Many of the changes relate to even greater transparency, and include:
Companies will have to make publicly available a short description of their support for patient organisations for both financial and significant indirect support.
Sponsorship declarations must accurately reflect the nature of the company’s involvement.
It will be a breach of the code to fail to disclose details on ongoing clinical trials.
Companies will need to have a contract for health professionals and others employed as consultants, and are strongly encouraged to require consultants to declare this as an interest.
Companies are also encouraged to make publicly available information about donations and grants to institutions etc that support healthcare and research.
As well as changes based on the two codes of the European Federation of Pharmaceutical Industries and Associations (EFPIA), others include heightening awareness of the need for health professionals to report adverse drug reactions (ADRs).
“The ABPI Code of Practice is continually evolving to ensure that the pharmaceutical industry and its stakeholders can have maximum confidence in the standards set for ethical and responsible behaviour of companies and staff,” said Chris Brinsmead, President of the ABPI.
“In this, the 50th year of the ABPI Code of Practice, the ABPI has not only agreed to revisions to implement the new requirements of the EFPIA code – as we are obliged to do – but also made further amendments to reflect experience, comments and suggestions received since the introduction of the 2006 code.”
Other changes include:
More guidance about meetings and hospitality.
Additional limitations over the supply of samples.
The publication of interim case reports when publication of the final report is delayed because the company’s procedures require audit.
Advertisements for the outcome of certain cases will now appear in the nursing media as well as in medical and pharmaceutical journals.
The changes have been approved by the ABPI following consultation, and will come into effect on July 1 with a transition period. Comments, proposals and suggestions on the code are always welcomed and, where relevant, will be considered for possible inclusion.
A summary of the changes can be viewed online.
About the ABPI:
The Association of the British Pharmaceutical Industry (ABPI) has 150 members including the large majority of the research-based pharmaceutical companies operating in the UK, both large and small. Our member companies research, develop, manufacture and supply more than 80 per cent of the medicines prescribed through the National Health Service (NHS). For further information visit: www.abpi.org.uk
Media contact: ABPI Press office, 020 7747 1410.