After carrying out a detailed search, I was unable to ascertain a definite explanation for the term Copy-Approval. However, I would coin the term as the following:
It is an assessment and evaluation activity; which examines both legal and ethical aspects of a material. It endeavours to ensure certified materials, although adhering to strict ethics and the code of practice does not stifle the creative delivery of the required message (promotional or non-promotional).
Why does copy approval occur?
It is a requirement of the ABPI code of practice and is also insinuated by the PAGB code of practice. The process ensures the industry is not brought into disrepute, and also ensures the company adheres to the relevant UK legislation. It helps uphold and maintain the integrity of the Company, Employees and the Pharmaceutical industry. Furthermore, it helps safeguard patients and ensures an ethical approach to advertising of medicines.
Who is involved in copy-approval?
The process varies within companies; the number of steps in place and the number of certifiers. However, the principles should stay the same.
The ABPI code stipulates that in the penultimate stage of copy approval, one senior members of the company must certify promotional materials before it can be used. Previously two signatories were required, one of the signatories had to be a medical signatory, this is usually a Medical Doctor but more recently a UK registered Pharmacist (March 2014).
Marketing personnel will also be involved in the process alongside subject matter experts (SME). The process involves a great degree of teamwork and deliberating, as the certifiers liaise with various Key opinion leaders (KOLs) to ensure a pragmatic resolution is reached to any uncertainties the signatory may have. It is important that a signatory is able to empathise and recognise the positions of the KOLs, whilst maintaining a high degree of professional integrity. For example, Marketing and Certifiers often find themselves in a conundrum. I personally think it is a beautiful challenge. The marketing team with their exciting ideas, constantly pushing down barriers and creating innovative methods to ensure the message reaches its target. However, a certifier would always ensure a cautious approach takes precedence. This challenge can lead to a stifling in the creativity of the marketing team and cause some frustration. Thus adequate negotiation and liaising skills are paramount. Empathy is also important at this stage, it is important for both parties to ensure they are emotionally detached and always remember that they have the same goal.
As a signatory, it is your responsibility to ensure that materials uphold the appropriate Legal requirements but also to ensure that they adhere to the highest standards of ethical practice and company values. Thus, a certain degree of professional autonomy is required, supporting the suitability of a Doctor or a Pharmacist for the role.
What Materials are subject to Copy Approval?
The ABPI code advocates the requirement for promotional materials to be certified, it also includes some non-promotional materials.
|Rep briefing materials||Promotional/Non-promotional||Yes/No|
|Meetings and symposia’s.||Promotional / Non-promotional||Yes|
|NHS joint working||Non-promotional||Yes|
|Joint working with patient
Tablet 1: shows the different types of materials, their status and certification requirement.
It is important to note that materials relating to new medications are subject to pre-vetting by the MHRA.
The PAGB pre-vets all materials subject to advertising for consumers. Nonetheless, the material should have been through a rigorous in-house approval process.
What should be considered during this process?
|Key aspects||Rational||Additional requirements|
|The code has more stringent requirements than the legislation. It encompasses the law and much more.||Adhere to the code not only to the letter but also in spirit (signatories must confirm this by signing).|
|PAGB Code||The code aims to protect consumers, and the PAGB will pre-vet materials before allowing them to be released.||OTC adverts must be pre-vetted by the PAGB.|
|MHRA-blue guide||The advertising regulations are included in this guide. Such as ensuring promotion of a material is within the Marketing authorisation.||MHRA Pre-vets materials relating to new medicines.
Signatories of a company must notify the MHRA advertising unit before carrying out any signatory duties for the company.
MHRA offers a list of approved words and definition of those words used – a useful guide to always refer.
|Advertising rules||CAP, BCAP, ASA||Relates to OTC medicines.|
|Trade description act||Claims, comparison|
|Anti- bribery act||Important to ensure promotional material does not act as an inducement. Directly or indirectly. It is important to ensure if non-promotional material, the material cannot be deemed as a disguised advertisement.|
|Ethical principles||In order to ensure intentions of the promotional materials are not misconstrued.||Consider different opinions and ethical dilemmas that the material could pose.|
|Company Values & Brand Values||Important to ensure the process adheres to company values such as transparency.||Always consider the position of the brand and keep inline with this theme.|
|Subject matter expert||Important to ensure these individuals knowledge and expertise in a therapeutic area are utilised effectively to ensure accuracy of promotional materials.|
Table 2: shows the key aspects to consider during certification.
