Code of practice: the main changes: Tim Worden, an IP lawyer at European law firm, Taylor Wessing, reviews the revised ABPI code of practice.

The UK Association of the British Pharmaceutical Industry's Code of Practice for the Pharmaceutical Industry (the Code) celebrated its 50th anniversary in October 2008, having started life as a two-page document on 2 October 1958. The Code has also been revised with effect from 1 July 2008, although there was a transition period until 31 October 2008.

Why the Changes?

The principal reason for the amendments to the previous (2006) version of the Code is to ensure compliance with the new EFPIA "Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organizations" and a revised and updated version of EFPIA's Code on the Promotion of Prescription--Only Medicines. The main changes required by the two EFPIA Codes relate to

* relationships with patient organizations

* relationships with healthcare professionals

* non-interventional studies.

Relationships with patient organizations: The requirement to have in place a detailed written agreement with a patient organization has now moved from the Code's supplementary information to the main body of the Code (Clause 23.3). The Code sets out what such agreements must include, such as the roles of the parties and their anticipated activities. A company may not require that it be the sole funding body of a patient organization or any of its major programmes, and must not seek to influence the text of patient organization material to favour its own commercial interests. By 31 March 2009, a company must make available a list of all patient organizations to which it provides financial support or significant indirect or non-financial support, including a short description of the nature of the support. Any sponsorship must be acknowledged from the outset and "must accurately reflect the nature of the company's involvement."

Relationships with healthcare professionals: A new Clause (20) sets out the points for a company to consider when engaging a healthcare professional, as an advisory board member, for example. A written agreement must be in place and the consultancy arrangement must be a genuine one.

Non-interventional studies: A new Clause (13) includes a definition of a "non-interventional study," which, in general terms, is a prospective study on a marketed medicine used in accordance with its marketing authorization. The Code "encourages" companies to publish the results of such studies in the same manner as clinical trials.

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Other Changes

In relation to the briefing of sales representatives, companies are encouraged to distinguish between "expected call rates" and "expected contact rates." The 2006 version of the Code states that a representative should "not normally" exceed, on average, three calls to a doctor per year. The Code now clarifies that certain contacts between representatives and doctors will not be regarded as calls, such as contact at group meetings or visits in response to specific enquiries. The provisions on the promotion of medicines that are not licensed in the UK at international meetings held in the UK have been made more stringent. Before 1 July, the relevant medicine needed to be authorized in another major industrialized country and a significant proportion of the meeting attendees needed to be from outside the UK. There is now an additional condition that a significant proportion of the attendees are from countries outside the UK in which the product is licensed.

The Code sets out when samples of a medicine can be provided to a healthcare professional. A new provision states that samples may not be provided of any medicine that has been on the UK market for more than 10 years. The 2006 version of the Code contained a blanket prohibition on quizzes and competitions as methods of promotion. The new Code now includes a limited exception for the use of quizzes at promotion meetings, where the quiz is used to gauge the attendees' knowledge of the topic at the meeting. No prizes can be offered. Where information on a company medicine for the general public is provided on a company website that also includes promotional material for healthcare professionals, there is no requirement to restrict access to the healthcare professional material, provided that the intended audience for each set of information is clear. An amendment to the Code also clarifies that the provisions on frequency of promotional "mailings" to healthcare professionals (including the cap of 8 mailings per year for a particular medicine) does not apply to e-mails. Promotional e-mails can only be sent with the prior consent of the recipient.

Next Moves

All promotional materials should be reviewed to ensure they comply with the new Code, and written arrangements with patient organizations and consultants should be in place. While many of the changes are clarificatory in nature, other changes, including those key ones driven by the EFPIA Codes, may require considerable resource to be put in place.

For more information

Tim Worden is a senior associate in the Cambridge office of the law firm, Taylor Wessing LLP. He specializes in transactional, non-contentious and regulatory intellectual property in the life sciences and healthcare sectors ([e-mail]).