Certification and Examination including Nominated Signatories
CERTIFICATION AND EXAMINATION
The PMCPA cannot approve any materials or activities, it can only give informal advice based on its interpretation of the ABPI Code. In the event of a complaint being received about a matter upon which advice was sought, it would be considered in the usual way; the ABPI Code of Practice Appeal Board would make the final decision if a case went to appeal.
Guidance is not a substitute for reading the ABPI Code.
A) BACKGROUND AND GENERAL COMMENTS
Certification has worked well since its introduction to the ABPI Code over 40 years ago and provides reassurance, particularly to those outside the industry that due diligence is performed to ensure compliance with the Code before materials are used or activities are carried out. Pharmaceutical companies are responsible for all materials, items and activities they, or a third party on their behalf, provide or deliver. The ABPI Code requires approval through certification or examination of certain material, items and activities and this helps to ensure companies comply with applicable UK applicable laws, regulations and codes of practice. The requirements are set out in Clause 14 and its supplementary information.
In most instances certification must be performed by a nominated signatory, who is either a registered medical practitioner or a pharmacist registered in the UK or alternatively, in the case of a product for dental use only, a UK registered dentist. When companies are deciding who can be a nominated signatory, account should be taken of product knowledge, relevant experience both within and outwith the industry, length of service and seniority. In addition, signatories must have an up-to-date, detailed knowledge of the ABPI Code (Clause 14.1). The person certifying must not be the person responsible for developing or drawing up the material, item or activity.
The certificate for promotional material must certify that the signatory has examined the final form of the material to ensure it is in accordance with relevant advertising regulations, the ABPI Code and is not inconsistent with the marketing authorization and the summary of product characteristics (SPC) and is a fair and truthful presentation of the facts about the medicine (Clause 14.5). The ABPI Code requires this certificate to be retained by companies. A sample of the material along with information about the method of dissemination, the persons it is to be used with and the date of first use must also be retained, as required by the Human Medicines Regulations (Clause 14.6).
The certification of meetings involving travel outside the UK, as detailed in Clause 14.2, can be carried out by an appropriately qualified person who does not need to be either a registered medical practitioner or a UK registered pharmacist. Such individuals must, nonetheless, have an up-to-date and detailed knowledge of the ABPI Code and account should be taken of their relevant experience both within and outwith the industry, length of service and seniority.
Companies must notify the Medicines and Healthcare products Regulatory Agency and the PMCPA of the names and qualifications of those nominated as signatories, this includes nominated appropriately qualified persons for the certification of meetings involving travel outside the UK.
It is important to note that the appropriately qualified person(s) a company nominates to check printed materials, where the electronic version has been certified, do not need to have the same experience as the appropriately qualified person who can certify meetings involving travel outside the UK. The names of the individuals who check printed material do not need to be notified to the MHRA or the PMCPA.
Final form for printed materials
The Supplementary information to Clause 14.1 states: When certifying material where the final form is to be printed companies can certify the final electronic version of the item to which no subsequent amendment will be made. When such material is printed the company must ensure that the printed material cannot be used until an appropriately qualified person has checked and signed the item in its final printed form. In such circumstances the material will have two certificates, and both must be preserved.
The certificate signed by the appropriately qualified person for the final form of printed material where the electronic version has been certified does not need to carry the certification wording set out in Clause 14.5. This certificate should carry wording which states the printed material has been checked and a copy of the final form of the material has been signed. The person’s name, signature and date should also be on this certificate.
Clause 14.3 lists material which is required to be certified. The supplementary information to Clause 14.3, Examination of Other Material, encourages the nominated signatory to examine certain non-promotional material to ensure that it does not contravene the ABPI Code or the relevant statutory requirements. A key requirement of certification is that signatories have all the pertinent information including how material is to be used. This is particularly important if the material is non-promotional. Nominated signatories need to be certain that such material is not being used for a promotional purpose.
Companies’ own policies and procedures are often more restrictive than the ABPI Code. There are examples where the arrangements for certification in a company go further than the requirements of Clause 14. For example the supplementary information to Clause 22.1, Certification of Meetings, states that companies must ensure that all meetings are checked to see that they comply with the ABPI Code and that companies must have a written document that sets out their policies on meetings and hospitality and the associated allowable expenditure. Only certain meetings which involve travel outside the UK must be formally certified as set out in Clause 14.2. Clause 14.2 of the ABPI Code states that all meetings involving travel outside the UK, unless the company’s only involvement is to support a speaker to present at the meeting, must be certified in advance. The supplementary information to Clause 14.2 sets out limited exceptions regarding certification and this should be consulted for details. Whether meetings require certification or not, companies are reminded that they nonetheless have responsibilities under the ABPI Code for meetings which they organise and when UK delegates and/or speakers are invited or supported to go to meetings outside the UK. Clauses 23 and 24 in relation to transfers of value also need to be followed.
