Changes to industry code of conduct in UK
Changes to the UK pharma industry's Code of Practice are to be introduced as part of pan-European reforms to make dealings with healthcare professionals more transparent.
The UK's industry association the ABPI and the self-regulatory body the PMCPA have just published a consultation on a series of amendments and additions to the existing Code.
However the European changes are not the only spur for the consultation - proposals for amendments have also arisen from work done by a group established by the ABPI Board to review the Code.
Finally, there is a third source of proposed amendments: changes to UK law aimed at reducing red tape will also need the industry Code to be updated.
The changes at European level are based on a new pan-European Code agreed by industry organisations on 6 June, and co-ordinated by Europe's industry association, EFPIA.
The new regulations go by the title of 'Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations' and correspond closely with US regulations known as the Physician Payment Sunshine Act. The new European rules centre on detailed disclosure of payments to doctors and other healthcare professionals – and are ultimately aimed at clearing up suspicions of inappropriate payments to doctors from the industry.
Updates to reflect electronic marketing
Among the many proposed amendments are a few significant ones which reflect the growing use of electronic marketing. Amendment 31 proposes supplementary information added to Clause 9.9 of the ABPI Code relating to prior permission for a promotional phone call, webchat or online call.
It suggests permission must be obtained in these circumstances, and full details of the company the caller will represent, their role and the purpose of the call must also be supplied in advance. Arrangements made to discuss a specific product should be adhered to.
Elsewhere, an existing clause which stipulates that print media that appears personalised is outlawed is also set for amendment. The amendment would read: 'Similarly, promotional material sent electronically such as emails must not give the impression that it is non-promotional. In addition the identity of the responsible pharmaceutical company should be obvious.'
Branded gifts
There has been a tightening-up on stationery branded with the names of companies and drug brands in recent years, and this will now be updated to reflect the new EFPIA Code.
Clause 18.3 Notebooks, Pens and Pencils will be amended to make clear that any pens and pads provided in conference bags at third-party organised events must not include the names of the donor companies, the name of any medicine or any information about medicines.
Making joint working easier
One of the changes arising from the UK reviews is an easing of the paperwork needed for pharma in joint working projects with the NHS.
The amendment relating to Clause 18.5 Joint Working Supplementary Information states:
'Only the final documents etc for any joint working project need be certified. All documents etc used during the development of the project should be capable of being certified but there is no requirement to certify such materials.'
The ABPI's Review Group says this change will help ease the certification burden without affecting the quality of such agreements.
Services provided to NHS – product related and non-product related
Pharmaceutical companies are increasingly offering services to the UK's health service, in an effort to meet the needs of their customers above and beyond the supply of medicines.
The UK review has suggested amendments aimed at clarifying the rules around these services – either directly or indirectly related to the medicines supplied.
The ABPI says services linked to the use of specific medicines can be provided under the rules laid out in Clause 18.1 of the Code.
The amendment states: 'Such services can be provided only to NHS and other organisations and there must be no direct or indirect personal financial gain or other advantage to any individual or GP practice and the like.'
On services not directly related to their medicines, the ABPI says an example might be the provision of a smoking cessation service linked to the purchase of a medicine for COPD.
The consultation document says: 'In some areas NICE, AWMSG or SMC [three cost effectiveness bodies operating in the UK] will endorse a number of products and encourage prescribers to decide which to use based on cost. The provision of a service related to a product could be taken into account in that decision making process.'
It continues that for products not covered by NICE, AWMSG or SMC guidance/guidelines, relevant independent guidelines from a national medical organisation such as a royal college can be used as a basis for providing product related services.
Whatever the nature of the services proposed, the ABPI makes it clear that the development of guidance/guidelines from a national medical organisation must not be funded by a pharmaceutical company, and must support high quality clinical care.
Central platform for disclosure
The new European rules mean that a new central platform for disclosing payments will be established. UK companies must use this platform, and not their own websites, and must also use a template supplied by the PMCPA. All of the relevant documents and templates can be found here.
New Code from January 2015
The proposed amendments were sent to ABPI members and other relevant stakeholders on 11 July, and the consultation will run until Friday 5 September.
The outcome of the consultation will then be reviewed by the ABPI Board of Management in October and the ABPI Half-Yearly General Meeting in November, with the new Code coming into force on 1 January 2015.
