Code Advice

The publication of the recently updated ABPI Code of Practice for the Pharmaceutical Industry has been delayed.

The amendments to the Code were based on the anticipated changes to the new regulations (The Human Medicines Regulations 2012)which were due to be published last month and become law on 2 July 2012. These regulations are yet to be published. Once the regulations are finalised, the Second 2012 Edition of the Code will be made available.

Following a number of recent cases the PMCPA has issued guidance on the application of Clause 3 of the Code to various activities.

The guidance covers:

1. The provision of information about unauthorized medicines / indications
2. Promotion at international meetings held in the UK
3. Advance notification of new products or product changes
4. Guidance issued following Health Technology Assessments
5. Pharmaceutical company staff
6. Information to the public.

The Bribery Act comes into effect on 1 July 2011. The ABPI and the PMCPA have been liaising with the Serious Fraud Office (SFO) to present the perspective of the pharmaceutical industry and its self regulatory body.

The PMCPA has moved offices from 12 Whitehall to 7th Floor, Southside, 105 Victoria Street, London SW1E 6QT. All correspondence should be directed accordingly. All other lines of communication including,
telephone, email and fax remain unchanged.

The PMCPA has issued informal guidance on frequently asked questions about the 2011 Code.

The PMCPA has issued informal guidance on digital communications.  The new guidance highlights relevant Code requirements and includes questions and answers.  A copy of the guidance is provided below.

It is sometimes the case that, having been informed of the Code of Practice Panel’s ruling in a case, one or other of the parties will request further information from the Panel as to the reasoning behind its ruling. Occasionally amendments to the Panel ruling might be suggested.

The supplementary information to Clause 14.1 of the Code states that under co-promotion agreements whereby companies jointly promote the same medicine and the promotional material bears both company names, each company should certify the promotional material involved as they will be held jointly responsible for it under the Code.

The PMCPA aims to deal with all complaints under the Code in a timely manner. The following is intended to guide complainants so that their submissions will help the Authority in this regard.

Companies are reminded that the ‘Guidance on Appeal Procedures’ states, inter alia, that new material, ie material which has not been included in the papers submitted in relation to the case, cannot be introduced at the appeal hearing as set out in Paragraphs 7.4 and 7.5 of the Constitution and Procedure. Presentations at an appeal can only refer to data previously submitted, by either party, in writing to the Authority. It is unacceptable to introduce new material at the appeal hearing itself.