New UK pharma code limits gifts but frees pharmacists
So, it’s now official – there will be a new code in 2011 and it goes live on 1st January. The proposals have been published by the Prescription Medicines Code of Practice Authority (PMCPA) for consultation, but of course by the time you read this the final decisions may have been made regarding the content and some aspects of this article may no longer be relevant. Therefore it is appropriate to separate what will almost certainly happen from some of the elements that are more likely to cause enough debate for a rethink. Be in no doubt, though – the Board of Management of the Association of the British Pharmaceutical Industry (ABPI) have already approved this set of proposed changes, so any amendments from this point are more likely to be tweaks than revolutionary alterations.
What is most interesting is what is (so far at least) absent. The proposed publications of honoraria payments and grants to HCPs and medical organisations have not (yet) materialized. Nor are there any proposed changes to clause 24, so as far as the regulations are concerned there is no direct guidance in relation to web 2.0 and the use of social media. Given the current discussions in Europe regarding information for patients, this may well be a political decision however that does not explain the absence of guidance for communications opposite an HCP audience. It looks like for this code at least, digital specialists will still be left to interpret the rules for themselves.
What we do know is that the recommendations of the Royal College of Physicians report from two years ago seem to have hit home. As from January, representatives will no longer be distributing scatter items. In fact what we know today as promotional items have all been banned. No mugs or pens, or pads or data-sticks or USB hubs or diaries. That’s right, not even diaries. Nor can pharma place adverts in diaries given out by anyone else. It is widely known that the outputs of the ABPI Trust initiative have concluded that the image of representatives and the industry must be enhanced by removing the impression of reps as distributors of small stationary items. It’s not as radical as it sounds however, as both the US and Canada banned pens and pads some time ago and their markets have not collapsed as a result of any negative reaction from customers. That said, hospitals and petrol stations all over the UK will now have to buy their own pens – the question is whether the budgets of the NHS and BP will be able to cope!
“It looks like for this code at least, digital specialists will still be left to interpret the rules for themselves.”
What representatives will be allowed to distribute are items related to formal patient support programmes. However, the previously allowed toys for the waiting room will now become a thing of the past.
There is not currently any sign of the Trust proposals to introduce co-funding of medical education programmes. Nor does pharma seem to be following the Medical Devices approach to sponsoring individual delegates to congresses (the Association of British Healthcare Industries (ABHI) Code states that the Med tech company can offer an individual HCP a place, but that HCP’s management can give it to someone else instead!).
The absence of the requirement to publish the honoraria payments and grants to HCPs is surprising since this was a core element of the Trust initiative, we understand that the intention is still there – it is just that discussions continue in order to find a method by which this can be achieved without crippling the administrative functions of the pharma companies. However the declaration requirements for Patient Groups have been tightened up so we know the direction that HCP funding transparency is likely to go in the future. For patient groups the requirement is now to publish the value of support provided, it is suggested that there is an indicated percentage of the patient group’s turnover, however this is not obligatory.
Joint Working has now formally been incorporated into the Code within clause 18. The rules are no clearer, however. The clause refers to the guidance document published by the ABPI working group 18 months ago, and clearly says that the guidance goes further than the code requires but fails to say which aspects. As with all developments in the code, case law will ensure progression, however it would be helpful to have more guidance to understand certain aspects more clearly. For example, how a company should manage the potential conflict of interest when deciding whether to pursue a project as a “Medical Education Goods and Services” (MEGS) where product return is not a valid consideration, and a Joint Working project, where return on investment is a fundamental requirement. How will an auditor ever know when a company has considered the return on investment of a proposal as a MEGS and Joint Working at the same time to see which suits its needs better? Joint Working has also been extended to incorporate partnership with private ventures.
“Joint Working has now formally been incorporated into the Code within clause 18. The rules are no clearer, however.”
For pharmacists, this edition of the code represents a landmark evolution. From January 1st 2011, pharmacists can legitimately be regarded as ‘medical’ signatories without the previous and burdensome requirement that they had to have worked on the product for at least 12 months. This means that a company can now move pharmacist medical signatories between products at will without having to remove their signatory status, which effectively means that pharmacist medical signatories are now a realistic mainstream option for the first time. It probably also means a reduction in the number of in-house medics and a reduction in the cost of engaging the services of contract medics – since pharmacists generally command lower rates. Before I upset any physicians, however, I should hastily add that plenty of other requirements for a fully-qualified physician remain!
No details have yet been released regarding the outcome of the proposals regarding the changes to the PMCPA’s constitution, however it is likely that the increase from 3-4 members of the panel will proceed – if only to free the current PMCPA employees from what appears to be an extremely high workload at present.
We will know the outcome of the proposals by the end of the Summer. In the meantime, please be assured that Compliance Hub is working hard to deliver training programmes (and pens) so we can help in any way we can!
The new code goes live on 1st January and any materials in circulation at that time can remain so until the end of April. In the meantime, readers are well advised to ensure 100% distribution of those 2011 diaries this side of Christmas…
About the author:
Steve Gray is Managing Director of Compliance Hub Ltd, and an established compliance professional. He can be reached at: firstname.lastname@example.org
Compliance Hub provides training and consultancy in respect of the ABPI Code of Practice. Visit www.compliance-hub.com to find out about their services and their 2011 Code package.
Does the new ABPI code provide a better and clearer framework for pharma?