Pharma industry treated to new code of practice
revealed a new code of practice for the pharmaceutical industry,
with an emphasis on patient safety especially material detailing
information about reporting adverse drug reactions.
The new code, set to come into effect on January 1, 2006, aims to revise the fundamental outline of the code following consultation with the public.
"We have listened to all these comments and taken action accordingly," said Vincent Lawton, President of the ABPI.
"The ABPI Code of Practice has been the gold standard for pharmaceutical industry regulation throughout the world for many years, and our aim was to ensure that it continued to be strong and effective as well as meeting changes and requirements that have occurred since the last review," said Andrew Hotchkiss, ABPI Board member and Managing Director of Lilly UK, who was in charge of the project.
Recent debacles concerning patient safety as well as questions concerning the dissemination of data and information of approved drugs have exposed loopholes within the code of practice that the ABPI has tried to rectify.
The key changes to the ABPI Code of Practice are mainly in safety, where the new code requires companies to include prominent information about adverse event reporting mechanisms on all promotional material.
This comes at a time when the Government is extending the 'Yellow Card' scheme so that patients across the country can report adverse effects, and will mean that all promotional material produced by companies will have to be changed.
The Code of Practice also sets out the definitions of what information can be supplied to the public to give more guidance and to clarify how companies may respond to patients' needs for reference information on medicines.
A reduction in the permitted number of pages of medicines advertising and an outright ban on all promotional competitions are introduced as is the promotion of prescription-only medicines to the public remaining strictly prohibited.
A new clause concerning relationships with patient advocacy groups is included. While companies are permitted to work with such groups, their involvement must be made clear, and rules on arrangements for meetings are the same as those for health professionals.
Companies must make public a list of all patient organisations to which they provide financial support, and a written agreement must be in place with every organisation spelling out terms of the relationship and funding of significant activity or co-operation.
"As well as the changes to the code itself, we want to ensure that more people and organisations know about it, its provisions and understand how it works," said Lawton.
"With this in mind, we are planning to create a new communications post within the Prescription Medicines Code of Practice Authority (PMCPA), which administers the code, and there will be a major campaign in the New Year to ensure that the code has as high a profile as possible."
Jeremy Mean, Senior Policy Manager at the Government regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said that the control of medicines advertising in the UK is based on a long-established system of self-regulation supported by the statutory role of the MHRA.
The MHRA's backing for the new code coincides with the publication of a joint memorandum of understanding between the ABPI, PMCPA and the MHRA.
The memorandum sets out the arrangements for the regulation of the promotion of medicines for prescribing in the UK, and is available on the MHRA website and the PMCPA.
