Chris Penfold CEO of Design Cognition describes how the introduction of Braille to pharmaceutical packaging will impact on the industry
Braille and medicines labeling
Louis Braille, born 200 years ago, could never have imagined that his invention would change the lives of millions of blind people all over the world. Despite the enormous technological changes which have taken place since, there is still no other way in which a blind person can see a label or what is written on a piece of paper. There can be very few innovations which have stood the test of time in this way. To safeguard the millions of blind and partially sighted patients in Europe, in 2005 the EMEA introduced legislation (Article 56(a) of Council Directive 2001/83/EC) which requires labeling in Braille on the secondary packaging of virtually all pharmaceutical products; the only exceptions are products which are never handled by a patient. This change will dramatically increase the safety and sense of security of the many Braille users in Europe.
Support for Braille introduction
At Design Cognition we take the implementation of Braille very seriously. That is why our Chief Technical Officer Annie Dallison volunteered to be a member of the European Committee for Standardization (CEN) working group on Braille standards. As a leading industry expert, Annie already had over 8 years of experience in the application of Braille on pharmaceutical packaging developing processes and establishing & setting standards for blue chip companies, making her an ideal member of the working group. This CEN working group is made up of dedicated representatives from the packaging industry, trade associations, regulatory bodies and blind associations from across Europe. The group has been working for over 3 years to determine and agree standards, including the Braille font style (Marburg medium) and measurement of Braille cell dot height that can be applied across the whole of the EU. One of the main issues for the team has been reaching agreement on the cell dot height that the blind associations feel will be sufficient to meet the needs of the blind users and also industry believe is commercially achievable. The final standard should be available for October 2010.
The Facts
It has been mandatory to include Braille on all new EU Marketing Authorisations since 30th October 2005.
According to Article 56(a) of Council Directive 2001/83/EC it will be mandatory to include Braille on all EU pharmaceutical packaging by October 2010.
This includes pharmaceutical products which were launched prior to October 2005.
Braille must show the name of the medicine and the appropriate strength, where more than one strength is available.
In some markets the dose-form will also be required, where more than one dose is available.
Currently there is no EU standard for the font type for the Braille cell dots or their height this will hopefully change sometime next year with the publication of the CEN standards.
There are currently many examples of packs incorporating Braille on sale with varying degrees of quality and readability both of the Braille and the underlying text.
There has, historically been reluctance by some in the pharmaceutical packaging industry to allocate the time or money to incorporate Braille onto their packs but this will have to change if they are to meet the new requirements.
Inclusion of Braille on pharmaceutical packaging will significantly improve the safety of medicines for blind Braille readers.
Significant improvements in processes and equipment have been made in the last 5 years and Braille can now be applied onto numerous media types.
So what does it mean for you?
Developing Braille-compliant packaging can be a long process. You will need to develop an understanding in your business of the requirements and how they affect your particular products. The best way to start is by developing a strategy and priority list for implementation.
You need to work with artwork studios that have the appropriate software and skills to develop the required layered artwork. Develop and implement robust processes to manage the approval and version control of Braille artwork, remembering that most sighted approvers will not be able to read and approve Braille.
Find printers and converters who are geared-up to make the formes and can emboss the quality of Braille correctly and consistently on your packaging. Your suppliers, packing facilities and whole supply chain will need to ensure that there is no detrimental impact on the Braille quality. To ensure that you meet the requirements of the legislation, you need to start as soon as possible.
The majority of pharmaceutical packaging will be carton board but there are a number of products on the market without cartons so an understanding of applying Braille to labels as well as cartons is critical to the inclusion of Braille to your products/Brands.
This process can be costly, so it is important to get it right from the beginning. You will need to consider the cost of the artwork production and approvals, and also costs of regulatory submissions and commercialization. These could include new cutting, creasing & embossing forms.
The penalties for non-compliance are serious. The regulatory authorities could revoke the marketing authorisation and non-compliant products may have to be recalled from the market.
Getting it right
Design Cognition recently worked for a client whose three products are produced by different factories in different countries across Europe, and all subject to the inclusion of Braille on their packaging. We advised on Braille text, position on pack, possible impact of Braille on the readability of text and on branding, and all possible technical constraints.
The legal name of the product to be converted into Braille was confirmed by cross checking against appropriate regulatory approvals. Technical carton drawings from the relevant suppliers were acquired to determine and confirm the available space for Braille.
Two of the products were presented in the same carton size but differed only by flavour which meant that product A used one panel of the carton for Braille whilst product B used three panels for the extra text. We worked on enhancing the text and layout to ensure minimal disruption by Braille to the readability of the printed text.
Regular discussion with the client allowed us to negotiate and agree changes to the various elements of the design and packaging in order to minimize any impact on the brand or product. As a result, the packaging satisfies all regulations in respect of Braille labeling and meets the needs of different carton manufacturers in the supply chain.
Finally:
Braille need not be confusing if companies talk to experts who have the relevant experience and understanding of the process. It is good to see the needs of partially sighted and blind consumers being taken seriously in the marketing of pharmaceutical products. By implementing the Braille standard on all secondary medicinal packaging by October 2010, greater product accessibility is assured, as well as safety and peace of mind.
