The 2016 ABPI Code of Practice, among other changes, now states that promotional material and activities can be certified by one suitably qualified individual as opposed to the previous requirement for two. It maintains that this person must be 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. The person certifying on behalf of the company must not be the person responsible for developing or drawing up the material.
The change was prompted to bring the code in line with the European Federation for Pharmaceutical Industry Associations (EFPIA) Code on the promotion of prescription-only medicines. It is not without its critics however, as was reflected during the consultation process, with many concerned about the quality of materials that will be produced and overall compliance and efficiency. This is to be expected as certification by two signatories was first introduced as far back as 1978.
What the change will mean
As an experienced medical signatory, my initial thoughts as the news broke were those of disbelief. Surely it would never come to fruition – signing off job bags without a check by a second signatory seemed inconceivable. I had come to depend on the invaluable input and expertise of my non- medical signatory colleagues, even with a solid compliance background behind me. Herein lies the controversy – are all medical signatories experienced on code issues? Now they’ll have to be as this new responsibility (and it is new) in effect merges both compliance and medical expertise.
Some companies have traditionally assigned medical signatory responsibility mainly based on the professional qualifications of the individual, give or take a few sessions of ABPI Code training, rather than on any associated in-depth experience of the Code. This worked because the non-medical signatories would then make up any shortfall in experience. This is no longer the case and although many, such as myself, would be confident going forward, I am aware of some who would not.
Companies can proceed with the existing status quo (two signatories in place) if they so wish
The Prescription Medicines Code of Practice Authority (PMCPA) recognises this and have said companies can proceed with the existing status quo (two signatories in place) if they so wish, however, the medical signatory, in their view, will be ultimately responsible for the final sign-off. Medical signatories should ensure that the job review procedure in place is robust and proficient before accepting roles, as this will help to ameliorate the even greater increase in pressure the change is bound to bring. It will also promote further engagement of medical and marketing teams and lead to an increase in knowledge and awareness, which is good for the industry.
What does this mean for the non-medical signatory? In some companies this role was simply foisted on product managers but in others it is a niche role that forms part of the compliance structure. In my opinion, this experience should not be undervalued but instead recognised and harnessed within the company.
There are advantages to the change. The ABPI Code should be consistent with the EFPIA as companies increasingly take on a more global streamlined structure. It is expected that marketing colleagues will reap the benefits of fewer cogs in the wheels of certification, freeing them up to do what they love, with a quicker turnaround of materials to boost. For managers, it would be wise to proceed cautiously when incorporating this change. I suggest this eight-step process:
- Create a sense of urgency – get people excited about the change.
- Build a guiding coalition – assemble a group with the power and energy to lead and support a collaborative change effort, but remember that a consideration of personality types is important here.
- Form a strategic vision – not every material has to be certified; some can be examined – an extra review cycle can be introduced with a final single sign-off to mitigate risk.
- Engage a competent medical signatory – nothing drives change like results, and competence will raise confidence within the organisation as a whole.
- Enable action by removing barriers – remove obstacles to this change such as computer systems that are not compatible.
- Generate a short-term win – consistently produce; track, evaluate and celebrate both small and large accomplishments, such as a reduction in job-bag turnover times.
- Sustain acceleration use – thereby increasing credibility to change systems, structures and SOPS.
- Institute, change and articulate the connections between the change and organisational success, and develop the means to ensure leadership development and succession.
Finally, as an industry, we should not be afraid to objectively evaluate the process – acknowledge it if it doesn’t work and celebrate if it does.
