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The changing regulatory environment

Code of practice changes are encouraging transparency in pharma/HCP relationships

The changing regulatory environment

The changes in the Association of the British Pharmaceutical Industry (ABPI) Code of Practice, which came into force in January 2014, are perhaps more significant in relation to what they indicate about the changes in the environment in which pharmaceutical activity takes place, rather than changes in the practical implementation of this activity.

Most of the changes result from changes to the codes of the European trade body the European Federation of Pharmaceutical Industries and Associations (EFPIA). Such changes must be incorporated into each of the national codes in Europe, emphasising that the ABPI Code does not exist in isolation, but within a European framework, which is becoming increasingly more prominent and more demanding.

Almost all of the other changes are a result of specific requirements from UK regulatory body the Medicines and Healthcare products Regulatory Agency (MHRA), further emphasising the dependence of the ABPI Code, this time on legislation.

Key Code updates

EFPIA Code demands that industry declares all transfers of value to healthcare professionals and healthcare organisations

This update must be reflected across EU nation codes, including ABPI's Code of Practice

ABPI Code now requires companies producing patient-focused material for medicines to include information on reporting of adverse events and a black triangle symbol

EFPIA's changes focus on the relationship between industry and healthcare professionals and the organisation has made clear its ethical stance on the matter:

'EFPIA believes that interactions between the pharmaceutical industry and healthcare professionals have a profound and positive influence on the quality of patient treatment and the value of future research. At the same time, the integrity of the decision of a healthcare professional to prescribe a medicine is one of the pillars of the healthcare system. EFPIA recognises that interactions between the industry and healthcare professionals can create the potential for conflicts of interest.

'There is a growing expectation that interactions between corporations and society are not only conducted with integrity but are also transparent.'

These statements appear in the new EFPIA Disclosure Code 2013. This requires that, throughout Europe, there is transparency in relation to interactions between the industry and health professionals or organisations which involve any 'transfer of value'. A 'transfer of value' may be cash, or a benefit in kind – anything which could be considered to be of benefit to the recipient - which is provided in connection with the development or sale of medicines. It thus encompasses all activity, whether promotional or non-promotional.

This is without doubt the change that will have the most impact, as companies will have to make public any such transfers. The first disclosures will be in 2016, for transfers made during 2015:

  • To a healthcare organisation 
  • donations
  • grants
  • contributions to the costs of meetings 
  • fees for service/consultancy and related expenses
  • To a health professional 
  • contribution to costs of meetings – registration fees, accommodation, travel
  • fees for service/consultancy and related expenses.

There are already requirements in the ABPI Code for disclosure but the scope is less wide and crucially, disclosure is of aggregate amounts. From 2016, disclosure will be on an individual basis, meaning that a company will have to state that, for example, Dr A has been paid £X for speaker engagements, that Dr B has been given £X funding to attend meetings, that Hospital C received a grant of £X for a research nurse.

The mechanism of disclosure, at the time of writing, has not yet been determined. It is intended that there will be a central UK platform which will host data from all companies. It is clear however that companies will need to make significant efforts to set up systems which will comprehensively and accurately document transfers, and enable the necessary information then to be made public. Companies will also have to make sure that healthcare professionals and health organisations are aware of the need for – and reasons for – disclosure. This will be incorporated in all contracts and agreements, but it is likely that it will also need to be communicated clearly by any employee or agency who is engaging with recipients.

There will be no requirement to disclose details of subsistence – food and drink - provided to individual health professionals, but there is now an absolute limit of £75 for any meal (this includes food and drink, but not VAT or tips). It is emphasised that this level of hospitality could be justified only in exceptional circumstances.

One group of stakeholders is the focus of another change, this time required by MHRA. Now, when companies produce material about a medicine for patients who are taking that medicine, there must be a statement about reporting of adverse events, and if relevant, a black triangle. Although this may seem simply a rather technical change, it is important in that it recognises the increasing role which patients play in their own healthcare, and emphasises their importance as stakeholders in the wider healthcare system.

So, perhaps there is little in the new Code which will affect you on a day to day basis, but there is no doubt that you will be profoundly affected by the movement towards full transparency in relation to how the industry conducts itself in relation to its various stakeholders.

'EFPIA hopes that, by taking this step, it can enable public scrutiny and understanding of these relationships and thus contribute to the confidence of stakeholders in the pharmaceutical industry.'

The next few years will reveal whether or not this aim has been achieved.

Article by
Dr Joan Barnard

is managing director of consulting firm Code in Practice. Her books, The Code in Practice and The Code in the Field, have been updated in line with the 2014 ABPI Code. Contact her on email via joan@codeinpractice.co.uk

23rd April 2014

Article by
Dr Joan Barnard

is managing director of consulting firm Code in Practice. Her books, The Code in Practice and The Code in the Field, have been updated in line with the 2014 ABPI Code. Contact her on email via joan@codeinpractice.co.uk

23rd April 2014

From: Marketing, Regulatory

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