As a final signatory the material presented to you should have been refined. The material would have been processed and should exclude basic errors. At this stage the above aspects should be considered, it should also be viewed inline with the bigger picture (end goal). Furthermore, at this stage your role should involve foreseeing future objections that the material may pose. Therefore, the final signatory acts as the final barrier or the final part of the risk management step.
Legal & technical aspects
Consider the following:
- ABPI & PAGB code
- MHRA blue guide
- Copyright laws – when using quotes.
- Trade description act & Company SOPs
- Prescribing information – ensure all required details present.
- Pharmacovigilance – reporting statement and black triangle (if required).
- Abbreviated adverts – ensure all required details present.
- Images use – Approach with caution. A pixel is worth a thousand words. Thus there are uncountable ways in which an image can be misconstrued. Basic principles – avoid celebrities, distasteful images, appropriate participants should be used in an image (i.e. age group).
Message concept & accuracy
Consider the following:
- Are the messages portrayed by the promotional material: Unambiguous, balanced, relevant and not denigrating.
- Quotes and reference – must reflect the updated view of the publisher.
- Ensure the message is inline with the following; SPC, Brand theme, Company values and ABPI code.
- Check reference – ensure accuracy of journals; critical appraisal to ensure relevant and not misleading.
Key Opinion Leaders & concordance
Consider the following:
- Ensure appropriate skill mix, respect and utilise expertise of each individual (SME).
- Embrace challenges and dilemmas; this breeds innovation.
Ethical aspects; a fine balance between intentions and actions
Consider the following:
- Understanding Intentions – Everybody has good intentions, yet not everything goes according to plan. Thus, the suggestion of a colleague may need a slight tweak to ensure their intentions match the result.
- Perception – Images may conjure countless views from a variety of audience. Always approach with caution!
- Dilemmas, which cannot be solved by mere adherence to Legal requirements, should always revert to basic principles. Ethics is the foundation of Law. Thus, often will guide you to the right result/answer.
We live in digital environment, social media and the fast pace of technology has changed the way in which patients and healthcare professionals interact and communicate. Thus engaging in digital communication is becoming essential, whether this will be in the form of an aboard or an educational video. A few key rules to remember when dealing with advertisement on a digital environment. Firstly, the ABPI code does not provide an exemption of obligation for a digital material – the obligations are the same and possibly require even more consideration-You may ask why? Well the reality is the digital environment has the potential to reach billions of people and thus bring the industry to disrepute instantaneously. For example, Facebook has over 1.35 billion users according to Time magazine. Lets put things in context:
The population of the earth is currently about 7.2 billion. There are about 2.9 billion people on the Internet, give or take a hundred million. (Mark Zuckerberg)
Now it becomes a bit more clearer how important social media can be in the context of your business, its essentially a double sword it has the potential to help raise awareness of a disease area and thus potential company profile. However, it can destroy a company profile overnight. Click here to learn about how one man took on British Airways using social media.
The ABPI code does offer specific guidance regarding digital promotions/campaigns and this includes ensuring that the Prescribing information is easily accessible – 1 click is all it should take to reach the PI. Also, the code stipulates that if the material is intended for offline then the PI should also be accessible offline. Audience is particularly key when carrying out digital promotion, thus tailoring the content carefully to the audience should be crucial remember information travels fast online.
One of the most daunting challenges faced by the pharmaceutical industry are the drug safety requirements, a digital material can trigger comments which MUST be reported to drug safety within a specific time frame. It is difficult in some instances to capture this and to control or manage it. A thorough risk analysis and scenario planning is required by competent individuals to ensure that all possibilities are covered.
Below is a length video by Jayne Packham who gives a brief intro into the ABPI code
Adebola S Tojuola MPharmS
Initially written : 04/08/2014
Photo credits: Khalid Albah