Are you ready for the 1st May?

Rebecca Aris

pharmaphorum

Well are you? It is just a Sunday after all, as Heather Simmonds, Director of the UK’s Prescription Medicines Code of Practice Authority (PMCPA), pointed out at a recent PM Society event. So not much to fear then?

For those of you not familiar with the significance of the 1st May, I suggest you promptly download and familiarise yourself with the latest (very purple) copy of the ABPI code of practice. The updated 2011 code comes into full force on the 1st May, with the PM society event entitled ‘Are you ready for 1st May, review of the new ABPI code’ highlighting the key changes.

What prompted the change?

The code is updated regularly (usually every 2–3 years) with changes that are primarily based on experience of using the prior code (in this case the 2008 version). Considerations for amendments to the current code were in part due to a report from the Royal College of Physicians in 2009, which highlighted the practice of pharma gifts to doctors. The resulting media surrounding this practice prompted change in this area in particular.

"The updated 2011 code comes into full force on the 1st May…"

So what’s going to change?

Well in essence it already has changed. The 2011 code came into practice on 1st January but existing material can remain in use until the 30th April. After this date however the 2011 code must be in practice.

Essentially there are three key areas that will be changing with the implementation of the 2011 code:-

• A change to the use of promotional aids

• Joint working will be formally incorporated

• Levels of expenditure must be declared from pharma for:

o Payments and expenses of consultants

o Travel grants and registrations at congresses for sponsored events

o Grants to organisations

In practice, this means the following:

1. Branded scatter items will be banned

Pharma will now only be allowed to give gifts that support healthcare, bringing an end to branded freebies. Bad news for those storage containers full of branded pens and so forth. The overall idea is that no branded items are given to individual healthcare providers and that MEGS (medical and educational goods and services) can only now be given to practices as opposed to individuals with that practice. Plus, such items must be relevant to the practice of medicine.

Information can be given on a data stick, but of a storage size relevant to the data in question. For example, giving away a storage stick large enough to also be used to store holiday snaps is clearly not wise, but with no hard and fast rules the idea is be sensible. Also remember that all gifts to practices must involve a contract (see clause 18:4 of the code for further clarification).

"Pharma will now only be allowed to give gifts that support healthcare, bringing an end to branded freebies."

Another tricky area is that pens and notepads are fine as giveaways at meetings where there is a clear use for them, provided they are not product branded (they can be company branded), but what about on exhibition stands? And if not what can be given away at exhibition stands to attract visitors - is good old fashioned information going to cut the mustard? And speaking of mustard, that’s another thing that’s been canned, snacks on exhibition stands are no longer permitted so no more enticing people with Jamie Oliver’s latest recipe.

2. No branding in patient support programmes

Items for patients must be relevant to patient care and part of a formal support programme. They should be void of the product name unless it is necessary (e.g. an issue of safety) and be of no more than £6 in value. So an item that would help patients with their treatment is allowed and a physician may have one to demonstrate its use. These items also cannot be given out at exhibition stands (these exhibition stands are looking less and less appealing) although a display copy could be allowed for demonstration purposes. The lesson here really is to ask yourself how the item supports the patient – if you have a solid answer then you should be on safe territory.

3. Risk clarification on promotional materials

You won’t be surprised to learn that this is another tricky area. Although greater clarification has been given around the area of adverts, which should make life somewhat easier, there arises the question of claims. Relative risk can no longer be referred to unless supported by referral of absolute risk. So what becomes of older papers that use only relative risk – should reprints of such material be allowed to be sold and whose responsibility is this? Some questions still remain.

4. Greater transparency on sponsorship

Pharma must now clearly and unambiguously declare any sponsorship on any material relating to medicines and their uses whether promotional or not. There will also be transparency from 2013 regarding pharma spend in 2012 with regards to delegates, travel, accommodation, grants and use of consultants. This is true for all spend within the UK even where commissioned outside the UK. Actual registration fee declarations must be available whilst an estimate of accommodation and travel is allowed.

"Pharma must now clearly unambiguously declare any sponsorship on any material relating to medicines and their uses whether promotional or not."

And for all projects that are ongoing on the 1st May this year sponsorship of individual patient group projects (over £250) must be declared on the company website including amounts and details. Time will tell whether this improves the level of trust with the industry.

5. Joint working guidance

Joint working will be formally coming into play, whereby the NHS and a pharma company pool skills, experience or resources for the joint development and implementation of patient centred projects in the interest of patient care. It is essential that the collaboration benefits the patient and the outcomes must be measured. In addition, the agreement must be in writing, be declared on the pharma company’s website before the onset of the partnership and the outcomes must be later published. Furthermore, a significant contribution must be made by all parties involved.

But what about digital promotion?

Everyone seems to be carrying an iPad these days and pharma is keen to know how it can utilise digital channels, mobile technology and apps. With so many new platforms and social media channels the regulators really have their work cut out and reality is that formal guidance is likely to follow use rather than precede it. Whilst this may seem short-sighted at first glance, bear in mind that once something is in the code of practice it is very hard to get out and so very careful consideration must be given before changes are made.

However, the regulators want to know what pharma would like to do online that it can’t do under the current code. So the ball is back in pharma’s court to define who it wants to speak to digitally and what it wants to say, the gauntlet has been thrown down for the industry to be clear and vocal about what it needs guidance on.

Conclusions

Well, we learnt that exhibition stands won’t be too inviting anymore and will serve as primarily information centres from now on. Out with the gifts, but in with the interaction.

"…the regulators want to know what pharma would like to do online that it can’t do under the current code."

So, as we bid farewell to our branded pens and jazzed up exhibition stands, we have to question where next for the ABPI trust imperative? Well for starts they’ll be maintaining the code in time for the next update. The code is important in relation to HCPs perception of reputation, and the PMCPA are keen to strengthen and uphold the industry’s reputation.

However, it was clear from the questions at the event that the main concern of the audience was digital formats and a desire for clearer guidance. The response right now is to treat all digital communication as you would a paper message and it’s clear that the regulators still feel they need to understand this space better. The reality is that restrictions will probably only come into place in reaction to pharma making the first move and shaping this space. However, informal guidelines in this area have since been released.

In the meantime, let’s hope common sense prevails. Or, as the follow up email to the event puts it ‘it’s often a question of judgement and being able to demonstrate the right process and motive.’ So keep that in mind as you get ready for the 1st May.

About the author:

Rebecca Aris is Managing Editor of pharmaphorum, the exciting online discussion and networking site for the pharma, medical devices and diagnostics industry. For queries she can be reached through the site contact form.

The PMCPA Code Awareness Week 2011 is running from the 4th April to the 8th April.

Are you ready for the 1st May?