The guidelines on company procedures relating to the ABPI Code of Practice (published at the back of the ABPI Code of Practice booklet) give helpful information about the process. It is important that all relevant materials are certified and that if an advertisement appears in two or more sizes or layouts each must be separately certified.
Companies may use validated electronic signatures for certifying the final form of material.
In relation to certifying material on databases, interactive systems and the Internet, companies must ensure that a written transcript of the material is certified including reproductions of any graphs, tables and the like that appear in it. In the event of a complaint, a copy of the written material will be requested. Alternatively, companies may certify material on interactive systems by means of producing an electronic copy, for example, on a CD ROM or data stick if the electronic copy is write protected and unable to be changed.
In relation to the certification of dynamic content on websites, the supplementary information to Clause 14.2 states: When certifying dynamic content for websites, care must be taken to ensure the dynamic content meets the requirements of the ABPI Code as a standalone item. As the final form of digital material might not be static, consideration needs to be given to the context in which it appears but each possible combination does not need to be certified.
B) WHAT NEEDS TO BE CERTIFIED?
- Promotional material.
- Meetings involving travel outside the UK unless the company’s only involvement is to support a speaker to present at the meeting.
- Educational material for the public or patients that relates to disease or medicines.
- Material relating to working with patient organisations as described in Clause 27 and its supplementary information.
- Material relating to joint working as described in Clause 20 and its supplementary information.
- Material relating to patient support programmes as described in Clause 18.2 and its supplementary information.
- Non-promotional material for patients or health professionals relating to the provision of medical and educational goods and services as described in Clause 19.1 and paragraph 8 of its supplementary information.
- Representatives’ briefing material as set out in Clause 15.9
C) JOINT VENTURES AND CO-PROMOTION
The supplementary information to Clause 14.1, Joint Ventures and Co-Promotion, makes it clear that under co-promotion arrangements, whereby companies jointly promote the same medicines and the promotional material bears both company names, each company will be held jointly responsible for it under the ABPI Code. In some instances where two companies are both promoting the same product the companies can agree beforehand to have only one final signatory to certify on behalf of both companies. The PMCPA and MHRA must be informed in advance who the signatory will be.
D) MULTI COMPANY PROJECTS – INCLUDING MULTI COMPANY JOINT WORKING PROJECTS
These are often quite detailed projects and project management is very important. The project plan should set out the responsibilities for each company in relation to ensuring that the arrangements and materials meet the requirements of the ABPI Code. Before finalising the project plan each company should be confident that any ABPI Code issues have been resolved. Often it is the way that activities are done that leads to problems rather than the project aim. With good planning, including early involvement of the appropriate personnel, final certification can be relatively straightforward.
As with joint ventures and co-promotion above, the companies can agree to have only one final signatory to certify on behalf of all the companies. The arrangements for certification should be clear and agreed at the outset.
If the companies decide to have only one final signatory for the project, rather than each company certifying the material, then as in Point C above, the arrangements must be agreed beforehand and the PMCPA and MHRA informed in advance who the nominated signatory will be.
If a complaint were received about a multi-company project then all the companies would be responsible under the ABPI Code. Similarly, if a complaint were received about a project run by an ABPI group then all the members would be contacted and would be responsible under the ABPI Code.
E) HOW TO HELP THOSE CERTIFYING JOINT WORKING PROJECTS
It is important that all staff in a position to identify a joint working opportunity are aware of the definition of such projects. Joint working is defined by the Department of Health (and detailed in the supplementary information to Clause 20).
The following may be useful questions to ask in relation to joint working but may apply more widely:
- Are staff drawing up joint working projects familiar with the ABPI Code requirements and other relevant documents including company policies and procedures?
- For each project, is all the documentation clear about each party’s role and contribution to the project?
- Have company compliance experts and signatories been involved in the project right from the start and throughout its development?
- Has sufficient time been allowed for approval?
- Are the materials put into the approval system capable of being approved? Does the material and suggested activity comply with the ABPI Code? Is it in line with company policies? Is it grammatically correct?
- Does the project plan cover certification arrangements?
- Are records of meetings and agreed actions kept and meeting outcomes followed up?
- Are the relevant personnel attending meetings?