommend that where any given system is devised and operated by an entity that
is not an organisation of the visually impaired, organisations of the visually
impaired (national as well as the European Blind Union) are informed and
consulted so as to make sure that the system adequately meets the needs of
people with a visual impairment.
It is the view of the EBU that any national organisation of the blind can act as a patients' organisation and, as a representative of end-users who for this purpose count as patients, request that the package leaflet of a specific product or of products in general should be made accessible for their members and for other visually impaired people in the country in question. In this context, organizations of the blind generally work on behalf not only of their registered members but of all persons in the country with a severe visual impairment. The organisation is considered the focal point of expertise when the issues relate to visually impaired persons. However, more mainstream patients' organizations may also make requests of MAH's, where they are nationally acknowledged and recognised, regarding the providing PIL information in accessible formats.
A request may arise either as a concrete request to the MAH on a specific product or category of products, or as a more general request to make all PIL's related to medicinal products comprised by the authorisation of a specific MAH available. However, it is the opinion of the EBU that a request may also arise as a consequence of general discussion between the patients' organisation(s) and representative bodies of the pharmaceutical industry. If such negotiations yield satisfactory results, this may lead to action designed to make all product information accessible in line with given specifications.
To meet the requirements in the Directive Art 56 A, 2nd sentence, the following
requirements should as a minimum be met:
6,1. To ensure that all visually impaired end-users of medicinal products are
accommodated, package leaflet information must be made accessible in all
relevant formats, i.e. in the three main formats: Audio, large print and
Braille.
6,2. All PIL information must be made available free of charge to visually
impaired end-users regardless of format.
6,3. The system/systems applied must be modular, i.e. flexible and available for
upgrades.
6,4. Any national system must offer the information in the relevant national
language/languages. If a system is meant for service in more countries/language
zones, it must be adaptable for all relevant languages.
6,5. It must be applicable in all relevant technical environments. Thus if
services are rendered via the telephone and/or the internet, the systems used
must accommodate the end-users' specific needs and possibilities regarding
ability to access information. The information must be made readily available,
i.e. in a timely manner and without delay.
6,6. To make the system as transparent as possible for the visually impaired
end-user, all possible efforts should be made to ensure that a single point of
contact nationally or even regionally is established. This will help avoid
confusion as to where to go to order PIL information and also be the best way to
avoid duplication of the same information. This principle of information
retrieval from a single point should not limit the possibility of
sub-contracting production to private or public entities with the necessary
expertise and equipment.
In the event that service providers, companies or agencies specifically serving visually impaired persons or of a more general nature offer systems that make package leaflet information accessible either in specific formats or in an integrated manner, be it nationally or for use in more countries, the requirements mentioned above under item 6 must be adhered to in order to meet with the preconditions following from the directive. The EBU cannot recommend any specific system but is happy to offer guidance, undertake tests, give guidance on quality control, etc. In the event that international standards are developed by authoritative bodies, EBU assumes that it may represent the end-users (visually impaired persons) in any working groups or other standardisation bodies set up.
Further information on matters at European level can be obtained
from the European Blind Union office
European Blind Union
58 Avenue Bosquet
75007 Paris
FRANCE
Tel: (33-1) 47 05 38 20
Fax: (33-1) 47 05 38 21
E-mail: ebuoffice@euroblind.org